Download pdf - DR AMBEDKAR DISSERTATION

THE TAMIL NADU DR.AMBEDKAR LAW UNIVERSITY

CHENNAI

PATENTING ON LIVING ORGANISMS: POLICY ISSUES

CONCERN AND INTRENATIONAL TRENDS

DISSERTATION SUBMITTED TO

THE TAMIL NADU DR. AMBEDKAR LAW UNIVERSITY

IN THE PARTIAL FULFILLMENT OF THE REQUIREMENTS FOR

THE COMPLETION OF THE DEGREE OF

MASTER OF LAW

IN

INTEELECTUAL PROPERTY LAW

UNDER THE GUIDANCE AND SUPERVISION OF

Dr.A.RAGHUNADHA REDDY,M.L.,Ph.D.,M.B.A

HoD, Dept. of International Law & Organisation, HoD i/c, Dept. of

Intellectual Property Rights.

Submitted by:

G.SILAMBARASAN

REG. No: ILP1214

BATCH: 2013-2014

THE TAMIL NADU DR. AMBEDKAR LAW UNIVERSITY

POOMPOZHIL, #5, GREENWAYS ROAD, CHENNAI – 600 028.

DECLARATION

I do hereby declare that the Dissertation work titled “PATENTING ON LIVING

ORGANISMS: POLICY ISSUES AND CONCERN INTERNATIONAL TRENDS

”has been prepared by me under the eminent supervision and guidance of

Dr.A.RAGHUNADHA REDDY,M.L.,Ph.D.,M.B.A HoD, Dept. of

International Law & Organisation, HoD i/c, Dept. of Intellectual

Property Rights. Post Graduate Department, The Tamil Nadu Dr. Ambedkar

Law University, Chennai – 28, and this work has not been submitted elsewhere

for any other degree or diploma or fellowship or any other title to any candidate

of any university.

Place: Chennai G.SILAMBARASAN

Date: M.L.,

INTELLECTUAL PROPERTY LAW

Dr.A.RAGHUNADHA REDDY,M.L.,Ph.D.,M.B.A.

HoD, Dept. of International Law & Organisation,

HoD i/c, Dept. of Intellectual Property Rights.

Tamil Nadu Dr. Ambedkar Law University, Chennai – 28.

CERTIFICATE

This is to certify that this Dissertation entitled “PATENTING ON

LIVING ORGANISMS:POLICY ISSUES AND CONCERNS INTERNATIONAL

TRENDS ” is an original work of G.SILAMBARASAN in partial fulfillment

of the requirement for THE DEGREE OF MASTER OF LAW in

INTELLECTUAL PROPERTY LAW during the academic year 2013 – 2014

under my guidance and supervision in the Post Graduate Department of Law,

The Tamil Nadu Dr. Ambedkar Law University, Chennai – 28. This

Dissertation work has not been submitted elsewhere for any other degree.

Place: Chennai

Date:

ACKNOWLEDGMENT

First and foremost I thank ALMIGHTY for blessing me with enormous strength

and knowledge to complete this Dissertation work successfully.

The outcome of this present Dissertation work has been possible only with the help of the

support, inspiration and academic assistance from various people. I express my heartfelt

thanks to my Prof. Dr.A.RAGHUNADHA REDDY,M.L.,Ph.D.,M.B.A. HoD, Dept. of

International Law & Organisation, HoD i/c, Dept. of Intellectual Property Rights.The

Tamilnadu Dr.Ambedkar Law University, Chennai, for his scholarly guidance and

inspiration. With deep sense of gratitude, I render my hearty thanks to my Tmt. Lucky

George Assistant professor, The Tamil Nadu Dr. Ambedkar Law University, Chennai,

for her valuable guidance and support given to me at every stage of my Dissertation work.

I am also thankful for the assistance provided by the staffs of The Tamil Nadu

Dr.Ambedkar Law University Library, Connemera Public Library, Egmore and Anna

Centenary Library, kotturpuram, Chennai, in completing my Dissertation work.

Finally, I am grateful to my beloved parents and friends, who have always inspired

me and whose affection and blessings has always been my guiding beacon.

CONTENTS

CHAPTERS

CONTENTS

PAGE NO

CHAPTER 1

INTRODUCTION

10-24

CHAPTER 2

ORIGIN AND DEVELOPMENT OF

RESTORATIVE JUSTICE

25-51

CHAPTER 3

RESTORATIVE JUSTICE IN

INTERNATIONAL SPHERE

52-77

CHAPTER 4

VICTIMS AND RESTORATIVE JUSTICE

78-99

CHAPTER 5

RESTORATIVE JUSTICE: A CRITICAL

ASSESSMENT

100-127

CHAPTER 6 CONCLUSION AND SUGGESTIONS 128-132

BIBLIOGRAPHY

133

WEBLIOGRAPHY

134

List of abbreviations

1. CBD - Convention on Biological Diversity

2. DNA - Deoxyribonucleic Acid

3. EC - European Community

4. ECJ - European Court of Justice

5. EPC - European Patent Convention

6. EPO - European Patent Office

7. EU - European Union

8. IPC - Intellectual Property Code

9. IPRs - Intellectual Property Rights

10. GATT - General Agreement on Tariffs and Trade

11. GMO s - Genetically Modified Organisms

12. IPRs - Intellectual Property Rights

13. UK - United Kingdom

14. UNCTAD - United Nations Conference on Trade and

Development

15. The UPOV - convention The International

Convention for the Protection of Varieties of Plants

16. WIPO - World Intellectual Property Organisation

17. WTO - World Trade Organisation

18. EC - The council of the European

community

19. EFB - The European Federation of

Biotechnology

20. EST - Essential sequence tags

21. HUGO - Human genome organization

22. ICMR - Council of Medical Research

23. A - Adenine

24. Cdna - Complementary DNA

25. CSIR - Council of Scientific and Industrial

Research

26. G - Guanine

27. GM - Genetically Modifed

28. GMO - Genetically Modified Organism

29. HBGF - Heparin Binding Growth Factor

30. HIF - Gamma: Human Immune Interferon

Gamma

31. Hgh - Human Growth Hormone

32. hINV - Human Involucrin Gene

33. HN - Hemagglutinin-Neuraminidas

34. IFN - Interferon

35. IGF - Insuling-like Growth Factor

36. IPC - International Patent Classification

37. IPO - Indian Patent Office

38. JPO - Japanese Patent Office

39. kd - Kilo Dalton

40. mRNA - messenger RNA

41. M.W. - molecular weight

42. MPPP – Manual of Patent Practice and Procedure

43. NDA - New Drug Application

44. NDV - Newcastle Disease Virus

45. NIH - National Institute of Health

46. OECD - Organization of Economic Cooperation and

Development

47. ORF - Open Reading Frame

48. PCK - Polycystic Kidney

50. PCT - Patent Cooperation Treaty

51. PTO - US Patent and Trademark Office

52. PTP - Protein Tyrosine Phosphatase

53. PTP-PEST -Protein Tyrosine Phosphatases - Proline (P),

Glutamic acid (E),

Serine (S) and Threonine (T)

54. rDNA - Recombinant DNA

55. rEpo - gamma Erythropoietin

56. RFLP - Restriction Fragment Length

Polymorphism

57. RNA - Ribonucleic Acid

58. RT - Reverse Transcriptase

59. SDS-PAGE - Sodium Dodecyl Sulphate

Polyacrylamide Gel Electrophoresis

60. SNP - Single Nucleotide Polymorphism

61.STS - Sequence Tagged Sites

62.T - Thymine

63.T-DNA - Transferred DNA

64.TI - Tumor Inducing

65.TM - Trans Membrane

66.TRIPs - Agreement on Trade Related Aspects of Intellectual Property

Rights

67.tRNA - Transfer RNA

68.U - Uracil

69.UK - United Kingdom

70.US - United States

71.USA - United States of America

72. USC - United State Code

73. USCA - United State Code Annotated

74. USPQ - United States Patent Quarterly

75. USPTO or PTO - United States Patent and Trademark Office

76. WARF - Wisconsin Alumni Research Foundation

77. WIPO - World Intellectual Property Organization

78. YAC - Yeast Artificial Chromosome

79. PCR - Polymerase Chain Reaction

80. uEPO - mew Erythropoeitin

PREFACE

This work has been carried out as a part of completion of masters’ degree focusing

on the rights of victims in the criminal justice system. The presentation of a paper on,

Victim’s Rights: Discarded Under Indian Criminal Justice System, in the National

Criminological Conference held in Dr. Ambedkar Law University, Chennai, has inspired

me to work more on the plight of crime victims. On studying the victims’ rights and issues

in India, I came to understand that except the victim compensation scheme and the

compounding of offences there is no specific provision to deal with the participation of

victims in criminal proceedings. The thought of doing a research in this area has been

lingering my mind for a year, till I get the opportunity of working on it in my dissertation.

As the research work started with operating on restitution and reparation for crime victims,

it is my guide who introduced me the term called “Restorative Justice” and advised me to

concentrate on it. When I started searching resources on it, I found the development and

practice of restorative justice in other countries to a great degree.

As a victim-centred justice the models adopted to address the interests of crime

victims is excellent and notable. The time and cost incurred in conventional criminal trials

can be evaded by applying restoration ideals and principles. It can be stated that restorative

justice is a best alternative to the traditional criminal trial. My research work centred on

analyzing the principles of restorative justice, its practice in international arena, its impact

on crime victims, offenders and community, its benefits and limits and finally conclusion

with some suggestions. In India adopting the concept of restorative justice will help in

facing the challenges posed by the failures in present criminal justice administration and

the same can be implemented along with the existing criminal court process in the

adjudication of criminal matters.

TABLE OF CASES

1.European Court in Relaxin case.

2. In Amgen v. Chugai pharmaceuticals

3. Graham's case

4. Biogen v. Medeva.

5. Kirin-Amgen Inc. v. Roche Diagnostics GmbH

6. KSR Intl' Co. v. Teleflex Inc.31 the United States Supreme Court

7. Dimminaco A.G v. Controller of patent and design,

CHAPTER 1

1.1 INTRODUCTION

1.2 DEFINITION AND MEANING OF BIOTECHNOLOGY

1.3 HISTORICAL DEVELOPMENT OF BIOTECHNOLOGY

1.4 PATENTABLITY OF BIOTECHNOLOGY INVENTIONS

CHAPTER 2

2.1 INTERNATIONAL STANDARDS AND POLICY ISSUES

2.2 INTERNATIONAL TREATIES

CHAPTER 3

3.1POSISITION IN USA

3.2 EVOLUTION OF BIOTECHNOLOGY IN US

3.3 PATENTING OF PLANTS

3.4 PATENTING OF ANIMALS

3.5 PATENTING OF MICRO ORGANISMS

3.6 PATENTING OF HUMAN CELLS AND GENETIC MATERIAL

3.7 PATENTING OF FRAGMENTS OF DNA AND GENES

3.8 PATENTING OF BIOTECHNOLOGY PROCESSES AND METHOS

3.9 ISSUES

CHAPTER 4

4.1 POSISTION IN EUROPEAN UNION

4.2 EVOLUTION OF BIOTECNOLOGY IN EUROPEAN UNION




4.6 PATENTING OF HUMAN CELL AND GENETIC MATERIAL

4.7 ISSUES

CHAPTER 5

5.1 POSISITION IN INDIA

5.2 EVOLUTION OF BIOTECHNOLOGY IN INDIA

5.3 PATENTABLITY SUBJECT MATTER IN INDIA



CHAPTER 6

6.1COMAPARATIVE STUDY IN USA,EUROPEAN UNION AND INDIA

6.1. USA

6.2. EUROPEAN UNION

6.3.INDIA

CHAPTER 7

7.1 CONCLUSION AND SUGGESTIONS

7.2 BIBLIOGRAPHY

7.3 WEBLIOGRAPHY

CHAPTER 1

1.1 INTRODUCTION

The term ‘biotechnology’ is a combination of two words ‘bios’, which

means life. ‘Technology’ means application of scientific knowledge for

practical purposes to get desired results. Biotechnology means the scientific

knowledge that uses life or living entities like micro-organisms, plants, and

animals for practical and commercial purposes to get desired results.

Biotechnology is defined in numerous ways in different terms however there

is no universally accepted definition. Biotechnology is very dynamic and

progressing rapidly therefore, it is not possible to define biotechnology- in

exact terms. There are many definitions of biotechnology and yet there is

more confusion as to what it is and what is involved in the practical activity.

Many organizations and working parties have published reports where an

attempt has been made to define biotechnology. The United Nations congress

office of technology assessment defines biotechnology to mean any technique

that uses living organisms to make or modify a product to improve plants or

animals or to develop micro-organisms for specific uses. The European

Federation of Biotechnology (EFB) considers biotechnology as the integration

of natural sciences and organisms, cells, parts thereof, and molecular

analogues for products and services. British biotechnologists define

biotechnology as an application of biological organisms system or processes

to manufacturing and service industries. Japanese biotechnologists define

biotechnology to means a technology using biological phenomena for copying

and manufacturing various kinds of useful substances.

1.2 DEFINITION AND MEANING OF BIOTECHNOLOGY

The term ‘biotechnology’ is a combination of two words ‘bios’, which means

life. ‘Technology’ means application of scientific knowledge for practical

purposes to get desired results. Biotechnology means the scientific knowledge

that uses life or living entities like micro-organisms, plants, and animals for

practical and commercial purposes to get desired results. Biotechnology is

defined in numerous ways in different terms however there is no universally

accepted definition. Biotechnology is very dynamic and progressing rapidly

therefore, it is not possible to define biotechnology- in exact terms. There are

many definitions of biotechnology and yet there is more confusion as to what

it is and what is involved in the practical activity. Many organizations and

working parties have published reports where an attempt has been made to

define biotechnology. The United Nations congress office of technology

assessment defines biotechnology to mean any technique that uses living

organisms to make or modify a product to improve plants or animals or to

develop micro-organisms for specific uses. The European Federation of

Biotechnology (EFB) considers biotechnology as the integration of natural

sciences and organisms, cells, parts thereof, and molecular analogues for

products and services. British biotechnologists define biotechnology as an

application of biological organisms system or processes to manufacturing and

service industries. Japanese biotechnologists define biotechnology to means a

technology using biological phenomena for copying and manufacturing

various kinds of useful substances.

However, biotechnology is broadly defined as any technique that uses living

organisms or parts of organisms to make or modify product to improve plants

or animals or to develop micro- organisms for specific uses. It is not a single

technique but a combination of different techniques used to manipulate living

organisms in directed fashions. Perhaps biotechnology is multi-disciplinary in

nature, a series of advanced technologies spanning biology, chemistry, bio-

chemistry, micro-biology protein engineering, process engineering, and

genetic engineering put together and collectively called as biotechnology in

other words biotechnology means the application of technology or scientific

knowledge to the biological process. It involves human intervention to the

natural biological process by way of technical contribution to arrive at desire

results therefore biotechnology is an application of human invented

techniques to natural biological process. The invention biotechnology or

called biotechnological invention is define to means, any invention which is a

product consisting or containing biological materials or process by means of

which biological material is produced, process or used.

1.3 HISTORICAL DEVELOPMENT OF BIO-TECHNOLOGY

In 1919 Karl Erkay, a Hungarian engineer, coined the term bio-technology. At

that time the term biotechnology encompassed the production of desired

goods from raw materials with the aid of living organisms. Basically,

biotechnology is a study relating to the application of technology to living

organisms or their components. Historically, biotechnology was an art,

involved in the production of wine, beer, and cheeses. Today, it involves a

series of advanced technologies spanning biology, chemistry, biochemistry,

microbiology, protein engineering, process engineering, and genetic

engineering. In recent years innovations involving genetic engineering have

had a major impact on biotechnology. The story of the use of biological

systems for the fulfillment of human needs perhaps started in 6000 BC. In

fact, biotechnology can be traced back to approximately 6000 BC when

Sumerians and Babylonians first used yeast to make beer. Egyptians were

baking leavened bred by 40000 BC and in China fermentation processes were

discovered for preserving milk by lactic acid bacteria to make yogurt to

produce cheeses. Beginning with fermentative use of biological processes,

many changes experienced over the centuries. Modern biotechnology can be

traced back to the eighteenth century when smallpox was cultured to invoke

an immune response and prevent development of more serious diseases later

in life. During the eighteenth century cross-fertilization was discovered and

crop rotation was practiced to increase yield. The process of sterilization was

also discovered during the eighteenth century.

In the nineteenth century, Louis Pasteur, known as the father of

biotechnology, demonstrated fermentative ability of micro-organisms. During

that time epidemiological observations were used to develop the hypothesis of

cross-infection by spread of childbirth fever from mother to mother by

physicians, which led to the practice that physicians wash their hands after

examining each patient. Another milestone during the nineteenth century was

the invention of a process of beer fermentation by Louis Pasteur in 1873. He

proved that microbes were responsible for fermentation. He also invented the

pasteurization process, which involves heating wine sufficiently to deactivate

microbes. In the 1940s complicated techniques were introduced for mass

cultivation of micro-organisms to exclude contaminated micro-organisms. In

fact, Gregor Mendel’s presentation of the law of heredity, development of

Pasteur’s rabies vaccine, discovery of chromosomes, discovery of the

protozoan plasmodium as a cause of malaria, and the investigation of anthrax

were all milestones in the development of biotechnology.

But the greatest revolution took place in the 1970s and 1980s when product of

interaction between the science of biology and technology came into wider

existence and the relationship got the name biotechnology. Modern

biotechnology has got its roots in the early 1980s when recombinant DNA

technology or genetic engineering developed modern biotechnology is more

concerned with genetic engineering. Commercial production of human insulin

through recombinant DNA technology in the United States showcased the

potential of recombinant DNA technology. The development of process

engineering and protein engineering that involves methods of protein

production through recombinant DNA technology adds another feather to the

wings of modern biotechnology. The development of biotechnology can be

classified into three generations.

First generation of biotechnology

The first generation of biotechnology is based on empirical practice and

minimal scientific or technical inputs. These techniques date back to the Stone

Age and involve using of biological organisms such as bacteria, yeasts,

enzymes, and traditional methods of fermentation to produce food and drink

such as bread and wine. Production of cheese and beer by using micro-

organisms was the milestone of this generation.

Second generation of biotechnology

This generation began during the interwar period when developments in

fermentation technology using pure cell culture and sterile manufacturing

facilities began to yield new products. During this generation innovations such

as acetone, butanol, glycerol, vitamin B2, citric acid, and lactic acid took

place. The invention of penicillin in 1928 was the milestone of the second

generation.

Third generation of biotechnology

Three important technologies, namely, tissue cell culture, Hybridoma

technology, and recombinant DNA technology also known as genetic

engineering were developed in the third generation. These three technologies

represent modern biotechnology. Tissue culture technology is used to

establish cell lines, which are used for medical diagnosis and treatments.

Hybridoma technology is used in the production of human monoclonal

antibodies, which are used to supplement natural human antibodies in medical

treatments.

The invention of DNA by Crick and Watson in 1953 was the turning point in

the third generation of biotechnology. The recombinant DNA technology is

the technique that involves manipulation of genetic materials of a living being

to get desired results. Indeed it is recombinant DNA technology which

brought biotechnology into limelight. Modern biotechnology is defined on the

basis of genetic engineering. The inventions of biotechnology are playing a

vital role in the industrial sector. Most of the biotechnology inventions fall in

the sphere of food, agriculture, and medical industry. Certain inventions of

biotechnology fall in the sphere of forestry, environment, energy, and

chemistry.

Biotechnology is an inter-disciplinary pursuit and it is multi-disciplinary in its

application. The term multidisciplinary describes a quantitative extension of

approaches to problems that commonly occur within a given area. Recently a

characteristic feature of the development of science and technology has been

the increasing resort to multidisciplinary strategies for the solution of various

problems. One such idea of multidisciplinary pursuit has resulted in the

crystallization of a new discipline called biotechnology. Being

multidisciplinary, biotechnology involves the marshalling of concepts and

methodologies from a number of separate disciplines and applying them to a

specific problem in another area. Besides, biotechnology has diverse

application in different fields. The successful application of biotechnology

depends upon the cooperation of the experts in different fields. The scope and

application of biotechnology is increasing day-by-day. Earlier biotechnology

was limited to fermentation of beer, but today it is significant in

revolutionizing certain areas of industry such as agriculture, animal

husbandry, medical and pharmaceutical industry, forestry, fisheries,

environmental protection, chemical industries, food, beverages, and many

others. In order to understand the scope and significance of biotechnology it

would be proper to discuss its application in different fields.

Agriculture and biotechnology

Agriculture is a sector which feeds the hungry of the world. The produce of

the sector is used at least twice or thrice a day by everyone. For many

economies including India agriculture sector is the backbone. The demand for

high production in the sector is increasing day-by-day, as there is increase in

the population. In order to meet the demand of the increasing population, there

should be increased production. Further, directly or indirectly, the industrial

sector also depends on the agriculture sector for raw material. Therefore,

demand for increased production in the agriculture sector is very much felt. In

ancient times agriculturists were practicing different methods to increase

production, e.g., changing crop in order to avoid continuous cropping of the

same crop, crossing, budding, grafting, and tissue culture. However,

application of biotechnology in the agricultural sector is giving rise to

revolutionary changes in the filed promising to yield good results. Today in

the era of biotechnology these traditional methods have been replaced by

methods such as genetic engineering, yielding the best results.

There are many plants that grow withstanding water shortages and a few

plants that resist pests and weeds. Further, there are plants that give high yield.

How would it be if plants in drought areas could grow with minimum use of

water. How would it be if regular crops could show resistance to pests and

weeds? How would it be if regular crops could give higher yield? It is just not

an imagination but very much in the realm of possibility through

biotechnology. Biotechnology through genetic engineering, a willow in its

armoury, is promising to produce such super crops with desired qualities. Any

crop or plant could be engineered for desired results. By manipulating the

genome of plants, genes coding for certain features like resistance to pests,

weeds, herbicides, and tolerance to drought conditions, high-yielding genes

could be isolated and incorporated into an intended crop. This technique of

isolating and incorporating genes is called genetic engineering. It involves

marshalling of genes to manifest characteristic features of plants in order to

get better and improved crops bestowed with desired characteristics.

This technique of marshalling genes birth to genetically engineered plants

with qualities such as high yield, capacity to result pests, insects and weeds

and also capacity to withstand drought conditions. If an engineered plant gives

higher yield that the regular plant at the same cost of production, it will

definitely benefit the farmer as well as the society. Further, a plant that is

resistant to insects, weeds, pests, and herbicides will reduce the cost of

production. It is estimated that 20 to 40 per cent of the world’s agricultural

production is lost due to pests, weeds and diseases and additional 40 per cent

would suffer the same fate without pesticides application. The global estimate

of loss due to plant diseases in 1987 was approximately US $ 90 billion.

Therefore, biotechnology, capable of producing crops that are featured to

result viruses, pests, and weeds, plays a vital role in modern-day agriculture.

In the developed countries the impact and application of biotechnology in the

agriculture sector is highly felt. In the United States of America fifteen

transgenic plants were given market permission in 1995. Another thirteen

plants were awaiting permission. In Europe reportedly 496 transgenic plants

were released during 1986-94. Slowly but gradually, the developing world is

caching up with the developed world. In India some field trials of transgenic

plants were conducted during 1995-96. A few multinational companies, active

in the agriculture sector, have tie-ups with Indian companies like Proagro

Seed and Mahyco Seed. In fact, Mahyco Seed Company is conducting trials

on imported BT cotton in India. Recently, Novavax, an American biotech

company, tied up with Bharath Biotech Company based in Hyderabad. Many

multinational companies are showing interest in tie-ups with Indian

companies and are intending to open their branches in India. It is a healthy

sign for the development of biotechnology in India. Application of

biotechnology has increased production levels and decreased the cost of

production. biotechnology produce engineered crops like BT cotton, BT rice,

BT soybeans, BT wheat, BT tomato, and BT potato. Compared to regular

crops, genetically engineered wheat and rice are said to yield up to 30 per cent

more under same cultivation conditions. It is evident that genetically

engineered plants are capable of giving better quality, higher yield, and

resisting pests and weeds. Therefore, the application of biotechnology in the

sector is yielding fruitful results.

Animal husbandry and biotechnology

In the field of animal husbandry application of biotechnology tends of

produce high yield of milk, and wool. Biotechnology is being applied in the

animal husbandry through tissue culture, cloning, and genetic engineering.

Tissue culture involves isolating and culturing of cells or organ of an animal

in vitro (outside the body) for a desired result. Tissue culture in animals is

useful in testing drugs and medicines. Cloning involves developing the replica

of a living being through isolating some tissue or cell of the original living

being and developing the same into a complete living being which resembles

the original. Dolly, the most popular sheep in the world, to a sequel of

cloning. Genetic engineering of animal involves isolation of specific genes

coding for certain characteristics and incorporation and expression of the same

in an intended animal to get desired results. We have seen hybrid animals

produced through crossing of two different animals with different genetic set

up. Crossing a disease-resisting animal with a high milk yielding animal may

result in offsprings possessing both the desired qualities of disease resistance

and high milk yield. Now genetic engineering is proving even more useful to

get desired results in animal husbandry.

A few animals resist diseases but are incapable of giving high yield of

mil, flesh or wool, whereas animals that give high yield of milk, flesh or wool

but are incapable of resisting diseases. How would it be like if the same

animal possesses both the features, viz. resisting diseases and giving high

yield as well. Genetic engineering, a sub-discipline of biotechnology,

promises to materialize such a dream in animal husbandry. Genetic

engineering made it possible to isolate the genes coding for specific

characteristics from different animals and to incorporate the same into an

intended animal. For example, gene coding for high yield can be isolated and

incorporated into an animal possessing both the characteristics. Through this

technique genetically engineered sheep capable of giving high yield of flesh

and wool, genetically engineered cow capable of giving high yield of milk

were produced. Further cow’s milk cab be enriched with high protein values

by incorporating a particular gene coding for such specific protein into its

body. Likewise, flesh of sheep can also be enriched with high protein values.

Similarly, through marshalling of genes it may be possible to produce

genetically engineered monkey, rabbit, or a mouse.

Besides, genetically engineered animals are used in testing drugs,

medicines, and therapies. It is a regular practice in the medical filed to test

drugs or medicines or therapies on animals before conducting their trials on

human. Sometimes genetically engineered animals are produced solely for the

purpose of testing drugs and medicines. Once-mouse is one such example

where it is produced with sole objective of testing cancer disease. Further

certain proteins, antibodies, and enzymes produced inside the body of

different animals have medicinal values. Such proteins, if produced

commercially, can be used for preparing drugs and medicines. Perhaps the

body of pig is known as the pharmaceutical factory. It produces many proteins

and antibodies inside its body, which have got significant medicinal values.

Biotechnology promises commercial production of such proteins through

isolation and incorporation of the specific gene coding for such protein into an

intended organism. Such genetically engineered organism produces the

desired protein in its body.

1.4 Patentability of Biotechnology Inventions

Inventions are patented on the basis of certain criteria. It is universally

recognized that an invention must satisfy a few requirements such as novelty,

non-obviousness, and industrial applications and written description before a

patent is granted. It is important to note that the three universally recognized

criteria of patentability, namely, novelty, non-obviousness, and industrial

applicability or utility applies to all inventions including biotechnological

inventions.1 However, patenting of life or living beings produced through

biotechnology commands special attention due to inherent complexities of the

nature of biotechnology inventions. Difficulty is felt in patenting a living

being mainly due to the following three reasons:

1. It is doubtful whether patent protection will be granted to living matters.

2. Biotechnology inventions are difficult to describe.

3. How to consider biotechnological new findings: as inventions or as

discoveries.

It is felt that the requirements of the traditional patent law are not

enough to test the patentability of biotechnological inventions. In case of

biotechnological inventions it is quiet difficult to differentiate between an

invention and a discovery. Since biotechnological inventions involve living

beings, it requires special attention before a patent is granted. Due to the

inherent complexities and technicalities, sometimes biotechnological

inventions cannot be described in the written specification. To overcome this

problem a solution was evolved in the form of deposit of the invention in any

recognized depositories.3 The Budapest treaty recognizes international

depositories where inventions related to living matter can be deposited and

maintained for the purpose of patent protection.4 The deposit of the invention

enables the patent examiner to test the genuineness of the invention before Jayashree Watal, Intellectual Property Rights in the WTO and Developing Countries, New

Delhi : Oxford University Press, First published 2001, Third impression 2002, p. 132.

M.S. Swaminathan. An Introduction to the Guiding Principles in the Decisions on Patent

Law, Delhi: Bahri Brothers, 2000, p. 331.. Budapest treaty, 1977, provides for the establishmenand

recognition of international

depositories to deposit inventions of life forms and other biotechnological inventions for

the grant of patent along with the patent application.

Budapest treaty was signed and done at Budapest, in 1977. Any member of the Paris

Convention may become party as per Article 15 of the treaty. See, Manish Arora, Guide to

Patent Law, Delhi : Universal Publishing Co., 2000, p. 410.

the grant of a patent. It is recommended that in case of claiming

biotechnological inventions for patents, the deposit of the invention shall

accompany the patent application. Therefore, a biotechnological invention

must satisfy the requirement of deposit of the invention along with the usual

patentability requirements. Hence, it is inferred that patentability of

biotechnological inventions depends on satisfying the regular requirements

under the patent laws along with the deposit of the invention. The essential

requirements that a biotechnological invention or an invention involving

living beings must meet the following criteria to be eligible for patents:

Patentable subject matter.

Novelty

Non-obviousness (inventive step).

Industrially applicable (utility).

Written description of disclosure of the invention and the deposit of the

invention

PATENTABLE SUBJECT MATTER

The first and foremost requirement is that an invention should fall within the

ambit of patentable subject matter. Inventions falling within the purview of

patentable subject matter are only eligible for patent protection. The

components of patentable subject matter were not initially uniform in different

countries. However, with the coming into being of TRIPS, there is uniformity

in bringing inventions within the scope of patentable subject matter in broad

terms. It states that patents shall be made available for any invention, whether

products or process, in all fields of technology provided that they are new,

involve an inventive step, and are capable of industrial application. It further

states that patents shall be available without discrimination as to the place of

invention, the field of technology, and whether the products are imported or

locally produced.6 However, members states of the TRIPS agreement may

exclude from patentability inventions, including inventions of life forms of

biotechnology, on grounds of public order, morality, protection of human,

animal or plant life, or health, or to avoid serious prejudice to the

environment. Members states may also exclude from patentability and also

diagnostic, therapeutic and surgical methods for the treatment of humans or

animals; plants and animals and essentially biological processes for the

production of plants or animals. However, it is believed that micro-

organisms, plants, and animals produced through non-biological or

microbiological processes could be patented under the agreement. Therefore,

it is inferred that biotechnological inventions resulting out of biotechnological

processes, which do not come within the meaning of essentially biological

processes, are patentable.

Article 27 of the TRIPS agreement.

The TRIPS agreement Article 27, sub-clauses (2) and (3).

Invention v. Discovery

It is universally accepted that patents are given for inventions and not for

discoveries. It has long been established that discoveries are not patentable.

Invention is something newly designed or created or the activity of designing

or creating new things. Discovery is the act of finding something that had not

been known before. The term invention is not defined under TRIPS or under

other international conventions on patents like the Paris convention or the

Patent cooperation treaty. Even the recent European directive on

biotechnological invention does not define the term invention. The US patent

statute defines the term invention to mean any invention or discovery. As per

the US patent law, there is no difference between an invention and discovery.

However, discovery amounts to the finding of a thing that is existing in the

nature but not known before, whereas invention means creation of design of

something totally new that was not there before.

The philosophy of patent law states that inventions can be living things.

At the same time discoveries can also be living things. It is believed that

discovery of living beings existing in nature is not patentable but inventions of

new living beings that do not exist in nature are patentable. It is felt that a

discovery does not involve creation or design of new thing, hence, it is not

patentable. Almost all patent laws throughout the world say that discoveries of

substances found in nature do not constitute an invention and are excludable

from the grant of patent. Strictly speaking, inventions of biotechnology are not

totally new but are manipulated living beings found in nature. Therefore, there

is a need to draw a distinguishing line between a discovery and an invention in

the light of patenting products of biotechnology. The very first objection

against patenting of living beings is that living beings are discoveries or

products of nature existing and found in nature. In fact, biotechnological

inventions are based on products foundin nature.

The starting point or raw material for these inventions is biological

material found in nature. It is believed that finding of biological things

existing in nature amounts to discovery. It is also believed that the

manipulation of pre-existing biological resources in nature gives rise to

biotechnological inventions. Perhaps human intervention makes a product of

biotechnology different from a natural biological product. Human intervention

to the biological resources yields new, non-natural, man-made, and hitherto

not existing living beings. Here the distinction between a pre- existing

biological product and a human-intervened, human-made, biotechnological

product is very thin. The distinction relevant to patentability, between the

‘discovery’ of something that exists in nature and the invention and creation

of something new, involving a predetermined degree of human effort, or

invention is, in practice, difficult to make in the field of biotechnology. One

of the contentious issues raised on aspect of biotechnological inventions is

that of the extent to which the traditional concept of invention can be applied

to protect these inventions.

Biotechnology is notable for designing or creating new things that were

not existing hithesto. Biotechnological inventions are the sequal of human

ingenuity and intellect to the existing natural resources. Finding of biological

things in nature amounts to discovery. However, adding human ingenuity to

such biological things gives rise to an invention. Therefore, till the addition of

human ingenuity a biological product remains a discovery and the application

of the human ingenuity thereafter makes it an invention. However, the

complication arises due to the fact that it is becoming increasingly difficult to

determine where ‘discovery’ ends and ‘invention’ begins. This issue is

resolved more through judicial decisions and patent office practices on the

facts and circumstances of each case rather than through clear-cut criteria laid

down in law.

The case law pronouncements have made it clear that finding of a product of

nature is a discovery. A product of nature becomes a product of man due to

the intervention of human being or due to the application of human ingenuity.

It is to say that, a product of nature through some human intervention becomes

product of man. This human intervention to the product of nature gives it a

new existence, making it possess some special features which it did not have

earlier, thus making it an invention. On the whole it creates a new living entity

with some special characteristic features, which were not in existence earlier.

Therefore, product of nature through some human intervention becomes a

product of man, which does amount to an invention. On the same lines the

process of isolating living entities from its natural surroundings in purified

form is patentable. Further, the result of such a process, the natural living

entities in the isolated and purified form, are also

patentable.

All unicellular organisms with dimensions beneath the limits of vision, which can be

propagated and manipulated in a laboratory, are termed as micro-organisms. Micro-

organism includes bacteria and yeasts as also fungi, algae, protozoa, plasmids, viruses.

P.K. Vasudeva, Patenting Biotech Products: Complex Issues EPW Commentary, 14-20

October, 2000.

Cambridge Dictionary of American English, Cambridge : Cambridge University Press, 2000.

Paris convention for the protection of industrial property, 1983, as amended in 1979.

Patent cooperation treaty, 1970, modified in 1984

European directive on the legal protection of biotechnological inventions, 1998.

35. United States Patent Act, Section 100

Dr K.V. Swaminathan. An introduction to the Guiding Principles in the Decisions on Patent

Law, Delhi : Bahri Brothers, p. 224.

A mere discovery of something that exists in nature, forming part of the state of the art

(prior art) is not patentable.

Dr T. Ramakrishna, Biotechnology and Intellectual Property Rights, Bangalore : Centre for

Intellectual Property Rights Research and Advocacy (CIPRA), National Law School of India

University, 2003.

CHAPTER 3

2.1 INTERNATIONAL STANDARDS AND POLICY ISSUES

1. AGREEMENT ON TRADE-RELATED ASPECTS OF

INTELLECTUAL PROPERTY RIGHTS

PART II STANDARDS CONCERNING THE AVAILABILITY, SCOPE AND USE OF

INTELLECTUAL PROPERTY RIGHTS

Section 4.PatentsSECTION 5: PATENTS

Article 27

Patentable Subject Matter

1. Subject to the provisions of paragraphs 2 and 3, patents shall be

available for any inventions, whether products or processes, in all fields

of technology, provided that they are new, involve an inventive step and

are capable of industrial application.5 Subject to paragraph 4 of Article

65, paragraph 8 of Article 70 and paragraph 3 of this Article, patents

shall be available and patent rights enjoyable without discrimination as

to the place of invention, the field of technology and whether products

are imported or locally produced

2. Members may exclude from patentability inventions, the prevention

within their territory of the commercial exploitation of which is

necessary to protect ordre public or morality, including to protect

human, animal or plant life or health or to avoid serious prejudice to the

environment, provided that such exclusion is not made merely because

the exploitation is prohibited by their law.

3. Members may also exclude from patentability:

(a) diagnostic, therapeutic and surgical methods for the treatment of

humans or animals;

(b) plants and animals other than micro-organisms, and essentially biological

processes for the production of plants or animals other than non-biological

and microbiological processes. However, Members shall provide for the

protection of plant varieties either by patents or by an effective sui generis

system or by any combination thereof. The provisions of this subparagraph

shall be reviewed four years after the date of entry into force of the WTO

Agreement.

2.2 INTERNATIONAL TREATIES

CHAPTER 3

3.1POSISITION IN US

3.1.1 Patentable subject matter in the United States

The United States Patent Act, 1952 states that any invention of new and useful

process, machine, manufacture, or composition of matter, or any new and

useful improvement thereof may constitute patentable subject matter. The

United States patent law expressly does not state what constitutes patentable

subject matter and what does not. It outlines broad scope of subject matter that

is patentable. Accordingly, the threshold inquiry of all patent applications is

whether the claimed invention can be classified within this range. Any subject

matter that falls within the prescribed range is patentable. It implies that the

patentable subject matter includes any method of manufacture, machine,

composition of matter, or process.

The United States patent law does not say anything specifically about

biotechnological inventions involving life. However, the US judiciary has

interpreted the patentable subject matter under the patent law to cover living

beings. In Diamond v. Chakraburty for the first time US Supreme Court was

confronted with a question whether the patentable subject matter under the US

patent law does cover living beings or not? The invention claimed was a

genetically engineered micro-organism. The inventor contended that the

invention is a patentable subject matter as it is a composition of matter. The

US Supreme Court liberally interpreted the term ‘composition of matter’ to

include living beings also. It was held that living beings are patentable, as the

patent law does not prohibit the same. It was observed that living beings

produced through biotechnology involve re-composition of physical and

chemical properties and hence are composition of matter within the meaning

of patentable subject matter under the patent law. After this decision patent

offices throughout the world started issuing patents on living beings produced

through biotechnology by considering them as a composition of matter within

the scope of patentable subject matter.

The decision of the Supreme Court was a trend-setting decision in the

annals of patent law as it interpreted the patentable subject matter to include

living beings produced through biotechnology. After the decision, patentable

subject matter under the US patent law now covers living beings also. As

biotechnological inventions are concerned with life or living beings the

decision had far reaching impact on biotechnological inventions. In later

decisions, the US Supreme Court and as well as the US patent office

interpreted patentable subject matter to include living beings such as plants,

animals and human genetic material. In Ex Parte Hibberd a plant was held to

constitute patentable subject matter. In Harward on co-mouse it was decided

that a genetically engineered animal does constitute patentable subject matter.

In Amgen Inc. v. Chugai Pharmaceuticals Co., human genetic material like

DNA was held to form patentable subject matter. Again in re Bell human

DNA was held to constitute a patentable subject matter.

Further, human cloning methods were also held to constitute patentable

subject matter. In all the above decisions the expression ‘composition of

matter’ was interpreted to cover living beings, within the meaning of

patentable subject matter. It is inferred that biotechnology processes and

biotechnology products like microorganisms, plants, animals, and human

genetic materials do constitute patentable subject matter in the United States

and are patentable. However, it is believed that human being does not

constitute a patentable subject matter under the US patent law, since cloning

of human is punishable under the Human Cloning Prohibition Act. It is

believed that human beings do not constitute a patentable subject matter.

US Patent Act, 1952, Section 101 Inventions patentable.

(1980) USSC 447 at 303.

Ex Parte Hibberd, See Jayashree Watal, Intellectual Property Rights in the WTO Countries,

Oxford University Press, First Published in India, 2001, Third impression, pp. 178-87.

Harward Onco-mouse decision in 1988.

Amgen Inc. v. Chugai Pharmaceuticals Co. Ltd 927 F.2d 1200.18 USPQ 2d 1016 (Fed.Cir.1991).

3.2 EVOLUTION OF BIOTECHNOLOGY IN US

In the United States, Thomas Jefferson drafted the first patent statute which

was enacted in the year 1793. The Act articulated the requirements of

patentability as enshrined under the Venetian statute such as ‘utility’,

‘novelty’, and ‘non-obviousness’. The philosophy behind the 1793 Act was

that ‘the ingenuity should receive a liberal encouragement’ The Act defines

patentable subject matter in broad terms to mean ‘any new or useful art,

machine, manufacture or composition of matter, or any new or useful

improvement thereof’. The subsequent Acts of 1836,1870, and 1874 reiterate

the philosophy outlined by the 1793 Act. In the year 1952 the law on patents

was recodified in the form of Patents Act, 1952. In doing so, the term art was

replaced with process in the definition of the patentable subject matter. The

altered definition of patentable subject matter stands as ‘any new and useful

process, machine, manufacture or composition of matter or any new and

useful improvement thereof.’ In all these enactments on patents, living

organisms were kept out. This was not due to any religious belief or ethical

consideration, but due to the fact that living organisms were considered to be

the ‘common heritage’ of mankind and not considered to be patentable

3.2.1History and evolution of biotechnology patent law

The evolution of biotechnology patent law can be traced back to the United

States. The United States Constitution states the Congress shall have the

power to promote the progress of science and useful arts, by securing for

limited times to authors and inventors the exclusive right to their respective

writings and discoveries. The plain meaning of the above provision does not

say anything about patenting of biotechnology. It merely signifies Congress’

power to promote the progress of science and arts by granting exclusive rights

to the inventors for a limited time. The promotion of science is the threshold

of Patent Law. The United States Patent Act in its original form does not say

anything about patenting of biotechnology inventions. It states that whoever

invents or discovers any new and useful process, machine, manufacture, or

composition of matter or any new and useful improvement thereof, may

obtain a patent there for, subject to the conditions and requirements under the

patent law. As in the Venetian statute, so also in the 1952 patent law living

beings are not considered patentable subject matter. The recent emergence of

the science of biotechnology made it possible to invent new and innovative

living beings. However, these developments of biotechnology were not

expected and no provision was made in the then existing patent laws. Before

the biotechnology era, patenting of living beings was out of all purviews. But

it was the judiciary that took initiative to interpret the existing patent law in an

innovative and liberal way, to offer patent protection to biotechnology

inventions. In fact, more than legislative initiatives, judiciary’s

pronouncements have laid the foundation for the evolution of biotechnology

patent law. The judiciary did not alter or change any provisions of existing

patent law; rather it has taken a liberal approach in interpreting patent law.

Today, biotechnological inventions do constitute patentable subject matter to

the credit of judiciary for its liberal and innovative interpretation of patent

laws. Earlier in the nineteenth century, there were moves to patent living

process in the United States. For the first time the United States Patent Office

granted a patent to Louis Pasteur on ‘yeast’ that is free from organic germs of

disease. It was the first incidence in the history of patent law wherein a patent

was granted on a living matter. The Patent Office considered the invention as

an article of manufacture within the meaning of patentable subject matter

under the US patent law, but the fact that the invention claimed was a living

process was not taken into account. Patent was indeed granted on a living

matter but the approach was not in favour of granting patents on living matter

or living processes. Subsequently in Exparte Latimer a patent claim for fibre

found in the

needle of the Pinus astralis was rejected. The belief was that plants, even those

artificially bred, were products of nature for purposes of the patent law. A

general principle was set that plants were natural products and not subjected to

patent protection. The view taken was that patent on such fibre would lead to

patents on the trees of the forest and the plants of the earth, which was

considered unreasonable. Besides, it was thought that it was not possible to

describe plants in a written form, as new plants might differ from old in colour

and perfume that cannot be described in a written form. Hence it was decided

that plants could not satisfy written description requirement under Section 112

of the United Sates patent statute. The case law has postulated the following

two principles

1.Plants are products of nature though artificially bred, and are not patentable.

2. Plants are not amenable to the ‘written description requirement’ of the

patent law.

The above two principles were found to be hurdles for granting patent

protection for plants. Since 1930 living organisms were not considered as

patentable. However, the Plant Patents Act, 1930, relaxed the situation by

providing that the work of plant breeder in aid of nature was patentable

invention. The Act extended patent protection to certain asexually reproduced

plants, such as reproduction of plants by grafting and budding. The Act was

viewed as reflecting the legislative attention to the problems of patenting

living organisms. The Act has also relaxed the requirement of written

description by stating that reasonable written description is enough to grant

patents. The purpose of the Act was to solve the technical problem of

description of plants referred to in the Latimer decision (no. 10 supra). In

1970 Congress enacted the Plant Variety Protection Act, 1970, which

extended protection to certain new plant varieties capable of sexual

reproduction. It seems Congress intended to promote the agricultural industry

by encouraging patents on asexually reproduced plants.

The 1930 Act as well as 1970 Act did not show any indication of including

bacteria within the purview of the patentable subject matter. These Acts

strongly evidence a congressional limitation that excludes bacteria from

patentability. The issue of including bacteria within the purview of patent

protection was considered at the time of passing of the 1970 Act but the same

did not materialize. Soon after the passage of the Plant Patent Act,

1930, US courts decided whether certain living things form part of the

patentable subject matter or not. An opportunity arose for the courts to

interpret the patentable subject matter under Section 101 of the patent statute.

As per the language of the patent statute patentable subject matter

encompasses any ‘new and useful process, machine, manufacture or

composition of matter or any new and useful improvement thereof.

The term ‘manufacture’ was interpreted in American Fruit Growers Inc v.

Brogdex Co. The claims were for ‘coated oranges’. It was considered whether

the claimed invention comes within the meaning of the term ‘manufacture’.

The court happened to interpret the term ‘manufacture’ to mean the products

of articles for use from raw or prepared materials by giving to these materials

new forms, qualities, properties, or combinations whether by manual labour or

by machinery. The term ‘manufacture’ implies the production of new articles

by using raw materials and giving such raw materials a new form, quality, and

properties or a combination of these. In the instant case the

court rejected the claims on the ground that coated oranges were not

sufficiently modified. The court held that the claimed oranges were not

attributed considerably new qualities, properties, or a combination of these in

order to be considered as a manufacture. The decision of the court lays down

that the inventors would have got the patent if their claimed oranges were

considerably modified to posses, new qualities, properties or their

combination. It seems that in the early part of the twentieth century itself

America was inching towards patenting of living beings. However, existing

living organisms or biological resources were used as raw materials in

producing biotechnology inventions. The living being was the manipulation

and manifestation of an existing living being giving it a new look or features,

which it was not. Such being the case, it can be inferred that biotechnological

inventions do come within the meaning of the term ‘manufacture’ forming

part of the patentable subject matter.


Patenting of Plant-related inventions

In the US, there are three forms of protection for plant-related inventions.

These are Utility Patents, Plant Patent Act (PPA), Plant Variety Protection Act

(PVPA). The utility patents and the plant protection patents are granted by

USPTO while the PVPA is granted by Plant Variety protection Office

governed by USDA. Utility patents awarded in the US cover conventionally

bred varieties or genetically modified plants. A number of examples of utility

patents have been give in the later sections.

Plant patent is a right granted by the government to an inventor who has

invented or discovered and asexually reproduced new plant variety other than

tuber-propagated plant or plant found in uncultivated state. This grant lasts for

20 years (in the US) from the date of filing the application, protects the

inventor’s right to exclude others from asexually reproducing, selling or using

the plant so reproduced. This protection is limited to one plant variety. A sport

or mutant of a patented plant is not considered to have same genotype as that

of the parent plant. Hence, such plants are separately patented instead of being

covered by the plant patent of the parent plant.

The first plant patent was issued in 1931 to Henry Bosenberg of New

Brunswick, NJ, for a climbing or trailing rose. This invention was for

climbing roses bearing true blooming character. There was another plant

patent for a rose plant named ‘Breapum’ granted to Ezio Brea in 2003

(USPP14, 226 P3). The new and distinct cultivar had the unique

characteristics of long erect flowering stems, creamy white flowers and

orange hips arranged in sprays. A patent for Chrysanthemum plant named

‘Zembla’ (US PP14, 052 P2) was granted which was for an invention distinct

in possessing decorative inflorescence and possessing excellent post-

production longevity.

Tissue Culture Techniques and Genetic Transformation of

Plants

An important area of research in plants relates to tissue culture and genetic

engineering of plants. The intellectual property scenario on genetic

transformation of plants is quite complex. The subject matter considered

patentable under this category involves the following:

Transformation techniques: there are various transformation methods

basically classified into two categories, which permit introduction of genetic

material into plants to render them with properties like disease resistance,

improved seed quality, and insect resistance.

Agrobacterium-mediated transformation is an indirect method of

transformation that involves Agrobacterium tumefaciens, which is a common

soil bacterium that naturally inserts its genes into plants and uses the

machinery of plants to express those genes in the form of compounds that the

bacterium uses as nutrients. Agrobacterium-mediated transformation has been

dealt with in detail in Chapter 15, Section 15.12.1.

Patents related to transformation of dicot plant

US5, 024, 944 Transformation, somatic embryogenesis and whole

plant regeneration method for Glycine species

US5, 986, 181 Transformation and regeneration of fertile cotton plants

EP910239 Transformation of cotton explants with Agrobacterium

WO0042207 Transformation of a soybean germline with

Agrobacterium

Patents related to transformation of monocot plants

US6,720,488 Transgenic maize seed and method for controlling

insect pests

WO05096806 Edible vaccine in the form of rice

AU3402897 Transformation of wheat with Agrobacterium

AU7134298 Transformation of sorghum with

Agrobacterium/Pioneer Hi-Bred

There exists large number of patents where Agrobacterium has been

used for the transformation of dicotyledonous plants. Examples of some of

these patents are given in Table 22-4.

Transformation using Agrobacterium is now becoming popular among

the monocots. Some of the important patents that were granted in this regard

are listed below in Table 22-5.

Direct method of transformation, where direct uptake of the genetic

material by plant cell occurs (see Chapter 15, Section 15.12.2 for details) are

also in use. Some of the patents that use these techniques have been listed

below in Table 22.6.

Regeneration Protocols. For genetic transformation of plants an

excellent system of regeneration is necessary. There are many patents granted

for methods of regeneration using different explants such as leaves, roots,

hpyocotyls, cotyledons and seeds. A patent has been granted for a method for

regenerating cotton plant from explant tissue comprising regenerating

embroygenc callus from a cotton tissue explants cultivated on cotton initiation

media not supplied with exogenous plant hormones (EP910239B1 and US5,

846, 797).

Explants: The different types of explants that have granted patents are

listed below in Table 22-7.

Other patentable component: Transformation vectors, selectable marker

genes, reporter genes, promoters and enhancers are some of the important

components that are also patentable. A list of these that were used in golden

rice manufacture is given below in Table 22-8.

Genetically modified plant: Genes conferring resistance to insect pests and

various fungal, viral and bacterial disease have been successfully introduced

in variety of crop plants. Similarly, transgenic plants containing genes for

drought and salt tolerance, improved quality for value addition and increased

shelf life are produced through genetic transformation. The classic example is

of Bt transgenic plants into which the genes elaborating the insecticidal toxins

of Bacillus thuringiensis have been introduced. However, in India since plants

per se are not patentable, patents for genetically modified plants are not

allowed.

More than 400 patents have been granted on Bt isolates, strains, genes,

Bt toxin receptors and on specific proteins toxic to a given insect class or pest.

Bt toxin receptor BT R2 from Pectinophora gossypiella (pink bollworm) has

been patented (US6,645,497). A USBTS02618A, BTS02654B and

BTS02652E strains. Patents have been granted to polynucleotide

compositions encoding broad spectrum endotoxins (US6,645,497;

US6,538,109; US6,521,442; US6,448,226). Plasmid(s) containing

heterologous DNA coding for Bt crystal protein in E.coli is protected under

US patent (US4,467,036). A US patent (US6,326,169) disclose polynucleotide

compositions encoding Cry 1 Ac/Cry 1F chimeric endotoxins. Bt cry ETI

toxin gene and protein toxic to lepidopteran insect, Plutella xylostella

(Dimondback moth), has been patented (US5,356,623). This patent also

discloses the method of controlling susceptible lepidopteran insects by

applying the effective amount of insecticidal toxins to the host plant. A

European patent (EP0358557B1) discloses a new DNA sequence that encodes

the 130 kDa protoxin, the ‘Bt 18 protoxin’, from the genome of the B.

thruingiensis var. darmstadiensis HD -146. This protoxin cleaves into 62 kDa

of active toxin and is highly active against Lepidoptera species from the

Noctuidae family such as Spodopter species and Manducasxta. Five novel

nematocidal cry gene sequences are disclosed in European patent

(EP0462721). Two crylgene sequences are disclosed in European patent

(EP0401979).

Patents for modifying the Bt gene to optimize expression of the

insecticidal protein in plants have also been granted. A US patent

(US6,242,241) disclosed novel synthetically modified Bt chimeric crystal

protein having improved insecticidal activity against coleopteran, dipteran and

lepidopteran. This patent also covers nucleicacid encoding for these novel

peptide, methods of making and using these genes, and proteins, method for

the recombianant expression and transformation of suitable host cells,

transformed host cells, and transgenic plants expressing the said Bt toxin. Two

US patents (US6,033,874; US6,423,828) have been granted where novel

synthetically-modified B. thuringiensis cry 1C gene sequence encoding

endotoxins having lepidopteran-specific insecticidal activity has been

disclosed.

More than 482 patents had been filed or granted for inventions related

to Bt crops, some 95 of these patents involve transgenic plants. US patents

have been granted for the production of transgenic maize expressing the

synthetic Bt protein (US5,484,956; US6,720,488). US patent (US6,720,488)

discloses the method of production of transgenic maize expressing synthetic

Bt insecticidal crystal protein genes in which the codon usage has been altered

to increase expression of the Bt gene.

Patenting of transgenic plants

The impact of the decision on Chakraburty was such that it had not only

interpreted the patenable subject matter under Section 101 of the United States

patent statute to encompass micro-organisms but it furthered the debate over

patenting of living material including plants and animals. With the

encouragement and inspiration from the Chakraburty decision, the scientific

community, with extended enthusiasm and spirit, furthered their research in

the field of biotechnology extending its scope to cover other living beings.

The streamlined research in the field resulted in transgenic plants.

Biotechnology proved that it was quite capable of producing transgenic plants

in a hitherto unknown manner by combining the qualities of different plants

and putting them together into an intended plant. The resulting plants were

genetically modified to possess certain special features such as high yield,

resistance to pests, and capacity to withstand drought conditions, which did

not exist earlier. As the progress in biotechnology

witnessed transgenic plants claims for patenting transgenic plants and related

inventions began to increase. Incessant filing of patent applications as such

was the sequel of Chakraburty decision. It was for the first time in 1986 in

Exparte Hibberd a mutant maize plant was claimed for a patent. The patent

examiner rejected the

patent application on the basis that the claim was for a living thing. The patent

examiner viewed the claimed invention as a product of nature and decided that

it was not patentable. However, United States Patent Board of Appeals

overturned the ruling of the examiner to grant patent on maize mutants. The

Board, relying on the principle outlined in Chakraburty that when human

ingenuity was added to a product of nature, it became product of man, decided

the claimed maize mutants as eligible for patent protection. The Board

followed the suit in Chakraburty and extended the philosophy of Chakraburty

to human-made transgenic plants. Soon after this decision the United States

Patent Office started entertaining patent applications claiming plants and

related inventions. A hike in the patent application claiming transgenic plants,

plant cells, and tissues was witnessed. In HiBred International v. JEM AG

Supply Inc., Supp, the United States Court of Appeals for the federal circuit

upheld patents on plants. Therefore, now plants and related inventions such as

plant cells and tissues are patent eligible. Dynamic as any science is

biotechnology is keeping a fast pace breaking new frontiers–pace so fast that

law is running behind it for regulations.

The decision of Diamond v. Ananda Chakraborty had its impact when a plant was claimed for patent for

the first time. The clamants contended the rationality of Diamond v. Anand Chakraborty where it was held

that anything under the sun made by man is patentable. Applying the same rationality claimants

contended that maize mutant plant which the claimed for paent is not available in the nature. They also

contended that the plant they are claiming is the modified form which is different from the natural form and,

hence, by applying the rationality of Diamond v. Ananda Chakraborty patent could be granted. Further it

was contended that there was another law, the United States Plant Variety Rights Law under which

protection can be sought rather than seeking patent. See Jayashree Watal, Intellectual Property Rights in

the WTO and Developing Countries,New Delhi : Oxford University Press, First published in India 2001, Third

impression 2002, pp. 177-82.


3.4.1 ANIMAL BIOTECHNOLOGY

Animal cell science focuse on the biological issues that subtend the

productivity of animal cells in culture .cell couture is no longer considered as

a technique to create cell lines but as an indispensable science to understand

the various cell signalling machanisms, the switches within the cells that

control growth by the control of gene expression .in simple term ,it is the basic

requisite for understanding of the intercellular and intercellular activities of a

cell .cultivation of animal cell is extremely important to the biotechnology

industry. With recent advances in research in manipulating the environment to

enhance cellular growth in vitro , novel compound for therapeutic and

prophylactic use have also been produced. animal cell culture systems have

been genetically engineered to produce clinically important

Patenting of higher life forms : Animals

Micro-organisms such as bacteria, algae, and plants are considered as

lower life forms. Animals are considered as higher life forms in biological

terms. The capacity of animals to think and express makes them different

from lower life forms and hence they are considered as higher life forms along

with human beings. The voyage of biotechnology patent law furthered to

cover animals and related inventions. Once transgenic plants were given

patents, biotechnologists started trying their hands in producing transgenic

animals. The result was new forms of animals with foreign genes called

genetically manipulated animals. Initiating debate over the patenting of

animals for the first time in the history of patent law in 1987, an animal was

claimed for a patent. In Exparte Allen the claim was for oyster, a genetically

modified animal. The patent was opposed on the ground of

product of nature. Opponents contended that animal being a creation of God

was a product of nature and could not be patented. God was the only owner of

products of nature; man could not own it by patenting it. Meanwhile, the

patent office rejected the claim for the invention on the ground of

obviousness, i.e., lack of inventive step. On appeal, the Board of Patent

Appeals and Interferences confirmed the rejection. However, the Board

rejected to affirm that the oysters were naturally occurring subject matter and

consequently left alive the issue of patenting of living organisms. In other

sense the Board accepted that the claimed

oyster is a non-naturally occurring living matter, further animiating the debate

on animal patenting. Meanwhile, patent applications claiming animals, animal

genes, tissues, and other inventions relating to animal genetic material started

pouring in. There was vehement pressure from the biotech industry to grant

patents on animals in the light of its enormous potential and utility of the

claimed inventions. In this background the patent office issued a statement

revealing its stand on animal patenting. It was stated, ‘The patent office now

considers non naturally occurring non-human multi-cellular living organisms,

including animals to be patentable subject matter within the scope of subject

matter under the United States Patent

Statute.’ Based on this policy the United States Patent Office granted the first

patent on an animal. In the year 1988 patent was granted on a genetically

engineered mouse, an Onco–mouse, susceptible to cancer. A foreign gene,

onco gene, was incorporated into the mouse by genetically engineering it,

which made it

susceptible to cancer. The mouse was useful in cancer testing. The patent

office granted patent on the ground that the invention is a non-naturally

occurring and human-made living being. The decision brought animals within

the purview of patentable subject matter. After onco–mouse was patented, the

mouse race continued and at least sixteen patents had been granted on

inventions relating to transgenic mice. The voyage of patent law witnessed

patents on transgenic sheep producing protein in its milk, transgenic pigs that

produced low cholesterol meat, and animals that produced pharmaceuticals in

bioreactors. The race continued and patents were also granted on goat and

cattle expressing diverse protein. The voyage of biotechnology patent law

reached a stage wherein it offered patent protection to genetically modified or

transgenic animals. As per the observations now it is possible to build a farm

of transgenic animals to which patent protection is offered.

However, biotechnology is capable of manipulating higher life forms. Biotechnology industry produced transgenic

animals that possess qualities such as high yield of milk, flesh, faster growth, etc. New forms of animals are produced

through biotechnology by genetically manipulating the existing animals. We have seen animals giving high yield of milk

such a jersey cows. We have seen animals giving high yield of flesh and wool such as hybrid sheep. We also saw animals

which grow fast. How would it be if all these features were found i a single animal? It is possible through biotechnology.

Genes coding for certain features i the animals can be isolated and incorporated into an intended animals which in turn

posses all the features. At the same time genes in the animals can be removed or suppressed to get the desired results.

Genes coding for certain qualities can also be isolated and incorporated into any living being to get the desired results.

Genes in animals coding for certain protei are isolated and commercially produced by incorporating such genes into a

bacteria other micro-organisms.1987 USPO 2d 1425.

See supra 4, p. 173.


The 1970s witnessed moves towards patenting living matter, which laid

foundation for the evolution of biotechnology patent law. During this time

there were claims for patents on living matter. In Diamond v. Chakraburty the

claim was for a genetically modified micro-organism capable of eating crude

oil spills. The inventor Chakraburty claimed both the process of producing the

bacteria and the bacteria. For the first time in the history of patent law, a

question arose whether living matter was patenable or not. The patent office

allowed process claims for the method of producing bacteria but the claim for

bacteria was rejected. Chakraburty appealed to the Patent Office Board of

Appeals, where the rejection was affirmed. The Board concluded that

patentable subject matter as enshrined under Section 101

of the United States Patent Code did not encompass living things such as

micro-organisms. The Board did not go into detail whether the invention

involved any inventive step or not. The claim was plainly rejected by stating

that patentable subject matter did not encompass living things. An appeal was

made to the Supreme Court. There was much anxiety and the whole world

was eagerly waiting for the decision. The Supreme Court by a 5:4 majority

overruled the patent examiners, rejection of the patent and held that the United

States patent statute is broad enough to cover living organisms. The Court

viewed that constitution had granted wide powers to the Congress to promote

the progress of science. The Congress has every power to legislate with

respect to the promotion and advancement of science. It was held that the

language of the patent statute was broad enough to encompass protection to

living organisms. While determining, whether the claimed invention came

within the meaning and scope of patentable subject matter, the Court in

particular considered two terms, ‘manufacture’ and ‘composition of matter’,

under Section 101 of the patent law. The Court relied on the decision of

American Fruit Growers while interpreting the term ‘manufacture’ and the

decision of Shell development while interpreting the term ‘composition of

matter’. The Court interpreted the phrase ‘composition of matter’ to

encompass living matter produced through biotechnology. The Court

observed that the claimed bacterium was a composite mixture of the features

of known species, put

together into one species. It was viewed that Chakraburty had genetically

modified the natural bacterium to possess capacity to eat crude oil spills.

Upholding the philosophy of Thomas Jefferson, the author of the first patent

law in the United States that ‘ingenuity should receive liberal encouragement’,

it was held that the invention was a result of human ingenuity and intellectual

labour which should receive liberal encouragement. The Court accepted the

contention of Chakraburty that the bacterium was a non-naturally occurring

human-made micro-organism

which did not exist in nature automatically. Responding to the contentions that

living matter was a product of nature and could not be patented, the Court

held that Chakraburty’s invention was not a product of nature; it was a

product of man, the human role involved in the invention differentiates it from

a product of nature. The Court accepted that the starting point of the invention

was a product of nature, but the inventor had added his ingenuity in making

the bacterium to possess the capacity to eat up oil spills with accuracy and

pace. Naturally, the bacterium did not possess such a feature; there was a role

of human agency in making the bacterium to possess such special skill.

Therefore, the invention was a non-natural

human-made product, a result of human ingenuity and labour. The very fact

that human agency had played a role in making the bacterium to possess

special skill renders the product of nature a product of man. The bacterium

was a product of nature till human intervention whereupon it turned into

product of man. Rejecting the argument that micro-organisms cannot qualify

as patentable subject matter until the Congress expressly authorized such

protection, the Court held that biotechnology was unforeseen by the Congress

when it enacted Section 101 on patentable subject matter. However, the

Congress employed broad general language in drafting Section 101 precisely

because such inventions were often unforeseeable. The Court highlighted the

constitutional objective of promoting the progress of science and also the

philosophy of Jefferson that ingenuity should receive liberal encouragement in

interpreting the patentable subject matter to encompass living matter. At the

time of the judgment there were at least 100 patent

applications pending before the United States Patent and Trademarks Office

(USPTO) that were disposed of on the rationality of the decision. There was

a plethora of patent applications before the USPTO soon after the decision on

Chakraburty. The case had set a new trend, it began a new era of patent law.

The decision had raised the curtain for the evolution of biotechnology patent

law and it opened floodgates for biotechnology patents.

3.6 PATENTING OF HUMAN CELLS AND GENETIC

MATERIAL

The voyage of patent law further continues, as there were moves to

patent human genetic material. The evolution of biotechnology patent law

adds another feather in its cap by extending patenting protection to human

genetic material such as human cells, genes, and DNA. New techniques in

biotechnology such as recombinant DNA technology, gene splicing, and gene

manipulation made the isolation and purification of human cells, genes, gene

sequences, DNA, and DNA sequences possible. These genes, gene sequences,

DNA are called genetic material, which have now become a subject of patent

protection. Genes code for some specific proteins which may have some

medicinal value. These genes, gene sequences, and DNA inside a cell or even

cells and cell lines have been claimed for patent.

For the first time in the history of patent law a human cell line was claimed for

a patent. The cell line was taken from the spleen of a person named John

Moore. This particular cell line was producing valuable antibacterial and

cancer-fighting proteins. The doctors of John Moore identified and isolated

the cell line and applied for patent. The United States Patent Office granted

patent on the cell line, thereby making human cells and genetic material a

subject of patents. As more and more research is being conducted in the field

and enormous utility of genetic material is being identified, a rush began for

claiming patents on specific genetic material like DNA and genes. In Amgen

v. Chugai the claim was for an isolated and purified DNA sequence. It was

for the first time in the history of patent law that a human genetic material,

i.e., DNA was claimed for patent. The claimed DNA codes for a protein called

erythropoietin that boosts red blood cell production. The invention is very

much useful to the people suffering from anemia having red blood cell

deficiency. The inventors wanted to commercialize the invention by patenting

it. Patenting of human genetic material did not attract opposition on the basis

of products of nature unlike patents on plants and animals. Oppositions

concentrated on the actual isolation, possession, and conception of the

inventions. Here the court investigated into the fact whether the inventor has

actually conceived the invention. The court defined the conception to mean

actual knowledge of the invention with its properties and reducing the

invention to successful practice. Considering the invention in the case it was

held that the conception of DNA meant actual knowledge of the DNA

sequence with its physical and chemical properties and experimenting the

DNA successfully. It was found that the inventors actually had the knowledge

of the DNA and had reduced successfully to practice, and eventually patent

was granted. As biotechnological inventions involve conception of different

genetic material or conception of different methods to isolate or employ

genetic material the definition provided for conception is very significant. It

can be said that biotechnology inventions, if actually conceived in the manner

provided in this case, will be eligible for patent. Further, in In re Vaeck the

claim related to manipulating a bacterium to insert a gene. Inventors isolated a

gene and combined it with a stretch of DNA from the bacteria and created

chimeric gene. A patent was claimed in 1991 and the same was

granted.Following the suit in Amgen in In re Bell there were claims on DNA

and RNA coding for human insulin like growth factors, which play a vital role

in the mediation of somatic cell growth on the administration of growth

hormones. As it was decided in the Amgen case that human genetic material is

patentable, oppositions were not against the patenting of human genetic

material but on the specificity and inventive step involved in the invention.

Patent was opposed on the basis of the prior art suggesting for a general

method for isolation of genes and DNA. The prior art was suggestive of a

general method for isolation of genes and DNA. The Federal Circuit held that

a general method for isolating genes or DNA would not render a specific

method of isolating a particular DNA coding for specific human insulin

growth factors obvious, and eventually patent was granted. Here the Federal

Circuit did set forth a principle that a general method suggested for isolating

genes, DNA, or other genetic material would not deprive the inventor, who

invents a specific method, from patent. This decision came as an

encouragement to the biotechnologists as at the time the industry was

regularly involved in isolating infinite number of human genes and DNA. If

one general method for isolating genes and DNA blocks other inventors from

patenting their specific methods, it obstructs the progress of the industry. A

general method always may not succeed or even if it succeeds, there results

may not be accurate. However, specific methods provide for accurate results,

particularly for isolating one specific gene or DNA in the light of infinite

number of genes and DNA present in our body. This approach provided much

needed encouragement to the biotech industry. Biotechnologists became busy

in claiming patents for their specific methods for the isolation of specific

genetic material after the above decision. The

race continued and in In re Deuel the invention related to an isolated and

purified DNA and cDNA (composite DNA) molecules coding for Heparin

Binding Growth Factors (HBGF) were claimed. Heparin Binding Growth

Factors are proteins that stimulate cell division and facilitate the repair or

replacement of damaged or diseased tissue. Patent was opposed on the basis

of the prior art suggesting for a general method for isolation of genes and

DNA. Prior art had also suggested the protein HBGF, with its amino acid

sequences. The Federal Circuit reiterated the principle laid down in In re

Bell’s case and held that prior art suggesting a general method for isolating

DNA molecules would not render a specific method obvious.

Now it is a settled fact that human genetic material is unambiguously

patentable. There is no opposition to the patenting of isolated and purified

human genetic material. The patent law does provide protection to the

inventions of genetic material in an isolated form. The interpretation of the

patentable subject matter under the patent code in an innovative and liberal

way has brought human genetic material within the purview of patentable

subject matter. The law on the patenting of biotechnological inventions now

offers patents to ultramicroscopic human genetic material such as genes,

DNA, and like materials.

927 F.2d 1200, 18 USPQ 2d 1016 (Fed. Cir. 1991).

Brian C. Cannon, ‘Toward a clear standard of obviousness for biotechnology patents’, Cornell

Law Review, Cornell University, March 1994.

991. F.2d 781 (Fed. Cir. 1993).

3.7 PATENTING OF FRAGMENTS OF DNA AND GENES

DNA is made up of sequences. In fact, a gene is the portion of DNA,

which expresses a particular protein. In turn, gene is also a composition of

sequences. Isolation and sequencing of DNA requires isolation and

sequencing of its different sequences. On the same line isolation and

sequencing of gene requires isolation and sequencing of its different

sequences. The 1980s and 1990s witnessed patents on DNA and genes. Late

1990s witnessed claims for small sequences and fragments of DNA and genes.

Essential Sequence Tag (EST) is a part of a sequence from a cDNA molecule.

Essential sequence tags are used in finding the full-length DNA or gene.

Patenting of ESTs proved controversial as it was challenged by a variety of

societies like HUGO (Human Genome Organization). HUGO says that EST

does not involve an inventive step and moreover it lacks substantial and

credible utility. Given the vehement opposition, patenting of EST proved

controversial and eventually the patent office did not prefer to grant patents on

EST. However, arguments in support of patenting EST are that EST can be

used as probes in identifying genetic material. It is useful in identifying full

stretch of genes or DNA. As isolation of any gene or DNA starts with the

isolation of its sequences, EST being a fragment of a gene or DNA comes to

the use for identifying the full stretch of a DNA or gene. In 1997, Clinton

administration announced that the patent office would begin allowing patents

on EST based on their utility as probe. Having received the green signal from

the government, the patent office started entertaining patent applications on

EST. This resulted in a flood of patent applications claiming EST.

Subsequently, on 6 October, 1998 the first patent on EST was issued to Incyte

Pharmaceuticals Inc. By the end of 1998, the same company filed patent

applications for over 1.2 million DNA sequences many of which are of human

origin. Reportedly by the end of 2000, the USPTO had received patent

applications on millions of gene fragments. The sheer numbers of

applications suggest that every human gene at least in part might already be

subject to a patent application.

F. 3d 1552 (Fed. Cir.1995).

3.8 PATENTING OF BIOTECHNOLOGY PROCESSES

AND METHOS

Not only human genetic material but also methods or processes to isolate

such material are claimed for patents. Methods of expressing specific proteins

in vitro (outside the body of animal or human) through incorporation of genes

coding are also claimed for patent. In order to produce a certain protein coded

by a particular gene, the gene is isolated and incorporated into the intended

body say, bacterium. The bacterium as a regular biological process produces

such protein for which it was genetically engineered. On the same lines

methods to produce antibodies45 from the genetic material are also claimed

for patent. In Hybertech Inc. v. Monoclonal Antibodies. Inc.,46the claim was

for an immunoassay (method)47that utilized monoclonal antibodies to

measure the concentration of certain antigens (viruses).48 The goal was to

evolve a process for measuring the quantity of certain antigens in a given

solution. Inventors produced a method to detect antigens by employing

antibodies (proteins) produced inside the body. The invention involves a

method to produce antibodies to fight against antigens in a given solution.

Patent was granted on the invention the first of its kind in developing a

method to employ antibodies against antigens. It was for the first time that the

patent office granted patent on a biotechnological method of employing

antibodies produced by the body’s immune system to fight against antigens.

This patent resulted in a number of patent applications claiming different

methods to raise antibodies and to employ against antigens. In In re Wards the

claim was for an ‘immunoassay’ utilizing monoclonal high affinity IGM

(immunoglobulin) antibodies. The invention involves immunoassay methods

for the detection of hepatitis-B surface antigen by using high-affinity

monoclonal antibodies.50 The invention was a method to produce protein

against specific viruses. The Federal Circuit, relying on the reasoning of

Hybertech decision, held that though it required some experimentation in

practising the invention, the invention is patentable. This case was another

example where a method to utilize antibodies against antigens was claimed.

Perhaps the isolation and purification of genetic material is a herculean task.

In fact, genetic material is not available for easy isolation. The intended

genetic material must be identified before its different parts are isolated. After

isolation the material needs to be purified in order, incorporate it into an

intended body for performing an intended task like producing a specific

protein. As per the latest decisions of the Court of Federal Circuit and the

decisions of the US Patent Office biotechnology processes or methods for

constitute a patentable subject matter

US patent No. 5,817,419, ‘Human Kinase Homologs’ issued to Incyte Pharmaceuticals, Inc. Lislei G. Restaino, Steven

E.Halpern, and Dr Eric L.Tang, ‘Patenting DNA-related inventions in the European Union, United States and Japan: A

trilateral approach or a study in contrast?’ UCLA Journal of Law and Technology, 2003. Antibodies are proteins

produced by the body’s immune system to fight against antigens, i.e., foreign bodies such as disease-causing bacteria and

virus. Antibodies are a class of proteins that help defend the body against invaders such as virus and bacteria. See supra5,

p. 292 802 F. 2d 1367(Fed. Cir. 1986), See also Chisum cases and materials on principles of patentlaw, New York

foundation press, New York, 1998, pp. 287-92 Immunoassay means a method for detecting or measuring antigens by

using antibodiesc as reagents. See supra 5, p. 293.

See supra 40.c858 F.2d 731 (Fed. Cir. 1988). Debra Z. Anderson, ‘How to enable your Biotech Disclosurec for the

United States Patent Application’, Lawyers Journal, Allegheny County Bar Association,c 11 July, 2003.cThe invention

was denied patent by the patent office on the ground of undue experimentationcrequired to practice the invention. In an

appeal made to the Federal Circuit it was viewedcthat the inventor had deposited the invention and the practice of the

invention does requirecsome experimentation. For example, genes are not available to be isolated. A gene is not situated

at a particular place. Gene comprises different fragments. Particular regions of DNA, which expresses proteins, are

called genes. These genes are located in the form of fragments on different regions of a DNA. Isolation of a gene requires

the isolation of its different fragments of DNA.

3.9 ISSUES

3.9.1 PATENTS RELATED INVENTIONS:

CHAPTER 4

4.1 POSISTION IN EUROPEAN UNION

4.2 EVOLUTION OF BIOTECNOLOGY IN EUROPEAN UNION

In Europe, German miners of the Alps seem to have been the first

develop

the notion of monopoly rights in their new processes as far back as in the

thirteenth century. The first more universal patent scheme evolved in Venice,

and then at the height of its international power, in a decree of 1474 which

rewarded inventors of new objects with a limited monopoly on condition that

the invention was disclosed to the state. In England, the Crown started

granting patents in the fifteenth and sixteenth centuries. Queen Elizabeth I

granted the earliest patent to an Italian inventor named Acountius. The Crown

was active in granting monopolistic privileges. However, this practice of

granting monopolies was criticized as it was abused to bestow privileges upon

favourites of the Crown. In this background the Parliament enacted the Statute

of Monopolies in the year 1624, which declared all monopolies and grants by

the Crown as void and contrary to law. The statute of

monopolies being the first English patent statute governed English patent law

for more than 200 years and forms the foundation of the present British patent

system.

In the European patent legislation history there are three significant milestones

contributing to the development of substantive law on patents. The first

milestone was the Paris convention for the protection of industrial property

adopted in 1883. The convention formulates the basic tenants of patent law in

Europe. The convention was formulated as an appreciation to the growth of

intellectual property rights. It intends to protect industrial properties such as

patents, trademarks, designs, etc. Here industrial property should be

understood in its broader sense to encompass agricultural and extractive

industries and to all manufactured or natural products, for example, wines,

grain, tobacco leaf, fruit, cattle, minerals, mineral water, beer, flowers, and

flour. Perhaps biotechnology has its impact on all the

components of industrial property that are offered protection under the Paris

convention. In the agricultural sector, in the production of wines and beer

biotechnology plays a vital role. Hence it can be inferred that though

specifically not mentioned, biotechnology is covered under the convention.

The second milestone in the history of European patent system is the

Strasbourg Convention adopted with an objective of establishing a common

market in Europe. The convention harmonizes the substantive patent law in

terms such as novelty and inventive step. The third milestone in the history of

European patent legislation was the European Patent Convention (EPC) 1973.

The convention provides for common patent-granting system in all European

countries. The convention says that European patents shall be granted for any

inventions which are susceptible to industrial application, which are new, and

which involve an inventive step. The convention prohibits patenting of living

beings produced through essentially biological processes, but it does not

prohibit living beings produced out of non-biological processes. The framers

of the convention seem to have some forethought of patenting living beings

produced out of non-biological processes. In Europe even before the adoption

of the proceedings of the convention, there were claims for patents on living

matter produced through non-biological processes. It seems, due to such

instances the European Union foresaw the growth of biotech industry and

provided for patenting of living beings produced through non- biological

processes. The convention does not state the inventions that are patentable but

also the inventions that are not patentable. Discoveries, scientific theories,

mathematical methods are the few mentioned in the list of inventions not

patentable. Further, the convention states under Article 53(b) that Plants or

animal varieties and essentially biological processes for the production of

plants and animals are not patentable. However this provision does not apply

to microbiological processes or products thereof.” "At the same time the

convention states under Article 53(a) that: ‘Inventions against public order

and morality are not patentable under the convention. The inventions falling

under exception clause do not qualify for patent though they satisfy the

requirements of novelty, industrial application, and inventive step. Inventions

which do not fall under the list of inventions not patentable but do not come

under exceptions to patenability are patentable. When we see the other side of

the coin, it seems that ‘plant and animal

varieties produced through essentially non-biological processes are patenable’

under the convention. The convention expressly says that microbiological

processes and products are patentable. Since essentially biological processes

and products thereof are not patentable it can be inferred that all the other

processes such as microbiological and biotechnological processes and

products82 thereof are patentable. On the same lines it can also be inferred

that products of biotechnological processes or inventions of biotechnology

such as transgenic micro-organisms, transgenic plants, transgenic animals and

isolated and purified human genetic material are patentable. Even the

European Patent Office believes in such an approach as it tried to interpret the

convention liberally to patent inventions produced out of non-biological

processes. These three conventions played a vital role in streamlining the law

on patents in Europe. In particular, EPC seems to have considered the issue of

patenting of biotechnological processes and

products.

Adam Hollyoak and John Torreman, Intellectual Property Law, London : Butterworths, Second Edition, 1998, pp. 37-9.

See supra 5, pp. 13-6 The British patent system has contributed to the development of patent law. The written description

requirement that every invention has to satisfy under the present patent law is a contribution made by the British patent

system. In Liardet v. Johnson [Jarret, English patent system, 26 J.pal.off. Soc’y 762 (1994)] it was held that the

consideration for a patent grant was the specification of the invention. The invention had to be described in a written

form in order to get a patent. This decision set forth the present written description requirement under the British patent

system and later on it was adopted by the patent systems throughout the world. See supra 44International Legal

Instruments of Intellectual Property Rights Law, Department of

Business Laws,Volumes I and II, National Law School of India University, Bangalore, 1998.

Article 1, sub-clause (3) of the Paris Convention on Industrial Property Rights.


Patenting of transgenic plants

The progress of biotechnology industry in Europe resulted in research in the

production of transgenic plants. As genetic manipulation in micro- organism

was a success, there ware attempts to manipulate plants genetically. The

biotech industry was successful in genetically manipulating plants and in

inventing new plants. There was encouragement for the research in transgenic

plants through grant of patents. On the basis of the rationality in granting

patents on micro-organisms and biotechnological processes, patents were

being claimed on plants produced through biotechnological processes.

European Patent Office was of the opinion that patents might stimulate further

research in the industry on transgenic plants. The EPO was in favour of

applying the rationality of patenting micro- organisms and biotechnological

processes to similar patent claims on plants also. In Ciba Geigy implying the

stand of the EPO, the European Patent Office

Technical Board of Appeal granted a patent on a plant. The invention was

propagating material for cultivated plant, in particular, seeds of cultivated

plants treated with a chemical agent, i.e., oxime derivative, in order to make it

resistant to agricultural chemicals. A definition of cultivated plants in the

description included all plants, which yielded substances in any form.

Propagating material from such cultivated plants comprised all reproductive

plant components, including plants, which had begun to germinate. The

subject matter of the claim was not an individual variety of plant

distinguishable from any other variety, but the claim related to any cultivated

plants in the form of their propagating material, which had been chemically

treated in a certain way.94 By referring to the exclusions under the European

Patent Convention, the Board observed that Article 53(b) of the EPC

prohibited only the patenting of plants or their propagating material in the

genetically fixed form of the plant variety. It further opined that the

propagating material claimed was not the result of an essentially biologica, but

was a non-natural process of treating cultivated plants in the form of their

propagating material with a chemical oxime derivative according to a set

formula. The Board held that the claimed invention was a non- natural plant,

which was a result of treatment with chemical agents. By interpreting Article

53(b) of EPC restrictively the Board held that non-natural plants did not fall

within the purview of exceptions and are patentable. It was the first case

where non-natural plants produced through a biotechnological process were

claimed and patented in Europe. The decision established a rule that non-

natural plants were patentable under the EPC. Further in 1993, in Plant

Genetic Systems95 genetically modified plant cells and seeds were claimed

for patent. The invention related to the genetic engineering of plants and seeds

in order to make them herbicide resistant. Patent protection was claimed for

plants, plant cells, and seeds possessing a foreign gene capable of resisting a

type of herbicide. The invention intended to develop plants and seeds resistant

to a particular class of herbicides, allowed the plant to grow in the presence of

GSI The invention was opposed from patenting by reason of exception under

Article 53 of the EPC which states : ‘invention the publication or exploitation

of which would be contrary to “ordre public” or morality is excluded from the

purview of patent protection.’ The issues before the court for decision were of

much importance. This case happened to discuss all the provisions in

exception to patentability. Given the raging demand for patenting of living

beings including plants, the decision of the case was very significant. namely,

glutamine synthesis inhibitors (GSI)96. The claimed patent disclosed The

invention was opposed from patenting by reason of exception under Article 53

of the EPC which states : ‘invention the publication or exploitation of which

would be contrary to “ordre public” or morality is excluded from the purview

of patent protection.’ The issues before the court for decision were of much

importance. This case happened to discuss all the provisions in exception to

patentability. Given the raging demand for patenting of living beings

including plants, the decision of the case was very significant. The case had

defined important terms under the EPC and settled many issues that were

troubling the patent office in granting biotech patents. Irrespective of the

outcome, this case had discussed in detail about what constituted ‘ordre

public’ or ‘morality’, ’plant varieties’, ‘essentially biological processes’, and

‘microbiological processes’. Expressing its view on the concept of ‘order

public’ the European Technical Board of Appeal held that ‘ordre public’

covered the protection of public security, physical integrity of individuals, and

also the protection of environment. In that sense any invention the exploitation

of which was likely to breach public peace or social order threatening the

public security or which might seriously prejudice the environment were to be

excluded from patentability as being contrary to ‘ordre public.’the ‘common

heritage of mankind Discussing on the concept of ‘morality’ it was held that

‘morality was related to the belief that some behaviour was right and

acceptable, whereas some other behaviour was wrong. This belief was

founded on the totality of the accepted norms which were deeply rooted in a

particular culture.

Therefore, any invention not in conformity with the conventionally accepted

standards of conduct pertaining to the culture, was to be excluded from

patentability, being contrary to morality. Deciding on the issue whether

patents on seeds and plants went against public order and morality, it was

viewed that seeds and plants per se should not constitute an exception to

patentability under Article 53(b) of the EPC merely because they represented

‘living matter’ on the A survey and opinion poll conducted in Sweden and

Switzerland showed that farmers were neither willing nor against genetic

engineering and production of super crops such as herbicide-resistant plants.

At the same time the survey results showed that farmers were against

patenting of animals and plants. Considering the survey and opinion poll

result the

Board held that survey and opinion poll, being subject to influences and

fluctuations within short time periods in an unforeseen manner, did not

necessarily reflect ‘order public’ or moral norms and could scarcely be

considered decisive per se. Expressing concern over genetically modified

plants and biotechnology patents, the Board opined that plant biotechnology

per se could not be regarded as being more contrary to morality than

traditional selective breeding. It was noted that both traditional breeders, and

molecular biologists, or biotechnologists, objective was to change the property

of a plant by introducing novel genetic material in order to obtain a new and

possibly improved plant. It was also observed that genetic engineering

techniques of biotechnology are more powerful and capable of giving accurate

results and control over genetic modifications. While deciding whether plant

cells and seeds do constitute ‘plant variety’ which was excluded under Article

53(b) of the EPC, the Board held that any claim on or encompassing plant

variety was not patentable. The Board defined a plant variety to mean any

plant grouping within a single botanical taxon of the lowest known rank

characterized by at least one single transmissible characteristic distinguishing

it from other plant groupings and which was However the Board held that

genetically modified plant cells could not be considered as plant varieties. Due

to the current practice of the European Patent Office considering plant cells to

be ‘microbiological products’ it was held that plant cells did not come within

the meaning of plant variety. Further, it was held that plant cells resulting

from microbiological process were considered equal to bacteria and yeast,

which were undoubtedly patentable as per the current practice of the EPO.

Interpreting the concept of ‘essentially biological process’101 it was held that

it depended on the totality of human intervention and its impact on the results

achieved to differentiate a microbiological process from an essentially

biological process. The invention in question for the preparation of hybrid

plants was an essential modification of known biological process and it had

got decisive impact on the desired result of hybrid population. Hence, it is not

an essentially biological process and the exclusion of Article 52(b) of the EPC

did not apply. It was also held that the invention, genetically modified cells, is

a result of microbiological process which differs from an essentially biological

process The board happened to clarify with regard to what constitutes a

‘microbiological process’ and ‘products thereof’ under Article 53(b) of the

EPC. It was held that processes in which micro-organisms or their parts were

used to make or to modify products or in which new micro-organisms are

developed for specific uses were microbiological processes. The ‘products

thereof’, i.e., products of microbiological processes encompass products made

or modified by micro-organisms as well as new micro-organisms as such.

Hence, it was held that the invention of plant cells and seeds in question being

products of microbiological processes were potentially

patentable under EPC This case happened to deal in detail with the exclusion

provisions under EPC. The Board defined important concepts pertinent to

patenting of biotechnological inventions. It was held that plant cells being

products of microbiological processes were patentable. However, it was

decided that the claimed plant, if, encompassed a plant variety, would remain

excluded from patenting. In Ciba Geigy, exclusions were restrictively

interpreted to allow patents on plants, but in Plant Genetic Systems, a more

liberal construction of the exclusions was made in rejecting claims over

plants. This led to the inference that plants produced as a result of genetic

engineering were not patentable since the starting point of every such

invention would be a plant variety

In the meantime the European Union adopted a directive on biotechnology

inventions in the year 1998. The directive nullified the decision of the Plant

Genetic Systems case, in saying that ‘inventions concerning plants shall be

patentable if the technical feasibility of the invention is not confined to a

particular plant variety. Accordingly, now genetically modified plants are

allowed patents even if they encompass a plant variety. The directive requires

its member states to harmonize their law relating to the patenting of

biotechnological invention

Soon after the European Union adopted the directive on biotechnological

invention in Novartis case108 the European Patent Office Enlarged Board of

Appeals happened to decide again on the question of patenting of plants. The

claims were for plants genetically modified to render them resistant to fungi.

The enlarged Board of Appeals ruled that so long as specific plant varieties

were not individually claimed, claim for plants should not be excluded from

patentability. Overturning Plant Genetic Systems decision

Therefore, a patent cannot be denied only on the ground that claim

encompassed a plant variety. Claim that encompassed more than one variety

was thus patentable. The decision, however, nullified the decision in the Plant

Genetic Systems Case in holding a genetically modified plant patentable even

when it encompassed plant varieties and brought the EPC in line with the

European Union directive on the biotechnological inventions. Now, after the

decision in Novartis clarifying that patents could be granted though claims

might encompass plant varieties and the adoption of the directive stating that

genetically modified plants were patentable, plants produced through a

biotechnological process have became undoubtedly patentable Therefore, a

patent cannot be died only on the ground that claim encompassed a plant

variety. Claim that encompassed more than one variety was thus patentable.

The decision, however, nullified the decision in the Plant Genetic Systems

Case in holding a genetically modified plant patentable even when it

encompassed plant varieties and brought the EPC in line withthe European

Union directive on the biotechnological inventions. Now, after the decision in

Novartis clarifying that patents could be granted though claims might

encompass plant varieties and the adoption of the directive stating that

genetically modified plants were patentable, plants produced through a

biotechnological process have became undoubtedly patentable


Patenting of transgenic animals

Biotechnology is capable of manipulating any living being. As the impact

and influence of biotechnology in the plant kingdom was effective and

successful and deep-rooted with transgenic plants coming into being, it

happened with animal kingdom also. Efforts were made in the European

Union to manipulate animals with the aid of biotechnology. Biotechnology

was successful in changing the properties of existing animals or in

manipulating them. The result was transgenic animals and related inventions,

which were being claimed for patents. In the process of evolution of

biotechnology patent law there were claims for patents on different

biotechnological inventions such as micro-organisms and transgenic plants

also on transgenic animals.

The evolution of biotechnology patent law took another turn with patents

being claimed on animals. For the first time in the history of Europe an animal

was claimed for patent In Harward onco mouse.110 The invention involved a

transgenic mammal,111 an animal susceptible to cancer, which was useful in

cancer testing. Inventors produced transgenic mice possessing foreign genes

(oncogenes), which made it susceptible to cancer. The inventor claimed for a

method for producing a transgenic non-human mammal susceptible to cancer

and for a transgenic non-human mammal containing oncogenes. The method

involved introducing an activated oncogene sequence into a non-human

mammal at a stage no later than the eight-cell stagehe evolution of

biotechnology patent law took another turn with patents being claimed on

animals. For the first time in the history of Europe an animal was claimed for

patent In Harward onco mouse.110 The invention involved a transgenic

mammal,111 an animal susceptible to cancer, which was useful in cancer

testing. Inventors produced transgenic mice possessing foreign genes

(oncogenes), which made it susceptible to cancer. The inventor claimed for a

method for producing a transgenic non-human mammal susceptible to cancer

and for a transgenic non-human mammal containing oncogenes. The method

involved introducing an activated oncogene sequence into a non-human

mammal at a stage no later than the eight-cell stage

Initially, patent was refused by the European Patent Office (EPO) examining

division on the ground that the invention was against public order and

morality and also on the ground that the invention encompassed an animal

variety, which is excluded from the purview of patenting. European Patent

Convention under Article 53(a) prohibits patent protection for invention,

exploitation of which is contrary to public order and morality. At the same

time the convention under Article 53(b) prohibits inventions encompassing

animal varieties from patenting.112 The examining division interpreted the

above provision of the Convention to exclude animals from patenting. The

invention was viewed as contrary to public order and morality. Besides, the

claim for non-human mammal was considered as very broad in the light of the

invention describing only a method to produce transgenic mice.

In appeal, the EPO Technical Board of Appeal rejected the interpretation of

Article 53(a) and (b) of the EPC to exclude the present animal invention from

patentability. The Board opined that the examining division was wrong in

refusing the patent application on the ground of exceptions to patentability

under Article 53(a) and (b). As there was no specific mention of animal

invention whether patentable or not, it was inevitable on the part of the Board

to interpret the existing provisions of the Convention to decide the issue. The

Convention provides for exclusions for patenting and also exceptions to

patentability. It was opined that any invention that did not fall under

exclusions or exceptions to patentability is generally patentable. The Board

viewed that as per the language of the convention animal inventions were not

excluded from patenting. Therefore, the issue before

the court was to decide whether the claimed invention did fall under any of the

exclusions under the Convention. In this background the Board happened to

interpret and analyse exceptions to patentability under the Convention such as

‘order public’, ‘morality’, ‘animal variety’, ‘essentially biological process’,

‘microbiological process. While considering exception from patentability

under Article 53(a) of the EPC on the ground of ‘order public’ it was believed

that inventions of biotechnology had too many folds which had to be

considered carefully. These included the suffering of animals, besides,

possible risks to the environment which were to be weighed with the

usefulness of the invention to mankind. The Board remanded the case to the

examining division to examine the above. The examining division viewed that

‘the development of new technologies is normally afflicted with new risks’

and this is an experience mankind has gained in the past. Due to this, the

Board opined that there should be careful preponderance of the risk vis–a–vis

the positive aspects of such inventions. The Board viewed that if the risk

associated with the invention was more and could not be balanced with the

positive aspects of such invention it was likely to lead to the question of

‘public order’ and ‘morality’ and patent could be rejected. Where higher life

forms were involved in the new technology, it was not only the risk, which,

must be considered, but also the possible harm, likely to happen to such

higher life forms

In the instant case different interests were involved which required balancing;

One, there was the basic interest of mankind to remedy widespread and

dangerous diseases; two, the environment should be protected against the

uncontrolled dissemination of unwanted genes; and, three cruelty to animals

should be avoided. If the invention caused any kind of imbalance of

environment or suffering to animal, it would be justified to deny patents on

the ground of public order and morality.113 The Board opined that the

usefulness to mankind of the present invention could not be denied. Cancer

was one of the most frequent causes of death in many countries of the world

and also caused severe suffering. Any contribution to the development of a

new anti-cancer treatment was, therefore, a benefit to mankind and must be

regarded as valuable and highly welcomed by everybody. The present

invention gave rise to a smaller number of animals needed in corresponding

conventional testing. Such being the case, the present invention contributed to

a reduction of the overall extent of animal suffering. As there were no

alternatives to animal testing in the given context, animal test models were

indispensable for cancer research. Therefore, in the interest of mankind the

invention could be allowed though it gave rise to animal suffering

Considering the possible risks to the environment, on the release of

genetically modified inventions the Board had taken the purpose of the

invention into account. It was viewed that the purpose of the invention was to

provide animal test models, which were to be used exclusively in the

laboratory under controlled condition by qualified staff. Such being the case,

risk of uncontrolled release would not arise except on the possible misuse or

blatant ignorance on the part of the laboratory personnel carrying out the tests.

This should not be a ground to deny grant of patent. Concluding its discussion

the examining division held that the claimed invention was not immoral or

contrary to public order due to the fact that the invention was very useful in

cancer testing. Usefulness to mankind outweighed animal suffering . While

considering whether the invention constitutes ‘animal variety’ within the

meaning of EPC (a), which probibits animal variety from being patented, it

was viewed that the claimed invention was a transgenic animal and did not

constitute an animal variety. Considering the fact that European patents were

not granted for essentially biological process the Board found that the claimed

process involved insertion of an oncogene into a vector – in the present case

plasmid – which required to be microinjected into the egg at an early

embryonic stage, and this was not possible through essentially biological

processes. The Board viewed the claimed invention as a result . of

microbiological process, which is not excluded form patenting. The Board

considered ‘microbiological processes’ as an exception to the essentially

biological processes and held the same as patentable. It was opined that cells

and genes are microbiological material and any process which involve

microbiological material is a microbiological process

The Board considered the argument that the claim for producing non-human

mammalian was too broad as the invention described only a method to

produce transgenic mice. It was held that ‘a biological invention is considered

sufficient, it clearly indicated at least one way in which skilled person could

accomplish it. The method need not disclose all the ways of practising the

invention on different mammals. Hence, it was held that the disclosure of a

non-natural method to produce transgenic mice is enough to practise the

method on other non-human mammals and the claim for the method of

producing transgenic non-human mammals was valid; hence, eventually

patent was granted on onco-mouse. It was for the first time in the history of

European patent law that a patent was granted on a transgenic mouse. This

case led to interpretation and discussion in detail of the various provisions of

the EPC with vis-a-vis the patentability of biotechnology

inventions. This decision cleared all doubts as to the interpretation of EPC

exclusion provisions for patenting of biotechnology inventions. With this

decision now the EPC encompassed patents to transgenic animals produced

through biotechnology.

Exceptions to patentability under Article 53 of the EPC See supra 28, p. 153. See also supra 88, pp. 32-3. T 19/90 (1990)

OJEPO 476, Tech. Bd App; (1991) E.P.O, R.525, Ex. D. A mammalian is that animal that breastfeeds its offspring.

Human being is also a mammal as human beings breastfeed their offspring. See supra 92, pp. 62-7.See supra 88, p.

31.Article 53(b) of the EPC says essentially biological processes are not patentable. Bar of patenting of essentially

biological processes does not cover microbiological processes. The present invention is a result of microbiological

process wherein an oncogene is inserted

into the mice at an early stage of eight cells.


In fact, Europe was ahead of the United States in patenting living beings.

In 1969 in Germany, a patent was claimed on a method for breeding doves

with red plumage.83 German patent office rejected the patent on the ground

that the method was not repeatable and the Supreme Court of Germany

confirmed the same. It was the first case where a process for producing living

matter was claimed in the European Union. Seemingly, it was the first case to

open the door to the patenting of biotechnology inventions.84 Further, in the

early 1970s, five years before the United States Supreme Court decision in

Chakraburty case, the German Federal Supreme Court upheld patent

protection for new micro-organisms if the inventor were to demonstrate a

reproducible way for its generation.85 In the meantime the

European Union adopted the European Patent Convention laying down a

comprehensive framework on the law relating to patents. The above decision

of the German Supreme Court was proved controversial in view of the EPC

excluding the patenting of plant and animal varieties, or essentially biological

processes for their production. The German Supreme Court’s decision can

be viewed from the positive side of the EPC. The Convention excludes patents

for products of essentially biological processes but it does not exclude

patenting of products of non-biological processes. Therefore, it can be inferred

indirectly or impliedly that the EPC laid the foundation for patenting of living

beings. For the first time after the adoption of the European Patent

Convention, which seemingly laid the foundation for the patenting of living

beings in Genentech-I/Polypeptide expression86 a living being was claimed

for patent. The invention was a plasmid, a micro-organism suitable for

transforming a bacterial host, which included an expression control sequence,

or ‘regulon’ which could enable the expression of foreign DNA as a

recoverable polypeptide. The applicants invented a general principle for

enabling plasmids to control the expression of polypeptides (proteins) in

bacteria. The European Patent Appeals Board opined that only essentially

biological processes and concomitant products are excluded under the

convention,

but non-biological processes and products thereof are not excluded. Therefore

non-biological processes and the sequel products are patentable under the

convention. The Board viewed the present invention as a product of

biotechnological processes which in the opinion of the Board do not constitute

essentially biological processes. It was held that the present invention, not

being a product of essentially biological process, is patentable. The decision

of the Board represents the patent office approach in patenting products of

processes other than essentially biological processes. The decision assured the

inventors that patents are granted for products of biotechnological processes

and established the rule that micro-organisms

are patentable in the European Union.

Microbiological process is defined under the convention to mean ‘any process involving or performed upon or resulting

in microbiological material.’ See Chapter VI, Rule 23B(6) of EPC. See also, Article 2(1)(b). Biotechnology invention is

defined under the European Patent Convention to mean, ‘any invention which concern a product consisting of or

containing biological material or process by means of which biological material is produced, processed or used.’ See

Chapter VI, Rule 23B(2) of EPC.. Adelman et al. (1998), p. 156. See supra 28.Wagner (1976), p. 335.

4.6 PATENTING OF HUMAN CELL AND GENETIC MATERIAL

After transgenic animals it was the turn of human genetic material which

was claimed for patents in the European Union. As biotechnology achived

success in manipulating animals, its next target was to manipulate human

genetic material. Biotechnology is capable of isolating and purifying human

genetic material and exploiting commercially. Human genetic material such as

cells, genes, gene sequences, DNA, and DNA sequences and fragments are

being claimed for patents. Along with human genetic material, products of

such genetic material such as proteins, antibodies, etc., are also claimed for

patents. For the first time in Europe in Relaxin case the EPO happened to

decide whether human genetic material are patentable or not. The claim was

for a gene coding for a hormone called relaxin. The hormone was expressed in

the body of a pregnant woman during the time of delivery to relax the body

that laboured and suffered pain in delivering the baby. It was the first case

where a patent for genetic material was claimed. The patent was opposed on

the plea that human genetic material did not

constitute a patentable subject matter under the EPC. Further, it was argued

that patenting of human genes amounting to owning property rights

achievement in Hepatitis-B as many people were working for the same result.

The decision of the EPO Board favoured the biotech industry. However, the

House of Lords decision went against the desires of the industry. Both the

decisions came at the same time. But the decision of the EPO Board had

binding force throughout the European Union. The decision of the Board

brought human genetic material like; gene, DNA within the purview of the

patent law.

Hence, the situation now in Europe is that living matter produced through

biotechnology such as micro-organisms, plants and related inventions, animals

and related inventions, human genetic materials such as cells, genes, and DNA

and parts thereof are indisputably patentable. Though there are no specific

legislations on patenting of biotechnology, the existing patent laws have been

interpreted in such a way as to encompass patent protection to

biotechnological inventions resulting in the emergence of biotechnology

patent law within the existing patent law. The voyage of the emerging

biotechnology patent law started with patenting of micro- organisms. Later,

the plants were given patent protection, followed by patents on animals, and

finally granting patent protection to human genetic material. Probably, there

ends the voyage of biotechnology patent law as there is a

universal conviction in prohibiting human being from the purview of

patentability. As the international society is against patenting of human being,

the quest should end with patenting of human genetic material. Though the

law has evolved on biotechnology, the international society is worried about

the regulation of the biotech industry. As it is proved that biotechnology is

capable of manipulating any living being, it may move towards producing

transgenic human beings, which is against the ethical and moral standards of

the society. Such inventions may give rise to problems of public order.

Though the international society is committed to prohibit research on

transgenic human being in the consideration of developments

in the industry, it is felt that there is a need to regulate the field by evolving

proper and adequate norms, safeguarding the ethical and moral standards of

society

Meanwhile, in the background of enormous progress of the biotech industry

and strong demands for proper legal protection of biotechnological inventions,

and on account of the fact that there is inadequate protection to the

biotechnological inventions in the existing patent system, the European Union

adopted a directive on the legal protection of biotechnological inventions.

The directive is a major breakthrough in the evolution of biotechnology patent

law as it provides a blueprint on the legal protection of biotechnological

inventions. The directive acknowledges and respects various decisions by the

European Patent Office and its Technical Board in granting patents on non-

natural living beings produced through biotechnology. The directive gives

statutory recognition to the various judicial decisions hitherto made on the

protection of biotechnological inventions

Microbiological processes are patentable under the convention in contrast to essentially biological processes.

(1995) Official Journal of the European Patent Office 388; (1995) E.P.O R 541.

See Modern Law Review, 1998, p. 675.

Article 52.

4.7 ISSUES

CHAPTER 5

5.1 POSISITION IN INDIA

India as a member of the World Trade Organization (WTO) needs to conform to certain

agreements, which form the basis of the WTO. One such agreement is TRIPs which was a

culmination of discussions on the need for uniform laws regarding patents in the member

countries of the WTO. The TRIPs came into force on January 1, 1995,with immediate

effect but with certain exceptions for which provisions (specifically) for the members from

developing world) were made which were thought to come into force by the year 2000.

However, these provisions could be delayed for an additional period of 5 years subject to

certain conditions, implying that the deadlines was January 1, 2005 for achieving

compliance with the TRIPs Agreement.

To fulfill the TRIPs objectives, India amended the Patent Act, 1970, three times in a span

of 5 years. The first was in the year 1999, to give effect to the above said provisions and

thereby meeting the first deadline. Some of these provisions were made retrospective from

1995. The second was made in 2002 keeping in mind the same objective, which brought

the Indian law substantial compliance with the agreement. The latest amendment with an

objective of making the Indian Patents Act, TRIPs compliant came into force from January

1, 2005. In this connections, the deletion of Section 5 of the Indian Patents Act, 1970, and

amendments to certain definitions in section 2 made the Indian Act TRIPs complaint. The

important guidelines laid down by the TRIPs which are significant for patents in

biotechnology will be discussed in the following section.

TEXTBOOK OF BIOTECHNOLOGY

EDITOR H.K.DAS 4TH EDITION WILEY INDIA PVT.LTD PAGE NO 1287 22.3 TRIPS AND PATENT LAW

(WTO)WORLD TRADE ORGANIZATION AND TRIPS

TRIPs : Article 27

Article 27, Article 28, Article 29 and Article 30 are relevant for the IPRs

related to patents. Of these, Article 27 is an important article for amending the

patent law in the member countries and for the same reason is being quoted

below. The patent law that will be discussed in this chapter refers to the

amended Indian Patents Act, 1970, as in force January 1,2005.

The basic requirements of novelty, inventive step and capable of industrial

application have been laid down as the minimum criteria for determining the

patentability of an invention. Article 27.1 does not clearly define these

concepts, but leaves it to the member countries to decide and formulate the

law that will be applicable to their territory, keeping in mind the above

essentials.

Criteria for Patenting Inventions

Novelty is the first requirement. It indicates that the invention claiming a

patent must be new, which implies that it should be different from prior art

Prior art refers to any material published or act performed or anything known

in the world before the date of filing to the patent application. Certain

countries also require that the subject matter of the application has not been

publicly used or known or publicly demonstrated or disclosed in oral or

written form before the date of applying for the patent. All these clauses

basically signify that the subject matter of the patent application should not be

a part of the public domain when the invention is being claimed through the

filing of the patent application.

Inventive step requires that the invention is not obvious (also known as the

test of nonobviousness) to a person skilled in the art at the date and time the

invention was actually made by that person. Various courts have described the

presence of an inventive step in different ways, but have all emphasized the

necessity of the same.

Industrial application requires that invention should have practical use and

utility. In the US, any invention with utility attached to it without perceptible

industrial application finds its place as a patentable subject matter.

The second part of Article 27.1 refers to the nondiscrimination between the

various member countries, and most importantly the equality assigned to

inventions from all fields of technology. This is important since it implies that

biotechnological inventions cannot be denied patents because of their nature.

Article 27.2 states that members may exclude from patentability such

inventions as is ‘necessary to protect ordre public or morality, including to

protect human, animal or may be made merely because the exploitation is

prohibited by their law. This concept has been incorporated in Section 3 (b) of

the Patent Act. The term ‘ordre public’ has been stated as public order in the

Indian Patents Act, and it is substantially related to must contain an ‘enabling

disclosure’. This implies that the details of the invention must be disclosed in

such a manner so as to enable a person skilled in the art to use or essential,

since it serves the purpose underlying the grant of a patent, which is beneficial

statutory monopoly granted to the inventor. The time period accorded for

protection of the invention has been set uniformly, at 20 years, for all

categories of inventions. Article 33 of the TRIPs states that the ‘term of

protection shall not end before the expiration of a period of twenty years

counted from the date of filing’.

Article 27.3 of the TRIPs has been the cause of great controversy and

deliberations. The implications of this part of the Article are enormous.

Therapeutic and surgical methods are not patentable because they depend on

the skill of the doctor aor surgeon practicing the method, and therefore cannot

be patented as a process. The US is the only country where such methods are

patentable subject matter, but clauses for protection of medical practitioners

against the suits for infringement have also been provided.

Article 27 (3) a(b) clearly obliges member states to grant patent protection for

the following inventions:

1. Microorganisms;

2. nonessential biological process for the production of plants and

animals;

3. protection of plants is granted under the Sui Generis system of

protection that each state (member country) evolves for itself, or patent

protection or a combination of both.

However, Indian law provides protection in the form of the Plant

Variety Protection and Farmers Rights Act. The Indian Patent Act,

1970 will now be dealt with in detail.

Patent Law in India

The recent amendments to the Patents Act, 1970 have incorporated

many important changes that haave a singnificant bearaing on the patent law

in Indiaa.

Section 2 (1) (j) defines an invention’ as ‘ a new product or process

involving an inventive step and capable of industrial apaplication’. The term

‘inventivie step’ is defined in Section 2 (1) (ja), which states that ‘inventive

step means aa feature of an invention that involves technical advance as

comparaed to the existing knowledge or having economic significance or both

and that makes the invention no obvious to a person skilled in the art’

Patents Act, 1970.

Thus, the patentability requirements as per the Indian Patents Act are as

follows:

1. It should be new (novelty).

2. It should involve an inventive step (nonobviousness of the invention).

3. It should be capable of industrial application.

These sections lay down the minimum requirements of an

invention to be patentable. However, the invention should not be

covered by the list of exclusion provided in the Act. Section 3 provides

a list of whata are not inventions (exclusions) under the Indian Patents

Act which is discussed in detail in the next subsection.

Section 3: What are not inventions?

The following are not inventions within the meaning of this Act:

(a) An invention which is frivolous or which claims anything obvisouly

contrary to well establhished natural laws;

(b) An invenion the primary or intended use or commericla explitation

of which could be contrary to public order or morality or which

causes serious prejudcie to human, animal or plant life or health or

to the environment;

(c) The mere discovery of a scientific principle or the formulation of an

abstract theory or discovery of any living thing or non-living

substances occurring in nature;

(d) The mere discovery of any new property or new use for a known

substance which does not result in the enhancement of the known

efficacy of that substance or the mere discovery of any new property

or new use for a known substance or of the mere use of a known

process results in a new product or employs at least one new

reactant;

Explanation: For the purposes of this clause, salts, esters, ethers,

polymorphs, metabolites, pure form, particle size, isomers, mixtures of

isomers, complexes, combinations and other derivatives of known substance

shall be considered to be the same substance, unless they differ significantly

in properties with regard to efficacy.

(e) a substance obtained by a mere admixture resulting only in the

aggregation of the properties of the components thereof or a process

for producing such substance;

(f) the mere arrangement or re-arrangement or duplication of known

devices each functioning independently of one another in a known

way;

(g) (omitted);

(h) a method of agriculture or horticulture;

(i) any process for the medicinal, surgical, curative, prophylactic,

diagnostic, therapeutic or other treatment of human beings or any

process for a similar treatment of animals to render them free of

disease or to increase their economic value or that of their products;

(j) plants and animals in whole and any part thereof other than micro-

organisms but including seeds, varieties and species and essentially

biological processes for production or propagation of plants and

animals.

(k) A mathematical or business method or a computer program per se;

(l) A literary, dramatic, musical or artistic work or any other aesthetic

creation whatsoever including cinematographic works and television

productions;

(m) A mere scheme or rule or method of performing mental act or

method of playing;

(n) A presentation of information;

(o) Topography of integrated circuits;

(p) An invention which in effect, is traditional knowledge or which is an

aggregation or duplication of known properties of traditionally

known component or components.

Another exception given in Section 4 of the Patents Act is that

inventions relating to atomic energy are not patentable subject matter in India.

The requirements of the TRIPs agreement have been further complied

with by the Indian Patents Act, by the provision in Section 53 of the Indian

Patents Act, which cite the term of the patent, and states that the ‘term of

every patent… shall be twenty years from the date of filing of the apaplication

for the patent’. Therefore, during these 20 year, the patent holder can

commercially exploit the invention in the market, since he/she holds a

monopoly, or can authorize any other person to do so, or license such usage.

TEXTBOOK OF BIOTECHNOLOGY

EDITOR H.K.DAS 4TH EDITION WILEY INDIA PVT.LTD PAGE NO 1287 22.3 TRIPS AND PATENT LAW

(WTO)WORLD TRADE ORGANIZATION AND TRIPS

Patents in Biotechnology

It is important to discuss and understand the patenting of biotechnological

inventions in various jurisdictions including the Indian scenario. In the field of

biotechnology, the TRPs Agreement clearly excludes the patenting of plant

and animals. Following this, India has implemented the same, as given in Sub-

section (j) of Section 2 of the Indian Patents Act. Most countries have merely

complied with the given TRIPs provisions, but India has gone one step further

and excluded ‘parts of plants or animals’ from being subject matter of patent.

However, for the grant of patent the said invention should not fall under the

exclusions as given in the Indian Act (Section 3).

The biotechnology industry is devoed to the development of

commercially valuable therapeutic, biochemical and pharmaceutical products.

Many of these products and processes involve manipulation of DNA moeculs

and their encoded proteins. Methods of cloning genes and moving them

beteen organisms have become common place.

In the field of biotechnology a number of patents have been granted world

wide in the area of:

1. R-DNA technology;

2. Microorganisms’

3. Vaccines;

4. Polymerase chain reaction (PCR);

5. DNA/RNA and protein sequences;

6. DNA sequencing methods;

7. Hybridoma technology;

8. Stem cell technology;

9. Plant tissue culture;

In India, a number of the above inventions are patentable. However,

some of these are excluded from patentability (see Section 3 of the Patents

Act, 1970) as discussed above. Patents are granted to all processes and some

products involving R-DNA (R-DNAA) technology. The patents involving the

R-DNa technology are discussed in detail in the following subsection.

Patents in R-DNA Technology

R-DNA technology has been routinely and extensively used for the purpose of

manipulating the function of the genes to our advantage. R-DNA technology

begins with the isolation of a gene of interest. The gene is then inserted into a

vector and cloned. The commonly used vectors are bacterial plasmids and

viral phages. The gene of interest (foreign DNA) is integrated into the plasmid

or phage, and this is referred to as R-DNA. Before introducing the vector4

containing the foreign DNA into host cells to express the protein, it is cloned.

Cloning in necessary to produce numerous copies of the DNA because the

initial supply is inadequate to insert into host cells. Once the vector is isolated,

it is introduced into the desired host cells such as mammalian, yeast or

bacterial cells. The host cells then synthesize the foreign protein from the R-

DNA from which the foreign or recombinant protein can be isolated and

purified in large amounts.

R-DNA technology is not only an important tool in scientific research,

but it has impacted the diagnosis and treatment of diseases and genetic

disorders in many areas of medicine. Some of the many important functions of

F-DNA technology are: isolation of large quantities of pure protein,

identification of mutations, diagnosis of affected and carrier states for

hereditary disease, transfer of genes from one organism to another, and

mapping of human genes on chromosomes.

R-DNA is very useful for combating one of the greatest problems in

plant food production, the destruction of crops by plant viruses or insect pests.

For example, by transferring the coat-protein gene of the zucchini yellow

mosaic virus to squash plants that had previously sustained great damage

from the virus, it has been possible to create transgenic squash plants having

tolerance to this virus. Scientists have also developed transgenic potato and

strawberry plants that are frost –resistant; potatoes, corn, tobacco and cotton

that resist attacks by certain insect pests; and soybeans, cotton, corn and

oilseed rape (the source of canola oil) that have increased resistance to certain

weed-killing chemicals cailed herbicides. R-DNA has also been used to

improve crop yield. Gene that controls plant height, known as a dwarfing

gene, has been transferred from a what plant to other cereal plants, such as

barley, rye and oats. The transferred gene causes the new plant to produce

more grain and a shorter stalk with fewer leaves. The shorter plant also resists

damage from wind and rain better than taller varieties. R-DNA also has been

used to clone large quantities of the gene responsible for the cattle growth

hormone bovine somatotropin (BST) in the bacterium Escherichia coli. The

hormone is then extracted from the bacterium, purified and injected into dairy

cows, incr3easaing their milk production by 10% to 15%.

Gene splicing technique is one of the important techniques of R- DNA

technology. The use of gene splicing technique for animal food production has

become a common place strategy. Gene splicing involves cutting out part of

the DNA in a gene and adding new DNA in its place. The process is entirely

chemical with restriction enzymes used as chemical ‘scissors’. Depending on

the type of restriction enzyme used, different parts of the DNA can be

targeted. A specific enzyme will split apart a specific strand of DNA leaving

behind a gap in the genetic code where new DNA can then be added. The new

strand of DNA added binds to the ends of the DNA strands that were

originally cut. Another enzyme called ligase is used in this repair process. The

modified stretch of DNA fragment formed is called the R-DNA and it is

capable of expressing desired protein. Gene splicing process is carried out in

most cases to repair a defective gene, where the imparted function of the gene

is functionally modified, producing engineered include salmon, which has

been modified for faster growth, and trout, which has been altered so that

they are more resistant to infection by a blood virus.

Patentable Processes Involving R-DNAA Technology

1. Method of transforming cells or complete biological entity such as

microbes, plants or animals.

2. Method of cloning and expression of desired genes in the same or

different cell.

3. Method of optimizing gene expressions to produce useful thereapeutic

proteins.

4. Method of producing a transgenic plant or animal.

5. Method of screening and detection of specific DNA sequences.

6. Method of designing probes, primers, recombinant vectors.

7. Method of modifying genomic sequences.

Examples of some of the granted patents sufficient to comprehend the types

listed above are ‘Method of producing a vaccine for prevention or treatment of

gastric infection’, ‘Process for preparing a non-glycosylated human chorionic

gonadotropin hormone (BHCG) useful as birth control vaccine’, ‘A method of

producing killed Vibrio cholera vaccine’, ‘Process for preparation of a vaccine

against tuberculosis’ and ‘In vitro method of producing Hepatitis E viral (hev)

antigen used as a vaccine or for detection of anti-hev antibodies’.

Patentable Products Involving R-DNAa Technology

1. Different cloning vehicles (vectors) such as plasmids, cosmids,

phagemids, etc.

2. Probes, primers and oligonuleotides.

3. Vaccines and other useful proteins.

4. Transgenic/genetically modified organisms.

In a nutshell, subject matter considered to be aa product/part of this

technology comprises a major portion of all the biotechnology-related

invention. This technology protection in the biotech domain. The following

are some of the various biotechnology patents granted using the techniques of

R-DNA technology

However, patentability of processes and products emplying tools of R-

DNA technology to obtain higher living organisms has been a debatable issue

since a along time. The famous Harvard Oncomouse case (refer to Section

22.10) has been one such landmark case that was successful to agreat extent in

laying down the guidelines addressing this issue.

Article 37 (3) (b) of the TRIPs Agreement states that plants and animlas

other than miroorgaanisms and the processes for producing them shall not be

patentable, but the Member Stataes shalal provide a Sui Generis system or an

alternate form of protection or patent protection or a combination of both to

safeguard the new varieties evolved as a

Patent related to R-DNA technology

Result of genetic modification. India has enacted the ‘Protection of Plant

Varieties and Farmers Rights Act, 2002’ as the Sui Generis system for the

above mentioned purpose. However in the US, there exist three methods of

protection for plant- related inventions, namely the Utility Patent, Plant Patent

(PPA) and the Protection of Plant Varieties (under PVPA). Moreover, in the

US double protection for an invention is possible. Since the utility patents and

plant patents are more stringent forms of protection as compared to PVPA, the

US provides double protection. If it is a plant variety it can be protected under

the utility patent and PVPA.

The issue of patentability of animals is more controversial and will be

discussed in detail, with specific reference to the Harvard Oncomouse case,

which caused a lot of debate worldwide.

For a fair understanding of all the issues discussed so far, patenting of

the different aspects like genes, micro organisms, plants and animals will be

explained in detail in the next sections.

Patenting of DNA/RNA Sequences

A gene is a structural unit of inheritance in living organisms. It is a segment of

DNA that has a particular purpose, thata is it codes for a protein or a specific

enzyme. The strands of DNA on which the genes occur are organized into

chromosomes. Each gene or an organism provides a blueprint for the synthesis

(viaa RNA) of enzymes and other proteins at a specific time. Genes govern

both the structure and metabolic functions of the cells, and thus of the entire

organism. Genes located in reproductive cells pass their information to the

next generation.

Gene patenting is a abroad term that refers to the patenting of a process

that involves isolation of DNA or associated materials like RNA as well as

chemical substances related to DNA such as proteins and peptides. For

patenting of DNA/RNA sequences, ESTs, SNPs, the following steps should

be undertaken:

1. Identify novel genetic sequences;

2. Specify the resulting product from the sequence;

3. Specify how the product functions in nature (use);

4. Enable one skilled in the filed to use the sequence for its stated purpose.

More than 10,000 patent apaplications have been filed on genes or gene

sequences worldwide. Granting of gene patents encourages genetic

research. Patents help biotech companies to recoup the investments that

they employ in indentifying genes and their associated use, novel

medical applications like gene therapy and diagnostics. Moreover, to

have gene patents makes business sense, since it provides the patentee a

clear cut business advantage over his competitors. With a different

view, majority of researchers in the biotech area argue that gene /DNA

patents discourage investment in genetic research. The pharmaceutical

industry would certainly do better if firms were able to work freely with

any gene instead of focusing much on the patenting aspect.

The patenting of genes and /or DNA sequences is popular in the

US and the EU. In India, no product patent protection of DNA/RNA or

genes per se was allowed till January 2005. However, a process using

R-DNA technology to produce a protein involving a gene or DNA

sequence was a patentable subject matter. Under the process patent,

genes and protein sequences may be described in patent application.

Once genetic material, which may include a gene, a DNA sequence,

cDNA, expressed sequence tag (EST) or single nucleotide

polymorphism (SNP), has been isolated from its natural state and is

able to meet the criteria of patentability, only then a patent is granted.

For several years patent offices have granted product or process patents

for genetic material (especially in countries like the US and the EU).

5.2 EVOLUTION OF BIOTECHNOLOGY IN INDIA

EVOLUTION OF BIOTECHNOLOGY PATENT LAW IN INDIA

In the latter part of the nineteenth century, new inventions in the field

of art, process, method or manner of manufacture, machinery, apparatus, and

other substances produced by manufacturers were on increase in India and the

inventors became very much interested in getting their inventions protected.

Inventors were much concerned about the enforcement of their inventions that

others should not copy or infringe their inventions. In this background British

rulers enacted the first ever patent law in India, i.e., Indian Patents and

Designs Act, 1911, to offer patent protection to the inventions. Later, in the

light of changing economic and political scenarios the Act was thought as not

comprehensive and outdated. After independence, since 1953, there were

moves to consolidate the patent law by bringing up a new comprehensive

legislation. At last in 1970, government enacted the Patents Act of 1970. At

the time of this enactment biotechnology had already

started affecting the world, particularly in the United States and in the

European Union. In these countries claiming of biotechnology inventions for

patents started in the 1960s

The Patents Act, 1970, highlights that an invention that satisfies the

universally accepted requirements of patentability such as novelty, inventive

step, and industrial application is patentable. The Act defines invention to

mean any new and useful art, process, method or manner of manufacture,

machine, apparatus or other articles produced by a manufacturer and

includes any new and useful improvement of any of them. The Act does not

specify the inventions which are patentable, but it illustrates subject matters

that are not patentable. The Act in its original form allows patenting of

processes but it does not consider patenting of products. Further, Indian

Patents Act enacted in the year 1970 does not mention anything about

biotechnological invention. The reason was that at that time biotechnology

was not developed in India. After biotech industry started flourishing in the

United States and in the European Union some momentum developed in India.

Once patents were granted for different biotechnology inventions in the USA

and in the European Union the demand for adopting same approach gained

significance throughout the world including India. As a matter of fact, the

judiciary was responsible for the evolution of patent law on biotechnological

invention in the US as well as in the European

Union. Following some judicial intervention patent laws were suitably

amended and efforts were made to grant patents on biotechnological

inventions. This momentum set new trends in the history of patent law and

influenced the adoption of international conventions like Trade Related

Intellectual Property Rights (TRIPS). The agreement states that patents shall

be made available to all types of inventions in all fields of science and

technology. The agreement mandates patenting of biotechnology inventions in

the member states. After ratifying TRIPS, India modified all its intellectual

property laws including patents law and started marching towards patenting of

biotechnological inventions.

To fulfil its obligation under the TRIPS agreement to provide patent

protection to all kinds of invention in all the fields of science and technology

including biotechnological inventions, India has thrice amended its patent law.

The first amendment was made in the year 1999; this amendment was brought

into effect retrospectively from 1995. The basic objective of this amendment

was to provide for mailbox applications for agricultural and pharmaceutical

inventions. The amendment brought changes in the original.

Act to extend patent protection to inventions relating to manufacture of

chemical substances intended for use or capable of being used as food or as

drug. These changes are significant in the light of the prosperity of the

biotechnology industry which were by now capable of isolating genetic

material coding for certain chemical substances in any living being which are

useful in the preparation of drugs and medicine. In fact, the 1999 amendment

provides only for accepting patent applications claming for inventions relating

to agriculture and pharmaceuticals. After the amendment thousands of

applications were filed before the Indian patent offices claiming inventions

relating to pharmaceuticals and agricultural products, among which

considerable number of applications were relating to biotechnological

inventions like chemical substances isolated from the body of living beings.

However, all these applications were kept in mailbox which was opened on 1

January, 2005 and are now under processing

For the second time India amended its patent law in the year 2002 bringing

major changes in allowing patenting of products of chemical, biochemical,

biotechnological process as well as micro-organism. Chemical processes are

patentable under the original Act. However, 2002 amendment added

explanation to chemical process, which states: ‘Chemical processes include

biochemical, biotechnological and microbiological processes.’ As chemical

processes are patentable with the added explanation to it, now ‘biochemical,

biotechnological, and microbiological processes are also patentable.

Biotechnological inventions concer n biochemical, biotechnological, and

microbiological processes in producing non-natural, human-made, and

transgenic living beings such as micro-organisms, plants, animals, isolating

human genetic material, and also in producing the end products of such

genetic materials. Such being the case, the amendment is

significant in encouraging and promoting biotechnological inventions in India

as it seems to cover almost all the above-mentioned biotechnological

inventions. Till the time of this amendment the term ‘invention’ under the

patent law was encompassing only processes but the amendment included the

term ‘product’ within the meaning of invention. After the amendment, the

definition to invention stands as ‘a new “product” or process involving an

inventive step and capable of industrial application. After this amendment,

products as well as processes in all the fields of science and technology are

patentable in India. The amendment brought a few major changes in the Act,

which is worth discussing here. The amendment restructures Section 3 of the

original Act, which illustrates subjects which are not considered inventions or

which are not patentable. The amendment adds the following provisions to

Section 3 of the Act, which is significant in technology are patentable in India.

The amendment brought a few major changes in the Act, which is worth

discussing here. The amendment restructures Section 3 of the original Act,

which illustrates subjects which are not considered inventions or which are

not patentable. The amendment adds the following provisions to Section 3 of

the Act, which is significant in consideration of patenting of biotechnological

inventions

An invention the primary or intended use of commercial exploitation of which

could be contrary to public order or morality or which causes serious

prejudice to human, animal or plant life or health or to the environment.

Discovery of any living thing or non-living substances occurring in nature

Therapeutic and diagnostic or other treatment of human beings or animals

Plants and animals in whole or any part thereof other than ‘micro- organisms’,

but including seeds, varieties and species and essentially biological processes

for production or propagation of plants and animals

The above-mentioned subjects are not considered inventions and are not

patentable. These amended provisions incorporate TRIPS provisions under

Article 27 in the patent law. The amendment states that micro- organisms are

patentable but plant and animal varieties and essentially biological processes

for the production of the same are excluded from the purview of patent

protection. However, it is mentioned that the above exclusion does not apply

to microbiological processes and products thereof. In the sense

microbiological processes and products thereof are patentable. At the same

time it is further stated that discovery of any living thing is not patentable.

Discovery of a living thing existing in nature does not involve any human

interference and hence is not patentable. On the same lines natural things

produced out of natural or essentially biological processes, which do not

involve any human interference, are not patentable. It implies that a non-

natural process that involves some technical interference to a natural process

is patentable. Technical interference to a natural or essentially biological

process renders it non-biological, which is patentable. On the same lines

products of biotechnological process produced through some technical

interference to natural process are non-natural, hence patentable.

In March 2005, for the third time India amended its patent law. The

amendment recognizes Budapest treaty for the deposit of micro-organisms for

the purpose of patent procedure. Patent applications claiming biotechnological

inventions involving living matter shall be accompanied by a deposit of the

invention in any depository recognized under the treaty.

As it may not be possible to describe a biotechnology invention, the treaty

recognizes the practice of depositing the invention to compensate for the

written description. In order to fulfil TRIPS mandates of providing patent

protection to biotechnological inventions, India recognized the Budapest

treaty, which facilitates the deposit of biotechnology inventions. Further, the

2005 amendment totally omits Section 5 of the original Act which restricted

patents only to the methods or processes of manufacture. The 1999

amendment altered this section by inserting sub-clause (2), which provided

exception to the main provision for product patenting of drugs and medicines.

With the latest amendment totally omitting this section, now both products as

well as processes are patentable. In the field of biotechnology, processes as

well as products are claimed for patents. Biotechnology inventions such as

micro-organisms, and genetically modified plants and animals are products of

biotechnological processes. So these are

being claimed for patent. Further, methods or processes to manipulate living

beings genetically or to produce genetically engineered living beings are also

claimed for patent.

The emergence of biotechnology patent law in India can be traced back to

the TRIPS agreement and the amendments made to the patent law by virtue of

TRIPS agreement. But even earlier to implementing the TRIPS agreement a

patent on a living being was granted. Dominico, a subsidiary of American

Home Remedies, was granted a patent on a process for the preparation of

infectious bursitis vaccine. The vaccine is useful in protecting poultry against

infectious bursitis. Initially, the patent office rejected the patent claim and an

appeal was made to the Calcutta High Court. The High Court held that there is

no bar for patenting a claim on a living being or living process. The Court

interpreted the term ‘manufacture’ under the patent law to include any living

being or living process and directed the patent office to grant patent. It was the

first instance where a living process was patented in India

With the amendments made to the patent law fulfilling obligations under the

TRIPS agreement there emerged biotechnology patent law in India. Unlike in

the United States and European Union where biotechnology patent law is a

result of judicial pronouncements, in India the emergence of biotechnology

patent law is a result of ratifying international conventions and obligations

under such conventions. Having ratified the TRIPS agreement, which

mandates for patent protection to biotechnological inventions, in India micro-

organisms are now patentable. However, the stand of India is not very clear

with regard to the patenting of non-naturally produced plant, and animals. We

shall have to wait and see whether India follows the path of the US and

Europe in holding non-natural living beings produced through

microbiological, biochemical, and biotechnological

processes as patentable or not

Further, research in human genetics (one among different spheres in

biotechnology) is not lagging behind too far in India. On account of enormous

potential of human genetics research there is a definite growth in the sphere of

human genetics, in India. In the absence of legal provisions on the regulation

of human genetics, the Indian Council of Medical Research (ICMR) brought

guidelines to regulate research in human genetics. The guidelines basically

focus on the ethical issues involved in human genetics and intend to safeguard

ethics and human rights in the human genetic research. The guidelines provide

for a comprehensive mechanism for the regulation of human genetics with the

establishment of ethics committees to evaluate research in human genetics. In

the absence of legal framework on the issues and the guidelines hold good.

Meanwhile, the Government of India is thinking of introducing legislation on

the basis of the guidelines issued by the ICMR. Further, the Government of

India brought DNA safety guidelines in the year 1994 to regulate the use,

storage, and release of genetic material in research. The DNA safety

guidelines are considered as a pre-arrangement for ensuring safety in usage of

biotechnological products and processes, which are offered protection by

virtue of amendments made to the patent Act. The consequences of such

patenting such as use of biotechnological inventions like DNA and gene

should be regulated and safety should be ensured. The DNA safety guidelines

intend to ensure safety in using, and storing of DNA and genes for research in

biotechnology. It can be inferred that as far as biotechnology and its

regulation is concerned, India is not lagging behind too far as it has got

considerable legal mechanism to patent, regulate, and monitor

biotechnological inventions.

Many foreign biotech companies have filed patent applications in India on

different biotechnological inventions. Till date, there is no substantive case

law or patent office reports or records in India on the patenting of

biotechnological inventions. It is expected that in future there may be judicial

pronouncements and patent office reports on the patenting of biotechnological

inventions as India is turning out to be a biotech hub in the near future. As

biotechnological inventions are based on biological sources, as the starting

point of any biotechnological invention is biological material, having

enormous biological resources in India is going to generate definite growth in

the biotech industry. Recognizing the significance of the upcoming sector of

biotechnology in the present world, the government of India has come out

with certain strategic plans to boost the industry. Further, the Government of

India has announced special assistance and scholarships for studies and

research in biotechnology to boost expertise and manpower in the sector.

Besides bringing changes in the patent law to give protection to

biotechnological inventions, having made all the legal arrangement, India is

ready to face the challenges that may arise as a result of biotechnological

inventions and researches in different spheres

On the whole the evolution of biotechnology patent law can be traced back to

the Constitution of America, which intends to foster the progress of science

and technology. The US judiciary has played an important role in the

emergence of biotechnology patent law through its interpretation of the patent

law. The liberal approach of the US judiciary was supported by the US Patent

Office by granting patents on biotechnological inventions. The suits in US

judiciary and the patent office were followed by other nations. Initially the

European Union was ahead of the US as there were patent claims on

biotechnological inventions involving life. However it was the US judiciary

which gave green signal to the emergence of biotechnology patent law

through its judgment in Chakraburty. The decision in Chakraburty is a

milestone and is the starting point in the evolution of biotechnology patent

law. The decision had its far-reaching impact where it influenced the entire

world. Even today, courts while adjudicating matters involving biotechnology

inventions, and patent offices, while granting patents on biotechnology

inventions, follow the rationality of Chakraburty.

The approach of the US is very liberal. Their philosophy is that anything

under the sun made by man is patentable. The evolution of biotechnology

patent law is heavily influenced by this philosophy evolved by Thomas

Jefferson, the author of American patent law. The European Union was quick

enough to follow the philosophy of America in liberally interpreting the

existing patent laws to provide patent protection to biotechnological

inventions. Later, the entire world including India followed the US cases by

amending their local laws or bringing suitable legislations to give patent

protection to biotechnological inventions. Meanwhile, the TRIPS agreement

also postulates patenting of inventions in all the fields of science and

including living beings produced through biotechnology. It is felt that the

coming into being of the TRIPS agreement has streamlined and uniformed

the law relating to biotechnological inventions. Though having faced strong

oppositions and objections the evolution of biotechnology patent law is

complete and all inventions of biotechnology like micro-organisms, plants,

animals, and human genetic material including different methods to produce

the same are now considered patentable

Patents Act as amended in March 2005 India allowed filing of mailbox patent applications on agricultural and

pharmaceutical

inventions from 1999. Many of those applications contain claims for biotechnological

inventions in relation to agricultural and pharmaceutical industry. On 1-1-2005 mailboxes

were opened for the processing of applications. Since 2002, by amending patent law, patents

are made available to living beings produced through biotechnology and on patent

applications living beings started pouring in. Finally with the 2005 amendment, all the

requirements for giving patent protection were fulfilled.

5.3 PATENTABLITY SUBJECT MATTER IN INDIA

Patentability of Biotechnology Inventions

Inventions are patented on the basis of certain criteria. It is universally

recognized that an invention must satisfy a few requirements such as novelty,

non-obviousness, and industrial applications and written description before a

patent is granted. It is important to note that the three universally recognized

criteria of patentability, namely, novelty, non-obviousness, and industrial

applicability or utility applies to all inventions including biotechnological

inventions. However, patenting of life or living beings produced through

biotechnology commands special attention due to inherent complexities of the

nature of biotechnology inventions. Difficulty is felt in patenting a living

being mainly due to the following three reasons

It is doubtful whether patent protection will be granted to living matters.

Biotechnology inventions are difficult to describe.

How to consider biotechnological new finds : as inventions or as discoveries.

It is felt that the requirements of the traditional patent law are not

enough to test the patentability of biotechnological inventions. In case of

biotechnological inventions it is quiet difficult to differentiate between an

invention and a discovery. Since biotechnological inventions involve living

beings, it requires special attention before a patent is granted. Due to the

inherent complexities and technicalities, sometimes biotechnological

inventions cannot be described in the written specification. To overcome this

problem a solution was evolved in the form of deposit of the invention in any

recognized depositories. The Budapest treaty recognizes international

depositories where inventions related to living matter can be deposited and

maintained for the purpose of patent protection. The deposit of the invention

enables the patent examiner to test the genuineness of the invention before

Jayashree Watal, Intellectual Property Rights in the WTO and Developing Countries, New

Delhi : Oxford University Press, First published 2001, Third impression 2002, p. 132.

M.S. Swaminathan. An Introduction to the Guiding Principles in the Decisions on Patent

Law, Delhi: Bahri Brothers, 2000, p. 331.

Budapest treaty, 1977, provides for the establishment and recognition of international

depositories to deposit inventions of life forms and other biotechnological inventions for

the grant of patent along with the patent application.

Budapest treaty was signed and done at Budapest, in 1977. Any member of the Paris

Convention may become party as per Article 15 of the treaty. See, Manish Arora, Guide to

Patent Law, Delhi : Universal Publishing Co., 2000, p. 410.

the grant of a patent. It is recommended that in case of claiming

biotechnological inventions for patents, the deposit of the invention shall

accompany the patent application. Therefore, a biotechnological invention

must satisfy the requirement of deposit of the invention along with the usual

patentability requirements. Hence, it is inferred that patentability of

biotechnological inventions depends on satisfying the regular requirements

under the patent laws along with the deposit of the invention. The essential

requirements that a biotechnological invention or an invention involving

living beings must meet the following criteria to be eligible for patents:

Patentable subject matter.

Novelty

Non-obviousness (inventive step).

Industrially applicable (utility).

Written description of disclosure of the invention and the deposit of the

invention

PATENTABLE SUBJECT MATTER

The first and foremost requirement is that an invention should fall within the

ambit of patentable subject matter. Inventions falling within the purview of

patentable subject matter are only eligible for patent protection. The

components of patentable subject matter were not initially uniform in different

countries. However, with the coming into being of TRIPS, there is uniformity

in bringing inventions within the scope of patentable subject matter in broad

terms. It states that patents shall be made available for any invention, whether

products or process, in all fields of technology provided that they are new,

involve an inventive step, and are capable of industrial application. It further

states that patents shall be available without discrimination as to the place of

invention, the field of technology, and whether the products are imported or

locally produced. However, members states of the TRIPS agreement may

exclude from patentability inventions, including inventions of life forms of

biotechnology, on grounds of public order, morality, protection of human,

animal or plant life, or health, or to avoid serious prejudice to the

environment. Members states may also exclude from patentability and also

diagnostic, therapeutic and surgical methods for the treatment of humans or

animals; plants and animals and essentially biological processes for the

production of plants or animals. However, it is believed that micro-

Article 27 of the TRIPS agreement.

Kevin W. Meccobe, ‘The January 1999 review of Article 27 of the TRIPS agreement, for

diverging views of developed and developing countries toward the patentability of

biotechnology’, Journal of Intellectual Property Law, Fall, 1998. See also 6J. Intelle. Prop.

L.41.

The TRIPS agreement Article 27, sub-clauses (2) and (3).

organisms, plants, and animals produced through non-biological or

microbiological processes could be patented under the agreement. Therefore,

it is inferred that biotechnological inventions resulting out of biotechnological

processes, which do not come within the meaning of essentially biological

processes, are patentable.

Invention v. Discovery

It is universally accepted that patents are given for inventions and not for

discoveries. It has long been established that discoveries are not patentable.

Invention is something newly designed or created or the activity of designing

or creating new things. Discovery is the act of finding something that had not

been known before. The term invention is not defined under TRIPs or under

other international conventions on patents like the Paris convention or the

Patent cooperation treaty. Even the recent European directive on

biotechnological invention does not define the term invention. The US patent

statute defines the term invention to mean any invention or discovery. As per

the US patent law, there is no difference between an invention and discovery.

However, discovery amounts to the finding of a thing that is existing in the

nature but not known before, whereas invention means creation of design of

something totally new that was not there before.

The philosophy of patent law states that inventions can be living things.

At the same time discoveries can also be living things. It is believed that

discovery of living beings existing in nature is not patentable but inventions of

new living beings that do not exist in nature are patentable. It is felt that a

discovery does not involve creation or design of new thing, hence, it is not

patentable. Almost all patent laws throughout the world say that discoveries of

substances found in nature do not constitute an invention and are excludable

from the grant of patent. Strictly speaking, inventions of biotechnology are not

totally new but are manipulated living beings found in nature. Therefore, there

is a need to draw a distinguishing line between a discovery and an invention in

the light of patenting products of

All unicellular organisms with dimensions beneath the limits of vision, which can be propagated and manipulated in a laboratory, are termed as micro-organisms. Micro- organism includes bacteria and yeasts as also fungi, algae, protozoa, plasmids, viruses. P.K. Vasudeva, Patenting Biotech Products: Complex Issues EPW Commentary, 14-20 October, 2000. Cambridge Dictionary of American English, Cambridge : Cambridge University Press, 2000.

Paris convention for the protection of industrial property, 1983, as amended in 1979. Patent cooperation treaty, 1970, modified in 1984 European directive on the legal protection of biotechnological inventions, 1998. United States Patent Act, Section 100 Dr K.V. Swaminathan. An introduction to the Guiding Principles in the Decisions on Patent Law, Delhi : Bahri Brothers, p. 224.

A mere discovery of something that exists in nature, forming part of the state of the art

(prior art) is not patentable. Dr T. Ramakrishna, Biotechnology and Intellectual Property Rights, Bangalore : Centre for Intellectual Property Rights Research and Advocacy (CIPRA), National Law School of India University, 2003.

biotechnology. The very first objection against patenting of living beings is

that living beings are discoveries or products of nature existing and found

in nature. In fact, biotechnological inventions are based on products found

in nature.

The starting point or raw material for these inventions is biological

material found in nature. It is believed that finding of biological things

existing in nature amounts to discovery. It is also believed that the

manipulation of pre-existing biological resources in nature gives rise to

biotechnological inventions. Perhaps human intervention makes a product of

biotechnology different from a natural biological product. Human intervention

to the biological resources yields new, non-natural, man-made, and hitherto

not existing living beings. Here the distinction between a pre- existing

biological product and a human-intervened, human-made, biotechnological

product is very thin. The distinction relevant to patentability, between the

‘discovery’ of something that exists in nature and the invention and creation

of something new, involving a predetermined degree of human effort, or

invention is, in practice, difficult to make in the field of biotechnology. One

of the contentious issues raised on aspect of biotechnological inventions is

that of the extent to which the traditional concept of invention can be applied

to protect these inventions.

Biotechnology is notable for designing or creating new things that were

not existing hithesto. Biotechnological inventions are the sequal of human

ingenuity and intellect to the existing natural resources. Finding of biological

things in nature amounts to discovery. However, adding human ingenuity to

such biological things gives rise to an invention. Therefore, till the addition of

human ingenuity a biological product remains a discovery and the application

of the human ingenuity thereafter makes it an invention. However, the

complication arises due to the fact that it is becoming increasingly difficult to

determine where ‘discovery’ ends and ‘invention’ begins. This issue is

resolved more through judicial decisions and patent office practices on the

facts and circumstances of each case rather than through clear-cut criteria laid

down in law.

The case law pronouncements have made it clear that finding of a product of

nature is a discovery. A product of nature becomes a product of man due to

the intervention of human being or due to the application of human ingenuity.

It is to say that, a product of nature through some human intervention becomes

product of man. This human intervention to the product of nature gives it a

new existence, making it possess some special features which it did not have

earlier, thus making it an invention. On the whole it creates a new living entity

with some special characteristic features, which were not in existence earlier.

Therefore, product of nature through some human intervention becomes a

product of man, which does amount to an invention. On the same lines the

process of isolating living entities from its natural surroundings in purified

form is patentable. Further, the

result of such a process, the natural living entities in the isolated and purified

form, are also patentable.

See supra 1, pp. 132–3. See supra 15, p. 329.

1. Patentable subject matter in India

In India only inventions are patentable but not discoveries. There is a clear

distinction between inventions and discoveries as the law specifies that only

inventions constitute patentable subject matter. Indian patent law defines

invention under Section 2(j) to mean: a new product or process involving an

inventive step and capable of industrial application. Here inventive step means

a feature that makes the invention not obvious to a person skilled in the art.

Indian patent law does not provide for subjects that are not patentable, instead

it does provide what is not patentable. Indian patent law provides for an

illustrative list where is has mentioned the subjects that are not patentable.

Any subject matter, which does not fall within the purview of the

illustrated list, does constitute a patentable subject matter. The list has

been updated and modified to comply with the provisions of the TRIPS

agreement. The Indian Patents Act states that the

The European Union Directive on the legal protection of biotechnology inventions,

1988,

Article 5. See Jasmine Chambers, ‘Patent eligibility of biotechnological inventions in

the

United States, Europe and Japan’. How much patent policy is public policy, George

Washington International Law Review, 2002.

European Union directive on the legal protection of biotechnology invention, 1998.

Leslie G. Restaino, Steven E. Halpern, and Dr Eric L. Tang, ‘patenting DNA related

inventions in the European Union, United States and Japan: A trilateral approach or

a

study in contrast?’ UCLS Journal of Law & Technology, J.L & Tech.2, 2003. The

Patents of India (as amended in 2005), Section 3.

The Indian Patents Act, as amended in 2002. India having signed the TRIPS

agreement

has made necessary amendments to its patent law to fulfil its obligations under the

agreement. The coming into being of the TRIPS agreement has made

biotechnological

inventions universally patentable.

following are not inventions and do not constitute patentable subject

Matter.

1. Inventions against natural laws.

2. Inventions contrary to public order and morality.

3. Discovery of a living thing occurring in nature.

4. A claim for a duplication of an earlier work.

5. Methods of treatment for human beings or animals.

6. Plants and animals in whole or in part, and essentially biological

processes for the production of plants and animals.

However, micro-organisms and such other inventions of biotechnology,

both products as well as processes, do constitute patentable subject matter.

India has amended its patent law in 2002 to bring life and living beings

created through biotechnology within the purview of patentable subject

matter. The original patent act states that chemical processes do form part of

patentable subject matter. The term chemical process is redefined through

amendments to include biochemical, biotechnological, and microbiological

process. As per the modified definition of the chemical process it is implied

that biotechnological processes and products of such processes are

unambiguously patentable. However, there are no decided case laws in India

on the patentability of biotechnological inventions. Meanwhile, patent laws

universally exclude certain inventions from the purview of patentable subject

matter. An invention, which falls within the purview of exclusions, cannot be

patented though it satisfies the requirements of novelty, inventive step, and

usefulness. The following inventions including certain biotechnological

inventions do not constitute patentable subject matter:

(1) Discoveries.

(2) Inventions against public order and morality, such as:

(a) Human body, discovery of its elements and genes in natural form

(isolation of human genes and gene sequences are patentable if isolated

by technical means), processes for cloning human beings;

(b) Processes for modifying the germ line genetic identity of human beings;

uses of human embryos for industrial or commercial purposes; and

For illustrative list of subject matters not patentable under the Act see, Sec. 3 of the

Indian Patents Act as amended in 2002. See Manish Arora, supra 4.

Inserted by amendment in 2002, to comply with the provisions of the TRIPS. Section 3

of the Indian Patents Act, as amended in 2002.

Indian Patents (Amendment) Act, 2002.

Section 5 of the Indian Patents Act as amended in 2005. With the amendment in 2002

chemical processes are given meaning to include

biochemical, biotechnological, and microbiological processes. See explanation given for

chemical process under Section 5 of the Act.

processes for modifying the genetic identity of animals which are likely to

cause them suffering without any substantial medical benefit to man or

animal, and also animals resulting from such processes.

(3) Plants, animals, and essentially biological processes. (Microbiological

and non-biological processes and products resulting from such

processes seem to be patentable.)

After the Chakraburty decision in the United States, throughout the

world living beings were recognized as patentable subject matter. As the

biotechnology industry progressed and engendered modern-day miracles of

enormous human values, there was a strong demand to include biotechnology

— invented living matter within the realm of patentable subject matter. Due to

the enormous impact of the field of biotechnology on the society and on the

day-to-day life of human being, it was considered necessary to include

biotechnology inventions within the gamut of patentable subject matter. This

proposal has got a strong back push from the decisions of the law courts of the

United States and Europe as well as from the practices of the United States

and the European Union patent offices.

Given the fact that research in biotechnology is growing day-by-day

promising many things to mankind, now patentable subject matter is believed

to include novel, non-obvious microbes, plants, animals, natural and synthetic

compounds, genes, proteins, DNA, RNA, recombinant cells, proteins

expressed by genes in recombinant cell lines, and methods of expressing

protein in animals and mammals. Methods of preparing proteins, processes for

recovery of proteins, processes for medically delivering recombinant proteins

and methods of altering natural properties of plants such as stress, disease, or

pest resistance are also recognized as patentable subject matter. The TRIPS

agreement has changed the contours of patent law by recognizing

biotechnological inventions as patentable subject matter. Now universally,

biotechnology inventions do constitute patentable subject matter. There are a

few universally accepted requirements such as novelty, inventive step,

industrial application, and written description on satisfaction of which

biotechnological inventions are patentable.

Howard B. Rockman, Intellectual Property Law for Engineers and Scientists, New

Jersy :

Wiley Interscience 2004.

TRIPS agreement aims to make available patents irrespective of the field of

inventions or

place of work. See Article; 27 sub-clause (1). See, European patent Convention Art.

5See

S. 35.U.S.C, Section 101. See, UK Patent Act, 1977, and also the Indian Patents Act

as

amended in 2002. Ramappa, Intellectual Property Rights under WTO, Tasks

beforeIndiaNew Delhi and

Allahabad. Wheeler Publishing, 2000, p. 133. TRIPS came into force from 1 January,

1995

for developed countries for developing and least developed countries there was

given a

transition period of ten years, which ended on 1 January, 2005. Now TRIPS

agreement in force for all the member states throughout the world.

See supra 1.

2.NOVELTY OF BIOTECHNOLOGICAL INVENTIONS

If an invention falls within the scope of patentable subject matter, the next

step is to test its novelty. As per the first modern patent statute enacted in

Venice in 1474, every person who shall build any new and ingenious device,

not previously made, shall be granted an exclusive right to use and operate the

device. The TRIPS agreement says that patents shall be available for any

inventions, whether products or processes, in all fields of technology provided

they are new. Any person who contributes some thing new to the society,

who brings out something novel, hitherto not known to the society, is eligible

for patent grant.

Novelty of biotechnology inventions in India

Novelty is not defined in the patent law of India. But invention is defined to

mean a new product or process involving an inventive step and capable of

industrial application. The Indian Patents Act defines inventive step and

industrial application but it does not define the term novelty. Hence it is left

to the patent office and the courts to define and mean the term novelty. As per

the definition given to the term invention a subject matter must be new to

constitute an invention. The Patents Act specifically states that a few subject

matters are not inventions. In doing so, it indirectly states that such subject

matters are not novel or new. In particular, subject matters such as discoveries

and finding of a living thing or substances occurring in

Article 53 of the EPC.

See decisions in oncomouse, plant genetic systems, Novartis, and Biogen.

The availability of a full-length gene does not preclude the novelty of a DNA fragment

coding for such gene. See supra 70.

Section 2(1)(j) of the Patents Act of India as amended in 2005.

nature are considered as not new and do not constitute an invention. Further,

plants, animals, and essentially biological processes are not considered new

and do not constitute an invention.

However, micro-organisms are considered new and can be patented.

Further, human genetic material in isolated and purified form is also

considered new invention. For the first time in the history of Indian patent law

a living process was claimed for patent. The process was useful in preparation

of a vaccine against infectious disease in poultry. The applicants contended

that the process was new and was patentable. The patent office initially

rejected the patent on the ground that it was a living process, which as not

new, and the same did not constitute invention. In appeal the Calcutta High

Court held that there is no bar in the patent law to patent a new living process

or living product. The High Court accepted the contention of the applicant that

the claimed living process is new and directed the patent office to grant patent

on the invention.

In the light of the TRIPS agreement considering biotechnological

inventions as new, India being a signatory to the agreement, amended its

patent law to implement the agreement. Now with the amendments to the

patent law biotechnological inventions, both products and processes, are

considered new. There was no strong debate in India unlike in the US on the

novelty of biotechnological inventions. As the matter is settled in developed

countries like the US and in the European Union that biotechnological

inventions are novel over and above the pre-existing biological products there

was no difficulty for India to follow suit.

3. Inventive step of biotechnology inventions in India(Non –

obviousness)

In India patents are granted for inventions involving an inventive step.

Inventive step is defined to mean a feature that makes the invention not

obvious to a person skilled in the art. Any new product or process that

involves an inventive step is patentable in India. In India the patent law

provides that when an application for patent is made, the patent examiner will

have to conduct an investigation to find the relevant prior art. If in the

investigation it is found that the invention has been anticipated by publication

in India or elsewhere before the date of the applicant’s filing of the complete

specification, the patent shall not be granted. In such circumstances the

invention falls within the realm of prior art, the knowledge in the public

domain involving no inventive step. Such knowledge in the public domain

being obvious to a person skilled in the relevant art shall not be given patent.

The requirement is no different with reference to biotechnology inventions.

However, there is no substantive case law development with regard to

inventive step in the biotechnology inventions in India.

For the first time in India inventive step involved in a biotechnology

invention had come before the courts in Dimminaco A.G. v. Controller of

Patents Designs & others The Calcutta High Court was confronted with a

question whether the claimed invention relating to a process for preparation of

infectious bursitis vaccine did involve inventive step and whether the claimed

subject matter constituted invention under the Indian Patents Act. The vaccine

was useful for protecting poultry against contagious bursitis infection. The

inventors contended that the process claimed involved certain chemical steps

under specific scientific conditions. The patent office initially rejected the

patent application by stating that living virus or living process did not

constitute invention under the Indian Patents Act. However, the Calcutta High

Court held that there was no statutory bar to patent living processes or product

that involved inventive step. In the instant case the process claimed did

involve certain inventive step, as it required certain chemical steps to be taken

in the production of the vaccine. The High Court directed the patent office to

grant patent on the claimed process. Therefore, as per the decision of the

Calcutta High Court a biotechnology invention involving a new process or

product could be patented if it involved an inventive step. Further, as per the

patent law if the invention was anticipated

The Indian Patents Act as amended in 2005, Section 2(j) : Invention.

Ibid. Section 2(ja) Inventive step. Indian Patents Act as amended in 2005.

Under the Indian Patents Act, the examiner is a person who will scrutinize the patent application

and conduct patent search to find relevant prior art.

191. The Indian Patents Act (as amended in 2005). Section 13, sub-clauses (1) to (4), See

also Manish Arora, Guide to Patent Law, Universal Law Publishing Co. Pvt. Ltd, Delhi,

2002, pp. 27-8.

192. See supra 17, p. 38.

in the prior art or is published, used, or patented, it did not involve an

inventive step. In case of biotechnology inventions also the claimed invention

did not constitute an inventive step if it was anticipated or published or used

or patented earlier or in any way formed part of the prior art.

However, nowhere in the United States patent law or in the Indian

patent law the term prior art is used or defined. The European Patent

Convention uses the term ‘state of the art’ which is equivalent to prior art and

states that state of the art comprises everything that is made available to the

public by means of a written or oral description or by use in any other way

before the date of filing of the European patent application. The United States

patent law, the European Patent Convention, and the patent law in India state

that any invention which is known or published or patented, being part of the

prior art, is obvious and does not involve inventive step. Therefore, an

invention, which is a part of the prior art, does not involve inventive step and

is not patentable. The invention shall be a leap forward from the state of the

art or it shall be a step forward from the already existing knowledge that is

prior art. It shall be an advancement of existing knowledge in the public

domain. It implies that courts while determining the obviousness of any

invention shall have to consider the scope of the prior art. In fact, law courts

have taken into consideration the knowledge in the public domain or the state

of the art in deciding the obviousness of an invention. The presumption is that

on the basis of prior art, if an invention becomes obvious to the person having

skill in the relevant art, such invention does not constitute an inventive step

and must not be patented.

4. UTILITY OR INDUSTRIAL APPLICATION

An invention must be useful and capable of industrial application in order to

be patented. There must be some demonstrable utility or specific benefit from

an invention. The invention must have some practical utility in the form of

immediate benefit to the public. As regards the conditions of industrial

applicability, no special considerations should apply to biotechnology

inventions. The requirement of industrial applicability shall be satisfied not at

the time of filing of patent application but at the time of grant of the patent. It

implies that at the time of filing the patent application if the invention has no

practical utility or industrial application, nevertheless patent shall be granted,

if the inventor could establish the utility before the date of the grant of patent.

US Patent Code, Section 101. See also, Patents Act of England, 1977, See supra 65, p. 729. See supra 15, p. 330.

Novelty and non-obviousness shall be established at the time of filing of application but industrial application shall be established at the time of granting of patent. See supra 15, p. 330.

Utility of biotechnology inventions

Utility poses a greater concern for chemical and biological inventions. The

utility of the invention shall be described in a written form along with the

written specification of the invention. The utility of biotechnology inventions

is almost undisputed except a few overtones. To illustrate, genetically

engineered plants give benefits such as high yield resistance to pests, weeds,

and herbicides. Likewise, a genetically engineered animal gives benefits such

as high yield of milk, wool or flesh. However, the utility of biotechnological

inventions such as DNA or gene remains unknown until the gene’s function is

characterized and the activity of its product is determined. Hence it is a

difficult task to identify the utility of a gene or DNA.

Requirement of Industrial application of biotechnology

inventions in India

The patent law of India states that any new product or process involving

inventive step and capable of industrial application does constitute an

invention and is patentable. The expression ‘capable of industrial application

in relation to an invention’ means that the invention is capable of being made

or used in an industry. The requirement of industrial application of inventions

in India is no different from the industrial requirement of Europe or utility

requirement of the US. However, there

In June 2000 a technical meeting of Trilateral Patent Offices took place. There was consensuson

the patenting practice of biotechnological inventions. As a result of thimeeting some

conclusions were made and added final report of the project. The Indian Patents Act as amended in 2005, Section 2(j). Ibid., Section 2(ac).

is no substantial case law development with regard to the industrial

application of biotechnology inventions in India as the industry is in an infant

stage. In Dimminaco AG v. Controller of Patents Designs & others for the

first time, utility of a biotechnology invention was demonstrated. The

invention related to a process for preparation of infectious bursitis vaccine.

The vaccine was useful for protecting poultry against contagious bursitis

infection. Initially the patent office rejected the patent application on the

ground that the claim did not constitute an invention. But the utility of the

invention was not disputed.

On appeal the Calcutta High Court decided that the claims constitute

invention as it involves certain chemical steps to be taken under certain

scientific conditions. At no stage the utility of the invention was questioned

implying the fact that almost all the biotechnology inventions are having

certain utility of industrial application. Likewise, the utility of biotechnology

inventions like genetically engineered plants, animal gene, DNA, and the like

is indisputable. Therefore, the utility or industrial application of biotechnology

inventions is accepted and assumed in India.

The inventions of biotechnology are very much useful in different

sectors, specifically and substantially. Biotechnology is being vastly used in

different sectors such as agriculture, medical, chemical industry, animal

husbandry, and many others. Biotechnology has brought up innovative

medical treatments and surgical procedures that are useful for the society.

Biotechnology inventions are useful in treating pollution, poultry, fisheries,

forestry, and others. This technology has got enormous importance in present-

day life.

5.Written description of biotechnology inventions in India.

India is no different as far as written description of biotechnology inventions

are concerned. The Patents Act states that the patent application shall be

accompanied by the complete specification or provisional specification of the

invention. The application must be accompanied by provisional or

301. Genentech v. Welcome Foundation, T (292/85 (1988) O.J EPO 275, (1989) R.P.C 613.

302. Ibid., also FN T 19/90 (1990) O.J. EPO 476, Tech Bd. App; (1991) E.P.O.R. 525, Ex.,

Biogen v.

Medeva (1997) R.P.C 1. H.L.

303. Genentech v. Welcome Foundation, Fn T (292/85 (1988) O.J EPO 275, (1989) R.P.C

613; Harvard Onco-mouse, FNT 19/90 (1990) O.J EPO 476,Tech Bd. App; (1991)

E.P.O.R.525, Asahi Kasu Kogyo’s application, FN (1991) R.P.C. 485. H, Collaborative

Research application decision T81/87 (1990) O.J EPO 250.

304. Asahi Kasu Kogyo’s application (1991) R.P.C. 485. H, Collaborative research application

Decision T81/87 (1990) O.J EPO 250, Biogen v. Medeva (1997) R.P.C 1. H.L

305. Ibid.

complete specification. The specification must describe the invention, its

operation or use with the help of drawings if necessary. If the applicant does

not give complete specification of the invention at the time of filing the

application, he can file the complete specification within twelve months

thereafter. Further, the specification must disclose the best mode of

performing the invention, which is known to the applicant. In case of claiming

the priority of an application filed earlier, priority shall be given only when

the earlier application does give the complete specification of the invention to

enable a person skilled in the art to practice the invention in the best possible

way. Further, the speciation shall define the scope of the claimed invention

with claim or claims on the invention.

The Patents Act was amended latest by 2005 keeping in mind the

necessity of deposit of invention in case of biotechnology patents. The

amendment recognizes the Budapest Treaty for facilitating the deposit of

biotechnology inventions for the sake of patent procedure. A biotechnology

patent application must be accompanied by a deposit of the invention in any

recognized depository as recognized by the government of India through

notification in the official gazette. The name and address of the depository and

the date of the deposit shall be mentioned in the application. Further, the

access number issued to the deposited invention shall also be mentioned in the

application. There is no case law development with regard to the fulfillment of

written description requirement by biotechnology inventions in India. Since

the biotechnology industry is in an infant stage in India and only since 2005

India is granting patents on biotechnology invention, there is no substantive

development of law in this regard. However, the disclosure of the invention

through specification while making the patent application is a prerequisite for

he grant of patent.

In contrast to the patent law of the United States of America and of the

European Union the Indian Patents Act mandates the disclosure of source and

geographical origin of the biological material used in producing the claimed

biotechnology invention. The Biological Diversity Act, 2001 read with the

Patents Act states that the use of biological resource in producing the claimed

biotechnology invention shall be disclosed and mentioned in the patent

application to share the benefits of the patents to the geographical

The Patents Act, 1970 as stands amended latest by 2005. Section 9: Provisional and

complete specification.

The Patents Act, 1970, Section 10 Contents of specification.

The Patents Act, 1970 as stands amended latest by 2005. Section 10, Sub-clause: 4(b)

The Patents Act, 1970, Section 11 Priority dates of claims of a complete specification.

Patents Amendment Act 2002 See supra 17, pp. 38–9.

Patents Act of India as amended in 2005, Section 10; sub-clause 4(d)(ii)(D).

Biological Diversity Act, 2001.

The Indian Patents Act as amended in 2005.

regions, which conserved the resource. The TRIPS agreement does not require

the mentioning of the origin of the resources. However, the convention on

biological diversity (CBD) states that the origin of the biological resources

used shall be acknowledged and the geographical regions shall be given a

share in the benefits of such usage. In fact, it is a crucial issue where the CBD

and the TRIPS do contradict. However, having ratified both the agreement,

India does provide in its patent laws that the patent application claiming a

biotechnology invention is complete only when it discloses the source of the

resources used.

Written description of the invention is a core principle of patent law. An

invention shall be described in a clear and comprehensive manner in order to

enable a skilled person in the art to practice the invention. The requirement of

written description has been applied to biotechnological invention in varied

form. In case of biotechnological invention the written description has to

furnish the chemical and physical properties of the inventions along with its

structure and sequences. However, in every case, it is not possible to describe

a biotechnological invention in a clear and comprehensive manner. Due to the

fact that biotechnological inventions are living beings it may not always be

possible to describe the invention as required under the patent laws. So the

practice of depositing the claimed invention has been adopted to satisfy the

written description requirement. It is accepted that the deposit of the invention

fulfils the requirement of written description. A deposit of the invention serves

as an additional security to the inventor in claiming the patent and also helps

in rebutting claims of invalidity against the patent.

A biotechnology invention, which satisfies the requirements of novelty,

non-obviousness, utility, and written description is patentable provided the

invention falls within the range of matters which are patentable. The patent

law states that a biotechnology invention, which is not a patentable subject

matter, cannot be patented though it may satisfy the requirements of

patentability. It is a settled principle in the patent law that a biotechnology

invention is patentable only when it does fall within the purview of patentable

subject matter. Difficulties arise in determining the novelty and non-

obviousness of biotechnology inventions. The fact that biotechnology

inventions are living beings which are manipulated from their earlier position

of natural existence to possess certain desired characteristics give rise to

certain difficulties. As per the present patent law it is believed that things or

living beings existing in nature are products of nature, which are not

patentable. It is also believed that addition of human ingenuity to these

products of nature renders them products of man. Therefore, the difference

between products of nature and products of man and the point from where a

product of nature becomes a product of man are very significant in deciding

the novelty and non-obviousness of biotechnology inventions. However, the

utility of biotechnology inventions is undisputed. Further, the satisfaction of

the requirement of written description is also problematic in case of

biotechnology inventions. It is felt that it may not be possible to describe a

biotechnology invention in a clear and complete manner. Therefore, difficulty

arises in satisfying the requirement of written description. Hence, in order to

compensate the non-fulfillment of written description requirement deposit of

the invention is recommended. It is believed that deposit of the invention

serves the purpose of describing the invention in order to enable the person

skilled in the art to practice the invention in the best possible way. With the

coming into being of the TRIPS agreement throughout the world patent laws

have been harmonized. Now in all the member states of the TRIPS agreement,

the requirements of patentability of biotechnology inventions are uniform.

Therefore, a biotechnology invention satisfying the requirements of novelty,

non-obviousness, industrial application, and written description or deposit of

the invention is patentable throughout the world.



CHAPTER 6

6.1COMAPARATIVE STUDY IN USA,EU AND INDIA

6.1. USA

6.2. EUROPEAN UNION

6.3.INDIA

6.1.USA

PLANT:

Patenting of Plant-related inventions

In the US, there are three forms of protection for plant-related inventions.

These are Utility Patents, Plant Patent Act (PPA), Plant Variety Protection Act

(PVPA). The utility patents and the plant protection patents are granted by

USPTO while the PVPA is granted by Plant Variety protection Office

governed by USDA. Utility patents awarded in the US cover conventionally

bred varieties or genetically modified plants. A number of examples of utility

patents have been give in the later sections.

Plant patent is a right granted by the government to an inventor who has

invented or discovered and asexually reproduced new plant variety other than

tuber-propagated plant or plant found in uncultivated state. This grant lasts for

20 years (in the US) from the date of filing the application, protects the

inventor’s right to exclude others from asexually reproducing, selling or using

the plant so reproduced. This protection is limited to one plant variety. A sport

or mutant of a patented plant is not considered to have same genotype as that

of the parent plant. Hence, such plants are separately patented instead of being

covered by the plant patent of the parent plant.

The first plant patent was issued in 1931 to Henry Bosenberg of New

Brunswick, NJ, for a climbing or trailing rose. This invention was for

climbing roses bearing true blooming character. There was another plant

patent for a rose plant named ‘Breapum’ granted to Ezio Brea in 2003

(USPP14, 226 P3). The new and distinct cultivar had the unique

characteristics of long erect flowering stems, creamy white flowers and

orange hips arranged in sprays. A patent for Chrysanthemum plant named

‘Zembla’ (US PP14, 052 P2) was granted which was for an invention distinct

in possessing decorative inflorescence and possessing excellent post-

production longevity.

Under Section 3(j) of Indian Patents Act, 1970 plants are not considered

patentable subject matter Under Section 3(h) of the Act, and methods of

agriculture and horticulture are not patentable. Similarly, essentially biological

processes for the production or propagation of plants are not patentable under

Section 3(j). Section 3 of the Patents Act has been dealt with in the earlier

sections. Plant varieties may be protected in India under PVPFRA which has

recently come into force.

Tissue Culture Techniques and Genetic Transformation of

Plants

An important area of research in plants relates to tissue culture and genetic

engineering of plants. The intellectual property scenario on genetic

transformation of plants is quite complex. The subject matter considered

patentable under this category involves the following:

Transformation techniques: there are various transformation methods

basically classified into two categories, which permit introduction of genetic

material into plants to render them with properties like disease resistance,

improved seed quality, and insect resistance.

Agrobacterium-mediated transformation is an indirect method of

transformation that involves Agrobacterium tumefaciens, which is a common

soil bacterium that naturally inserts its genes into plants and uses the

machinery of plants to express those genes in the form of compounds that the

bacterium uses as nutrients. Agrobacterium-mediated transformation has been

dealt with in detail in Chapter 15, Section 15.12.1.

Patents related to transformation of dicot plant

US5, 024, 944 Transformation, somatic embryogenesis and whole

plant regeneration method for Glycine species

US5, 986, 181 Transformation and regeneration of fertile cotton plants

EP910239 Transformation of cotton explants with Agrobacterium

WO0042207 Transformation of a soybean germline with

Agrobacterium

Patents related to transformation of monocot plants

US6,720,488 Transgenic maize seed and method for controlling

insect pests

WO05096806 Edible vaccine in the form of rice

AU3402897 Transformation of wheat with Agrobacterium

AU7134298 Transformation of sorghum with

Agrobacterium/Pioneer Hi-Bred

There exists large number of patents where Agrobacterium has been

used for the transformation of dicotyledonous plants. Examples of some of

these patents are given in Table 22-4.

Transformation using Agrobacterium is now becoming popular among

the monocots. Some of the important patents that were granted in this regard

are listed below in Table 22-5.

Direct method of transformation, where direct uptake of the genetic

material by plant cell occurs (see Chapter 15, Section 15.12.2 for details) are

also in use. Some of the patents that use these techniques have been listed

below in Table 22.6.

Regeneration Protocols. For genetic transformation of plants an

excellent system of regeneration is necessary. There are many patents granted

for methods of regeneration using different explants such as leaves, roots,

hpyocotyls, cotyledons and seeds. A patent has been granted for a method for

regenerating cotton plant from explant tissue comprising regenerating

embroygenc callus from a cotton tissue explants cultivated on cotton initiation

media not supplied with exogenous plant hormones (EP910239B1 and US5,

846, 797).

Explants: The different types of explants that have granted patents are

listed below in Table 22-7.

Other patentable component: Transformation vectors, selectable marker

genes, reporter genes, promoters and enhancers are some of the important

components that are also patentable. A list of these that were used in golden

rice manufacture is given below in Table 22-8.

Genetically modified plant: Genes conferring resistance to insect pests and

various fungal, viral and bacterial disease have been successfully introduced

in variety of crop plants. Similarly, transgenic plants containing genes for

drought and salt tolerance, improved quality for value addition and increased

shelf life are produced through genetic transformation. The classic example is

of Bt transgenic plants into which the genes elaborating the insecticidal toxins

of Bacillus thuringiensis have been introduced. However, in India since plants

per se are not patentable, patents for genetically modified plants are not

allowed.

More than 400 patents have been granted on Bt isolates, strains, genes,

Bt toxin receptors and on specific proteins toxic to a given insect class or pest.

Bt toxin receptor BT R2 from Pectinophora gossypiella (pink bollworm) has

been patented (US6,645,497). A USBTS02618A, BTS02654B and

BTS02652E strains. Patents have been granted to polynucleotide

compositions encoding broad spectrum endotoxins (US6,645,497;

US6,538,109; US6,521,442; US6,448,226). Plasmid(s) containing

heterologous DNA coding for Bt crystal protein in E.coli is protected under

US patent (US4,467,036). A US patent (US6,326,169) disclose polynucleotide

compositions encoding Cry 1 Ac/Cry 1F chimeric endotoxins. Bt cry ETI

toxin gene and protein toxic to lepidopteran insect, Plutella xylostella

(Dimondback moth), has been patented (US5,356,623). This patent also

discloses the method of controlling susceptible lepidopteran insects by

applying the effective amount of insecticidal toxins to the host plant. A

European patent (EP0358557B1) discloses a new DNA sequence that encodes

the 130 kDa protoxin, the ‘Bt 18 protoxin’, from the genome of the B.

thruingiensis var. darmstadiensis HD -146. This protoxin cleaves into 62 kDa

of active toxin and is highly active against Lepidoptera species from the

Noctuidae family such as Spodopter species and Manducasxta. Five novel

nematocidal cry gene sequences are disclosed in European patent

(EP0462721). Two crylgene sequences are disclosed in European patent

(EP0401979).

Patents for modifying the Bt gene to optimize expression of the

insecticidal protein in plants have also been granted. A US patent

(US6,242,241) disclosed novel synthetically modified Bt chimeric crystal

protein having improved insecticidal activity against coleopteran, dipteran and

lepidopteran. This patent also covers nucleicacid encoding for these novel

peptide, methods of making and using these genes, and proteins, method for

the recombianant expression and transformation of suitable host cells,

transformed host cells, and transgenic plants expressing the said Bt toxin. Two

US patents (US6,033,874; US6,423,828) have been granted where novel

synthetically-modified B. thuringiensis cry 1C gene sequence encoding

endotoxins having lepidopteran-specific insecticidal activity has been

disclosed.

More than 482 patents had been filed or granted for inventions related

to Bt crops, some 95 of these patents involve transgenic plants. US patents

have been granted for the production of transgenic maize expressing the

synthetic Bt protein (US5,484,956; US6,720,488). US patent (US6,720,488)

discloses the method of production of transgenic maize expressing synthetic

Bt insecticidal crystal protein genes in which the codon usage has been altered

to increase expression of the Bt gene.

ANIMAL:

Genetically Modified Organisms

Unicellular Organisms

the patentability of unicellular organisms was questioned and clarified by the

US Supreme Court in Chakrabarty’s case. In Diamond v. Chakrabarty, which

is considered to be the most important biotech case relating to patentable

subject matter, the United States Supreme Court, by holding that everything

under the sun made by man is patentable, cleared all doubts and opened the

gates for patentability of biotech inventions. The case involved Chakrabarty’s

invention of a genetically modified pseudomonas bacterium capable of

degrading oil spills and a process by which four different plasmids, capable of

degrading four different oil components, could be transferred to and

maintained stably in a single Pseudomonas bacterium, which by itself had no

capacity for degrading oil. Chakrabarty’s patent claims were of three types:

first, process claims for the method of producing the bacteria; second, claims

for an inoculum comprising a carrier material floating on water, such as straw,

and the new bacteria; and third, claims to the bacteria themselves. The patent

examiner accepted the claims falling into the first two categories, but rejected

claims for the bacteria. The decision rested on two grounds:

(1) micro-organisms are ‘products of nature’, and (2) as living things the

Pseudomonas bacteria are not patentable subject matter under section 101

The US Supreme Court rejected both the arguments. It rejected the product of

nature argument by stating that Chakrabarty had produced a new bacterium

with markedly different characteristics from any found in nature. The court

went on to say that the test for determining whether an invention falls within

the scope of ‘Product of nature’ is whether the invention in question involves

a hand of man. If yes, the invention is not product of nature or naturally

existing. If no, it is naturally existing and, therefore, not patentable. As the

Pseudomonas bacterium in question involved the hand of man in inserting

four different plasmids into it, the court held that it was not naturally existing

and therefore patentable. The court rejected the second argument by holding

that micro-organisms were patentable as manufactures or compositions of

matter and that the Congress did not intend to keep them out of the scope of

subject matter The decision in the Chakrabarty case opened the gates for

patentability of genetically engineered unicellular organisms and processes

involved in genetic engineering. After this decision, non-naturally existing

unicellular organisms became patentable in USA. Since then micro-organisms

have been considered by USPTO as manufactures or compositions of matter

and thus numerous patents have been granted to micro-organisms.

Multicellular Organisms:

In the year 1987, the USPTO announced that non-naturally occurring, non-

human multicellular organisms are patentable. The notice, signed by Donald J.

Quigg, Commissioner of Patents and Trademarks stated that, ‘as a result of the

Board’s decision in Ex parte Allen, the USPTO considers non- naturally

occurring, non-human multicellular living organisms, including animals, to be

patentable subject matter within the scope of section 101.The case involved a

patent application over polyploid oysters and a process of inducing polyploidy

in them. The examiner allowed claims relating to the process but rejected

claims over the oysters stating that they were living organisms, which were

not a patentable subject matter under section 101. The Board of Patent

Appeals and Interferences reversed the examiner’s rejection by holding that

the polyploid oysters were subject matter, as they did not naturally exist and

required the involvement of the hand of man in creating them. Relying on the

decision in Chakrabarty’s case the Board stated that the relevant enquiry for

subject matter was not the difference between living and inanimate things, but

between products of nature and human-made inventions After the oyster

decision USPTO granted a patent to an invention relating to a transgenic

mouse into which an oncogene sequence was introduced. The mouse was

created for study of breast cancer and was called oncomouse. The USPTO

granted a patent over the mouse in the year 1988, one year after ex parte

Allen. The Harvard mouse patent can be said to be the first patent that

expanded the scope of patent protection to multicellular organisms. After

oncomouse, a number of patents were granted to transgenic animals including

mice, rabbit, etc

In a case relating to patentability of genetically modified plants3, the US

Supreme Court held that newly developed plant breeds could be protected

under the utility patent statute and concluded that neither the Plant Protection

Act nor the Plant Variety Protection Act bars obtaining utility patents for

plants. The court in this case held a genetically modified corn plant to be

patentable subject matter as it involves human intervention. The decision

elucidates the fact that genetically modified plants are patentable in USA.

Genes:

Gene sequences, ESTs and gene probes are patentable in USA. As there

has not been any judicial scrutiny of patentable subject matter relating to gene

or DNA sequences, the interpretation of USPTO stands good. The USPTO has

extended patent protection to isolated DNA, RNA and proteins under section

101 stating that gene and protein sequences are new compositions of matter

resulting from human intervention as opposed to naturally occurring products,

which are not patentable. The exclusion of any product of nature is not a

hurdle to patenting of gene or DNA sequences because isolated and purified

sequences are not naturally existing and contain only the regions of naturally

existing DNA that code for proteins. A large number of patents have been

granted to DNA sequences based on the aforementioned analysis. The number

of patents over gene sequences increased after NIH filed patent applications

over cDNA sequences and ESTs in the early 1990s.4 Organizations like

Human Genome Sciences, Millennium Pharmaceuticals, Incyte

Pharmaceuticals, Celera Genomics, etc., filed and acquired hundreds of

patents over DNA sequences

The US Supreme Court recently declined to decide the validity of aprocess

patent relating to an amino acid. The patent at issue related to methods for

detecting Cobalamine (Vitamin B12) and Folate (Folic Acid) deficiency by

determining the levels of homocysteine in the body. Claim of the patent

claims a method for detecting deficiency of cobalamine or folate in warm-

blooded animals comprising the dual steps of assaying a body fluid for an

elevated level of total homocysteine and correlating such elevated level in the

said body fluid with deficiency of cobalamine or folate Metabolite, the

licensee of the patent, sued Laboratory Corporation, the sub-licensee, for

patent infringement in the District Court of Colarodo. The district court held

that Laboratory Corporation, by supplying the results relating to levels of

homocysteine in human body to doctors was liable for contributory

infringement and granted damages to the tune of seven million dollars. The

court said that the doctors, by correlating levels of homocysteine to Vitamin B

deficiency directly, infringed claim of the patent. As Laboratory Corporation

supplied the data to make such an analysis, it said that Laboratory Corporation

was liable for contributory infringement. On appeal the Federal Circuit upheld

the decision of the district court Thereafter, Laboratory Corporation filed a

writ of certiorari before the US Supreme Court claiming patent invalidity The

US Supreme Court admitted the writ of certiorari filed by Laboratory

Corporation, challenging the decision of the Federal Circuit on validity of

claim 13 of the patent. The question to be decided by the court was ‘Whether

a vaguely worded patent claim directing a party simply to correlate test results

can validly claim a monopoly over a basic scientific relationship used in

medical treatment such that any doctor necessarily infringes the patent merely

by thinking about the relationship after looking at a test result. Professor Jon

Barton of Stanford Law School and Affymetrix filed an amicus brief before

the US Supreme Court submitting that upholding claim of the patent valid

would expand the scope of patentable subject matter to such an extent that one

may effectively own a natural biochemical relationship by excluding others

from any and all testing of that relationship. They believed that such a broad

scope of patentable subject matter would nullify the doctrine of law of nature

and would impact genetic research adversely. Under such broad patentable

subject matter, patents would be available for relationship of a gene to a

disease/amino acid, or relationship between genes of different individuals, and

so on. They also submitted that grant of such broad patents over biological

relationships would block genetic research and chill gene testingThe US

Supreme Court dismissed the writ of certiorari as improvidently granted. By

dismissing the writ, the Supreme Court upheld the decision of the Federal

Circuit, which means that claim of the patent is valid and that Laboratory

Corporation is liable for patent infringement. As a result the Supreme Court

has broadened the scope of subject matter by narrowing the doctrine of

product of nature. According to this decision, discovery of a relationship

between a gene and a disease can get a patent

Gene Therapy:

Genetic therapy is used to correct genetic disorders and can be

considered to be a method of medical treatment. The expansive scope of

subject matter under section 101 allows the right to patent a method of

medical treatment as a process. However, the patent statute under section

287(c)(1)4 abrogates the remedy available for its infringement, thus nullifying

the right to patent. Section 287(c)(1) states that infringement provisions shall

not apply to a medical activity performed by a medical practitioner or a

related health care entity. The term medical activity has been defined in the

same section to include performance of any medical or surgical procedure.

These provisions were added to the statute in the year 1996 through an

Omnibus Consolidated Appropriations Act. They deny the patentee a remedy

for infringement of a medical or surgical procedure. Therefore, though gene

therapy, which is a medical method, is patentable subject matter, a patent over

it is ineffective as it is not enforceable

Human beings: Human beings are not patentable in USA. The Patent and Trademark Office

has stated in a notice that human multicellular living organisms are not a

patentable subject matter within the scope of section 101. A patent claim

including or covering a human being at any stage of development is

considered by the USPTO as a non-statutory subject matter under Section

101.2 Though the Manual of Patent Examining Procedure (MPEP) does not

expressly address claims directed to a human embryo, in practice, examiners

would treat such claims as non-statutory

The US Patent and Trademark Office recently rejected a 1997 patent

application, filed by Dr Stuart Newman of New York Medical College

covering fusion of embryonic human and animal cells to create chimeras for

medical research. The patent application related to a mammalian embryo

developed from embryo cells, a mixture of embryo cells and embryonic stem

cells, or embryonic stem cells exclusively, in which at least one of the cells is

derived from a human embryo, a human embryonic stem cell line, or any

other type of human cell, and any cell line, developed embryo, or animal

derived from such an embryo.5 The applicant’s objective was to prevent grant

of patents over human-based living organisms either by obtaining a patent on

technology he would not use or by getting the USPTO to declare such

inventions contrary to law. The USPTO’s rejection was based on the ground

that the patent would violate the thirteenth amendment’s ban on slavery and

would be inconsistent with the constitutional right to privacy

6.2. EUROPEAN UNION

Genetically Modified Organisms :

Unicellular Organisms:

Article 53(b) of the European Patent Convention (EPC) excludes plant and

animal varieties and essential biological processes for the production of plants

and animals from the scope of patent protection but provides an exemption fo

patenting microbiological products or processes. Rule 23b(6) of the

Implementing Regulations provides that a ‘Microbiological process’ means

any process involving or per formed upon or resulting in microbiological

material and rule 23c(c) provides that a microbiological or other technical

process, or a product obtained by means of such a process other than a plant or

animal variety is patentable subject matter. It was held in T356/93 that micro-

organisms are patentable as products of

microbiological processes, and micro-organisms were defined as generally

unicellular organisms with dimensions beneath the limits of vision, which can

be propagated and manipulated in a laboratory. As per the aforementioned

provisions when a process of genetic engineering if applied on a micro-

organism the resultant micro-organisms become patentable subject matter as

they come within the ambit of microbiological process and product.

Multicellular Organisms:

Article 53(b) of EPC provides that European patents are not available for

plant or animal varieties and essentially biological processes for the

production of plants or animals.5 Rule 23c of the regulations provides that

plants or animals are patentable if the technical feasibility of the invention is

not confined to a particular plant or animal variety.6 Genetically modified

animals and plants have been held to be patentable as they fall outside the

scope of animal or plant variety

‘Plant variety’ has been defined in the regulations as any plant grouping

within a single botanical taxon of the lowest known rank, which grouping,

irrespective of whether the conditions for the grant of a plant variety right

are fully met, can be

Defined by the expression of the characteristics that results from a

given genotype or combination of genotypes

Distinguished from any other plant grouping by the expression of at least one

of the said characteristics, and

Considered as a unit with regard to its suitability for being propagated

unchanged

A plant variety is considered patentable if it falls outside the meaning of the

term plant variety defined in the implementing regulations. The biotechnology

directive provides that a plant grouping which is characterized by a particular

gene (and not its whole genome) is not covered by the protection of new

varieties and is, therefore, not excluded from patentability even if it comprises

new varieties of plants. As per the directive transgenic plants fall outside the

scope of the definition of plant variety and are, therefore, patentable subject

matter

In a case involving Novartis, relating to patentability of transgenic plants into

which DNA had been inserted using recombinant technology, the Technical

Board of Appeals held that genetically modified plants were patentable

subject matter. The Technical Board observed that as genetically modified

plants were not conceived at the time of drafting, it could be concluded that

they do not fall within the scope of exclusion to patentable subject matter. It

further stated that if a genetic modification can be applied to more than one

variety, the invention is patentable subject matter as it falls outside the scope

of exclusion that is plant variety

As the term ‘animal variety’ has not been defined in the Convention or

Regulations, patentability of genetically modified animals depends on the

interpretation of EPO. Patentability of genetically modified animals has been

tested and approved through the decision of the Technical Board of Appeals in

the Oncomouse case. The case related to a genetically altered mouse, which

involved inserting an activated oncogene to develop cancer in the mouse. The

patent application was initially rejected by the examination division based on

the reasoning that the Oncomouse falls within the scope of Article 53(b),

which excludes animal varieties from the scope of patentable

subject matter.1 The examination division interpreted the term ‘animal

variety’ to include all animals. On appeal, the Technical Board held that the

wording of Article 53(b) indicates that all animals are not excluded from

patentable subject matter because the usage of both the terms ‘animal

varieties’ and ‘animals’ in the same provision illustrates that the legislature

did not intend to exclude all animals from patentability. As rodents and

mammals form a taxonomical unit higher than any animal variety, the Board

held that they are patentable. On remand, the examination division granted a

patent on the mouse based on the aforementioned interpretation. As it stands

today, genetically modified multicellular organisms including rodents and

mammals are patentable subject matter in Europe

Genes

The EPC is silent about patentability of genes but the implementing

regulations that adopted the EU Biotechnology Directive has specific

provisions dealing with patentability of genes. The implementing regulations

provide that biological material, which is isolated from its natural

environment or produced by means of a technical process even if it previously

occurred in nature, is patentable. Biological material has been defined as any

material containing genetic information and capable of reproducing itself or

being reproduced in a biological system. A gene is considered a biological

material because it can be reproduced in a biological system such as a cell or

bacteria and is patentable if isolated from its natural state. Rule 23e

specifically mentions that gene sequences are patentable. It provides that

though the sequence or partial sequence of a gene cannot constitute a

patentable invention, an element isolated from the human body or otherwise

produced by means of a technical process, including the sequence or partial

sequence of a gene, may constitute a patentable invention, even if the structure

of that element is identical to that of a natural element. Based on the

implementing regulations, partial and complete gene sequences are patentable

under the EPC In a case relating to patentability of a DNA sequence coding

for Human H2 Relaxin, the Opposition Division of EPO held that the DNA

sequence was patentable subject matter. While holding so, the Opposition

Division observed that if a substance found in nature has first to be isolated

from its surroundings and a process for obtaining it is developed, that process

is patentable. Moreover, it also observed that if this substance can be properly

characterized by its structure and it is new in the absolute sense of having no

previously recognized existence, the substance per se may be patentable.

Based on the aforementioned principle, the Opposition Division held that the

DNA sequence of Human H2 Relaxin was patentable subject matter because

Human H2 Relaxin had no previously recognized existence, the patent holder

developed a process for obtaining H2 Relaxin and the DNA encoding it and

the patent holder characterized these products by their chemical structure and

found a use for the protein. The Opposition Division went on to state that it

was justified to grant patent protection in this case as H2 Relaxin was made

available to the public for the first time. After this decision, EPO has granted a

number of patents over different types of genes till date.

Gene Therapy

Article 52, clause (4), excludes methods of treatment of the human or

animal body by surgery or therapy and diagnostic methods practised on

humans from the scope of patentable subject matter. The law relating to

patentability of medical methods has been elaborated by decisions of the EPO

board of appeals and other national boards. These decisions have laid down

certain guidelines to be followed while deciding upon the patentability of

surgical, therapeutic and diagnostic methods

The term ‘surgery’ has been held by the Board to include not only invasive

operations, but also non-invasive procedures such as repositioning.

Therapeutic methods have been held to be not patentable if they involve a

therapy on human or animal body. The term ‘therapy’ has been defined by the

EPO to include anything that relates very broadly to the treatment of a disease

in general or to a curative treatment as well as to the alleviation of the

symptoms of pain and suffering.6 The patentability of a ‘therapy’ depends

upon the nature of the treatment. Generally cosmetic methods are patentable

in EPO.7 As per the Board, in vivo diagnostic methods are barred from

patentability but in vitro methods are patentable. In the light of the decisions,

surgical and therapeutic methods using genes would not be patentable prima

facie. However, diagnostic methods using genes would be patentable provided

they are in vitro. There is no ban on patentability of implements and kits used

for genetic therapies

Human Beings: Article 53(a) of the European Patent Convention provides that inventions,

the publication or exploitation of which would be contrary to public order or

morality, are not patentable. Rule 23d of the regulations provides that under

Article 53(a), European patents shall not be granted in respect of

biotechnological inventions which, in particular, concern processes for

cloning human beings, processes for modifying the germ line genetic identity

of human beings, uses of human embryos for industrial or commercial

purposes and processes for modifying the genetic identity of animals which

are likely to cause them suffering without any substantial medical benefit to

man or animal, and also animals resulting from such processes. Further, Rule

23e provides that the human body, at various stages of its formation

and development, and the simple discovery of one of its elements is not

patentable. However, elements isolated from the human body or otherwise

produced by means of a technical process are patentable even if the structure

of that element is identical to that of a natural element. As per the provision,

human beings or parts/elements of human body and processes of cloning or

altering them are not patentable but elements isolated from human body

through a technical process are patentable in Europe

In a recent case, the examination division of EPO rejected a patent relating

to human embryos stating that it is in violation of Article 53(a) of EPC. The

case related to a patent application titled ‘primate embryonic stem cells’ filed

by Wisconsin Alumni Research Foundation (WARF). The examination

division rejected the application as it did not comply with Article 53(a) of

EPC in conjunction with rule 23d(c) of EPC. Rule 23d(c) of EPC precludes

the grant of a European patent for the use of human embryos for industrial of

commercial purposes

The examination division considered that the application related to the

generation of human embryonic stem cell cultures where human embryos

were described in the application as filed as indispensable starting materials,

which meant a use thereof for industrial purposes within the meaning of rule

23d(c) of EPC. As the description of the application in suit provided only one

source of starting cells, namely pre-implantation embryos, the examination

division thus regarded it as irrelevant that the claimed subject matter related to

cell cultures and not a method of their production. WARF appealed to the

Technical Board, which referred the case to the enlarged Board for clarifying

the scope of exclusion of patentability of human embryo

6.3.INDIA:

PLANTS RELATED INVENTIONS:

Under Section 3(j) of Indian Patents Act, 1970 plants are not considered

patentable subject matter Under Section 3(h) of the Act, and methods of

agriculture and horticulture are not patentable. Similarly, essentially biological

processes for the production or propagation of plants are not patentable under

Section 3(j). Section 3 of the Patents Act has been dealt with in the earlier

sections. Plant varieties may be protected in India under PVPFRA which has

recently come into force.

As per the Indian Patent Act, any product or process is patentable subject

matter.1 However, the Act provides a long list of inventions that are excluded

from patentable subject matter, which includes certain genetic inventions.

Living Organisms, Genes and Gene Therapies:

The Indian Patent Act prohibits patents on discovery of any living thing

occurring in nature. It provides that plants and animals in whole or any part

thereof including seeds, varieties, species, and essentially biological processes

for production or propagation of plants and animals are not patentable subject

matter. However, the Act allows patents for micro- organisms and

microbiological processes. In a case, the Controller of Patents rejected a

patent application over a vaccine for infectious bursitis virus on the ground

that it is a living organism. The Calcutta High Court reversed the decision of

the controller holding that a living micro-organism constitutes patentable

subject matter as a manufacture. Based on this decision, it can be said that in

India, genetically modified micro-organisms are patentable as per the statute

and case law

Genetically modified multicellular organisms including plants, animals,

human beings, and their parts are not patentable in India as per section . The

Manual of Patent Practice and Procedure provides that biological materials

such as recombinant DNA, plasmids, and processes of manufacturing thereof

are patentable if they are produced by substantive human intervention .

Gene sequences and DNA sequences having disclosed functions are

considered patentable in India.6 The processes for cloning human beings or

animals, processes for modifying the germ line, genetic identity of human

beings or animals, uses of human or animal embryos for any purpose are not

patentable as they are against public order and morality

The list of non-patentable inventions in India also includes any process for the

medicinal, surgical, curative, prophylactic, diagnostic, therapeutic, or other

treatment of human beings or any process for a similar treatment of animals to

render them free of disease or to increase their economic

value. As genetic therapies are therapeutic and are meant for rendering an

animal or human being free of disease, they are not patentable in India

COMPARATIVE ANALYSIS OF PATENTING ON LIVING

ORGANISMS RELATED TO SUBJECT MATTER IN USA,

EUROPEAN UNION AND INDIA

patentable subject matter gives countries the power to define the size of

public and patent domains in their respective countries. By defining the list of

subjects eligible for subject matter and list of subjects excluded from subject

matter, a government lays down straightforward entries or exclusions from the

scope of patent system. The differences in the scope of patentable subject

matter of LIVING ORGANISMS based inventions in USA, Europe, and India

gives rise to variances in patentability. the patentability of genetically

modified organisms, genes, gene therapies, and human beings in these

countries based on the scope of patentable subject matter. There is no

variation of the subjects eligible for patentability when it comes to genetically

modified unicellular organisms, genes, and genetically modified human

beings. While genes and genetically modified unicellular organisms are

patentable in all three countries, genetically modified human beings are not

patentable in all three countries. However, there is a variation in the scope of

subject matter when it comes to genetically modified multicellular organisms

and gene therapies. While all genetically modified multicellular organisms are

patentable in USA, only genetically modified mammals and genetically

modified plants are patentable subject matter in Europe and genetically

modified multicellular organisms are not patentable subject matter in India.

As a result all genetically modified multicellular organisms are eligible for

patentability in USA and only genetically modified mammals and plants are

eligible for patentability in Europe, which means that non-mammalians and

plants not genetically modified are in public domain in Europe and all

genetically modified multicellular organisms fall into the public domain in

India. Above illustrates the variance in patent/public domain when it comes

to genetically modified multicellular organisms. In case of gene therapies,

they are patentable in USA but not patentable in Europe and India. So, gene

therapies fall within the scope of eligible patent domain in USA and into the

public domain in Europe and India.

CHAPTER 7

7.1 CONCLUSION AND SUGGESTIONS

7.2 BIBLIOGRAPHY

7.3 WEBLIOGRAPHY