Protection of new medical uses and exceptions for medical treatment in patent law of India Suja Subramaniam US Patent Counsel Consultant F. Hoffmann La

Protection of new medical uses and exceptions for medical treatment in patent

law of India

Suja Subramaniam

US Patent Counsel

Consultant F. Hoffmann La Roche

AIPPI 2011 Forum/ExCo

Copyright- Suja Subramaniam, 2011, IdeeIP Consultants, LLP

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Agenda

1. Background

2. What is NOT patentable1. 3(b)

2. 3 (i)

3. Protection of Method of Use and Method of Treatment

4. Conclusion


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Background Progress of the Indian Patent System

• 1856 Act: based on British patent system– Provided for a 14 year term

• Patents Act of 1970– Lengthy examination and opposition procedures– Protected methods and processes of manufacture – Did not Protect compositions (drugs, food)

themselves


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Requirements for Patentability

Absolute Novelty Inventive step (non obvious)Industrial Applicability Must not fall foul of Sections 3 and 4.

Section 3 lists what are NOT inventions within the meaning of the ACT.

Section 4 lists Atomic Energy related inventions


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WHAT IS NOT PATENTABLESection 3

Mere Discovery ( non living thing or those occurring in nature) is not patentable

Use or commercial exploitation of which will be contrary to public use or public order

Causes serious prejudice to human, animal or plant life or health or to the environment

New form of a known substance is not patentable 3(d) New use of known substance , process, machine, apparatus. Mere admixtures resulting in the aggregation of properties Mere arrangement and rearrangement of known devices. Process for any medicinal, surgical, curative, prophylactic,

diagnostic or therapeutic treatment of human being or animal 3 (i)

Traditional knowledge or aggregation or duplication of known properties of traditionally known components


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WHAT IS NOT PATENTABLE3(d)

what are not inventions- the following are not inventions within the meaning of this Act,-

"(d) the mere discovery of a new form of 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, machine or apparatus unless such 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;".


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WHAT IS NOT PATENTABLE3(d)

Under this Section, certain acts are excluded from the definition of “invention”

mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance

– New forms such as a polymorph, salt, derivative, crystalline form, pure form, etc., considered as discovery and same compound

– may be patentable provided there is significant difference in efficacy.

– Burden of proof is on the applicant

the mere discovery of any new property or new use for a known substance


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WHAT IS NOT PATENTABLE3(i)

what are not inventions- the following are not inventions within the meaning of this Act,-

"(i) any process for the medicinal, surgical, curative, prophylactic, diagnostics, 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.


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Protection of Method of Use and Method of Treatment

Patent for a new compound would indirectly cover all its use as well

Second medical Use is not permitted

“Swiss type” use claims not permitted

methods of treatment also statutorily prohibited by Section 3(i).


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Protection of Method of Use and Method of Treatment- Using Aspirin as an Example

• Aspirin- First medical use : analgesic

– Second medical use : anti stroke – Further medical uses: rheumatoid arthritis ;

– None of them patentable in India except Aspirin as a compound may be Patentable.

• The following Claim language would be rejected– Use of compound with Formula A (aspirin) as an

anticoagulant– use of Compound with formula A (aspirin) in preparation of

a medicament to treat blood clotting– a method treatment...which comprises administering to a

patient an effective amount of compound of Formula A (aspirin)


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Protection of Method of Use and Method of Treatment- Using Aspirin as an Example

The Following May be Patentable: New Form of Aspirin as for use in treatment of Cancer

as long as Applicant can show that this “new Form” has enhanced efficacy compared to Aspirin.

combination of Aspirin with a new Compound for a new indication

Combination of Aspirin with another known active as long as Applicant can new synergy

A new process of manufacturing Aspirin


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Protection of Method of Use and Method of Treatment- A quick Chart Comparison

Category of Claim Patentable or Not

New And Novel Compound (A)

Yes

First Use of A No

Second medical use of A No

Swiss Type Claim No

New Method of Making Compound A

Yes

A with Novel Compound B Maybe

A with known compound C Maybe


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Conclusion

A Patent for a new Compound will cover all its uses Second Medical use claims are statutorily prohibited Method of treatment or diagnosis are also Prohibited New Form of a known compound may be patentable as

long as enhanced efficacy can be shown If a combination of known compounds ensure that it has

new synergy not known and not mere aggregation of properties


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Questions??

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Protection of new medical uses and exceptions for medical treatment in patent law of India Suja Subramaniam US Patent Counsel Consultant F. Hoffmann La