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IPR Protection Strategies for EU SMEs from the
Pharma Sector in the PhilippinesSouth-East Asia IPR SME Helpdesk
Email: [email protected]: www.southeastasia-iprhelpdesk.eu
15 December 2015
Mr. Edmund Jason Baranda
IP Expert
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Nora BihariProject Executive
South-East Asia IPR SME Helpdesk
Welcome to the Webinar
15 December 2015
Samuel SabasteanskiProject Executive
South-East Asia IPR SME Helpdesk
Webinar Interaction Tools
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Webinar 24 hour technical support number: http://support.gotomeeting.com ‘Contact Us’ section
15 December 2015
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Snapshot: Helpdesk Free Services
Enquiry Helpline
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Business Tools
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15 December 2015
Speaker’s bio
Name: Edmund BarandaFirm: Baranda & Associates, RouseLocation: Manila, the Philippines
Email: [email protected]
Edmund is an IP lawyer in the Philippines with over 10 years experience. He has abackground in Molecular Biology and Biotechnology and is a qualified Patent Agent.Edmund has handled the prosecution of local and international patent applicationsand is highly regarded by clients who value his practical and quick approach.
Edmund has extensive experience in drafting of patent specifications, advising onfreedom to operate searches and prosecution of local and international patentapplications. He has also been involved in patent litigation, particularly patentcancellation and patent infringement actions in the pharmaceutical field, and trademark/copyright litigation. Edmund is a member of the Integrated Bar of the Philippinesand the New York Bar. Edmund joined the Helpdesk network in October 2013.
15 December 2015
Agenda
Free services of the Helpdesk The Pharma sector in the Philippines The IP System in the Philippines -
focusing on patents Case studies Take-Away Messages - Preparation for
IP Owners Q&A
715 December 2015
Source: Partnering for Nation Building: The Contributions of the Philippine Pharmaceutical Industry to Health and Economy Philippine Copyright. 2015. The Pharmaceutical and Healthcare Association of the Philippines (PHAP)
815 December 2015
The Philippine pharmaceutical industry
• Sales of pharmaceutical products (as of 2011):
915 December 2015
70%
24%
6%
Ethical or prescription drugs Over-the-counter products nutritionals
The Philippine pharmaceutical industry
• Top 10 Philippine pharmaceutical companies based on value (as of 2011)1. UNITED LABORATORIES2. PFIZER INC.3. GLAXOSMITHKLINE4. NOVARTIS5. MSD6. SANOFI-AVENTIS7. ASTRAZENECA8. BOEHRINGER INGELHEIM9. JOHNSON10. PASCUAL LABS
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The Philippine pharmaceutical industry
15 December 2015
• Top 10 therapeutic classes based on value (as of 2011)
1. CEPHALOSPORINS & COMBS2. NON-NARCOTIC ANALGESICS3. BROAD SPECTRUM
PENICILLIN4. CALCIUM ANTAGONISTS
PLAIN5. ANTIRHEUMATIC NON-
STEROID6. MULTIVITAMINS + MINERALS7. EXPECTORANTS8. CHOLEST&TRIGLY,
REGULATOR9. ANGIOTENS-II ANTAG, PLAIN10. VIT C INC. MINERAL COMBS
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Recent issues
• First to file system
• Registration required to enforce rights (except for copyright)
IP System in the Philippines
15 December 2015
Copyrights and Related Rights
Trademarks and Service Marks
Geographic Indications
Industrial Designs
Patents
Lay-out Designs (Topographies) of integrated circuits
Protection of Undisclosed Information
“Intellectual property rights” under the IP Code
15 December 2015
Any technical solution of a problem in any field of human activity which is
• new/novel - not prior art
• involves an inventive step – not obvious to a person skilled in the art
• industrially applicable – useful, for practical purpose
– Term is 20 years from filing date
Patentable inventions
15 December 2015
Discoveries, scientific theories and mathematical methods
Schemes, rules and methods of performing mental acts, playing games or doing business, and programs for computers
Methods for treatment of human or animal body by surgery or therapy and diagnostic methods practiced on the human or animal body
Plant varieties or animal breeds or essentially biological process for the production of plants or animals
Aesthetic creations
Anything contrary to public order or morality
Non-patentable inventions
15 December 2015
Plant varieties or animal breeds or essentially biological process for the production of plants an animals
Does not apply to microorganisms and non-biological and microbiogical processes (Art. 22, IP Code)
√ Microorganisms per se, e.g., bacteria; yeasts; fungi; algae; protozoa; viruses; human, animal or plant cells; plasmids
√ Industrial processes using microorganisms/processes for producing new microorganisms
√ Treatment of plant by application of growth-stimulating substance or radiation (although a biological process is involved, essence of invention is technical) [Bureau of Patents Manual of Substantive Examination Practice (MSEP)]
Non-patentable inventions
15 December 2015
Methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practiced on the human or animal body
Does not apply to products and compositions for use in any of these methods (Art. 22, IP Code)
√ Surgical, therapeutic or diagnostic instruments for use in such methods
√ Non-biological/technical methods of treatment of human beings or animals (e.g., treatment of sheep to promote growth)
√ Treatment of blood for storage in a blood bank or diagnostic testing of blood samples (MSEP)
Non-patentable inventions
15 December 2015
• Utility model – inventive step not a requirement
– Term is only 7 years
• Industrial designs – composition of lines/colors or 3-D form which gives a special appearance to, and can serve as a pattern for, an industrial product or handicraft
– Term is 5 years, renewable twice
Other types of “patents”
15 December 2015
Undisclosed information must be…
• Secret
• Commercially valuable because it is secret
• Subject to reasonable steps to keep it secret
Protection of Undisclosed Info
15 December 2015
• Certificate of Plant Variety Protection
– new
• not sold for > 1 year in Phil, > 4 years abroad; > 6 years for vines/trees
– distinct
• distinguishable from any common variety
– uniform
• sufficiently uniform in relevant characteristics
– stable
• relevant characteristics remain unchanged after repeated propagation
Plant Variety Protection Act of 2002
15 December 2015
• Patent on product –– restrain, prohibit and prevent the making, using, offering for sale,
selling or importing the product
• Patent on process –– restrain, prohibit or prevent anyone from
• using the process
• manufacturing, dealing in, using, selling or offering for sale, or importing any product obtained directly or indirectly from such process
Rights Conferred by Patent
15 December 2015
• Assign or transfer by succession the patent
• Conclude licensing contracts for the patent
Rights Conferred by Patent, cont.
15 December 2015
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Question: Do you have any patents/patent applications filed in the Philippines?
a) Yes
b) No
Poll I.
15 December 2015
The Universally Accessible Cheaper and Quality Medicines Act (Republic Act No. 9502)
International exhaustion of patent rights
Express exclusions of new forms/new properties of known substances from patentability
Early working exception (“Bolar” exception)
Important IP Code amendments
15 December 2015
• Drug patent owned by US company
• Drug patent existing/drug sold in
– US
– Europe
– Philippines
• No patent in India – same US brand but lower price due to competition
– Parallel import/”gray market” goods
• Third party can import from India
• Allowed under a system of “international exhaustion”
Parallel imports (drugs)
15 December 2015
• Using a patented product which has been put on the market in the Philippines* by the owner of the product, or with his express consent, insofar as such use is performed after that product has been so put on the said market (Note: Amended by Cheaper Medicines Act)
• *Domestic exhaustion
Limitation of Patent Rights – no right to prevent third parties from:
15 December 2015
• Domestic exhaustion
– After first authorized sale of patented item in a given domesticmarket, patent owner has no enforceable right to control disposition or profit from subsequent resale of same physical item within domestic market
• International exhaustion
– Patent owner’s rights extinguished at the first authorized sale of patented item anywhere in the world
Exhaustion of patent rights
15 December 2015
• "72.1. Using a patented product which has been put on the market in the
Philippines by the owner of the product, or with his express consent, insofar as such use is performed after that product has been so put on the said market: Provided, That, with regard to drugs and medicines, the limitation on patent rights shall apply after a drug or medicine has been introduced in the Philippines or anywhere else in the world by the patent owner, or by any party authorized to use the invention: Provided, further, That the right to import the drugs and medicines contemplated in this section shall be available to any government agency or any private third party;
Limitation of Patent Rights – no right to prevent third parties from… (as amended by Cheaper Medicines Act)
15 December 2015
• Case study: ranitidine hydrochloride• Phil. Patent No. 13540
– Patent for the compound ranitidine – One example provides a formulation with a pH of 5.0
• Phil. Patent No. 20574 – "Aqueous formulations of ranitidine have been found to have
enhanced shelf life provided that they are formulated with a pH in therange 6.5-7.5. Suitable aqueous formulations include injections forintravenous and intramuscular administration, continuous infusionsand oral preparations such as syrups.”
Exclusion of new forms of known substances from patentability
15 December 2015
• “SEC. 22. Non-Patentable Inventions. – The following shall be excluded from patent protection:
22.1. Discoveries, scientific theories and mathematical methods, and in the case of drugs and medicines, the mere discovery of a new form or new property 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 the mere use of a known process unless such known process results in a new product that employs at least one new reactant.
For the purpose of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations, and other derivatives of a known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy;...”
Non-Patentable Inventions
15 December 2015
new form or new property of a known substance which does not result in the enhancement of the known efficacy of that substance◦ Polymorphs, in new pH formulation
new use for a known substance◦ Second medical use (Viagra)◦ Swiss type claims: “Use of substance X for the manufacture of a
medicament for the treatment of disease Y.”
the mere use of a known process unless such known process results in a new product that employs at least one new reactant◦ Use of a process for manufacturing drug A in the manufacture of drug B
Non-patentable drugs and medicines
15 December 2015
• Salts : Na/K. etc.• Esters: R-O-R’• Ethers: O=C-OR’• Polymorphs• Metabolites• Pure form• Particle size• Isomers• Mixtures of isomers• Complexes• Combinations, and • Other derivatives of a known substance
“Same substance” – unless they differ significantly in properties with regard to efficacy
15 December 2015
Salts: Ascorbic Acid and Sodium Ascorbate
15 December 2015
Salts: Ascorbic Acid and Sodium Ascorbate
15 December 2015
Ethers: Phenol and Diphenyl Ether
15 December 2015
See G.L. Perlovich, et al., Polymorphism of Paracetamol, 89 Journal of Thermal Analysis and Chemistry 767 (2007).
Polymorphs: Paracetamol
Metabolites: Caffeine
15 December 2015
Isomers: Linalool and Geraniol
15 December 2015
Complexes: Palladium Catalysts
15 December 2015
Mixtures of Isomers: Carotene
15 December 2015
• testing, using, making or selling the invention, including any data related there to• solely for purposes reasonably related to the development and
submission of information and issuance of approvals by government regulatory agencies required under any law of the Philippines or of another country that regulates the manufacture, construction, use or sale of any product
• regulations to protect the data submitted by the original patent holder from unfair commercial use still to be issued
Early working exception - now allowed
15 December 2015
• Patent Infringement
– Making, using, offering for sale, selling, or importing a patented product or a product obtained directly or indirectly from a patented process, or the use of a patented process without authorization
Enforcing patent rights
15 December 2015
• Requires a comparison to be made of– The allegedly infringing item, method, or process with
– Each claim of the patent
• Claims: the heart of a patent– statements that define the composition and/or utility of the invention
– also describe obvious variations on the invention to prevent others from easily engineering around the patent
Determining patent infringement
15 December 2015
Sample claim - Phil. Patent No. 13232 for Tetracycline compositions
15 December 2015
• Civil action for infringement/damages
• Criminal action for repetition of infringement
• Administrative action
– Bureau of Legal Affairs (BLA) of the IPO
• Who can file?
– Patent owner
– Including foreign national not licensed to do business in the Philippines
Remedies
15 December 2015
• Defenses in action for infringement
– Invalidity of patent
– Invalidity of claims
– Any ground for petition for cancellation
• Not new/patentable
• No sufficient disclosure
• Contrary to public order or morality
Remedies
15 December 2015
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Question: Is the IP system in the Philippines, particularly the patenting of drugs/pharmaceutical products, similar to your country?
a) Yes
b) No
c) Not sure
15 December 2015
Poll II.
Case Study I: Supreme Court cases on pharma patents
15 December 2015
• ROMA DRUG ,et al. vs. THE REGIONAL TRIAL COURT OF GUAGUA, et al., G.R. No. 149907, 16 April 2009
• Seized medicines were manufactured by SmithKline but imported directly from abroad and not purchased through the local SmithKline, the authorized Philippine distributor of these products
• SC: Republic Act No. 8203 (Special Law on Counterfeit Drugs) classification of "unregistered imported drugs" as "counterfeit drugs” is in conflict with Rep. Act No. 9502, which grants private third persons the unqualified right to import or otherwise use such drugs.
Pharma patents jurisprudence
15 December 2015
• PHILPHARMAWEALTH INC. vs. PFIZER, INC. and PFIZER (PHIL.), INC. , G.R. No.167715, 17 November 2010
• Infringement complaint filed by Pfizer vs Philpharma, with preliminary injunction issued in favor of Pfizer
• CA upheld injunction and denied motion to dismiss (ground was lapse of patent)
• SC: CA should have dismissed the case as the only issue raised is the propriety of extending the writ of preliminary injunction issued. Since the patent which was the basis for issuing the injunction, was no longer valid, any issue as to the propriety of extending the life of the injunction was already rendered moot and academic.
Pharma patents jurisprudence
15 December 2015
• SAHAR INTERNATIONAL TRADING, INC. vs. WARNER LAMBERT CO.,LLC and PFIZER, INC. (Philippines), G.R. No. 194872, 9 June 2014
• SC was asked to resolve propriety of the writ of preliminaryinjunction issued by CA in favor of Warner Lambert and Pfizer
– Sahar argued the patents were expiring overseas, and itsforeign sourced products could thus be sold.
• SC, however, had to dismiss the petition on the ground ofmootness.
– The CA already resolved the case, from which the writstemmed, and found Sahar liable for patent infringement anddamages.
Pharma patents jurisprudence
15 December 2015
• SMITH KLINE BECKMAN CORPORATION vs COURT OF APPEALS and TRYCO PHARMA CORPORATION, G.R. No. 126627, 14 August 2003
• Infringement complaint filed against Tryco for its use of Albendazole, which Smith Kline claims to be covered by its Patent No. 14561
• Mere absence of Albendazole in Patent No. 14561 is not determinative of non-inclusion in the claims of patent, there is nothing in the language of Patent No. 14561 that yield anything regarding Albendazole
• Smith Kline’s patented compound may perform substantially the same function as Albendazole but identity of result does not amount to infringement unless Albendazole operates in substantially the same way or by substantially the same means as the patented compound.
• Doctrine of equivalents requires the satisfaction of the function-means-and-result test.
Jurisprudence on patents
15 December 2015
• The Philippine Supreme Court has consistently upheld the grant of compulsory license in cases where the patent relates to medicine and is therefore necessary for public health.
• BARRY JOHN PRICE, et. al., vs UNITED LABORATORIES, G.R. No. 82542, 29 September 1988
– SC declared there is no error in granting compulsory license in this case involving Patent No. 13540 (for “aminoalkyl furan derivatives” used as component in manufacturing anti-ulcer medicine) which relates to medicine and is necessary for public health.
Pharma patents jurisprudence - compulsory licensing cases
15 December 2015
• SMITH KLINE & FRENCH LABORATORIES, LTD, vs COURT OF APPEALS, et. al., G.R. No. 121867, 24 July 1997
– SC upheld grant compulsory license noting that patented invention (Cimetidine) relates to medicine.
• SMITH KLINE & FRENCH LABORATORIES, LTD, vs COURT OF APPEALS and DANLEX RESEARCH LABORATORIES, INC. G.R. No. 121267, 23 October 2001
– SC upheld grant of compulsory license to Danlex noting that the patented invention (Cimetidine) relates to medicine.
– The grant of compulsory license will not create confusion to the public as licensee expressly acknowledges that Smith Kline is the source of the patented product.
Pharma patents jurisprudence –compulsory licensing cases
15 December 2015
• Despite parallel importation being allowed, actual introduction to themarket of the imported product may be prevented if:
– The Bureau of Customs has grounds to seize or forfeit the importedproducts for violation of customs regulations such as using falsedeclaration, invoice or document in the importation, Importation ofitems.
– The Food and Drug Administration, in upholding safety and quality ofdrugs in the market, finds that the manufacturer or sources of theimported drugs cannot be fully ascertained of their compliance tolabeling requirements and good manufacturing practice.
Parallel Importation
15 December 2015
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Question: Have you had any experience in any Intellectual Property disputes?
a) Yes
b) No
15 December 2015
Poll III.
Emerging issues
15 December 2015
• Association for Molecular Pathology et al. vs. Myriad Genetics, Inc. et al., 133 S. Ct. 2107 (2013)
– Patents for human DNA (BRCA1 and BRCA2 genes – linked to breast cancer) invalidated
– Synthetic DNA (cDNA) patents upheld
– Implications
• naturally occurring DNA not patentable
• How about other substances isolated from natural products, such as drugs derived from microorganisms or plants?
Case Study II: The Madrid case
15 December 2015
Case Study II: The Madrid case
15 December 2015
• Implications• Naturally occurring DNA not patentable
• How about other substances isolated from natural products, such as drugs derived from microorganisms or plants?
• USPTO issued in 2014 the Interim Guidance on Patent Subject Matter Eligibility (Interim Eligibility Guidance)
– Products of nature that are "not significantly different than what exists in nature" are not patentable in view of the US Supreme Court decision in Myriad
Case Study II: The Madrid case
15 December 2015
• Growth in the pharma sector in PH is expected to be 4.5% per yearover the next 5 years
• PH has an effective IP system in place
• New forms/uses of known drugs now excluded from patentprotection
• Biological materials are still considered patentable
• Enforcement of patents may be a challenge due to the lack ofexpertise in courts
6115 December 2015
Take-Away Messages
Name: Edmund Jason BarandaFirm: Baranda & Associates, RouseLocation: Manila, the Philippines
Email: [email protected]
15 December 2015
Questions?
Check it out NOW!
6321 May 201415 December 2015
Helpdesk Country IP Factsheets for the ASEAN countries?
• Follow us on social media for latest news and developments on IP issues in China and South-East Asia, as well as project activities e.g. events, webinars, new guides.
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@iprASEAN
‘South-East Asia IPR SME Helpdesk’
www.yourIPinsider.eu
Channel: Helpdesk TV
15 December 2015
Social Media: Stay Connected…
The South-East Asia IPR SME Helpdesk provides free, confidential, business-focused advice to European Small and Medium Enterprises (SMEs) relating to IPR in South-East-Asia.
To learn about any aspect of intellectual property rights in Vietnam or elsewhere in South East Asia, including
Local partners
Due diligence
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Or to simply learn about the local landscape and adapt your IP plan accordingly – something which can save you EUR in the long term
Contact us on [email protected]
“know before you go, we’re here to help you grow…”
6515 December 2015
