Generic competition has consistently proven the single most effective method for reducing price over time. Over six million people in LMI countries today on lifesaving ARV treatment. Need to expand to second line, third line; also heart disease, cancer, biologic medicines, more.
Intellectual Property Provisions of the TPP Proposals and Dangers for Access to Medicines
Intellectual Property Provisions of the TPP Proposals andDangers for Access to Medicines Dr. Burcu Kilic Global Access to Medicines Program email@example.com December, 2011
What is Intellectual Property?• Creations of Mind: – Inventions – Literary and Artistic Works – Symbols and Images used in commerce• Intellectual Property Rights: – Allow the creator, or owner, of a patent, trademark or copyright to benefit from his or her own work or investment
Intellectual Property Categories• Industrial Property • Copyright – Patents for inventions – Literary works; novels, – Trademarks poems and plays – Industrial Designs – Artistic works; drawings, – Geographical Indications paintings, photographs, sculptures and architectural designs
PATENTS• A patent is an exclusive right to exploit invention, which is a product or a process that provides a new way of doing something, or offers a new technical solution to a problem.• Patent owner has right to use, sell, licence and exclude others from making, using, distributing selling or importing the invention• Patents provides 20 years exclusivity to the inventor
Patent Theory• Patent is a contract between the inventor and the Government• Inventor agrees to disclose fully (operative) the invention to the public• In exchange, the Government grants for a “limited time” a “limited monopoly” on the invention to the inventor if certain patentability requirements are met.
What are the patentability requirements?Patent protection is availablefor invention in all areastechnology provided thatthey fulfil followingrequirements:• Novelty• Inventive Step• Industrial Applicability
Patentability RequirementsNovelty• Is the claimed invention disclosed anywhere in the prior art? WIPO Publication No. 485 (E)
Patentability Requirements WIPO Publication No.485 (E)Inventive Step• Even if new and novel, would the claimed invention have been obvious to one skilled in the art at the time of the invention?
Patentability Requirements Industrial Applicability • Does the invention really do anything and, if so, does it solve the problem it is designed to solve?WIPO Publication No.485 (E)
What cannot be patented?• Certain inventions are excluded from patentability – inventions that adversely affect public order or morality – diagnostic, therapeutic and surgical methods for the treatment of humans or animals are not patentable – plants and animals (other than microorganisms)
Patents and Pharmaceuticals • Patents for pharmaceuticals (the TRIPS Agreement) • Price Increases • Global Crisis in Access
Pharma vs. Generics• Pharma Industry too often fails to bring needed drugs to market• Inadequate record of drug development• By 2015, $ 200 billion worth of branded drug sales may be lost to generic competition
Trans-Pacific Partnership Agreement• The leaked US proposals for the intellectual property chapter of the TPPA would require significant changes to Malaysian Law, including changes that would limit competition and raise drug prices, thereby restricting access to affordable access to medicines.
Leaked US IP ProposalsExpands pharmaceutical patenting and creatingnew drug monopolies – Ensures patentability for new uses of older, known drugs and minor variations • Patents for new uses, forms, methods • No exclusions for therapeutic methods of treating humans • Lower “industrial applicability” standard (imposes US utility standard)
Leaked US IP Proposals• Adjust patent term for regulatory delays (patent and/or registration) – Allows patent owners to postpone patent expiry. – Delay market entry of generic drugs• Prevents drug regulatory authority from relying on established data regarding medicine safety and efficacy to register generic medicines for at least 5 years (data exclusivity).
Leaked US IP Proposals• Links the patent system to drug registration process (patent linkage)• Favors big pharmaceutical companies in court by requiring courts to – presume any challenged patent valid – weigh the patent holder’s measure of the value of damages.
What consequences for Access to Medicines? • Patent protection for many years to come • Late market entry of generic drugs • Artificially high drug prices • Restrictions on access to medicines
Thank You!! Any Questions? Dr. Burcu KilicPublic Citizen - Washington, D.C. firstname.lastname@example.org +1 202 588 1000