1. Intellectual Property Provisions
of the TPP Proposals and
Dangers for Access to Medicines
Dr. Burcu Kilic
Global Access to Medicines Program
bkilic@citizen.org
December, 2011

2. 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

3. 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

4. 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

5. 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.

6. What are the patentability requirements?
Patent protection is available
for invention in all areas
technology provided that
they fulfil following
requirements:
• Novelty
• Inventive Step
• Industrial Applicability

7. Patentability Requirements
Novelty
• Is the claimed invention
disclosed anywhere in
the prior art?
WIPO Publication No. 485 (E)

8. 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?

9. 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)

10. 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)

11. Patents and Pharmaceuticals
• Patents for
pharmaceuticals
(the TRIPS
Agreement)
• Price Increases
• Global Crisis in
Access

12. 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

13. Pharma vs. Generics

14. 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.

15. Leaked US IP Proposals
Expands pharmaceutical patenting and creating
new 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)

16. 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).

17. 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.

18. 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

19. Thank You!!
Any Questions?
Dr. Burcu Kilic
Public Citizen - Washington, D.C.
bkilic@citizen.org
+1 202 588 1000