Intellectual Property Rights and
Access to Medicines: The
Struggle for HIV/AIDS Drugs in
Thailand
Noah Metheny, Esq.
Thai AIDS Treatment Action Group (TTAG)
Chiang Mai University, Faculty of Law
February 2, 2011
S
Introduction to Intellectual
Property Law
1.
General IP Law
2.
International Legal Regime Surrounding Patents
3.
Breakout Session #1
4.
TRIPS Flexibilities
5.
Breakout Session #2
Coffee Break
Thailand: A Case Study
1. The Fight for ARVs in Thailand over the
Past Decade
2. TRIPS-Plus Legal Mechanisms within Free
Trade Agreements
3. Breakout Session #3
Introduction to IP Law
S
An Animated Introduction
1. General IP Law
 What is a patent?
 A patent grants a legal right meant to offer
incentives to innovators/inventors by giving
them a time limited right to exclusively
exploit their ideas for profit (monopoly)
 Patents confer legal rights on inventors, for at least 20
years
 Necessary to encourage R& D
 Patents create monopolies on the invention, limiting
competition
 Patents cover pharmaceutical products
How are Patents Granted in
Thailand?
An inventor must submit a (pharmaceutical) patent
application to the Department of Intellectual Property.
The application is then reviewed by the Division of
Patents to determine whether the invention is:
S New,
S Involves an inventive step, and
S Is capable of industrial application
2. International
Legal Regime and
Patents
 Trade-Related Aspects of Intellectual
Property Rights (TRIPS) Agreement 1994
 Requires all 151 World Trade Organization (WTO)
member states to adopt US-style patent protection
rules (staggered deadlines)
 Established minimum standards for IP rights and
rules for their enforcement
 Set a 20-year protection period for patented
inventions
 Includes some ‘flexibilities’ which allow countries
to get around or break patents
2. International Legal Regime
and Patents
S Doha Declaration on the TRIPs Agreement and
Public Health (2001)
S Reaffirmed the TRIPS flexibilities
S Clarified that developing countries and least
developed countries (LDCs) have the right to
implement flexibilities to promote public health
under the TRIPS Agreement
S Created new rights for LDCs to delay the
introduction and/or enforcement of patents
until at least 2016
International and Thai Right to
Health
S Universal Declaration of Human Rights
S Article 25(1) – “Everyone has the right to a standard of living
adequate for the health and well-being of himself and of his
family, including…medical care and necessary social
services…”
S International Convention on Economic, Social and
Cultural Rights (ICESCR)
S Article 12(1) – Everyone has the right to “enjoyment of the
highest attainable standard of physical and mental health.”
S Thai Constitution (2007)
S Section 52 – Everyone has an equal right to receive quality
public health service
3. Breakout Session #1
S How does one fairly balance the right
to health (patients) vs. the right of the
patent holder
(inventor/pharmaceutical
companies)?
S Who decides what the balance is?
S How is this balance maintained?
4. TRIPs Flexibilities
 Provisions in the TRIPs agreement that allows
countries to break or work around patents
 Ways to break patents/achieve lower drug costs:
a) Price Negotiations
b) Voluntary Agreements
c) Patentability Standards
d) Exceptions to Patent Rights
e) Parallel Importation
f) Patent Challenges
g) Compulsory licensing: Government use/Noncommercial use of patents
a) Price Negotiations
S Governments or NGOs negotiate with
pharmaceutical companies to reduce the cost of
patented pharmaceutical products needed in
developing and least developed countries
S Targeted pharmaceutical products include those
still under patent without therapeutic (generic)
equivalents currently on the market
S If pharmaceutical companies are unwilling to
negotiate, often governments will then pursue
other TRIPs flexibilities to obtain the patented
product
b) Voluntary Agreements
S Pharmaceutical companies agree to issue
licenses to governments or NGOs to
manufacture, import, export, and/or
distribute a patented product, for which the
companies receive royalties on every item
S Prevents governments from having to use
other TRIPs flexibilities (like CLs) to get
patented pharmaceutical products
c) Patentability Standards
S Art. 27 of TRIPS allows member states to exclude
certain categories of inventions from patentability
S Member states may also set high patentability
criteria, denying new patents on new uses, forms,
formulations or combinations of known medicines
S Prevents “evergreening” of patents, where
pharmaceutical companies will obtain new patents
by making minor changes to the medicine to
extend its monopoly period
d) Exceptions to Patent Rights
S Art. 30 of TRIPS allows states to establish limited
exceptions to the exclusive rights of a patent
owner, as long as they do not unreasonable
prejudice his or her ownership rights
S Bolar Exception – an ‘early working’ exception
which allows for research and experimental use of
products still under patent
S This allows generic versions to promptly enter
the market right after the patent expires
e) Parallel Importation
SThe purchase of a patented medicine from a lawful source in an
exporting country, the importation of which is without the
consent of the “parallel” patent holder in the importing country
SAllows countries to import a patented medicine from other
countries where it is produced and sold at a lower price than in
the domestic market
SExample: A Thai firm buys ARVs produced in India and
imports them into Thailand without the approval of the local
distributor owning the patent rights
SThe Principle of Exhaustion (of IP rights) determines under
what circumstances the local patentee may oppose the
importation of a patented product into the local market (domestic
or international exhaustion)
f) Patent Oppositions
S Countries may permit any person to oppose
patent applications before the patent is granted
by filing a case in court (pre-grant opposition)
S Under certain circumstances, a patent can be
challenged after it has been granted by filing a
case in court (post-grant opposition)
S Ensures higher scrutiny of patent applications
before and after they are granted (to ensure a
novel, inventive step)
g) Compulsory Licensing
S Government license that breaks a patent, authorizing a 3rd party
to make, use, or sell a patented invention without the patent
owner’s consent (Art. 31)
S Allows for increased competition and lower prices (especially
with generics)
S Member states are able to decide the grounds on which to issue
compulsory licenses:
S An inventor’s refusal to grant a voluntary license
S Promotion of the public interest or public health
S A national emergency or situation of extreme urgency
S To encourage anti-competitive practices
CLs: Government Use
S A type of compulsory license which allows the
government to use a patented invention for a
public, non-commercial use
S Countries can also issue government licenses to
third parties to make patented medications
available to the public at a much lower cost
S Art. 31 of TRIPS, which requires prior
negotiations with the patentee before the issuance
of a compulsory license, does not apply to
government use
Breakout Session #2
What are the ways the TRIPS flexibilities –
Help developed countries protect intellectual
property rights (IPRs)?
2. Hurt developed countries by hampering
research and development of new inventions?
3. Help developing countries access crucial
pharmaceuticals?
4. Hurt developing countries in accessing
crucial pharmaceuticals?
1.
Coffee Break!
Thailand, A Case
Study:
The Fight for ARVs
S
TRIPS+ Provisions
in Free Trade
Agreements
S
History of FTA Negotiations
S US and Thailand started negotiating FTA in 2004
S Stalled negotiations, but recent efforts to restart
S Draft language of US-Thai FTA Patent section
leaked during 6th round of negotiations in 2006
S EU and ASEAN entered into negations for EU-
ASEAN FTA in 2007, in part due to break down
in Doha negotiations
S Draft language of FTA again leaked
Categories of Enhanced IPR in
Draft FTAs
1) Stronger IP rules than what is
required in TRIPS
2) Weakening of TRIPS flexibilities
3) Greater IP enforcement mechanisms
I. Beyond TRIPS—
stronger IP rules
S
Expansion of IP Rules
S Definition of Patentable: Expand products able to patent to
include plants, animals, diagnostics, therapeutics, and
surgical procedures (EU FTA Art. 2;US FTA Art. 9.2)
S Evergreening: Ability to patent new uses of already
commercialized products (EU Art. 10.4; US Art. 9.8)
S Parties to Other Treaties: Must become signatories to other
treaties and incorporate provisions into domestic IP Law:
Patent Cooperation Treaty, Patent Law Treaty, and
Budapest Treaty on the International Recognition of the
Deposit of Micro-organisms for the Purposes of Patent
Procedure (EU Art. 9.1)
Increasing Length of Patent and
Data Protection
S Extend exclusive rights to patent holder for
the time needed for marketing
authorization—covers duration of
examination of patent and process to grant
marketing approval (US FTA Art. 9.7; EU
FTA Art. 9.3)
S Data exclusivity for undisclosed
information (EU Art. 10; US Art. 10.1)
II. Weakening of
TRIPS Flexibilities
S
Increasing Procedural Barriers
on TRIPS Flexibilities
S 3rd parties are not allowed to challenge patent
applications before they are granted=no pregrant opposition (US FTA, Art. 9.4)
S Stricter conditions for issuing CL (even for
government use):
S Higher compensation for use (US Art. 9.6)
S Higher data protection (US Art. 9.6).
III. Greater IP
Enforcement Mechanisms
S
FTA IP Enforcement Measures
S Efforts to make generic manufacturers more
vulnerable to IP challenges
S Increase in the number of parties that have
standing to defend IPRs (EU FTA Art. 14)
S Decrease in the rights of the accused infringers
(EU Art 15 &16).
S more information required from alleged
infringers
S Increased punishments for infringement (more
than just fines, includes imprisonment,
confiscation, disqualification, etc)
State Enforcement of Increased
IPRs
S Burden on the State to implement new enforcement mechanisms
S Stricter border measures (EU FTA Art. 28)
S Customs authorities would have greater power to suspend the
release of goods
S Increases the number of IPRs whose alleged infringement can
trigger custom measures
S Already see in action: seizure of Indian generic drugs by Dutch
and French customs authorities in transit to Brazil
Challenges to Using TRIPS
Flexibilities
S FTAs (and other efforts) will shift the current delicate balance between
IP protection and public health in favor of IP protection by:
S Increasing IPR protection standards (expanding the scope of what
falls in the realm of IP protection, extending the duration of exclusive
rights, introduction data exclusivity, etc)
S Limiting the scope of the Doha declaration on TRIPs and public
health.
S Increasing enforcement standards as well as a broad set of
enforcement measures and actions
Breakout Session #3
There is an outbreak of ox flu in Thailand. An
international pharmaceutical company has
developed a vaccine for it, but it costs 325,000
baht per shot. The vaccine is patented in
Thailand.
What strategies and approaches would you take
to tackle the problem?