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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. Introduction to Intellectual Property Law. General IP Law
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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
Introduction to Intellectual Property Law • General IP Law • International Legal Regime Surrounding Patents • Breakout Session #1 • TRIPS Flexibilities • Breakout Session #2 Coffee Break
Thailand: A Case Study • The Fight for ARVs in Thailand over the Past Decade • TRIPS-Plus Legal Mechanisms within Free Trade Agreements • Breakout Session #3
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: • New, • Involves an inventive step, and • 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 • Doha Declaration on the TRIPs Agreement and Public Health (2001) • Reaffirmed the TRIPS flexibilities • Clarified that developing countries and least developed countries (LDCs) have the right to implement flexibilities to promote public health under the TRIPS Agreement • Created new rights for LDCs to delay the introduction and/or enforcement of patents until at least 2016
International and Thai Right to Health • Universal Declaration of Human Rights • 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…” • International Convention on Economic, Social and Cultural Rights (ICESCR) • Article 12(1) – Everyone has the right to “enjoyment of the highest attainable standard of physical and mental health.” • Thai Constitution (2007) • Section 52 – Everyone has an equal right to receive quality public health service
3. Breakout Session #1 • How does one fairly balance the right to health (patients) vs. the right of the patent holder (inventor/pharmaceutical companies)? • Who decides what the balance is? • 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/Non-commercial use of patents
a) Price Negotiations • Governments or NGOs negotiate with pharmaceutical companies to reduce the cost of patented pharmaceutical products needed in developing and least developed countries • Targeted pharmaceutical products include those still under patent without therapeutic (generic) equivalents currently on the market • If pharmaceutical companies are unwilling to negotiate, often governments will then pursue other TRIPs flexibilities to obtain the patented product
b) Voluntary Agreements • 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 • Prevents governments from having to use other TRIPs flexibilities (like CLs) to get patented pharmaceutical products
c) Patentability Standards • Art. 27 of TRIPS allows member states to exclude certain categories of inventions from patentability • Member states may also set high patentability criteria, denying new patents on new uses, forms, formulations or combinations of known medicines • 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 • 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 • Bolar Exception – an ‘early working’ exception which allows for research and experimental use of products still under patent • This allows generic versions to promptly enter the market right after the patent expires
e) Parallel Importation • The 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 • Allows countries to import a patented medicine from other countries where it is produced and sold at a lower price than in the domestic market • Example: A Thai firm buys ARVs produced in India and imports them into Thailand without the approval of the local distributor owning the patent rights • The 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 • Countries may permit any person to oppose patent applications before the patent is granted by filing a case in court (pre-grant opposition) • Under certain circumstances, a patent can be challenged after it has been granted by filing a case in court (post-grant opposition) • Ensures higher scrutiny of patent applications before and after they are granted (to ensure a novel, inventive step)
g) Compulsory Licensing • 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) • Allows for increased competition and lower prices (especially with generics) • Member states are able to decide the grounds on which to issue compulsory licenses: • An inventor’s refusal to grant a voluntary license • Promotion of the public interest or public health • A national emergency or situation of extreme urgency • To encourage anti-competitive practices
CLs: Government Use • A type of compulsory license which allows the government to use a patented invention for a public, non-commercial use • Countries can also issue government licenses to third parties to make patented medications available to the public at a much lower cost • 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)? • Hurt developed countries by hampering research and development of new inventions? • Help developing countries access crucial pharmaceuticals? • Hurt developing countries in accessing crucial pharmaceuticals?
History of FTA Negotiations • US and Thailand started negotiating FTA in 2004 • Stalled negotiations, but recent efforts to restart • Draft language of US-Thai FTA Patent section leaked during 6th round of negotiations in 2006 • EU and ASEAN entered into negations for EU-ASEAN FTA in 2007, in part due to break down in Doha negotiations • Draft language of FTA again leaked
Categories of Enhanced IPR in Draft FTAs • Stronger IP rules than what is required in TRIPS • Weakening of TRIPS flexibilities • Greater IP enforcement mechanisms
Expansion of IP Rules • 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) • Evergreening: Ability to patent new uses of already commercialized products (EU Art. 10.4; US Art. 9.8) • 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 • 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) • Data exclusivity for undisclosed information (EU Art. 10; US Art. 10.1)
Increasing Procedural Barriers on TRIPS Flexibilities • 3rd parties are not allowed to challenge patent applications before they are granted=no pre-grant opposition (US FTA, Art. 9.4) • Stricter conditions for issuing CL (even for government use): • Higher compensation for use (US Art. 9.6) • Higher data protection (US Art. 9.6).
FTA IP Enforcement Measures • Efforts to make generic manufacturers more vulnerable to IP challenges • Increase in the number of parties that have standing to defend IPRs (EU FTA Art. 14) • Decrease in the rights of the accused infringers (EU Art 15 &16). • more information required from alleged infringers • Increased punishments for infringement (more than just fines, includes imprisonment, confiscation, disqualification, etc)
State Enforcement of Increased IPRs • Burden on the State to implement new enforcement mechanisms • Stricter border measures (EU FTA Art. 28) • Customs authorities would have greater power to suspend the release of goods • Increases the number of IPRs whose alleged infringement can trigger custom measures • Already see in action: seizure of Indian generic drugs by Dutch and French customs authorities in transit to Brazil
Challenges to Using TRIPS Flexibilities • FTAs (and other efforts) will shift the current delicate balance between IP protection and public health in favor of IP protection by: • 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) • Limiting the scope of the Doha declaration on TRIPs and public health. • 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?
