Access to Medicines as a Human Right: Case study of India

1. Access to Medicines as a Human Right: Case study of India Prof. Frederick M. Abbott Harvard Human Rights Journal Symposium April 11, 2013 Cambridge, USA

2. Progress in the decade since Doha • Widened global awareness of public health problems, including those affecting developing countries • Substantially increased funding for procurement and distribution of necessary treatments, especially for HIV/AIDS, malaria and tuberculosis • Enabled by generic pricing • New R&D and production/distribution mechanisms established • For example, DNDi and Medicines Patent Pool • Stakeholder participation widened (e.g., Gates Foundation) • Improved cooperation among multilateral institutions

3. IP policy remains highly politicized • Case of South Africa Medicines Act led to Doha Declaration • Misuse of TRIPS Agreement • Inadequate institutional response entailed long-term damage • TRIPS Agreement embodies well-known flexibilities, as recognized by Doha Declaration • Common appreciation of nature of global public health problems not matched by cooperative approach to solutions • Stakeholder conflicts persist

4. Case Study of India • Commonwealth British Patents Act prior to 1970 resulted in foreign patent holder domination of the Indian pharmaceutical market, predominantly served by imports • 1970 Amendments to Patents Act eliminated product patents for medicines, allowing process patents • Indian generic industry developed advanced reverse engineering and production skills, and by mid-1990s was a major producer and exporter of drugs, often “on patent” elsewhere

5. The TRIPS Negotiations • India was among the lead "resisters" in the TRIPS negotiations, 1986-1993 • The transition arrangements for pharmaceutical product patents, including the "mailbox" and the provision for exclusive marketing rights, were largely the result of late-night endgame negotiations between India and the USA • India was subject to WTO dispute settlement complaint by the USA leading to first TRIPS dispute to reach the Appellate Body (India- Patent Protection for Pharmaceutical and Agricultural Chemical Products, Report of the Appellate Body, AB-1997-5,WT/DS50/AB/R, 19 Dec. 1997)

6. India-Mailbox decision confirmed TRIPS flexibilities • The Appellate Body said, "Members, therefore, are free to determine how best to meet their obligations under the TRIPS Agreement within the context of their own the legal systems. And, as a Member, India is ‘free to determine the appropriate method of implementing’ its obligations under the TRIPS Agreement within the context of its own legal system.”

7. India and the Doha Declaration • India played principal role in developing and negotiating the Doha Declaration • The initial "strong form" of the main provision (ultimately Paragraph 4), "Nothing in the TRIPS Agreement shall prevent” was developed by India • India was a key mover in the subsequent Paragraph 6 negotiations, authorizing "predominant" compulsory licensing for export • The issue was initially flagged at an MSF hosted meeting in New Delhi in 2001

8. Amendment of the Patents Act • India faced January 1, 2005 deadline for implementing pharmaceutical product patent protection • Intensive discussions commenced in 2003, early 2004 regarding potential form of amendments • Originator industry lobbied Government and was attentive to the drafting process • Initial proposal by Government reflected both policy and drafting problems from generic industry and "access" standpoint • Parliament became intensively involved, with social progressives demanding and ultimately obtaining important modifications

9. Key features of 2005 Patents Act • Pre-grant opposition maintained • Patenting of new forms of known compounds requires an enhancement of the "known efficacy" of the compound, with explanation: Explanation.- For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy (Section 3(d))

10. Key features of 2005 Patents Act • Transition form of prior user right in favor of drugs on market or in development as of January 1, 2005, with payment of reasonable royalty • Parallel imports authorized • Compulsory licensing provisions maintained with certain modifications • Improved procedure for exports under compulsory license • No "linkage" between Patents Act and Drug Regulatory Authority marketing approval process

11. Originator litigation • Novartis challenges constitutionality and compatibility with TRIPS Agreement of Section 3(d) • Faced "known" insurmountable obstacle to finding that statute was inconsistent with TRIPS Agreement because India follows Commonwealth model wherein treaties are not directly effective in national law • Despite known obstacles spent millions on attorney's fees • Constitutional challenge equally problematic • Madras High Court rejects challenge in 2007 • No direct effect of TRIPS Agreement • No constitutional infirmity from delegation of implementing and interpreting statute to India Patent Office

12. Bayer loses challenge on patent linkage • In February 2010, High Court of New Delhi dismisses Bayer against Drug Regulatory Authority marketing approval of cancer drug, Nexavar (sorafenibtosylate, prescribed for the treatment of advanced renal cell carcinoma) • Cipla had undertaken "at risk" launch, following marketing approval • Bayer argued linkage could be implied from a form used in approval submissions to the DRA querying whether drug patented • Court found that Parliamentary action would be required to establish linkage -- a well-known and important issue in India and elsewhere -- and that extrapolation from a question on an application form a to0 wide stretch

13. India challenges drug seizures • On May 11, 2010, India initiates dispute settlement consultations at the WTO with the European Union and the Netherlands challenging seizures by Dutch customs authorities of generic drugs in transit based on local patents in the Netherlands • Following consultations, EU agrees to interim settlement acknowledging that mere transit through EU territory does not constitute sufficient basis for suspicion of infringement of patent rights • Commits to issuing guidelines to customs authorities and proposing revision of customs regulations • Final settlement and withdrawal of dispute settlement claim contingent on terms of revised regulation

14. Compulsory license on Nexavar granted • India Controller of Patents grants compulsory license on same Bayer drug, Nexavar, in favor of NATCO • Three grounds applied • Lack of accessibility • Lack of reasonable affordability • Failure of local working • Bayer had supplied very limited quantities to the Indian market • Bayer argued that Cipla already adequately supplying market, so that compulsory license unnecessary • Bayer introduced limited evidence of program designed to provide accessible-affordable product

15. Compulsory license on Nexavar granted • Prices far in excess of those affordable to the public, including with government assistance • Had sought to supply requirements only through importation, and had not demonstrated sufficient obstacle to local production • Bayer alleges Cipla production infringes patent, cannot rely on activities it claims are illegal as defense • Affirmed by Intellectual Property Appellate Board on March 4, 2013 • Minor variation in ruling on local working • Bayer has indicated intent to appeal

16. Novartis Appeals rejection of Glivec/Gleevec patent application • Decision of Supreme Court of India of April 1, 2013 • Referring now to my contribution to Intellectual Property Watch: Inside Views, "The Judgment in Novartis v. India: What the Supreme Court of India Said” • <http://www.ip-watch.org/2013/04/04/the-judgment-in-novartis-v-india-what-the-supreme-court-of-india-said>

17. Decision of India Supreme Court • A reasonable and balanced interpretation of the India Patents Act • Novartis claims of enhanced efficacy problematic • Court does not hold that new forms of known compounds may not be patented • Court does not find that bioavailability may not enhance therapeutic efficacy • Court leaves open important interpretative issue regarding enhanced therapeutic efficacy as between curative effect, alone, or also improve safety or toxicity profile • Court refers to evidence that Novartis was not marketing beta crystalline form in India

18. The continuing cycle of action and reaction • Novartis, Pfizer and US Chamber of Commerce strongly condemned decision as anti-innovation • Represents instead reasoned decision regarding appropriate place in continuum for granting patents, reflecting in large measure pre-1995 patent law • Press is mobilized to question India's suitability as investment destination and trading partner • Perhaps not so successfully as in past, see e.g., New York Times editorial

19. The human rights angle • Each of the decisions by the Indian courts referred to above pay particular attention to the interests of India's large poor population and need for access to medicines • A number of the cases are argued by Anand Grover, UN Special Rapporteur on the Right to Health • Specific reference to Human Rights instruments is not a prerequisite to a human rights decision