2005 09 15 APLF India Pharma industry

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The Indian Pharma Industry, Regulations, and Insight: The Indian Pharma Industry, Regulations, and Insight Susan K. Finston Finston Consulting, LLC India Intellectual Property Seminar Association of Patent Law Firms (APLF) Washington, DC September 15, 2005

Key Points: Key Points High-level leadership to promote pharmaceutical R&D, biotechnology Intellectual Property regime in transition: Patent Act Amendments Inter-ministerial Commission on Data Protection Biological Diversity Act and Regulations Wildcard: WTO Hong Kong Ministerial

Bio-Pharmaceuticals and India’s Knowledge Economy: Bio-Pharmaceuticals and India’s Knowledge Economy “India is the Land of Ideas”* 300,000 biotech, bio-informatics and biological science grads annually (more than all of Europe) India’s Reverse Brain drain fuels biotech in India: Non-Resident Indians (NRIs) lead in biotech research; 20% of scientists in U.S., European labs, now many coming home * Dr. Mashelkar, Maharashtra Biotechnology Day, Mumbai, India November 13, 2002

India Inc.’sSupport for Biotechnology: India Inc.’s Support for Biotechnology Hon. Kamal Nath: India will not be wishy-washy on patents Key to continued growth in pharmaceuticals, shift from copying to R&D Hon. Kapil Sibal: Biotech is the government’s priority Biotech crosses $1b in 2005, 40% annual growth India seeks $5b in revenues, one million jobs by 2010 New Government sponsored biotech parks, streamlined approval process New initiative on technology transfer legislation (“Bayh-Dole India”)

India’s Enabling Environment: India’s Enabling Environment Patent Law Reform: Key milestone of TRIPS 2005 met through patchwork-quilt of Patent Act of 1970 Goal to restore India to the patent mainstream Best seen as a work in progress (pending Mashelkar Committee recommendations)

Patents Pending?: Patents Pending? Product Patent Protection: Wonderful, yet fundamental anti-patent slant of Patent Act of 1970 Political process limited reforms (e.g. pre-grant opposition), added or left intact TRIPS inconsistent provisions (e.g. mailbox limits, local working req., compulsory licensing, genetic invention disclosure) Mashelkar Committee reviews patentability (incremental innovation critical issue for India)

India’s Enabling Environment (2): India’s Enabling Environment (2) Data Exclusivity (WTO TRIPS Article 39.3) remains in political play in Inter-ministerial Committee on Data Protection OECD states provide for fixed period of non-disclosure and non-reliance Zero-sum game: protection for clinical dossiers likely fall short of global standards

Value of DE in India: Value of DE in India Why data exclusivity (DE) in addition to patents? DE provides the upfront incentive for commercialization and launch via an exclusivity period during which the governmental health authorities protect the data (non-reliance and non-disclosure) Fixed DE period recognizes proprietary nature of data After time expires, reference permitted to the data on file with the health authorities by generic producers (never disclosure), with proof of bio-equivalence Government as Gatekeeper Conserves valuable judicial resources Again critical to small biotech firms

Compare Canadian Approach: Compare Canadian Approach “The first option considered was to maintain the status quo. Because these amendments are to clarify and reflect the original policy objective of the NAFTA and TRIPS agreements, as well as to harmonize with the terms of protection offered in other jurisdictions, maintaining the status quo is not an acceptable alternative to amending the Regulations.” Proposed Regulation: (3) The Minister shall not issue a notice of compliance to a manufacturer, in respect of a new drug that the manufacturer compares to an innovative drug, before the end of a period of eight years after the day on which the first notice of compliance was issued to the innovator in respect of the innovative drug if (a) the manufacturer, in its new drug submission, abbreviated new drug submission, supplement to a new drug submission or supplement to an abbreviated new drug submission, directly or indirectly, compares the new drug to the innovative drug and the innovative drug contains a medicinal ingredient that had not been approved in Canada before the first notice of compliance was issued to the innovator; (b) the comparison forms the basis on which the manufacturer seeks the issuance of a notice of compliance; and (c) the medicinal ingredient in the new drug is identical to the medicinal ingredient in the innovative drug. Regulations Amending the Food and Drug Regulations (1390 — Data Protection) Gazette Canada, Vol. 138, No. 50 — December 11, 2004

Slide10: Table produced by Pharmaceutical Association of Malaysia Compare Other Asian Markets

India’s Enabling Environment (3) : India’s Enabling Environment (3) Dilution of biotechnology patentability: Biological Diversity Act (2002), Regulations (2004) restrict genetic resource patent rights: creates major hurdles for researchers, researchers have to bio-prospect without patent rights in India, could cloud patent rights gained abroad,  no national treatment, and no track record of approval of applications Related patent law provisions limit patentability for biotech inventions, provide additional grounds to challenge, revoke patents

Leadership on Biotech or of G77 at Hong Kong?: Leadership on Biotech or of G77 at Hong Kong? India’s WTO Agenda for Hong Kong, 2005: Compulsory Licensing for Export Weaker TRIPS protections for biotechnology patents; would extend Indian regime to all WTO members At logger-heads with U.S.; contrasts with India’s positive commercial environment for biotechnology

KAMAL NATH CALLS FOR AMENDMENT TO TRIPS AGREEMENT TO PROTECT BIODIVERSITY: KAMAL NATH CALLS FOR AMENDMENT TO TRIPS AGREEMENT TO PROTECT BIODIVERSITY          Shri Kamal Nath, Union Minister of Commerce & Industry, has called for amendment to the WTO TRIPs (Trade-related Intellectual Property Rights) Agreement in order to protect traditional knowledge and bio-diversity. In a letter recently addressed by him to 31 Trade Ministers, Shri Kamal Nath has emphasised the need to develop a sharper and more aggressive strategy on this issue as it has a strong bearing on large sections of people who are holders of traditional knowledge and are poor or disadvantaged. “We need to form a common position before Hong Kong for taking the process towards a logical outcome”, he has proposed.            “While insisting on an amendment to the TRIPs Agreement in line with our consistent policy, we could also think of a parallel line of action, similar to what we did on public health issues during the Doha Ministerial Meeting, namely, getting a Ministerial Declaration on TRIPs and Biological Diversity, Traditional Knowledge and Folklore. If we are able to achieve this at Hong Kong, it would strengthen our hands in getting an eventual amendment to the TRIPs Agreement”, the letter says. Ministry of Commerce and Industry Press Release, New Delhi, July 29, 2005

Does India Mean Business for Biotechnology?: Does India Mean Business for Biotechnology? Property enhancing vs property reducing approaches in play India is now too important for WTO politics as usual on biotech patents Change is hard, takes a long time

Points of Contact: Points of Contact Finston Consulting, LLC 3514 30th Street, NW Washington, DC 20008 1-202-364-3566 (ph) 1-202-330-5550 (fax) sfinston@finstonconsulting.com www.finstonconsulting.com www.bayhdole25.org Because Chance Favors Only the Prepared Mind