The Indian Pharma Industry, Regulations, and Insight

1
The Indian Pharma Industry, Regulations, and
Insight
India Intellectual Property Seminar Association
of Patent Law Firms (APLF) Washington, DC
September 15, 2005
Susan K. Finston Finston Consulting, LLC
2
Key Points

• High-level leadership to promote pharmaceutical
  RD, 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

3
Bio-Pharmaceuticals and Indias Knowledge Economy

• India is the Land of Ideas
• 300,000 biotech, bio-informatics and biological
  science grads annually (more than all of Europe)
• Indias Reverse Brain drain fuels biotech in
  IndiaNon-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
4
India Inc.sSupport for Biotechnology

• Hon. Kamal Nath India will not be wishy-washy
  on patents
• Key to continued growth in pharmaceuticals,
  shift from copying to RD
• Hon. Kapil Sibal Biotech is the governments
  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)

5
Indias 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)

6
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(increme
  ntal innovation critical issue for India)

7
Indias 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

8
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

9
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
10
Compare Other Asian Markets
Table produced by Pharmaceutical Association of
Malaysia
11
Indias 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

12
Leadership on Biotech or of G77 at Hong Kong?

• Indias 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 Indias
  positive commercial environment for biotechnology

13
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
14
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

15
Points of Contact

• Finston Consulting, LLC
• 3514 30th Street, NW
• Washington, DC 20008
• 1-202-364-3566 (ph)
• 1-202-330-5550 (fax)
• sfinston_at_finstonconsulting.com
• www.finstonconsulting.com
• www.bayhdole25.org

Because Chance Favors Only the Prepared Mind