Intellectual%20Property%20Rights%20and%20Pharmaceuticals

1
Intellectual Property Rights and Pharmaceuticals

• (Case study- Novartiss claim in India)
• Background note prepared for PHM Vic Internet
  Workshop

2
India Pharmaceutical Industry

• Huge drug manufacturing capacity (2nd after US in
  having USFDA approved manufacturing companies)
  Prominent generic sector (Mueller, 2007)
• Production as well as export
• Generic drugs manufactured in India constitute
  25 of total drug purchase of MSF and 80 of
  total anti-HIV drugs used to treat 80,000 HIV
  patients under MSFs AIDS projects in more than
  30 countries (MSF, 2007)

3
Patent Legislation, WTO and India

• 1972 The Patent Act 1970 came in to force (Only
  Process Patents) (CGPDT, 2007)
• 1994/1995 Creation of the World Trade
  Organization entry into force of the TRIPS
  Agreement, which obliges developing countries to
  grant patents on medicines no later than 2005.
  (WTO-TRIPS)
• Patents (Amendments) Act, 1999 ( EMR provision)
• Patents (Amendments) Act, 2002
• April 2005 Amendment of India's Patents Act
  medicines can now be patented in India. However,
  the law stipulates that only true medical
  innovations will be protected by patents. Section
  3(d) specifies that new forms of known substances
  do not deserve patents.
• Patents (Amendments) Rules 2005 (oppositionfees
  etc)
• Patents (Amendments) Rules 2006 (Datesfees etc)
• (CGPDT, 2007)

4
Section 3 (d), Patents (Amendments) Act 2005

• " the mere discovery of a new form of a known
  substance which does not result in the
  enhancement of the known efficacy of that
  substance or the mere discovery of any new
  property or new use for a known substance or of
  the mere use of a known process, machine or
  apparatus unless such known process results in a
  new product or employs at least one new reactant.
  
• 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". (Gazette of India, 2005)

5
What is the issue???

• Glivec (Gleevec in US) (Compound-imatinib
  mesylate) by Novartis is patented in 35 countries
  helpful in Chronic Myeloid Leukemia
• Generic brand is already available in India at
  less than one tenth (around 200 USD/Pt/Month) of
  the price Novartis is selling this drug in other
  countries (around 2,600 USD/Pt/Month)
• July 1998- Novartis applied to get patent for
  Glivec in India and was granted EMR
• January 2006- IPO rejected Novartiss application
  on the basis of its structural similarity to old
  compound
• May 2006- A legal petition filed in the Chennai
  High Court by Novartis challenging Indian Patent
  Office for denial of its patent application for
  Glivec as well as challenging section 3(d) of
  Indian Patent Law
• September 2006- First hearing of the appeal and
  challenge. No decision made. Referral to 2 judge
  panel. No decisions till now. (Mueller, 2007)
  (MSF, 2006)

6
What Novartis says..

• Strong IPRs Economic incentives Innovation
• Gilvec International Patient Assistance Program
  (GIPAP)- Free drugs to more than 17000 patients
  in 83 countries, 99 of Indian patients who are
  getting Glivec are getting it free through
  Novartiss Patient Assistance Program
• Access to medicines clearly favors people in
  affluent societies- limited access to medicines
  and limited research to address disease burden in
  Developing world should be priority- PPPs, Govt
  funded health system, Strong IPRS Other economic
  incentives for R D)
• 3 PPP with WHO (Leprosy, Malaria and
  Tuberculosis)
• ITD (Institute for Tropical Diseases) Singapore-
  (Dengue, Drug resistant TB, Malaria) (WHO, 2006)

7

• Major Orgs raising concern against Novartiss
  claim
• Peoples Health Movement
• Centre for Trade and Development
• Medecins Sans Frontieres (MSF)
• Oxfam International
• Indian Cancer Patients Aid Association
• INP (Indian Network for People with HIV/AIDS)
  etc.
• Why?
• Access to affordable drugs
• Interpretation of TRIPS in favor of public health
• Modes of opposition
• Petitions, Pre-grant oppositions, Mobilization of
  civil society

8
Future issues

• Judicial Interpretation of Indian Patent Act
  (esp. section 3 (d))
• US influence (MOU on Bilateral Cooperation on
  IP) (Bilateral FTA)
• Priority to public health within IPRs Framework
• Use of other public health measures
• (US-India IP)