London

1
DFID The Lancet Seminar on Access to
Medicines (ATM)

Generics What is the Outlook?
by Dilip G Shah Secretary General Indian
Pharmaceutical Alliance
London 19 April 2007
2
Outline of Presentation

• Indian Patent Law
• Triggering Shift
• Impact on Access
• Role of Indian Generics

IPA04/07
3
Indian Patent Law Salient Features
What are Not Inventions Sec 3 (d), Sec 3
(e) Mandatory Compulsory Licensing Sec 11-A
(7) Pre-Grant Opposition Sec 25 Compulsory
License for Exports Sec 92A (1)
IPA04/07
4
Triggering Shift Globalization of Business
Region wise Exports
SOURCE CHEMEXIL
IPA04/07
5
Triggering Shift Globalization of Business
Exports of Pharmaceuticals
1990
2005
2010P
IPA 04/07
6
Impact on Access
IPA04/07
7
Impact on Access
PhRMA Mandate to USTR for India

• Modify Mandatory Compulsory Licensing for
• Mail Box Applications Sec 11-A (7)
• Adopt US Standards for Patentability and Scope
• of Patentable Subject Matter Sec 3 (d)
• Abolish Pre-Grant Opposition Sec 25
• Tighten Compulsory Licensing Provisions Sec 92
  (A)
• Seek Data Protection Beyond TRIPS Article 39.3

IPA04/07
8
Impact on Access Loss of Consumer Welfare
In the absence of any price regulation or
compulsory licensing the total annual welfare
losses to the Indian economy from the withdrawal
of all four domestic product groups in the
quinolone sub-segment would be on the order of
Rs. 32 billion in 2000. At the then prevailing
exchange rate this translates into a figure of US
713 million. Of this amount, foregone profits
of domestic producers constitute roughly Rs. 2.3
billion or US 50 million. The overwhelming
portion of the total welfare loss therefore
derives from the loss of consumer welfare.
The Effects of Extending Intellectual Property
Rights Protection to Developing Countries A
Case Study of the Indian Pharmaceutical Market
Shubham Chaudhuri Pinelopi K Goldberg
Panle Ji Columbia University
Yale University NBER Yale
University Source Columbia University
Discussion Paper No. 0304-08
IPA 04/07
9
Impact on Access
New Initiatives Creating Barriers to Access
FTAs Distorting Balance
Courtesy GPhA
IPA04/07
10
Impact on Access
Harmonization of Patent Law - SPLT
TRIPS-Plus Agenda of WIPO

• Trilateral Want Four Issues on Fast Track
• Prior Art
• Grace Period
• Novelty
• Inventive Step
• Harmonization will Take Away Flexibilities
• to Design Own IP System
• A Move to Stall Generics in the World

IPA04/07
11
Role of Indian Generics Emergence of New Players
Indian Pharmaceutical Industry MAT December 2006
Top 50 Companies Include 11 Foreign Companies
Having MS of 18
IPA04/07
12
Role of Indian Generics New Investment for Global
Markets
Investment in Pharmaceuticals
Source CMIE, Study Report 1996-2004
IPA 04/07
13
THANK YOU
dgshah_at_vision-india.com
IPA04/07