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VISION: 10/03

Growth Perspective of Indian Pharmaceutical Industry. by D G Shah Secretary General Indian Pharmaceutical Alliance. New Delhi October 30, 2003. 1. VISION: 10/03. Patents & Implications for the Indian Pharmaceutical Sector. Outline of Presentation. Introduction

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VISION: 10/03

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  1. Growth Perspective of Indian Pharmaceutical Industry by D G Shah Secretary General Indian Pharmaceutical Alliance New Delhi October 30, 2003 1 VISION: 10/03

  2. Patents & Implications for the Indian Pharmaceutical Sector Outline of Presentation • Introduction • Global Generics Markets • Opportunities • Challenges-Post 2005 2 VISION: 10/03

  3. Patents & Implications for the Indian Pharmaceutical Sector Global Generics Markets Boundaries of Change • Demand will Grow Fastest in Emerging Markets • Generic Options Available for Most Large Disease Segments • ‘Westernization’ of Disease Patterns in the Developing World • Elderly Population will Fuel Demand In Developed Markets 3 VISION: 10/03

  4. Patents & Implications for the Indian Pharmaceutical Sector Global Generics Markets • Increase in Over 65 Population Percent of Population 65+ Years Old Source: US Census Bureau: National Institutes on Aging Note: Represents 2002 data 4 VISION: 10/03

  5. Patents & Implications for the Indian Pharmaceutical Sector Global Generics Markets Volume Growth from Generics in Strategic Markets 1998 % absolute Change in Volume & Mix 2002 % absolute Change in Volume & Mix Source: IMS Health: MIDAS, MAT Dec 2002 5 VISION: 10/03

  6. Patents & Implications for the Indian Pharmaceutical Sector Global Generics Markets 2002 Generic Growth • Dramatically Outpaced Brand Growth • % Growth @ Constant Dollars Source: IMS Health: MIDAS, MAT Dec 2002 6 VISION: 10/03

  7. Patents & Implications for the Indian Pharmaceutical Sector Global Generics Markets • Generic Utilization by Country Generics Prescriptions as % of Total Prescriptions Source: PharmaHandbook Note: Represents 2002 data 7 VISION: 10/03

  8. Patents & Implications for the Indian Pharmaceutical Sector Global Generics Markets Region-Wise Exports: 2001-02 Source: Chemexcil 8 VISION: 10/03

  9. Patents & Implications for the Indian Pharmaceutical Sector Global Generics Markets India’s Top 20 Markets 9 Source: Chemexcil VISION: 10/03

  10. Patents & Implications for the Indian Pharmaceutical Sector • Global Generics Market • Size and Growth ($Billions) 2001-07 CAGR% Overall 13.3% ROW 8.9% Europe 15.5% U S 13.6% 111% Source: Datamonitor 10 VISION: 10/03

  11. Patents & Implications for the Indian Pharmaceutical Sector Opportunities • Leveraging Knowledge Base • Partnering Global Players 11 VISION: 10/03

  12. Patents & Implications for the Indian Pharmaceutical Sector Opportunities Leveraging Knowledge Base • Lead Optimization • Synthesizing Designed Structure • Manufacture of Clinical Trial Samples • Global Clinical Research Projects • Moving – Up the Value Chain of R & D 12 VISION: 10/03

  13. 2005 5% 30% 35% 30% 35% 65% Patents & Implications for the Indian Pharmaceutical Sector Opportunities Moving up the Value Chain of R & D 2000E NCE Chiral Analogue NDDS Process Development 13 VISION: 10/03

  14. Patents & Implications for the Indian Pharmaceutical Sector Opportunities Partnering Global Players • Product Development • In/Out Licensing of New Products • Addressing Public Health Problems • Market Access 14 VISION: 10/03

  15. Patents & Implications for the Indian Pharmaceutical Sector Challenges – Post 2005 • National Patent Law • Data Exclusivity • Patent Law Treaty (PLT) • Substantive Patent Law Treaty (SPLT) • Non Tariff Barriers 15 VISION: 10/03

  16. Patents & Implications for the Indian Pharmaceutical Sector Challenges – Post 2005 National Patent Law • Manufacture For Exports Under Para 6 • Safeguards & Conditions • Patentability 16 VISION: 10/03

  17. Patents & Implications for the Indian Pharmaceutical Sector Challenges – Post 2005 Patentability Patenting In Pharmaceuticals The number of new chemical entities approved for use by US Food and Drug Administration (FDA) declined to 27 in 2000, compared to about 60 in 1985… …but the number of patents granted in the main patent class for new drug compositions was 6,730 in 2000. Year: 2000 NCEs: 27 Patents: 6,730 17 VISION: 10/03

  18. Patents & Implications for the Indian Pharmaceutical Sector Challenges – Post 2005 Patentability Patenting Minor or Trivial Developments • Formulations/Dosage Forms • Salts • Processes • Combinations • Polymorphs • Optional Isomers • New Indications (therapeutic methods) 18 VISION: 10/03

  19. Patents & Implications for the Indian Pharmaceutical Sector Challenges – Post 2005 Patentability Patenting Strategies Blanketing: a jungle or a minefield of patents Flooding: multiple patents, major as well as minor Fencing: blocking certain lines or directions of R & D Surrounding: an important central patent is fenced in or surrounded by other less important patents that block the use of the central patent, even after its expiration Networking: building of a patent portfolio to strengthen overall protection and bargaining power 19 VISION: 10/03

  20. Patents & Implications for the Indian Pharmaceutical Sector Challenges – Post 2005 Data Exclusivity • TRIPS Article 39.3 • Period of Exclusivity ? • Retrospective Effect ? • Impact of Data Exclusivity 20 VISION: 10/03

  21. YEARS 0 10 13 15 20 25 27 CLINICAL DEVELOPMENT & REGULATORY APPROVAL MARKETING EXCLUSIVITY IN INDIA PATENT FILING REGULATORY APPROVAL SOUGHT IN INDIA REGULATORY APPROVAL GRANTED IN INDIA PATENT EXPIRY GENERIC SUBMISSION GENERIC APPROVAL 0 10 13 15 20 25 27 Patents & Implications for the Indian Pharmaceutical Sector Challenges – Post 2005 Impact Of 10-year Data Exclusivity 21 VISION: 10/03

  22. Patents & Implications for the Indian Pharmaceutical Sector Challenges – Post 2005 Patent Law Treaty (PLT) • Diplomatic Conference Comprising 140 States Adopted PLT by Consensus in June 2000 • 104 Countries Signed the Final Act For Adoption and 43 Countries Signed PLT • Main Features of PLT • Harmonizes Formality Requirements • Streamlines Procedures for Patenting • Excludes Substantive Patent Law Issues 22 VISION: 10/03

  23. Patents & Implications for the Indian Pharmaceutical Sector Challenges – Post 2005 Substantive Patent Law Treaty (SPLT) • 1st Draft in November 2001 • Revised in May 2002-Lays Down World Patent Law • Makes TRIPS Obsolete • Secures What Could Not Be Achieved in TRIPS • Implications • End of Patent Policy as a Tool For National Development Strategies • Deviation Can be Subject to Sanctions • “No Exclusions to What is Patentable” • A Pipe Dream Takes On Real Proportions! 23 VISION: 10/03

  24. Patents & Implications for the Indian Pharmaceutical Sector Challenges – Post 2005 Non-tariff Barriers • Spreading Doubts About Product Quality • Working to Deny/Delay Product Registrations • Raising Standards of Regulatory Approvals 24 VISION: 10/03

  25. Patents & Implications for the Indian Pharmaceutical Sector Challenges – Post 2005 UN Nod for Generic Drugs “Under no circumstances do companies based in some countries that have poor regulatory quality standards match the standards of quality, service, and innovation on a sustainable basis that international companies provide.” IFPMA 25 VISION: 10/03

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