1 Brussels September 2008 by D G Shah Secretary General Indian Pharmaceutical Alliance Indian Pharmaceutical Industry Innovation, IPRs & Counterfeits EICC – IMC Roundtable on Pharmaceutical Industry

2  Indian Pharmaceutical Industry  The Patents Act – Restoring “Balance”  TRIPS Article 39.3  IPRs & Innovation  IPRs & Public Health  Anti-Counterfeit Drive Outline of Presentation IPA:09/08

3 Investment in Capacity Creation Source: CMIE, Study Report: Indian Pharmaceutical Industry IPA: 09/08

4 Globalization of Business: Source: Pharmexcil IPA: 09/08 Indian Pharmaceutical Industry

5 Global Sales of Pharmaceuticals: P Mn $ P Domestic Sales10004,5648,000 Global Sales1783,71120,000 Total Sales1,1788,27528, P IPA: 09/08 Indian Pharmaceutical Industry Pharmacy of the World

6 R & D Spend: How Top Sectors Fare IPA: 09/08 Source: Capitaline Plus Indian Pharmaceutical Industry Pharma Spends More Than All Industries Put Together

7 R & D Constant $ (1 = INR 45) Source: IPA Year$ Mn Balancing Short-Term Profitability with Sustainable Long-Term Growth IPA: 09/08 Indian Pharmaceutical Industry

8 Moving Up the Value Chain of R & D NCE Chiral NDDS Analogue Process Development 30 % 65 % 5%5% % 35 % % IPA: 09/08 Indian Pharmaceutical Industry

9 The Patents Act Embodies TRIPS Agreement IPA:09/08  Article 7 (OBJECTIVE): The Enforcement of Intellectual Property Rights should be “…… in a manner conducive to social and economic welfare, and to a balance of rights and obligations”.  Article 8 (PRINCIPLES): WTO Members are Allowed to “…… adopt measures necessary to protect public health and nutrition, and to promote the public interest”.

10 The Patents Act IPA:09/08  Criteria for Patentability - S.3 (d) & (e)  Use of Transitional Period - S.11A(7)  Pre-Grant Opposition - S.25  Compulsory Licence - S.84  Government Use Licence - S.92 & 92A  Exception For Early Working - S.107(a)  Parallel Imports – S.107A(b) Implements Flexibilities Focus on Quality of Patents & Public Health

11 The Patents Act Encourages Innovation IPA:09/08 “We need to ensure that the global IP systems evolve so that they may contribute to the development of developing countries, by stimulating innovation and technology transfer relevant to them, while also making available the products of technology at the most competitive prices possible.” Integrating Intellectual Property Rights and Development Policy-CIPR - Prof John Barton - George E. Osborne Prof of Law, Stanford University - Mr Daniel Alexander – Barrister, London, UK - Prof Carlos Correa – Director, Masters Programme on Science and Technology Policy and Management, University of Buenos Aires, Argentina - Dr Ramesh Mashelkar FRS – Director General, Indian Council of Scientific and Industrial Research, New Delhi, India - Dr Gill Samules CBE – Senior Director of Science Policy and Scientific Affairs (Europe) at Pfizer Ltd, Sandwich, UK - Dr Sandy Thomas – Director of Nuffield Council on Bioethics, London, UK

12 The Patents Act  Pressure to Emulate the US System: United States spends over 14% of GDP on Healthcare and yet 1/3 of its people do not have access to medicines  India Trying to Evolve Own System: India needs a system that encourages real innovation while ensuring access to medicines IPA:09/08 FDA Granted Priority Status to Less than 25% of 1,284 Drug Patents Restoring “Balance” Should India Emulate or Evolve?

13 Restoring “Balance” Healthcare Spend as % of GDP The Patents Act Source : WHO IPA:09/08 Should India Emulate or Evolve?

14 TRIPS Article 39.3 Member States’ obligation is to protect “undisclosed test or other data” submitted to Regulatory Authority against “unfair commercial use” It does not mean “Market Exclusivity”; and Use of originator’s data for regulatory approval is “not unfair commercial use.” Protection of Undisclosed Test Data Canadian Federal Court Judgement IPA:09/08

15  10-Year “Data Exclusivity”  From Date of Marketing Authorization in the Country  Irrespective of Patent Status  For Any ‘New Product’ Demand of Big Pharma TRIPS Article 39.3 IPA:09/08

16 “different salts, esters, ethers, isomers, mixture of isomers, complexes or derivatives of an active substance shall be considered to be same substance unless they differ significantly in properties with regard to safety and/or efficacy” European Parliament Directive 2001/83/EC, as amended by Directive 2002/98/EC, as amended by 2004/24/EC, as amended by 2004/27/EC, Art. 10(1) (2004) Data Exclusivity in EC Derivative, if Significantly Different, is also Eligible for 10-Year Exclusivity TRIPS Article 39.3 IPA:09/08

17  Longer than 20-Year Market Monopoly  Delays Entry of Generics  Protection to Weak Patents  Tool for “Evergreening”  Offers Market Exclusivity to Pre-1995 Molecules Implications of Exceeding TRIPS Obligations TRIPS Article 39.3 IPA:09/08

18  No Obligation to Go Beyond TRIPS Agreement;  Taking Calibrated Approach;  Avoiding Data Exclusivity;  Making Appropriate Provision for Protection of “Undisclosed Test Data”;  Protecting Flexibility Conferred by the TRIPS Agreement for Defining Patentability;  Monitoring Impact of the TRIPS Agreement on Access to Medicines and the Local Industry What India is Doing TRIPS Article 39.3 IPA:09/08

19 Protection v/s Competition IP Laws are Designed to Provide Exclusive Rights as Incentives for Investment in R & D But In Many Sectors Competition (Absence of Exclusivity) Drives Technological Development IPRs & Innovation There is Inherent Tension between IPRs & Competition IPA:09/08

20 Protection v/s Competition IPRs are Designed to Foster Innovation and Sustain Economic Growth But Kill Competition and thereby Restrict Innovation Need for Balancing IPRs & Competition IPRs & Innovation IPA:09/08

21 IPRs & Innovation Protection (P) vs. Innovation (I) Minimal Protection Level Optimal Protection Level Source: Swiss Federal Institute of Intellectual Property, October 2006 Beyond a Point, IPRs are Counterproductive Maximal Innovation Level IPA:09/08

22 IPRs & Public Health Key Elements of India’s IPR Policy  Exclusive Rights should Not Prevent Pro-competitive Environment. Both are Needed for Innovation  There is No “One-Size-Fits-All” Model for Striking the Balance between IPR and Innovation  Stronger IPR = More Innovations? Not So Simple  Access to Medicine – Public Health Need for Flexibility in the IPR System IPA:09/08

23 IPRs & Public Health World Audited Market Region +MAT Mar 2005*Population-Mn $ Bn % Share 2005 % of Total Latin America Asia/Africa/Australia Japan Europe North America Worldwide Source: IMS Health: MIDAS, MAT March 2005 * Source: EarthTrends Data Tables 18% of the World Population Contributes 89% of Sales IPA:09/08

24 Anti–Counterfeit Drive Scope & Definition “Medicines which are deliberately and fraudulently mislabeled with respect to identity or source. Counterfeiting occurs both with branded and generic products and counterfeit medicines may include products with the correct ingredients but fake packaging, with wrong ingredients, without active ingredients or with insufficient active ingredients” Source : WHO IPA:09/08

25 Anti–Counterfeit Drive Report of the EC Taxation and Customs Unit “China, responsible for almost 60% of all counterfeit goods seized, continues to be the main source. However, in some categories, such as articles for personal care, other countries such as Georgia and Turkey are the main sources whilst Switzerland, India and United Arab Emirates top the list for medicines” Source : Community customs activities on counterfeit and piracy - Results at the European border IPA:09/08

26  IMPACT by WHO  SECURE by World Customs Organization  ACTA by G–8 / USTR  EU Council Regulation No. 1383/2003 Other Initiatives – Diffusing the Focus Anti–Counterfeit Drive Expanded IP Protection & Enforcement of Patents and Data Exclusivity Diffuse Anti-Counterfeiting Focus IPA:09/08

27 EU Directive 2004/48/EC: Article 3.2 Anti–Counterfeit Drive Yet, Anti-Counterfeiting Campaigns Go Beyond Counterfeits “The measures, procedures and remedies shall be applied in such a manner as to avoid the creation of barriers to legitimate trade and to provide for safeguards against their abuse” IPA:09/08

28 Anti–Counterfeit Drive Adopt One Uniform Definition  Counterfeits: Medicines which are deliberately and fraudulently mislabeled with respect to identity or source  What is not Counterfeit  Products infringing Patent Rights  Parallel importation of original products from a third country where they have been sold by the appropriate right- holder  Diversion of supplies of authorized items  Import of medicines for personal use, not duly registered in the country  Substandard need not be counterfeit and should be defined as Any medicine with incorrect ingredients IPA:09/08

29 THANK YOU IPA:09/08