1. Hale & Tempest A View from India Dr. Brian W Tempest www.briantempest.com Opinion Formers’ Conference on Intellectual Property for Better Health Wellcome Trust, London 2 November 2010

2. Hale & Tempest Dr Brian Tempest advises Companies, Banks, High Net Worth Individuals and Investment Funds on their Strategy in the Emerging World based on his wide experience in China, Japan, South East Asia and India where he has lived for the last decade. Brian has worked for Ranbaxy Laboratories since 1995 holding the position of Managing Director and Chief Executive Officer until 2005. He was then Chief Mentor and Non Executive Director until 2008. He is one of the few westerners to have led a Sensex Nifty 50 Indian blue Chip MNC and as a result has a valuable insight into India. Brian has also been Regional Director, Far East for Glaxo where he was responsible for businesses in Japan, China, Korea, and Taiwan. Brian has worked in the Pharmaceutical Industry for the last 39 years and led Healthcare businesses in North America, South America, Europe, Africa, Middle East, Asia and India. He has also led sessions at Investor Meetings across Asia, Europe and USA. He is now an International Advisor to MAPE – India, Religare -India and UNCTAD - Switzerland. In addition he is a member of the SCRIP Global awards panel. Brian speaks at global conferences on the Challenge from India and China and more information on these presentations can be found on his website www.briantempest.com. Brian has a PhD in Polymer Chemistry from Lancaster University and is a member of the Royal Society of Medicine, the Royal Society of Chemistry and is a Chartered Chemist. He is now Chairman of Hale & Tempest Co Ltd.

3. Hale & Tempest AGENDA *Generics & Patented Medicines *TRIPS & Compulsory Licences *India & Patent Protection *Likely Future Development

4. Hale & Tempest *Generics & Patented Medicines

5. Hale & Tempest Healthcare Pressures Forever - 2050

6. Hale & Tempest Public Health Reform will continue

7. Hale & Tempest The R&D Model is failing

8. Hale & Tempest Sales Force Job Cuts in Press since 2009 H1 2010

9. Hale & Tempest Sources: 1.IMS Midas, March 2005 2.Earth Trend Data Tables 2005 82% of the world population accounts for only 12% of the global pharma sales RegionPharma SalesPopulation North America Europe Japan $255 b 47% $158 b 30% $59 b 11% 332 5% 725 11% 128 2% Asia/Africa/Aus Latam 88% $41 b 8% $20 b 4% 18% 4711 73% 558 9% 12% 82% Worldwide$533 b 100%6454 100%

10. Hale & Tempest Emerging World Share of Pharma Source EIU, OECD, WHO, IMS, Roland Berger

11. Hale & Tempest Big Pharma & the Emerging World source IMS - BRIC, Mexico, Turkey, South Korea

12. Hale & Tempest Regional Operating Margins - GSK

13. Hale & Tempest Top 22 Generic Companies over $1b Source: Company Reports Generics Bulletin 28 May 2010 (excludes Apotex & Actavis Private Companies)

14. Hale & Tempest Next18 Generic Companies < $1b Source: Company Reports Generics Bulletin 28 May 2010 (excludes Recalcine Private Company)

15. Hale & Tempest *India & Patent Protection

16. Hale & Tempest The Education Advantage

17. Hale & Tempest Indian DMFs 62% April 2010

18. Hale & Tempest ANDAs ex India > ANDAs ex USA

19. Hale & Tempest WHO Pre Qualified Products

20. Hale & Tempest An Indian View

21. Hale & Tempest Another Indian View

22. Hale & Tempest India IP Enforcement 2009

23. Hale & Tempest Supreme Court has 20,000 cases pending source Business World 16 Nov 2009

24. Hale & Tempest *TRIPS & Compulsory Licences

25. Hale & Tempest Cipla - Washington Post Ad

26. Hale & Tempest India – Route for Compulsory Licenses India Patent Act 1970 has always required the working of a patent locally Indian Patent Office has only recently taken a serious note of this In Feb 2010 the Patent Office issued a circular calling patentees to furnish information on the working of granted patents If information not received on form 27 a fine is levied of Rs 10Lacs A patent that has not been worked for 3 years from grant is vulnerable to the issuance of a compulsory license Any party which has been unsuccessful in obtaining a voluntary license from the patentee can file an application with Controller of Patents requesting a compulsory license

27. Hale & Tempest TRIPS Article 66.2 Developed countries shall promote technology transfer to LDCs and submit Annual Reports – Actual submissions from 60 countries to TRIPS Council 1999-07 Source: UN ICTSD 2008

28. Hale & Tempest Patent Evergreening tried since 1990 Source : JGM Vol. 7,3, 227-242  Polymorphs  Metabolites  Enantiomers  Change in strength, dosage  Impurities  New dosing routes  Methods of use (in USA)  Packaging/patient instructions  Pharmaco-kinetic/therapeutic parameters  Combinations with other drugs  Segmented patient population

29. Hale & Tempest *Likely Future Development

30. Hale & Tempest Likely Future Developments  Parts of Big Pharma will look for a second marketing face in the Emerging World (EW)  New young Big Pharma CEOs have diametrically different views to the past  Dual pricing is already in place  3 levels of IP are possible – LDCs, OECD, EW  In EW there will be more compulsory licenses and less patent evergreening  What happens when India offers oncology monoclonal biosimilars at knock down prices?

31. Hale & Tempest Will Biosimilars follow HIV Prices? source www.msfaccess.org

32. Hale & Tempest Thank You brian.tempest@clara.co.uk www.briantempest.com