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

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 He was then Chief Mentor and Non Executive Director until 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 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.

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

Hale & Tempest *Generics & Patented Medicines

Hale & Tempest Healthcare Pressures Forever

Hale & Tempest Public Health Reform will continue

Hale & Tempest The R&D Model is failing

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

Hale & Tempest Sources: 1.IMS Midas, March Earth Trend Data Tables % 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% % 128 2% Asia/Africa/Aus Latam 88% $41 b 8% $20 b 4% 18% % 558 9% 12% 82% Worldwide$533 b 100% %

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

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

Hale & Tempest Regional Operating Margins - GSK

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

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

Hale & Tempest *India & Patent Protection

Hale & Tempest The Education Advantage

Hale & Tempest Indian DMFs 62% April 2010

Hale & Tempest ANDAs ex India > ANDAs ex USA

Hale & Tempest WHO Pre Qualified Products

Hale & Tempest An Indian View

Hale & Tempest Another Indian View

Hale & Tempest India IP Enforcement 2009

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

Hale & Tempest *TRIPS & Compulsory Licences

Hale & Tempest Cipla - Washington Post Ad

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

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 Source: UN ICTSD 2008

Hale & Tempest Patent Evergreening tried since 1990 Source : JGM Vol. 7,3,  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

Hale & Tempest *Likely Future Development

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?

Hale & Tempest Will Biosimilars follow HIV Prices? source

Hale & Tempest Thank You