Hale & Tempest A View from India Dr. Brian W Tempest Opinion Formers’ Conference on...

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

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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.

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AGENDA

*Generics & Patented Medicines

*TRIPS & Compulsory Licences

*India & Patent Protection

*Likely Future Development

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*Generics & Patented Medicines

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Healthcare Pressures Forever - 2050

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Public Health Reform will continue

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The R&D Model is failing

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Sales Force Job Cuts in Press since 2009 H1 2010

Hale & TempestSources: 1. IMS Midas, March 20052. Earth Trend Data Tables 2005

82% of the world population accounts for only 12% of the global pharma sales

Region Pharma Sales Population

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%

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Emerging World Share of PharmaSource EIU, OECD, WHO, IMS, Roland Berger

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

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Regional Operating Margins - GSK

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

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

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*India & Patent Protection

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The Education Advantage

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Indian DMFs 62% April 2010

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ANDAs ex India > ANDAs ex USA

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WHO Pre Qualified Products

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An Indian View

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Another Indian View

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India IP Enforcement 2009

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

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*TRIPS & Compulsory Licences

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Cipla - Washington Post Ad

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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

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TRIPS Article 66.2Developed 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

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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

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*Likely Future Development

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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?

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Will Biosimilars follow HIV Prices? source www.msfaccess.org

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Thank Youbrian.tempest@clara.co.uk

www.briantempest.com