Embed Size (px)
Citation preview
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
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.
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 - 2050
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 & 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%
Hale & Tempest
Emerging World Share of PharmaSource 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 66.2Developed 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
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
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 www.msfaccess.org
