Chennai Court Ruling: India's Innovative Potential Continues To Be Stifled By Its Poor Patent Law
Professor Trevor Jones, who led the development of AZT, the first antiretroviral (ARV) medicine for HIV/AIDS, noted that Section 3d excludes certain pharmaceutical/biotechnological inventions: "For the purposes of this clause, salts, esters, ether, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combination and other derivatives of known substances shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy" Professor Jones commented that this clause "severely restricts innovation through incremental steps. Incremental innovation… is the way in which the vast majority of advances in medical science has occurred". He also noted that "a test, such as that of 'efficacy', is almost impossible to perform at a time when patents are filed."1
IFPMA Director General Dr. Harvey Bale said: "India's 2005 Patent Law recognized the importance of intellectual property rights for the future development of its emerging economy and the need to comply with international agreements. However, there is a mismatch between India's huge innovative potential, especially in the field of pharmaceutical and biotechnology R&D, and the wording of the 2005 Patent Law, which explicitly defines pharmaceutical innovation so narrowly as to render potentially unpatentable many breakthroughs delivering real benefits for patients. India has a strong incentive to remove this restriction and thereby give its scientists full scope to impress the world with a growing stream of innovative new medicines, researched, developed and made in India."
Section 3d also works against public health, because ongoing development frequently leads to medicines which are easier to take, often because fewer pills are required, and so encourage patient compliance - a major issue in the treatment of long-term diseases. It can create medicines which can be stored at ambient temperatures, making them more useable in resource-poor tropical countries. Dr. Bale added, "In many cases, a medicine patented for one indication may be effective against other diseases, but a lot of incremental development work has to be done to determine how it should be used and to confirm its safety and efficacy - this too is innovation. Last, but not least, extensive development work is invariably needed to create a child-friendly, or pediatric, version of an existing medicine which has been developed and approved for adults."
The Indian Patent Law's failure to recognize the importance of incremental pharmaceutical innovation was highlighted by Novartis' innovative anti-cancer medicine Glivec®, which has transformed the treatment of chronic myeloid leukemia. Although patented in some 40 countries worldwide, including China, Glivec® was refused a patent in India because it did not meet the enhanced efficacy requirement in Section 3d.2 Novartis mounted legal challenges to Section 3d and the Indian Patent Office's ruling against a patent for Glivec®. The Section 3d challenge was dismissed today by the Chennai High Court, but the patent appeal is still pending.
Section 3d of the 2005 Indian Patent Law and today's court decision do not enhance patients' access to medicines. Indian generic copies of Glivec® cost four times the average Indian's salary and the uptake is extremely small, whereas Novartis, using means-tested criteria, gives Glivec® for free to 99% of the 7,000-plus patients prescribed it in India. Equally, Indian generic second-line ARVs are generally more expensive than the original products offered at no profit to low income countries by innovator companies3; which also provide a range of information, monitoring and training services that generic companies do not. Indian generic ARVs have not improved access to treatment for Indians living with HIV/AIDS: UNAIDS estimates that ARV coverage in India in 2005 was 7%, compared to 25% in China, 24% in Kenya and 20% in Haiti.4
IFPMA Director General Harvey Bale noted, "At its Heiligendamm summit in June this year, the G8 spelt out the vital role of intellectual property in economic development; this approach is fully applicable and even overdue in India.5 But how long will India take to recognize this and at what cost to its economy and patients? India has the potential to be a global leader in biomedical R&D, but its current patent legislation condemns it to lag behind."
1 "India: Innovation at the Crossroads", by Prof. Trevor M. Jones, CBE, Creative & Innovative Economy Center, May 2007, The George Washington University Law School, Washington DC.
2 The Indian Patent Office compared the base compound, which is not useable in humans and patented only to give Novartis scientists the extra time needed to develop a useable form, with the final formulation of Glivec® that is approved and marketed worldwide. Novartis was able to provide the Indian Patent Office with substantial clinical evidence as to its efficacy versus the base compound but the application was refused.
3 "Untangling the web of price reductions; a pricing guide for the purchase of ARVs by developing countries", Médecins Sans Frontières, 9th edition, 2006.
4 "2006 Report on the Global AIDS Epidemic", UNAIDS
5 "Growth and Responsibility in the World Economy" Summit Declaration, 7 June 2007, G8 Summit, Heiligendamm
About the IFPMA
The International Federation of Pharmaceutical Manufacturers & Associations is a non-profit, non-governmental organisation representing national industry associations and companies from both developed and developing countries. Member companies of the IFPMA are research-based pharmaceutical, biotech and vaccine companies.
http://www.ifpma.org
Chennai o decizie a instanþei: India, potenþialul de inovare continuã sã fie înfundat sale de drept sãrace în materie de brevete - Chennai Court Ruling: India's Innovative Potential Continues To Be Stifled By Its Poor Patent Law - articole medicale engleza - startsanatate