[Ip-health] IFPMA: India’s Innovative Potential Con tinues to be Stifled by Its Poor Patent Law

[Mike Palmedo]

http://www.ifpma.org/News/NewsReleaseDetail.aspx?nID=7860

Chennai Court Ruling: India’s Innovative Potential Continues to be
Stifled by Its Poor Patent Law

IFPMA

Geneva, 8/6/2007 - Geneva, 06 August 2007 – The High Court in Chennai,
India, has today dismissed a legal challenge to Section 3d in India’s
2005 Patent Law that seriously handicaps Indian patients, emerging
research-based Indian and international pharmaceutical companies alike
by discouraging development of innovative medicines.

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.”

(Ends)

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.

For More Information Please Contact
Guy Willis
Director of Communications, IFPMA
Ch. Louis-Dunant, 15
P.O. Box 195
1211 Geneva 20, Switzerland
Email: g.willis@ifpma.org
Tel: +41 (22) 338 32 00
Fax: +41 (22) 338 32 99

--
Mike Palmedo
Research Coordinator
Program on Information Justice and Intellectual Property
American University, Washington College of Law
4910 Massachutsetts Ave., NW Washington, DC 20016
T - 202-274-4442 | F 202-274-0659
mpalmedo@wcl.american.edu