[Ip-health] EU urged to support India in drug-patent battle

[Alexandra HEUMBER]

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EU urged to support India in drug-patent battle
Published: Tuesday 16 January 2007 | Updated: Wednesday 17 January 2007

Humanitarian aid group M=E9decins Sans Fronti=E8res has urged the EU to
support the Indian government in a bitter legal fight against Swiss Pharma
company Novartis over patented medicines.

Background:

In January 2006, Novartis's patent application on a cancer drug (imatinib
mesylate) was rejected in India on the grounds that it only represented a
new form of a known substance and therefore was not an innovation and not
patentable under Indian law. The company filed an appeal over the patent
rejection and is also challenging the Indian patent law, arguing that it
violates WTO rules.
The WTO Doha Declaration on Trade-Related Aspects of Intellectual Property
Rights (TRIPS) and Public Health states that "the Agreement can and should
be interpreted and implemented in a manner supportive of WTO members'
right to protect public health and, in particular, to promote access to
medicines for all".
The EU has endorsed the WTO rules allowing compulsory licensing of
patented products and processes to ensure access to affordable medicines
for poor countries.
Issues:

A legal action by Swiss pharma group Novartis against the Indian
government over patented drugs is raising concerns about the potential
impact of the case on access to medicines in developing countries.
Referring to a European Parliament resolution of September 2005,
humanitarian group M=E9decins Sans Fronti=E8res (MSF) is urging the EU to
react to the Novartis case. It has also launched a 'drop the case'
petition against Novartis.
The resolution  stressed the importance of India with regards to access to
medicine for developing countries and calls on the EU to support India in
further implementing its intellectual property laws in a manner that will
"create an environment that will continue to encourage and facilitate
investment by the Indian generic manufacturing industry in providing
affordable essential medicines for developing countries".
Positions:

According to Novartis's statement on the case "the best way to encourage
innovation is via respect for intellectual property. We do not believe
that denying patent protection for innovative medicines and promoting
unlawful generic production and use within developing countries will help
patients or increase their access to medical treatment. Indeed, the Indian
case demonstrates the opposite.
"The tension between intellectual property rights and access to medicine
is addressed by the Doha declaration offering the instrument of compulsory
licenses to tackle public health problems, and Novartis supports the
flexibilities offered in this declaration."
The humanitarian group M=E9decins Sans Fronti=E8res fears that if Novartis
wins the case, patents on new derivatives or combinations of existing
drugs demonstrating no real innovation will become as easily granted in
India as they are in most other countries. This would mean that Indian
companies could no longer produce cheap generic drugs, which are essential
for access to medicines for people in developing countries.
The MSF also regrets that the current WTO rules allowing compulsory
licensing of drugs for developing countries have not improved those
countries' access to medicines. According to MSF, the WTO rules are
"prohibitively complex" for the organisation to buy drugs under them and
provide no incentive for companies to produce the drugs. The organisation
therefore hopes that the WHO's intergovernmental working group on public
health, innovation and intellectual property will find a workable solution
respecting medical R&D priorities, access to medicines and intellectual
property.
The European Parliament resolution (September 2005) on strategic
partnership between EU and India points out that "half of the patients who
take antiviral medicines in poor countries are using medication produced
in India" and "calls on the EU to support India in further implementing
its intellectual property laws in a manner that will avoid barriers to the
production, marketing and export of essential medicines".
Latest & next steps:

The hearing of the case is expected to take place before the end of
January 2007.
A M=E9decins Sans Fronti=E8res' hearing on the issue, supported by a coalit=
ion
of MEPs, will take place in the European Parliament on 23 January 2007.
Following the recommendations of WHO's Commission on Intellectual Property
Rights, Innovation and Public Health (CIPIH ) an intergovernmental working
group on public health, innovation and intellectual property was mandated
in May 2006 to find a solution to the tension between intellectual
property rights and access to medicines.

Links


EU official documents

European Parliament: European Parliament resolution on EU-India relations:
A Strategic Partnership (29 September 2005) [FR] [DE]
Commission: Access to essential medicines [FR]
Industry Federations

Novartis: Novartis position - Glivec patent case in India (December 2006)
International Organisations

WHO - Commission on Intellectual Property Rights, Innovation and Public
Health: Public health - innovation and intellectual property rights (April
2006)
WHO - Commission on Intellectual Property Rights, Innovation and Public
Health: Intellectual property and public health [FR]
WTO: TRIPS and public health
NGOs

M=E9decins Sans Fronti=E8res: Q&A on patents in India and the Novartis case
(20 December 2006)
M=E9decins Sans Fronti=E8res: Neither expeditious, nor a solution: The WTO
August 30th decision is unworkable (August 2006)
Press articles

News Nature: Petition aims to maintain cheap drugs
Reuters: MSF urges Novartis to drop patents case in India
L'Humanit=E9: Novartis veut fermer la =AB pharmacie des pauvres =BB


Alexandra Heumber
EU Advocacy Liaison Officer
M=E9decins Sans Fronti=E8res
Access to Essential Medicines Campaign
Rue Dupr=E9, 94. 1090 Brussels
++32 (0) 2 474 75 09 (Dir off)
++ 32 (0) 479 514 900 (Mob)
++ 32 (0) 2 474 75 75 (Fax)