[e-drug] MSF - Brazil rejects patent on an essential AIDS medicine

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E-DRUG: MSF - Brazil rejects patent on an essential AIDS medicine
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Brazil rejects patent on an essential AIDS medicine
Precedent-setting move likely to increase access to important AIDS drug

Rio de Janeiro/New York, 2nd September 2008 - The Brazilian Patent Office
has rejected a patent application by Gilead on the drug tenofovir
disoproxil fumarate (TDF), in a move that could increase access to a key
HIV/AIDS medicine across the developing world, says international medical
humanitarian organisation Médecins Sans Frontières (MSF).

"Securing wider access to TDF is absolutely crucial" said Dr. Tido von
Schoen-Angerer, Executive Director of MSF's Access Campaign. "TDF is a
cornerstone drug, recommended by the World Health Organization both for
patients starting treatment and for those whose medications aren't working
anymore. In the past Brazil's production of ARV drugs has helped to bring
down prices of ARVs globally. We hope this will happen again."

The decision now means that the medicine can be produced by Brazilian
generic companies or imported from other generic sources from abroad.
With around 31,000 people currently receiving the drug through Brazil's
universal AIDS treatment programme and an estimated 37,000 by the end of
2008, the consequences on the sustainability of Brazil's efforts to provide
AIDS treatment for all will be considerable. Companies in India for example
produce WHO-approved TDF at a tenth of the price: US$158 for one
patient's yearly treatment, compared to the US$1,387 charged by Gilead in
Brazil.

The patent application filed by the US pharmaceutical company Gilead
Sciences was opposed by a coalition of Brazilian NGOs and a government
pharmaceutical laboratory. The patent office in Brazil rejected it on the
grounds that it lacks inventiveness - one of the key requirements for a
patent in Brazilian and international patent law.

This is the first time that a patent related to an antiretroviral (ARV)
medicine has been rejected as a result of a pre-grant opposition in Brazil.
But the consequences extend far beyond Brazil's borders.

"This sets an important precedent for people living with HIV/AIDS in all
developing countries whose lives depend on these treatments", said Leena
Menghaney, MSF's Access Campaigner in India. "In India, where MSF
purchases most of our ARVs, civil society organisations have filed a similar
opposition to Gilead's patent application, and we hope that the Indian
patent office will be taking note of the Brazilian decision".

For further information, please contact:
Leena Menghaney, MSF (New Delhi) +91 9811 365 412
Daniel Berman, MSF (Geneva) +33 6 32 35 37 54
Michel Lotrowska, MSF (Rio de Janeiro) +55 21 8111 3666
Sandra Murillo, MSF (New York) +1 646 207 0405

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E-DRUG: MSF - Brazil rejects patent on an essential AIDS medicine (2)
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I personally do not believe/share the sentiments of rejecting patent application purely or in the disguise of opposition by NGOs or other groups for non scientific reasons. Every one who invents ANYTHING deserves the PROTECTION. Let us stop mystifying HIV/AIDS-patenting is recognised worldwide as one of the ways of rewarding ingenuity. HIV drugs no exception. Malaria is KILLING children and adults alike especially in developing countries, it is not less important than HIV. Developed countries will only be doing us (poor nations and people) good by teaching us "how to fish" rather than giving us fish. Africa and my country forexample has witnessed some real teaching by some American Scientists in the area of Drug development from our natural biomass, and more of this will sooner than later put African scientists/companies in a position to patent their inventions.

If the REAL reason for the rejection of this patent application by the Brazilian patent office is as a result of opposition with no clear scientific reason(s), (not coated reasons), then, it is unfair not only to the company but to creative thinking and innovations.

Martins Emeje
Research Fellow
National Institute for Pharmaceutical Research Development (NIPRD)
Ministry of Health
Idu Industrial Estate, Abuja
Nigeria
E-mail: martinsemeje@yahoo.com

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E-DRUG: MSF - Brazil rejects patent on an essential AIDS medicine (4)
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Dear Martins,

To respond to your message:

The opposition to Gilead's patent application for tenofovir, presented by
NGOs and other groups, was indeed based on technical arguments, showing
the lack of inventiveness - one of the three requirements for a patent
protection, according to Brazilian and international law.

Indeed, tenofovir's activity against viral infection was described in the
80s by an academic from former Czechoslovakia, and the inventive step
involved received due patent protection at that time.

It is important to highlight that at that time, most developing countries
did not grant patents for pharmaceuticals.

This has now changed.

As such, the introduction of oppositions has been a crucial tool to avoid
improper application for patents - including those that concern old
innovations.

Innovation must be rewarded, and patent protection is one form of reward.
But when it comes to developing countries needs, it cannot be the only
model. The 2006 report from the WHO's Commission on Intellectual Property,
Innovation and Public Health shows clearly that the patent system does not
bring the right solutions to address the Innovation and Access needs of
populations in developing countries.

Governments and WHO have acknowledged these problems and are beginning to
act. Indeed, the Intergovernmental Working Group on Public Health,
Innovation and Intellectual Property, which concluded in May 2008 after
two years of work, has produced a Global Strategy and Plan of Action which
recognises the need for change. A major contribution of the Strategy is
to further the development of new types of incentives for innovation that
do not come at the expense of access to medicines, and that prioritise
innovation according to health needs.

Sincerely,

Michel Lotrowska and Gabriela Chaves,
MSF, Rio de Janeiro

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E-DRUG: MSF - Brazil rejects patent on an essential AIDS medicine (5)
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Thank you for this comment Martins. I would add that rejection of a patent
on any ground other one than stated in the law would be a violation of a
fundamental principle - that is respect for the rule of law. Societies must
have a rules based system to protect rights. It seems that historically
societies protect property rights first. Witness what has happened in post
Communist societies. Once a legal system is in place to protect property
rights, it is then available to protect intangible rights such as health,
freedom to associate, to vote, equality and others we all value.
We all want to see the human right to health protected and respected. But at
bottom it is a right recognized in the law. If the door is opened to
respecting some rights but not others there is grave risk to all rights -
including that of health.

Michele Forzley, JD, MPH
Visiting Distinguished Professor of Law
Widener School of Law
Wilmington, DE
301-565-0680