MSF Supports Opposition To Gilead's Tenofovir Patent Application in India

Tenofovir Patent Would Set Dangerous Precedent for Global Access to Newer Essential Medicines

New Delhi, May 10, 2006 – The medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF) is today expressing its support for Indian civil society groups in their battle against a patent application by Gilead Sciences for the key AIDS drug tenofovir (tenofovir disoproxil fumarate, TDF). People living with HIV/AIDS in India opposed the patent application yesterday on the grounds that the drug consists of a previously known compound, and should not be considered an invention according to India's Patent Act.

If Gilead were granted this patent, generic production of tenofovir in India, where a generic version has been marketed since 2005, could be prevented until 2018, and any existing production would be in jeopardy. In addition, future generic production of fixed-dose combination pills containing tenofovir would also be blocked. Such combination drugs have had a major impact in helping scale up global AIDS treatment by simplifying it.

"Granting this patent would set a dangerous precedent. Limiting production of tenofovir and that of other newer essential drugs to a single company keeps prices high because generic competition is blocked," said Ellen 't Hoen, Director for Policy and Advocacy at MSF's Campaign for Access to Essential Medicines.

Access to tenofovir in resource-poor settings is extremely limited. While Gilead, the patent-holder in most developed countries, has announced that it will offer the drug at a discount to 97 developing countries, the company has been extremely slow in making the drug available in these countries.

In MSF's HIV treatment project in Khayelitsha, South Africa, where nearly 4,000 patients receive antiretroviral drugs, the difficulty in accessing tenofovir has resulted in only 40 patients with only the most urgent needs receiving the drug.

"We need tenofovir for more and more of our patients, but the supply from Gilead has simply been too unreliable, so we can't put more patients on it," said Dr. Eric Goemaere of MSF in South Africa. "We have all been waiting impatiently to get tenofovir as a generic from India. Our project is a microcosm for what is to come elsewhere, and it is clear the world desperately need more sources of this essential drug."

Tenofovir is commonly prescribed as part of first-line antiretroviral treatment in the US and Europe. It is increasingly needed in resource-poor settings, both for patients starting treatment for the first time, because it leads to fewer side effects than other commonly used drugs, and for those patients who have been on therapy for several years. The latest World Health Organization (WHO) antiretroviral treatment guidelines recognize the importance of tenofovir for resource-limited settings, recommending its use in first and second-line regimens. But at the same time as tenofovir's importance is being underlined, access to it may be severely restricted.

The Indian Network for People Living with HIV/AIDS, represented by the Alternative Law Forum, Bangalore, registered their opposition to the patent at the Delhi patent office yesterday. The public interest lawyers are arguing that forming a salt (fumaric acid) out of an existing compound (tenofovir disoproxil) is a common practice within the pharmaceutical industry, and should not be considered patentable under Indian law.

"For many of us living with HIV/AIDS, newer drugs like tenofovir offer new hope of continuing treatment. With patents interfering with our lives we have no choice but to oppose them," said Loon Gangte, from the Delhi Network of Positive People, speaking at a press conference in Delhi.

Under the 2005 Indian Patents Act, anyone can submit comments in opposition of a patent before the patent office decides to grant or reject it. Cancer patients and generic drug manufacturers recently opposed a Novartis patent application for Gleevec (imatinib mesylate), an anti-cancer drug, on the grounds that the application claimed a new form of an old drug. The patent was subsequently rejected by the patent office.

MSF has been providing antiretroviral treatment to people living with HIV/AIDS since 2000. Over 60,000 patients currently receive ARVs through MSF worldwide.