AIDS groups file pre-grant opposition against Tenofovir patent application
The Indian Network for People Living with HIV/AIDS (INP+) and the Delhi Network of Positive People have jointly filed a pre-grant opposition against Gilead Science's patent application on tenofovir disoproxil fumarate (TDF), a second line AIDS drug, at the Delhi Patent Office on May 9, 2006. Médecins Sans Frontières (MSF), an international health NGO, is supporting the move.
Announcing this at a press conference here, the NGOs said that once the patent application filed by Gilead Sciences is granted, generic production of the drug would be blocked until 2018. "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," Loon Gangte, from the Delhi Network of Positive People, said.
"Currently, there is one Indian company (Cipla) that is manufacturing the generic version of tenofir. If the innovator is awarded the patent rights, there will not be any generic versions of the drug. We need to have increased generic competitions and thereby reduced prices for tenofir," they said.
The World Health Organization (WHO) recognizes the importance of
tenofovir and recommends on their website the drug for use in first and second-line drug regimens in resource poor settings.
Widely available in the US and Europe, tenofovir is commonly prescribed because there are fewer known side effects associated with the use of this drug in adults. However, tenofovir is largely unavailable and often unaffordable in the developing world and treatment providers like MSF is keen to source it from India.
"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. 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's clear the world desperately need more sources of tenofovir. If Gilead is granted the patent, our patients will face a potentially deadly delay," said Dr. Eric Goemaere of MSF, South Africa.
Public interest lawyers providing legal support to INP+ argue 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 a new invention.
"If this patent is granted, it will set a dangerous precedent for global access to newer essential drugs," explains Anand Grover, Director of the Lawyers Collective HIV/AIDS Unit. "Tenofovir production, just like that of other newer essential drugs, would remain solely in the hands of a single pharmaceutical company and block the generic competition that is needed to bring prices down," he added.