Rejection of Tenofovir patent strengthens the pre-grant opposition in India

The USPTO has rejected four patents of Gilead Sciences on a key HIV drug Tenofovir, which ultimately strengthens the pre-grant opposition filed in 2006 by Indian Network for People Living with HIV/AIDS to several patent applications filed by Gilead on tenofovir disoproxil fumarate (TDF) in India, on the ground that they did not meet the country's patentability standards.

TDF is important for people suffering with AIDS as a first line treatment, and also for those who have developed resistance to first-line antiretroviral therapy. WHO treatment guidelines include TDF in first and second-line antiretroviral regimens.

For the domestic generic industry, the development encourages production of the drug in the country, and gives them opportunities to export to developing countries to provide affordable treatment for millions of people suffering from AIDS.

US public interest organization, Public Patent Foundation (PUBPAT) challenged the patents in the US patent office, saying that Gilead's patent on TDF did not fulfil the criteria of novelty.

With this rejection, Gilead Sciences faces an uphill task to get a patent in India, and other developing countries. Legal experts say, Gilead will now have to share this information with the Indian patent office, which is in the process of examining patent applications on TDF by Gilead.