US body denies Gilead HIV drug patent

US-based drug maker Gilead Sciences has found four of its US patents on Viread being turned down by the US Patent and Trademark Office (USPTO).

The company entered into non-exclusive license agreements with Indian drug companies such as Ranbaxy and Hetero for supply of the generic versions of its patent-protected AIDS medicine Viread (tenofovir) in over 90 developing countries.

The rejection of patents, a decision that can be appealed against, was based on the post-grant opposition filed by a US-based NGO Public Patent Foundation (PUBPAT).

The initial set back to Gilead has strengthened the case of Indian patient groups and health NGOs who have filed pre-grant oppositions against similar patent applications of Gilead in the Indian patent office.

If the US decision is to have an impact on Indian patent office's verdict, the license agreements, which called for restricted supply of the medicines on a royalty basis may turn redundant, experts feel.

It was in 2006, that the Indian Network for People Living with HIV/AIDS (INP+) filed pre-grant oppositions to several patent applications on Gilead's Viread on the ground that they did not meet the Indian patentability criteria.

Months later, PUBPAT approached the US patent office challenging the patent grants on the medicine. Both oppositions were based on the premise that the patents granted in the US and the ones sought in India are not patentable.

According to a PUBAT announcement on January 24, the USPTO has rejected all four patents on the drug. The decision, subject to challenge by Gilead, is likely to have an international impact on Gilead's patents on tenofovir in other countries, PUBAT stated.

Indian patient groups said that Gilead will now have to share the US patent office decisions with the Indian patent office.

Interestingly, Gilead had almost succeeded in stalling probable patent oppositions from Indian generic companies such as Ranbaxy, Strides Acrolab, Emcure, Hetero Drugs and Matrix Laboratories by entering into licensing pacts with them in August 2006.

The agreement allows its partners to manufacture and sell these products in over 90 developing countries, which accounts for 95 per cent of AIDS population, on payment of a nominal royalty.

However, INP+ went ahead with the patent opposition as it felt that if patents on tenofovir are granted in India, it will affect the access to affordable generic versions of the medicine in the country.