Brazilian group opposes Gilead's AIDS drug patent
By Neelam Raaj
Times of India
June 27, 2008
India's generic drug industry is a lifeline for millions of AIDS patients in developing countries. Now in a bid to protect access to this lifeline, a foreign patient group has for the first time filed an opposition against the grant of a patent in India to US-based Gilead Sciences for the key AIDS drug tenofovir.
Brazilian AIDS advocacy group ABIA (Brazilian Inter-disciplinary AIDS Association), which filed the opposition along with Indian NGO, Centre for Residential Care & Rehabilitation), says the step was necessary since a patent in India would have a direct impact on ability of Brazil to produce and access affordable generic versions of tenofovir.
The patent has been opposed on the grounds that the drug is only an addition of a salt (fumaric acid) to an existing compound (tenofovir disoproxil) and not a new invention. India's Patents Act includes a provision against patenting of minor improvements of known medicines: Section 3(d)).
The law allows any party to oppose patent applications. In 2006, Indian patient groups had also registered their pre-grant opposition to a patent on tenofovir.
Now, Brazil has entered this patent battle. An opposition to Gilead's patent application on tenofovir has also been filed in Brazil. The patent offices in both India and Brazil will be reviewing the case in July.
Tenofovir, a second-generation drug with fewer known side effects, has emerged as an important option for patients starting AIDS treatment for the first time, and those who have been on anti-retroviral treatment therapy (ART) for some time and require access to newer drugs due to occurrence of toxic effects or as they develop resistance to first-line drug regimens.
The drug is recommended under the updated World Health Organization (WHO) ART guidelines.
[FREE] Access to affordable tenofovir is particularly important for Brazil, as by the end of 2008, an estimated 31,000 people living with HIV will receive the drug through its national treatment program.