In a sign that civil society is turning up the heat in the struggle to access affordable medicines, two more oppositions to patents on AIDS drugs have been filed in India.
Pre-grant opposition filed on Gilead's patent application for tenofovir
The Brazilian AIDS advocacy group ABIA (Brazilian Interdisciplinary AIDS Association) and the Indian NGO SAHARA (Centre for Residential Care & Rehabilitation) have submitted an opposition against the grant of a patent in India to Gilead Sciences for the key AIDS drug tenofovir.
A patent in India would not only restrict genenic competition in India, but would also have a direct impact on the ability of Brazil to produce and access affordable generic versions of the drug.
The opposition has been filed on the ground that the drug consists of a previously known compound, and should not be considered an invention according to India’s Patents Act.
India’s patent law is pro-public health, with strict patentability criteria. A major public-health safeguard in the law is the provision against patenting of minor improvements of known medicines (section 3(d)). The law also allows any party to oppose patent applications that do not deserve patents under Indian law.
Civil society groups have also filed an opposition to Gilead’s patent application on tenofovir in Brazil. The patent offices in both India and Brazil will be reviewing the case in July.
Post-grant opposition on to Roche's patent for valganciclovir
The Delhi Network of Positive People (DNP+), an organization run by and representing the needs of people living with HIV/AIDS (PLHAs), filed a post-grant opposition against a patent for valganciclovir, a treatment for a common infection that can cause blindness or death to people living with HIV/AIDS. Roche, a Swiss multinational pharmaceutical company was granted the patent last year by the Chennai Patent Office.
Valganciclovir is a treatment for cytomegalovirus (CMV), a virus that often attacks the retina of people with compromised immune systems, such as PLHAs. Left untreated, CMV retinitis leads to irreversible blindness. CMV infection can also attack other parts of the person's body, such as the gastro-intestinal system or brain. Such systemic CMV infection is serious, and without treatment, will progress and invariably result in death in a person whose immune system is weakened by HIV.
The opposition filed by DNP+ argues that valganciclovir is a known compound, that it is insufficiently inventive, and that it is, at most, a "new form" of an already known substance that shows no improvement in efficacy.