For the first time, a pre-grant opposition filed by Indian civil society for an antiretroviral (ARV) has led to a patent rejection. This sets an important precedent for the remaining 12 ARV oppositions filed and is an important victory for access to medicines across the developing world.
The Indian Patent Office on 11 June rejected the patent application filed in 1998 by German pharmaceutical company Boehringer Ingelheim for nevirapine syrup, used in the treatment of children living with HIV/AIDS. The patent decision was based on the opposition filed on technical and public health grounds by the Positive Women’s Network and the Indian Network for People Living with HIV/AIDS in 2006.
This ruling represents a landmark legal precedent in Indian civil society’s fight to ensure that India’s strict patent law is upheld and patents are not granted frivolously. India’s 2005 patent law allows any interested party to oppose patents under review by the patent office, or after they have been granted. Affected groups in India have been investing tremendous effort over the last several years to take advantage of the patent law’s public health safeguards, in order to protect and promote access to treatment for themselves and their counterparts across the developing world. As much of the developing world relies on affordable medicines produced in India, these efforts have a global impact.
India’s patent law does not consider improvements or new forms of known medicines to be patentable. The opposition argued that the syrup formulation of nevirapine was a new form of a known drug first invented in 1989, and thus older than the 1995 cut-off that India’s Patents Act considers eligible for patenting. Pharmaceutical companies make variations to existing medicines in order to extend their monopolies for as long as possible – a tactic called ‘evergreening.’ To extend its patent monopoly to 2018, Boehringer in 1998 applied for patents on the syrup formulation of nevirapine in many developing countries, including India.
The decision refers extensively to the August 2007 Indian High Court ruling in Novartis’ legal action against the Indian government and its patent law. The judgement against Novartis upheld the public health safeguards enshrined in India’s law, e.g. preventing evergreening.
This patent rejection shows how important the safeguards in India’s patent law are and how crucial it is that civil society mobilizes to make sure patents are not granted that should not be. Unnecessary patenting leads to the restriction of competition and therefore to high prices.
Two further oppositions filed on AIDS patents by civil society
In a further 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 June 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 generic 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.
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), has 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.