E-DRUG: Successful pre-grant opposition to nevirapine syrup patent in
Pre-grant Opposition in India Leads to Rejection of ARV Patent,
Setting Critical Precedent!!
Great news! 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
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
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
Advisor, Analysis and Advocacy Unit, Gen Dir.
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