The company had filed the patent application for Combivir, which is a combination of Epivir and Retrovir, nearly eight years back.
However, the Indian Network for People Living with HIV/AIDS and the Manipur Network of Positive People had filed a pre-grant opposition at the Kolkata patent office stating the drug was not a new invention.
Combivir is a widely-used fixed dose combination and used preferably in projects run by several international organisations.
The NGO had claimed that Combivir, a fixed-dose combination of two essential AIDS drugs zidovudine and lamivudine does not deserve an exclusive patent right as both these drugs are already off patented and
are int he public domain. GSK has currenlty filed applications for a patent on Combivir in many developing countries affected by HIV/AIDS including India.
GSK, had earlier projected Combivir as one of the most promising products in its portfolio to be launched in the country. However, the current move to withdraw the patent application in India would create roadblocks for the company's plan to launch the drug here with exclusivity.
The activists associated with Manipur Network of People Living with HIV/AIDS said its pre-grant opposition was valid as this drug is a widely used fixed dose combination of zidovudine and lamivudine and is used extensively in the AIDS treatment programs of India, Thailand and other developing countries.
"Patents create monopolies on drug manufacture and prevent the production of affordable generic versions of the same drug by local pharmaceutical companies. The manufacture of affordable quality generic versions of Combivir and other anti-retroviral medicines has allowed
developing country governments to put more people on treatment and thus extend their lives," Anand Grover, project director, Lawyers Collective HIV/AIDS Unit, an NGO which helped the Manipur Network of
People Living with HIV/AIDS, in filing the pre-grant opposition.
This was the second instance of a multinational drug company facing strong opposition from the healthcare activists and NGOs over patenting lifesaving drugs in India in the post TRIPs period. Earlier, health NGOs and generic companies in India had launched an opposition aganist Novartis' patent application for its cancer drug Glivac. Subsequently, the company lost the case in India early this year following a legal battle.