Drug major GlaxoSmithKline's plan to patent its HIV/AIDS drug - Combivir - in India may hit a roadblock as a Kolkata-based NGO, Manipur Network of People Living with HIV/AIDS, has filed a pre-grant opposition with Patent Control Office in New Delhi.
The NGO 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 in the public domain.
GSK has filed applications for a patent on Combivir in many developing countries affected by 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 move to oppose the patent application is likely to thwart the company's plan to launch the drug in India with an exclusive right.
The activists associated with the NGO said its pre-grant opposition is valid as this drug is a widely used fixed-dose combination of zidovudine and lamivudine and is used extensively in the AIDS treatment programmes in India, Thailand and some 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," said Anand Grover, project director, Lawyers' Collective HIV/AIDS Unit, an NGO helping the Manipur Network of People Living with HIV/AIDS, in fighting the case.
However, a GSK India spokesperson said, "We cannot comment anything on the patent-related issues as these are handled directly by the parent company and, also, the application for Combivir was filed by GSK Plc."
GSK is engaged in research and development of innovative drugs for the diseases predominantly found in developing countries.
It supplies these drugs to over 63 least developed countries free of cost or at cost prices, also in partnership with NGOs and other patient organisations.
The company also has plans to volunteer licensing arrangements with generic companies to manufacture these drugs in developing countries, including India, he added.This is the second instance of a multinational drug company facing a strong opposition from healthcare activists and NGOs over patenting lifesaving drugs in India in the post-TRIPs era.