Patent application for AIDS drug opposed for first time in India

Patents in India endanger global access to affordable medicines and treatment scale-up.

New Delhi/Geneva - Today, the Indian Network of People Living with HIV/AIDS (INP ), the Manipur Network of Positive People (MNP ), and the Lawyers' Collective HIV/AIDS Unit officially submitted their opposition to a patent application filed in the Kolkata patent office by Glaxo Group Limited for Combivir, a fixed-dose combination of two AIDS drugs (zidovudine/lamivudine, or AZT/3TC).

The opposition is based on technical and health grounds. If India grants a patent on this AIDS drug, it will set a precedent that will hamper access to affordable AIDS medicines worldwide.

"Affordable generic AIDS medicines have been one of the cornerstones of our ability to keep more people alive, including here in India where we began treating people with AIDS this year," said Dr. Pehrolov Pehrson, of MSF's treatment project in Manipur, where all patients on antiretrovirals receive generics produced in India.

"Without a reliable supply of low cost AIDS drugs - made possible because medicines patents did not exist in India for many years - national governments and treatment providers alike will be faced with an uphill battle, and patients risk having vital treatment interrupted or priced out of their reach."

Of the over 60,000 patients in nearly 30 countries in MSF projects, 84% receive generic AIDS medicines made in India. Over 90% of all patients using AZT/3TC in MSF projects are on generic versions of the drug. National treatment programmes in India, Burkina Faso, Mongolia, Central African Republic, Malawi, Peru, the Republic of Kyrgizstan, Cambodia, Ukraine and Swaziland heavily rely on generic AZT/3TC.

The availability of affordable quality generic versions of Combivir (AZT/3TC) and other anti-retroviral medicines has allowed developing countries to put more people on treatment and thus extend their lives.

The Indian groups opposing the patent are arguing that Glaxo's Combivir (AZT/3TC) is not a new invention but simply the combination of two existing drugs. They say the granting of such a patent risks increasing the cost of anti-retroviral treatment for many people living with HIV/AIDS, thereby further increasing the burden on developing countries already struggling to treat patients.

"Universal Access to AIDS medicines will remain an elusive goal if there isn't a steady supply of affordable medicines. Decisions made by Indian patent offices are a question of life or death for people living with HIV/AIDS worldwide who rely on the availability of these drugs made in India," said Ellen &#‘t Hoen, Director of Policy Advocacy at MSF's Campaign for Access to Essential Medicines.

Last year, India changed its patent law to comply with the World Trade Organization's patent rules. Three weeks ago, India granted its first ever patent to Roche for a hepatitis C treatment.

However, the Indian Patent law allows oppositions to a patent application before it is granted. Indian cancer patients and generic drug manufacturers recently opposed a Novartis patent application for Gleevec (Imatinib Mesylate), an anti-cancer drug, on the grounds that the application claimed a new form of an old drug. The patent was subsequently rejected by the patent office. Petitioners are now demanding that the Combivir patent application be rejected on similar grounds.