Protest Submitted To First Patent Filing Of HIV/AIDS Drug In India

Two Indian HIV/AIDS networks and an international group of lawyers today submitted a protest to the first application for a patent for an HIV/AIDS drug filed in India.

The opportunity to stage a “pre-grant opposition” is the “beauty of the Indian patent system,” said Ellen ‘t Hoen of Médecins Sans Frontières (MSF) in an interview. Under India’s new patent law, parties are allowed to indicate officially in advance why they think a patent should not be granted.

The current protestors, who include the Indian Network for People Living with HIV/AIDS, the Manipur Network of Positive People, and the Lawyers’ Collective HIV/AIDS Unit, say they have technical and health reasons for objecting.

At issue is a patent application filed by Glaxo Group Limited for its fixed-dose combination of two AIDS drugs, zidovudine/lamivudine or AZT/3TC (Combivir).

The technical argument is based on prior art, as the groups argue that the combination is not an invention but simply the combination of two existing drugs. There are generic versions available of both drugs separately and in combination, according to ‘t Hoen. “A combination of two known molecules is not an innovation,” she said.

On the health grounds, the three networks are concerned that a patent for this drug could set a bad precedent. “If India grants a patent on this drug, it will set a precedent that will hamper access to affordable AIDS medicines worldwide,” MSF said in a press release.

If a patent were to be granted, the Indian generics companies that currently produce the drug would probably be allowed to continue to do so, but prices would go up, new companies would not be allowed to produce it, and there would be greater uncertainty, ‘t Hoen said.

Of the more than 60,000 patients in nearly 30 countries in MSF projects, 84 percent receive generic AIDS medicines made in India. More than 90 percent of all patients using AZT/3TC in these projects are on generic versions of the drug, MSF said. As this is the first HIV/AIDS patent application, ‘t Hoen says the protest is highly symbolic. “It is crucial,” she says.

The India patent law passed in 2005 to comply with World Trade Organization rules allows opposition to a patent application prior to its granting. Recently, Indian cancer patients and generic drug manufacturers opposed a Novartis patent application for an anti-cancer drug on the grounds that the application “claimed a new form of an old drug,” MSF said. The patent was then rejected by the patent office.

GlaxoSmithKline Pharmaceuticals Limited in Mumbai was unavailable for comment as there is a public holiday in India today. GSK headquarters in the United Kingdom was also unavailable at press time.

Three weeks ago, India granted its first-ever patent for a pharmaceutical product, to Roche for a hepatitis C treatment.

Editor’s Note: a company response to the pre-grant opposition appeared in a subsequent story on Intellectual Property Watch (IPW, Public Health, 30 March 2006).