Indian health activists are seeking to prevent Gilead from patenting its new treatment for Hepatitis C in the country in a fresh battle over affordable access to medicine

November 24, 2013 6:56 pm

Indian health activists move to prevent Gilead’s drug patent

By Andrew Jack in London

Indian health activists are seeking to prevent Gilead from patenting its new treatment for Hepatitis C in the country in a fresh battle over affordable access to medicine. The Initiative for Medicines, Access & Knowledge in India said it had filed a “pre-grant” application in Calcutta to block a patent application on the drug sofosbuvir, just as Gilead, the US pharmaceutical group that developed the medicine, won European regulatory authorisation for its use.The legal action, which follows previous spats in India over intellectual property on medicines including those for HIV and cancer, could open the way for local generic drug manufacturers to sell low-cost versions of the product domestically and export it to other low-income countries without strong patent protection laws.

The move would be a blow to Gilead, which is spearheading a race for new, more effective oral treatments for Hepatitis C with fewer side-effects, widely viewed as having the potential to cure Hepatitis C, a condition that affects nearly 200m people around the world and causes damage to the liver and sometimes cancer.

Following its European approval for drug, branded as Sovaldi, Gilead is braced for regulatory authorisation in the US next month. Other drug companies includingAbbVie

, Johnson & Johnson and Bristol-Myers Squibb are competing with experimental products for the condition in a market that analysts forecast could generate billions of dollars in annual sales.

“Old science, known compound,” said Tahir Amin, lawyer and director at the I-MAK, the group that filed the opposition. “India’s patent law doesn’t give monopolies for old science or for compounds that are already in the public domain. We believe this patent on sofosbuvir does not deserve to be granted in India.”

The legal action could stall for several years the granting of patents in India, which one generic drug manufacturer said could permit the production of low-cost equivalents over several years.

Médecins Sans Frontières, the humanitarian organisation, said it welcomed the legal challenge, expressing concern that even at a significant discount to the estimated $80,000 US price for the drug treatment, it would be inaccessible to the vast majority of Hepatitis C patients who live in low and middle income countries.

Dr Simon Janes, medical co-ordinator with MSF in India, said: “We know from our experience providing HIV treatment over more than a decade in dozens of developing countries that treatment needs to be simple and affordable – preferably less than $500 to start with. An unaffordable price for this drug will have a chilling effect on funders and governments who need to start financing and providing treatment.”

Gilead has in the past sought to develop an access programme for patients in low-income countries by licensing its HIV drugs to generic manufacturers while controlling for quality.

“As Gilead [Hepatitis C] medicines advance through the research and development pipeline, we will evaluate opportunities to incorporate them into our access programmes,” the company said on its website.