Gilead Sciences ($GILD) has received Indian Patent Office approval for Sovaldi, with the U.S. drugmaker saying that the nod for a patent on the blockbuster hepatitis C medicine does not hinder access--even as civic groups such as Médecins Sans Frontières (MSF) decried the ruling.
Gilead has worked with several Indian drug manufacturers to produce licensed versions of the drug for defined emerging markets at a significantly lower cost for the therapy in major reimbursed developed markets in the U.S., Europe and Japan.
But the access program has not ended complaints from MSF, and other groups, that the particular decision sends a poor signal on access to a wide variety of generics made by Indian firms--some of which were approved under compulsory licenses in the country. At the same time, Indian officials have denied reports that patent policies are changing in favor of stronger intellectual property rules sought by multinational drug firms.
“There has been excessive pressure building up on the Indian government to dilute the independent functioning of the patent office to ensure that patent claims are granted far more easily to U.S. firms," Leena Menghaney, head of the South Asia MSF Access program, said in a statement.
Sovaldi (sofosbuvir) had earlier faced a thumbs down on the patent application by the Controller General of Patents, Designs and Trademark--but the latest ruling overturns that decision, according to the Hindu newspaper.
A spokesman for Gilead however said in an emailed statement that the decision does not hinder access for developing countries.
"We welcome news that the Indian Patent Office (IPO) of New Delhi has granted our patent application [No. 6087/DELNP/2005] claiming the active metabolites of sofosbuvir. The recognition of intellectual property (IP) is central to investment in pharmaceutical research and development, and this decision underlines the scientific innovation involved in the development of this breakthrough treatment for chronic hepatitis C," spokesman Nick Francis said in a statement.
"It is the company’s goal to enable access to these medicines for as many people as possible, as quickly as possible. In developing countries the issuing of patents is often cited as a barrier to access, however the company believes that if used responsibly IP does not hinder access, supporting a sustainable model of voluntary generic licensing for more than a decade. This licensing program enables the manufacture and distribution of high-quality, low-cost versions of the company’s medicines for HIV, hepatitis B and hepatitis C," Francis said.
"This decision from the IPO of New Delhi serves to further strengthen the partnership between Gilead and the innovative Indian manufacturing industry; a partnership which has shown to be a proven and effective approach to expanding access to treatment, leveraging each company’s expertise for maximum benefit of patients living in resource-challenged countries.”
Still, according the Hindu, the drug may not be out of the woods yet in India, with a separate application before the Kolkata patent office with civic groups geared up to offer opposing views.
- here's the story from the Hindu