- The Indian Patent Office has awarded a patent to Gilead's hepatitis C drug Sovaldi, reversing a prior decision rejecting Gilead's patent application in January of last year.
- A number of patient and humanitarian groups, including Doctors Without Borders (MSF), had opposed Gilead's efforts, arguing a patent would hurt patient access to affordable copies of the highly effective treatment.
- Patentability standards in India have become a flash point between patient groups and the global pharmaceutical industry, as the country provides many of the world's generic drugs.
Sovaldi is one of several new direct-acting antiviral hepatitis C treatments, including the company's other drug Harvoni and Merck's Zepatier. While it effectively "cures" over 90% of patients, Gilead has been criticized for the high price it charges in developed countries. A 12-week regimen of the drug lists for $84,000 in the U.S.
Gilead does offer the drug at lower prices in other developing and low-income countries, but the humanitarian group MSF claims many patients in middle-income countries are unable to access the drug at affordable prices.
In January 2015, the India Patent Office had rejected Gilead's patent application, citing lack of improvement over earlier compounds. Gilead appealed, however, and the Patent Office has now ruled its compound sofosbuvir is "novel, inventive and patentable."
A Gilead spokesman told Stat the company's goal is to "enable access to these medicines for as many people as possible."
Doctors Without Borders saw the decision as harmful to patient interests. "This decision will now stop those Indian generic companies [that] were planning to enter the market independently from supplying not just patients in India but also those in middle-income countries with large numbers of people living with hepatitis C, which Gilead currently forbids from receiving sofosbuvir produced under Gilead’s licensing deal," said Leena Menghaney, South Asia regional head of MSF's Access Campaign.
Gilead currently licenses Sovaldi to 11 generic drugmakers in India for distribution to 101 developing countries, notes Reuters. But the drug would be inaccessible to other countries without licensing deals in place.