Gilead to challenge hepatitis C drug patent rejection decision

Gilead Sciences Inc will appeal against the decision of the Indian Patent Office rejecting its patent application for hepatitis C drug sofosbuvir.
"Gilead strongly defends its intellectual property. The company will be appealing the decision as well as exploring additional procedural options," Gilead Sciences Corporate and Medical Affairs Executive Vice President Gregg Alton said.
This rejection relates to the patent application covering the metabolites of sofosbuvir. Gilead is pleased that the Patent Office found in favour of the novelty and inventiveness of its claims, but believes their Section 3(d) decision to be improper, he added.
"The main patent applications covering sofosbuvir are still pending before the Indian Patent Office," Alton said.

These proceedings do not impact the company's commitment to enabling access to its hepatitis C medicines in India and other developing countries, and its generic licensing programme with its Indian partners continues as normal, he added.
An order by Deputy Controller of Patents & Designs Hardev Karar has said Gilead, which sells the drug under the Sovaldi brand in the US, failed to prove that there were enhancement of therapeutic efficacy in the new discovery.

Gilead's patent application was opposed by Hyderabad-based Natco Pharma and Capital-based NGO Delhi Network of Positive People (DNP+). Another entity Initiative for Medicines, Access & Knowledge {1-MAK), Inc, USA had also opposed it.

Gilead had last year entered into licensing agreements with seven India-based firms, including Cipla, Ranbaxy and Cadila for the hepatitis C drugs to make them available in 91 developing countries.
Gilead had said it planned to launch its own branded Sovaldi in India at a price of USD 300 per bottle, while the Indian companies were allowed to fix their own price for the generic product they produce, paying a royalty on sales.
As per reports, Sovaldi was priced USD 84,000 for a 12-week course in the US which has been criticised by advocates of patients.
When contacted Natco Pharma officials declined to comment on the development.