16 Jan 2015
Gregg Alton, executive Vice President, Corporate and Medical Affairs Gilead Sciences said:
The main patent applications covering sofosbuvir are still pending before the Indian Patent Office. This rejection relates to the patent application covering the metabolites of sofosbuvir. We are pleased that the Patent Office found in favor of the novelty and inventiveness of our claims, but believe their Section 3(d) decision to be improper. Gilead strongly defends its intellectual property. The company will be appealing the decision as well as exploring additional procedural options.
These proceedings do not impact our commitment to enabling access to our hepatitis C medicines in India and other developing countries, and our generic licensing program with our Indian partners continues as normal. We welcome the news that on the 13th January 2015 the authorities in India granted sofosbuvir regulatory approval in an unprecedented four months – the first country in Asia to approve sofosbuvir – recognizing the need to bring this innovative new medicine to patients in India as quickly as possible.”