FDAnews Drug Daily Bulletin
Pharmaceuticals / Commercial Operations

Gilead’s Sovaldi Facing Another International Patent Challenge, This Time in Europe

Feb. 18, 2015

Gilead’s pricey hepatitis C blockbuster Sovaldi is facing another international patent challenge, this time by a French nonprofit.

Médecins du Monde, or Doctors of the World, said that it had filed a challenge to Sovaldi (sofosbuvir) with the European Patent Office. While Sovaldi is an important development in hepatitis C treatment, it is not sufficiently innovative to deserve patent protection, the group claims.

The challenge mirrors one brought in India by the Initiative for Medicines, Access & Knowledge.

MDM maintains that branded Sovaldi, priced at $84,000 for a full 12-week treatment in the U.S., is far too costly and is forcing drug rationing. The group wants generic competition to drive down Sovaldi’s cost.

Gilead declined a request for comment. The company is actively fighting the decision by India’s patent office to deny one of the patents it sought for Sovaldi, and won a temporary victory when that decision was thrown out by the Delhi high court late last month on procedural grounds. — Bryan Koenig