Court blocks Roche's sales of Mircera in USA until 2014, as Amgen prevails in EPO patent dispute

Ending a five-year patent dispute, the US District Court in Boston has entered final judgment and a permanent injunction against Swiss drug major Roche from infringing US biotechnology firm Amgen's patents on recombinant erythropoietin (EPO).

The judgment was accompanied by Roche's admission that the five Amgen EPO patents involved in the law suit are valid, enforceable and infringed by Roche's pegylated-erythropoietin (peg-EPO) product, Mircera, and by Amgen allowing Roche to begin selling the drug in the USA in mid-2014 under terms of a limited license agreement. The settlement terms do not include any financial payments between the parties.

In the third quarter, the Thousand Oaks, Calif.-based company Amgen reported third-quarter sales of $685 million for its EPO drugs Aranesp (darbepoetin alfa) and $663 million for Epogin (epoetin alfa). Aranesp revenue has been in decline since 2008 due to safety concerns, which led to stronger warnings on its label.