Appeals Court Affirms Patent Infringement Rulings Against Roche

Amgen has announced that the Court of Appeals for the Federal Circuit affirmed the Massachusetts District Court’s decision that Roche’s peg-EPO product, Mircera, infringes four Amgen patents (‘868, ‘698, ‘933 and ‘422) relating to recombinant erythropoietin (EPO) and processes for making it.

Regarding a fifth patent (‘349), the Federal Circuit reversed the holding of non-infringement by the District Court and remanded that issue for a new trial allowing Amgen to show that Roche’s product infringes that patent as well. The Federal Circuit also affirmed the validity of Amgen’s patents except for a single issue of obviousness-type double patenting which only impacts Amgen’s later expiring patents (‘933, ‘422 and ‘349). The Federal Circuit remanded this issue to the District Court for further analysis.

David Scott, senior vice president and general counsel of Amgen, said: “We are pleased with today’s decision. The successful enforcement of intellectual property rights enables Amgen to continue to invest in truly innovative new medicines.”

The Federal Circuit left undisturbed the permanent injunction that prohibits Roche from selling its pegylated EPO product, Mircera in the US.