US Appeals Court backs Amgen against Roche's peg-EPO product

The Court of Appeals for the Federal Circuit affirmed the Massachusetts District Court's has ruled that Swiss drug major Roche's peg-EPO product, Mircera (methoxy polyethylene glycol-epoetin b), infringes four patents of US biotechnology giant Amgen ('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.

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

Roche said in a statement that it was "disappointed the court did not find" in its favor on all of the matters. Early this year, the Swiss firm said Mircera's sales worldwide were "modest" but "progressing

The Court's decision affirms the infringement and validity on all grounds for Amgen's process patents ('868 and '698), affirms the infringement on Amgen's product patents ('933 and '422), affirms all but one validity issue which will be further reviewed by the district court on the '933, '422 and '349 patents, and allows Amgen a new trial to show infringement of the '349 patent. The Federal Circuit left undisturbed the permanent injunction that prohibits Roche from selling its Mircera in the USA.