Patent Law

The following is excerpted from a September 16, 2009 article at World Pharma News:

Amgen (Nasdaq: AMGN) 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.

Today'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 pegylated EPO product, Mircera in the United States.

Read the full article here and a brief description at the Brooks Consulting LLC website of the EPO contract dispute on which I consulted with Amgen for two years is available here.