A Medical Device Daily

Amgen (Atlanta) reported that the Court of Appeals for the Federal Circuit affirmed the Massachusetts District Court's decision that Roche's (Basil, Switzerland) 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.

The 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 U.S.

In other legal news, Medtronic (Minneapolis) reported that it has settled a patent lawsuit it initiated against W.L. Gore & Associates (Newark, Deleware). Medtronic sued W.L. Gore in 2006 for patent infringement of selected patents in Medtronic's Jervis and Wiktor patent families. Medtronic expects to recognize a one-time gain in the company's second fiscal quarter ending Oct. 30, 2009, in connection with the settlement. Specific terms of the settlement agreement were not disclosed.

Patents in the Jervis patent family, the last of which is scheduled to expire in 2018, cover the use of stress to restrain certain self-expanding medical devices made of nitinol. Nitinol is a shape-memory metal alloy frequently used in medical device applications, including Medtronic's own transcatheter coronary heart valve program. The last patent in the Wiktor family expired in 2007.