Court Rules for Amgen in Patent Infringement Suit

Amgen won a patent dispute with Roche Aug. 28 over the latter’s erythropoietin-stimulating agent Mircera, which is approved in the European Union, but not yet in the U.S., for the treatment of anemia related to chronic renal failure.

The U.S. District Court for the District of Massachusetts ruled that the Roche product infringes Amgen’s erythropoietin (EPO) pharmaceutical composition patent ‘422. In a separate decision, the court also granted summary judgment in favor of Amgen on certain Roche defenses against the patents at issue. The case will proceed to trial Sept. 4, and the court will hear Amgen’s claim of infringement for additional patents, as well as Roche’s arguments on the validity and enforceability of Amgen’s patents.

“Amgen continues to believe that its patents are valid and enforceable, and that Roche’s peg-EPO product will infringe other Amgen patents relating to recombinant erythropoietin and its production,” Amgen said. “In addition to infringing its EPO patents, Amgen firmly believes Roche’s peg-EPO product provides no clinical or patient benefit over Amgen’s innovative therapies, Epogen (epoetin alfa) and Aranesp (darbepoetin alfa).”

Roche responded, “Regardless of the recent U.S. district court rulings on process patent ’349 and pharmaceutical composition patent ’422, Roche remains confident in our position that all of the Amgen patents are invalid and not infringed.” The company added that the ruling “is only one step along the way, and the trial has yet to begin. While we disagree with the judge on the matter of infringement, the ruling does not determine the ultimate validity of any Amgen patents. Roche looks forward to presenting its case in court.”

The federal court ruling runs counter to last year’s decision by the U.S. International Trade Commission that Roche’s importation and use of Mircera in the U.S. did not violate Amgen’s patents on Epogen. In May, the FDA issued an approvable letter to Roche for Mircera.