Amgen reports Roche infringement of erythropoietin patent

Amgen has reported that the US Federal District Court has granted its motion for summary judgement, with the court ruling that the pegylated-erythropoietin (peg-EPO) product from Roche will infringe the company’s patent.

Noting that the peg-EPO product will breach the pharmaceutical composition patent number 5,955,422, the court has also granted summary judgement on certain defences presented by Roche against the patents-in-suit in favour of Amgen.

“The case will proceed to trial [on] September 4th 2007 where the court will hear Amgen’s claim of infringement for additional patents and also hear other Roche arguments on the validity and enforceability of Amgen’s patents,” Amgen reports.

The company contends that its patents are both valid and enforceable, while the release of the peg-EPO will violate other Amgen patents for recombinant erythropoietin and its manufacturing procedure.

Furthermore, Amgen also claims that the peg-EPO product from Roche provides no clinical benefit when compared to its own Epogen (Epoetin alfa) and Aranesp (darbepoetin alfa).

Amgen initiated this legal action against Roche in November 2005, accusing the firm of violating six of its patents relating to the manufacture and sale of EPO products.

Roche had attempted to avoid patent infringement with the planned launch of Cera – which is chemically dissimilar from its NeoRecormon EPO – though Amgen maintained that this product is effectively a peg-EPO.