Judge rules in Amgen's favour over Mircera patent row

A US judge has ruled that Roche's pegylated-erythropoietin (peg-EPO) anaemia drug Mircera (continuous erythropoietin receptor activator) infringes one of biotech company Amgen's patents.

The judge ruled that Mircera will infringe Amgen's EPO pharmaceutical composition patent number 5,955,422, and in a separate decision the Court also granted summary judgment in favour of Amgen on certain Roche's defences against the patents-in-suit. The court denied requests for summary judgment on the remaining five motions.

The case will now go to trial on September 4 2007, where the court will hear Amgen's claim of infringement for additional patents and also hear Roche 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," said Amgen in a statement.

Amgen said it also believes that Mircera "provides no clinical or patient benefit" over Amgen's own therapies, Epogen (epoetin alfa) and Aranesp (darbepoetin alfa).

Analysts from Citigroup said: "We believe that Amgen's case is now stronger since [Judge] Young seems to disagree with Roche's claims  that Mircera is a distinct molecular entity that falls outside the scope of Amgen's claims."

Mircera was approved in the EU in July 2007 but has yet to be approved in the US. According to media reports, Roche  still intends to launch the drug in the US once it is approved by the FDA, despite the ruling.