A judge in the USA has ruled that Swiss-based company Roche’s antianaemia drug Mircera® (continuous erythropoietin receptor activator) infringes a patent held by rival firm Amgen.
Judge William Young granted a motion for a summary judgement that Mircera breaches a pharmaceutical composition patent belonging to Amgen.
The court in Boston heard Mircera is currently being reviewed by regulators in the USA.
Amgen also alleges that Mircera violates some of its other patents, and a trial is now due to start to rule on whether this is the case.
Amgen, based in California, sells the antianaemia drugs Aranesp® (darbepoetin alfa) and Epogen® (epoetin alfa). It claims Roche’s plan to sell Mircera in the USA will violate its intellectual rights.
But Roche disputes these allegations, saying the Amgen patents are invalid and have not been infringed.
In a statement, Roche said it disagrees with the judge’s decision, adding: “The ruling does not determine the ultimate validity of any Amgen patents.”
Amgen said the court also granted a summary judgement in favour of the company on certain aspects of Roche’s defence.
Roche has applied for FDA approval of Mircera as a treatment for anaemia associated with chronic renal failure.
The FDA issued an approvable letter for the application in May, which typically means the regulator needs more information before granting final approval.
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