Roche to appeal US Mircera sales bar

Swiss drug major Roche says it plans to appeal a Federal Circuit Court ruling that bars it from selling its anemia drug Mircera (methoxy polyethylene glycolspoetin beta) in the USA for the remaining life of erythropoietin patents held by rival Amgen.

The action follows a court decision last year that Roche's product infringed certain patents of the US biotechnology major and ordering increased royalties to be paid (Marketletter October 29, 2007), which has prevented the product's launch, despite gaining regulatory approval from the US Food and Drug Administration.

According to Lehman Brothers analysts, the move is significant because by moving the decision to Appeals Court, the District Court has now lost jurisdiction, which means that Amgen cannot be made to issue a compulsory licence to Roche to market Mircera in return for royalties to Amgen for its EPO patent estate, which had been discussed. The appeal by the Swiss firm will extend by at least 12 months the final decision on the anemia drug.