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Roche still plans to launch Mircera after court backs Amgen patent claim


Published :
Wed, 29 Aug 2007 10:59
By : Agencies
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ZURICH (Thomson Financial) - Roche Holdings AG still plans to launch anaemia drug Mircera in the US as soon as it receives FDA approval, disregarding a court ruling that the drug will infringe US pharma group Amgen Inc's erythropoietin (EPO) composition patents.

'We still plan to launch the product upon FDA approval,' a Roche spokeswoman told Thomson Financial News.

Yesterday, a US federal court granted a motion by Amgen for a summary judgement and ruled that Roche's long-acting EPO Micera will infringe its EPO composition patents.

Analysts had speculated that the ruling might prompt Roche to reconsider its plan to launch the drug 'at risk' given the possibility of significant damage claims.

'Roche could pay triple damages to Amgen if it loses the case after having launched Mircera at risk,' BNP Paribas analyst Sebastien Berthon said.

'The summary judgement...is an important step forward for Amgen as it may effectively prevent Roche from launching Mircera at risk...,' Morgan Stanley analyst Steven Harr seconds.

However, Roche maintains that yesterday's ruling 'does not determine the ultimate validity of any Amgen patents' and reiterated that Mircera is longer lasting than other anaemia drugs and does not violate any patent.

A further dispute relating to Roche's potential infringement of patents covering Amgen's anaemia drugs will be resumed in US courts on Sept 4, with the Swiss pharma group confident it can show its drug does not violate patents.

Micera is expected to receive approval for renal anaemia in the US at the end of the year. It is set to compete with Amgen's blockbusters Epogen and Aranesp, as well as Johnson & Johnson's Procirt.

johanna.treeck@thomson.com

jmt/mas/jmt/jr

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