German court grants injunction after ruling that Sanofi, Regeneron's Praluent infringes patent on Amgen's Repatha

A court in Germany granted an injunction prohibiting Sanofi and Regeneron Pharmaceuticals from manufacturing, selling and marketing Praluent (alirocumab) in the country after ruling that the PCSK9 inhibitor infringes one of Amgen's patents covering Repatha (evolocumab). Specifically, the Düsseldorf Regional Court found that Praluent infringes the German part of Amgen's European patent directed to antibodies targeting PCSK9.

Sanofi and Regeneron said "we are disappointed in this decision," adding "we remain confident that the law and facts support our positions." The companies indicated that Praluent remains on the market in Germany as Amgen is required to post a bond for the injunction to go into effect.

The decision comes after last month, a high court in Germany rejected Sanofi's request for a licence to use Amgen's patent to secure Praluent's continued market presence in the country. Sanofi had appealed to the high court after the patent court rejected its plea last September.

Sanofi and Regeneron noted that the latest ruling "is relevant only to Germany and is not binding on other national courts in Europe." Meanwhile, in February, a jury in the US delivered a verdict upholding the validity of two Amgen patents related to PCSK9 antibodie, such as Repatha.

For further analysis, read ViewPoints: Amgen one step closer to clinching the market for Repatha, and ViewPoints: Germany backs the power of the patent in PCSK9 dispute – will the US follow suit?

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