Court decision upholds Amgen patents related to PCSK9 antibodies.

Amgen announced that a Delaware jury delivered a verdict in Amgen's favor upholding the validity of two Amgen patents related to PCSK9 antibodies. These patents describe and claim antibodies, like Amgen's Repatha (evolocumab) product, that bind to a specific region on PCSK9 and reduce LDL-C levels in the body. This verdict follows a previous trial in March 2016 where Sanofi and Regeneron admitted infringement of Amgen's patents and where a prior jury also upheld the validity of Amgen's patents. The prior jury decision was partially reversed on appeal and the case was remanded to the district court for a new trial on two validity issues. In the verdict, the jury found that the Amgen patents meet the legal requirements of written description and enablement.

The decision follows recent decisions in the European Patent Office and the Japanese Patent Office which also rejected challenges to the validity of Amgen's PCSK9 antibody patents brought by Sanofi, Regeneron and other potential competitors. Amgen is seeking to enforce these patents in the national courts in Europe and Japan against Sanofi and Regeneron.

Sanofi and Regeneron intend to file post-trial motions with the District Court over the next few months, seeking to overturn the jury verdict and also requesting a new trial. In addition, if necessary, the companies plan to appeal to the Court of Appeals for the Federal Circuit. On 8 February 2019, the District Court dismissed Amgen's claim for willful infringement.