Amgen patent claims on PCSK9 inhibitor Repatha upheld by US jury

Amgen announced Monday that a Delaware jury delivered a verdict upholding the validity of two Amgen patents related to PCSK9 antibodies, such as Repatha (evolocumab). The decision follows a 2016 trial where a US federal jury had concluded that two patents protecting Repatha were infringed by Sanofi and Regeneron Pharmaceuticals' PCSK9 inhibitor Praluent (alirocumab). 

According to Amgen, the patents in question describe and claim antibodies that bind to a specific region on PCSK9 and reduce LDL-cholesterol levels in the body. CEO Robert Bradway stated that "today's decision protects intellectual property which is essential to innovators who are bringing forward new medicines for patients with serious diseases."

Amgen said the latest ruling follows recent decisions in the European Patent Office and the Japanese Patent Office, which also rejected challenges to the validity of the company's PCSK9 antibody patents brought by Sanofi, Regeneron and others.

Meanwhile, Sanofi and Regeneron stated that they "strongly disagree" with certain aspects of the Delaware verdict. Specifically, the jury "upheld the validity of three of the five asserted claims of two Amgen US patents covering antibodies targeting PCSK9," the companies said, but noted that the "jury agreed with Regeneron and Sanofi for two of the five asserted claims, finding they were invalid based on lack of written description." Sanofi and Regeneron vowed to file post-trial motions in the coming months seeking to overturn the verdict and requesting a new trial. Meanwhile, they noted that the ruling "does not impact US physicians and patients' access to Praluent."

The case stems from a 2014 patent infringement lawsuit that Amgen filed after Sanofi and Regeneron had disclosed plans to submit Praluent for FDA approval. Praluent was cleared in the US in 2015 for the treatment of high cholesterol in certain patients, followed by Repatha a month later.

In 2017, a US district court issued a permanent injunction barring Sanofi and Regeneron from marketing Praluent. The injunction was suspended shortly thereafter and eventually dismissed

Praluent sales jumped nearly 55 percent in the fourth quarter of 2018 to 82 million euros ($93 million), while revenue from Repatha surged 62 percent year-on-year to $159 million. Analysts estimate that Repatha will generate $2.2 billion in 2022, and Praluent is forecast to bring in about 704 million euros ($800 million).

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