Amgen prevails against Sanofi and Regeneron

A jury has upheld two of  Amgen’s patents for its cholesterol drug Repatha (evolocumab), rejecting a challenge brought by two competitors.

On Monday, February 25, a jury for the US District Court for the District of Delaware confirmed the validity of two of Amgen’s patents (US numbers 8,829,165 and 8,859,741).

The patents cover antibodies which target PCSK9 (proprotein convertase subtilisin/kexin type 9).

PCSK9 is an enzyme that binds to and causes certain liver cell receptors to be destroyed, reducing the capacity and effectiveness of the liver cells’ ability to reduce cholesterol.

In 2014, Amgen accused US-based  Regeneron Pharmaceuticals and French pharmaceutical company Sanofi SA of infringing its patents after they collaborated to create a competitor to Repatha, known as Praluent.

Sanofi and Regeneron argued that the patents didn’t adequately describe the invention or explain how to make the full scope of antibodies the patents cover. The jury rejected these arguments.

Amgen chief executive Robert Bradway said in a statement that the company was “thankful that the jury weighed the evidence carefully and recognised the validity of Amgen’s patents”.

Bradway said the decision “protects intellectual property which is essential to innovators who are bringing forward new medicines for patients with serious diseases”.

In a statement, Regeneron and Sanofi said they “strongly disagree with the verdict” and will seek to overturn the jury verdict and request a new trial. The companies said that if necessary, they will appeal to the US Court of Appeals for the Federal Circuit.

“We will continue to vigorously defend our positions against Amgen’s overly broad patent claims,” Joseph LaRosa, Regeneron’s general counsel, said in the statement.

Karen Linehan, general counsel for Sanofi said it is the company's “long standing belief that all of Amgen's asserted US patent claims are invalid”.

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