A federal judge has ruled in favor of Regeneron Pharmaceuticals Inc. and Sanofi in litigation that began five years ago involving Amgen’s patent claims that the California biotech company said it had for antibodies targeting the PCSK9 gene.
Judge Richard Andrews’ Aug. 28 ruling overturned portions of a jury verdict in February that found Amgen’s patents on its cholesterol drug Repatha were valid. Regeneron and Sanofi sell rival drug Praluent. The jury did find in Regeneron and Sanofi’s favor that two other asserted Amgen patent claims were invalid.
This means that Regeneron and Sanofi have successfully invalidated all five asserted Amgen patent claims.
According to the National Institutes of Health, the PCSK9 gene instructs the body to make a protein that helps regulate the amount of cholesterol in the bloodstream.
Praluent was approved by the U.S. Food and Drug Administration (FDA) on July 24, 2015, as a secondary treatment for adults with high cholesterol that is not controlled by diet and statin treatment. It is antibody that belongs to a novel class of anti-cholesterol drugs, known as PCSK9 inhibitors.
The FDA had expanded the indication for Praluent to reduce the risk for myocardial infarction, stroke and unstable angina requiring hospitalization in adults with established cardiovascular disease.
“(The) decision by the U.S. District Court for the District of Delaware validates our position that Amgen’s patents are overly broad and invalid,” said Joseph LaRosa, executive vice president, general counsel and secretary for Regeneron. “Praluent was developed using Regeneron’s proprietary science and technology and the judge has confirmed our position by issuing this ruling.”
“It has been our longstanding belief that all of Amgen’s asserted U.S. PCSK9 patent claims are invalid, and we are pleased today’s decision reaffirms this,” said Karen Linehan, executive vice president and general counsel for Sanofi.
Amgen said in a statement that it disagreed with aspects of the judge’s decision and will ask an appellate court to review it.
Repatha had worldwide sales of $152 million in the second quarter of this year. Regeneron reported Praluent sales of $73.7 million for the same period.
Praluent was developed by Regeneron and Sanofi under a global collaboration agreement and invented by Regeneron using the company’s proprietary VelocImmune technology that yields optimized fully human monoclonal antibodies.