Amgen wins PCSK9 patent case against Sanofi and Regeneron

A US District Court jury on Wednesday ruled in favor of Amgen, backing the validity of two of its patents for cholesterol-lowering drug Repatha. Sanofi and Regeneron manufacture a drug, known as Praluent, in the same therapeutic class.

Amgen brought the case to Federal Court in October 2014, alleging that Praluent infringed upon its patents for Repatha. Neither drug had been approved by the FDA at that time. Amgen's CEO said in a statement that the company was “thankful that the jury weighed the evidence carefully and recognized the validity of Amgen's patents on Repatha.”  

Sanofi and Regeneron said in a statement that they strongly disagree with the jury's verdict and plans to appeal the decision in the US Court of Appeals for the Federal Circuit.

Evercore ISI analyst Mark Schoenebaum wrote in an investor note that he believes Amgen could potentially receive a 5% royalty on Praluent's U.S. sales, based on the fact that Regeneron had settled another patent dispute with Roche's Genentech over Regeneron's eye treatment, Eyela. Genentech markets Avastin. The two companies ultimately settled, with Regeneron agreeing to pay a 5% royalty. Schoenebaum described Amgen's patents as “broad” and added that an appeal could take between 12 to 18 months.

Praluent had sales of $7 million for the last three months of 2015, and generated $11 million since it was approved in July 2015, one month prior to Repatha's approval in August 2015. Amgen has not yet released any sales figures for Repatha.

Praluent is approved to treat patients with a genetic disorder that causes unusually high levels of bad (LDL) cholesterol in the blood, known as heterozygous familial hypercholesterolemia (HeFH). Repatha is also approved to treat HeFH, as well as another rare genetic condition characterized by high levels of bad cholesterol known as homozygous familial hypercholesterolemia.