A federal judge ruled against biotech giant Amgen in a patent-infringement lawsuit it had filed against Regeneron Pharmaceuticals and Sanofi over the companies’ competing cholesterol drugs.
On Wednesday, Judge Richard Andrews of the U.S. District Court for the District of Delaware ruled against the Thousand Oaks, California-based company in its suit, which it originally filed in October 2014, against Paris-based Sanofi and Tarrytown, New York-based Regeneron. Amgen alleged that the latter companies’ drug, Praluent (alirocumab), infringed on patents protecting its product, Repatha (evolucumab). The ruling overturns a decision by a federal judge in Amgen’s favor two years ago and means Praluent can stay on the market.
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In an emailed statement, Amgen said it planned to appeal.
“Protecting intellectual property is critical to our business since it allows for our investment in the research and development of new medicines,” the statement read. “Consequently, we are disappointed with today’s decision, and we look forward to presenting our case to uphold the jury’s verdict.”
Meanwhile, Regeneron and Sanofi welcomed the court’s ruling.
“Today’s decision by the U.S. District Court for the District of Delaware validates our position that Amgen’s patents are overly broad and invalid,” Regeron general counsel Joseph LaRosa said in a statement. “Praluent was developed using Regeneron’s proprietary science and technology, and the judge has confirmed our position by issuing this ruling.”
Earlier this year, in February, a jury had found in favor of Regeneron and Sanofi, that two other patent claims Amgen had asserted were also invalid. As such, it means that the two companies have invalidated all five of the patent claims Amgen had asserted, Regeneron said.
Both drugs have Food and Drug Administration approval for use together with cholesterol-lowering medications in patients with homozygous hypercholesterolemia who require addition lowering of LDL cholesterol. The drugs belong to a class known as PCSK9 inhibitors, which target a protein that reduces the liver’s ability to remove LDL cholesterol from the blood. Repatha had won approval in August 2014, and Praluent won approval the next year.
Praluent had global sales of $306.8 million in 2018, according to Regeneron. Meanwhile, Repatha’s global sales were $550 million during the same period. Both companies had previously moved to lower the prices of their respective products. In March of last year, Regneron and Sanofi lowered the list price of Praluent to $5,850 per year, a 60 percent reduction from its original price. And in October, Amgen said it would do the same for Repatha, also lowering the price by 60 percent, to $5,850 annually.
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UPDATE: This story has been updated to include a statement from Amgen that was received subsequent to publication.
