WASHINGTON (Northern California Record) -- The U.S. Court of Appeals for the Federal Circuit has stayed a Delaware court’s decision allowing for the continued sale of the cholesterol-fighting drug Praluent until the courts can render a final verdict in the manufacturers Sanofi and Regeneron’s legal battle with Amgen Inc.
In 2016, a jury found that Sanofi infringes patents owned by Amgen, which markets the competing drug Repatha.
Since then, attorneys for Sanofi have insisted that enforcing the order would inflict undue harm, ranging from putting a patient’s health at risk to disrupting medical research and rendering countless Sanofi employees out of work.
"This decision is important for patients in the U.S. who will continue to have access to Praluent during the appeal process giving them a choice in PCSK9 inhibitor treatments to best meet their individual needs," Sanofi general counsel Karen Linehan said in a news release made available to the Northern California Record. "It is our longstanding position that Amgen's asserted patent claims are invalid and we look forward to moving forward with the appeal process."
Throughout litigation, Amgen has maintained Sanofi and Regeneron officials were aware that they were violating infringement laws when they hastily and aggressively launched Praluent.
Prior to their ongoing legal showdown, both companies spent billions independently developing monoclonal antibodies that bind to a protein called PCSK9, preventing the protein from disrupting the liver's ability to remove LDL cholesterol from the bloodstream.
While lamenting being put in the position of having to decide between a patent owner’s right to be free of competition and the public’s benefit of having choice, U.S. District of Delaware Judge Sue Robinson had previously issued a permanent injunction ordering Praluent off the market.
Sanofi countered by arguing that only Praluent has been approved by the FDA at a low dose, meaning some patients who do well on Praluent may not necessarily tolerate Repatha.
Robinson’s decision allowed the Regeneron/Sanofi legal team 30 days to finalize an appeal to the federal circuit and request a longer stay from the higher court.
In the United States, removing a drug from the marketplace over infringement concerns is a rare occurrence. The last such instance also involved Amgen, which successfully sued Roche, resulting in the latter being forced to pull an anemia drug from off the market.
"Amgen's patent claims are invalid and the best interests of patients will be greatly disserved by an injunction preventing access to Praluent,” Linehan said.
Praluent is billed as the first PCSK9 inhibitor approved for use in the U.S. The drug is also the only PCSK9 inhibitor available in two doses with two levels of efficacy (75 mg and 150 mg), allowing physicians to adjust dosage according to the needs of their patients.
The standing verdict allows Sanofi and Regeneron to continue the commercialized sale of Praluent in the states for the duration of the appeal process.