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
In 2016, a jury found
that Sanofi infringes patents owned by Amgen, which markets the competing
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.
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."
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
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.
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
verdict allows Sanofi and Regeneron to continue the commercialized sale of
Praluent in the states for the duration of the appeal process.