The U.S. Supreme Court is breaking out the big guns to help make sense of Amgen and Sanofi's long-running PCSK9 patent feud.
“The Solicitor General is invited to file a brief in this case expressing the views of the United States,” SCOTUS said this week in a docket update. The case revolves around dueling cholesterol meds Repatha—made by Amgen—and Praluent—sold by Sanofi and Regeneron.
The Supreme Court has summoned the government’s top lawyer as it decides whether to hear Amgen’s appeal of a ruling that invalidated two Repatha patents last February.
Amgen first sued Sanofi and Regeneron back in 2014, alleging PCSK9 patent infringement by Sanofi and Regeneron when the partners sought approval for Praluent. At the time, Amgen asked the court to back broader protections on antibody drugs like Repatha.
Amgen and its supporters contend that without broader protections, me-too drugs could hit the scene and make minor changes to successful meds without committing resources to research. On the other hand, Sanofi and Regeneron argue that upholding of Amgen’s patents could allow companies to swat down entire classes of drugs by offering overly broad protections.
In December, several big biopharma players—including Biogen, Bristol Myers Squibb and Merck & Co.—filed a brief backing Amgen. They argued the court’s decision would “slow the pace of research and development and hinder innovation, to the detriment of patients and the public at large.”
Amgen initially won its suit, but the federal appeals court later sent the case back for a new trial, citing procedural errors. After that trial, jurors upheld certain Amgen patent claims and tossed others aside. The U.S. Court of Appeals for the Federal Circuit upheld the lower court's decision last year, ultimately prompting Amgen to petition SCOTUS.
Naturally, Sanofi and Regeneron want the Supreme Court to reject Amgen’s appeal.
Repatha full-year sales lept 26% in 2021 to about $1.1 billion, Amgen said in its earnings report published in February.
Praluent, for its part, remains well below the blockbuster threshold. Last year, Regeneron tallied $170 million in U.S. sales of the med, while Sanofi said Praluent reeled in more than $200 million in revenue abroad.
Amgen told Fierce Pharma it was "encouraged" by the Supreme Court’s request.
The company and others in the industry “view the issues we present as vitally important in supporting innovation,” an Amgen spokesperson said over email.
“Amgen is seeking review by the Court of the Federal Circuit’s lack of deference to a jury’s determination that a patent enables one to make and use an invention, as well as the standard the Federal Circuit uses to determine whether a patent meets the enablement requirement,” the company said, adding that it “firmly believes that the jury, in this case, reached the correct decision in upholding the validity of Amgen’s patents on antibodies to PCSK9.
Amgen says patents are essential for the biopharma industry to "make the significant investments required to discover and develop new innovative therapeutics that serve unmet patient needs."
Without strong protections, "the incentive to invest in pathbreaking research and development diminishes," the company argues.