Last April, Amgen said it was encouraged by the solicitor general’s planned review of its Supreme Court petition to rehear a Repatha patent case. They are probably much less optimistic about the outcome now.
Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further examination is not warranted.”
The case dates back to a lawsuit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market just a month later.
Both antibodies are designed to control LDL cholesterol, often called “bad cholesterol,” because it can increase the risk of heart disease and stroke. They work by preventing PCSK9, a naturally occurring protein, from binding to LDL receptors in the liver and causing them to be destroyed.
Amgen initially sued Sanofi and Regeneron before the drugs hit the market, seeking to block the sale of Praluent. Although sales are higher than Praluent’s, neither drug has met expectations when it leaves the factory, and both competitors significantly reduced their prices a few years ago. Sales of Praluent reached around $124 (128 million euros) last quarter, while Repatha earned $154 million.
Amgen scored a victory in 2019, but a federal judge in Delaware later overturned that verdict and ruled in favor of Sanofi and Regeneron. This decision was later upheld by the Federal Circuit Court of Appeals.
“We have long believed that all of Amgen’s US PCSK9 patent claims are invalid, and we are pleased that the Solicitor General recommends that the Supreme Court not grant Amgen’s request for certiorari,” a doorman said on Friday. -word from Regeneron in an email. Amgen did not respond to a request for comment at press time.
Amgen took the case all the way to the Supreme Court, which in April called on the solicitor general to intervene. The pharmaceutical giant argued in its motion that the lower court’s decision would have a devastating impact on innovation, and several companies have filed suit. “friend of the court” briefs in support, in particular Biogen, Bristol Myers Squibb and Merck.
“If left unchanged, the decision below could slow the pace of research and development and impede innovation, to the detriment of patients and the general public,” they wrote. “The patentee, having invested huge sums in discovering the underlying target, has provided a blueprint for others who, now aware of the targets, can quickly create their own version of an effective antibody.”
A panel of judges previously ruled that “[d]cutting a wide fence around the subject, without plugging the holes, is not inventing the genre.
“Amgen is encouraged by the Supreme Court’s request for the Solicitor General’s opinion on the issues presented in Amgen’s motion,” a spokesperson said. Terminal news in April. “Amgen is seeking Supreme Court review because we, and others in our industry, view the issues we present as vitally important to sustaining innovation.”
It’s now up to the Supreme Court to decide whether to take up the case – although if you ask Prelogar the answer is no, it shouldn’t.
“The plaintiffs argue that the Court of Appeal erred in treating entitlement as a question of law and considering the full scope of the claims to assess whether they are fully entitled,” she wrote. “These arguments lack merit and further examination is not warranted.”