Should SCOTUS hear Amgen's Repatha case? Solicitor general says no
September 23, 2022 at 17:17
Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely 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 review is not warranted.”
The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.
Both antibody drugs are designed to control LDL cholesterol, often called “bad cholesterol” because it can increase patients’ risk of heart disease and stroke. They work by preventing PCSK9, a naturally occurring protein, from binding to and eventually causing the destruction of LDL receptors in the liver.
Amgen initially sued Sanofi and Regeneron before the drugs went to market, seeking to block the sale of Praluent. Despite sales coming in higher than Praluent’s, neither drug reached expectations coming out of the gate, and both competitors cut their prices significantly a few years ago. Praluent sales reached about $124 (€128 million) last quarter, while Repatha earned $154 million.
Amgen scored a win in 2019, but a federal judge in Delaware later overturned that verdict and ruled in favor of Sanofi and Regeneron. That decision was then upheld in the Court of Appeals for the Federal Circuit.
“It has been our longstanding belief that all of Amgen’s asserted U.S. PCSK9 patent claims are invalid, and we are pleased that the Solicitor General recommends that the Supreme Court not grant Amgen’s petition for certiorari,” a Regeneron spokesperson said in an email on Friday. Amgen did not respond to a request for comment as of press time.
Amgen took the case all the way to the Supreme Court, which back in April called on the solicitor general to weigh in. The pharma giant argued in its petition that the lower court’s decision would have a devastating impact on innovation, and several companies filed a “friend of the court” brief in support, including Biogen, Bristol Myers Squibb and Merck.
“If left unchanged, the decision below could slow the pace of research and development and hinder innovation, to the detriment of patients and the public at large,” they wrote. “The patentee, having invested enormous sums in discovering the underlying target, has provided a blueprint for others who, now aware of the targets, can quickly make their own version of an effective antibody.”
A panel of judges previously ruled that “[d]rawing a broad fence around subject matter, without filling in the holes, is not inventing the genus.”
“Amgen is encouraged by the Supreme Court’s request for the Solicitor General’s views on the issues presented in Amgen’s petition,” a spokesperson told Endpoints News in April. “Amgen is seeking review by the Supreme Court because we, and others in our industry, view the issues we present as vitally important in supporting innovation.”
Now it’s up to the Supreme Court to decide whether to take the case — though if you ask Prelogar, the answer is no, it shouldn’t.
“Petitioners contend that the court of appeals erred by treating enablement as a question of law and by examining the full scope of the claims in assessing whether they are fully enabled,” she wrote. “Those arguments lack merit and further review is not warranted.”