Amgen files brief to Supreme Court ahead of oral arguments — with industry amicus support

 Amgen is coming out swinging against Sanofi and Regeneron in a Supreme Court case with substantial implications.

In its brief filed Dec. 27, the Big Pharma laid out its case, saying among other things that the Federal Circuit’s standard harms innovation and alters the “basic patent bargain” — denying an inventor a patent based sheerly on the number of possible embodiments, even if the patent’s disclosures teach the world how to “make and use” the claimed invention. The crux of the case is around enablement, which is essentially if someone “reasonably skilled in the art could make or use the invention from the disclosures in the patent coupled with information known in the art without undue experimentation,” per the US Patent and Trademark Office.

The Court will consider Amgen’s request to revive patents on its blockbuster biologic Repatha and block the sale of Praluent, Sanofi and Regeneron’s independently developed but similar PCSK9 inhibitor antibody drug. Both drugs, which are antibodies that differ in amino acid sequence and bind to PCSK9, reduce low-density lipoprotein cholesterol.

Amgen scored a win in 2019 in an initial trial, but a Delaware federal judge overturned that ruling and ruled in favor of Sanofi and Regeneron. That decision was then upheld in the Court of Appeals for the Federal Circuit, denying a rehearing in 2021 and leading Amgen to file an initial petition to SCOTUS in November that year. Amgen claimed that the Federal Circuit decision incorrectly requires patent owners to identify and make all or nearly all possible variations of the invention — without “substantial time and effort.”

Sanofi had previously said that Amgen’s patents surrounding Repatha were overly broad, which the federal judge had concurred with.

GSK filed an amicus brief to the Supreme Court Tuesday in support of Amgen, saying that genus claims — a type of patent that covers not just one specific entity, but a group of related entities — are necessary to protect “groundbreaking discoveries in the life sciences,” and encourage downstream innovation. Instil Bio also filed a brief supporting Amgen, noting that using a requirement called the “full-scope requirement” to determine enablement is inconsistent with the statute, and asking for the court to revert the standard to an “undue experimentation” requirement.

Amgen’s writ of certiorari — which was accepted two months ago — faced setbacks starting out, one of which occurred when Solicitor General Elizabeth Prelogar wrote in a 27-page brief in September that Amgen’s arguments “lack merit and further review is not warranted.”

“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 at the time.

Sanofi has until Feb. 3 to file its brief to the case, after which oral arguments will be made before the bench.

https://endpts.com/amgen-files-brief-to-supreme-court-ahead-of-oral-arguments-with-industry-amicus-support/