Amarin Corp Plc (AMRN)

[HinduKush]

Appellants (Singer's) opening brief Case: 20-1723 Document: 30 Page: 14 Filed: 05/12/2020

Upon FDA approval in 2012, VASCEPA® thus became the first (and still only) approved severe hypertriglyceridemia medication that does not raise LDL-C. These issues were largely undisputed at trial. Defendants’ expert acknowledged that an ordinary artisan would have understood, at the time of the invention, “that somewhere above 500 milligrams per deciliter the system for clearing triglycerides
jams up,” thus leading to the problem in the art. And, despite opining Amarin’s patents were obvious over the prior art, that same expert conceded: “I don’t think there’s any evidence in the prior literature about what the impact of EPA would be on LDL cholesterol in patients with triglycerides above 500 milligrams per deciliter.”
Nonetheless, the district court found the patents-in-suit obvious based on prior art about EPA that had been known for nearly a decade or more, none of which had led skilled artisans to solve the long-felt need met by VASCEPA®. In so doing, the district court put the cart before the horse, finding that “defendants have satisfied their burden” to provide “clear and convincing” evidence of obviousness (prima facie and otherwise) before even considering the proven objective indicia of long-felt need and commercial success. Even then, the district court improperly weighed these two proven objective indicia against those the district court decided Amarin had not proven, as if Amarin’s alleged failures to prove praise or skepticism carried independent evidentiary weight. Under this Court’s precedent, they do not.

EVIDENCE OF JAMMIMNG UP CLEARANCE PRESENT SINCE 1973:


No clear idea what EPA vs. DHA did specifically by POSA's in reviews as late as 2006: