A federal appeals court on Thursday upheld an earlier court ruling that had invalidated six patents covering Amarin’s heart drug Vascepa, increasing the likelihood that generic competitors could soon launch copycat versions of the fish oil-derived pill in the U.S.Tough questions from the three-judge panel on Wednesday had sunk Amarin shares by nearly a third, and news of the decision just one day later dragged the company’s stock down further. Amarin has lost 80%, or roughly $7 billion, of its value since late last year as investor hopes Vascepa could become a blockbuster drug for the company dimmed.Vascepa is Amarin’s only drug, approved since 2012 for lowering high triglycerides. In mid-December, the Food and Drug Administration cleared its use for reducing the risk of events like heart attacks or strokes, dramatically widening the number of people who could potentially benefit from treatment.
Two years ago, Amarin surprised many with news Vascepa significantly reduced major cardiovascular adverse events in a trial known as REDUCE-IT.
That Vascepa, a highly purified form of an acid contained in fish oil, would prove so beneficial for heart health wasn’t expected. The study results, which were later published in The New England Journal of Medicine, changed Amarin’s fortunes overnight, raising the company’s value by billions and putting it in position to widely sell a heart pill that compared favorably to more expensive drug options already on the market.
A district court ruling in March put that all at risk. Judge Miranda Du of the U.S. District Court for the District of Nevada found that patents held by Amarin on Vascepa were invalid due to “obviousness,” a term indicating the information contained would be readily apparent to an expert in the field and therefore undeserving of legal protection.
Amarin had argued that the unexpectedly large benefit shown in REDUCE-IT justified its patents, but Du disagreed.
Now, three judges on the U.S. Court of Appeals for the Federal Circuit have upheld Du’s decision, making it more likely that generic drugmakers Hikma Pharmaceuticals and Dr. Reddy’s could soon launch a generic version of Vascepa.
In a statement, Hikma said is “working towards” a launch of its copycat drug, which the FDA approved in May.
Amarin, though, isn’t giving up, indicating Thursday it expects to request an “en banc” hearing by all 12 appeals court judges. The company added that it doesn’t believe its would-be competitors can readily make large supplies of generic Vascepa, so it will continue its current marketing efforts around the drug.
While the decision dims Amarin’s prospects in the U.S., the company is putting greater emphasis on the potential for sales of Vascepa in Europe, Canada and elsewhere. No generic litigation is pending outside the U.S., Amarin said.
Earlier this summer, the company opted to commercialize Vascepa in Europe on its own, rather than seeking a large drugmaker as a partner. The drug is currently under review by EU regulators.