Amarin Asks Fed. Circ. To Undo Heart Drug IP Decision
By Adam Lidgett · Listen to article
Law360 (March 22, 2023, 7:42 PM EDT) -- Amarin Pharma Inc. has asked the Federal Circuit to reverse a Delaware federal judge's finding that Hikma Pharmaceuticals USA Inc.'s generic heart drug does not infringe patents underlying Amarin drug Vascepa.
In an opening brief with the appellate court, Amarin challenged U.S. District Judge Richard G. Andrews' early January 2022 decision dismissing Amarin's patent infringement claims against Hikma, saying the judge wrongly examined "Amarin's allegations in isolation instead of weighing them together." The case originally involved three patents, but the parties settled over one of them, according to court documents.
Amarin alleged in the "skinny label" case that Hikma induced doctors to infringe the patents by instructing them to use the Hikma generic for the use indications that Amarin patented. Skinny labels allow generic-drug makers to sell versions of drugs that still have some patent protection by carving out those protected indications from their labels.
But Amarin said on Tuesday that "this is not a true skinny label case" and that its "allegations are based not just on Hikma's label, but on its public statements made in press releases and on its website that encouraged physicians to prescribe Hikma's generic drug for an off-label use patented by Amarin."
"The district court erred when it considered each of those allegations one-by-one without considering whether it was at least plausible that Hikma's label together with its various public statements collectively encouraged infringement by prescribing physicians," Amarin argued.
Hikma's generic was put on the market after getting approval from the U.S. Food and Drug Administration, but that approval was only for the indication that was not patented, according to court documents.
U.S. Magistrate Judge Jennifer L. Hall had said in a report that she disagreed with Hikma's argument that the suit fails to allege a plausible inducement claim against it.
But Judge Andrews declined to take the magistrate judge's recommendation as to Hikma's bid to dismiss. Further, Judge Andrews had found that press releases and statements on Hikma's website about its drug do not induce infringement.
Vascepa had been the first drug and, according to Amarin, remains the only drug that can treat severe hypertriglyceridemia without increasing bad cholesterol, the company has said. Amarin reported in regulatory filings that Vascepa netted $427.4 million in sales in 2019, predominantly in the United States.
Counsel for Amarin and Hikma did not immediately respond to requests for comment on Wednesday.
The patents at issue are U.S. Patent Nos. 9,700,537 and 10,568,861.
Amarin is represented by Nathan K. Kelley, Nathanael D. Andrews and Mark T. Smith of Perkins Coie LLP.
Hikma is represented by Charles B. Klein, Claire A. Fundakowski, Eimeric Reig-Plessis and Alison M. King of Winston & Strawn LLP.
The case is Amarin Pharma Inc. v. Hikma Pharmaceuticals USA Inc., case number 23-1169, in the U.S. Court of Appeals for the Federal Circuit.
--Editing by Patrick Reagan.
