Amarin Corp Plc (AMRN)

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Hikma Should Face Amarin's Patent Suit, Magistrate Says
Hikma Should Face Amarin's Patent Suit, Magistrate Says
By Adam Lidgett

Law360 (August 3, 2021, 8:54 PM EDT) -- Hikma Pharmaceuticals should not be able to dodge a lawsuit claiming it encouraged doctors to prescribe its generic version of the heart drug Vascepa for uses covered by a series of Amarin patents, a Delaware federal magistrate judge says.

Magistrate Judge Jennifer L. Hall on Tuesday issued a report and recommendation in a lawsuit filed by Amarin Pharma Inc., Amarin Pharmaceuticals Ireland Ltd. and Mochida Pharmaceutical Co. Ltd. alleging that Hikma induced infringement of three patents.

Specifically, Amarin alleged in the so-called "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.

The magistrate judge disagreed with Hikma's argument that the suit fails to allege a plausible inducement claim against it.

Amarin's claims "plausibly suggest … that Hikma's label and public statements could instruct and/or encourage third parties to use its product for the" indication that Amarin said is covered by the patents at issue, the magistrate judge said. Judge Hall added that Amarin has also plausibly claimed "Hikma both knew and intended that third parties would use its product for that purpose."

"In my view, that is enough," the magistrate judge wrote.

The lawsuit also targeted health insurer Health Net LLC, which Amarin accused of coming up with an "approval and payment process for Amarin's product and Hikma's generic version [that] amounts to active encouragement to use Hikma's generic version for the patented indication." Amarin alleged that amounted to induced infringement, as well.

The magistrate judge said the claims against Health Net should proceed, too.

"Like Hikma, Health Net points out that it has no duty to discourage others' infringement," the magistrate judge said. "While that is true, plaintiffs also allege that Health Net took active steps — including adopting its formulary and prior authorization procedure for icosapent ethyl prescriptions and taking coverage and payment actions — that are alleged to encourage others' infringement."

The Amarin drug has two indications that the U.S. Food and Drug Administration has approved, only one of which is patent protected, according to the magistrate judge.

Hikma's generic was put on the market after getting FDA approval, but that approval was only for the indication that was not patented, according to the magistrate judge.

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 U.S.

Representatives for the parties did not immediately respond to requests for comment.

The patents-at-issue are U.S. Patent Nos. 9,700,537; 8,642,077; and 10,568,861.

Amarin is represented by Jeremy D. Anderson, Elizabeth M. Flanagan, Michael Kane, Deanna J. Reichel and Jonathan E. Singer of Fish & Richardson PC.

Hikma is represented by Dominick T. Gattuso of Heyman Enerio Gattuso & Hirzel LLP and Charles B. Klein, Claire A. Fundakowski, Eimeric Reig-Plessis and Alison M. King of Winston & Strawn LLP.

Health Net is represented by John C. Phillips Jr. and David A. Bilson of Phillips McLaughlin & Hall PA and Don J. Mizerk and Dustin L. Taylor of Husch Blackwell LLP.

The case is Amarin Pharma Inc. et al. v. Hikma Pharmaceuticals USA Inc. et al., case number 1:20-cv-01630, in the U.S. District Court for the District of Delaware.


Courtesy of Patc at ivillage,

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