Amarin Says Vascepa Patent Suit Dismissed

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By Dana A. Elfin

Jan. 26 — Amarin Corp. Plc said in a Jan. 25 securities filing that a federal district court granted the company's request to dismiss all patent infringement litigation related to abbreviated new drug applications (ANDAs) filed with the FDA to market generic copies of its lipid treatment Vascepa (icosapent ethyl capsules).

The court no longer had jurisdiction to hear the patent litigation because the Food and Drug Administration had changed the status of the generic filers' applications, Judge Mary L. Cooper of the U.S. District Court for the District of New Jersey said in a Jan. 22 unpublished opinion.

“There is nothing for this Court to adjudicate because the ANDA litigation process cannot proceed without the existence of a ‘received' ANDA,” Cooper wrote. “Therefore, this Court must grant the Motion to Dismiss because it lacks the authority to adjudicate the Consolidated Actions for want of an ANDA having been deemed as ‘received' by the FDA.”

Ireland-based Amarin sought dismissal of patent litigation it had filed against six different generic companies—including Apotex, Inc., Andrx Labs, LLC, Dr. Reddy's Laboratories, Inc., Roxane Laboratories, Inc., Teva Pharmaceuticals USA Inc. and Watson Laboratories, Inc.—on the grounds that the change in the generic applications' status to submitted but not accepted meant the court no longer had jurisdiction to hear the consolidated cases.

The grant of dismissal is advantageous for Amarin because the generic company defendants will have to restart the ANDA notification and litigation process, and that will further delay the onset of any generic competition to Vascepa. An appeal of the court's decision can be filed within 30 days.

FDA's Exclusivity Denial Vacated

In June 2015, the FDA changed the status of the Vascepa ANDAs to submitted but no longer accepted. The change in status followed a ruling from the U.S. District Court for the District of Columbia setting aside the FDA's decision to deny five-year, new chemical entity (NCE) exclusivity for Amarin's Vascepa (13 PLIR 798, 6/5/15).

NCE exclusivity protects pioneer drug companies from generic competition for five years after FDA approval of an eligible pioneer drug. It also prevents generic competitors from challenging the pioneer drug companies' patents for four years after FDA approval.

In 2014, Amarin had sued the FDA in the U.S. District Court for the District of Columbia, seeking to overturn its denial of a NCE exclusivity period for Vascepa (12 PLIR 299, 3/7/14).

In May 2015, Judge Randolph D. Moss vacated the FDA's denial of marketing exclusivity for Vascepa and remanded the exclusivity matter back to the FDA for proceedings consistent with his decision. However, the agency hasn't yet made a new exclusivity determination for Vascepa, Amarin said in its Jan. 25 8-K securities filing with the Securities and Exchange Commission.

FDA Still Hasn't Made New Exclusivity Determination

Cooper addressed the exclusivity issue in her opinion.

Dismissing any pending counterclaims in the consolidated actions without prejudice, she wrote that any “counterclaims would be without merit until the FDA ultimately determines whether the exclusivity period for Vascepa should be three years or five years.”

Amarin NCE exclusivity would protect Vascepa through July 25, 2017, and Amarin has said that it would try to protect Vascepa until beyond 2030 with its patent portfolio.

The firms of Covington & Burling LLP in Washington and Robinson Miller LLC in Newark, N.J., represented Amarin in the now-dismissed patent litigation.

To contact the reporter on this story: Dana A. Elfin in Washington at

To contact the editor responsible for this story: Allison Gatrone at

For More Information 
A copy of the not-for-publication Jan. 22 opinion granting the dismissal is available at