Amarin Corp Plc (AMRN)

[HDGabor]

c-

Yep

On May 6, 2020, Amarin received a new notice from Apotex with new paragraph IV certifications (the “2020 Notice”). The 2020 Notice reflects that Apotex has amended its ANDA and has made new paragraph IV certifications with regard to patents listed in the Orange Book for the VASCEPA indication, originally approved by the FDA in July 2012, for the reduction in triglyceride levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia. As previously disclosed, Amarin is currently appealing the United States District Court for the District of Nevada’s March 30,2020 ruling in favor of generic companies in Amarin’s patent litigation against two filers of ANDAs for VASCEPA (the “Nevada Litigation”) to the United States Court of Appeals for the Federal Circuit. The 2020 Notice alleges to varying degrees that the certified patents, including those subject to the Nevada Litigation and related appeal, are invalid, unenforceable and/or will not be infringed by the manufacture, use or sale of the proposed generic product for which the Apotex ANDA was submitted. In light of the Nevada Litigation and related appeal, Amarin is currently considering the most effective path to respond to the 2020 Notice and plans to update investors at an appropriate time after such decision is acted upon. Because Apotex is not a party to the Nevada Litigation or related appeal, it is not directly subject thereto. Generally, options include litigation and settlement.

Item 8.01 Other Events

Best,
G