$AMRN Form 8-K

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Form 8-K for AMARIN CORP PLC\UK


25-Jan-2016

Other Events

Item 8.01. Other Events.On January 22, 2016, the U.S. District Court for the District of New Jersey granted Amarin’s motion to dismiss all patent infringement litigation related to the acceptance by FDA of abbreviated new drug applications, or the ANDAs, to Vascepa� (icosapent ethyl) capsules in the first half of 2014. With this dismissal, there is no pending patent litigation related to Vascepa. Separately, as previously disclosed and described below, the FDA no longer considers the ANDAs accepted.This dismissal of the patent infringement litigation follows the May 2015, U.S. District Court for the District of Columbia order granting Amarin’s motion for summary judgment that set aside FDA’s denial of five-year, NCE exclusivity in connection with FDA approval of Vascepa on July 26, 2012. That order vacated FDA’s denial of Amarin’s claim for such exclusivity and remanded to FDA for proceedings consistent with the decision. A new exclusivity determination by FDA has not been made. In June 2015, following communication with the parties, the FDA changed the status of the ANDAs at FDA to submitted, but no longer accepted. In July 2015, Amarin moved to dismiss the ANDA patent litigation on the basis that the statutory grounds for patent infringement (accepted ANDAs) no longer existed. The New Jersey court adopted this reasoning in its ruling granting Amarin’s motion to dismiss. An appeal of the court’s decision can be filed within 30 days.


 

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