Amarin Pharma, Inc. v. Apotex, Inc.

Case Name: Amarin Pharma, Inc. v. Apotex, Inc., Civil Action No. 14-2250 (MLC), 2016 U.S. Dist. LEXIS 7555 (D.N.J. Jan 22, 2016) (Cooper, J.)

Drug Product and Patent(s)-in-Suit: Vascepa® (icosapent ethyl); U.S. Patents Nos. 8,293,728 (“the ’728 patent”), 8,318,715 (“the ’715 patent”), 8,357,677 (“the ’677 patent”), 8,367,652 (“the ’652 patent”), 8,377,920 (“the ’920 patent”), 8,399,446 (“the ’446 patent”), 8,415,335 (“the ’335 patent”), 8,426,399 (“the ’399 patent”), 8,431,560 (“the ’560 patent”), 8,440,650 (“the ’650 patent”), 8,501,225 (“the ’225 patent”), 8,518,929 (“the ’929 patent”), 8,524,698 (“the ’698 patent”), 8,546,372 (“the ’372 patent”), 8,551,521 (“the ’521 patent”), and 8,617,594 (“the ’594 patent”)

Nature of the Case and Issue(s) Presented: Amarin owns various patents that cover Vascepa, which is used to reduce triglyceride levels in adults. Amarin brought suit against the Defendants asserting that the Defendants infringed those patents by seeking approval to sell generic Vascepa. The Defendants moved to dismiss the claims against them for a lack of case or controversy because the FDA had not deemed any of the related ANDAs to be “received.” The court agreed and dismissed the case.

Why Defendants Prevailed:  The FDA originally issued a determination providing for a three-year exclusivity period for Vascepa, and then accepted ANDAs from the Defendants. Subsequently, the District Court for the District of Columbia vacated the determination and remanded to the FDA. On remand, the FDA ruled that a five year exclusivity period was more appropriate, and advised the Defendants that it considered their ANDAs submitted, but not yet “received.”

The Court granted the Defendants’ motion to dismiss based on the fact that the ANDAs were not deemed “received” by the FDA. Indeed, the court ruled that the ANDA litigation process cannot even begin until the corresponding ANDA is “received” by the FDA, not merely delivered or submitted to the FDA. Thus, the court was required to dismiss the case because it lacked the authority to adjudicate the matter.