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Oct. 19 — Watson Laboratories Inc. will have to wait for a decision on whether it may intervene in Amarin Pharmaceuticals Ireland Ltd.’s ongoing litigation against the FDA over the lipid treatment Vascepa.
Watson Laboratories is hoping to launch a generic version of Amarin's lipid treatment.
Judge Randolph D. Moss of the U.S. District Court for the District of Columbia Oct. 15 deferred action on Watson's motion to intervene pending an indicative ruling from the U.S. Court of Appeals for the District of Columbia Circuit.
Moss said he couldn't rule on Watson's intervention motion because Watson’s filing a notice of appeal to the D.C. Circuit deprives the district court of jurisdiction over Watson's motion to intervene. Nonetheless, he said if the issue did come back to his court, he would grant Watson's motion because Watson had met the factors necessary to intervene as of right.
Watson is seeking to intervene in the Amarin case so that it can appeal a decision that effectively prevents the Food and Drug Administration from approving any generic versions of Vascepa until at least January 2020. Watson says the decision, which vacated the FDA's denial of a five-year new chemical entity exclusivity period for Vascepa and remanded the matter to the agency, could eviscerate Watson's valuable 180-day generic exclusivity period on the product.
Neither Amarin nor the FDA chose to appeal the district court's decision in the case.
Because the FDA declined to appeal the decision, Watson said that the FDA could no longer adequately represent Watson's interests in the matter, requiring Watson to move to intervene in the case so it can appeal the district court's decision.
In Moss's Oct. 15 opinion, he said the D.C. Circuit also has to decide whether the court's order is a final and appealable order before the district court can move ahead in the matter.
Moss said that issue of finality would be “more appropriately addressed by the Court of Appeals.”
“[T]hat question implicates appellate jurisdiction and has already been briefed in the Court of Appeals,” he said.
Meanwhile, both Amarin and the FDA have asked the D.C. Circuit to dismiss Watson's appeal for lack of jurisdiction. Briefing on those motions is almost complete, Moss said.
But Moss said if the appeals court were to deny the motions to dismiss and send the case back to the district court, he would grant Watson’s motion to intervene. Watson had met the prerequisites under Federal Rule of Civil Procedure 24(a) for intervening as of right in the case, he said.
“Watson has shown that it has at least two interests in the proceeding that the Court’s May 28, 2015, Order is likely to impair,” Moss said. “First, the Court’s Order is likely to delay the FDA’s review of Watson’s ANDA [abbreviated new drug application]. If the FDA decides to grant Amarin a five-year exclusivity period for Vascepa, it will not be able to review Watson’s ANDA until, at the very earliest, July 2016, when four of the five years of Amarin’s period of market exclusivity will have elapsed.”
“This delay,” he wrote, “would be sufficient, standing alone, to permit Watson to intervene.”
“But,” he added, “because the five-year exclusivity period also bars the FDA from even accepting an ANDA for review . . . a decision approving Amarin’s application for a five-year exclusivity period would also arguably require Watson to resubmit its “Paragraph IV” ANDA four years into Amarin’s five-year exclusivity period, causing it to lose its current claim as the “first applicant” and its hold on the statutory 180-day exclusivity period available to generic drug manufacturers.”
Watson, based in Corona, Calif., and Parsippany, N.J., is now part of Allergan Plc (formerly Actavis Plc). Amarin is based in Dublin.
James N. Czaban and Brett A. Shumate of Wiley Rein LLP in Washington represent Watson Laboratories.
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