There are currently two cases working their way through the legal system relating to Amarin and their quest for exclusivity and protection of their First Amendment rights. Both cases are currently stalled: one is waiting for a court decision on a notice of appeal and motion to intervene, and the other is awaiting settlement discussions; however, both have recent updates and speculation swirling around them, which are addressed below.
District Court for District of Columbia: Exclusivity Case
You may recall when the District Court for D.C. issued their Amarin-friendly opinion back in May 2015. Both the FDA and Amarin were given a sixty-day window following that decision to make an appeal, but neither the FDA nor Amarin appealed that decision.
However, fifty-five days after the decision (five days before the notice to appeal window closed), Watson Laboratories decided they wanted to intervene. When Watson filed their motion to intervene on that day, they also filed a notice of appeal, since neither the FDA nor Amarin had filed one. Watson is interested in intervening and filing an appeal since the May 2015 decision effectively prevents the FDA from approving any generic versions of Vascepa until at least January 2020, which would eviscerate Watson’s valuable 180-day generic exclusivity period on the product.
Once Watson filed the notice of appeal, the Amarin action got sent to the Court of Appeals, where it currently sits and waits for a decision, including a decision on whether or not the Court of Appeals has jurisdiction to actually hear the appeal.
While the case sits on appeal before the Court of Appeals, the District Court for D.C. wrote an opinion earlier this month stating that they no longer have the jurisdiction to make a determination on granting or denying Watson’s request to intervene, since the case is currently before the Court of Appeals.
However, if the appeal is denied by the Court of Appeals (FDA and Amarin both moved the Court of Appeals to dismiss Watson’s appeal for lack of jurisdiction) and remanded back to the District Court, the District Court would have jurisdiction over permitting Watson to intervene, and the District Court judge seems likely to allow that to happen. Judge Randolph D. Moss, the District Court judge responsible for this case, believes Watson has the ability to intervene because, “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. 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 would be sufficient, standing alone, to permit Watson to intervene.”
Judge Moss has also commented that, “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.”
Speculation
It is interesting to note that the FDA is not only disinterested in filing an appeal of this decision themselves, but is also against Watson intervening to appeal. This is strange considering they were the ones that lost at the District Court level and Watson intervening could potentially give them a win without getting any more blood on their hands. However, it is also possible that the FDA does not want Watson to intervene because they do not want the case appealed and affirmed by a higher, more far-reaching court.
For the time being, we are awaiting the Court of Appeals decision. If the Court of Appeals denies Watson’s appeal for lack of jurisdiction, since Watson is not currently a party, the case would be bounced back to the District Court, who would likely allow Watson to intervene. Once Watson has been permitted to intervene, it would then likely try file an appeal, taking it back up to the Court of Appeals.
Southern District of New York: First Amendment Case
Back in August 2015, Judge Paul Engelmayer of the United States District Court for the Southern District of New York granted a motion for preliminary injunction in favor of Amarin. Amarin had challenged the FDA regulations that prohibited Amarin from giving physicians “truthful and non-misleading” information on off-label uses for its prescription drug Vascepa on the basis that the regulations violate the company’s First Amendment rights and the First Amendment rights of physicians to receive the information.
That motion for preliminary injunction did not settle the entire case, however. During that ruling, Judge Engelmayer gave both parties until August 28, 2015 to send him a joint letter detailing how they would like to see the case proceed, and Amarin and the FDA responded that they thought they would be able to work out a settlement by October 30th.
Recently, however, Floyd Abrams of Cahill Gordon & Reindel, LLP, who represents Amarin in the case, authored a letter to Engelmayer, writing, “I write pursuant to Your Honor’s August 10, 2015 Order to update you as to the status of the parties’ negotiations. We have engaged in and continue to engage in settlement discussions in hopes of resolving this case, and the parties request that further proceedings be stayed until December 17, 2015 to continue those discussions. At or before that time, the parties will again file a letter advising the Court of any updates with regard to next steps.”
Essentially, Judge Engelmayer is asking Amarin and the FDA to come to terms on disclaimer language Amarin can use if it wants to share information with doctors on off-label use of its Vascepa product. At last check, both sides agreed on approximately 80 percent of what Amarin would like to communicate, but neither side would agree to make tweaks and settle on the other 20 percent.
For now, we await December 17th to see if the two sides will come to an agreement, or if the case will proceed to trial.