Trailblazer Amarin Continues to Blaze New Trails: ANDA Paragraph IV Litigation Dismissed

By Kurt R. Karst –

Whether in the context of asserting First Amendment protection for a pharmaceutical manufacturer’s off-label promotion of an otherwise approved drug (see our previous post here), or challenging FDA’s denial of New Chemical Entity (“NCE”) exclusivity for VASCEPA (icosapent ethyl) Capsules (NDA 202057) (see our previous post here), Amarin Pharma, Inc. (“Amarin”) blazed new trails in food and drug law with victory after victory in court against FDA in 2015. Amarin’s litigation track record continues in 2016 with another court victory last Friday when much of the East Coast of the United States was bracing for Winter Storm Jonas (a.k.a. Snowmageddon 2016).  Although this time Amarin’s win was not against FDA, it’s another first-of-its-kind ruling, and it is of interest to the Hatch-Waxman Community. 

On January 22nd, the U.S. District Court for the District of New Jersey issued an unpublished Memorandum Opinion and Order granting Amarin’s Motion to Dismiss (without prejudice) Paragraph IV patent infringement litigation with several companies that had submitted ANDAs to FDA seeking approval to market generic versions of VASCEPA (opposition, response, and reply briefs available here, here, and here). 

According to FDA’s ANDA Paragraph IV Certifications List, the first ANDA submitted to FDA containing a Paragraph IV certification to a patent listed in the Orange Book for VASCEPA occurred on January 15, 2013. Subsequent Paragraph IV ANDAs followed.  Each ANDA, however, was submitted to FDA earlier than the not-yet-here four-year anniversary of the approval of NDA 202057 for VASCEPA (i.e., July 26, 2016).  Why is that important?  After all, the electronic Orange Book does not even identify an unexpired period of non-patent exclusivity associated with VASCEPA; and the period of “New Product” 3-year exclusivity that previously appeared in the Orange Book expired on July 26, 2015.  So what’s the hang-up?

As folks may recall (and as noted above), on May 28, 2015, the U.S. District Court for the District of Columbia issued an Opinion vacating FDA’s February 21, 2014 Exclusivity Determination that VASCEPA is not eligible for 5-year NCE exclusivity and remanded the matter to FDA for proceedings consistent with the court’s Opinion. ANDA sponsor (and suspected first applicant) Watson Laboratories Inc. (“Watson”), which was not a party to the proceedings before the district court issued its May 2015 decision, sought to intervene and appealed the district court ruling.  In October, 2015, the district court deferred resolution of Watson’s Motion to Intervene pending further action from the U.S. Court of Appeals for the District of Columbia Circuit. In December 2015, the DC Circuit dismissed Watson’s appeal for lack of jurisdiction. 

Meanwhile, FDA, in light of the district court’s May 28, 2015 decision, issued letters to ANDA applicants notifying them that review of their ANDAs was suspended, and that the status of their applications was (and still is) “submitted, but not yet received.” “If, after further review, FDA determines that Vascepa qualifies for NCE exclusivity, the exclusivity will bar an applicant from submitting an ANDA which references Vascepa until July 26, 2017 or an ANDA containing a [Paragraph IV certification] until July 26, 2016,” wrote FDA. FDA has not yet issued an exclusivity determination based on the district court’s May 2015 ruling; however, to avoid complicating matters even further, we suspect FDA will issue a ruling in the coming months, and almost certainly before July 26, 2016, which is the so-called NCE-1 date if 5-year exclusivity is granted. If FDA denies NCE exclusivity a second time, then we suspect Amarin will challenge that decision as unlawful.

Moving back to last week’s dismissal of ANDA Paragraph IV litigation, the New Jersey District Court relied on previous case law concerning so-called “premature” Paragraph IV certification notice. In those cases (see our previous post here), and in SB Pharmco P.R., Inc. v. Mutual Pharm. Co, Inc., 552 F. Supp. 2d 500 (E.D. Pa. 2008), in particular, the court found that notice sent prior to FDA’s acceptance (i.e., receipt, or filing) of an original ANDA is considered premature and ineffective.  Citing and quoting SB Pharmco P.R., the New Jersey District Court reasoned as follows:

The current procedural posture of the Consolidated [Patent Infringement] Actions demonstrates the “important distinction between physically-received ANDAs . . . and officially-received ANDAs.” SB Pharmco P.R., 552 F.Supp.2d at 506.  Therefore, “the FDA’s role in accepting an ANDA for review, so that it is received and not merely delivered, acts as a safeguard” against premature litigation. Id. at 508 (emphasis in original).  Therefore, this Court must grant [Amarin’s] Motion to Dismiss because [this Court] lacks the authority to adjudicate the Consolidated Actions for want of an ANDA having been deemed as “received” by the FDA. Id. at 511. . . .

The court granted Amarin’s Motion to Dismiss despite arguments from ANDA sponsors that FDA’s suspension action was premature and improper because the Agency has not made a final exclusivity determination with respect to VASCEPA. Moreover, wrote several ANDA applicants:

It would lead to unnecessary litigation and a waste of judicial resources if the Court were to dismiss the case now, while the action is stayed, and before the FDA has an opportunity to rule on Vascepa’s NCE status. Accordingly, the Court should deny Plaintiffs’ Motion, or at minimum, stay the action and defer its decision until after a final determination on Vascepa’s NCE status . . . .

So where do we go from here? Absent an appeal by the ANDA sponsors, everyone is waiting for FDA to act.  A grant or denial of NCE exclusivity will almost certainly spawn more litigation . . . not only over the merits of FDA’s exclusivity decision, but what the exclusivity decision means for companies that previously submitted ANDAs (and in light of the New Jersey District Court’s January 22nd dismissal).