Rehearing Sought in Colchicine 505(b)(2) Listed Drug/Patent Certification Dispute

September 6, 2016

By Kurt R. Karst –      

Last week, Elliott Associates, L.P., Elliott International, L.P. and Knollwood Investments, L.P. (collectively “Elliott”), a hedge fund with investment interests in Takeda Pharmaceuticals U.S.A., Inc.’s (“Takeda’s”) gout flare drug COLCRYS (colchicine) Tablets, 0.6 mg (NDA 022352), filed a Petition for Rehearing and/or Rehearing en banc with the U.S. Court of Appeals for the District of Columbia Circuit seeking reconsideration of a July 2016 Per Curiam Judgment from a panel of DC Circuit Judges (Judges Kavanaugh, Wilkins, and Silberman) affirming a January 2015 ruling from DC District Court Judge Ketanji Brown Jackson. Judge Jackson upheld FDA’s September 26, 2014 approval of a 505(b)(2) application (NDA 204820) submitted by Hikma Pharmaceuticals LLC (“Hikma”) and its U.S. partner West-Ward Pharmaceutical Corp. (“West-Ward”) for MITIGARE (colchicine) Capsules, 0.6 mg, for prophylaxis of gout flares, which 505(b)(2) NDA did not cite COLCRYS as a listed drug (and thus did not include patent certifications to patents listed in the Orange Book for COLCRYS). 

As we previously posted (, here, , and ), Takeda and Elliott unsuccessfully sued FDA in October 2014 alleging that the Agency’s approval of MITIGARE violates the FDC Act and the Administrative Procedure Act (“APA”) in several respects, including that “FDA’s failure to require Hikma to reference Takeda’s own colchicine drug, Colcrys®, in its application interfered with Takeda’s rights to participate in the administrative process, including the Paragraph IV certification process under the Hatch-Waxman Act and the Citizen Petition process.”  On appeal, the DC Circuit panel concluded that as to the issue of whether or not Hikma should have certified to the COLCRYS patents listed in the Orange Book, the issue is moot because of the Delaware District Court’s decision, rendered outside of the Hatch-Waxman context, resolving the issue of patent infringement in favor of Hikma (see our previous post here).

Elliott contends in its Rehearing Petition that the case involves a question of “exceptional importance,” and that rehearing is warranted because “[t]he panel’s decision dismissing this appeal as moot conflicts with precedent from the Supreme Court and several courts of appeals regarding the proper application of the Hatch-Waxman Amendments . . . and the 30-month stay provision.” “After the District Court for the District of Delaware dismissed Takeda’s patent-infringement suit against Hikma, the panel dismissed this appeal as moot, citing the provision of the Hatch-Waxman Amendments that terminates the 30-month stay upon entry of a judgment of non-infringement only ‘[i]f the applicant made a certification’ to the innovator’s patents and the innovator subsequently sued ‘for infringement of the patent that is the subject of the certification,’” writes Elliott (emphasis in original).  “But here, Hikma never made the required certification and Takeda was precluded from bringing a Hatch-Waxman infringement suit.  The panel’s unprecedented decision departs from a uniform body of case law distinguishing between post-certification patent-infringement cases subject to the limitations of [FDC Act § 505](c)(3)(C), and non-certification patent-infringement cases like the Delaware Proceeding to which that provision does not apply” (emphasis in original).

For its part, Takeda filed a Partial Joinder in Elliott’s Rehearing Petition. “This Court has not expressly addressed the possibility that the judgment in the Delaware proceedings could be reopened,” writes Takeda.  “And the parties have not fully briefed the statutory question that would follow: whether an approval under 21 U.S.C. § 355(c)(3)(C)(i)(I) remains in effect if the district court itself withdraws an initial erroneous judgment of non-infringement” (emphasis in original).