October 20, 2017

Case Name: Allergan Sales, LLC v. Teva Pharms. USA, Inc., Civ. No. 2:15-cv-01471-FRG-RSP, 2017 U.S. Dist. LEXIS 127886 (E.D. Tex. July 25, 2017) (Payne, M.J.) 

Drug Product and U.S. Patent: Delzicol® (mesalamine); U.S. Patent No. 6,649,180 (“the ’180 patent”)

Nature of the Case and Issue(s) Presented: Allergan had maintained brand exclusivity for a 400 mg mesalamine tablet since at least 1992, first with Asacol and more recently with Delzicol. The Asacol NDA was approved on Jan. 31, 1992 and two Orange Book-listed patents were identified: U.S. Patents Nos. 5,541,170 (“the ’170 patent”) and 5,541,171 (“the ’171 patent”). Those patents claimed a pharmaceutical composition suitable for orally administering mesalamine. Before the ’170 and ’171 patents expired, Allergan obtained a license to the patent-in-suit. The ’180 patent did not claim a mesalamine composition; rather, it claimed a hard capsule formed of a film composition comprising, among other things, hydroxypropyl methyl cellulose [HPMC] with limited amounts of aliphatic propoxyl and methoxy groups. On Feb. 1, 2013, the FDA approved the NDA for Allergan’s mesalamine HPMC capsule, marketed as Delzicol, which identified one Orange Book patent: the ’180 patent. There was evidence that Warner Chilcott switched to the capsule claimed in the ’180 patent to maintain brand exclusivity of its mesalamine product.

In July 2015, Teva submitted an ANDA, including a PIV certification against the patent-in-suit, seeking approval for a generic version of Delzicol. Allergan filed suit on Aug. 28, 2015. Sometime between when Delzicol was approved and September 2015, Allergan revised the Delzicol label in one important respect: the drug was to be administered as four 100 mg tablets instead of one 400 mg tablet. By March 2017, Teva had made similar changes to its proposed generic label. On May 31, 2016, the FDA sent Teva a deficiency letter rejecting Teva’s mesalamine ANDA for various reasons, including inconsistencies between Teva’s proposed label and the most recently approved label for Delzicol. Teva submitted an amendment, explaining that the original ANDA was based on Allergan’s existing label that described Delzicol as a single 400 mg tablet in a capsule. The amendment acknowledged the revised label, which described Delzicol as four 100 mg delayed release tablets.

On Mar. 31, 2017, Allergan moved to stay the lawsuit against Teva, contending that Teva had just disclosed that it had reformulated the accused product and abandoned the formulation that had served as the basis for the case. On Apr. 11, 2017, Allergan moved to dismiss the suit against Teva for lack of subject-matter jurisdiction, insisting the case was moot. On Apr. 21, 2017, Allergan filed a new lawsuit against Teva, contending that Teva infringed the ’180 patent by virtue of submitting its amended ANDA and the 2017 PIV certification. Teva acknowledged at the hearing that for purposes of this case, the amended ANDA permitted Allergan to file a new lawsuit and that Teva’s PIV recertification notice triggered an additional 30-month stay, subject of course to earlier resolution by the Court. The issue here was whether the court had continued subject-matter jurisdiction over the original lawsuit against Teva. The court recommended that Allergan’s motion to dismiss should be denied.

Why Teva Prevailed: Allergan’s argument about lack of subject-matter jurisdiction rested on the false premise that a PIV certification is a jurisdictional prerequisite to an ANDA lawsuit. But jurisdiction is not based on any certification, and the statute’s text did not even require the relevant patent to be listed in the Orange Book. Rather, jurisdiction was based only on § 271(e)(2)(A) and § 1338(a). In terms of mootness, Teva’s original ANDA remained on file (though it had been amended), and the alleged § 271 act of infringement had not been reversed. Thus, there was continuing subject-matter jurisdiction.

The slightly more difficult question the court entertained was what effect, if any, did Teva’s changed product have on subject-matter jurisdiction in the original lawsuit? Plaintiffs focused almost entirely on the root of ANDA subject-matter jurisdiction and Teva argued that the infringement allegations in the new suit were substantively identical to those in the operative complaint; this was primarily true because the composition of Teva’s reformulated product was insignificantly different from the original one, aside from dosage form. Finally, Allergan’s arguments concerning the mootness of Teva’s counterclaims were not persuasive. As long as Allergan’s original infringement claim was not moot, as was the case here, Teva’s declaratory judgment counterclaims were not moot.