Start the Clock: NJ Court Holds Declaratory Judgment Available to Later ANDA Filers

Yesterday, the United States District Court for the District of New Jersey held that patents listed in the Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”), but not asserted under the Hatch-Waxman framework, are subject to declaratory judgment actions by later ANDA filers seeking to trigger the first ANDA filer’s exclusivity period.

To encourage the development and marketing of generic versions of banded pharmaceutical products, Congress passed the Drug Price Competition and Patent Restoration Act of 1984 (“Hatch-Waxman Act”). Under the Hatch-Waxman Act, generic drug companies can file Abbreviated New Drug Applications (“ANDA”) which can rely on the research of the NDA holder so long as the proposed generic product is bioequivalent to the brand product. See 21 U.S.C. § 355(j), (j)(2)(A), (j)(8)(B). Additionally, the ANDA filer is required to include a certification to each of the patents listed in the Orange Book covering the brand product. In the case of a paragraph IV certification, where the generic company claims that the listed patent(s) are invalid or not infringed, the NDA holder and/or the patent owner may sue the ANDA filer for patent infringement within 45 days of receiving notice of the ANDA filing. If such suit is brought, the FDA is prohibited from approving the ANDA for 30 months. The first ANDA filer to submit a paragraph IV certification is entitled to a 180-day period of generic market exclusivity before the FDA may approve any subsequent ANDA with a paragraph IV certification for the same brand product.

A 2003 amendment to the Hatch-Waxman Act changed the triggering of the 180-day exclusivity period for the first ANDA filer. In addition to the launch of the first ANDA filer’s generic product, the 180-day clock can also start if a later ANDA-filer obtains a final judgment that the Orange Book patents are invalid or not infringed. In that circumstance, the first ANDA-filer must market its ANDA product within 75 days or forfeit its period of exclusivity.

Purdue Pharmaceutical is the holder of an NDA for sublingual tablets containing zolpidem tartrate to treat middle-of-the-night insomnia. Purdue Pharma markets the tablets under the tradename Intermezzo® (hereinafter, Purdue Pharmaceutical and Purdue Pharma are collectively, “Plaintiffs”). There are four patents listed in the Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”) covering Intermezzo®.

TWI Pharmaceuticals, Inc. (“TWI”) filed an ANDA with a paragraph IV certification seeking to market a generic version of Intermezzo®. By the time TWI submitted its ANDA to the FDA, there were at least four other ANDAs directed to generic zolpidem tartrate tablets. In accordance with 21 U.S.C. § 355(j)()(B)(iii), Plaintiffs filed a complaint alleging that TWI’s ANDA was an act of infringement under 35 U.S.C. § 271(e)(2). The Court specifically noted that Plaintiffs’ complaint only alleged infringement of two of the four listed Orange Book patents. This is of significance because TWI subsequently filed a counterclaim seeking declaratory judgment that its proposed ANDA product does not infringe any of the four listed Orange Book patents. Plaintiffs presented a covenant not to sue TWI on the two unasserted patents and then sought to dismiss TWI’s declaratory judgment counterclaim of non-infringement as to those two patents.

A federal court may exercise declaratory judgment jurisdiction where (1) the plaintiff has standing, (2) the issues presented are ripe for judicial review, and (3) the case is not rendered moot at any stage of the litigation. Caraco Pharm. Lab., Ltd. v. Forest Labs., Ltd., 527 F.3d 1278, 1291 (Fed. Cir. 2008). Plaintiffs argued that no Article III case or controversy existed because (i) the covenant not to sue rendered TWI’s counterclaims moot, (ii) the Court could not redress TWI’s alleged injury, and (iii) the dispute is not ripe because TWI had not obtained tentative approval.

Citing Caraco and Dey Pharma, LP v. Sunovision Pharms., Inc., 677 F.3d 1158, 1159 (Fed. Cir. 2012), the Court held that because “TWI’s counterclaims could potentially trigger the first ANDA filer’s 180-day exclusivity period” and expedite the timing of TWI’s entry into the market, “TWI’s counterclaims present a substantial controversy appropriate for judicial review.” In regard to the other factors, the Court held that the Hatch-Waxman Act does not require the ANDA filer to obtain tentative approval before seeking declaratory judgment of non-infringement with respect to any Orange Book patent. And, the filing of an ANDA is sufficient to satisfy the ripeness requirement for a declaratory judgment action on non-infringement.

Gibbons will continue to monitor issues that arise in Hatch-Waxman litigations and incidents of declaratory judgment actions brought by later ANDA filers in the United States District Court for the District of New Jersey and other jurisdictions.

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