Impax's Declaratory Judgment Complaint in ANDA Case Against Medicis Dismissed

Includes: IPXL, VRX
by: Aaron F. Barkoff

On April 16, the U.S. District Court for the Northern District of California dismissed a declaratory judgment complaint filed by Impax against Medicis, ruling that the court lacks jurisdiction because there is no case or controversy between the parties. The decision (pdf file) is interesting because it follows two recent decisions in ANDA cases where the Federal Circuit expanded declaratory judgment jurisdiction: Teva (NASDAQ:TEVA) v. Novartis (NYSE:NVS) and Caraco (NYSEMKT:CPD) v. Forest (NYSE:FRX). The district court, however, distinguished this case by finding that Impax had not alleged a cognizable injury-in-fact.

Medicis manufactures and sells Solodyn, a minocycline extended-release tablet used as an oral acne medication. Medicis owns U.S. Patent No. 5,908,838, which claims methods of treating acne by administering minocycline. However, because minocycline is an "old antibiotic," Medicis was not required (or allowed) to submit any patents on Solodyn to the FDA for listing in the Orange Book.

Impax filed an ANDA for a generic version of Solodyn in 2007 and, on December 20, voluntarily sent Medicis a letter informing Impax of its ANDA and asserting that Impax does not infringe any valid claim of the '838 patent. In the same letter, Impax asked Medicis for a covenant not to sue under the '838 patent. Medicis replied on January 11, 2008, stating that it would consider Impax's letter and have a further response within two weeks. Impax did not wait for that response, and instead filed a complaint for a declaratory judgment of invalidity and noninfringement on January 15, 2008.

According to the court, Impax argued, based on 35 U.S.C. § 271(e)(2), that the filing of an ANDA is sufficient to create an actual controversy for purposes of the Declaratory Judgment Act. The court, however, found that

an act of infringement under § 271(e)(2) is not, by itself, sufficient to create an actual controversy for purposes of standing for declaratory judgment relief.
The court stated that the defendant must have
taken some affirmative action sufficient to constitute a threat of imminent injury.

Citing the Supreme Court's recent decision in MedImmune (MEDI) v. Genentech (Private:DNA), the court further stated that even if Impax had pled facts sufficient to give rise to standing, the court would use its "substantial discretion in deciding whether to declare the rights of litigants." According to the court:

[P]laintiff's allegation of jurisdiction rests on the existence of the '838 patent, plaintiff's filing an ANDA, and defendant's failure to immediately agree to a covenant not to sue. If, under such circumstances, the Court were to exercise declaratory judgment jurisdiction, it would promote the premature filing of declaratory judgment actions and reduce the incentive for potential infringers to communicate with patentees before filing suit.

Given Medicis's public statements about its intent to vigorously enforce its patents on Solodyn, it will be interesting to see whether Medicis files suit against Impax at some point in the future.


  • Complaint (pdf file)
  • Motion to Dismiss (pdf file)
  • Memorandum in Opposition to Motion to Dismiss (pdf file)
  • Reply Brief in Support of Motion to Dismiss (pdf file)