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Minnesota Mining and Manufacturing Co. v. Barr Laboratories, Inc.

Manufacturer lacked private right of action under FFDCA to determine another party's statutory compliance; district court was entitled to dismiss patent infringement action with prejudice, thus triggering ANDA filer's 180-day exclusivity period.

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Opinion for the court filed by Circuit Judge DYK. Opinion concurring in judgment filed by Circuit Judge GAJARSA.

This case presents a question under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (“FFDCA”), which were enacted as part of the Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585 (1984), codified at 21 U.S.C. �� 355, 360cc, and 35 U.S.C. �� 156, 271, 282. Appellants, Minnesota Mining and Manufacturing Co. (“3M”) and Alphapharm Pty. Ltd. (“Alphapharm”), urge that the district court should have dismissed 3M’s infringement action against appellee, Barr Laboratories, Inc. (“Barr”), without prejudice pursuant to Rule 41(a)(2) of the Federal Rules of Civil Procedure, so that the dismissal of that suit would not have triggered the running of a 180-day waiting period under 21 U.S.C. � 355(j)(5)(B)(iv)(II) for approval of Barr’s Abbreviated New Drug Application (“ANDA”). Appellants urge that a dismissal without prejudice was required because Barr improperly caused the 3M suit to be brought. Barr allegedly did so by failing to provide 3M with information (before 3M filed suit) showing that Barr did not infringe. In particular appellants alleged that Barr failed to comply with the requirement of 21 U.S.C. � 355(j)(2)(B)(ii) that it provide “a detailed statement of the factual and legal basis of the applicant’s opinion that the patent is not valid or will not be infringed.” Pursuant to our decisions in Mylan Pharmaceuticals, Inc. v. Thompson, 268 F.3d 1323, 60 USPQ2d 1576 (Fed. Cir. 2001) and Andrx Pharmaceuticals, Inc. v. Biovail Corp., 276 F.3d 1368, 61 USPQ2d 1414 (Fed. Cir. 2002), we hold that � 355(j)(2)(B) cannot be enforced by a private party in a patent infringement action, but must be enforced, if at all, only in the context of an action under the Administrative Procedure Act (“APA”), 5 U.S.C. �� 702-706. We also conclude that the district court did not lack subject matter jurisdiction to determine the form of dismissal or otherwise abuse its discretion in declining to dismiss without prejudice. We accordingly affirm the judgment of the district court.

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