Third Circuit Court of Appeals Holds Mutual Release Bars Generic Drug Company's Antitrust Claim

• Published in: Intellectual property & technology law journal 2023-03, Vol.35 (3), p.19-21
• Main Authors: Storey, Harold, Uekawa, Madisyn M
• Format: Article
• Language: English
• Subjects: Agreements; Antitrust; Appeals; Cosmetics; FDA approval; Generic drugs; Generic products; Infringement; Injury analysis; Litigation; Pharmaceuticals; State court decisions
• ISSN: 1534-3618

The U.S. Court of Appeals for the Third Circuit, in Perrigo Co. v. AbbVie Inc., has affirmed a district court's judgment that the mutual release in the settlement agreement between the parties from an earlier patent infringement and Hatch-Waxman Act litigation barred the plaintiffs' subsequent antirust claim.1 BACKGROUND In 2000, defendants AbbVie Inc. and Abbott Laboratories (Defendants) launched the brand product named AndroGel.2 AndroGel is a topical gel used to treat hypogonadism.3 Co-Defendants, Unimed Pharmaceuticals LLC and Besins Health Care Inc. (Patentees), hold U.S. Patent No. 6,503,894 (the '894 patent), which claims a pharmaceutical composition that treats hypogonadism.4 The plaintiffs, Perrigo Co. and its corporate relatives (collectively, Perrigo), produce a generic version of AndroGel 1% (1% generic).5 In 2011, Perrigo filed a new drug application (NDA) under Section 505(b)(2) of the Federal Food, Drug, and Cosmetics Act, seeking U.S. Food and Drug Administration (FDA) approval to market the 1% generic.6 Pursuant to the Hatch-Waxman Act,7 Perrigo sent Patentees notice stating that the 1% generic does not infringe the '894 patent and that "a lawsuit asserting the '894 patent against [Plaintiffs] would be objectively baseless and a sham . . . for the improper purpose of, inter alia, delaying [Plaintiffs'] nDa approval. "8 Patentees sued Perrigo for patent infringement within 45 days of receiving notice and triggered the Hatch-Waxman Act's automatic 30-month stay on the FDA's ability to approve the 1% generic.9 The parties, however, came to an early settlement in 2012, and they settled the case before Perrigo filed an answer.10 As part of the settlement agreement, the parties agreed to a mutual release of claims.11 In 2013, the FDA approved Perrigo's 1% generic, and Perrigo then launched the 1% generic in 2014.12 Dissatisfied with the delay that the litigation caused, Perrigo sued Patentees for violation of the Sherman Act in 2020.13 Perrigo alleged that the patent infringement litigation was a "sham" that "delayed [Perrigo's] launch of its generic version of AndroGel 1%. '"15 In response, Patentees claimed that the settlement agreement barred Perrigo's claim and moved for judgment on the pleadings.16 The U.S. District Court for the District of New Jersey agreed with Patentees and granted judgment on the pleadings, finding Perrigo's claim was barred by the release.17 Perrigo appealed the case to the Third Circuit.18 ANALYSIS Parties' Arguments