API Manufacturer Protected by Safe Harbor Provision for Customer’s Use “Reasonably Related” to ANDA Filing

Last week, the Eastern District of Kentucky declined to stop a third-party company from importing a key pharmaceutical compound on behalf of a generic drug developer, holding that the company was protected by the Hatch-Waxman Act’s “safe harbor” provision. Although the importer itself was not developing the generic drug, its actions were “in furtherance” of the unnamed developer’s protected activities and, therefore, were protected themselves.

Earlier this year, patentholder UCB, Inc. sued Catalent Pharma Solutions, Inc. for infringement of a patent related to its anticonvulsant drug Vimpat®. UCB, Inc. v. Catalent Pharma Solutions, Inc., No. 5:21-cv-00038 (E.D. Ky. Feb. 5, 2021). The complaint alleged that Catalent had been importing lacosamide—the active ingredient in Vimpat™—since April 2019, pursuant to a supply contract with a generic drug manufacturer. UCB filed a motion for a preliminary injunction, seeking to prevent Catalent from further importation. In response, Catalent admitted to importation—which would constitute direct infringement—but alleged that its activities were protected by the safe harbor created by 35 U.S.C. § 271(e)(1). According to Catalent, this provision protects infringing actions “reasonably related to the submission of an ANDA.” Shire LLC v. Amneal Pharms. LLC, 802 F.3d 1301, 1310 (Fed. Cir. 2015) (finding the safe harbor protected a third-party indirect infringer).

Judge VanTatenhove agreed with Catalent, finding that—although Catalent itself was not contemplating an ANDA filing—it had “a reasonable basis for believing that its use of the lacosamide compound would yield information to be used in furtherance of [its customer’s] FDA submission.” Order at 7. According to the court, this was sufficient to render Catalent’s actions “reasonably related” to the FDA submission, and, therefore, protected by the safe harbor. In so holding, the court contrasted the facts of Proveris, where a downstream supplier of testing equipment not subject to premarket approval was found to fall outside §271(e)(1)’s protections. See Proveris Sci. Corp. v. Innovasystems, Inc., 536 F.3d 1256, 1265–6 (Fed. Cir. 2008). Judge VanTatenhove found it significant that Catalent was importing the central component of the drug product at issue, and not a more tenuously associated testing device (as in Proveris).

This opinion confirms the safe harbor protects third parties involved in a generic developer’s pre-filing research.