Post-approval studies of generic drugs that are “reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs,” fall within the scope of the Hatch-Waxman Act safe harbor, 35 U.S.C. § 271(e)(1).

The patentee of a quality analysis method used in the production of a generic drug brought suit against another generic drug manufacturer, alleging that the competitor infringed the patent each time it conducted an analytical test on each batch of drugs to determine the presence and amount of a certain non-naturally occurring sugar, which validated the drug product. The district court issued a preliminary injunction against the alleged infringer. The alleged infringer appealed, and the Federal Circuit stayed the injunction. A divided panel ultimately vacated the injunction.

The majority concluded that the alleged infringer’s testing fell within the scope of the Hatch-Waxman Act safe harbor, 35 U.S.C. § 271(e)(1), which provides that use of patented technology is not infringing when it is “solely for uses reasonably related to the development and submission of information under a federal law which regulates the manufacture, use, or sale of drugs.” The majority determined that this language was unambiguously broad enough to encompass submissions made pursuant to the Federal Food, Drug, and Cosmetic Act and did not consult the statute’s legislative history. The majority also concluded that the generation of data for potential FDA inspection could constitute a “submission” for purposes of the safe harbor.

The majority distinguished Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057, 1070 (Fed. Cir. 2011), in which it held that § 271(e)(1) “does not apply to information that may be reported to the FDA long after marketing approval has been obtained.” This case fit “well within [the rule established by] Classen” because in applying the rule, the information submitted was not routine but rather was essential both to the continued approval of the alleged infringer’s ANDA and to its ability to market the generic drug. Even if there were other ways to perform the testing, the alleged infringer’s actions would still fall within the safe harbor because the only limitation in the provision is the “reasonably related” one.

Noting the Supreme Court’s observation that § 271(e)(1) is “not plainly comprehensible,” Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 669 (1990), the dissent looked to legislative history and concluded from it that the safe harbor was intended to apply only in pre-approval experimentations, not to commercial sales. The dissent further argued that the majority’s position could not be squared with Classen, Eli Lilly, and Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193 (2005) and called for the case to be reheard en banc. It also contended that the majority’s interpretation disincentivized innovation and could render manufacturing method patents worthless in cases involving FDA regulatory testing.

A copy of the opinion can be found here.