New Judicial Interpretations on Scope of Hatch-Waxman Safe Harbor

by Polsinelli

The Federal Circuit recently provided additional clarity about the scope of the Hatch-Waxman safe harbor. In Classen Immunotherapies, Inc. v. Elan Pharmaceuticals, Inc., the appellate court sharpened the line between activities that fall outside the safe harbor provision of 35 U.S.C. § 271(e)(1) from those that fall within it and are consequently exempt from claim for patent infringement. Pharmaceutical researchers that avail themselves of the safe harbor's protection may benefit from this additional guidance.

The Hatch-Waxman safe harbor is an important exemption that furthers Congress' goal of bringing generic drug and medical device products to market as soon after patent expiration as possible. Nonetheless, courts' interpretations of the statutory text continue to evolve, and particular conduct needs to be carefully evaluated on a case-by-case basis.

Pursuant to the Federal Food, Drug, and Cosmetic Act ("FDCA"), pharmaceutical companies cannot market drugs in the United States without the approval of the U.S. Food and Drug Administration. The FDA will not grant approval without determining a proposed drug has acceptable safety and efficacy characteristics. Measuring those characteristics and reporting them to the FDA may involve performing methods or manufacturing, using, or importing compounds that are protected by United States patent rights.

It is an act of infringement to make, use, offer to sell, sell, or to import into the United States a patented invention. The Hatch-Waxman Act, however, created an exception that "[i]t shall not be an act of infringement" when the conduct 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." This "safe harbor" exempts drug companies from claims of infringement for activity "reasonably related to the development and submission of any information under the FDCA." Merck KGaA v. Integra Life Sciences, 545 U.S. 193, 202 (2005) (emphasis in original). So long as there is "a reasonable basis for believing that use of the patented invention might yield information that would be appropriate to include in a submission to the FDA, that use is 'reasonably related' to the 'development and submission of information under . . . Federal law.'" Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc., 686 F.3d 1348, 1357–57 (Fed. Cir. 2012).

Background on Elan

At issue in Elan was post-approval clinical trials conducted for the purpose of characterizing the effect of food on the absorption of the drug Skelaxin. In early 2001, Elan learned that the FDA intended to grant a Citizen's Petition to reclassify Skelaxin as a "bio problem" drug, meaning the drug had potential or actual bioequivalence problems such that ANDA applicants would need to perform both in vitro and in vivo testing to demonstrate equivalence. See FDA Docket No. 01P-0117/CP1. Elan conducted its own clinical studies and determined that bioavailability significantly increased in the fed state. Elan submitted its information to the FDA together with a supplemental new drug application that revised the product labeling accordingly. Elan also filed patent applications based on the clinical bioavailability data it developed.

Classen sued Elan for infringing a patent directed to a method for accessing and analyzing data on a commercially available drug to identify a new use of that drug, and then commercializing that new use. The Federal Circuit held that conducting a clinical study on the bioavailability of a drug and submitting the results to the FDA to revise that drug's product label were within the scope of the Hatch-Waxman safe harbor because the activities were not "routine" post-approval reporting like those found to be outside the safe harbor in Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057, 1070–72 (Fed. Cir. 2011) (finding voluntary studies of relationship between timing of childhood vaccinations and development of immune-mediated disorders not subject to safe harbor despite submission of adverse experience information to FDA). Rather, they were "necessary" to the approval of the drug and any generic versions, akin to the post-approval batch reporting necessary to maintain FDA approval. Momenta, 686 F.3d at 1357-61 (finding such reports within the scope of the safe harbor). Thus, Elan's performance of clinical studies and its submission of information from those studies to the FDA were not acts of infringement.

Classen also alleged that Elan's use of the information in filing patent applications and in labeling products for sale were acts of infringement. The mere dissemination of information derived from clinical studies is not itself an act of infringement as previously held in Telectronics Pacing Sys. v. Ventritex, Inc., 982 F.2d 1520 (Fed. Cir. 1992). Classen argued, however, that it was the filing of the applications and the sale of the products—not the dissemination of information or its placement on labeling—that constituted the infringing acts. The Federal Circuit did not explicitly reach these issues, but instead deferred to the district court to make findings in view of its guidance about the scope of the safe harbor. The Court did take the unusual step, however, of offering several "observations" that suggest Classen faces an uphill battle in prevailing on its remaining infringement theories.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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