Post-Approval Clinical Data and the §271(e)(1) Safe Harbor Provision

By: Sandra King  |   June 5, 2015

Last month, the Court of Appeals for the Federal Circuit held in Classen Immunotherapies Inc. v. Elan Pharmaceuticals, Inc., that the safe harbor provision set forth in 35 U.S.C. § 271(e)(1) exempted Elan’s post-approval activities that reasonably related to “developing clinical data on its approved drug Skelaxin (metaxalone) and submitting that information to the Food and Drug Administration in a citizen petition and a supplemental new drug application (sNDA).” --- F.3d ---, 2015 WL 2216154, at *1 (C.A.Fed. (Md.) 2015).

Elan Pharmaceuticals had previously marketed and sold Skelaxin, a muscle relaxant, for many years before they learned that another company had conducted bioequivalence fasting studies. Id. Such studies had prompted the FDA to propose a change to the designation of metaxalone tablets from “non bioproblem” to “bioproblem.” Id. Elan initiated its own clinical studies confirming the significant effect of food on the drug’s bioavailability. Id.

Elan subsequently submitted a citizen petition to the FDA, requesting that the FDA require both fed and fasting bioavailability data from ANDA applicants and also submitted a sNDA to revise the product label. Id. The FDA granted the citizen petition and approved the sNDA. Id. Elan also filed two patent applications claiming the new bioavailability data. Id.

The patent at issue in Classen was U.S. Patent No. 6,584,472, which was 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 the new use.” Id., at 2. Classen sued Elan alleging that Elan infringed the ’472 patent by studying the effects of food on the bioavailability of Skelaxin, using the clinical data to identify a new use of the drug and commercializing the new use. Id. Elan moved for summary judgment of noninfringement and the district court granted the motion under the safe harbor provision of § 271(e)(1), finding that Elan’s activities were “reasonably related to the submission of information” under the Federal Food, Drug, and Cosmetic Act. Id.

The Federal Circuit stated that Elan’s clinical study and FDA submissions “clearly fall within the scope of the safe harbor.” Id. at 5. The Federal Circuit asserted that Elan submitted the clinical study information to the FDA “to revise the Skelaxin product label and to propose changes to the approval requirements for generic versions of Skelaxin.” Id. These activities were deemed by the Court to be “necessary” to the approval of both the brand and generic version of Skelaxin. Id. The Court contrasted Elan’s activities with the more “routine” activities, i.e. reporting vaccine relationships, described in Classen Immunotherapies, Inc. v. Biogen. Id., see also 659 F.3d 1057, 1070 (Fed. Cir. 2011).

Classen further argued that Elan’s subsequent actions of reanalyzing the clinical data to identify patentable information and filing patent applications were considered commercial activities outside the scope of the safe harbor. Classen, --- F.3d ---, 2015 WL 2216154, at *5.  The Federal Circuit, however, stated that filing a patent application is generally not an infringement of a patent as it is not the act of “making, using, offering to sell, selling or importing of an invention,” nor is it commercializing an invention. Id. at *6. Additionally, the Federal Circuit stated that, placing the submitted information “on the product label after approval of the sNDA also cannot generally be considered infringement.” Id. For these reasons, the Federal Circuit vacated the District Court ruling and remanded the case for a determination of infringement. Id.

The decision in Classen v. Elan further clarifies the scope of the §271(e)(1) safe harbor provision to protect post-approval activities “necessary” to FDA approval in contrast to those activities that are “routine” submissions not required for approval of the drug. When engaged in post-approval activities, it is important for stakeholders to consider whether their actions fall into the “necessary” or “routine” categories to determine any infringement risks associated with those activities.