Case Name: Classen Immunotherapies, Inc. v. Elan Pharms., Inc., 786 F.3d 892 (Fed. Cir. May 13, 2015) (Circuit Judges Prost and Lourie, and District Judge Gilstrap presiding; Opinion by Lourie, J.) (Appeal from D. Md., Quarles, Jr., J.)
Drug Product and Patent(s)-in-Suit: Skelaxin® (metaxalone); U.S. Patent No. 6,584,472 ("the '472 patent")
Nature of the Case and Issue(s) Presented: Classen owns a patent directed to a method of obtaining and analyzing data on a commercially available drug to identify and commercialize new uses of the drug. Classen asserted that certain actions of Elan related to its sNDA for Skelaxin constituted infringement. After obtaining approval for Skelaxin, a muscle relaxant, Elan conducted additional clinical testing to revise its product label to reflect the significantly increase in bioavailability of Skelaxin when administered with food. It submitted these clinical data in an sNDA to the FDA. The district court found this activity did not constitute infringement under the safe harbor provision in § 271(e)(1).
Classen appealed, asserted that such actions were not covered by the safe harbor because they are routine post-filing activities. Elan argued that these activities were not routine as they were directed at obtaining approval for a change in the label. Classen also argued that Elan’s use of the data to identify patentable information and filing patent applications constituted infringement. Elan asserted that it did not re-analyze the data in order to identify potential patentable information or when submitting the patent applications. The Federal Circuit vacated the judgment of non-infringement and remanded.
Why Defendant Prevailed: The Federal Circuit first addressed the district court’s holding that Elan’s actions did not constitute infringement under the safe harbor provision in § 271(e)(1). Although in the post-approval context it may be less straightforward to determine whether an accused infringer’s use of a patented invention was “solely for uses reasonably related to the development and submission of information” under the FDCA, the Federal Circuit found that the statutory language did not categorically exclude post-approval activities from the ambit of the safe harbor. Indeed, under the FDCA, drug manufacturers may voluntarily, or sometimes may be required to, conduct post-approval studies on their products for purposes of further development and submission to the FDA. Just like NDA or ANDA applicants, sNDA applicants must submit relevant data to the FDA to support their applications. Thus, after the initial approval of a drug, its manufacturer may perform additional research to further characterize the drug and submit that information to the FDA for a labelling change. Thus, the Federal Circuit held that “such post-approval studies serve similar purposes as pre-approval studies in ensuring the safety and efficacy of approved drugs. As an integral part of the regulatory approval process, those activities are ‘reasonably related to the development and submission of information’ under the FDCA, 35 U.S.C. § 271(e)(1), and are therefore exempt from infringement liability.”
Applying this to Endo’s actions, the Federal Circuit found that after learning that the FDA proposed to change the designation of metaxalone tablets, Elan initiated its own clinical trial to characterize the effect of food on the absorption of Skelaxin and observed a significant increase in bioavailability when Skelaxin was administered with food. Elan submitted that information to the FDA to revise the Skelaxin product label and to propose changes to the approval requirements for generic versions of Skelaxin. Those activities were not “routine” post-approval reporting, and subject to the safe harbor.
Classen also argued that after Elan generated and submitted the clinical data to the FDA, its subsequent actions of re-analyzing the clinical data to identify patentable information and filing patent applications are commercial activities outside the scope of the safe harbor. When it granted summary judgment, the district court did not determine whether those post-submission activities constituted infringement of the ’472 patent or whether they were exempt under the safe harbor. Thus, the Federal Circuit vacated the judgment of non-infringement and remanded the case to the district court for further proceedings on the parties’ pending claims and counterclaims, including issues of validity, enforceability and infringement of the asserted patent. However, the Federal Circuit did provide guidance to the district court that the act of filing a patent is not an act of infringement generally, nor is it an act of commercialization. Likewise, the act of placing information on a label after obtaining approval from the FDA is not an act of infringement.
