In a May 13, 2015 decision, the Federal Circuit agreed with the district court’s conclusion that certain post-FDA-approval submissions did not infringe Classen Immunotherapies’ business method claims because they were protected by the safe harbor provision of § 271(e)(1). Nevertheless, the court vacated the judgment of noninfringement and remanded the case to allow the district court to determine whether other post-submission activities infringed the patent. The asserted claims cover a method for identifying a new use for an existing drug and commercializing that new use. Classen accused Elan Pharmaceuticals of infringing the claims by submitting a supplemental new drug application (sNDA) to the FDA reflecting the results of a clinical trial studying the effect of food on the absorption of Elan’s Skelaxin muscle relaxant, as well as engaging in other post-submission activities. The district court determined that Elan’s conduct was protected under § 271(e)(1) because it was “solely for uses reasonably related to the development and submission of information” to the FDA, and granted summary judgment of noninfringement. With respect to Elan’s sNDA submission, the Federal Circuit agreed with the district court. The court observed that the safe harbor in § 271(e)(1) “extends to all uses of patented inventions,” and is not limited to activities related to seeking approval of a generic version of a drug. Noting that “post-approval studies serve similar purposes as pre-approval studies in ensuring the safety and efficacy of approved drugs,” the court determined that Elan’s post-approval sNDA submission was covered by § 271(e)(1). But the Federal Circuit found that certain other accused activities—namely Elan’s filing of patent applications and its revision of the Skelaxin label—were not necessarily exempt, and reversed the district court’s summary judgment of noninfringement. The court reasoned that, while FDA submissions and the dissemination of information learned in exempt clinical studies are clearly protected under the safe harbor provision, post-submission activities are not necessarily exempt. Accordingly, the court remanded the case so that the district court could determine if Elan’s non-submission related activities constituted infringement. Although it left the issue for the district court to determine, the Federal Circuit observed that filing patent applications and placing information submitted to the FDA on product labels are not generally considered to be infringing conduct.
Classen Immunotherapies, Inc. v. Elan Pharm., Inc., 2014-1671 (Fed. Cir. May 13, 2015)