The patent at issue claimed 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.” Elan had FDA approval in an NDA for a drug called Skelaxin. Following approval, Elan learned of studies on the drug and it submitted a citizen petition to the FDA seeking new requirements for ANDA filers and submitted an sNDA seeking a labeling supplement. Elan also filed two patent applications based on data it had generated.
The Federal Circuit affirmed the district court’s grant of summary judgment of non-infringement on the grounds that Elan’s post-approval activities met the safe harbor requirements of Section 271(e)(1). The court held that Section 271(e)(1) was not limited to pre-approval activities so long as the activities were not routine post-approval reporting. Elan’s activities were not routine but were necessary to update the product label and change the approval process for generic versions of its drug. With respect to Elan’s activities to reanalyze data for the purpose of filing patent applications, the district court did not determine whether these acts constituted infringement or were exempt under the safe harbor provisions of Section 271(e)(1). The Federal Circuit vacated the judgment of non-infringement and remanded for further proceedings on the parties’ pending claims and counterclaims. The court noted, however, that the filing of a patent application is generally not an infringement of a patent, because it is not the making, using, offering to sell, selling, or importing of an invention.
Classen Immunotherapies, Inc. v. Elan Pharmaceuticals, Inc., Case No. 2014-1671 (May 13, 2015); Opinion by: Lourie, joined by Prost and Gilstrap (by designation); Appealed From: District Court for the District of Maryland, Quarles, J. Read the full opinion here.