Acts After Regulatory Submission Do Not Enjoy Blanket Protection Under the Section 271(e)(1) Safe Harbor


Classen Immunotherapies, Inc. v. Elan Pharmaceuticals, Inc., ___F.3d ___ (Fed. Cir. May 13, 2015) (Prost, LOURIE, Gilstrap) (D. Md.: Quarles) (3 of 5 stars)

Federal Circuit vacates judgment of noninfringement.

Classen's patent claims methods for analyzing data on a commercially available drug to identify new uses, and then commercializing such uses. In 2001, Elan initiated a study of its own approved drug Skelaxin to assess whether its bioavailability was affected by administration with or without food. After the study indicated that administration with food increased absorption, Elan made various submissions to the FDA and obtained approval to supplement Skelaxin's label. In late 2001 and early 2002, Elan filed patent applications relating to its clinical results. It subsequently sold Skelaxin according to the supplemented label.

The district court correctly found that Elan's study and its submissions to the FDA could not infringe because they were within section 271(e)(1)'s safe harbor for preparing and transmitting regulatory submissions. It did not matter that they occurred after initial approval—they served the same function of ensuring safety and efficacy as pre-approval studies, and they were necessary to approval of the label change.

However, the district court erred in failing to determine whether other acts (e.g., filing patent applications and selling Skelaxin under its new label) were themselves infringement. Unlike Telectronics Pacing Sys. v. Ventritex, Inc., 982 F.2d 1520 (Fed. Cir. 1992), which held that subsequent use or dissemination of information from an exempted clinical study was permissible because it was not itself a possible act of infringement, here, Classen alleged that the acts here were themselves infringements. A remand was thus necessary to consider this issue, although the Federal Circuit observed that the filing of a patent application is "generally not an infringement of a patent," nor is (without more) placing information on a product label following FDA approval of a label supplementation. Slip op. at 12.