Classen Immunotherapies, Inc. v. Elan Pharmaceuticals, Inc.

The Supreme Court decision in Merck v. Integra, 125 S.Ct. 2372 (2005) left uncertainty as to the enforceability of research tools under 35 U.S.C. §271(e)1 . The Supreme Court commented in Footnote 7 on p. 2382 , “We therefore need not and do not-express a view about whether, or to what extent, 35 U.S.C. §271(e)1 exempts from infringement the use of “research tools” in the development of information for the regulatory process.” The CAFC has come to different conclusions on research tools used after marketing approval. Two CAFC panels arrived at opposite rulings (Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc., 686 F.3d 1348 (Fed. Cir. 2012) , (Momenta Pharm., Inc. v. Teva Pharm. USA, Inc., 809 F.3d 610, 620 (Fed. Cir. 2015. In the current case the two separate CAFC panels came to a different opinion on the applicability of Telectronics Pacing Sys. v. Ventritex, Inc., 982 F.2d 1520, 1523–24 (Fed.Cir. 1992) to a research tool. In the current case, in contrast to Momenta, the court ruled use of the research tool was “non-routine” and raises different questions than Momenta: 1.The CAFC has developed a litmus test to determine when 35 U.S.C. §271(e)1 applies to research tools used after marketing approval. The litmus test was introduce in Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057 (Fed. Cir. 2011) “The statute does not apply to information that may be routinely reported to the FDA, long after marketing approval has been obtained. Id at 1070 .” In subsequent cases including the current case the CAFC has struggled with defining what constitutes “non-routinely” reported and thus protected