Post-Submission Use of FDA Clinical Data Did Not Constitute Infringement

Tuesday, October 25, 2016

The “safe-harbor” provision of 35 U.S.C. § 271(e)(1) allows a potential competitor to make, use, sell, or import certain inventions solely for uses related to the development and submission of information under a Federal law which regulates drugs or veterinary biological products.  The defendant argued that the safe harbor extended to certain of its activities that related to but occurred after it made its FDA submission – including identifying patentable information, filing patent applications, and revising product labels.  Judge Richard D. Bennett agreed with the defendant that there was no patent infringement, ruling that “the subsequent disclosure or use of information obtained from an exempt clinical study, even for purposes other than regulatory approval, does not repeal that exemption of the clinical study, provided that the subsequent disclosure or use is itself not an act of infringement of the asserted claims.” Classen Immunotherapies, Inc. v. Elan Pharms., Inc., No. RDB-04-3521, --- F.Supp.3d ---, 2016 WL 5390803 (D. Md. Sept. 27, 2016).