Classen Immunotherapies, Inc. v. Elan Pharms., Inc.

Reanalyzing clinical data to identify patentable information and filing patent applications as well as making and selling a drug with a revised label reflecting the information derived from that clinical study falls into the § 271(e)(1) safe harbor provision and does not infringe as a matter of law.

October 25, 2016

GENERICally Speaking

Case Name: Classen Immunotherapies, Inc. v. Elan Pharms., Inc., Case No. RDB-04-3521, 2016 U.S. Dist. LEXIS 131964 (D. Md. Sept. 27, 2016) 

Drug Product and Patent(s)-in-Suit: Skelaxin® (metaxalone); U.S. Patent No. 6, 584,472 (“the ’472 patent”)

Nature of the Case and Issue(s) Presented: The district court received the case on remand from the Federal Circuit. The Federal Circuit had agreed with the district court’s conclusion of non-infringement because Elan’s activities were encompassed by the safe-harbor provision of § 271(e)(1) as relating to developing clinical data and submitting those data in an sNDA to the FDA. Because the district court did not consider activities—“(1) reanalyzing the clinical data to identify patentable information and filing patent applications; and (2) making and selling Skelaxin with the revised label that contained the information derived from the clinical study”—that occurred after the submission to the FDA, however, the Federal Circuit remanded the case for further proceedings. The court granted Elan’s motion for summary judgment of non-infringement.

Why Elan Prevailed: The court determined that both post-FDA submission activities fell within the scope of the § 271(e) safe harbor. In remanding the case, the Federal Circuit advised that, generally, filing a patent application is not infringement of a patent, nor is it an act of infringement when placing information submitted to the FDA on a product label after submitting an sNDA. Classen failed to provide any evidence that those general principles were inapplicable in this case. Elan’s post-FDA submission acts were not of a sufficiently commercial nature to form a basis for infringement. Thus, as a matter of law, Elan did not infringe Classen’s patent.

In addition, Classen provided no evidence that the reanalysis was for commercial purposes. Accordingly, even if the Elan could infringe as a matter of law, Classen failed to demonstrate that there was a genuine issue of material fact relating to infringement.

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