Metaxalone - USA

On Oct 17, 2017, by Rule 36 judgment Federal circuit affirmed District court of Maryland’s decision (Sep 27, 2016) of non-infringement of U.S. Patent No. 6,584,472 in Skelaxin® (Metaxalone) under safe harbor  provision.

On May 13, 2015, the Federal Circuit vacated and remanded Judge Quarles’ 2012 judgment of non-infringement in favor of Elan. In its opinion remanding this case to this Court, the Federal Circuit concluded that “the district court correctly decided that § 271(e)(1) exempts Elan’s activities reasonably relating to developing clinical data on its approved drug Skelaxin® (“Skelaxin”) and submitting that information to the Food and Drug Administration (“FDA”) in a citizen petition and a supplemental new drug application (“sNDA”).” Classen, 786 F.3d at 894. However, the court also found that because Judge Quarles’ opinion did not address Plaintiff’s “assert[ion] that certain activities that occurred after the FDA submissions infringed the ‘472 patent and that those activities are not exempt under the safe harbor of § 271(e)(1),” remand was appropriate.

Accordingly, the sole question before the court was whether Elan’s “post-submission activities constituted infringement of the ‘472 patent or whether they were exempt under the safe harbor.” In its decision remanding this case to this Court, the Federal Circuit offered the following guidance with respect to Plaintiff’s claims:

1.       Filing a patent application is generally not an infringement of a patent. It is not the making, using, offering to sell, selling, or importing of an invention.

2.       Placing the information submitted to the FDA on the product label after sNDA approval generally cannot be an infringement. Information obtained from exempt activities does not cease to be exempt once the sNDA is approved.

Elan argued that summary judgment is appropriate because its allegedly infringing activities are protected by 35 U.S.C. § 271(e)(1)’s safe harbor provision. In its Opposition, Classen argues that Elan’s post-submission activities—that is, submission of clinical data to the FDA—are aimed at commercialization and thus, in Classen’s view, fall outside of the safe harbor of § 271(e)(1). The allegedly infringing activities are: (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.”

Court in view of Federal Circuit’s guidance said that Elan’s alleged “reanalyzing the clinical data to identify patentable information and filing patent applications,” and “making and selling Skelaxin with the revised label that contained the information derived from the clinical study” fall squarely within the safe harbor of § 271(e)(1). Therefore court granted defendant’s motion for Summary Judgment of Non-infringement (Classen Immunotherapies, Inc. v. Elan Pharms., Inc. , 2016 BL 318007, D. Md., No. 1:04-cv-03521-RDB, 9/27/16).