Docket No. 2014-1671
PROST, LOURIE, GILSTRAP (DJ)
May 13, 2015
Update (October 17, 2017): DC grant of Elan’s Motion for SJ of noninfringement affirmed (DC 1:04-cv-03521-RDB; FC Docket No. 2017-1033). Classen “argued Elan’s post-submission activities” (“submission of clinical data to the FDA”, “reanalyzing 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”) “are aimed at commercialization and, therefore…fall outside the safe harbor of § 271(e)(1).” The DC explained, however, that “Momenta (FC 2012) “clarified that there is no pre/post FDA approval dichotomy under the safe harbor provision”. Further, it explained that “[t]he alleged acts of commercialization by Elan…appear…far less commercial’ in nature than those activities deemed protected in Telectronics” (FC 1992 (“subsequent disclosure or use of information obtained from an exempt clinical study” at a conference)).
Brief Summary: DC grant of SJ to Elan of noninfringement based on the safe harbor provision of § 271(e)(1) affirmed; noninfringement decision regarding post-filing activities vacated and remanded since the DC “did not determine whether those post-submission activities constituted infringement”.
Summary: Classen appealed DC grant of SJ to Elan of noninfringement of US 6,584,472 relating to Skelaxin (metaxalone) based on the safe harbor provision of § 271(e)(1). Classen argued Elan’s study of the effect of food on the availability of Skelaxin, used the clinical data to identify a new use, and commercialized that new use. The DC granted SJ of noninfringement based on the safe harbor exemption since Elan submitted the clinical data to the FDA in a citizen’s petition and a supplemental NDA (use was “reasonably related to the submission of information” under the FDCA). The opinion presents claim 36 as representative, which is directed to “[a] method for creating and using data associated with a commercially available product” including a “commercializing step” in which “a manufacturer or distributor of the product must inform consumers…about at least one new adverse event associated with exposure to or use of the product.” Kit claim 59 requires a “product and…documentation notifying a user…of at least one new adverse event relating to the product”. Under the law of the Fourth Circuit DC, the FC panel reviewed the grant of SJ de novo. The opinion explained that the § 271(e)(1) exemption “extends to all uses of patented inventions that are reasonably related to the development and submission of any information under the FDCA”, does not exclude “certain information…on the basis of the phase of research in which it is developed or the particular submission in which it could be included”, and is not limited to “only to those activities necessary for seeking approval of a generic version of a brand-name drug product” (Merck KGaA, US 2005) (“the statutory language does not categorically exclude post-approval activities from the ambit of the safe harbor” (Momenta, FC 2012)). It determined that “Elan’s clinical study and its FDA submissions clearly fall within the scope of the safe harbor” (“Elan initiated its own clinical trial…[and] submitted that information to the FDA to revise the Skelaxin product label and to propose changes to the approval requirements for generic versions…Those activities were any but ‘routine’ post-approval reporting [but] were ‘necessary’ to the approval of both the brand-name and generic versions….”) The DC grant of SJ on this point was therefore affirmed. Classen also argued that Elan’s reanalyzing of data after the FDA submissions were made should not be exempt. The FC panel explained that “the subsequent disclosure of use of information obtained from an exempt 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 not itself an act of infringement of the asserted claims” (Teletronics, FC 1992 (“the mere dissemination of data” is not identified by § 271(e)(1) as a potentially infringing activity)). Since the DC “did not determine whether those post-submission activities constituted infringement”, the judgment of noninfringement was vacated and remanded (noting that “[f]iling a patent application is generally not an infringement of a patent”, and neither is “placing the information submitted to the FDA on a product label after sNDA approval generally”).