Classen Immunotherapies, Inc. v. Elan Pharmaceuticals, Inc., No. 2014-1671, 2015 U.S. App. LEXIS 7854 (Fed. Cir. May 13, 2015) (Reyna, CJ.). Click Here for a copy of the opinion.
Elan marketed and sold metaxalone tablets as a branded muscle relaxant called Skelaxin, after obtaining approval for its new drug application ("NDA"). Subsequently, the FDA proposed to change the designation of metaxalone from "non bioproblem" to "bioproblem" based on clinical studies conducted by a third party. (A "bioproblem" drug requires in vivo bioavailability and bioequivalence data for generic drug approval.) In response, Elan initiated its own clinical study and observed a significant effect of food on the metaxalone's bioavailability. Elan submitted a citizen petition requesting that the FDA require both fed and fasting bioavailability data for generic metaxalone, before approving any abbreviated new drug applications ("ANDAs") that reference Elan's NDA. Elan also submitted its clinical study report and a supplemental NDA to revise its product label. The FDA granted Elan's citizen petition and approved its supplemental NDA. Elan also obtained patent protection based on its clinical findings, but these patents were later invalidated.
Classen owns US Patent 6,584,472, which is directed to "a method for accessing and analyzing data on a commercially available drug to identify a new use of that drug, and then commercializing that new use." Classen sued Elan, alleging that Elan infringed the '472 patent "when it studied the effect of food on the bioavailability of Skelaxin, used the clinical data to identify a new use of the drug, and commercialized the new use." On summary judgment, the district court granted Elan's motion, holding that the safe harbor provision of §271(e)(1) protects Elan from infringement liability. Classen sought to vacate the court's summary judgment decision but was unsuccessful. On the parties' joint motion, the district court entered final judgment of noninfringement, and Classen appealed.
The safe harbor provision, 35 U.S.C. §271(e)(1) states, in part: "[i]t shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention ... solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs ...." Exemption from infringement "extends to all uses of patented inventions that are reasonably related to the development and submission of any information under the FDCA," regardless of whether the activity is pre or post-approval. Here, the Federal Circuit found that Elan's clinical study and FDA submissions were within the scope of §271(e)(1). Elan's activities were not "routine post-approval reporting" but were "necessary to the approval of both the brand-name and generic versions of Skelaxin."
Classen also argued that "reanalyzing the clinical data to identify patentable information and filing patent applications" constituted commercial uses by Elan that are not protected by the safe harbor. Since the district court did not address this issue, the Federal Circuit vacated the judgment of non-infringement and remanded. However, the Court provided some guidance. It pointed out that "[f]iling a patent is generally not an infringement of a patent" and does not constitute "commercialization" of an invention. Because Classen's claims require "commercialization," Elan likely did not infringe.
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