Classen Immunotherapies, Inc. v. Elan Pharma., Inc., No. 14-1671 (Fed. Cir. 2015)Annotate this Case
Elan marketed metaxalone, a muscle relaxant, under the brand-name Skelaxin. Years after Skelaxin’s approval, Elan learned that another company conducted in vivo bioequivalence fasting studies and in vitro dissolution tests on metaxalone and that, based on the results, the FDA proposed to change the designation of metaxalone from “non bioproblem” to “bioproblem.” Elan initiated a study and observed a significant effect of food on bioavailability. Elan petitioned the FDA to require both fed and fasting data for any abbreviated new drug application for a generic version of Skelaxin and to revise its product label. The FDA granted both. Elan obtained patents based on its bioavailability data, which were later invalidated in light of prior art. Classen’s 472 patent is directed to a method for accessing and analyzing data on a commercially available drug to identify a new use of that drug, and commercializing that new use. Classen alleged that Elan infringed that patent when it studied the effect of food on Skelaxin’s bioavailability, used the data to identify a new use, and commercialized that use. The court entered summary judgment of noninfringement, finding Elan protected by the safe harbor provision of 35 U.S.C. 271(e)(1), for activities “reasonably related to the submission of information” under the Federal Food, Drug, and Cosmetic Act. During ex parte reexamination of the 472 patent, the PTO cancelled 107 of the 137 originally issued claims. The Federal Circuit affirmed with respect to the 271(e)(1) exemption, but remanded an allegation that activities that occurred after the FDA submissions infringed the 472 patent and were not exempt.