“[W]hether 35 U.S.C. § 271(e)(1) renders activities that would otherwise constitute patent infringement noninfringing if they are undertaken for the purpose of developing and submitting to the Food and Drug Administration (FDA) information necessary to obtain marketing approval for amedical device under § 515 of the Federal Food, Drug, and Cosmetic Act (FDCA).”
“On appeal, the Court of Appeals for the Federal Circuit [held] that by virtue of § 271(e)(1) respondent’s activities could not constitute infringement if they had been undertaken to develop information reasonably related to the development and submission of information necessary to obtain regulatory approval under the FDCA. . . . As far as the text is concerned, . . . we conclude that we have before us a provision that somewhat more naturally reads as the Court of Appeals determined, but that is not plainly comprehensible on anyone’s view. . . . We think the Court of Appeals’ interpretation is confirmed, however, by the structure of the 1984 Act taken as a whole.”
