IP Litigation Newsletter – April 2024 | BakerHostetler

The safe harbor exception in 35 U.S.C. § 271(e)(1) applies “solely for uses reasonably related to the development and submission of information” to the Food and Drug Administration (FDA). The Federal Circuit interpreted the word “solely” as modifying “for uses,” finding that “for each act of infringement the safe harbor is available only for acts or uses that bear a reasonable relation to the development and submission of information to the FDA.” Edwards Lifesciences Corp. v. Meril Life Scis. Pvt. Ltd., — F.4th —, 2024 WL 1243032 (Fed. Cir. Mar. 25, 2024) (Stoll, J., joined by Cunningham, J.). “It is not that the use must only be reasonably related to the development and submission of information to the FDA.” Dissenting, Judge Lourie stated, “I believe that ‘solely’ creates a safe harbor only for uses, sales, and importations that solely are for, as the statute says, development of information for the FDA.”

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