District Court: Factual Disputes Preclude Application of Safe Harbor to Gene Editing Technology at the Pleading Stage

January 17, 2025Patent Litigation, Patent Law, Litigation, Food and Drug Administration (FDA)

The District of Delaware recently denied a motion to dismiss a patent infringement complaint involving gene editing technology that sought relief under the Safe Harbor Provision of the Hatch-Waxman Act. Specifically, the court found the patentee’s complaint sufficiently alleged at least some uses of the claimed technology that, when taken as true, were not solely uses of a “patented invention” that were “reasonably related” to an FDA submission.

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