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NIH is issuing an Intramural Research Program (IRP) policy to promote access to IRP-supported inventions resulting in drugs, biologics, vaccines, or devices. As of June 1, 2025, organizations applying to NIH for certain commercial patent licenses will be required to submit Access Plans to NIH
In Merck KGaA v. Integra Lifesciences I, Ltd., 125 S. Ct. 2372 (Jun. 13, 2005), the Supreme Court considered the scope of the exemption from patent infringement embodied in 35 U.S.C. § 271(e)(1). Under §271(e)(1), also referred to as the safe harbor provision, "[i]t shall not be an act of