As an essential component of the drug development process, human clinical trials assist in determining whether a given drug will serve its intended purpose, but patent applicants should consider disclosure of such trials in their overall patent strategy. Disclosure of a protocol summary of the human clinical trial to the National Institutes of Health (“NIH”) is federally mandated. The NIH, in turn, must report information about the study publicly on ClinicalTrials.gov. The Federal Food, Drug, and Cosmetic Act labels failing to timely submit clinical study information to the NIH as a “prohibited act” that carries criminal and potential civil liability.
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