Dr Malcolm AbelPreclinical Studies and the Federal Food, Drug, and Cosmetic Act of 1938: Application of the Reasonable Relation Requirement.
Recently, the U.S. Supreme Court decided that patented drugs could be used in preclinical studies without permission of the holder of the patent. The question before the Court was how long a competitor in drug development could continue to experiment with patented drugs in what would otherwise be infringing activities without incurring liability for that infringement? This paper considers whether this case expands the definition of the fair use exception, whether this ruling will have a material effect on drug research, and, if the effect of this case on the drug application process constitutes a significant economic benefit.
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