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Authors

Tara Stuart

Abstract

The U.S.S.C. expanded the scope of the Hatch-Waxman Act’s safe harbor provision in Merck III to include protection for infringing use of any type of invention as long as a researcher intended to perform research reasonably relevant to FDA approval. This broad interpretation is inconsistent with the legislative intent of the Hatch-Waxman Act, and the policies of the U.S. patent system. Many patent owners may unnecessarily experience such a reduction in their property rights as to constitute a regulatory taking. The proposed narrow interpretation would rectify the constitutional problems and inconsistencies in infringement exemptions. Section 271(e)(1) should apply only to the invention studied, and even then, “solely” for the limited purpose of obtaining FDA approval. This approach would allow courts to balance the need for safe and effective drug equivalents with the right of the patent owner to the exclusive use of his invention in addition to promoting the progress of science.