Washington International Law Journal


The patent laws of the United States and Japan contain provisions that permit the experimental use of patented inventions. In the United States, the common law experimental use exception has been utilized to permit the use of a patented invention to satisfy intellectual curiosity, as long as the use is not commercial. In 1984, the Hatch-Waxman Act provided a statutory experimental use exception in 35 U.S.C. § 271(e)(1). It amended the Patent Act to allow a generic drug company to experiment with a pioneer drug during the pioneer drug's patent term to generate data for obtaining regulatory approval. In contrast, § 69(1) of the Japanese Patent Law provides for a general statutory experimental use exception that allows use of any patented invention for experiment or research. The general experimental use exception in Japan is much broader than the two experimental use provisions in the United States and permits more beneficial uses. The experimental use approaches taken in the United States have been problematic. To remedy these problems, the United States Congress has proposed several bills, each with differing breadth, which would protect additional types of experimental use or modify the Hatch-Waxman Act. No such reform has passed to date. This Comment argues that the United States may benefit from adopting a general statutory experimental use exception like Japan's. This Comment further argues that broadening the experimental use exception in the United States would not decrease the incentives created by the patent system. Furthermore, since the Japanese approach is more consistent with the patent systems of other countries, it facilitates patent harmonization better than the narrow exception provided in the United States.

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