Washington International Law Journal


With the passage of the Drug Price Competition Act of 1984 in the United States, the recent German Supreme Court decision allowing for experimental use of patented pharmaceuticals, and indirectly through the adoption of the Supplemental Protection Certificate in Europe, Japan seems to be the lone large pharmaceutical market which does not allow in some way for the experimental use of patented drugs to gain regulatory approval for a generic equivalent. Japanese generic pharmaceutical manufacturers had, until recently, operated under the assumption that the testing of a generic equivalent to a patented drug to gain regulatory approval was allowable as long as the drug was not marketed until after the patent had expired. This assumption proved incorrect in a recent Nagoya District Court decision, which essentially relied on the logic of an earlier decision to find that pre-patent experimental use for commercial exploitation is not allowable under the Japanese Patent Law. However, with Japan's society graying more rapidly than many other industrialized nations, the Ministry of Health and Welfare has taken a hard look at generic pharmaceuticals as a mechanism for reducing health-care costs. The favorable view that generic pharmaceuticals are receiving from the Ministry of Health and Welfare combined with the move toward greater transparency between the government and industry leads to the logical conclusion that the Ministry of Health and Welfare, through the Diet, will likely propose a change to the Japanese Patent Law which would allow for the pre-patent expiry testing of generic pharmaceutical equivalents. While there are drawbacks to such an experimental use doctrine, the long term benefits are many. From helping a Yen-conscious government reduce health-care costs to bolstering domestic pharmaceutical innovation by fostering greater competition, an experimental use allowance for generic pharmaceuticals is right for Japan.

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