Judicial Lawmaking and the Influence of Comparative Law
Edited by John O. Haley and Toshiko Takenaka
Chapter 5.1: A change of leadership in patent policy and law development? The active role played by Japanese courts in Japan’s patent term extension reform
In both developed and developing countries, the high cost of healthcare is a serious concern for both policy makers and the public. Because prescription drug costs account for a significant portion of healthcare expenditure, replacing brand-name drugs with their generic equivalents is an effective way to reduce healthcare costs. However, generic drug manufacturers are unable to market the bio-equivalent of a brand-name drug until the patents on the brand-name drug have expired. Marketing of drugs requires approval from a drug regulatory authority, which requires submission of certain data. Generic drug manufacturers cannot perform the clinical trials necessary to develop this data, which requires making and using the brand-name drug to establish bio-equivalency between the brand name and generic drug, until the patent on the brand-name drug expires. To expedite the entry of generic drugs into the market, the patent systems in the United States, Japan and member states of the European Union provide immunity for acts related to the development of data necessary for regulatory agency approval. Brand-name drug manufacturers continue to attempt to extend their market exclusivity in spite of immunity provisions. Brand-name drug manufacturers sue generic drug manufacturers that are performing clinical trials, claiming the generic drug manufacturers’ making and using patented drugs for alleged clinical trials are outside the scope of immunity. They also obtain additional patents on the technologies associated with soon-to-expire patents.
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