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Spring/Summer 1998

SHUSAKU YAMAMOTO is glad to present its seventh issue of I.P. Japan. This issue will discuss the series of revolutionary Osaka and Tokyo Court cases that have endorsed the view that clinical tests conducted by generic drug makers before the expiration of the patent right for the purpose of obtaining Japan's Ministry Health & Welfare (Koseisho) regulatory approval for the manufacture of medicines did not infringe the patent right as long as the generic drug was not marketed until after the patent had expired. The issue will also describe the recent Bill that was introduced to the Japanese Diet which had been de-toothed of its effectiveness in deterring patent infringement and a report on a new legal procedures on discovery of documents during patent litigation. We are sure that this issue of I.P. Japan will be of great interest to our clients & associates.

Issue Highlights

The Kyorin, Ono, Glaxo & Daiichi Cases
  • Generic drug makers' Koseisho clinical trials during patent term not patent infringement
  • A pro-public health policy interpretation adopted to experimental use exception
  • Cases harmonize Japanese law with US & German law - generic drug makers ' clinical trials are non-infringing acts
Important Litigation News
  • Treble Damages Idea Rejected
  • Discovery of Koseisho Documents May be Permissible

In This Issue

The Kyorin Case
The Ono Case
The Glaxo Case
The Daiichi Case -Facts & Judgement
The Old Hardline Position
The Synthelabo Nagoya Decisions
The Generics Strike Back
Japan Softens the Hardline
Alarm Bells are Ringing
US & EC position
Broader Health Policy Concerns
Patent Reform Bill Watered Down
Discovery of Koseisho Documents

I.P. Japan is only general information. For legal advice on Japanese IP matters, please write to us.
We also welcome any comments or suggestions on I.P. Japan.

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