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Japan - Experimental Use Exception to Patent Infringement

In the case of Ono Pharmaceutical Co. Ltd. v. Kyoto Pharmaceutical Co. Ltd. the Japanese Supreme Court has held that it is not an infringement of a patent for a new chemical compound or a medicine for a third party to carry out any necessary testing that will be required to obtain approval to market a medicine containing the same active ingredient after the patent on it has expired. The Japanese Patent Law contains a specific provision excluding from infringement acts carried out for the purposes of experiment or research. The court reasoned that to read this exception narrowly so as to allow patentees to prevent experiments required to allow others to market a medicine that had been the subject of patent protection until after the patent had expired would have the effect of extending the effective life of the patent (Japanese Law already provides for an extension of the patent term for pharmaceutical inventions to compensate the patentee for the delay it has suffered in bringing its product to market as a result of the need to obtain marketing approval.) On the other hand the Supreme Court reaffirmed that any use beyond that strictly required for the purpose of securing marketing approval, such as manufacture and stockpiling of product prior to the patent expiration preparatory to a launch immediately after the patent's expiration, would be an infringement.


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© Copyright 1999 Ladas & Parry - Posted 10/11/1999
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