JAPAN Trends and Developments Contributed by: Kenji Tosaki and Takahiro Hatori, Nagashima Ohno & Tsunematsu
tion surgery. In the course of the surgery (the “Surgery”), the Defendant (a) produced medi - cine by mixing (i) plasma from which the cel - lular component of blood taken from the recipi - ent was removed, (ii) “Fiblast® Spray”, which is a genetically modified trafermin product, (iii) “Intralipos®”, which is a fat emulsion, and other medicines, and (b) administered the medicine into the recipient’s chest by injection. Whether a single drug made by mixing all of (i) through (iii) was used, or whether two separates were used sequentially, is disputed between the parties. Judgment in the First Instance (Tokyo District Court, Judgment 24 March 2023, Case Number: 2022 (Wa) 30029) The Plaintiff sued the Defendant seeking com - pensation for damages, arguing that the act of manufacturing the above-mentioned medicine for use in the Surgery constitutes working of the patented invention (production of the patented product). The Tokyo District Court did not find that the Defendant prepared medicine containing cell- free plasma gel, trafermin, and Intralipos® at the same time and administered it to the recipient. Therefore, the Tokyo District Court dismissed the Plaintiff’s claim. The Plaintiff filed an appeal to the IP High Court. Procedure for calling for opinions from the third parties The IP High Court decided to call for opinions from third parties. The matters for which opin - ions are requested are as follows. • Should the Patent be invalidated through a patent invalidation trial on the ground that it was granted for “an invention lacking indus - trial applicability” (Article 29(1) of the Patent Act)?
• Does the Patented Invention fall under “a medicinal invention that is to be manufac - tured by mixing two or more medicines (medi - cine meaning a product used for diagnosis, therapy, treatment or prevention of human diseases) being mixed together” (Article 69(3) of the Patent Act)? • Assuming that the ingredients (i) through (iii) above fall under “autologous plasma”, “basic fibroblast growth factor (b-FGF)”, and “fat emulsion” of the patented invention respec - tively: (a) does the act of the Defendant, a phy - sician, instructing nurses or assistant nurses without issuing of a prescription to prepare the medicine (the “Mixed Medi - cine”) by mixing all of the ingredients (i) through (iii) together for use in the Surgery at the Clinic fall under “the act of prepara - tion of a medicine as per a physician’s or dentist’s prescription” (Article 69(3) of the Patent Act)? (b) can it be said that the effect of the patent right does not extend to the act of prepar - ing the Mixed Medicine by the Defendant, a physician, for some reason, while the act is closely related to medical treat - ment? (c) when the Defendant, a physician, uses in the Surgery a medicine containing the ingredients (i) and (ii) above, and another medicine containing the ingredient (iii) above separately in the Clinic and these ingredients (i) through (iii) are mixed in the body of the recipient, does the Surgery performed by the Defendant fall under a “production” of the “composition” per - taining to the patented invention? Comments This case is noteworthy because there have been only two cases where the Procedure for Calling
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