JAPAN Trends and Developments Contributed by: Kenji Tosaki and Takahiro Hatori, Nagashima Ohno & Tsunematsu
The court then moved forward to determine whether the notification that a biosimilar corre - spondent to Eylea would constitute an infringe - ment of the Patent is a false statement, and concluded that it was a false statement because while the Patent covers a pharmaceutical com - position comprising aflibercept for use in the treatment of a certain group of wAMD patients, the Claimant’s Product does not specifically tar - get that specific group of wAMD patients and would not infringe the Patent. The court then proceeded to the determina - tion of whether there are special circumstances where the act is considered as seriously lack - ing reasonableness in light of the purpose and objective of the patent linkage system. The court pointed out the following. • It cannot be understood that the Respond - ent’s allegation that the Claimant’s Product infringes the Patent is totally unreasonable because the Claimant’s Product would be partly used for the treatment of the specific group of wAMD patients and there had been no Supreme Court precedent that makes the Respondent’s argument totally groundless. • There had been no court precedent which addressed whether the provision of informa - tion by a patentee, etc, under the patent linkage system in Japan falls under an “Unfair Competition” set forth in the UCPA. • Similar patent infringement actions had been filed worldwide in which the issue of whether a biosimilar infringes the Patent is disputed and this case is a part of the global dispute, so it was inevitable that the Respondent made the argument that the Claimant’s Prod - uct infringes the Patent to the MHLW and the PMDA.
Based on the above-mentioned analysis, the court concluded that “unless the Notification is repeatedly made in the future, it cannot be said that the Notification is considered as seriously lacking reasonableness in light of the purpose and objective of the patent linkage system, and the aforementioned special circumstances can - not be found.” Comments This decision is noteworthy because there had been no court decision addressing the issue handled by the court, ie, whether an act of a patentee pertaining to the brand-name drug providing a false response to the effect that a generic infringes the patent pertaining to the brand-name drug under the patent linkage sys - tem falls under an “Unfair Competition” set forth in Article 2(1)(xxi) of the UCPA. The Tokyo District Court set the criteria to handle the issue for the first time. However, it should be noted that this decision is that of the court of first instance and the upper court may make a different decision. As this issue is not widely discussed, it would be better to keep checking further discussions by scholars and practitioners.
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