JAPAN Trends and Developments Contributed by: Kenji Tosaki and Takahiro Hatori, Nagashima Ohno & Tsunematsu
responded to the MHLW’s inquiries through Bayer Yakuhin, saying: (iii) “the sale of the Eylea BS with the same description in the package insert as Eylea will constitute an infringement of the Patents” (statements (i)–(iii) are collectively referred to as “the Statements”). The Claimant filed a preliminary injunction applica ‑ tion with the court, seeking to enjoin Regeneron from notifying the MHLW and PMDA that the Claimant’s Product would infringe the Patents. The Claimant argued that the notification of the Statements consti ‑ tutes unfair competition because this was an act of making or disseminating false statements that would harm the credibility of a business competitor (ie, the Claimant) (Article 2 (1)(xxi) of the Unfair Competition Prevention Act (“UCPA”)) and hurt the Claimant’s busi ‑ ness interests. Decision of the Tokyo District Court The court dismissed the Claimant’s preliminary injunc ‑ tion application on 16 December 2024. It ruled that, even if a patent holder’s statements could be tech ‑ nically considered “false statements that harm the business credibility of a business competitor” under Article 2 (1)(xxi) of the UCPA, the act of making such statements is a legitimate act that is expected under the patent linkage system and should not be consid ‑ ered unlawful when considered reasonable in light of the purpose of providing information on drug patents under the patent linkage system. The court concluded that the notification of the Statements by Regeneron was considered a legitimate act given the facts in the case. Decision of the IPHC The Claimant filed an appeal against the Tokyo District Court’s decision. The IPHC dismissed the appeal for the following reasons. The IPHC stated that “business credibility” under Arti ‑ cle 2 (1)(xxi) of the UCPA means the reputation of a business operator and its economic value in the mar ‑ ketplace, which may affect decisions of others regard ‑ ing whether to engage in transactions with such busi ‑ ness operator, given the UCPA’s objectives.
On the other hand, the IPHC found that: • matters relating to marketing authorisation for a pharmaceutical product correspond to administra ‑ tive activity to be handled by the minister of the MHLW under authority granted by the Pharma ‑ ceuticals and Medical Devices Act to ensure the quality, efficacy and safety of medicines and to prevent the occurrence and spread of illness and injuries that may arise from their use, and thus is clearly different by nature from transactions in the marketplace; • requesting the holder of the substance patent and/ or a use patent to submit drug patent information report sheets and make supplemental submissions in case of necessity in relation to a brand name drug is considered an information-gathering act preceding administrative activities; in that regard, it did not appear that the MHLW or the PMDA would form a view as to a business operator’s economic value in the market with respect to applicants for the marketing authorisation; and • considering that the minister of the MHLW makes decisions, by virtue of their authority and responsi ‑ bility, taking into account not only the information provided by patent holders but also all relevant circumstances, and the fact that such information is generally not made public, it could not be said that such information would be disseminated to the market and thereby potentially harm the reputa ‑ tion of the applicant as a business operator or its economic value in the market. Based on the above, the IPHC concluded that the provision of information of a potential infringement of the brand-name drug patents by the manufacture and sale of its follow-on drug by the brand-name drug patent owner to the MHLW and PMDA is not con ‑ sidered to constitute making or disseminating false statements that harm the business credibility of a business competitor, and, therefore, the notification of the Statements is not regarded as unfair competi ‑ tion under Article 2 (1)(xxi) of the UCPA. Comments This IPHC’s decision is noteworthy because, accord ‑ ing to the decision, there is no possibility that the pro ‑ vision of information on the relevant patents regard ‑
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