Recent Tokyo District Court Decision: Does Patent Information Disclosure under Japan’s Patent Linkage System Violate the Unfair Competition Prevention Act?

Japan’s current patent linkage process for generics/biosimilars allows innovator-patent holders for innovative drugs to provide relevant patent information about active pharmaceutical ingredients to the regulatory authorities on a voluntary basis. This case involved an argument by Samsung Bioepis Co., Ltd. (“Samsung”), a generic/biosimilar company, that the provision by Bayer HealthCare LLC (“Bayer”), the patent holder and manufacturer of the innovative pharmaceutical product aflibercept, of information to the Ministry of Health, Labour and Welfare (MHLW) claiming that a Samsung biosimilar product infringed a Bayer patent (Japanese Patent No. 7320919) (“919 Patent”) constituted unfair competition under Article 2, Paragraph 1, Item 21 of the Unfair Competition Prevention Act (UCPA). Samsung sought a preliminary injunction to stop Bayer from providing information to the MHLW....To read the full article, please see the PDF file

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