JAPAN Trends and Developments Contributed by: Kenji Tosaki and Takahiro Hatori, Nagashima Ohno & Tsunematsu
for Opinions from Third Parties was implement - ed. In addition, there have not been many cases involving disputes over the interpretation and/ or application of “an invention lacking industrial applicability” (Article 29(1) of the Patent Act) or Article 69(3) of the Patent Act. This case is pending before the Grand Panel of the IP High Court. Note that at the IP High Court, cases are heard by a panel of three judges but in cases that address a particularly impor - tant issue, a Grand Panel of five judges over - see the proceedings and render the judgment. According to the website of the IP High Court, the Grand Panel of the IP High Court will render a judgment on 19 March 2025. Samsung Bioepis v Bayer HealthCare LLC. (Tokyo District Court Decision regarding Preliminary Injunction, 28 October 2024, Case Number: 2024 (Yo) 30029) Background Japan does not have a statutory patent linkage system. In other words, there is no statute requir - ing the health authority to consider whether there is any patent that may cover a generic or a bio - similar when determining whether to issue mar - keting authorisation of that generic or biosimilar. Even so, the health ministry of Japan, the Min - istry of Health, Labor and Welfare (the MHLW), does consider at its own discretion in practice. The MHLW relies on a letter (the “MHLW Let - ter”) which it issued to the prefectures stating that when reviewing a marketing authorisation application for a generic or a biosimilar: • if the manufacture of the active ingredient of the brand-name drug is not possible due to the patent covering the active ingredient, marketing authorisation for a generic shall not be issued; and
• if a patent covers certain indications, or dos - age and administration (“Indications, etc”) of the brand-name drug but it is possible to manufacture a drug with other Indications, etc, marketing authorisation for a generic or a biosimilar may be issued without the Indica - tions, etc covered by the patent. It should be noted that the MHLW Letter is an internal administrative document and does not have any legally binding effect. Based on the MHLW Letter, when a marketing authorisation application for a generic or a bio - similar is filed, the MHLW takes into account the relevant patents that cover the brand-name drug, and if the MHLW believes that the generic or the biosimilar would infringe the patents, the MHLW does not issue marketing authorisation. Facts Bayer HealthCare LLC. (the “Respondent”) owns the Japanese Patent No 7320919 titled “Treat - ment of age-related macular degeneration with a small active choroidal neovascularization lesion” (the “Patent”). The Patent was registered on 27 July 2023. Claim 1 of the Patent covers a phar - maceutical composition comprising aflibercept, as a VEGF inhibitor, for use in the treatment of a certain group of wet age-related macular degeneration (wAMD) patients. Bayer Yakuhin, Ltd, an affiliate of Bayer HealthCare, started selling EYLEA solution for IVT inj. 40mg/mL (the “Respondent’s Product”) in November 2012. Global Regulatory Partners GK (GRP) filed a marketing authorisation application for Afliber - cept intravitreal injection solution 40 mg/mL GRP (SB15) (the “Claimant’s Product”) as a biosimilar correspondent to the Respondent’s Product on 31 May 2023. The Claimant’s Product was to be produced by Samsung Bioepis (the “Claim -
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