JAPAN Trends and Developments Contributed by: Kenji Tosaki and Takahiro Hatori, Nagashima Ohno & Tsunematsu
Several notable IP litigation judgments and decisions were issued in the life sciences and pharma field in Japan in 2025. These included the 16th Grand Panel judgment of the IP High Court (“IPHC”) rendered on 19 March 2025 in Tokai Ika v an individual . The following cases can also be highlighted. • Samsung Bioepis Co., Ltd. v Regeneron Pharma- ceuticals, Inc . (IPHC Decision 13 August 2025). • Two judgments addressing the scope of a patent during its extended term: • Sawai Pharmaceutical Co., Ltd. v Bristol-Myers Squibb (Tokyo District Court Judgment 15 May 2025); and • Toray Industries, Inc. v Sawai Pharmaceutical Co., Ltd . , et al . (IPHC Judgment 27 May 2025). Samsung Bioepis Co., Ltd. v Regeneron Pharmaceuticals, Inc. Background The Japanese patent linkage system is not based on any specific statute but operates in accordance with a relevant administrative notice having no legal bind ‑ ing effect. Under this system, when the Ministry of Health, Labour and Welfare (“MHLW”) reviews a mar ‑ keting authorisation application for a follow-on drug (ie, a generic and biosimilar), it considers the relevant patents regarding the brand-name drug based on the information provided by the original drug company (ie, the brand-name drug manufacturer or patentee) in a “drug patent information report sheet” which is not generally made public. According to the relevant notice: • if the manufacture of the active ingredient of the brand-name drug is not possible due to the patent covering the active ingredient, marketing authorisa ‑ tion for a follow-on drug will not be issued; and • if a patent covers certain indications, or dosage 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 follow-on drug may be issued without the Indications, etc, covered by the patent. Given the relevant notice, when a marketing authorisa ‑ tion application for a follow-on drug is filed, the MHLW does not issue marketing authorisation if it believes
that the follow-on drug would infringe the relevant patents that cover the brand-name drug. Facts Bayer Yakuhin, Ltd., (“Bayer Yakuhin”) an affiliate of Bayer HealthCare LLC. and the marketing authori ‑ sation holder, started selling EYLEA solution for IVT inj. 40mg/mL (“Respondent’s Product”) in November 2012. Regeneron Pharmaceuticals, Inc. (“Regeneron”) owns Japan Patent No 6855480 (“the ‘480 Patent”) and Japan Patent No 7233754 (“the ’754 Patent”, and, collectively with the ‘480 Patent, “the Patents”). Claim 1 of the ’480 Patent covers a use of a VEGF inhibitor in the manufacture of a pharmaceutical composition for the treatment of a certain group of age-related macu ‑ lar degeneration (“AMD”) patients. Claim 1 of the ‘754 Patent covers a use of aflibercept in the manufacture of a pharmaceutical composition for the treatment of another group of AMD patients. Samsung Bioepis Co., Ltd. (“the Claimant”) devel ‑ oped a biosimilar correspondent to the Respondent’s Product (“the Claimant’s Product”). Global Regula ‑ tory Partners G.K. (“GRP”) filed a marketing authori ‑ sation application for the Claimant’s Product on 31 May 2023 as its agent of manufacture and distribution in Japan. When this application was filed, the word ‑ ing “age-related macular degeneration with choroidal neovascularisation in the subfoveal area” (“wAMD”) was included in the “indications and usage” section of the draft package insert for the Claimant’s Product. However, it was later removed from the package insert based on the MHLW’s comments. Upon GRP’s filing of the marketing authorisation application for the Claimant’s Product, Bayer Yakuhin provided the drug patent information report sheets regarding the Patents to the MHLW and a supplemen ‑ tal submission to the Pharmaceuticals and Medical Devices Agency (“PMDA”) in accordance with Regen ‑ eron’s instruction. In the supplemental submission, the following was stated: (i) “there is a concern that the ‘480 Patent will be infringed if the Eylea BS is approved for use with wAMD”; and (ii) “it is clear that it will infringe the ’754 Patent if the Eylea BS is approved for the indications and usage for wAMD”. Regeneron
120 CHAMBERS.COM
Powered by FlippingBook