On March 19, 2025, the Intellectual Property High Court of Japan, in the Grand Panel decision, issued its first ruling recognizing patent infringement due to a medical activity (Case No. 2023 (Ne) 10040).<\/p>\r\n
The patent invention in question is a \u201cbreast-augmentation composition\u201d containing three components: (1) autologous plasma, (2) basic fibroblast growth factor (b-FGF), and (3) fat emulsion (Patent Registration Number: 5186050<\/a>). It was alleged that the patent rights were infringed at a beauty clinic operated by the accused infringer.<\/p>\r\n In Japan, a medical activity is not subject to patent as it is considered \u201cnot industrially applicable\u201d (the so-called \u201cupstream regulation\u201d). On the other hand, unlike the United States, which has a general provision that a medical practitioner\u2019s performance of a medical activity is exempt from patent infringement (the so-called \u201cdownstream regulation\u201d, 35 U.S. Code \u00a7 287 (c)), Japan does not have such a provision. Instead, only the act of preparation of a medicine for medical purposes is exempt from patent infringement under Article 69, Paragraph 3 of the Patent Act [1]<\/a>.<\/p>\r\n The key points of the ruling are as follows:<\/p>\r\n The patent invention in question relates to a composition based on \u201cblood collection,\u201d but it does not constitute an invention of a medical method. It is industrially applicable, and the patent is valid.<\/p><\/li>\r\n The patent invention aims at aesthetic enhancement through breast-augmentation (cosmetic purpose) and does not fall under the act of preparation of a medicine for medical purposes as stipulated in Article 69, Paragraph 3 of the Patent Act. Therefore, the argument that the patent rights do not apply is unfounded.<\/p><\/li>\r\n<\/ol>\r\n In this ruling, it was confirmed that, except for cases falling under Article 69, Paragraph 3 of the Patent Act, \u201ceven a medical activity performed by a medical practitioner is not exempt from infringement of valid patent right related to an invention of a product.\u201d<\/p>\r\n\r\n