IP High Court of Japan Issues Landmark Ruling on Patent Infringement due to Medical Activity

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).

The patent invention in question is a “breast-augmentation composition” containing three components: (1) autologous plasma, (2) basic fibroblast growth factor (b-FGF), and (3) fat emulsion (Patent Registration Number: 5186050). It was alleged that the patent rights were infringed at a beauty clinic operated by the accused infringer.

In Japan, a medical activity is not subject to patent as it is considered “not industrially applicable” (the so-called “upstream regulation”). On the other hand, unlike the United States, which has a general provision that a medical practitioner’s performance of a medical activity is exempt from patent infringement (the so-called “downstream regulation”, 35 U.S. Code § 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].

The key points of the ruling are as follows:

1. The patent invention in question relates to a composition based on “blood collection,” but it does not constitute an invention of a medical method. It is industrially applicable, and the patent is valid.
2. 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.

In this ruling, it was confirmed that, except for cases falling under Article 69, Paragraph 3 of the Patent Act, “even a medical activity performed by a medical practitioner is not exempt from infringement of valid patent right related to an invention of a product.”

[1] Article 69, Paragraph 3 of the Patent Act

A patent right for a medical invention (medicine meaning a product used in the diagnosis, therapy, treatment or prevention of human diseases; hereinafter the same applies in this paragraph) that is to be manufactured by two or more medicines being mixed together or for the invention of a process by which a medicine is manufactured by two or more medicines being mixed together has not effect against the act of preparation of a medicine as per a physician’s or dentist’s prescription nor against medicine prepared as per a physician’s or a dentist’s prescription.