1. Introduction
 In this article, we introduce a case in which it was disputed whether a physician's act of preparing a mixed drug for breast augmentation surgery infringed another party's patent rights.
 In this case, which involved an invention related to a medical practice, various issues were raised, including patent eligibility and the scope of patent rights. The Intellectual Property High Court (hereinafter, referred to as the "IP High Court") upheld the claims of the rights holder, and judged that the doctor's act constituted an infringement of the patent right (IP High Court Case No. 2023 (Ne) 10040, decision rendered on March 19, 2025).

2. Summary of Case
 The Appellant (Plaintiff in the first instance) is the holder of Patent No. 5186050 (hereinafter, referred to as the "Subject Patent") directed to "composition for promoting an increase in subcutaneous tissue and subcutaneous adipose tissue." The Appellee (Defendant in the first instance) is a physician who provided aesthetic medical services, such as breast augmentation surgery, at the Appellee's own clinic.
 In the first instance, the Appellant claimed that the Appellee's act of mixing multiple drugs to prepare a single drug for use in breast augmentation surgery constituted an infringement of the patent right of the Subject Patent (hereinafter, referred to as the "Subject Patent Right"), and sought damages from the Appellee.
 The first-instance court rejected the Appellant's claims, holding that the Appellee had not prepared a drug that falls within the technical scope of the invention of the Subject Patent by mixing the multiple drugs (Tokyo District Court Case No. 2022 (Wa) 5905, decision rendered on March 24, 2023).
 The subject case is an appeal filed against this decision.

3. Subject Invention
 The patented invention at issue in this case is the invention of Claim 4, which is dependent on the invention of Claim 1 (hereinafter, referred to as the "Subject Invention"), and is defined as follows:
"A composition for promoting the increase of subcutaneous tissue, for use in breast augmentation, comprising autologous plasma, basic fibroblast growth factor (b-FGF), and a fat emulsion."

4. Acts of the Appellee
 The Appellee, a physician, established a clinic on June 10, 2019, and during a certain period until around October 2022, provided a surgical procedure referred to as "3WAY Plasma Breast Augmentation," which utilized "cell-free plasma gel" (hereinafter, referred to as the "Subject Procedure").
 The Subject Procedure involves producing "cell-free plasma gel" by collecting blood from the patient and centrifuging it to completely remove cellular components, mixing the cell-free plasma gel with "trafermin" (a growth factor), and "Intralipos" (an emulsifier), and then injecting the resulting mixture into the patient's breasts.
 It is not in dispute between the parties that, among the components of the drugs used by the Appellee in the Subject Procedure, "trafermin" corresponds to the "basic fibroblast growth factor (b-FGF)" of the Subject Invention and "Intralipos" corresponds to the "fat emulsion" of the Subject Invention.

5. Issues in Dispute
 In the subject case, even with regard to the issue of infringement alone, various points of contention were raised, as outlined below.

(Issues Related to Satisfaction of Constituent Elements)
► Does the "cell-free plasma gel" correspond to the "autologous plasma" of the Subject Invention? (Issue 1-1)
► Did the Appellee produce a composition by mixing plasma, trafermin, and Intralipos? (Issue 1-2)
► When the Appellee administers "Drug A," containing plasma and trafermin, and "Drug B," containing Intralipos, separately to the patient so that they are mixed in the patient's body, does the Appellee's act fall under "production" of the composition of the Subject Invention? (Issue 1-3)

(Issues Related to the Validity of the Subject Patent)
► Does the Subject Patent have grounds for invalidation due to violation of the requirements of industrial applicability (Article 29(1), Main Paragraph of the Patent Act)? (Issue 2-1)
► Does the Subject Patent have grounds for invalidation due to violation of the requirements of support (Article 36(6)(i) of the Patent Act)? (Issue 2-2)
► Does the Subject Patent have grounds for invalidation due to violation of the requirements of clarity (Article 36(6)(ii) of the Patent Act)? (Issue 2-3)

(Issues Related to Grounds for Defense)
► Can it be said that the effect of the Subject Patent Right does not extend to the Appellee's act by virtue of the exemption provision for working of the invention for experimental or research purposes (Article 69(1) of the Patent Act)? (Issue 3-1)
► Can it be said that the effect of the Subject Patent Right does not extend to the Appellee's act by virtue of the exemption provision for acts of preparation of medicines (Article 69(3) of the Patent Act)? (Issue 3-2)

6. Court's Judgment
 As this case concerns an infringement lawsuit involving an invention related to medical practice, particular attention was drawn to the court's determinations on Issue 2-1 and Issue 3-2. The following section mainly discusses the court's determination on these issues.

(1) Issue Concerning Industrial Applicability (Issue 2-1)
 The Appellee argued as follows: Production of the composition of the Subject Invention requires collecting blood from the patient, and the composition is intended to be administered to the patient. Based on this, the Subject Invention, which inherently presupposes a medical practice before and after its implementation, does not constitute an "industrially applicable invention" under the main paragraph of Article 29(1) of the Patent Act, and therefore should not be eligible for patent protection. Accordingly, the Subject Patent is invalid.

(Reference) Article 29(1), Main Paragraph of the Patent Act
"A person that invents an invention with industrial applicability may obtain a patent for that invention, unless the invention is as follows."

 In response, the IP High Court stated as follows:
-"The main paragraph of Article 29(1) of the Patent Act does not expressly provide that substances to be administered to the human body, including compositions such as the one in the Subject Invention intended for use in breast augmentation, are excluded from the scope of the patentable subject matter."

-"In light of the background of the revision of the Patent Act in 1975, it should be regarded as clearly established that even inventions of pharmaceuticals intended to be administered to the human body are eligible for patent protection."

- "Act of producing pharmaceutical products or the like using materials collected from humans as raw materials are not necessarily conducted by physicians, and blood collection, the production of the composition, and administration thereof to the patient cannot always be regarded as inseparable acts."

- "Rather, considering recent circumstances with dramatic progress in advanced medical technologies such as regenerative medicine and gene therapy, it should be recognized that technological advancements, such as production of pharmaceutical products or the like using materials collected from humans as raw materials, are significantly supported not only by physicians but also by research and development in the pharmaceutical industry and other industries. Therefore, it is recognized that there is a need to allow patent protection in order to promote technological advancement."

- "The fact that a substance is produced using materials collected from a human and is intended to be ultimately returned into that same human body cannot be grounds for regarding the invention of the substance as a ‘method invention,' or regarding it not eligible for ‘industrially applicable invention' as a series of acts constitute a medical practice."

Based on such reasoning, the IP High Court concluded that the Subject Invention constitutes an "industrially applicable invention."

(2) Issue Concerning the Applicability of the Exemption Provision for Acts of Preparation of Medicines (Issue 3-2)
 The Appellee argued as follows: The Subject Invention related to aesthetic medical treatment falls under an "invention of a medicine that is to be manufactured by two or more medicines being mixed together" (Article 69(3) of the Patent Act). Further, the Appellee's act constitute a lawful act of preparation of a medicine carried out in accordance with medical regulations. Therefore, the Subject Patent Right does not extend to the Appellee's act.

(Reference) Article 69(3) of the Patent Act
"A patent right for an invention of a medicine (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 an 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."

 In response, the IP High Court stated as follows:
- "The composition of the Subject Invention is intended ‘for use in breast augmentation,' and its primary purpose lies in aesthetics. Even in light of current social norms, the composition of the Subject Invention cannot be regarded as a substance intended for diagnosis, therapy, treatment, or prevention of human diseases."

- "It is difficult to regard a condition requiring breast augmentation surgery, which is primarily for aesthetic purposes, as a ‘disease' in the ordinary sense of the word, and it is likewise difficult to consider a composition for breast augmentation as a ‘substance used for diagnosis, therapy, treatment, or prevention of human diseases.'"

- "The gist of Article 69(3) of the Patent Act is to ensure, from the perspective of the public interest in the smooth execution of medical practice, that a physician's choice is not hindered by patent rights."

- "With regard to the selection of drugs for use in breast augmentation surgery according to the Subject Invention, such public interest cannot be readily recognized, and no substantive reason can be found to justify special protection from the exercise of patent rights while departing from the ordinary meaning of the term ‘disease.'"
- "The Subject Invention does not fall under an ‘invention of a medicine that is to be manufactured by two or more medicines being mixed together.'"

Based on such reasoning, the IP High Court held that the effect of the Subject Patent Right extends to the Appellee's acts.

(3) Other Issues
 With respect to Issue 1-1, the term "autologous plasma" was interpreted based on the descriptions in the specification of the Subject Patent and the Appellant's arguments during the prosecution history, and it was determined that the "cell-free plasma gel" produced in the Subject Procedure corresponds to the "autologous plasma" of the Subject Invention.
 Regarding Issue 1-2, based on the content of advertisements by the Appellee's clinic, documents distributed to patients, and entries in the drug preparation notes created at the clinic, the court made a factual finding that the Appellee had "manufactured" a composition by mixing plasma, trafermin, and Intralipos.
 Since the court made the above findings on Issues 1-1 and 1-2 and recognized that the constituent elements were satisfied, the Appellant's alternative claim lost its significance. As a result, the court did not render a judgment on Issue 1-3 (i.e., whether administering a two-component drug and a one-component drug separately to the patient constitutes the "production").

7. Our Comments
 This case is significant in that it has demonstrated acts related to "aesthetic medicine," which are aimed at beauty or improvements of appearance, differ from "medical practice" in the intrinsic sense (i.e., diagnosis, therapy, treatment, or prevention of human diseases) and can constitute patent infringement.
 In recent years, the aesthetic medical market has been rapidly growing, driven by technological innovation and increasing consumer interest in beauty. The court's decision recognizing that patent rights may extend to acts related to aesthetic medicine suggests that, from the standpoint of rights holders, there may be expanding business opportunities in this field in Japan. On the other hand, from the standpoint of medical institutions that provide aesthetic medical services, attention should be paid to the growing necessity of implementing careful measures to avoid legal risks.

End of Article