In a lawsuit where the plaintiff, as the patent holder, sought damages from the defendant for patent infringement, the defendant argued that the invention covered by the plaintiff's patent involved medical practice both before and after its manufacturing process and thus lacked industrial applicability, that the defendant's act of manufacturing a breast augmentation composition is subject to the limitations on the effect of the patent right under Article 69 paragraph (3) of the Patent Act (“Article 69 (3)”) regarding the preparation of a medicine, and that the defendant's manufacturing act, which involves mixing two pharmaceuticals within the patient's body, does not constitute “production” as an act of working the invention. The Tokyo District Court, as the first instance, dismissed the plaintiff's claims, found that the defendant's composition manufacturing act could not be established. However, in the judgment of the IP High Court, which is the appellate court, the IP High Court recognized the defendant's manufacturing act, rejected all of the defendant's arguments, and partially granted the claim for damages (IP High Court Judgment, March 19, 2025 (Case No. 2023 (Ne) 10040)).
Summary of the case
This case concerns a patent infringement lawsuit over Patent No. 5186050 (the “Patent”). The plaintiff-appellant (Tokai Medical Co., Ltd., the “Plaintiff”) sought damages (100 million yen and delay damages) from the defendant-appellee (Doctor Y, the “Defendant”), alleging infringement of the above patent right by the act of the Defendant to manufacture a pharmaceutical agent used in “blood breast augmentation mammoplasty” provided at the cosmetic clinic managed by the Defendant.
The court of first instance found that it could not be established that the Defendant manufactured the composition containing all three components (the “Composition”) disclosed in the patented invention (the “Invention”) simultaneously, and thus the manufacturing by the Defendant did not fall within the technical scope of the Invention. It therefore denied patent infringement.
The Plaintiff appealed this decision to the IP High Court. In consequence, the IP High Court reversed the fact-findings regarding the Defendant's activities to manufacture the Composition and found patent infringement to have occurred.
Details of the Invention
(1) Summary of the Invention
The Invention is a “composition for breast augmentation” comprising the following three components: autologous plasma; a basic fibroblast growth factor (b-FGF); and lipid emulsion.
(Hereinafter, autologous plasma, b-FGF, and lipid emulsion shall be referred to as Components ➀ through ➂, respectively.)
(2) Technical Significance of the Invention
Various methods have existed for cosmetic breast augmentation, such as injecting silicone gel, breast implants using silicone gel bags, fat grafting surgery, and hyaluronic acid injections. However, each method has faced challenges such as the risk of complications, sequelae, and health hazards.
Recently, a breast augmentation technique combining leucocyte-containing plate rich plasma (PRP) and a growth factor (GF), and injecting the mixture of them has been proposed. However, the amount of plasma separable as PRP from collected blood is insufficient for practical breast augmentation.
Given the abovementioned circumstance, the present invention focuses on plasma, the liquid component making up half of the blood components. It combines plasma with b-FGF among growth factors and injects the combination into the subcutaneous tissue of the breast. The defining feature of the Invention is the discovery that the above combination effectively promotes the accumulation and enlargement of adipose tissue in the subcutaneous breast area by combining the effects of a lipid and b-FGF, thereby achieving a breast augmentation effect.
(3) Correspondence with the Defendant's Act
The Defendant opened a clinic (the “Clinic”) and offered an operation called “3-WAY blood breast augmentation” (the “Operation”) using “cell-free plasma gel” at the Clinic. The Defendant claimed to have administered the Agent A (the “Agent A”), a mixture of “cell-free plasma gel” and Trafermin (brand name: Fiblast) and the Agent B (the “Agent B”), consisting of Intralipos, separately to the patients. The “cell-free plasma gel” corresponds to Component ➀ (disputed), Trafermin corresponds to Component ➁, and Intralipos corresponds to Component ➂.
First Instance Judgment
In the first instance, the dispute centered on whether the Defendant manufactured the Composition containing all Components ➀ through ➂. Based on documents regarding the monitor treatment provided by the Defendant and the existence of a consent form given to the patient, it was acknowledged that the Defendant administered abovementioned Components ➀ to ➂ to the patient. However, based on facts asserted by the Plaintiff, such as the Defendant's website descriptions and the lack of explanation regarding separate administration of the agents, the court found it could not be established that the Defendant administered a pre-mixed formulation containing all three Components ➀ to ➂. Consequently, the court determined that the Defendant did not manufacture a pharmaceutical agent satisfying all the requirements of the Invention.
In response, the Plaintiff added the argument that mixing the Agent A and the Agent B, composed of Components ➀ to ➂ within the patient's body, also constituted “production,” and appealed to the IP High Court.
The IP High Court Judgment
The IP High Court organized the issues concerning the fulfillment of constituent features, the validity of the patent, and the limitation of the patent right. Among these, the court specifically addressed: whether the Invention, which involves medical practice before and after the manufacturing process of the Composition, lacks the industrial applicability requirement (Issue 1), whether the Defendant's actions fall under Article 69 (3) of the Patent Act, thereby excluding them from the scope of the Patent (Issue 2), and whether administering multiple components separately to a patient and mixing them within the patient's body constitutes the “production” of the Composition (Issue 3).
The IP High Court overturned the first instance judgment finding that the Defendant actually did manufacture a pharmaceutical agent simultaneously containing Components ➀ to ➂ before injunction to the patient and thereby, affirmed patent infringement.
As to the issues addressed by the court, the decision stated as follows:
(1) Industrial Applicability (Issue 1)
The Composition requires drawing blood from the patient, using it to manufacture the Composition, and then administering it into the patient’s body. The court states:
Given that the 1975 amendment of the Patent Act clarified that even an invention of a medicine can be patented, it is difficult to construe that the "invention that is a product" is substantively an "invention that is a process" targeting medical practice, and that it does not constitute an "invention with industrial applicability," only based on the fact that it is intended to be administered to the human body.
In addition, an act of manufacturing a medicinal product, etc., by using an ingredient collected from a human is not necessarily conducted by a doctor. Furthermore, development of such technologies greatly owes to not only doctors, but also research and development in the pharmaceutical industry and other industries, and such technologies can be used for maintaining or recovering humans' lives or health. Therefore, it is necessary to allow the protection of such technologies by patents in order to promote their development. Thus, with regard to an invention that is a product which uses an ingredient collected from a human and which is intended to be finally returned inside the body of that human, it cannot be said that this invention, due to such intended use thereof, substantively constitutes an "invention that is a process," or that it does not constitute an "invention with industrial applicability" because it is medical practice if it was regarded as a series of acts.
The court thus ruled, recognizing the industrial applicability of the Invention.
(2) Applicability of Article 69 (3) (Issue 2)
Regarding the issue of whether the Defendant's manufacturing activities within the Clinic fall under Article 69 (3), thereby falling outside the scope of the patent rights, the court states:
In light of the statements in the description, etc., the composition relating to the Invention is to be used for breast augmentation, and the purpose of the breast augmentation is primarily regarded to be aesthetic. In addition, even if the current social norm is taken into account, the composition relating to the Invention is not found to be a "product used for any of the purposes of the diagnosis, therapy, treatment, or prevention of human diseases". Accordingly, the Invention does not constitute "a medical invention that is to be manufactured by two or more medicines being mixed together" under Article 69 (3).
The gist of the Article 69 (3) introduced upon the law amendment in line with deletion of the provision concerning an "invention of a medicine” that had not been able to obtain a patent is that it should be ensured that the selection by a doctor would not be obstructed by a patent right, from the viewpoint of realizing the public interest of smooth implementation of medical practice. However, at least with regard to the selection of the pharmaceutical agent to be used in the breast augmentation operation relating to the Invention, such public interest cannot immediately be found, and as mentioned above, it should be said that no practical reason can be found to deviate from the general meaning of the term "disease" and specially protect such act from exercise of the patent right.
The court thus ruled, denying the application of Article 69 (3) without examining whether the Defendant’s act constituted “act of preparation of a medicine based on a doctor’s prescription”.
(3) Applicability as a “Production” (Issue 3)
Regarding Issue 3, the IP High Court did not rule on this point because it had already determined that the pharmaceutical agent containing Components ➀ to ➂ was manufactured outside the patient's body.
Comments
Regarding Issue 1, the Tokyo High Court ruling of April 11, 2002 (Case No. 2000 (Gyo-Ke) 65) stated that the Patent Act does not recognize patentability for medical practice itself, as this could lead to the situations where doctors must perform medical practice while constantly fearing liability for patent infringement.
The JPO's Examination Guidelines for Patent and Utility Model in Japan (the “Examination Guidelines”), revised in light of this ruling, form the background of this case. The relevant Examination Guidelines pertaining to this case are as follows:
| 3.1 List of industrially inapplicable inventions |
| An invention considered as any one of (i) to (iii) shown below does not comply with the industrial applicability requirements. |
| (i) Inventions of methods of surgery, therapy, or diagnosis of humans |
| Methods for operating on, treating, or diagnosing humans are generally methods by which a physician (including persons under the physician's direction; the same applies hereinafter) performs surgery, treatment, or diagnosis on a human, referred to as “medical treatment.” |
While this IP High Court Judgment does not negate the aforementioned 2002 judgment and Examination Guidelines denying patentability to an "invention that is a process” constituting medical treatment, it affirms the industrial applicability of the Invention based on two grounds: (1) the amended Patent Act permits patenting of pharmaceuticals intended for administration to the human body, and (2) the practice of the Invention does not necessarily require the intervention of a doctor performing medical practice. Consequently, it appears that the conclusion may differ from this case depending on the degree of the doctor’s involvement and the extent to which the medical practice is integrated with the manufacturing act.
Regarding Issue 2, this judgment states that regarding the meaning of “disease” under Article 69 (3), which refers to “a state in which a living organism experiences a disorder in its form or physiological or mental functions, accompanied by pain or discomfort, and cannot lead a healthy daily life”, it is clarified that a state requiring breast augmentation surgery for aesthetic purposes does not fall under this definition. Furthermore, the judgment denies the application of Article 69 (3) since the selection of a medicine for use in the breast augmentation surgery covered by the Invention does not immediately serve the public interest constituting the gist of preparation of a “medicine” under Article 69 (3), which prioritizes the public interest of the smooth implementation of medical practice. From the view that the “medicine” targets “a product used in the diagnosis, therapy, treatment, or prevention of human diseases” simply because preparing a medicine under the direction of a doctor is not required except in the cases described above, it may be possible to expand the interpretation of the wording “a product used in … human disease” and its scope in the future as societal conditions change.
This is particularly relevant if the preparation of a medicine is conducted under the direction of a doctor, given that the field of cosmetic surgery has developed and preparing a medicine in cosmetic surgery, such as restoring the appearance of victims of traffic accidents, can be recognized as it serves the public interest on a par with the standard medical practice.
Regarding Issue 3, this judgment does not conclude on the applicability of “production” when multiple pharmaceuticals mix within the body.
As for the meaning of “production,” the Osaka District Court ruling of September 27, 2012 (Case No. 2011 (Wa) 7576, “Pioglitazone Case”) stated that while “production” is not limited to specific acts like processing, repair, or assembly, it requires some form of intervention on the supplied material. On the other hand, the IP High Court ruling of September 30, 2005 (Case No. 2005 (Ne) 10040) and the IP High Court ruling of May 26, 2023 (Case No. 2022 (Ne) 10046) do not appear to impose such a requirement. Considering the above cases, when examining whether an act constitutes “production”, the evaluative aspects judging the applicability of “production” normatively may be important in individual, concrete cases, in addition to the consideration of whether it constitutes a physical act of production that satisfies the constituent features. In this sense, the pharmaceutical agents used in the Pioglitazone Case were each completed product, making it a different case from the present case. Therefore, it is noteworthy to consider whether this point would have influenced the outcome had the IP High Court reached a conclusion.
In summary, while the decisive factor in this judgment regarding patent infringement was the factual finding of whether the pharmaceutical agent combining Components ➀ to ➂ was pre-manufactured, the ruling clarified the IP High Court's current stance on medical practice and patent. This makes it a noteworthy judgment for businesses potentially affected by its scope, such as those operating in the field of the cosmetic surgery. Furthermore, there is room for debate regarding whether upstream or downstream regulation is the more appropriate approach for addressing the relationship between medical-related acts and patents. Additionally, whether the “production” of a composition can be recognized when multiple pharmaceutical agents are mixed within the human body to satisfy the constituent features is another point warranting attention in future court rulings.