On 19 March 2025, the Intellectual Property High Court (grand panel) ruled on a patent infringement case (IP High Court Case No. 2023 (Ne) 10040) which involved issues regarding patent eligibility and exemption from patent infringement in relation to a doctor’s medical activity. This case drew significant public attention not only as the first in which a doctor was sued for patent infringement but also because the IP High Court sought public opinion through written submissions (the Japanese version of an Amicus Brief) before making its decision, considering the significance of the issues (see AIPPI Newsletter in July 2024). The IP High Court found the facts of the case to be different from those found by the Tokyo District Court. Further, upon considering the legal issues, it reversed the district court’s decision and ruled that the doctor’s acts constituted patent infringement.
- The Invention
The plaintiff Tokai Medical holds a patent (Japanese Patent No. 5186050) directed to a pharmaceutical composition containing three materials (as underlined below) for use in breast enlargement surgery. The claim at issue was Claim 4 (a dependant claim referring to Claim 1), which had the following elements:
A composition for promoting subcutaneous tissue increase, to be used for breast enlargement, characterized in that it contains autologous plasma, basic fibroblast growth factor (b-FGF) and fat emulsion.
- Facts of the Case
The defendant was an individual doctor who conducted breast enlargement surgery in his plastic surgery clinic. The defendant argued that upon conducting the surgery, he would create a first drug comprising a cell-free plasma gel and Fiblast Spray containing trafermin (b-FGF) (“Drug A”), and a second drug comprising Intralipos (fat emulsion) (“Drug B”), which were injected into the patient’s body separately. Thus, he argued that he never “created” the claimed composition containing all three elements combined into a single composition.
The Tokyo District Court (Case No. 2022 (Wa) 5905) accepted the defendant’s non-infringement argument and dismissed Tokai Medical’s claim. However, the IP High Court saw the evidence differently, opining that the defendant’s testimony was vague, inconsistent and unsubstantiated, and found that it was reasonable to infer that the defendant did in fact prepare the claimed composition containing all three elements in one composition before injecting it into the patient’s body.
- Legal Issues of the Case
The IP High Court further considered and decided on the legal issues, including the following.
- Patent eligibility
The defendant had argued that, since autologous plasma could only be obtained by taking blood from the patient, and the claimed composition was subcutaneously injected to the patient, both the creation and use of the claimed composition inevitably required a “medical activity” which was unpatentable. In relation to this, there is a precedent that ruled that medical activity is unpatentable for not satisfying the “industrially applicable” requirement under Article 29(1) of the Patent Act.
The IP High Court ruled that the invention of Claim 4, which was a “product invention,” satisfied the “industrially applicable” requirement of Article 29(1) and was patentable. The court’s reasoning was that (i) a “pharmaceutical medicine” intended to be delivered into a person’s body is clearly patentable under the Patent Act, and (ii) the creation of pharmaceutical medicine using materials taken from a person’s body is not necessarily conducted by doctors, and such inventions must be protected by patents to encourage technological development in the field.
- Exemption from patent infringement
There are no explicit provisions in the Japanese Patent Act addressing “medical activity,” except for an infringement exemption clause under Article 69(3) which reads that in case the patent right is for an invention of a pharmaceutical medicine (for the diagnosis, treatment, or prevention of human diseases) manufactured by mixing two or more medicines, it cannot be enforced against the act of dispensing such medicine, or such medicine dispensed, based on a physician’s or a dentist’s prescription.
The IP High Court applied the facts of this case to this exemption clause and ruled that, since the claimed composition is “to be used for breast enlargement” which purpose is “aesthetic,” it is not a “pharmaceutical medicine (for the diagnosis, treatment, or prevention of human diseases)” under Article 69(3), and thus the defendant’s acts are not eligible for exemption from infringement. The defendant argued that aesthetic medicine is also a medical field that contributes to people’s mental and physical health and improvement of self-esteem, but the court rejected this, stating that Article 69(3) was established to protect the acts of selecting and prescribing of medicine by doctors for the benefit of the public, but at least in relation to the selection of medicine for breast enlargement surgery, such public benefit cannot be readily identified.
- Comments
In Japan, “medical activity” was long considered as being exempt from patent infringement, but the scope was vague due to the lack of clear provisions and precedents. By this IP High Court decision, medical practitioners in the field of “aesthetic” medicine now need to be aware of the risk of infringing patents when they prepare and use medicine for “aesthetic” purpose at their clinics and hospitals, as well as at pharmacies even based on a doctor’s prescription.
This IP High Court decision also leaves concerns for medical practitioners regardless of their field of medicine, because it did not provide any decision on whether mixing and using medicine at clinics and hospitals without any prescription would constitute infringement of patents related to medicine “for the diagnosis, treatment, or prevention of human diseases.”
This case highlights the need for further discussion within the medical and legal communities regarding the treatment of medical activity under patent law, including the necessity of revising Article 69(3).