IP High Court Calls for Opinions Regarding a Doctor’s Patent Infringement

The IP High Court recently announced that it will gather opinions from the public from 24 June 2024 to 6 September 2024, before making its decision on a patent infringement case (IP High Court Case No. 2023 (Ne) 10040) which involved issues on patent eligibility and exemption from patent infringement of a doctor’s medical activity. In a patent case in Japan, if the court finds it to be necessary at the request of either party, the court may seek the submission of written opinions from the public (the Japanese version Amicus Brief) on any matter related to the case, for example how certain articles of the Patent Act should be construed and applied to the case. The opinions, often submitted by industries and practitioners in and outside of Japan, will be later selected and submitted by the parties as evidence in the litigation.

1. Case Summary

The patentee and plaintiff Tokai Medical holds a patent directed to an invention of a pharmaceutical composition containing three elements (as underlined in Claim 1 below) for use in breast enlargement surgery. Claim 1 reads as follows:

[Claim 1]

A composition for promoting subcutaneous tissue increase, characterized in that it contains autologous plasma, basic fibroblast growth factor (b-FGF) and fat emulsion;

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”). The two drugs were created and injected into the patient’s body separately, so he argued that he never “created” the claimed composition containing all three elements in one composition. He also 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 the use of the claimed composition inevitably required a “medical activity.” He made non-infringement and invalidity arguments based on the Japanese practice that a “medical activity” (which refers to methods of surgery, therapy or diagnosis of humans) is exempt from patent infringement, and that “medical activity” is unpatentable.

It should be noted that there are no explicit provisions in the Patent Act addressing “medical activity,” except an infringement exemption under Article 69(3) which we will discuss later. Regarding the patent eligibility, there is a precedent that ruled that medical activity is unpatentable for not satisfying the “industrially applicable” requirement under Article 29(1). Also, as to the exemption from patent infringement, there is an opinion that, while Article 68 stipulates that “(t)he patentee has an exclusive right to work the patented invention in the course of trade,” a medical activity of a doctor is a benevolent act and not “trade,” so that it should be outside the scope of the patent right. There has been no court precedent in Japan in which a medical doctor is sued for a patent infringement, and this case is the first one which directly handles such issues.

The Tokyo District Court (Case No. 2022 (Wa) 5905) accepted the defendant’s argument that he only created Drugs A and B separately, which were not the claimed composition containing three elements, and dismissed Tokai Medical’s claim without making any decision on other arguments of the parties. The patentee Tokai Medical appealed.

2. Issues on which opinions are sought by the IP High Court

The IP High Court is now gathering opinions from the public on specifically the following issues. Article 69(3) seems to have become a new issue at the IP High Court as can be seen in Issues (2) and (3)(A) below. The provision stipulates that in case the patent right is for an “invention of a pharmaceutical medicine manufactured by mixing two or more medicines (for the diagnosis, treatment, or prevention of human diseases),” it cannot be enforced against (a) the act of dispensing medicine based on a physician’s or dentist’s prescription or (b) a pharmaceutical medicine dispensed based on a physician’s or a dentist’s prescription.

• Whether the patent at issue was granted for an “invention that is not industrially applicable” (main paragraph of Article 29(1) of the Patent Act) and thus should be invalidated.
• Whether the present invention falls under an “invention of a pharmaceutical medicine manufactured by mixing two or more medicines (for the diagnosis, treatment, or prevention of human diseases)” as stipulated under Article 69(3) of the Patent Act.
• On the assumption that the cell-free plasma, Fiblast Spray and Intralipos used by the defendant satisfy the three elements contained in the claimed composition,
• Whether the defendant’s act of creating a pharmaceutical medicine containing cell-free plasma, Fiblast Spray and Intralipos (hereinafter the “Defendant’s Mixed Medicine”) by instructing a nurse or associate nurse to do so without any prescription can be considered an “act of dispensing medicine based on a physician’s or dentist’s prescription” (Article 69(3) of the Patent Act).
• As the defendant’s act of creating the Defendant’s Mixed Medicine is closely related to medical activity, whether there is any basis to construe that such act shall be exempted from patent infringement.
• In case the defendant uses Drug A and Drug B separately in his surgery, and the three elements contained in those drugs are only mixed within the patient’s body, whether such surgery by the defendant can be considered a “creation” of the claimed “composition.”

3. Comments

Although details of arguments of the parties at the IP High Court are not disclosed, Issues (3)(A) and (3)(B) above suggest that the IP High Court may find the facts differently from the Tokyo District Court, for example the defendant may have instructed nurses to mix, or may have mixed himself the cell-free plasma, Fiblast Spray and Intralipos as one medicine before injecting into the patient’s body. Article 69(3) only stipulates a limited case where a pharmacist mixes medicine based on a physician’s or dentist’s prescription, and it does not seem to assume in its scope the mixture of certain elements of medicine by doctors and nurses before surgery without a prescription. With no explicit provision in the Patent Act that “medical activity” in general should be considered to be exempted from a patent infringement, the IP High Court should be hoping that it will find some insights to resolve this matter logically and reasonably by gathering opinions from the industries, academias and practitioners both in Japan and abroad.