IPHC Grand Panel Finds Patent Infringement and Clarifies Medical Exemption in Cosmetic Procedures

Date of Judgment: March 19, 2025
Court: Intellectual Property High Court (Grand Panel)
Case No.: 2023 (Ne) 10040
Patent No.: 5186050
Title of Invention: Composition for Promoting Increase of Subcutaneous Tissue and Subcutaneous Fatty Tissue

Background of the Case

On March 19, 2025, the Grand Panel of the Intellectual Property High Court (IPHC) issued a landmark decision in a dispute over patent infringement related to a cosmetic breast augmentation procedure. For the first time in Japan, a court found that a cosmetic procedure could constitute patent infringement, deciding that the medical exemption under Article 69(3) of the Patent Act was not applicable.

This decision reversed a prior decision by the Tokyo District Court (first instance) and ordered the defendant, a cosmetic clinical doctor, to pay approximately JPY 15 million in damages to the patentee, a Tokyo-based medical and pharmaceutical company.

Facts of the Case

The patented invention concerns a composition used in breast augmentation, comprising:

• Autologous plasma
• Basic fibroblast growth factor (b-FGF)
• Fat emulsion

In the first instance at the Tokyo District Court, the Patentee (Appellant-Plaintiff) alleged that a cosmetic surgery clinic (Appellee-Defendant) used the patented drug formulation containing agents that promote plasma and cell growth during breast augmentation procedures without permission from the patentee.  The Tokyo District Court dismissed the plaintiff’s claim, stating that the cosmetic operation does not constitute patent infringement.  The patentee filed an appeal against the District Court decision at the IPHC.

Key Findings by the IP High Court

1. Medical Exemption Does Not Apply (Patent Act Article 69(3))

The defendant contended that the preparation of the composition was exempted under Article 69(3) as a medical act.  However, the court concluded:

• The operation was conducted for aesthetic, not therapeutic purposes.
• Therefore, it does not qualify for the medical exemption, and the patent rights are enforceable.

This is the first Grand Panel decision to clarify that the medical exemption does not extend to a cosmetic or aesthetic operation.

2. Industrial Applicability Affirmed

A further issue was whether the invention, which utilizes patient-derived materials, meets the requirements for industrial applicability under Article 29 of the Patent Act. The court held that:

• The use of patient-derived materials still holds industrial applicability.
• Such inventions are developed by industrial stakeholders, including pharmaceutical companies, and thus qualify for patent protection.

The court confirmed that “product inventions” used in cosmetic medicine are eligible for patent rights.

3. Damages Awarded

The defendant earned approximately JPY 170 million through these operations between May 2020 and July 2021. The court awarded 8% of this amount (about JPY 15 million) as damages under Article 102(3) of the Patent Act.

This court decision provides a practical benchmark for calculating damages in cases involving cosmetic and medical patent infringements.

Implications for IP Practice

This decision suggests that patents related to aesthetic or cosmetic applications can be enforced, even when the actions are conducted by doctors.

It would be advisable for IP practitioners to

• Clearly distinguish cosmetic and therapeutic purposes when drafting claims.
• Refrain from assuming that Article 69(3) automatically exempts all physician-performed procedures.

 Conclusion

The Grand Panel’s decision marks a significant development in how Japanese patent law distinguishes between medical and cosmetic operations. It affirms that cosmetic use does not benefit from the medical exemption traditionally granted under Article 69(3).

Presiding Judge Tomonari Honda emphasized the importance of protecting innovation in medical and cosmetic technologies, particularly where industrial research and development are vital.

An appeal to the Supreme Court remains possible, but this decision currently serves as a pivotal precedent for intellectual property strategies in the medical and cosmetic sectors.