Japan IP Court Recognizes Patent Infringement in Cosmetic Medical Activity for the First Time

Judicial Determination and Statutory Context

The Grand Panel of the Intellectual Property High Court of Japan rendered a seminal judgment in Case No. 2023 (Ne) 10040, marking the first judicial recognition of patent infringement arising from the performance of a medical procedure involving a patented composition. The dispute concerned Patent No. 5186050, which pertains to a breast augmentation formulation composed of autologous plasma, basic fibroblast growth factor (b-FGF), and a fat emulsion. The claimant alleged that this composition was utilized without license at a commercial aesthetic clinic operated by the respondent.

Under Japanese patent jurisprudence, medical procedures are typically deemed non-industrial and thus excluded from patentable subject matter. However, the statutory framework, unlike certain foreign regimes such as that of the United States, does not afford a comprehensive exemption from infringement liability for acts conducted by medical professionals. Article 69, Paragraph 3 of Japan’s Patent Act carves out a limited exception solely for the preparation of medicines pursuant to individual prescriptions issued by physicians or dentists. There exists no statutory immunity for broader therapeutic or cosmetic interventions involving patented products.

Reasoning and Key Findings of Japan IP Court

The Grand Panel categorically rejected the respondent’s assertion that the act in question constituted a non-patentable medical activity. It held that the patented invention was a product-oriented formulation, distinct from a medical method, and therefore satisfied the criterion of industrial applicability. The Court further determined that the application of the composition was intended for aesthetic enhancement rather than therapeutic treatment, thereby falling outside the protective scope of Article 69(3).

Critically, the ruling affirmed that the statutory exemption applies strictly to pharmaceutical preparations intended for diagnosis, treatment, or disease prevention, and not to compositions administered for cosmetic purposes. Consequently, the unauthorized use of the claimed invention in a commercial clinical setting amounted to an infringement of the patentee’s exclusive rights under Article 68 of the Patent Act.

The decision also clarified that the professional status of the infringing party as a medical practitioner does not in itself absolve liability, particularly where the use involves a patented product and not a medical method per se. This interpretation establishes a firm boundary between legitimate medical exemptions and infringing commercial use of protected intellectual property.

Implications and Strategic Considerations

This decision constitutes a watershed moment in Japan’s patent enforcement landscape, particularly as it relates to the intersection of medical services and proprietary biotechnological innovations. It underscores the enforceability of product-based patent rights even within the context of clinical or aesthetic applications, except where narrowly tailored statutory exceptions apply.

Stakeholders in the cosmetic surgery, regenerative medicine, and biotechnology sectors must now recalibrate their compliance frameworks to ensure adherence to patent laws. Due diligence, including freedom-to-operate analyses and pre-emptive licensing negotiations, will be indispensable for mitigating infringement risks.

The judgment is poised to influence future adjudication involving the commercial deployment of patented compositions in clinical practice and reinforces the necessity for precise statutory interpretation in demarcating the limits of medical-use exemptions.