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“Composition for Promoting Augmentation of Subcutaneous Tissue and Subcutaneous Adipose Tissue”

Overview:

This case concerns an appeal for damages relating to a patent right (Japanese Patent No. 5186050) associated with cosmetic surgery (breast augmentation surgery). After soliciting third-party opinions pursuant to Article 105 bis undecies of the Patent Act, the Special Division (Grand Panel) of the Intellectual Property High Court overturned the original judgment and upheld the appellant’s (patent holder’s) claim for damages.

▶Summary of Judgment and Link to Full Text (in Japanese)

Disputed Issue Subject to Third-Party Opinion Solicitation

In order to produce the composition of the patented invention at issue, it is necessary to collect blood from the patient. Furthermore, this composition is intended to be administered to the patient. Given that the patented invention at issue presupposes medical acts both before and after its use, the question arises whether it should be excluded from patentability on the grounds that it does not constitute an “industrially applicable invention” (main clause of Article 29(1) of the Patent Act), and whether the patent is invalid.

(The patented invention at issue: Among the inventions described in claim 4, the invention that cites the invention described in claim 1)

“A composition for promoting subcutaneous tissue augmentation for use in breast augmentation, characterized by containing (i) autologous plasma, (ii) basic fibroblast growth factor (b-FGF), and (iii) a fat emulsion.”

[The numbers (i) to (iii) were added by the author.]

(Acts of the Appellee)

The appellee (defendant in the court of first instance) is a physician operating a plastic surgery clinic (hereinafter referred to as “the Clinic”). At the Clinic, the appellee provided a blood-based breast augmentation procedure in which (i) plasma obtained by removing cellular components from blood collected from the patient, (ii) the trafermin (genetically recombinant) preparation “Fiblast® Spray”, (iii) the fat emulsion “Intralipos®”, and other pharmaceuticals were mixed to prepare a drug, which was then injected into the patient’s breasts.

Summary:

3. Regarding Issue 2-1 (Whether the patent relating to the invention at issue is invalid for violating the requirement of industrial applicability (main clause of Article 29(1) of the Patent Act))

…the mere fact that administration to the human body is contemplated does not make it reasonable to interpret the “invention of a product” in question as substantively an “invention of a method” directed to medical acts, and therefore not an “industrially applicable invention.”

…acts such as manufacturing pharmaceuticals or the like using materials collected from humans as raw materials are not necessarily performed by physicians, and it cannot be said that blood collection, manufacture of the composition, and administration to the patient should always be regarded as inseparable acts that form a single, unified process. …

Accordingly, with respect to an invention of a product that uses materials collected from humans as raw materials and is ultimately intended to be returned to the body of that human, it cannot be said, solely for that reason, that the invention is substantively an “invention of a method,” or that, when viewed as a series of acts, it constitutes a medical act and therefore does not qualify as an “industrially applicable invention.”

Comments:

It is considered that the court approved the JPO Examination Guidelines (Part III, Chapter 1, 3.2.1(1)), which state that, regardless of the extent to which an invention is related to “medical acts,” an “invention of a product” is not to be excluded from being an “industrially applicable invention” on the grounds of being a “medical act.”

In addition, the court stated: “Given the recent rapid advances in cutting-edge medical technologies such as regenerative medicine and gene therapy, the development of technologies such as the manufacture of pharmaceuticals using materials collected from humans as raw materials is greatly supported not only by physicians but also by research and development in the pharmaceutical industry and other industries. Since such technologies can be used to maintain and restore human life and health, there is a recognized need to grant patent protection in order to promote technological development.” This can be considered an appropriate judgment that also takes into account the potential conflict of interest between physicians and the pharmaceutical industry, among others.

Furthermore, regarding another issue—whether the act constitutes “preparing a drug based on a prescription from a physician or dentist” (Article 69(3) of the Patent Act)—the court held as follows:

“As is clear from the description in the scope of claims, the composition is ‘for use in breast augmentation’ and…is primarily for aesthetic purposes. In light of such statements in the specification and current social conventions, the composition relating to the invention at issue cannot be regarded as a product intended for the diagnosis, treatment, care, or prevention of human diseases. …

Therefore, the invention at issue does not fall under ‘an invention of a drug to be prepared by mixing two or more drugs,’ and thus…the appellee’s defense that the effect of the patent right does not extend under Article 69(3) of the Patent Act is without merit.”

As such, it may be that, because the appellee (the defendant in the first instance) was a “physician” engaged in “cosmetic surgery,” the court was able to render a clear judgment not only with respect to Article 69(3) but also with respect to the main clause of Article 29(1).

Akiteru TAMURA