Inventions of methods of surgery, therapy or diagnosis of humans are not patentable in Japan

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In this article, we explore the key differences between the patent systems in the United States and Japan, with a special focus on the patent requirements for inventions related to medical practices.

We hope this information will be helpful for those looking to obtain patent rights in Japan.

Inventions Protected Under Japan’s Patent Law

In Japan, an "invention" under patent law is defined as "creation of technical idea utilizing the laws of nature" (Article 2, Paragraph 1 of the Japanese Patent Act).

Inventions that do not meet this definition are not eligible for patent protection. Additionally, since the goal of Japan’s patent law is to promote industrial development, even if an invention meets the definition of an "invention," it must also be capable of industrial application to be granted a patent.

Therefore, under Japan’s patent law, an invention for which protection is sought must meet the following two requirements (Article 29, Paragraph 1 of the Japanese Patent Act):

(i) A statutory "invention"
(ii) An "industrially applicable invention"

Methods of Surgery, Therapy, or Diagnosis on Humans Are Not Considered "Industrially Applicable Inventions"

Under the practice of Japan's Patent Act, methods of surgery, therapy, or diagnosis performed on humans are not considered "industrially applicable inventions" (JPO, Examination Guidelines for Patent and Utility Model in Japan, Ch.1, Part III, 2015).

This is because medical activities conducted by physicians should be made widely available for humanitarian reasons, as their primary purpose of Japan's Patent Act is to save human lives.

Therefore, in Japan, patents cannot be granted for such medical practices.

While medical practices can be patented under U.S. patent law, they are not patentable in Japan. Special attention is required when claiming priority based on U.S. applications or when entering the Japanese national phase of a PCT international application that designates the USPTO as the receiving office.

What Happens if You File a Patent Application in Japan for a Method of Surgery, Therapy, or Diagnosis on Humans?

If a patent application for such medical practices is filed in Japan, the examiner at the Japan Patent Office will issue a Notice of Reasons for Refusal (Article 49, Item 2 of the Japanese Patent Act).

Since a patent cannot be granted in this case, it will be necessary to take measures such as amending the claims to delete the medical practices or filing a divisional application.

Considering Filing a Patent Application in Japan? Contact Us for Consultation

As exemplified in this article, the scope of protection under patent laws can vary from country to country. An invention that is patentable in one country may not be patentable in another.

If you are considering filing a patent application in Japan, feel free to reach out to APEX Patent Solutions for a consultation.

Thank you for reading!