Treatment of Medical Inventions in Japan and Other Countries
Under the patent examination criteria, a method of operating on, treating, or examining a human being is not considered to be an “invention that can be industrially exploited” (industrial applicability*; Article 29.1, Pillar 1 of the Japanese Patent Law).
*Eligibility for Patent and Industrial Applicability／Japanese Patent Office
Thus, inventions of articles such as medical devices, pharmaceuticals, and medical materials are patentable, whereas surgical, therapeutic, and diagnostic methods, such as gene therapy methods and MRI measurement methods, are all outside of the scope of patent protection in Japan.
As mentioned above, methods of operating on or treating humans are not subject to patent protection in Japan, and the same is true in China and Europe. On the other hand, in the U.S., methods of operating on or treating humans are recognized as subjects of protection.
International differences in the treatment of Secondary Pharmaceutical Inventions
With regard to so-called secondary pharmaceutical inventions, special attention should be paid to the fact that the categories of protectable inventions in Japan are different from those in the United States.
Here, a secondary pharmaceutical application invention is an invention in which a new efficacy (use) is discovered for a known substance, as shown below. Following is an example where a cold remedy containing active ingredient A is conventionally known, and an anticancer effect is discovered as a new efficacy.
Such an invention of a secondary pharmaceutical may be protectable in Japan as an invention of an article, such as “an anticancer drug containing active ingredient A” (the same is true in Europe). In the U.S., on the other hand, if the invention is an invention of an article, it cannot be protected as a patent because it is not recognized as being novel. Instead, in the U.S., the invention may be protected as an invention of a method, such as “a method of treating cancer by administering a medicament containing the active ingredient A”.
Examples of claim descriptions for obtaining rights for medical-related inventions in Japan
As was mentioned above, in Japan, inventions relating to methods of operating on, treating, or examining humans are not protectable as patents. On the other hand, there are cases in which inventions with substantially similar concepts can be protected by describing them as inventions of articles, such as a secondary pharmaceutical invention.
The following is an example of a case in which a claim that was not eligible for patent protection is rewritten into a potentially protectable invention by changing the claim description.
*Cases pertinent to Eligibility for Patent and Industrial Applicability／Japanese Patent Office
One point to keep in mind when acquiring patent rights is that the following claim modification is an amendment that changes the category of the invention, and depending on the timing, it may not be possible to make such an amendment. Specifically, it should be noted that while it is possible to make such amendments after a First OA, it is not possible to do so after a Final OA, because the scope of possible amendments is limited.
The above is an explanation of the treatment of inventions of methods of operating on, treating, or diagnosing humans in Japanese patents.
Takaoka IP has pharmaceutical specialists on staff, including a Doctor of Pharmacy, and specialized patent attorneys, as well as medical device specialists. We develop customized strategies for the most effective rights acquisition, ensuring that our recommendations are strictly aligned with the latest Japanese laws, regulations, and standards to meet your unique needs.