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On March 19, 2025, the Intellectual Property High Court (IP High Court), Grand Panel, rendered a Decision, 2023 (Ne) 10040.  For details on the case, please refer to the IP High Court website, which is mentioned at the end of this document.

 

The IP High Court case is an appeal against a judgment of non-infringement made by the Tokyo District Court.  In the Tokyo District Court, the patentee sued a physician who provided medical treatments using a pharmaceutical composition.  The patentee alleged that the pharmaceutical composition fell within the scope of their patent right relating to a composition involved in a medical action that involves taking biological material from a human, processing it, and then returning the processed material to the same human.  The Tokyo District Court found the physician did not infringe the patent right; however, the IP High Court reversed the first-instance judgment and found that the physician had infringed the patent right.

 

In Japan, in order to ensure universal access to medical treatment from a humanitarian standpoint, inventions involving medical actions are rejected as not satisfying the patent eligibility requirement (Patent Law Article 29(1), introductory clause) and cannot be patented.  If, however, a medical method claim involves the use of a pharmaceutical composition, current Japanese practice leaves leeway for the claimed invention to be patented if it is reformulated into a medical purpose-limited product claim.  While on the one hand allowing such medical purpose-limited product claims to be patented, to ensure that the act of formulating a pharmaceutical composition by physicians or dentists is not restricted by such patented inventions, on the other hand, the Patent Law defines that the patent right shall not be effective against the act of formulating a pharmaceutical composition by physicians, etc. (Patent Law, Article 69(3)).

 

One of the contested issues was whether the patented invention met the patent eligibility requirement.  Specifically, it was alleged that the patent should be invalidated because the invention, although claimed as a product invention, substantially qualifies as a method invention involving medical action; thus, the patent fails to meet the patent eligibility requirement and is therefore invalid. 

The IP High Court determined that the patent is valid because, even if the claimed pharmaceutical composition involves taking biological material to be processed from a human and subsequently returning the processed material to the human, “it is unreasonable to interpret ‘the product invention’ as substantially being ‘a method invention’ and thereby unreasonable to interpret the actions concerning the claimed pharmaceutical composition as falling under the category of medical action.”  

 

Another contested issue was whether the physician’s action in formulating the composition falls under the exemption provision for the formulation of medicines.  

The IP High Court determined that the physician’s action does not fall under the exemption provision because “the composition in question, which is intended for breast augmentation and serves an aesthetic purpose, cannot be considered as ‘medicine for diagnosing, treating, curing, or preventing a disease in a human’ according to the specification of the patent, additionally in light of the current social norms.”

 

IP High Court website:

– 2023 (Ne) 10040 – Arguments to be judged by the Grand Panel (Japanese)

– 2023 (Ne) 10040 – Summary of the IP High Court’s decision (Japanese)