Japanese Patent Act requires that an invention for which a patent is solicited (that is, an invention claimed in the claims) shall be disclosed in the detailed description of the invention (Patent Act 36-6(1)) (hereinafter, this requirement is referred to as “Support Requirement”). Violation of the Support Requirement is one of Reasons for Rejection (Patent Act 49(4)), and also one of Reasons for Invalidation (Patent Act 123(4)). Therefore, studying a specific case will help you understand how the Support Requirement is determined under the Japanese patent practice.

The case we introduce herein is a case where compliance with the Support Requirement in Japanese Patent No. 6018822 was determined differently in the invalidation trial (Invalidation Trial No. 2017-800070) and the lawsuit against its trial decision (2018 (Gyo-ke) 10175) despite the fact that the same framework for determination was used. This lawsuit against the trial decision was also addressed as one of the subjects of study in Trial and Appeal Practitioner Study Group (2021) organized by Trial and Appeal Department of the Japan Patent Office.

 

 

 

Claim 1 of Japanese Patent No. 6018822 is recited as follows (hereinafter, “Subject Invention 1” refers to the invention pertaining to this claim 1).

[Claim 1]

An access port capable of automatic injection for providing subcutaneous access to a patient, used for a computed tomography scanning process, the access port capable of automatic injection comprising:

a body configured to hold a septum; and

at least one identifiable feature of the access port, the at least one identifiable feature being configured to enable identification of the access port capable of automatic injection via an X-ray subsequent to subcutaneous implantation of the access port, the at least one identifiable feature being correlated with information on the access port capable of automatic injection that can distinguish the access port capable of automatic injection from an access port not defined as being capable of automatic injection, and the at least one identifiable feature being visible on the X-ray,

wherein the access port capable of automatic injection enables injection and pressurization with mechanical assistance, and

wherein the septum is a septum to allow therethrough a needle to be repeatedly inserted into a cavity defined in the body.

 

 

 

The framework for determination on compliance with the Support Requirement used in both the trial decision in the above invalidation trial and the court ruling in the above lawsuit was the same as one presented in Grand Panel Case (No. 2005 (Gyo-ke) 10042): “Method of Manufacturing Polarizing Film” detailed below:

Hereinafter, we summarize how the problem(s) of the invention was acknowledged, and as a consequence, how compliance with the Support Requirement was determined in each of the trial decision and the court ruling.

 

 

 

In the trial decision, the following problem is acknowledged as one of the problems of the invention:

 

 

 

Although the trial decision found that the invention of claim 1 is an invention disclosed in the detailed description of the invention in terms of formality, the invention of claim 1 was determined as not complying with the Support Requirement for the following reasons: “the access port identified by matching the feature perceived through imaging of an X-ray to the shape of the template is not an access port that is indicated as being capable of automatic injection by the perceived feature itself, that is, even when the feature perceived through imaging of an X-ray matches the shape of the template, doctors or other medical personnel cannot immediately identify the access port as being capable of automatic injection”; “even when it is apparent that use conditions are given in use of the access port and the access port is capable of automatic injection in a range that fulfills the use conditions set forth in an attached document, and the attached document gives the meaning of the identifiable feature as “access port capable of automatic injection”, practitioners such as doctors cannot identify the access port as being capable of automatic injection without checking the attached document. Thus, it is not apparent that the feature perceived through imaging of an X-ray enables immediate identification of the access port as being capable of automatic injection”; “the Specification of the subject case neither discloses nor suggests the attached document regarding the access port”, etc.

 

 

 

The problem of the invention was acknowledged as “being capable of identifying, subsequent to implantation of the access port capable of automatic injection, whether the access port is an access port capable of automatic injection”.

 

 

 

The court ruling found that the invention of claim 1 complies with the Support Requirement for the reasons as follows:

 

 

 

This case study shows that even the same framework for determination on compliance with the Support Requirement would lead to different determinations if the problem of the invention is interpreted differently. It can be said that the court ruling acknowledged “the problem of the invention” in a broader manner than the trial decision did. Furthermore, this case study can be considered to be an example of how a narrower interpretation of the problem of the invention leads to a determination that makes it more difficult to find compliance with the Support Requirement and vice versa.

It would be advisable for any person who is to stand for affirming or denying compliance with the Support Requirement to consider how the problem of the invention of the subject patent should be interpreted based on these determinations presented in this case study.

 

 

 

The case we introduced herein is one example presenting determination on compliance with the Support Requirement. We would like to introduce trial decisions and court rulings of similar cases if we find the same in the future. In addition to determination on compliance with the Support Requirement, the presence of inventive step was also practically determined in the case we introduced herein. We will introduce this on another occasion.

 

 

Edited by Seiji Kimura