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2022.10.17 Patent

Case Study of Determination on Support Requirement

1. Introduction

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.
 
 
 

2. Details of the Invention

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.
 
 
 

3. Framework for Determination on Compliance with Support Requirement

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:
“whether or not recitations in the claims comply with the Support Requirement for Specification is to be judged by considering whether, based on comparison between the recitations in the claims and the descriptions in the detailed description of the invention, (i) the invention claimed in the claims is the invention described in the detailed description of the invention and is within a scope that allows a person skilled in the art to recognize that the problem of the invention can be solved based on the descriptions in the detailed description of the invention, or (ii) even when such descriptions or suggestions are not found, whether the invention is within a scope that allows a person skilled in the art to recognize that the problem of the invention can be solved in light of the technical common knowledge at the time of filing of the application”.
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.
 
 
 

4. Determination in the Trial Decision

(i) The Problem of the Invention Acknowledged in the Trial Decision

In the trial decision, the following problem is acknowledged as one of the problems of the invention:
“once the access port is subcutaneously implanted, it is difficult to identify a model or the like of the access port. To address this problem, there is provided an access port capable of automatic injection that enables injection and pressurization with mechanical assistance, and can be used for injecting a contrast medium into a venous line using an automatic injection system in a computed tomography scanning process. The access port capable of automatic injection is provided with an identifiable feature that has a correlation with the access port capable of automatic injection and can be perceived subsequent to subcutaneous implantation of the access port. Thus, the access port can be identified as being capable of automatic injection subsequent to the subcutaneous implantation”.
 
 
 

(ii) Determination in the Trial Decision

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.
 
 
 

5. Determination in the Court Ruling

(i) Problem of the Invention Acknowledged in the Court Ruling

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”.
 
 
 

(ii) Determination in the Court Ruling

The court ruling found that the invention of claim 1 complies with the Support Requirement for the reasons as follows:
“according to the descriptions of the Specification, it is disclosed that the “identifiable feature” is formed into a shape and/or a size specific to the access port to thereby be capable of identifying the access port, whereby “the identifiable feature can have a correlation with information related to the access port”. Furthermore, since “the information on the access port capable of automatic injection that can distinguish the access port from an access port not defined as being capable of automatic injection” according to Subject Invention 1 is “information related to the access port”, the above descriptions of the Specification can be understood as one embodiment of “correlation” between “the information on the access port capable of automatic injection that can distinguish the access port from an access port not defined as being capable of automatic injection” and “the identifiable feature visible on an X-ray”.
 
 
 

6. Consideration and Advice

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.
 
 
 

7. Concluding Remarks

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
名古屋国際弁理士法人

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