Article 17-2(3) of the Japanese Patent Law stipulates that any amendment to the specification, claims, or drawings must be made within the scope of the matters described in the specification etc. originally attached to the application (prohibition of addition of new matter).

This article introduces a court decision (2021 (Ne) No. 10043) where the issue was whether an amendment at the examination stage constitutes addition of new matter.

In this decision, the court determined that an amendment to limit to a specific combination of compounds in a Markush claim, which lists many alternative compounds, falls under addition of new matter. The Markush claim is a type of claim commonly used for chemical and biopharma applications. For example, the Markush-form is useful for inventions of chemical compounds where multiple components cannot be recited in a comprehensive manner or expressed in a generic concept.

We hope that this article will assist you in considering how to amend Markush claims, or how to write a specification when filing an application in preparation for future amendments, in order to obtain a patent.

 

 

 

The Intellectual Property High Court (IP High Court) presented general judgement criteria concerning addition of new matter in its Grand Panel Decision (2006 (Gyo-Ke) No. 10563).

 

The “matters stated in the specification or drawings” are disclosed to third parties by the applicant as a prerequisite for gaining a monopoly based on a patent right for an invention, the highly advanced creation of technical ideas, and such “matters” must be technical matters concerning the invention disclosed in the specification or drawings. And the “matters stated in the specification or drawings” mean technical matters that a person skilled in the art can understand, taking into account all statements in the specification or drawings. Where an amendment does not add any new technical matters to the technical matters that can be understood in this manner, the amendment can be deemed to be made within the “scope of the matters stated in the specification or drawings.”

 

Since the issuance of this decision, it has served as the basis for the criteria for determining addition of new matter. Furthermore, the Examination Guidelines for Patent and Utility Model in Japan were revised in 2010, following the finalization of this decision.

 

In addition, the Examination Guidelines in Japan include the following statement as criteria for determining addition of new matter when an amendment is made to a Markush claim.

 

a.  In a claim written in an alternative form such as the Markush-form, an amendment for removing part of the alternatives is permitted if the remaining matters used to specify the invention do not introduce any new technical matter.

b.  In the case where the originally attached specification, etc. includes combinations of many alternatives for stating a chemical substance, it may not be perceived that a combination of specific alternatives added or left by the following amendment (i) or (ii) does not introduce any new technical matter.

i).  An amendment which adds a combination of specific alternatives to a claim within the scope of the many alternatives stated in the originally attached specification, etc.

ii).  An amendment which leaves a combination of specific alternatives in a claim as a result of the deletion of alternatives.

For example, if a substituted group that had several alternatives as of the filing has only one alternative as a result of the amendment and has no room for change, the amendment is not permitted except when employing a combination of such specific alternatives has been stated in the originally attached specification, etc. This is because the original statement as alternatives would not mean employing a specific alternative.

 

 

 

In the present case, the Appellant obtained a patent right (Patent No. 5701205) for the invention titled “Composition containing 2,3-dichloro-1,1,1-trifluoropropane, 2-chloro-1,1,1-trifluoropropene, 2-chloro-1,1,1,2-tetrafluoropropane, or 2,3,3,3-tetrafluoropropene”. The Appellant claimed that the Appellee’s action infringed the patent right and sought an injunction against the Appellee’s action (original trial: Tokyo District Court, 2019 (wa) No. 30991). However, the Tokyo District Court ruled to dismiss the Appellant’s claim, and the Appellant, dissatisfied with the original decision, filed an appeal demanding an injunction against infringement of the patent right.

 

 

 

Original claims 1-2 and amended claims 1-2 are shown below.

 

 

[Claim 1]

A composition comprising:

HFO-1234yf; and

at least one additional compound selected from the group consisting of HFO-1234ze, HFO-1243zf, HCFC-243db, HCFC-244db, HFC-245cb, HFC-245fa, HCFO-1233xf, HCFO-1233zd, HCFC-253fb, HCFC-234ab, HCFC-243fa, ethylene, HFC-23, CFC-13, HFC-143a, HFC-152a, HFC-236fa, HCO-1130, HCO-1130a, HFO-1336, HCFC-133a, HCFC-254fb, HCFC-1131, HFO-1141, HCFO-1242zf, HCFO-1223xd, HCFC-233ab, HCFC-226ba and HFC-227ca.

 

[Claim 2]

The composition according to claim 1, the composition comprising less than about 1 wt.% of the at least one additional compound.

 

 

[Claim 1]

A composition for use in a heat transfer composition, a refrigerant, an aerosol spraying agent, or a foaming agent, the composition comprising:

HFO-1234yf; and

HFO-1243zf and HFC-245cb in excess of 0 (zero) wt.% and less than 1 wt.%.

 

[Claim 2]

The composition according to claim 1, the composition further comprising at least one additional compound selected from the group consisting of HFO-1234ze, HCFC-243db, HCFC-244db, HFC-245fa, HCFO-1233xf, HCFO-1233zd, HCFC-253fb, HCFC-234ab, HCFC-243fa, ethylene, HFC-23, CFC-13, HFC-143a, HFC-152a, HFC-236fa, HCO-1130, HCO-1130a, HFO-1336, HCFC-133a, HCFC-254fb, HCFC-1131, HFO-1141, HCFO-1242zf, HCFO-1223xd, HCFC-233ab, HCFC-226ba, and HFC-227ca,

wherein HFO-1243zf and HFC-245cb and the additional compound in total is less than 1 wt.%.

 

As noted above, this amendment added a matter specifying the invention to amended claim 1, i.e., “… comprising…HFO-1243zf and HFC-245cb in excess of 0 (zero) wt.% and less than 1 wt.%”.

 

 

 

The court upheld the original decision, citing the original decision.

The following texts are excerpts from the court’s decision. The text of the decision below has been modified as appropriate by the present editor to make it easier for readers to understand.

 

”In the original specification, in the first place, there is no mention of selecting a specific combination of HFO-1243zf and HFC-245cb, among the many listed compounds, as the “additional compound” to HFO-1234yf. In this regard, HFO-1234yf, HFO-1243zf and HFC-245cb are individually stated in the original specification, but not as a combination of three specific compounds, and there is no mention of any basis for requiring the combination of the three specific compounds. In addition, as for Table 6 (Example 16), eight compounds and “unknown” ingredients are listed; however, the reason for focusing on “245cb” and “1234yf” among them is not stated in the original specification. Furthermore, the original specification lists a number of compounds not shown in Table 6 as recited in original claim 1. In a case of selecting only HFO-1243zf and combining it with HFC-245cb and HFO-1234yf, despite that, to form a composition comprising the three compounds, it is considered necessary to provide a description that would motivate a person skilled in the art to derive such composition; however, there is no such description.”

 

“In light of the above, the technical matter that can be derived by a person skilled in the art comprehensively from the entire descriptions in the original specification, claims, or drawings is merely as follows: in the preparation of HFO-1234yf, which is a compound with low global warming potential (GWP), there exist impurities and side-reaction products in HFO-1234yf or its raw materials (HCFC-243db, HCFO-1233xf, and HCFC-244bb) in small amounts as specific “additional compounds”. Such disclosure should be regarded as a discovery rather than an invention. If the technical matter derived from the descriptions in the original specification, etc. is only of this nature, amending the composition to be composed of a combination of the three specific compounds among many listed compounds (the Amendment) must be evaluated as introducing a new technical matter that is different from the original specification, etc. in view of the fact that, as stated above, there is no description in the original specification, etc. that is sufficient to understand the technical significance of deriving such a specific combination. Therefore, the Amendment is determined to introduce a new technical matter in relation to the technical matter derived from the descriptions in the original specification, etc.“

 

 

 

When a specific combination is selected from multiple alternative compounds, such combination is determined to be addition of new matter if the composition composed of the specific combination is not disclosed in the specification or cannot be derived as an obvious matter. This determination can be interpreted as a reasonable determination in line with the current examination guidelines.

It should be noted that when making an amendment to Markush claims, selecting a combination of alternatives that is not specifically described in the specification is likely to be determined to be addition of new matter.

In addition, with regard to the combinations of alternatives that are important for business strategy and that may be selected in the claims through future amendments, it is advisable to describe the specific combinations in the specification as of the filing.

If an applicant wishes to make an amendment to limit to a specific combination that is not stated in the original specification, the amendment must satisfy slightly higher requirements.

Specifically, in order for such amendment to be accepted, the combination is required to relate to a technical matter that is obvious from the original specification even if there is no description of the combination in the original specification.

In order to be “technical matter obvious from the original specification,” it is necessary to satisfy the following requirement: based on the judgment criteria indicated in the decision by the Intellectual Property High Court on December 25, 2009 (2009, (Gyoke) No. 10131), the technical matter (the combination) itself is a well-known technical matter in the technical field to which the invention belongs, and it can be easily determined that a person skilled in the art who reads the original specification can naturally extract the combination in view of the purpose of the invention described in the original specification, and the technical matter may be deemed as being stated in the original specification.

 

 

Edited by Yusuke Tsuji