Let us introduce the court precedent related to presumption of production process (Article 104 of the Patent Act) in Japan (Appeal Case Seeking Injunction against Infringement of Patent Right (Intellectual Property High Court decision on February 9, 2022, Case No. 2020 (Ne) 10059)).

This case is a dispute over whether the presumption of production process (Article 104 of the Patent Act) is applicable.

 

 

 

 

Article 104 of the Patent Act was stipulated in view of difficulty of proving infringement of an invention of a process for producing a product. The provision aims to shift the burden of proof of infringement under certain conditions when the patented invention is an invention of a process for producing a product.

 

In principle, a plaintiff (patent right holder) is responsible for alleging and proving that the defendant’s act constitutes infringement. However, when a patent is granted on an invention of a process (process for producing a product), it is not easy to prove that an act has been made by infringing on the process.

On the other hand, if the product produced by the process of the patented invention is not publicly known in Japan prior to the filing of the patent application, it is considered highly probable that the same product as produced by the process of the patented invention is the product produced by that process.

This provision presumes that the alleged product has been produced by the patented process as long as the alleged product is proved to be the same as the product produced by the process of the patented invention, in order to ensure fairness in litigation.

 

 

 

In the present case, the Appellant, who is the patentee of a patent for an invention of a method for producing a product (Patent No. 6275313 (hereinafter, the “Patent”), sought against the Appellees A and B (hereinafter, the “Appellees”) an injunction against production and transfer, etc. and the disposal of the material (hereinafter, the “Appellees’ Material”) and the product (hereinafter, the “Appellees’ Product”).

 

[Appellant’s allegations]

The Appellant’s allegations are as follows.

-   The method by which Appellee A produces the Appellees’ Material (hereinafter, the “Appellees’ Method”) falls within the technical scope of the invention of the Patent.

-   Appellee A’s acts of producing and transferring the Appellees’ Material and Appellee B’s acts of producing the Appellees’ Product by using the Appellees’ Material purchased from Appellee A and transferring, etc. the Appellees’ Product correspond to infringement of the Patent.

 

 

 

The Patent is a patent obtained by filing a divisional application of an application (national phase application (Japanese Patent Application No. 2009-519326) of an international application (PCT/JP2008/060913)) (hereinafter, “Original Application”). This international application was made by claiming the internal priorities of the following three basic applications (A) – (C):

(A) Japanese Patent Application No. 2007-156822;

(B) Japanese Patent Application No. 2007-156825; and

(C) Japanese Patent Application No. 2007-156833,

all of which were filed on June 13, 2007.

A number of divisional applications have been filed in relation to the Original Application, and the Patent in question has been granted for the third divisional application (Japanese Patent Application No. 2017-125880). A request for correction was filed in the invalidation trial of the Patent, and the correction has been finalized. The constituent features of the corrected invention of claim 1 (hereinafter, “Patented Invention”) are as follows (the underlined parts indicate the corrections).

[A’]:   A method for producing a powdery fermented substance containing ornithine and equol: comprising:

[B’]:   adding arginine to at least one daidzein compound selected from the group consisting of daidzein glycosides, daidzein, and dihydrodaidzein; and

[C’-1]:  applying a fermentation treatment to a fermenting material containing the daidzein compound and the arginine

[C’-2]:  by using a microorganism having the ability to produce ornithine and equol, wherein

[D’]:   not less than 8 mg ornithine and not less than 1 mg equol per gram by dry weight of the fermented substance are produced by the fermentation treatment, and

[E’]:   the fermented substance is used as a food material.

 

 

 

The Appellees’ Method is as follows.

[α1]:  A method for producing a powdery fermented substance containing ornithine and equol, comprising:

[α2]:  isoflavone containing daidzein (approximately 50% by weight), which is a daidzein glycoside, and a small amount (approximately 1% by weight) of daidzein

[α3]:  being subject to an enzyme treatment to cleave the sugar in daidzein, which is a daidzein glycoside, to form daidzein,

[α4]:  a treatment solution containing the daidzein obtained through the enzyme treatment, … (omitted) … being mixed with a culture solution containing arginine to be subject to a fermentation treatment, wherein

[α5]:  not less than 18.40 mg ornithine per gram and approximately 6.6 g equol per 100 grams (66 mg per gram) are produced by the fermentation treatment, and

[α6]:  the fermented substance is used as a food material.

 

Fermented soy germ extract

Product name: FlavoCel EQ-5

 

 

 

Issue 1: Whether the Appellees’ Method falls within the technical scope of the Patented Invention

Issue 2: Whether the Patent deserves to be invalidated in a trial for patent invalidation

Issue 3: Whether the correction to the Patent does not fulfill the requirement for the correction

Issue 4: Whether it is necessary to seek an injunction and disposal against Appellee B

 

This time, we will focus on Issue 1. Explanation of Issues 2-4 are omitted.

 

 

 

The Appeal Court (Intellectual Property High Court) judged as follows as to whether the Appellees’ Method falls within the technical scope of the Patented Invention.

 

(i)  The Appellees do not indicate approval or disapproval of the fact that the Appellees’ Material constitutes the product of the Patented Invention (hereinafter, “Patented Invention Product”), and do not clarify the fact, so the Appellees are deemed to have admitted the fact that the Appellees’ Material constitutes the Patented Invention Product (Article 159, paragraph (1) of the Code of Civil Procedure).

In that case, if the Patented Invention Product was not publicly known in Japan prior to the filing of the patent application for the Patent, the Appellees’ Material is presumed to have been produced using the method of the Patented Invention.

 

(ii)  In order for a product (i.e., Appellees’ Product) to have been “publicly known” as referred to in Article 104 of the Patent Act, there should at least be a fact that was sufficiently known to enable a person skilled in the art to acquire clues for producing that product as of the reference date (i.e., priority date). However, it cannot be said that the Patented Invention Product was described in the evidence documents, which were publicly known as of the priority date, and hence a person skilled in the art could not have easily conceived of the Patented Invention from the evidence documents.

In that case, a person skilled in the art who read the above evidence documents could not have been able to acquire clues for producing the Patented Invention Product as of the priority date.

It can be said that the Patented Invention Product was “not publicly known” as of the priority date.

 

 

 

In the court ruling prior to this case (Tokyo District Court on July 21, 1972 (Tetracycline Case)), the court decision was that the judgment of whether the requirement for the application of Article 104 (specifically, the requirement “not publicly known” in Article 104) is satisfied must be made separately from the determination of patentability.

In the present case (Appeal Court decision), in order to fall under the category of “not publicly known” in Article 104, it is determined necessary that not only the Patented Invention is not described in publicly known technical documents at the time of the priority date but also the Patented Invention is not described in publicly known technical documents “enough to acquire clues” for conceiving the product obtained by applying the production method of the Patented Invention.

Conversely speaking, the fact that it is required not to be described in the publicly known technical documents “enough to acquire clues” could mean that, for example, if a combination of a plurality of publicly known technical documents can lead to a product obtained by the production method of the Patented Invention, the requirement “not publicly known” in Article 104 is no longer satisfied. This is a way of thinking that sounds close to the logic when determining the presence or absence of inventive step, which is an interesting point in consideration of the Tetracycline Case above. It is worthwhile to continue to watch whether the application of Article 104 will be judged by applying a logic close to determination on the presence or absence of inventive step in the future, as in the present case (Appeal Court decision).

 

 

 

In the present case, the Appeal Court (Intellectual Property High Court) approved that, as a result of interpretation in consideration of the common technical knowledge as of the priority date, in addition to the description of the basic application, the Patented Invention can be read from the basic application even if the “material containing a daidzein compound” other than a “soybean hypocotyl” is used as a fermenting material. In other words, the validity of the priority claim was approved.

The Examination Guidelines for Patent and Utility Model in Japan stipulate that “the effects of internal priority claim shall not be recognized where such amendment introduces new technical matters to the claimed invention relative to the matters stated in the originally attached descriptions etc.”, and there is no explicit statement regarding consideration of common technical knowledge. However, common technical knowledge at the time of filing (priority date) can be an important factor at the examination stage, infringement disputes, etc.

In this regard, we should be fully aware once again that the priority claim was approved in the judgment of this Appeal Court in consideration of the common technical knowledge.

 

 

Edited by Makoto Iwata