Interpretation of Product by Process Claims in Japan

1. Introduction

A product by process claim (hereinafter referred to as “PBP claim”) relates to an invention of a product, of which claim includes a manufacturing method of the product.

In Japan, the drafting practice of identifying a product by the manufacturing method of the product conventionally has been regarded as allowable when identifying the structure of the product to be the subject matter directly from physical properties or the like without referring to the manufacturing method thereof is impossible, difficult, or inappropriate in some terms[1].

In Japan, two issues had been pointed out primarily regarding the PBP claim. The first is the issue of interpreting the PBP claim, and second is the issue of clarity.

The first issue relates to whether the product recited in the form of the product by process is narrowly interpreted as a product manufactured by the manufacturing method (so-called Manufacturing Process Limitation Theory), or would not be interpreted narrowly as aforementioned (so-called Product Identity Theory).

Furthermore, the second issue relates to the scope of the invention becoming less clear due to product identification based on a process compared to a case where identification is based on structures and properties.

In regard to these issues, the Supreme Court established a new standard unique to Japanese practice in its ruling of June 5, 2015, on the Second Petty Bench of Supreme Court, for the Pravastatin Na case.

 

2. Overview of Case

In the present case, Teva Pharmaceutical Industries Ltd. (hereinafter, Teva), the owner of the patent right (Japanese Patent No. 3737801) related to “Pravastatin sodium substantially free of pravastatin lactone and EPI-pravastatin, and compositions containing same,” insisted that a pharmaceutical product manufactured and sold by Kyowa Hakko Kirin Co., Ltd. (hereinafter, Kyowa Hakko Kirin) infringed the patent right, and demanded an injunction and disposal of stock therefor.

In connection with determination the technical scope of the PBP claim, the Tokyo District Court (March 31, 2010; Heisei 19 (Wa) 35324) ruled that it should be interpreted by limiting the scope to the product manufactured by the manufacturing method, unless other special circumstances apply. In addition, the demand by Teva was dismissed in the present case because the pharmaceutical product of Kyowa Hakko Kirin is not dependent on the process recited in the technical scope of the patent of the present case.

The Grand Panel of the IP High Court, which is the appeal court of the trial in the Tokyo District Court, (January 27, 2012; Heisei 22 (ne) 10043) had set the presence or absence of a situation in which it would have been either impossible or difficult to have directly identified the product from its structure or property at the time of filing as judgment criteria (hereinafter, “impossibility/difficulty criteria”), and made classification in which the PBP claim is genuine when such a situation is present, and is pseudo when such a situation is not present. Furthermore, as to the interpretation of the PBP claim, it ruled that the genuine PBP claim is to be interpreted based on Product Identity Theory and the pseudo PBP claim is to be interpreted based on Manufacturing Process Limitation Theory, in both the case of determination the technical scope of the patented invention and the case of identifying the gist of the invention. On this premise, a determination was made as being a pseudo PBP claim because the claim did not satisfy impossibility/difficulty criteria in the present case, and the pharmaceutical product of Kyowa Hakko Kirin is not dependent on the process described in the technical scope of the patent, thus the appeal by Teva was dismissed.

 

3. Supreme Court Ruling

The Supreme Court reversed the ruling of the Grand Panel of the IP High Court.

It ruled that the technical scope of the patented invention and the gist of the invention regarding the product invention described in the form of PBP claim are determined as a product having the same structure, property, and the like as a product manufactured by the manufacturing method. That is, it was clarified that the interpretation of the PBP claim is based on Product Identity Theory.

Furthermore, the Supreme Court ruled that “a limitation is made to cases where a situation is present at the time of filing, in which it is either impossible to directly identify the product from its structure or property, or such is not at all practical” for the description in the PBP claim format to satisfy the clarity requirement of Article 36(6)(ii), and in the event such a situation is not present, the clarity requirement would thereby be violated. That is, the Supreme Court presented new criteria on “the presence of the situation at the time of filing, in which it is either impossible to directly identify the product from its structure or property, or such is not at all practical” (hereinafter, “impossibility/impracticality criteria”) as criteria as to whether the PBP claim satisfies the clarity requirement.

Furthermore, the present case was referred back to the IP High Court so that a thorough trial discussion on whether or not the description of the claims of the present case satisfies the clarity requirement could be conducted.

 

4. Consideration

(1) 1994 Patent Law Revision and Current Examination Guideline

The 1994 Patent Law Revision revised the requirements of Article 36(5), and moderated the description requirement on the claims. As a result, it was clarified that what is to be described in the claims is wholly up to the patent applicant’s free selection. Therefore, claims have been allowed to describe so-called functional claims and PBP claims.

In response to this legal revision, the current examination guideline defines that descriptions identifying the product itself by the manufacturing method of the product are allowable when identification of the structure of the product to be the subject matter directly from physical properties or the like without referring to the manufacturing method thereof is impossible, difficult, or inappropriate in some terms (hereinafter referred to as “impossible/difficult/inappropriate situation.”[2][3]

 

(2) Problem of Clarity Requirement for PBP Claims

The criteria of the impossible/difficult/inappropriate situation as employed by the current examination guideline allows the description of the PBP format also in fields such as machines, in which the need to identify a product by a process is generally not recognized.

As a result, in the examination on the clarity requirement of the invention described in the PBP claim, the presence and absence of the impossible/difficult/inappropriate situation are not substantially determined. Accordingly, it can be said that the clarity requirement for PBP claims had been moderate then.

However, it seems that the Supreme Court regards that PBP claims are admitted as exceptions, and consideration on whether or not the situation under which the PBP claims should be admitted should be made strictly. The Supreme Court had now newly set forth impossibility/impracticality criteria for testing the presence and absence of the clarity of PBP claims.

It is not necessarily clear as of now what these impossibility/impracticality criteria are, and we must wait for an accumulation of prospective rulings. However, according to the supplemental opinion of Judge Katsumi Chiba, “impossible” refers to a case where analysis and identification of the product to be the subject matter according to its structure and property (property herein refers to a property that is appropriate and meaningful in terms of indicating that the invention is different from other inventions, upon a determination on the novelty and inventive step of the invention) at the time of filing is impossible for a person skilled in the art primarily from a technical viewpoint. Furthermore, “not at all practical” anticipates a case where identification work cannot be conducted practically in terms of cost rather than the technical aspects thereof, at the time of filing for a person skilled in the art, where time and cost are burdensome, and the requirement for such identification work would be excessively severe in patent-obtaining circumstances that are under the rapid technological development and harsh international competition.

Nonetheless, in the prospective practices, when the PBP claim is determined not to comply with impossibility/impracticality criteria, it would be treated as violating the clarity requirement. As a result, it can be said that the possibility of descriptions in the PBP claim format being rejected or invalidated has been increased.

 

(3) Problem of Interpreting PBP Claims

(i) In regard to the interpretation of PBP claims, Manufacturing Process Limitation Theory, which insists that interpretation should be limited to a product manufactured by the process described in the claim, and Product Identity Theory, which insists that the process is described for identifying the product, and coverage of the claim encompasses products that are identical to the product manufactured by the method, had long been causing controversy. Furthermore, rulings by the courts had also been split by these theories.

On the one hand, in the current examination guideline, if the invention of a product is identified and described in the PBP claim format, that description is normally understood as meaning the produced product itself that is obtained as a final product, and the gist of the invention is identified based on Product Identity Theory. This also applies similarly to a number of court trials against JPO Appeal Decisions.

In the present case, the Supreme Court ruled that the interpretation of the PBP claims would be made under the Product Identity Theory, assuming that the product has structure, property, and the like that are identical to those of the product manufactured by the manufacturing method, either in the event of determination the technical scope or of identifying the gist of invention.

(ii) The reason why the Supreme Court has unified the interpretation of the PBP claims in both events is as follows. That is, the 2004 Patent Law revision has enabled the accused infringer to refute by insisting on the invalidity of patent in infringement trials (Patent Law Article 104_ter). As a result, in an infringement trial, upon determining the presence and absence of infringement, the aspect of determination the technical scope of the patented invention and the aspect of identifying the gist of the invention in allowing refutation based on the invalidity of the patent are taken into consideration at the same time. Under such circumstances, it would be unreasonable to employ different interpretations depending on the aspects, based on either Product Identity Theory or Manufacturing Process Limitation Theory, in the interpretation of PBP claims. Thus, the court decided to integrally refer to the interpretation of PBP claims in both aspects, thus it has employed Product Identity Theory.

Furthermore, by the present Supreme Court ruling, a conclusion has been presented that the gist of an invention should be identified based on Product Identity Theory. This point complies with the current examination guideline, and it seems that its impact in practice is small.

However, as described in 3. above, the Supreme Court has newly employed the impossibility/impracticality criteria, and presented its judgment that any PBP claims that do not satisfy these criteria should be rejected under the clarity requirement. As a result, in the event of identifying the invention of a product in a PBP claim format, the applicant must be even more careful. Especially in the fields of chemistry and biotechnology, identifying the invention of a product in the PBP claim format based merely on a snap judgment requires greater care.

(iii) Furthermore, in the present Supreme Court ruling, it has been clarified that a determination based on Product Identity Theory is to be made even in the aspect of determination the technical scope of a patented invention.

According to the foregoing academic theories, the claims serve the function of publicly announcing the scope of a patent right, and there had been some indications that an interpretation based on the PBP claims grounded on Product Identity Theory would make the scope of the patent right obscure[4]. Furthermore, because PBP claims do not have a broader meaning than identifying a product by process, there have been some indications of a risk that the technical scope of a patented invention is interpreted too broadly[5].

The present Supreme Court ruling seems to suggest there are more advantages for the patentee because Product Identity Theory has been employed also in the aspect of determination the technical scope of the patented invention. However, at the same time, PBP claims need to satisfy the clarity requirement based on impossibility/impracticality criteria. As a result, even if the invention of a product that had been allowed to directly identify itself from its properties and the like is patented in the PBP claim format, it may be invalidated as above; thus, it is considered that, at least for such an invention, the right would be prevented thereby from being exercised under the over-broadly interpreted technical range.

 

5. Tips on Filing Japanese Applications

In regard to the interpretation of PBP claims, the United States makes judgments based on Product Identity Theory for identifying the gist of an invention, and makes judgments based on Manufacturing Process Limitation Theory for determination the technical scope of a patented invention. Furthermore, in the European Patent Convention (EPC) as well, a determination is made at the prosecution stage based on Product Identity Theory[6]. However, interpretation of PBP claims upon the exercise of right is determined uniquely in each country.

Accordingly, as to the interpretation of PBP claims upon identifying the gist of an invention, Japan takes the same approach as the United States and EPC. However, in the present Supreme Court ruling, Japan employed impossibility/impracticality criteria, as a result of which the clarity requirement for PBP claims is to be judged more strictly than before. As a result, when filing Japanese applications that contain PBP claims, attention should be given to whether or not those PBP claims satisfy impossibility/impracticality criteria. Furthermore, for those that have already been patented, it should be noted that the possibility of their invalidation or cancellation has been increased.

Furthermore, similar to the case of identifying the gist of an invention, the Supreme Court ruling employed Product Identity Theory likewise for determination the technical scope of the patented invention at the right-exercising stage. As a result, attention should be paid hereto as well because Japan has now come to employ an interpretation method that differs at least from that of the United States.

Notably, in response to the current Supreme Court ruling, JPO announced that it would employ impossibility/impracticality criteria in examinations from July 6, 2015. Furthermore, adaptation of impossibility/impracticality criteria will not be limited to those filed hereafter, but will also be applied to those already filed. Moreover, it also plans to revise the examination guideline sometime around October 2015.

 

[1] JPO Examination Guideline, Part I, Chapter 1, 2.2.2.4(2)①(i)

[2] JPO Examination Guideline, Part I, Chapter 1, 2.2.2.4(2)①(i)

[3] Tokyo High Court, ruling of June 11, 2002; Heisei 11 (gyo-ke) 437

[4] Ryuichi Shitara and Yugo Ishigami, “Interpretation on Product By Process Claims,” Top 100 Patent Rulings [Ver. 4], page 131

[5] Shitara, as afore-noted

[6] Guidelines for Examination in the EPO Part F, Chapter IV, 4.12