Court judgment that established criteria for the technical scope and clarity of product-by-process claims (the "Pravastatin Sodium Case", July 5, 2015, Supreme Court Decision (2012 (Ju) 1204, 2012 (Ju) 2658))
Nov. 22, 2016
The Case
In this case, the issue was whether or not the following product-by-process claim (hereinafter, "PBP claim") of the patent right owned by the plaintiff had been infringed.
Pravastatin sodium prepared by a process comprising the steps of:
(a) forming an enriched organic solution of pravastatin;
(b) precipitating pravastatin as its ammonium salt;
(c) purifying the ammonium salt by recrystallization;
(d) transposing the ammonium salt to pravastatin sodium; and
(e) isolating pravastatin sodium,
and containing less than 0.5 wt% of pravastatin lactone and less than 0.2 wt% of epiprava.
The method of manufacturing the defendants' product did not include step (a).
IP High Court Decision
In the IP High Court's original decision, it was determined that the technical scope of the invention according to a PBP claim "should be determined as being limited to products manufactured by the manufacturing process recited in the claim, except when there were circumstances where it was impossible or difficult to directly define the product subject to the invention by means of its structure or characteristics at the time of the filing of the application (hereinafter such circumstances are referred to as 'impossible or impractical circumstances')", and since no such circumstances existed in the invention of the present case, the technical scope of the invention of the present case should be determined as being limited to a product manufactured by the manufacturing method of the claim, whereby it was determined that the appellees' manufacturing method did not fall within the technical scope of the invention of the present case.
In other words, PBP claims should be divided into the following two categories and the scope of rights is interpreted on a case-by-case basis.
(1) When "impossible or impractical circumstances" existed (a legitimate PBP claim): product identity.
(2) When "impossible or impractical circumstances" did not exist (an illegitimate PBP claim): manufacturing method limitation.
Supreme Court Decision
The Supreme Court delivered the following verdict regarding the IP High Court Decision described above, and remanded the case to the IP High Court.
(1) The technical scope of PBP claims is determined in terms of a product having an identical configuration, properties or the like to the product manufactured by the manufacturing method of the claim.
(2) PBP claims satisfy the clarity requirement of Article 36(6)(ii) only when "impossible or impractical circumstances" existed.
Summary
(1) The technical scope of PBP claims is based on product identity.
(2) PBP claims satisfy the clarity requirement of Article 36(6)(ii) only when "impossible or impractical circumstances" existed.
JPO Response
On November 25, 2015, the JPO added "Examples of arguments and verification presented by applicants involving 'impossible or impractical circumstances' concerning product-by-process claims" to their guidelines dated July 6, 2015, on "Interim Handling Procedures for Examinations and Appeal Trials involving Product-by-Process Claims". According to these examples, PBP claims will be issued with a Notice of Reasons for Rejection unless it can be recognized that "impossible or impractical circumstances" existed, whereupon the applicant may respond by explaining these circumstances in a written Argument or change the PBP claims to manufacturing method claims, for example.
A Revised Patent and Utility Model Examination Handbook was published on March 30, 2016, which has been applied to examinations since April 1, 2016. Of particular note among the revised content is the addition of: "In particular, even if a claim corresponds formally to one of the following types or examples showing 'a case where a claim recites the manufacturing process of the product', when it is clear what configuration or characteristics of the product are represented by the manufacturing process in consideration of the description, claims and drawings, as well as the common technical knowledge at the time of the filing of the application in the technical field to which the invention pertains, the Examiner will not deem that the claimed invention violates the clarity requirement on the grounds that it corresponds to 'a case where a claim recites the manufacturing process of the product'." In the relation to the addition of this content, the case example of "a device having a fixed portion wherein a bolt having a convex portion is inserted into a hole having a concave portion such that the convex portion and the concave portion are engaged, and a nut is screwed to the end of the bolt", which was described among the examples corresponding to "a case where a claim recites the manufacturing process of the product" in the Examination Handbook prior to revision, was deleted as it was deemed to correspond to a case in which "it is clear what configuration or characteristics of the product are represented by the manufacturing process". This case study is henceforth held not to correspond to "a case where a claim recites the manufacturing process of the product". This revision is explained as a change from the initial position of the JPO of strict interpretation of the conclusion of the Supreme Court Decision to a position where the clarity requirement is not held to be violated when it is clear what configuration or characteristics of the product are represented by the manufacturing process.
On September 28, 2016, an account of the JPO's actions to date was made available on the JPO website, entitled "Handling Procedures for Examinations involving Product-by-Process Claims".
Overview of the Supreme Court Decision
http://www.courts.go.jp/app/hanrei_en/detail?id=1365
Handling Procedures for Examinations involving Product-by-Process Claims
https://www.jpo.go.jp/tetuzuki_e/t_tokkyo_e/product_process_C151125_e.htm
Revised Patent and Utility Model Examination Handbook, Part II, Chapter 2, "Requirements for Claims" (2203-2205)
https://www.jpo.go.jp/tetuzuki_e/t_tokkyo_e/files_handbook_sinsa_e/02_e.pdf
Summary prepared by International Information Group
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