[author: Dr. Shoichi Okuyama*]

Product-by-process claim drafting and interpretation practice were greatly modified by the Pravastatin Sodium Case decisions (Japan Supreme Court, June 5, 2015, Second Petty Bench, case Nos. 2012(ju)1204 and 2012(ju)2658).  Japan's highest court reversed the Grand Panel of the IP High Court; two points were emphasized in the opinion of the Court:

Products made by a Different Process Infringe the Claim:  "[E]ven if a patent claim concerning a product invention recites the manufacturing process of a product, the technical scope of the patented invention should be determined to cover products that have the same structure and characteristics, etc., as those of the product made in accordance with the manufacturing process."

Product-by-Process Claims When Only Way to Define Product:  "[W]hen patent claims concerning a product invention recite the manufacturing process of a product, the claims would satisfy the requirement [that] "the invention be clear" according to Article 36(6)(ii), Patent Act, only if circumstances exist under which it is impossible or utterly impractical to directly identify the structure or characteristics of the product at the time of filing."

An analysis follows, with more expansive extracts from the Supreme Court opinion at the end of this paper.

The Supreme Court Lipase Decision (1991):  The Supreme Court in this decision recognized the importance of the public notice function of patent claims.  Citing the Lipase Decision, the Court in the Pravastatin Sodium Case reiterated the public notice function of patent claims.  In the earlier Lipase Decision the Supreme Court rejected the idea of reading a limitation from the specification into pending claims.  The Tokyo High Court (now IP High Court) read "lipase" in the claim as the species "Ra lipase" because all examples in the specification in the context of the patent examination proceedings were for Ra lipase.  The Lipase Decision was an appeal from a JPO decision to reject the application.

The Supreme Court stated that:

When the patentability requirements according to Article 29(1) and (2), Patent Act are examined; that is, the novelty and inventive step of an invention found in a patent application, the gist of the invention in the application has to be determined in order for the invention to be compared with prior art defined in Article 29(1).  Unless special circumstances exist, this determination of the gist has to be made based on the recitations in the claims.  Only if special circumstances exist such as when the technical meaning of a recitation in the claim cannot be understood without ambiguities, or when it is apparently clear that such recitation is an error with reference to the detailed descriptions of the invention in the specification, it is permitted to refer to the detailed description of the invention in the specification.

The Supreme Court has thus apparently Justice Yamamoto's sharply worded Concurrence once again rejected the idea of differentiating the scope of a patent claim based on circumstances or conditions that exist outside the claim.

Justice Yamamoto's Sharply Worded Concurrence:  Justice Yamamoto, who started his career as a bureaucrat at the Ministry of International Trade and Industry (now the Ministry of Economy, Trade and Industry), concurred with the Judgement but criticized the majority opinion.

Supreme Court Reference to American Court decisions:  In the supporting opinion, Justice Chiba discussed the en banc decision of the Federal Circuit in Abbott Labs. v. Sandoz, Inc. (2009), and the Nautilus United States Supreme Court decision.

Implications for Product-by-Process Claiming:  Under these new Supreme Court decisions, the Japan Patent Office now has to examine patent applications containing product-by-process claims to determine whether or not any circumstances exist under which it was impossible or utterly impractical to directly identify the structure or characteristics of the product at the time of filing.  The burden rests on the applicant to show to show such circumstances existed as of the filing date.  It is generally not easy to show that something is impossible to accomplish while it may be easier to show the contrary.  Also, the applicant may have to make sure that the structures or characteristics of, say, antibiotics, microorganisms or modified cells are described in detail in the patent application, although claims identifying such structures or characteristics may be more difficult to understand.

Questioning the Validity of Existing Patents:  The validity of existing patents that have product-by-process limitations in the claims may have to be questioned.

* * *

Pravastatin Sodium Case
Case No. 2012 (ju) 1204
Patent infringement case demanding injunction
June 5, 2015
Ruling of the Second Petty Bench

Excerpts from the opinion**

Judgement

The original decision is reversed.

The case is remanded to the Intellectual Property High Court.

Reason

Concerning the first, second, fourth, and fifth points raised in the Petition for Acceptance of Final Appeal by appeal attorney Kiyoshi Kamiya.

1        In the present case, the appellant, who has a patent including a so-called product-by-process claim which recites the manufacturing process of a product with the patent being granted on a product invention, asked for an injunction on the manufacture and sale of pharmaceutical products the appellee produces and the disposal of such products, because the appellee's pharmaceutical products allegedly infringe on the appellant's patent.  The appellee asserts, for example, that such pharmaceutical products does not fall under the technical scope of the patented invention of the appellant.  An issue in dispute is how the technical scope of a patented invention should be determined when the manufacturing process is recited in a patent claim directed to a product invention.

2        Summary of the original court decision and determined facts are as follows.

(1) The present patent
The appellant has a patent on an invention entitled "Pravastatin sodium substantially free of pravastatin lactone and epi-pravastatin, and compositions containing same," (patent No. 3,737,801, and the number of claims is nine. Hereinafter, it is called "the subject patent.")

(2) The present invention
Claim 1 of the claims of the patent (hereinafter referred to as "the subject claim.") is as follows (hereinafter referred to as "the present invention").
"Pravastatin in which the mixing amount of the pravastatin lactone is less than 0.5 wt%, pravastatin sodium contamination of epiprava is less than 0.2% by weight, prepared by a process comprising the following steps:
    a) forming a concentrated organic solution of pravastatin;
    b) precipitating pravastatin as an ammonium salt thereof;
    c) purifying the ammonium salt by recrystallization;
    d) transposing the ammonium salt to the pravastatin sodium; and
    e) isolating pravastatin sodium."

(3) The appellee's product

A. The appellee manufactures and sells pravastatin Na salt tablets 10mg of the drug "KH" (formerly known as pravastatin Na salt tablets 10mg "Merck", hereinafter referred to as "the appellee product".).

B. The appellee's product contains pravastatin sodium that has less than 0.5 wt% of mixed pravastatin lactone and less than 0.2 wt% of mixed epiprava.  Its method of manufacture, at least, does not involve "a) forming a concentrated organic solution of pravastatin" recited in the subject claim.

3        The original decision made determinations as follows and dismissed the demand of the appellant.

(1) The technical scope of a patented invention, when the manufacturing process of a product is recited in patent claims directed a product invention, the technical scope of such invention should be limited to products manufactured according to the manufacturing process described in the claim, unless there exist circumstances in which it is impossible or difficult at the time of filing to directly identify the product by its structure or characteristics.

(2) Since no such circumstances as in (1) above exist for the present invention, the technical scope of the present invention should be limited to those produced by the production process.  The process for making the appellee's product does not involve at least "a) forming a concentrated organic solution of pravastatin" recited in the subject claim, the appellee's products do not fall within the technical scope of the present invention.

4        However, we cannot accept the criteria indicated in 3(1) above discussed in the original decision, and we cannot accept the determination made on the basis of such criteria discussed in 3(2) above.  The reasons for this are as follows:

(1) The claims attached to the application has the function of defining the technical scope of the patented invention based on what is described in the claims (Article 70(1), Patent Act), and also determining the gist of the invention in the patent application for which examination of patentability requirements such as those prescribed in Article 29 of the same Act is carried out based on what is in the claims (Supreme Court decision of March 8, 1991, Case No. 1987(gyotsu), the ruling of the Second Petty Bench, published in Minshu, Vol. 45, No. 3, page 123).  While patents are granted on product inventions, method inventions, and inventions of processes for producing products, when a patent is granted on a product invention, the effect of the patent covers products that have the same structure and characteristics, etc. as those of the patented product without any regards to the manufacturing process.

Therefore, even if a patent claim concerning a product invention recites the manufacturing process of a product, the technical scope of the patented invention should be determined to cover products that have the same structure and characteristics, etc., as those of the product made in accordance with the manufacturing process.

(2)  By the way, according to Article 36(6)(ii), Patent Act, recitations in the claims have to satisfy the requirement that "the invention be clear".  The patent system is to provide protection over inventions for patentees by granting patents that are monopolistic rights to those who disclosed inventions, and encourage the utilization of inventions by letting third parties know of patented inventions, for the purpose of encouraging inventions, and thereby contributing to the development of industry (Article 1, Patent Act).  We understand that the requirement of clarity of the invention in the claims according to Article 36(6)(ii) is provided for this purpose.  In view of this, in every case where the manufacturing process of a product is described in a patented claim directed to a product invention, if the effect of the patent is determined in such a manner that the technical scope of a patented invention is determined to cover products that have the same structure and characteristics, etc. as those of the product made in accordance with the manufacturing process, it is problematic in that third party interests may possibly be unjustifiably prejudiced.  In other words, if the manufacturing process is recited in a patented claim directed to a product invention, it is generally unclear what structures or characteristics of the product are represented by the manufacturing process, or it is unclear whether the technical scope of the claim directed to a product invention is limited to products manufactured by the manufacturing process.  The reader of such recitation in the claims cannot clearly understand the content of the invention, and it makes unpredictable what scope of monopoly the proprietor has.  This is not entirely appropriate.

On the other hand, in patent claims directed to a patent for a product invention, such product is ordinarily identified by clearly reciting its structure and characteristics in a direct manner.  However, depending on the nature, property or the like of the product, it may be technically impossible to analyze its structure or characteristics at the time of filing, or it may require an outrageously large economic expenditure or time to carry out work necessary to identify.  In view of the nature of patent applications which requires speed, etc., there may be cases where it is not practical to require applicants such identification.  Therefore, it should be made possible to recite a manufacturing process in a claim directed to a product invention.  If the above-mentioned circumstances exist, third party interests would not be unjustifiably harmed even if the technical scope of the patented invention is determined to be products that have the same structure and characteristics, etc. as those of the product made by such manufacturing process.

As we have discussed above, when patent claims concerning a product invention recite the manufacturing process of a product, the claims would satisfy the requirement of "the invention be clear" according to Article 36(6)(ii), Patent Act, only if circumstances exist under which it is impossible or utterly impractical to directly identify the structure or characteristics of the product at the time of filing.

5        Differing from the above, the judgement in the original decision, which says that when the manufacturing process of a product is recited in the claims, while generally allowing such recitation in the claims, the technical scope of the patented invention should be determined to be limited, as a rule, to products manufactured according to the manufacturing process described in the claim, contains a clear violation of law which affects the conclusion of the decision.  The drift of the arguments is reasoned, and the original decision has to be reversed.  Then, the case is remanded to the original court, so that in accordance with what is discussed in this decision, proceedings should be completed concerning whether the recitation in the claims satisfies the requirement of "the invention be clear" and allowable when the circumstances discussed in section 4(2) above exist, and the technical scope of the invention should be determined.

Thus, in the opinion of the justices unanimously, it is ruled as in the Judgment.  In addition, Justice Katsumi Chiba has a supporting opinion[1], and Justice Tsuneyuki Yamamoto has an opinion[2].

 -- The rest of the decision has not been translated --