Date

January 27, 2012

Case number

2010 (Ne) 10043

CourtIntellectual Property High Court,Special Division– A case in which, with regard to how to define the technical scope of a claim that isgenerally referred to as a product-by-process claim, the court ruled that if there are nosuch circumstances as that it is impossible or difficult to directly specify the technicalscope of a product-by-process claim by means of the structure or feature of the productat the time of filing an application, the technical scope is limited to products
manufactured through the manufacturing process stated in the claim– A case in which, with regard to a defense under Article 104-3 of the Patent Act, thecourt ruled that, in the process of recognizing the gist of a claim that is generally
referred to as a product-by-process claim, if there are no such circumstances as that it
is impossible or difficult to directly specify the constitution of the product by means of
the structure or feature of the product at the time of filing an application, the gist of theinvention is recognized as being limited to products manufactured through themanufacturing process stated in the claim
References:
Article 29, paragraphs (1) and (2), Article 100, and Article 104-3 of the Patent Act(Summary)
The appellant, who has a patent right for the invention entitled "Pravastatin sodium
substantially free of pravastatin lactone and epi-pravastatin, and compositions
containing the same" (Patent No. 3737801), filed this case against the appellee,
asserting that the appellee's products infringe the appellant's patent right. The appellant
sought an injunction against the manufacturing and sale of the appellee's products anddisposal of the appellee's products in stock.
Claim 1 in the scope of claims of the patent (Invention 1) states a process tomanufacture an invention of a product (this type of claim is generally referred to as a"product-by-process claim").
The major issues of this case are (i) whether the appellee's products fall within thetechnical scope of the inventions in question and (ii) whether the patent should beinvalidated by a trial for patent invalidation. In particular, interpretation of a
product-by-process claim became an issue.
In the judgment in prior instance, the Tokyo District Court made a determinationon the aforementioned issue (i) alone. The court held that, for an invention of a product,when the scope of claims states a process to manufacture the product, it isimpermissible to interpret the technical scope excluding said manufacturing process1unless there are special circumstances such as difficulty in stating the constitution of
the product, and determined that the process to manufacture the appellee's products
does not fulfill the requirements for the manufacturing process of Invention 1. Basedon these holdings, the court dismissed the appellant's claims.
The Intellectual Property High Court indicated the methods of defining thetechnical scope of a product-by-process claim and recognizing the gist of the invention
as follows, and held that the technical scope of the patent and the gist of the claimed
invention are limited to products manufactured in accordance with the requirements
for the manufacturing process stated in Claim 1 of the patent. Accordingly, the court
determined that the judgment in prior instance is justifiable in terms of the conclusion,and dismissed the appeal.
1. Regarding the technical scope of the inventions in question(1) Regarding the definite determination of the technical scope of a patented invention
in a patent infringement lawsuit
A. With regard to the definite determination of the technical scope of a patented
invention in a patent infringement lawsuit, Article 70, paragraph (1)of the Patent Act
provides that "The technical scope of a patented invention shall be determined based
upon the statements in the scope of claims attached to the application." Paragraph (2)of said Article provides that "In the case of the preceding paragraph, the meaning ofeach term used in the scope of claims shall be interpreted in consideration of thestatements in the description and drawings attached to the application."
Therefore, where a claim for an injunction or damages has been made on thegrounds of infringement of a patent right, statements in the "scope of claims" should
be used as standards in definitely determining the technical scope of a patentedinvention, based on which such claim has been made. The statements in the scope ofclaims should be understood as specifically demarcating the technical scope of thepatented invention. If this idea is denied, and a specific "wording" used in the scope ofclaims is interpreted as not intending to limit the technical scope of the invention, thiswill undermine the trust of third parties who acted in accordance with the statements inthe "scope of claims" appearing in the patent gazette, which will result in impairing
legal stability.
Assuming so, where the scope of claims of an "invention of a product" states a"process to manufacture" the product, as it happens in this case, the technical scope of
the invention should be interpreted or definitely determined as being limited toproducts manufactured by said manufacturing process. It is, in principle, impermissible2

to interpret or definitely determine the technical scope of the invention as including
other manufacturing processes beyond said manufacturing process stated in the scopeof claims.
In the case of an "invention of a product," like with the one disputed in this case, it
is desirable that the scope of claims is stated and defined by means of the structure orfeature of the product. However, if there are circumstances where it is impossible ordifficult to directly specify the product by means of the structure or feature of theproduct at the time of filing an application, it is also permissible to specify the productby means of a process to manufacture the product in light of the purpose of Article 1,etc. of the Patent Act, i.e. encouraging inventions and thereby contributing to thedevelopment of industry, and such manner of specifying the product does not seem togo against Article 36, paragraph (6), item (ii) of the Patent Act.
Where there are such circumstances, even if a specific manufacturing process isstated in the scope of claims, such manufacturing process is regarded as being stated
for the purpose of specifying the product, and the technical scope is to be interpreted
and definitely determined as not being limited to products manufactured through themanufacturing process stated in the scope of claims but also covering "products" ingeneral.
B. Where, for an invention of a product, a process to manufacture the product is statedin the scope of claims, such a claim is generally called a "product-by-process claim."
In light of the perspective mentioned in A. above, product-by-process claims as
mentioned above fall into two types, specifically: (i) claims "in which a product is
specified by means of a process to manufacture the product because there arecircumstances where it is impossible or difficult to directly specify the product bymeans of the structure or feature of the product at the time of filing an application (inrelation to this case, such claims are referred to as "Authentic Product-by-Process
Claims" for convenience)"; and (ii) claims "in which a process to manufacture theproduct is stated in addition to a product, though it cannot be said that there arecircumstances where it is impossible or difficult to directly specify the product subject
to the invention by means of the structure or feature of the product at the time of filingan application (in relation to this case, such claims are referred to as "Unauthentic
Product-by-Process
Claims"forconvenience)."
Thecourt
examines
product-by-process claims based on this distinction.
According to A. above, for Authentic Product-by-Process Claims, the technicalscope of the invention is interpreted as "not being limited to products manufactured
through the manufacturing process stated in the scope of claims but also covering any

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"products" that are identical to the products manufactured through said process."
Contrarily, for Unauthentic Product-by-Process Claims the technical scope of theinvention is interpreted as being limited to "products manufactured through themanufacturing process stated in the scope of claims."
In addition, from the perspective of distribution of the burden of proof in a patent
infringement lawsuit, where a manufacturing process is stated in the scope of claims ofan invention of a product, the statement is in principle to be interpreted literally.
Therefore, a person who asserts that the claim falls under Authentic
Product-by-Process Claims should bear the burden of proving that "it is impossible ordifficult to directly specify the product by means of the structure or feature of theproduct at the time of filing an application." If such a person is unable to fully provethis, it is reasonable to regard the claim as an Unauthentic Product-by-Process Claimand to interpret or definitely determine the technical scope of the invention as stated in
the scope of claims.
(2) Regarding Invention 1, there are no "circumstances where it is impossible ordifficult to directly specify the product by means of the structure or feature of theproduct at the time of filing an application." Therefore, Invention 1 should beunderstood as being stated in an Unauthentic Product-by-Process Claim as mentioned
above, and the technical scope thereof is limited to products manufactured inaccordance with the requirements for the manufacturing process.
(3) The appellee's manufacturing process does not fulfill process (a) out of therequirements for the manufacturing process of Invention 1.
According to the above, the appellee's products are recognized as not falling within
the technical scope of Invention 1, without needing to determine other points.
2. Regarding whether the patent should be invalidated by a trial for patent invalidation
According to 1. above, the appellee's products manufactured and sold by theappellee (defendant) do not fall within the technical scope of Invention 1. However, by
way of caution, the court also makes a determination on the issue of whether "thepatent should be invalidated by a trial for patent invalidation," argued by the appellee
as a defense.
(1) Recognition of the gist of the invention
Article 104-3 of the Patent Act provides that "Where, in litigation concerning theinfringement of a patent right or an exclusive license, the said patent is recognized as
one that should be invalidated by a trial for patent invalidation, the rights of thepatentee or exclusive licensee may not be exercised against the adverse party."
However, the gist of the invention, which serves as a premise in determining the4validity of a defense under Article 104-3 of the Patent Act, should be recognized in thesame manner as recognizing the specific content of the claims, which the Japan Patent
Office, the decision-making entity, should understand in the aforementioned procedureof a request for a trial for patent invalidation.
More specifically, regarding the gist of the invention in the case of a
product-by-process claim as mentioned above (where the scope of claims of an"invention of a product" states a "process to manufacture" the product), like with theone disputed in this case, the same reasons as those explained in connection with theaforementioned method of defining the technical scope of a patented invention in apatent infringement lawsuit would apply, that is: (i) if there are circumstances where it
is impossible or difficult to directly specify the constitution of the product subject tothe invention by means of the structure or feature of the product, without referring to
the manufacturing process, at the time of filing an application, the gist of the invention
should be recognized as covering "products" in general, not limited to products
manufactured through the manufacturing process stated in the scope of claims(Authentic Product-by-Process Claim); (ii) if it cannot be said that there are suchcircumstances as mentioned in (i) above, the gist of the invention should be recognized
as being limited to products manufactured through the manufacturing process stated in
the scope of claims (Unauthentic Product-by-Process Claim).
In this case, it is reasonable to understand that a claim should be handled as an
Unauthentic Product-by-Process Claim mentioned in (ii) above when it is not foundthat there are circumstances as mentioned in (i) above.
Examining the present case from the aforementioned perspective, as describedabove, there are no such circumstances as mentioned in (i) above (impossibility of or
difficulty in specifying the product) with regard to the patent. Therefore, the procedure
to recognize the gist of the invention in the process of a request for a trial for patent
invalidation should be carried out while regarding the claimed invention as relating toproducts manufactured through the manufacturing process as stated in the scope ofclaims. Consequently, the same understanding should also apply to a defense underArticle 104-3 of the Patent Act.
(2) Invention 1 is recognized as an invention that a person ordinarily skilled in the art
would have been able to easily make based on the invention disclosed in Exhibit Otsu
No. 30, the document of Exhibit Otsu No. 1, and common general technical knowledge
as of the priority date. Thus, the patent was granted in violation of Article 29,
paragraph (2) of the Patent Act and therefore should be invalidated by a trial for patent
invalidation.

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