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Supreme Court Case Summary:2012 (Ju) 2658: 

<Invention>

The title of the invention at issue is “Pravastatin Sodium substantially free of Pravastatin Lactone and Epi-Pravastatin, and Compositions containing the same”. Claim-1 is “Substantially pure pravastatin sodium, containing less than 0.5% pravastatin lactone and less than 0.2% epiprava, prepared by a process comprising the steps of:

 a) forming an organic solution of pravastatin;

 b) obtaining solid pravastatin as a pravastatin salt;

 c) purifying the pravastatin salt by recrystallization;

 d) transposing the cation of the pravastatin salt to pravastatin sodium; and,

 e) isolating pravastatin sodium substantially free of pravastatin lactone and  epiprava.”

Pravastatin Sodium

<IP High Court Decision> 2011 (Gyo-ke) 10287

IP High Court decided that if there are no such circumstances as that it is impossible or difficult to directly specify the technical scope of a product-by-process claim by means of the structure or feature of the product at the time of filing an application (Unauthentic Product-by-Process Claim), the technical scope is limited to products manufactured through the manufacturing process stated in the claim.

However, if there are such circumstances as above (Authentic Product-by-Process Claim), the technical scope is the final product in itself and is not limited to the manufacturing process stated in the claim.

In this case, claim-1 belongs to Unauthentic Product-by-Process Claim, then the technical scope is limited to products manufactured through the manufacturing process stated in the claim.

<Supreme Court Decision>

(1) Technical Scope

Supreme Court ruled that the technical scope of a product-by-process claim belongs to the final product in itself and is not limited to the manufacturing process stated in the claim. Then, Supreme Court denied the interpretation as above by IP High Court.

(2) Requirement for Clarity of claims

Supreme Court ruled that a product-by-process claim can satisfy the requirement for the clarity of claims only if it is impossible or almost unpractical to directly specify the technical scope of a product-by-process claim by means of the structure or feature of the product at the time of filing an application.

<Comments>

This Supreme Court decision is in the case of the patent invalidation. In addition, another Supreme Court decision (2012 (Ju) 1204) in the case of the patent infringement ruled the same as this Supreme Court decision. Then, the interpretation of a product-by-process claim is the same between the case of the patent invalidation and the case of patent infringement, which is also the same as the rule under the present Examination Guideline issued by the JPO. This is an important point of view.

According to this Supreme Court decision, the technical scope of a product-by-process claim becomes broader than before, which is advantageous for the patentee.

On the other hand, the requirement for the clarity of a product-by-process claim, ruled by this Supreme Court decision, seems to be severe. Applicants might try to avoid a product-by-process claim from now. However, a product-by-process claim has played an important role as one of the types of claims so far.

Japan Patent Office (JPO) announced on July 6 that a product-by-process claim would be examined in the JPO according to this Supreme Court decision on the requirement for the clarity of a product-by-process claim for the time being. JPO also announced on July 6 that the revision of Examination Guideline will be discussed in the JPO from now.

http://www.courts.go.jp/app/files/hanrei_jp/144/085144_hanrei.pdf