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Supreme Court Overturns Grand Panel’s Decision of IPHC and Admits that “Product-by Process” Claim should Cover Same Products Irrespective of Process, But …
Teva Gyogyszergyar Zartkoruen Mukodo Rt. (Patentee) v. Kyowa Hakko Kirin Co., Ltd. (Accused Infringer), Case No. 2012 (Jyu) 1204 (Decision rendered on June 5, 2015)
The Supreme Court overturned a decision of the Grand Panel1) of the Intellectual Property High Court (IPHC) relating to the construction of the scope of a “product-by-process” claim2) rendered in 2012, and ruled that the scope of a “product-by-process” claim should be determined as products having the same structure, properties and the like as a product produced by the process defined in the claim, even though the process of producing the product is defined in the claim. Namely, the Supreme Court admitted that a “product-by-process” claim covers all the products having the same structure or properties as a product produced by the process defined in the claim even if the actual process for producing the product is different from the process in the claim.
Nevertheless, the Supreme Court further decided that in the case of a “product-by-process” claim, clarity requirement (provided in Art. 36(6)(ii) of Patent Law) is satisfied only when there is a reason that makes it impossible or entirely impractical to directly define the claimed product by its structure or properties at the filing of a patent application.
For further examination, the Supreme Court remanded the case to the IPHC. This is the first case that the Supreme Court overturned the Grand Panel’s decision of the IPHC since the IPHC was established in 2005.
In this case, Teva’s “product-by-process” claim at issue is as follows:
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 the ammonium salt to pravastatin sodium;
wherein the amount of pravastatin lactone* is less than 0.5 wt.% and the amount of epiprava* is less than 0.2 wt.%.
(Pravastatin sodium is a drug for reducing cholesterol in blood. *: Impurities)
The IPHC had previously ruled that the scope of a “product-by-process” claim should be limitedly determined as covering only the products produced by the process defined in the claim insofar as there was not any reason that it had been impossible or difficult to directly define the product by its structure or properties at the filing of the patent application.
1) The Grand Panel is convened to hear cases where it is necessary to virtually unify court decisions, or cases involving important issues, which is somewhat similar to en banc session in CAFC of the U.S.A. Since the founding of the IPHC in 2005, 9 cases including the above case have been heard.
2) A “product-by-process” claim is a type of product claim where a preparation process of the product is defined.
This decision will definitely have a huge impact on the patent examination practice for a “product-by-process” claim. Examiners would require applicants to show that there is any reason that makes it impossible or entirely impractical to directly define the claimed product by its structure or properties at the filing of a patent application when a “product-by-process” claim is found. We are seriously concerned that it would be quite difficult to show the foregoing reason in a number of patent applications having a “product-by-process” claim. If the attempt fails, there may be little chance but to modify the “product-by-process” claim to a process claim.