Case No.: H24(Ju)-1204
Plaintiff: Teva Gogyszergyar Zartkoruen Mukodo Reszvenytarsasag
Defendant: Kyowa Hakko Kirin Co. Ltd.
Claim 1 of the patent in question, Japanese Patent No. 3737801, relates to a pravastatin sodium which is specified not only by certain remaining amounts of pravastatin lactone and epiprava but also by the process for manufacturing it (i.e., granted claim 1 can be regarded as being a “product-by-process” claim). In the Supreme Court, it was disputed whether the scope of a patent covers an act of manufacturing and selling a drug which satisfied the claimed remaining amounts but which was manufactured by a different process from the claimed process.
In 2012, this case was judged by a Grand Panel of the IP High Court (Grand Panels are generally assembled to judge important cases). The Grand Panel stated that a product-by-process claim falls into two categories: (a) a “genuine” product-by-process claim which is used in the circumstance where the claimed invention is impossible or difficult to define by its structure or properties at the time of filing the application; and (b) a “non-genuine” product-by-process claim which is used in the absence of the above circumstance. The Grand Panel concluded that the technical scope of a patented invention according to the “genuine” product-by-process claim shall be interpreted to cover any products identical to the claimed product regardless of the manufacturing process, while that according to the “non-genuine” product-by-process claim shall be construed as being limited to the product manufactured by the specific process recited in the claim. As a result, the Grand Panel judged that the products manufactured and sold by the Defendant do not fall within the scope of the patent because granted claim 1 corresponds to a “non-genuine” product-by-process claim and the process used by the Defendant was not considered to be identical to the claimed process.
This time, the Supreme Court judged whether the IP High Court Grand Panel’s Judgement was legitimate.
Supreme Court’s Judgement
The Supreme Court dismissed the IP High Court Grand Panel’s Judgement. The Supreme Court clearly stated that a patent right of a product-by-process claim should be interpreted as covering a product which is manufactured via a different process from a claimed process. Furthermore, the Supreme Court focused on a clarity issue of a product-by-process claim. Specifically, the Supreme Court stated that clarity requirements for a product-by-process claim are satisfied only when it is impossible that a product is directly specified by its structure or properties at the time of filing the application or only when such a specification is impractical. As a result, the Supreme Court remanded this case to the original bar in order for the IP High Court to rigorously judge the technical scope of granted claim 1, whether granted claim 1 satisfies the clarity requirements, and the like.
This Supreme Court’s Judgment is very important because they set a new precedent in which a patent right of a product-by-process claim covers a product manufactured via a different process from a claimed process. Furthermore, the Judgment indicated the clarity requirements which a product-by-process claim must satisfy. We believe that these clarity requirements are much stricter than the current Japanese patent practice. We are currently paying attention to whether the Japanese Patent Office changes their approach to the product-by-process claim.