Case No.: H24(Ju)-1204
Plaintiff: Teva Gogyszergyar Zartkoruen Mukodo Reszvenytarsasag
Defendant: Kyowa Hakko Kirin Co. Ltd.

Introduction

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.

Background

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.

Shiga’s Comments

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.