In accordance with recent Supreme Court Decisions (Case Nos. H24(Ju)-1204 and -2658), the Japanese Patent Office (JPO) has changed its practice concerning the examination of  “product-by-process (PBP)” claims on July 6, 2015.

If the JPO judges that a product claim is defined by a process for manufacturing it (i.e., they  judge that the claim corresponds to a PBP claim), the JPO examines whether or not it was impossible  to directly specify the product with the structures and/or properties thereof as well as whether or  not such specification is impractical.   Unless the JPO can conclude that this  “impossible/impractical” requirement is satisfied by the PBP claim, a reason for rejection  concerning “lack of clarity” will be issued.

If an applicant receives the above reason for rejection, he/she will have to make one of the  following responses:

  1. cancelling the PBP claim;
  2. amending the PBP claim such that the subject matter of the claim is changed to a process for  manufacturing the product;
  3. amending the PBP claim such that the subject matter of the claim is changed to a product  which is not specified by a process for manufacturing the product; and
  4. proving that at the priority date of the patent application, it was technically impossible to  analyze a structure and/or properties of the product, or the enormous economic burden and time were  required to analyze the structure and/or properties

This new practice is applied to not only patent applications which will be filed in the future but  also to those which have already been filed.    Furthermore, it also retroactively applies to  existing registered patents. Therefore, a registered patent that includes a PBP claim might have  potential risk of an invalidation trial being requested due to a “lack of clarity”.

We are currently paying attention to how strictly the JPO applies this new practice to a PBP claim.