K&P's Intellectual Property High Court Decision Report in November, 2013

CosMED Pharmaceutical Co. Ltd. v. Bioserentach Co., Ltd., Case No. 2013 (Gyo-Ke) 10134 (Decision rendered on November 27, 2013)

The Patentee, Bioserentach, obtained a patent relating to a percutaneously absorbable preparation in 2012, against which CosMED filed an invalidation trial before the JPO in 2012. During the trial proceedings, Bioserentach made a correction of claims, and the JPO dismissed CosMED's demand in 2013, followed by CosMED's appeal against the JPO's decision to the IPHC in 2013.

Claim 1 of the patent at issue claims as follows:

"A percutaneously absorbable preparation adapted for insertion into skin to percutaneously administer an objective substance into the body, comprising a base consisting of a water-soluble and biologically soluble polymer material with the objective substance held in the base,
wherein the polymer material is at least one material selected from the group consisting of ... , and
wherein the percutaneously absorbable preparation has a needle-like or filamentous shape which has a pointed tip end, and the pointed tip end is inserted into the skin by being pushed onto the skin".

The main issue in this case was whether or not the claimed phrase "the objective substance held in the base" should be construed in a limited way with reference to the description of the specification. The IPHC answered to the issue as follows.

First, having reviewed prior art reference (p.a.r.) 7 in detail, the IPHC found that the prima facie difference between the patented invention at issue and the invention disclosed in p.a.r. 7 was that the objective substance was "held in the base" in the former, while the objective substance was in a chamber in a medical needle made from the base or the like in the latter.

Regarding the above prima facie difference, the JPO had found in its decision that those skilled in the art would have understood the technical meaning of the phrase "the objective substance held in the base" such that the objective substance had existed in a mixture with the base, and that such a construction had been supported by the description of the specification. Thus the JPO had acknowledged the prima facie difference as a substantial difference.

However, the IPHC decided (i) that it was clear from the recitation of the phrase itself that the phrase "the objective substance held in the base" just literally defined that the objective substance was held in the base, and did not limit the invention to any specific embodiment, and (ii) that there were no exceptional circumstances that allow to refer to the detailed description of the specification , where, for example, the technical meaning of the phrase could not be unambiguously and clearly understood, and thus (iii) that the JPO's limited construction was incorrect.

Conclusively, the IPHC upheld CosMED's appeal, and cancelled the JPO's decision.

An appeal to the Supreme Court was not filed against this decision, and thus the decision is final and binding.

This decision basically follows the leading case law made by the Supreme Court on March 8, 1991, regarding the construction of a claimed term in examining patentability ("Ra lipase" case). In that case, the Supreme Court decided that the finding of a claimed invention should be made on the basis of the recitation of the claim unless the circumstances were exceptional, and that the description of the specification could be refereed to only when the circumstances were exceptional, for example, when the technical meaning of the claim could not be unambiguously and clearly understood, when it was immediately obvious in view of the description of the specification that the recitation of the claim had an error, and the like.
This decision as well as the Supreme Court's decision teaches that an argument which is not based on the recitation of a claim, but only on a limited construction of the claim or on any specific embodiment would not be acceptable.