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Intellectual Property High Court vacates board of appeal decisions that “formulation of boronic acid compound” claims are not supported by the text

    On July 2, 2020, the Intellectual Property High Court (IPHC) overturned the JPO Board of Appeal’s decisions (Invalidation Trial No. 2016-8000966) that some claims fail to comply with the support requirement and upheld the board’s decisions that some claims satisfy the support requirement.

BACKGROUND
    The patent owner (appellee) obtained a patent (JP Patent No. 4162491, referred to as “the patent”) concerning the invention of “FORMULATION OF BORONIC ACID COMPOUNDS,” which was published on August 1, 2008.  An invalidation of the patent was demanded on August 5, 2016 (Invalidation Trial No. 2016-800096).  In response, the patent owner requested a trial for correction of the patent claims.  The JPO board of appeal entered the correction, and decided that product claims 17, 19, 20, 44, and 46 are invalid and process claims 21 and 38-42 are valid.  The patent owner and the challenger respectively appealed to the IPHC.  The questions at issue in this suit were the support requirement and the inventive step, but only the support requirement will be discussed in this article.

CLAIMED INVENTION
Corrected product claim 17 recites:
17. A lyophilized compound of D-Mannitol N- (2-pyrazine) carbonyl-L-phenylalanine-L-leucine boronate.

Corrected process claim 21 recites:
21. A method of preparing a lyophilized compound of D-Mannitol N- (2-pyrazine) carbonyl-L-phenylalanine-L-leucine boronate, comprising:
(a) preparing a mixture comprising
    (i) water,
    (ii) a compound of D-Mannitol N- (2-pyrazine) carbonyl-L-phenylalanine-L-leucine boronate, and
    (iii) mannitol; and
(b) lyophilizing the mixture.

JPO BOARD OF APPEAL’S DECISION
    The JPO board of appeal entered the correction and then determined that, although process claims 21 and 38-42 are maintained, the product claims 17, 19, 20, 44, and 46 are invalid because they do not meet the support requirement.

DECISION OF IP HIGH COURT
(1) Support Requirement
    Whether the claims are supported by the written description should be determined by, upon considering the recitations of the claims and the teachings of the written description, ascertaining whether the claimed invention is considered to be described in the written description and whether those skilled in the art would recognize that the problems at issue are solved with the teachings or suggestions in the written description or otherwise by reference to the conventional technologies at the filing of the application.

(2) Determination of whether the support requirement is met
    A reasonable recognition of those skilled in the art that the claimed invention is disclosed in the written description would suffice to meet the support requirement.  Also, a likelihood that those skilled in the art could solve the problem by reference to the conventional technologies would reasonably satisfy the expectation that the solution solves the problem and no strict and scientific explanation is needed.

(3) Reasons
    The reasoning behind this is that the support requirement derives from the essence of the patent system which grants a patent right as a reward for laying the invention open to the public.  Therefore, the purpose of imposing the support requirement is achieved to some extent if those skilled in the art who read the description can contribute to the further development of the art by conducting a retest and an analysis of the invention.  Further, it is not reasonable to require that the contents of the description be strictly demonstrated to the same degree as required in a scientific paper, considering the fact that the application is urged to be prepared as early as possible under the first-to-file system.

(3) Conclusion
    In light of common general technical knowledge at the time of filing of the present application, those skilled in the art can understand from the description in the working examples in the present application that the present invention can solve the problem in the sense as described in the above (1) and (2).

COMMENTS
    The IPHC judgment stated that, on compliance with the support requirement, “a consideration is made on whether the invention recited in the claims is the invention disclosed in the written description of the invention, and is within the scope that those skilled in the art can recognize that the statement or the suggestion of the written description can solve the problem of the invention; and even if there is no such statement or suggestion, whether the claimed invention is within the scope if those skilled in the art would recognize that the problem can be solved in light of common general technical knowledge at the time of filing the application.”

    A similar interpretation of the support requirement was stated in the IPHC en banc judgement of the case “Process for Polarizing Film” on November 11, 2005.  Recently, the IPHC has reiterated this similar interpretation regarding the support requirement.  According to the JPO Examination Guideline, the interpretation is indicated as follows.

<JPO Examination Guideline> (Part II, Chapter 2, Section 2: Support Requirement)
    The consideration of the substantial correspondence done by the examiner is to examine whether or not the claimed invention exceeds “the extent of disclosure in the description to which a person skilled in the art would recognize that a problem to be solved by the invention would actually be solved.”  When it is determined that the claimed invention exceeds “the extent of disclosure in the description,” the claimed invention and the invention disclosed in the description do not substantially correspond with each other, and thus, the statement in the claims does not satisfy the support requirement.

    The IPHC stated that, in the determination on compliance with the support requirement, “a degree of description that provides those skilled in the art with a reasonable expectation that the problem can be solved in light of common general technical knowledge would suffice” and “a degree of description equivalent to a strict scientific proof is not needed.”

    As above, the IPHC rejected an excessively strict requirement, and reduced the applicant’s burden in preparing patent applications, which is thought to be significant for future practice.

    The IPHC did not show the criteria of “a degree of description that provides those skilled in the art with a reasonable expectation” or “a degree of description equivalent to a strict scientific proof.”  This is because the criteria may vary depending on the technical field, so that the JPO Examination Guideline explains that “the examiner firstly determines to which technical field the invention concerned pertains and the common general knowledge at the time of filing which exists in the relevant technical field.”

    Note that the accumulation of further precedents is necessary to clarify the determination on compliance with the support requirement, and future court cases should be carefully monitored.

IP Court HP: Summary of the Judgment 2018 (Gyo-ke) 10158