- “Lipid-Containing Compositions and Uses Thereof” case
- Asha Nutrition Sciences, Inc. v. Commissioner of the Japan Patent Office
- Japanese Intellectual Property High Court Case No. 2016(Gyo-Ke)10216
- Decided 13 October 2017
In this judicial review of an adverse decision by the JPO Trial and Appeal Division, the Japanese Intellectual Property High Court upholds the decision of the JPO Trial and Appeal Division which affirmed the rejection by the Examiner of the patent application at issue (Japanese Patent Application No. 2011-506377 which is the Japanese counterpart of International Application No. PCT/US2009/041114) for failure to satisfy the enablement requirement.
This case is instructive for understanding how Japanese courts frame questions of enablement and for understanding the importance of disclosing working examples commensurate with recited claim scope and asserted utility or benefit under Japanese practice. In the present case, the Court begins its analysis with a review of the law of enablement, pointing out that for a product claim to be enabled the specification must disclose not only how to make that product but also how to use, i.e., practice, it. And since a medical invention cannot be practiced unless its use, i.e., the benefit that may be obtained when the invention is practiced, would be understood by one of skill in the art upon reading the specification, a nexus must therefore be established between the claim limitations on the one hand and the purported benefit on the other. But since the Court in the present case takes the benefit of the invention to be the prevention and/or treatment of the expansive list of diseases recited in claim 25 of the Japanese application (loosely corresponding to claim 29 of the international application), it finds the case studies given in the working examples of the specification inadequate to convey to one of skill in the art which of the many asserted benefits might be expected to accrue from each of the many varied lipid blends and formulations presented in the specification, this deficiency being exacerbated in the view of the Court by comments made by the Applicant in the background section, apparently interpreted by the Court as an admission against interest, to the effect that the state of the art prior to the invention was such that one of skill in the art would not have known what benefits might be expected to accrue from the various omega-3 fatty acids, omega-6 fatty acids, and other categories of lipids described in the specification and recited in the claims. The Applicant having admitted that it was not within the knowledge of one of skill in the art to relate lipid content to disease prevention and/or treatment, and the case studies presented in the specification failing in the opinion of the Court to remedy this deficiency, the Court concluded that the enablement requirement was not met.
Based on the Court’s repeated reference to assertions by the Applicant perceived by the Court to have been counter to “the common sense prevalent in the art,” it would seem that a more modest and focused assertion of medical benefit, or more rigorous and exhaustive experimental data in proof of such benefit, might have been helpful to overcome the Court’s skepticism in the present case. While statements by the Applicant regarding surprising and unexpected effects which were not known or understood by those of skill in the art may help make the case for the novelty and inventive step of the invention, one must remember that especially under Japanese practice such statements can serve as a double-edged sword, since there will be a heightened burden on the Applicant when the asserted benefit is overly broad, contrary to common sense, or not commensurate with what is supported by the experimental data presented in the working examples.
- Japanese original of the decision in this case can be found at:
- English translation of the decision in this case, should one be made available by the Court, can be found by entering the court, year, code, and number of this case from the caption above into the appropriate fields at:
- Writeup (in Japanese) of this case by Unius patent attorney Kenichiro AKAMA can be found at: http://www.unius-pa.com/wp/wp-content/uploads/26-3.pdf
The foregoing Japanese intellectual-property-related court case summary has been provided by the Japanese patent attorneys at Unius Patent Attorneys Office. A complete list (in Japanese) of all cases reviewed by Unius Patent Attorneys Office can be found at http://www.unius-pa.com/precedent.