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Supreme Court Reverses IPHC Decision on How Unexpected Remarkable Effect should be Considered in Examining Inventive Step

Alcon Research Ltd. and Kyowa Kirin Co., Ltd. v. X (Individual), Case No. 2018 (Gyo-hi) 69 (Decisions rendered on August 27, 2019)

The Supreme Court reviewed how an unexpected remarkable effect of the invention should be considered in examining inventive step, and reversed the IPHC decision made by comparing the effect of the claimed compound at issue with that of the compounds which were not disclosed in the cited documents, but in other references. The details of the case are as follows:

1. History of the Case
(1) The 1^st Stage
The Patentee, Alcon Research and Kyowa Hakko, now Kyowa Kirin (AR and KK), obtained a patent relating to a topically administrable ophthalmic composition for treating allergic eye diseases in 2000.
Against the AR and KK’s patent, X, an individual, filed an invalidation trial on the grounds of lack of inventive step on the basis of cited document 1 (D1) in view of cited document 2 (D2) and the like with the JPO in 2011. During the trial procedure, AR and KK demanded a correction of claims. The JPO admitted the correction, but rendered a decision of invalidating the patent in 2011 (the JPO’s 1^st decision).
AR and KK filed an appeal against the JPO’s 1^st decision to the IPHC, and also filed a trial for correction with the JPO in 2012. Accordingly, the IPHC remanded the case to the JPO with no substantial examination in accordance with the Patent Law at that time in 2012 (the IPHC’s 1^st decision).

(2) The 2^nd Stage
During the remanded trial procedure, AR and KK demanded a correction of claims in 2012. The JPO admitted the correction, and rendered a decision of dismissal on the X’s demand in 2013 (the JPO’s 2^nd decision).
X filed an appeal against the JPO’s 2^nd decision to the IPHC in 2013. The IPHC rendered a decision of cancellation of the JPO’s 2^nd decision in 2014 (the IPHC’s 2^nd decision).
AR and KK filed an appeal against the IPHC’s 2^nd decision to the Supreme Court, but the appeal was not accepted, and thus the IPHC’s 2^nd decision was made final and binding in 2016. Accordingly, the case was remanded to the JPO in 2016.

(3) The 3^rd Stage
During the remanded trial procedure, AR and KK demanded a correction of claims, and supplemented a new argument on the basis of new experimental results published after the priority date of the patent at issue that the patent at issue showed an unexpected remarkable effect. The JPO admitted the correction, and rendered a decision of dismissal on the X’s demand in 2016 (the JPO’s 3^rd decision).
X filed an appeal against the JPO’s 3^rd decision to the IPHC in 2017. The IPHC rendered a decision of cancellation on the JPO’s 3^rd decision in 2017 (the IPHC’s 3^rd decision).
AR and KK filed an appeal against the IPHC’s 3^rd decision to the Supreme Court in 2018.

2. The corrected Claim 1 of the AR and KK’s patent at issue which was examined by the IPHC and the Supreme Court in the 3^rd stage
“An ophthalmic human conjunctival mast cell stabilizer prepared as a topically administrable ophthalmic solution for treating allergic eye diseases in human, comprising a therapeutically effective amount of 11-(3-dimethylaminopropylidene)-6,11-dihydrodibenz[b,e]oxepin-2-acetic acid or a pharmaceutically acceptable salt thereof”.

3. Summary of the IPHC’s 3^rd Decision
The IPHC found that D1 disclosed experimental results of a study where effects of an ophthalmic solution containing hydrochloride salt of the cis-isomer of the compound of the patent at issue on conjunctivitis were evaluated by placing a drop of the solution in guinea pig’s eyes, and that D2 was a Japanese patent publication, whereas neither of them stated whether the compound of the patent at issue exhibited histamine release inhibition from the human conjunctival mast cell, and the extent of the inhibition in the case where the compound of the patent at issue exhibited the inhibition. On the basis of the above findings, the IPHC decided as follows:

Those skilled in the art having regard to D1 and D2 could have easily conceived of applying the compound of D1 to a use as a human conjunctival mast cell stabilizer, and therefore it cannot be said that the compound of the patent at issue having in itself histamine release inhibition from human conjunctival mast cell is unexpected and remarkable for those skilled in the art.
Moreover, some other references, which were published before the priority date and indicate technical standards at the time of the priority date, show more than one compound other than the compound of the patent at issue exhibiting high histamine release inhibition rate in the order of 70% to 90% by applying an ophthalmic formulation with a given concentration (hereinafter referred to as “each of the other compounds”), and, among the above compounds, those keeping high histamine release inhibition rate over a concentration range in the order of 2.5 to 10-fold were known. Considering these circumstances, it cannot be said that the histamine release inhibition effect of the human conjunctival mast cell stabilizer containing the compound of the patent at issue is remarkable beyond the scope that those skilled in the art having regard to the technical standards at the time could have expected.

4. Summary of the Supreme Court’s Decision
However, the Supreme Court overturned the above IPHC’s 3^rd decision as follows:

“(E)ach of the other compounds” exhibits histamine release inhibition effect which is a same kind of effect as that exhibited by the compound of the patent at issue. However, all of “each of the other compounds” are compounds with different structures from that of the compound of the patent at issue, “each of the other compounds” is not related to the compound of D1, and relevance between “each of the other compounds” and D2 also cannot be found. Further, in D1 and D2, there are no disclosures showing whether the compound of the patent at issue exhibits histamine release inhibition from the human conjunctival mast cell, and the extent of the inhibition in the case where the compound of the patent at issue exhibits the inhibition. Under these circumstances, it cannot be said that those skilled in the art could have expected the extent of the effect of the compound of the patent at issue immediately from the fact that “each of the other compounds” having comparable effect to that of the compound of the patent at issue was known at the time of the priority date.

Moreover, considering that the effect of the compound of the patent at issue relates to a medical use of a compound, it also cannot be denied that the extent of the effect of the compound of the patent at issue is remarkable beyond the effect of the scope that those skilled in the art could have expected from the features defined in the corrected claims of the patent at issue, solely on the basis that “each of the other compounds” which is a compound exhibiting a comparable effect to that exhibited by the compound of the patent at issue, but having a different structure therefrom was known at the time of the priority date.

The IPHC does not clarify specific contents of various circumstances to be considered other than the fact that “each of the other compounds” was known at the time of the priority date, and other circumstances and the like that make it possible to infer the extent of the effect of the compound of the patent at issue from the extent of the effect of “each of the other compounds” are not found at all.

Accordingly, the IPHC consequently failed to sufficiently consider the effect of the invention of the patent at issue, in particular, whether the effect was unexpected and remarkable, from the perspective of whether those skilled in the art could not have expected the effect as being brought about by the features defined in the corrected claims of the patent at issue at the time of the priority date, and whether the effect was remarkable beyond the scope that those skilled in the art could have expected from the features. There is no other choice but to consider that the IPHC immediately denied that the effect of the invention of the patent at issue was unexpected and remarkable only relying on the fact that it was known that “each of the other compounds” having a comparative effect to that of the compound of the patent at issue existed at the time of the priority date, and rescinded the JPO’s 3^rd decision, in light of the decision that it could have been easily conceived of to apply the compound of the patent at issue to a use relating to the invention of the patent at issue. This IPHC’s decision reflects an error in the interpretation and application of law or regulation.

Conclusively, the Supreme Court reversed the IPHC’s 3^rd decision, and remanded the case to the IPHC. The Supreme Court’s decision is made final and binding, and thus, the IPHC will re-examine the case, while being bound by the Supreme Court’ decision.

K&P’s Comments Under the Japanese practice, unexpected remarkable effect of the claimed invention is often considered in examining inventive step, in particular, in the chemical or pharmaceutical field.
The above Supreme Court’s decision teaches that, when considering unexpected remarkable effect, the effect of the claimed invention should be compared with the effect of the invention disclosed in the cited document(s) or at least that of the invention closely related to the cited document(s), and should not be compared with that of the invention not related to the cited document(s).