November 29, 2019

Patent news

The Supreme Court cancelled and remanded an IP High Court decision saying that a medicament including a certain compound had no "remarkable effect".

In "a formulation for allergic eye disorder" Case on August 27, 2019, the Supreme Court of Japan noted that the Intellectual Property High Court ("IP High Court") had erred by simply assuming that it would have been obvious to use the claimed compound for the intended purpose of the invention (i.e. medicament) without adequately considering:

1. whether an effect exhibited by the invention in its specific configuration could not have been predicted by a person skilled in the art; and
2. whether the effect is a remarkable effect that goes beyond a range that could be predicted by a person skilled in the art.

(Supreme Court Case No. 2018 (Gyo-hi) 69.)

Background
Alcon Laboratories Incorporated and Kyowa Hakko Kirin own a patent (the "Patent") regarding a composition for treating allergic eye disorder including a certain compound ("Compound A"). Company X filed an invalidation trial against the Patent.

This case went back and forth between the JPO and the IP High Court and the first two decisions of the JPO trial board was remanded by the IP High Court. Therefore, the JPO had to issue three decisions on this case.

JPO's Second Decision: The Patent owner filed a request to amend claims. The JPO's Second Decision on this request maintained the validity of the amended Patent and denied the invalidation request, holding that the Patent was not obvious based on prior art references 1 and 2. However, the IP High Court cancelled the JPO's Second Decision and remanded the case to the JPO, finding that it would have been easy to conceive of the Patent based on prior art references 1 and 2.

JPO's Third Decision: The Patent owner filed the same request to amend claims as above. The JPO's Third Decision on this request maintained the validity of the amended Patent, finding that it showed a remarkable effect even though it would have been easy to conceive the invention based on prior art references 1 and 2. However, the IP High Court also cancelled the JPO's Third Decision, finding that a person skilled in the art would have been able to predict the effect based on prior art references 1 and 2 in combination with prior art disclosing other compounds.

Judgment

The Supreme Court cancelled the IP High Court Judgement on the JPO's Third Decision for the following reasons.

1. Other compounds showed an effect similar to Compound A, but these compounds were still different from Compound A, which is the compound described in prior art references 1 and 2. There appeared to be no relation between the other compounds and Compound A.
2. Prior art references 1 and 2 did not disclose whether Compound A had a certain effect, or the degree of the effect.
3. Under such circumstances, a person skilled in the art would not have immediately predicted the degree of effect of each invention merely because it was known at the time of the priority date that there were other compounds having the same effect as the compound of invention.
4. The judgment of the IP High Court was in error because:
   a) the IP High Court did not fully consider whether the effect of the invention is remarkable in view of (1) whether, at the priority date, an effect exhibited by the invention in its specific configuration could not have been predicted by a person skilled in the art, and (2) whether the effect is a remarkable effect that goes beyond a range that could be predicted by a person skilled in the art; and
   b) the IP High Court cancelled the JPO's decision based on the improper rationale that it would have been obvious to use the compound for the intended purpose of the invention (i.e. medicament).

Comments

The Supreme Court showed that it is needed to consider whether the effect of an invention is remarkable in view of (1) whether, at the priority date, an effect exhibited by the invention in its specific configuration could not have been predicted by a person skilled in the art, and (2) whether the effect is a remarkable effect that goes beyond a range that could be predicted by a person skilled in the art when determining whether the effect of the present invention is remarkable and unexpected in order to determine whether or not the inventive step is present.

This judgment clarifies that even if an effect exhibited by the invention in its specific configuration could have been predicted by a person skilled in the art, an inventive step is recognized if the effect is a remarkable effect that goes beyond a range that could be predicted by a person skilled in the art.

In the field of chemistry, it is said that it is difficult to predict the activity from the structure.
Therefore, unless the degree of effect of a compound having a structure similar to that of the present invention or data capable of inferring the degree of the effect is known before filing, it would be difficult to prove the range of the effect that could be predicted by a person skilled in the art from the configuration of the present invention. We would like to see what judgments will be made in the future based on this Supreme Court decision.

Written by: Ms. Emiko Yano (Patent Attorney)