A case in which Intellectual Property High Court determined that an use invention for “sedation of critically ill patients undergoing intensive therapy” has the novelty and inventiveness even though they compared it to the cited invention which relates to administration to critically ill patients as a sedative agent

(Judgment of Intellectual Property High Court, July 18, 2018 / 2017 (Gyo-Ke) 10114)

Key words: novelty, inventiveness, inventive step, use invention

Parties: [Plaintiff] Nissin Pharmaceutical Co., Ltd., Nippon Chemiphar Co., Ltd.

            [Defendant] Orion Corporation, Hospira Incorporated

1. Key points of the judgment

            This judgment is a case in which the novelty/inventiveness of the Claimed Invention with limitation of usage was in issue. Although the usage of the cited invention (prior art) and that of the Claimed Invention are seemingly identical, the Court eventually determined that the Claimed Invention has the novelty/inventiveness considering that “sedation” recited in the Claimed Invention and “sedation” intended by the cited invention were different, after precisely examining the difference between these “sedation” usages.

2. Patent concerned

  • Patent No. 4606581
  • Title of the Claimed Invention: “Dexmedetomidine Applications for ICU Sedation”
  • Statement of the claims

[Claim 1]

            In the manufacture of a medicament for use in sedating critically ill patients undergoing intensive therapy, to the use of dexmedetomidine or a pharmaceutically acceptable salt thereof, said patient is awake, disorientation is kept used.

3. Conventional technology (cited invention)

            The pharmaceutical named dexmedetomidine was widely used as a sedative agent at the time of filing of the Patent concerned. Ref. 3 (primary prior art) indicates that dexmedetomidine was administered to patients undergoing a vascular surgery.

4. Summary of the judgment

            (1) Significance of “sedation of critically ill patients undergoing intensive therapy” intended by the patented invention

            Considering the recitation of Claim 1 and the content of the description…, “sedation of critically ill patients undergoing intensive therapy” recited in the Claimed Invention 1 means not only actual sedation of critically ill patients undergoing intensive 

therapy but also means sedation as “treatment of conditions affecting the peace of mind of patients” including pain, anxiety, etc. caused by the presence of various catheters and treatment such as physical therapy in an IC situation” (involving intensive respiratory, circulation, metabolic and other whole-body management), thus both two types of sedation usages are considered necessary.

 (2) Identity of the patented invention and the invention stated in Ref. 3 (Novelty)

“a         (…) Ref. 3 does not indicate that, with respect to vascular surgery patients referred to therein after surgery, either actual sedation or sedation as “treatment of conditions affecting the peace of mind of patients” including pain, anxiety, etc. caused by the presence of various catheters and treatment such as physical therapy in an IC situation” was confirmed. Further, it does not indicate that administration of dexmedetomidine to vascular surgery patients referred to therein was for both of the aforementioned sedation usages, either.

            Therefore, “sedation of critically ill patients undergoing intensive therapy” recited in the Claimed Invention 1 is not contained in Ref. 3.

b          In light of the found facts regarding “analgesia” and the description regarding the “sympatholytic effect of dexmedetomidine” in Ref. 3, which is to block the sympathetic nervous system in order to inhibit blood pressure and heart rate from being increased by an endocrine response resulting from activation of sympathetic nervous system by surgical stress, neither “analgesia” of the “patients after surgery” (vascular surgery patients) nor the “sympatholytic effect of dexmedetomidine”, alleged by the Plaintiff side and referred to in Ref. 3, correspond to sedation as “treatment of conditions affecting the peace of mind of patients” including pain, anxiety, etc. caused by the presence of various catheters and treatment such as physical therapy in an IC situation.

c           In these respects, the Plaintiff’s allegation - administration of dexmedetomidine to vascular surgery patients as referred to in Ref. 3 corresponds to the usage “sedation of critically ill patients undergoing intensive therapy” of the Claimed Invention 1 - cannot be accepted.”

  (3) Inventiveness of Invention 1 comparing to the invention stated in Ref. 3

“The difference from the Claimed Invention 1 is exhibited in light of the fact that Ref. 3 does not contain “sedation of critically ill patients undergoing intensive therapy” recited in the Claimed Invention 1, and administration of dexmedetomidine to vascular surgery patients as referred to in Ref. 3 does not correspond to the use of dexmedetomidine or a pharmaceutically acceptable salt thereof in the manufacture of a medicament for the use in “sedation of critically ill patients undergoing intensive therapy” recited in the Claimed Invention 1, therefore it cannot be said that the Claimed Invention 1 and the invention stated in Ref. 3 are different from each other only in these differences (while the Claimed 

Invention contains “critically ill patients undergoing intensive therapy”, the Ref. 3 does not contain such description), whereas they are identical in the remaining points.

            In this regard, the Plaintiff’s allegation as stated earlier (omitted) is unfounded without need for further consideration as the premise thereof is found insufficient.”

5. Operational guidelines

            The Court determined that the Claimed Invention has the novelty and inventiveness of use of dexmedetomidine for sedation of critically ill patients undergoing intensive therapy despite the fact that the cited document indicated the sedative effect of dexmedetomidine and administration of dexmedetomidine to critically ill patients undergoing intensive therapy. More specifically, this judgment found the meaning of “sedation” recited in the Claimed Invention ((1) actual sedation of patients and (2) sedation as “treatment of conditions affecting the peace of mind of patients”) based on the content of the claims and description, and found that although the cited invention mentioned administration of dexmedetomidine to patients as a sympatholytic agent, it did not mention “sedation” in the meaning used by the Claimed Invention.

In my opinion, the cited document can be read to indicate administration of dexmedetomidine for sedation of critically ill patients undergoing intensive therapy, and therefore, the novelty/inventiveness of the Invention could have been negated. The court found the meaning of “sedation of critically ill patients”- the usage of the Invention - according to the content of the description, etc., covering detailed technical matters and effects that the said usage would deliver, and determined that “sedation” meant by the Claimed Invention was not indicated in the cited document.

 From the facts stated above, it should be noted that there is a chance that an invention with the limitation of usage would have novelty/inventiveness even though its usage is seemingly similar to that of the cited invention, as the court would consider the detailed explanation of the invention contained in the description and affirmed the novelty/inventiveness thereof covering detailed technical matters and effects that the said usage would deliver.

            When asserting the novelty/inventiveness of an invention with the limitation of usage, it should be examined if there is any difference between the usage of the cited invention and that of the claimed invention by carefully looking through the description, conventional technologies, etc., without giving attention only to apparently identical terms.