https://www.j-platpat.inpit.go.jp/c1801/PU/JP-6025881/15/en
Osaka District Court Case No. 3344 (Wa) 2022, September 26, 2024 “Lyophilized Preparation Containing High-purity PTH and Method for Producing Same” Case (Presiding Judge Takemiya)
The Present Invention, Subject Method, Excerpts from the Judgment, Excerpts from the Prior Preliminary Injunction Decision, Some Considerations
“1C: A method for producing … wherein contact between a PTH peptide-containing liquid and ozone of 0.1 ppm or less contained in air in a sterile injectable manufacturing facility is suppressed”
(1) Whether constituent feature 1C is satisfied
“Constituent feature 1C merely stipulates the suppression of contact between a PTH peptide-containing solution and ozone present at 0.1 ppm or less in air within a sterile injection manufacturing facility, without limiting the means to any specific method. Furthermore, no description in the other claims of the present invention limits this aspect.
Furthermore, this specification explicitly states that the means for suppressing contact between a PTH peptide-containing solution and ozone present at 0.1 ppm or less in air within a sterile injection manufacturing facility is not specifically limited … Examples of such means include suppressing the air flow rate and volume around a PTH peptide- containing solution … and replacing the air surrounding a PTH peptide-containing solution with an inert gas …
In light of these constituent features and the description in the specification, it is understood that in the present invention 1, the means for suppressing contact between a PTH peptide-containing solution and ozone present in air within a sterile injection manufacturing facility at 0.1 ppm or less is not limited, and it is sufficient to achieve this by any method.
The defendant’s method satisfies constituent feature 1C because it suppresses contact between a PTH peptide-containing solution and ozone present at 0.1 ppm or less in air within a sterile injection manufacturing facility during processes including the transfer step.”
(2) Issue of Invalidity and Lack of Inventive Step (Novelty is not an issue)
“The invention described in Exhibit B1 focuses on aseptic transfer and cannot be recognized as having the purpose of suppressing drug oxidation. Indeed, as described in the claims of B1, the invention of B1 employs a ‘sterilizing inert’ protective gas (nitrogen), which has an oxidation-inhibiting effect. However, this is understood to be aimed at transferring the agent in a sterile state. Considering the detailed description of the invention above, it is difficult to conclude that a person skilled in the art would recognize that the purpose is to inhibit oxidation caused by contact with the surrounding air …
The Invention of B1 is an invention that, in the process of transferring liquid medicine to a freeze-drying machine, prevents the medicine’s hygiene from being adversely affected by exposure to the air environment (ambient air), etc., and prevents oxidation of the liquid medicine due to the air environment (ambient air). It achieves this by introducing nitrogen at a constant flow rate to continuously and evenly distribute it over a non-sealed medicine container, thereby suppressing contact with the air environment (ambient air). Therefore, the inherent structure itself suppresses contact between pharmaceutical agents and ozone contained in air within a sterile pharmaceutical manufacturing facility, and the ‘method characterized by suppressing contact with ozone’ of the present invention 1 is naturally realized by the structure of the invention in B1 …
However, the invention of Exhibit B1 is aimed at transferring pharmaceutical solutions under sterile conditions. A person skilled in the art who has access to Exhibit B1 would not necessarily recognize the problem of PTH-related substances being generated during the transport process of PTH-containing lyophilized preparations. Thus, it cannot be said that there is motivation to suppress contact between a PTH-peptide-containing solution and ozone present at 0.1 ppm or less in air within a sterile injection manufacturing facility. Therefore, it cannot be said that those skilled in the art would understand and recognize, based on the invention of Exhibit B1 and common technical knowledge, the need to suppress contact between a PTH-peptide containing solution and ozone present at 0.1 ppm or less in art within a sterile injection manufacturing facility.”
The judgment does not interpret the invention’s specific feature of “contact between … ozone … is suppressed” as a “use”. Therefore, the judgment does not make a finding or judgment that the defendant used the method while claiming “contact between … ozone … is suppressed.” The judgment only finds the fact is objectively achieved that “in the defendant’s method, contact between a PTH peptide-containing solution and ozone present in air within a sterile injection manufacturing facility at levels below 0.1 ppm is suppressed” during the process including the delivery step. Based solely on this factual finding, the court recognized that constituent feature 1C was satisfied.
Writer: Hideki TAKAISHI
Attorney at Law & Patent Attorney