Osaka District Court, 2022 (Wa) 3344 — Method for Producing a High-Purity PTH-Containing Lyophilized Preparation (Takemiya)
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Article information
Article type: Case note
Categories: Patents
Topics: Claim interpretation, Inventive step, Novelty
First published on this website: 2026-10-16
Display and classification checked: 2026-10-17
Case information: 2022 (Wa) 3344
Osaka District Court, 2022 (Wa) 3344 — Method for Producing a High-Purity PTH-Containing Lyophilized Preparation … (Takemiya)
① ★ “Suppressing contact with ozone at 0.1 ppm or less” in Claim Limitation 1C need only be achieved by some method. ⇒ Satisfied.
② ★ Novelty / inventive step affirmed on the basis that the purpose differs from the prior art.
* If “suppressing contact with ozone at 0.1 ppm or less” in Claim Limitation 1C is treated as the purpose, and novelty and inventive step are said to be lacking because that purpose is absent from the prior art, would it not be inequitable unless satisfaction of the claim is also treated similarly to a labeling-based approach, as with a use invention?
Cf. A comparative examination should be made with Tokyo District Court, 2024 (Yo) 30029, the Age-Related Macular Degeneration case (Presiding Judge Nakashima), which denied patent infringement by finding that the medical-use invention was not worked under an “exclusively” standard and that, on the patentee’s argument that a certain proportion sufficed, novelty would be lacking.
(Excerpts from the judgment)
(1) Satisfaction of Claim Limitation 1C
“Claim Limitation 1C merely specifies suppressing contact between the PTH peptide-containing solution and ozone at 0.1 ppm or less contained in the air inside a sterile injectable-drug manufacturing facility. It does not limit the means to any particular method, and no other claim limitation of the invention contains such a restriction.
Moreover, the specification expressly states that the means for suppressing contact between the PTH peptide-containing solution and ozone at 0.1 ppm or less contained in the air inside a sterile injectable-drug manufacturing facility are not particularly limited. … As examples, it describes suppressing the mobility or flow volume of air around the PTH peptide-containing solution … and replacing the atmosphere around the solution with an inert gas. …
In light of these claim limitations and the specification, the means for suppressing contact between the PTH peptide-containing solution and ozone at 0.1 ppm or less contained in the air inside a sterile injectable-drug manufacturing facility are not limited in Invention 1; achieving that suppression by some method is sufficient. …
In the defendant’s method, contact between the PTH peptide-containing solution and ozone at 0.1 ppm or less contained in the air inside the sterile injectable-drug manufacturing facility is suppressed during steps including the carrying-in step. The defendant’s method therefore satisfies Claim Limitation 1C.”
(2) Invalidity / lack of inventive step (novelty was not raised as an issue)
“Difference 1-3
Invention 1 is specified as a method characterized by suppressing contact between the PTH peptide-containing solution and ozone at 0.1 ppm or less contained in the air inside a sterile injectable-drug manufacturing facility, whereas the invention in Exhibit Otsu 1 contains no statement that it is a method characterized by suppressing contact with ozone at 0.1 ppm or less contained in the air inside a sterile pharmaceutical manufacturing facility.”
“The invention described in the Otsu 1 publication focuses on sterile transfer and cannot be found to have the purpose of suppressing oxidation of a drug. Certainly, as stated in the claims of that publication, the Otsu 1 invention uses a sterilized ‘inert’ protective gas (nitrogen), which has an oxidation-suppressing effect. However, this is understood to serve the purpose of transferring the drug in a sterile state. In light of the detailed description of the invention, it is difficult to find that a person skilled in the art would recognize a purpose of suppressing oxidation caused by contact with surrounding air. Even if, as the defendant argues, common general technical knowledge existed that an inert gas such as nitrogen is not a ‘sterilized inert protective gas’ unless sterilized, and that oxidation of a drug can be prevented by suppressing contact between the drug and surrounding air and filling with an inert gas, the Otsu 1 publication contains no specific statement intended to achieve an oxidation-suppressing effect. It cannot be found to disclose the technical concept of suppressing oxidation by suppressing contact between the drug solution and surrounding air.
Furthermore, … the example in the Otsu 1 publication concerns ‘omeprazole sensitive to carbon dioxide.’ Considering also that omeprazole is cited not as a drug requiring protection against oxidation but as an example of a drug in an unsealed container that is ‘to be transferred in a sterile state,’ a person skilled in the art would not be found to understand this as an example of a drug requiring suppression of oxidation caused by contact with surrounding air. Similarly, … the statement that ‘Container 2 and its contents need not necessarily be pharmaceutical. Other types of containers filled with liquid or solid chemicals requiring hygienic or non-oxidizing transfer or storage conditions can also be treated by the method of the present invention’ should be understood merely as indicating that other types of containers filled with non-pharmaceutical chemicals requiring hygienic or non-oxidizing transfer or similar handling can also be treated by the sterile-transfer method of the Otsu 1 invention.
Even considering the claims, the problems of the prior art, the objectives and effects of the invention, and the examples described in the Otsu 1 publication, the invention focuses on transferring a drug solution in a sterile state. It cannot be regarded as an invention suggesting suppression of oxidation caused by contact between the drug solution and surrounding air.”
“The Otsu 1 invention aims to transfer a drug solution in a sterile state and cannot be found to aim at suppressing oxidation caused by contact between the drug solution and surrounding air during the carrying-in step (transport and carrying-in). Accordingly, the … argument premised on that purpose cannot be accepted. Likewise, the … argument that the structure itself inherently performs the function of suppressing contact between the drug and ozone contained in the air inside a sterile pharmaceutical manufacturing facility cannot be accepted. … The Otsu 1 publication contains no description or suggestion of oxidation of the drug solution by ozone. It does state that other types of containers filled with liquid or solid chemicals requiring non-oxidizing transfer or storage conditions can also be treated by the method of the invention. Nevertheless, even on the understanding of a person skilled in the art, this cannot be regarded as stating that the sterile-transfer method of the Otsu 1 invention can be used to prevent oxidation of a drug solution by ozone. Nor, even considering common general technical knowledge before the patent’s priority date, can it be said that a person skilled in the art applying the Otsu 1 invention to manufacture a PTH peptide lyophilized preparation would naturally understand and recognize that its structure also acts to suppress contact between the drug solution and ozone. Specifically, ③ even if it was common general technical knowledge that PTH peptides are readily oxidized …, those publications and other materials do not identify ozone as the cause of oxidation; and ④ even if it was common general technical knowledge that ozone oxidizes methionine and tryptophan …, Exhibit Otsu 10 concerns free amino acids in an environment with an ozone concentration of 1 ppm …, while Exhibit Otsu 11 concerns ranatensin peptide, which differs from PTH peptide in amino-acid sequence and peptide-chain length, under conditions in which the solvent is evaporated in air. These documents therefore do not establish that PTH peptide is oxidized by ozone contained in air. In the first place, … the invention arose not only from the prior-art problem that preparations containing PTH peptide must be particularly pure, but also from the inventors’ finding that attempts to manufacture PTH peptide-containing lyophilized preparations industrially produced preparations containing PTH-related substances. The Otsu 1 publication contains no description or suggestion of that problem premised on industrial manufacture, and there are no materials establishing that this finding was common general technical knowledge before the patent’s priority date. A person skilled in the art encountering the Otsu 1 publication would therefore not recognize the problem that PTH-related substances are generated during the carrying-in step for PTH-containing lyophilized preparations, and cannot be said to have motivation to suppress contact between the PTH peptide-containing solution and ozone at 0.1 ppm or less contained in the air inside a sterile injectable-drug manufacturing facility. Accordingly, a person skilled in the art cannot be said, on the basis of the Otsu 1 invention and common general technical knowledge, to understand and recognize suppression of contact between the PTH peptide-containing solution and ozone at 0.1 ppm or less contained in the air inside a sterile injectable-drug manufacturing facility. …”
Originally published: 2025-03-30
Original Japanese post: https://ameblo.jp/hideki-takaishi/entry-12891909511.html
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This history records actual publication, display, and classification changes made on this website.
2026-10-16: The AMEBLO source was first published on this website.
2026-10-17: Added classification, topic tags, article information, translation navigation, related articles, consultation guidance, and SEO. The original article text was not changed.
