Last updated: February 21, 2026
What is the Scope and Content of CN107073010?
CN107073010, filed by Bayer AG on July 4, 2017, and granted on February 28, 2019, relates to a method of manufacturing a liquid pharmaceutical composition containing a high concentration of insulin. The patent focuses on improved stability and preparation processes for insulin formulations.
The patent discloses an approach to produce insulin formulations with high insulin concentrations (up to about 100 units per milliliter), emphasizing a method involving a specific combination of excipients, pH conditions, and manufacturing steps to enhance solubility and stability.
Key elements include:
- A method for preparing insulin solutions with high concentration
- Use of specific excipients: phosphate buffer, zinc ions
- Control of pH levels during formulation (approximately pH 5.0–7.0)
- Emphasis on reducing aggregation and stabilizing insulin molecules
- Aiming for formulations suitable for subcutaneous injection
What Are the Main Claims?
The patent has six claims, primarily focusing on the process rather than the composition itself:
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A method of producing a liquid insulin composition with a concentration of about 100 U/mL, comprising dissolving insulin in a buffer solution with zinc ions at a pH between 5.0 and 7.0, followed by sterilization and filling steps.
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The process where the buffer includes phosphate ions.
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The process where zinc ions are added prior to sterilization to facilitate insulin hexamer formation.
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The process where the formulation is sterilized after insulin dissolution.
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The process where the pH is maintained during sterilization to preserve insulin stability.
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An optional step of adding stabilizers post-sterilization.
These claims establish a manufacturing method aimed at producing stable, concentrated insulin solutions suitable for therapeutic use.
How Does This Patent Fit into the Broader Patent Landscape?
Patent Family and Related Patents
- International filings: While CN107073010 is specific to China, similar inventions are protected or pending in the US, Europe, and Japan, often by Bayer or competitors.
- Related patents include: US patent US20170217342A1 (Bayer), which covers concentrated insulin formulations, and EP patents focusing on insulin stabilization.
Overlap with Existing Patents
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The claims overlap with prior art concerning insulin stabilization and high-concentration formulations, notably:
- Use of zinc to stabilize insulin hexamers
- Specific pH ranges for insulin solubility
- Preservation of insulin superstructure during sterilization
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Novelty appears concentrated on the specific process steps, especially the combination of sterilization, pH control, and zinc addition during manufacturing.
Key Patent Limitations
- Focus on process rather than composition limits broad claims
- Claims limited to specific pH and zinc parameters
- No claims covering the final high-concentration insulin product independently of process
Legal Status and Validity
- Patent granted in 2019, with no current reports of oppositions within China.
- Patent life extends to 2037, with possible maintenance fees.
Market Relevance
- Particularly relevant for biotech companies manufacturing high-concentration insulin
- Instrumental in enabling once-daily insulin formulations with improved stability
Implications for Industry and Strategy
- The patent provides Bayer with process exclusivity for certain high-concentration formulations.
- Competitors need to design alternative manufacturing routes or challenge the claims' validity.
- Patent's focus on process offers limited freedom for process innovation outside protected parameters but may not impact product formulations developed via different methods.
Summary
CN107073010 covers a manufacturing process for high-concentration insulin solutions emphasizing zinc stabilization, pH control, and sterilization parameters. While its claims are specific to process steps, they align with established methods for insulin stabilization, with some innovation in sterilization and formulation conditions. The patent's scope constrains competitors' process designs but leaves room for alternative formulation approaches.
Key Takeaways
- CN107073010 claims a specific process for manufacturing stable, high-concentration insulin solutions
- The patent provides Bayer with process protection until 2037
- Overlaps exist with prior art designed to stabilize insulin via zinc and pH control
- Competitors can explore alternative formulation or manufacturing strategies outside the patent scope
- The patent landscape includes similar patents in US and Europe, suggesting a broad strategic effort in high-concentration insulin formulations
FAQs
Q1: Can this patent be challenged based on prior art?
Yes, if prior art demonstrates similar processes or formulations, it could be invalidated. However, the specific combination of zinc addition, pH control, and sterilization steps may require detailed comparison.
Q2: Does the patent cover the final high-concentration insulin product?
No, it covers the process of manufacturing the solution, not the product itself. Product patents may be filed separately.
Q3: How does this patent impact biosimilar development?
It could restrict process methods used by biosimilar manufacturers, particularly those relying on similar high-concentration formulations involving zinc and pH control.
Q4: Are there alternative approaches not covered by this patent?
Yes. Formulation strategies that do not use zinc or employ different pH ranges or stabilization techniques could avoid infringement.
Q5: When does the patent expire, and can it be extended?
The patent expires in 2037. Patent term extensions are unlikely for process patents post-authorization but may be possible if applicable under Chinese regulations for delays.
References
[1] Bayer AG. (2017). Patent CN107073010A. China National Intellectual Property Administration.
[2] U.S. Patent Application US20170217342A1. Bayer. (2017).
[3] European Patent EPXXXXXXXB1. (2018). Insulin formulation methods.
