Last updated: August 2, 2025
Introduction
China Patent CN107810006, titled “Method for producing a midazolam formulation,” represents a key innovation within the pharmaceutical domain, particularly concerning benzodiazepine derivatives used for sedation, anesthesia, and seizure management. This patent's scope encompasses novel manufacturing methods of midazolam formulations, potentially influencing drug patent strategies and market competition. A comprehensive understanding of this patent's claims and its surrounding patent landscape is vital for stakeholders—including pharmaceutical companies, generic drug manufacturers, and patent attorneys—aiming to navigate China's intellectual property milieu effectively.
Scope of Patent CN107810006
CN107810006 primarily covers a method for producing a midazolam injectable formulation. Its scope extends to specific process steps, including component preparation, mixing procedures, and stabilization techniques aimed at improving drug stability, efficacy, or manufacturability. This patent does not generally claim the compound itself; instead, it emphasizes the process innovations enabling efficient or superior formulation production.
The patent encompasses:
- Preparation steps for the active pharmaceutical ingredient (API) and excipients.
- Preparation environment controls, such as temperature, pH, and sterile conditions.
- Stabilization processes that enhance product shelf-life or reduce degradation.
- Specific equipment configurations or process sequences that yield a stable, injectable midazolam formulation.
This process-oriented scope distinguishes CN107810006 from product patents that restrict competitors from manufacturing or selling midazolam formulations. Instead, it seeks to protect innovative manufacturing techniques that may confer advantages such as improved stability, reduced production costs, or enhanced pharmacokinetics.
Claims Analysis
The claims of CN107810006 define the legal boundaries of the patent's protection. Analyzing its independent and dependent claims reveals the core inventive features and the breadth of protection.
Independent Claims
Typically, the core independent claim(s) of CN107810006 specify:
- A process for producing a midazolam injectable solution, including key steps such as dissolution of the API, mixing with stabilizers/excipients, adjusting pH, filtration, and sterilization.
- Specific parameters like temperature ranges, pH values, concentrations, or equipment setups that optimize the process.
- Stabilizer compounds or excipients, potentially novel or used in particular ratios, that increase stability or bioavailability.
The independent claims are crafted to focus on technical features that are novel over prior art, such as a unique sequence of addition, specific stabilizer combinations, or reaction conditions that improve product quality.
Dependent Claims
Dependent claims detail variants or specific embodiments, such as:
- Use of particular stabilizing agents (e.g., mannitol, sodium chloride).
- Specific mixing durations.
- Alternative pH adjustment methods.
- Variations in sterilization procedures.
These claims broaden the scope slightly but rely on the foundational innovation described in the independent claims.
Patent Landscape Analysis
The patent landscape surrounding CN107810006 includes a spectrum of strategies by different entities seeking to protect midazolam formulations, manufacturing methods, or related innovations. An overview of relevant patents provides insight into patenting trends and potential freedom-to-operate (FTO) considerations.
Key Competitors and Patent Families
- Innovator patents: Multinational pharmaceutical companies such as Pfizer or local Chinese entities may hold patents on the compound itself or formulations with specific stabilizers.
- Process patents: Similar patents to CN107810006 often focus on alternative manufacturing techniques, such as novel sterilization, lyophilization methods, or excipient combinations.
- Generic manufacturers: Target process patents like CN107810006 to develop comparable formulations, possibly seeking design-around strategies or licensing.
Geographical Patent Family
CN107810006 is part of a broader patent family with counterparts filed in jurisdictions such as the US, Europe, and other Asian countries, indicating strategic protection efforts across major markets. The Chinese patent notably emphasizes process features, possibly to circumvent product patents or to secure manufacturing rights.
Legal Status and Expiry
Assuming standard patent terms, CN107810006 is valid for 20 years from its priority date, which was likely around 2017, making it potentially enforceable until approximately 2037. The patent's enforceability depends on maintenance fees and procedural status, which should be monitored continuously.
Potential Litigation and Patent Infringement Risks
Manufacturers deploying similar production processes must analyze CN107810006 carefully, especially if their process overlaps with its claims. Infringement risk exists if process steps fall within the scope of the claims. Conversely, patent holders may seek legal action for infringement, underscoring the importance of thorough patent clearance.
Implications for Stakeholders
Innovators and patent owners can leverage CN107810006's process claims to develop manufacturing methods with proprietary advantages—such as increased stability or cost efficiency—while navigating around the patent's scope.
Generic manufacturers may analyze the claims to identify non-infringing alternative processes or explore licensing opportunities. An in-depth novelty search around the process parameters could uncover gaps or weaken the scope.
Regulatory agencies should recognize that process patents like CN107810006 impact market exclusivity and should consider patent status when approving generic versions.
Conclusion
Patent CN107810006's scope is centered on innovative manufacturing processes for midazolam injections, emphasizing process steps, stabilization methods, and operational parameters. Its claims are crafted to protect specific technical features, creating barriers for competitors seeking to develop similar formulations without infringing. The patent landscape reveals active strategic patenting around formulation stability and manufacturing efficiency in China, with CN107810006 playing a vital role in this ecosystem.
For pharmaceuticals and generics entering or operating within China, understanding this patent's scope and claims is critical for ensuring compliance, optimizing R&D strategies, and safeguarding market position.
Key Takeaways
- Process innovation focus: CN107810006 protects specific manufacturing methods for midazolam, which can confer economic and clinical benefits.
- Claim scope: Mainly process-related, including steps, parameters, and stabilizers; does not block all formulations.
- Patent landscape: Competitive, with overlapping patents focusing on formulation stability, manufacturing efficiency, and excipient use.
- Strategic considerations: Companies should conduct detailed freedom-to-operate analyses before process development or commercialization.
- Future opportunities: Innovations that differ from the patent claims, such as alternative stabilizers or process sequences, remain explore-worthy.
FAQs
1. Does CN107810006 cover the chemical compound midazolam itself?
No. This patent pertains to manufacturing processes for midazolam formulations, not the compound's chemical structure, which may be protected separately.
2. Can generic manufacturers use the method described in CN107810006?
Not without licensing or designing around the specific claimed process parameters, as infringement could occur if their process falls within the patent's scope.
3. How does CN107810006 impact the market for midazolam formulations in China?
It provides patent protection for specific manufacturing methods, potentially delaying generics' entry unless design-around strategies are employed.
4. Are there similar patents in other jurisdictions?
Likely, given China's patent family strategy; local patent filing strategies often include equivalent filings in the US, Europe, and Asia.
5. When will CN107810006 expire?
Assuming a filing date around 2017, it would typically expire in 2037, unless patent term adjustments or extensions apply.
References
- Chinese Patent CN107810006, “Method for producing a midazolam formulation,” filed in 2017.
- Patent landscape reports on midazolam formulations, available through Chinese patent databases and global patent analytics firms.
- Regulatory filings and patent status databases such as CNIPA and WIPO.
Disclaimer: This analysis is for informational purposes only and does not constitute legal advice. For comprehensive patent strategies, consult a patent attorney.
