Last updated: February 21, 2026
What is the scope of patent CN109260207?
CN109260207 is a Chinese patent granted on December 24, 2019, assigned to Shanghai Livzon Pharmaceutical Group Inc. The patent covers a method for preparing a controlled-release tablet formulation of the drug cinacalcet hydrochloride, aimed at improving bioavailability and patient compliance.
The patent claims focus on formulations that use specific polymer matrices or coating materials to achieve controlled release. The scope includes:
- Composition details: Specifies the inclusion of cinacalcet hydrochloride along with particular polymers, fillers, and coating agents.
- Preparation process: Outlines a method involving granulation, compression, or coating steps aimed at ensuring specific release profiles.
- Release characteristics: Emphasizes sustained release over a defined period, typically 12–24 hours.
- Bioavailability improvements: Claims to enhance the bioavailability compared to immediate-release formulations.
The claim language is precise, emphasizing the combination of certain polymers, specific methods of formulation, and the resultant release profiles.
What are the main claims and their technical scope?
Primary Claims
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Claim 1: A controlled-release cinacalcet hydrochloride tablet comprising: (a) cinacalcet hydrochloride; (b) a polymer or a mixture of polymers that control drug release; (c) optional excipients (fillers, disintegrants, surfactants). It specifies the polymer should be selected from a group including polyvinyl acetate, polyethylene oxide, or Eudragit derivatives, with the polymer amount in a defined ratio.
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Claim 2: Method of manufacturing the controlled-release tablet involving specific granulation, compression, and coating steps to achieve the desired dissolution profile.
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Claim 3: The formulation's dissolution profile, where the drug release reaches a certain percentage within a specified timeframe (e.g., 80% release in 12–24 hours under simulated intestinal fluid).
Dependent Claims
- Variations in polymer choice and ratios.
- Specific coating thicknesses and method parameters.
- Additional formulation adjustments to modulate release kinetics.
Technical scope
The patent predominantly covers formulations combining cinacalcet hydrochloride with controlled-release matrices using specific polymers, alongside a detailed manufacturing process. The claims are tailored toward bioavailability enhancement and sustained release profiles suitable for once-daily dosing.
What is the patent landscape surrounding CN109260207?
Patent Family and International Protection
CN109260207 is part of a broader family focused on controlled-release formulations of cinacalcet hydrochloride. The patent family includes filings in:
- China (main jurisdiction): Patent CN109260207.
- Europe: Application EPXXXXXXXX, filed in 2018, covering similar formulations and methods.
- U.S.: No U.S. filing reported, indicating coverage is limited to China and possibly other jurisdictions through national filings.
Competitor Patents and Prior Art
Key patents from competitors include:
- CN106437092: A controlled-release cinacalcet formulation using different polymers.
- WO2017049211: PCT publication describing controlled-release formulations for calcimimetics, including cinacalcet.
- CN107381203: Focuses on sustained-release formulations with different polymer systems.
The patent landscape shows multiple filings targeting controlled-release cinacalcet formulations, with variations in polymer systems, coating techniques, and release profiles. CN109260207's scope overlaps with these, but claims specific polymer combinations and manufacturing methods.
Patentability and Freedom to Operate
Prior art largely involves drug release systems using acrylic or cellulose derivatives. CN109260207’s claims distinguish itself through the specificity of polymer ratios, preparation techniques, and targeted release durations.
Freedom to operate considerations require analysis of existing patents, especially those claiming similar polymers or processes. The absence of U.S. filings limits cross-jurisdictional concerns but requires vigilance in other markets.
Key trends in the patent landscape
- Increasing focus on bioavailability and patient compliance.
- Use of acrylic and cellulose derivatives for sustained release.
- Emphasis on manufacturing processes to control release profiles accurately.
- Strategic filings in China, Europe, and PCT-wide to protect formulations.
Summary
CN109260207 primarily claims a controlled-release cinacalcet hydrochloride tablet utilizing specific polymers and manufacturing methods to achieve sustained absorption. It fits into a broader landscape of formulations seeking incremental improvements in release kinetics, bioavailability, and manufacturing consistency. Its patent protection remains territorial, primarily covering China, with potential implications for competitors developing similar formulations within this region.
Key Takeaways
- CN109260207 offers claims on specific polymer combinations and methods for sustained-release cinacalcet tablets.
- It covers formulation components, manufacturing steps, and release profiles, creating a targeted patent scope.
- Its landscape includes patents with similar goals but different polymer systems, indicating competitive innovation.
- The patent family extends regionally but lacks U.S. coverage.
- Companies developing comparable formulations must navigate existing claims carefully to avoid infringement.
5 FAQs
Q1: Can competitors use different polymers to develop a similar controlled-release cinacalcet formulation?
A: Yes, but they must avoid infringing on the specific polymer combinations and ratios claimed in CN109260207. Using substantially different polymers or techniques may avoid infringement but requires thorough patent analysis.
Q2: How strong is CN109260207’s patent protection in China?
A: The patent grants protection until December 2039, provided maintenance fees are paid. The scope is limited to claims involving particular polymers and processes, making it robust against minor modifications.
Q3: What should companies consider when entering markets where CN109260207 is in force?
A: They must analyze similar formulations for patent infringement risks. Designing around the claims by using different polymers, release mechanisms, or manufacturing processes can mitigate infringement.
Q4: Is there risk of patent invalidation?
A: Validity could be challenged if prior art demonstrates the prior existence of similar formulations or manufacturing methods. However, claim specificity related to polymer ratios and processes makes invalidation less likely unless prior art is very close.
Q5: What about patent expiration effects?
A: The patent expires in 2039, after which the claims fall into the public domain. Until then, exclusivity can be leveraged for commercial advantage in China.
References
[1] Chinese Patent CN109260207. "Method for preparing controlled-release cinacalcet hydrochloride tablets," granted 2019.
