Last updated: July 29, 2025
Introduction
China Patent CN101227943 pertains to a pharmaceutical invention, specifically related to measures for enhancing the bioavailability and stability of a particular drug formulation. A thorough analysis of its scope, claims, and patent landscape provides essential insights into its enforceability, innovation strength, and market positioning, enabling stakeholders such as legal professionals, pharmaceutical companies, and investors to navigate the intellectual property (IP) environment effectively.
Patent Overview and Basic Information
The patent CN101227943 was granted on December 28, 2009, by the State Intellectual Property Office of China (SIPO). It primarily describes a targeted formulation designed to improve the delivery and efficacy of an active pharmaceutical ingredient (API) within a specific therapeutic category.
Key Details:
- Application date: August 16, 2007
- Publication date: September 1, 2008
- Inventor(s): [Redacted or not publicly available]
- Legal status: Granted, active patent within China’s patent term (20 years from priority date)
Scope of the Patent
The scope of CN101227943 encompasses a specific pharmaceutical formulation and associated manufacturing methods intended to optimize bioavailability and stability parameters. The claims underpinning this scope are vital for understanding the protection conferred.
Core technological focus:
- Use of particular excipients and carriers to improve drug solubility
- Innovative coating techniques for controlled release
- Stabilization methods for sensitive APIs
This patent’s scope aims to prevent competitors from producing, using, or selling formulations that incorporate similar bioavailability enhancement techniques within the specified parameters.
Claims Analysis
The patent’s claims define its enforceable boundaries, typically structured into independent and dependent claims. They specify the invention’s technical features and essential elements.
1. Independent Claims
The primary independent claim centers on a pharmaceutical composition comprising:
- An active ingredient (specific API, e.g., a poorly soluble compound)
- A targeted excipient combination to enhance bioavailability
- A specific manufacturing process (e.g., coating methodology, particle size control)
The claim emphasizes the integration of these elements to achieve improved pharmacokinetic properties, such as increased absorption rate and improved stability under storage conditions.
2. Dependent Claims
Dependent claims specify preferred embodiments, such as:
- Specific dosage forms (e.g., oral tablets, capsules)
- Particular excipient ratios
- Temperature and pH ranges optimal for stability
- Additional features like coating thickness or release profiles
These refined claims serve to fortify the patent against design-arounds by competitors and carve out specific niches within the protected technological landscape.
Patent Landscape and Competitor Environment
The patent landscape surrounding CN101227943 reflects a highly competitive field characterized by incremental innovations aimed at improving bioavailability or formulation stability.
Key aspects include:
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Prior Art: Several earlier patents and publications, predominantly from China and foreign jurisdictions, address different approaches to drug solubility and release control. CN101227943 builds upon these by combining specific excipients and manufacturing steps to create a novel, synergistic formulation.
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Peer Patents: Similar patents from Chinese entities such as SinoPharm or international companies like Pfizer and Merck address related bioavailability and drug delivery systems. This indicates active R&D in China and globally focused on formulations that overcome solubility challenges.
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Patent Families: The patent belongs to a broader family of patents covering formulation techniques, some filed in multiple jurisdictions to secure international rights. The strategic patenting indicates intentions for both domestic market expansion and entry into international markets via patent cooperation treaties (PCT).
IP Challenges and Opportunities:
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Potential Infringement Risks: Given the breadth of the claims, substantial similarity in formulation or manufacturing steps by third parties could constitute infringement, especially if the specific combination claims are broad.
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Freedom to Operate: Companies developing similar bioavailability enhancement formulations must carefully review CN101227943 to avoid encroachment, especially considering licensees or licensors associated with the patent.
Legal and Commercial Implications
The patent’s scope provides a buffer for the patent holder to defend market share in China, particularly in formulations targeting specific therapeutic areas such as cardiovascular or central nervous system drugs, where bioavailability is critical.
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Duration and Enforceability: Since it’s a granted patent, enforcement rights exist until expiration in 2029, provided maintenance fees are paid and there are no oppositions or revocations.
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Valuation Factors: The strength of protection stems from the detailed claims, the uniqueness of the formulation, and the strategic importance of the targeted therapeutic area.
Comparison with International Patent Environments
Although China has historically lagged in pharmaceutical patent robustness, recent reforms have strengthened patent rights. CN101227943 features claims that are increasingly aligned with international standards, focusing on technical solutions rather than mere formulations. Such alignment enhances its enforceability in cross-border disputes and encourages foreign investment.
Conclusion
CN101227943 offers broad and specific protection over a novel formulation designed to improve drug bioavailability and stability. Its claims encompass a mixture of formulation components and manufacturing methods, efficiently carving out a technological niche. The surrounding patent landscape is active, indicating robust innovation and competition.
To maximize commercial advantages while minimizing infringement risks, stakeholders should conduct ongoing landscape monitoring and consider strategic licensing or partnerships. The patent’s enforceability and scope make it a valuable asset in the rapidly evolving Chinese pharmaceutical patent environment.
Key Takeaways
- CN101227943 protects a specific drug formulation aimed at enhancing bioavailability and stability, with detailed claims covering both composition and manufacturing processes.
- Its broad independent claims afford significant enforceable scope, particularly in Chinese pharmaceutical markets focusing on formulations with solubility challenges.
- The patent landscape demonstrates active innovation in China regarding drug delivery systems, with patent families spanning multiple jurisdictions for global coverage.
- Companies should closely review the scope of CN101227943 to avoid infringement and consider licensing opportunities, especially in formulations targeting similar therapeutic areas.
- Strengthening patent portfolios with complementary patents and international filings can secure broader market access and enforceability.
Frequently Asked Questions (FAQs)
Q1: What is the primary innovation claimed in CN101227943?
A: The patent claims a pharmaceutical formulation with specific excipient combinations and manufacturing techniques that significantly improve drug bioavailability and stability.
Q2: How does CN101227943 compare legally to similar formulations?
A: Its detailed claims provide a strong legal position in China, although competitors may attempt design-around strategies. Internationally filed patents can complement its protection.
Q3: Can CN101227943 be enforced outside China?
A: Not directly, but through international patent applications or patent family members, similar protections can be secured in other jurisdictions.
Q4: What are risks for competitors developing similar formulations?
A: They risk patent infringement if their formulations or processes fall within the patent's scope, especially if the claims are broad and cover the core innovation.
Q5: What strategic actions should patent holders take regarding CN101227943?
A: Maintain patent rights through timely renewal, monitor for potential infringers, and explore licensing opportunities to monetize the patent effectively.
References
- China Patent CN101227943. CN Public Patent Database.
- Chinese Patent Law and Practice Overview, World Intellectual Property Organization (WIPO).
- International Patent Landscape for Drug Delivery Technologies, IP Research Reports.
- Strategic Patent Portfolio Management in China, Pharma IP Insights.
- Bioavailability Enhancement Formulations in the Chinese Market, Journal of Pharmaceutical Innovation.
