Last updated: August 5, 2025
Introduction
China Patent CN101123946, filed by Guangzhou Baiyunshan Pharmaceutical Holdings Co., Ltd., pertains to a pharmaceutical invention aimed at improving the efficacy, stability, and manufacturing process of a specific drug compound. Understanding its scope and claims provides insight into its patent protection and its position within China's intellectual property landscape. This analysis offers a comprehensive examination of its claims, legal scope, and the broader patent environment surrounding similar pharmaceuticals in China.
Patent Overview and Filing Details
- Patent Number: CN101123946
- Filing Date: June 30, 2009
- Grant Date: December 29, 2009
- Patent Term: 20 years from the filing date (expected expiry in 2029)
- Applicant: Guangzhou Baiyunshan Pharmaceutical Holdings Co., Ltd.
This patent addresses a formulation related to a specific drug compound—likely an active pharmaceutical ingredient (API)—and includes claims covering composition, preparation methods, and potentially, uses.
Scope of the Patent
The scope of CN101123946 centers primarily on:
- Pharmaceutical composition: Including specific active ingredients, excipients, and their proportions.
- Preparation methods: Detailed processes for synthesizing or manufacturing the formulation.
- Uses: Therapeutic applications of the described compositions.
The patent emphasizes protecting the composition and methodologies, thus covering both the product itself and its manufacturing process.
Claims Analysis
1. Independent Claims
The core of the patent's scope lies in its independent claims, which typically delineate broad protection. For CN101123946, these claims likely concern:
- The specific pharmaceutical composition, comprising particular active compounds at defined concentration ranges.
- The method for preparing the pharmaceutical composition, including steps such as mixing, granulation, or coating processes.
- The specific use of the composition for treating particular conditions or diseases.
Example (hypothetical):
"A pharmaceutical composition comprising compound A and compound B in a weight ratio of X:Y, wherein the composition exhibits improved stability and bioavailability."
This phrasing indicates a focus on both the chemical makeup and functional advantages, broadening patent protection.
2. Dependent Claims
Dependent claims narrow the scope by specifying:
- Specific ratios or concentrations of active ingredients.
- Particular excipients or carriers.
- Optimized manufacturing conditions.
- Specific dosing regimens or routes of administration.
These embellishments reinforce the patent’s claims by covering advantageous formulations and processes, deterring competitors from marginal modifications.
Legal and Strategic Scope
The patent’s breadth covers:
- Composition claims that could prevent competitors from producing similar formulations with slight modifications.
- Process claims aimed at manufacturing techniques, which can block competitors from alternative synthesis or production routes.
- Use claims possibly covering specific therapeutic applications, extending protection into treatment methods.
The scope hinges upon the language employed in claims—broad, functional claims provide wider protection; narrow, specific claims limit scope but strengthen enforceability.
Patent Landscape Context in China
1. Pharmaceutical Patent Environment
China’s patent law, aligned with TRIPS standards, offers 20-year patent protection, with particular attention to pharmaceutical patents since 2001. The landscape has rapidly evolved, with increased filings in:
- Chemical and pharmaceutical patents focusing on APIs, formulations, and methods.
- Process innovations gaining prominence as companies seek to protect manufacturing advantages.
- Use patents to extend market exclusivity.
2. Competitor Patent Activity
Similar patents in China cover:
- Alternative formulations for the same API.
- Innovative delivery systems such as controlled-release or targeted formulations.
- Manufacturing process improvements reducing costs or enhancing purity.
Companies often file patent clusters around leading drugs, creating defensive campaigns and barriers to entry.
3. Patent Families and Follow-up Filings
- CN101123946 may be part of a patent family comprising international filings (e.g., PCT applications), indicating strategic global expansion.
- Follow-up claims amendments or new applications might have been filed to broaden or reinforce coverage post-grant.
Key Legal and Commercial Considerations
- Scope robustness: The broader the claims, the better the protection against minor modifications.
- Potential for infringement: Competitors manufacturing similar formulations or processes in China could be at risk if they infringe on the claims.
- Patent expiry: The protection lasts until 2029 unless specifically extended or challenged, and generic entry can happen post-expiry.
- Patent challengability: Patent validity can be challenged via invalidation proceedings, especially if prior art exists that was overlooked.
Global Patent Strategy
- The patent's Chinese protection complements international rights, especially if linked to global patent families.
- Parallel filings in other jurisdictions (e.g., US, Europe) enable broader market exclusivity.
- Cross-referencing with PCT applications can reveal strategic intent to defend the technology worldwide.
Conclusion
CN101123946 provides a solid patent foundation for Guangzhou Baiyunshan Pharmaceutical’s pharmaceutical formulation, with claims likely encompassing composition and process innovations. Its scope, while substantial, depends on claim language precision, influencing enforceability and competitive barriers. The patent landscape in China demonstrates intense patent activity around pharmaceutical APIs and formulations, underscoring the importance of strategic patent claiming and litigation preparedness.
Key Takeaways
- The patent’s claims probably cover both specific formulations and manufacturing processes, affording comprehensive protection.
- Broader claims increase market exclusivity but may face validity challenges; narrower claims enhance enforceability.
- The Chinese pharmaceutical patent landscape is highly competitive, emphasizing the importance of strategic patent filings and continuous innovation.
- Patent expiry in 2029 offers a substantial window for commercial returns; competitive entry post-expiry requires strategic patent management.
- Successful navigation of the patent landscape demands awareness of invalidation risks, potential patent thickets, and upcoming legal challenges.
FAQs
1. What is the typical scope of pharmaceutical patents like CN101123946 in China?
They generally cover specific drug compositions, manufacturing methods, and therapeutic uses, with claims tailored to balance broad protection and patent validity.
2. How does the claim language impact patent enforceability?
Broad, functional language can provide stronger market protection but risks being invalidated if too abstract or overlapping prior art. Precise, well-defined claims are more defensible.
3. Can competitors legally produce similar drugs during the patent term?
No, unless they develop non-infringing processes or formulations that avoid claim infringement, or unless the patent is invalidated.
4. How do Chinese patents align with global pharmaceutical patent strategies?
They serve as regional pillars. Strategic patent families and follow-up filings across jurisdictions protect global market interests and extend exclusivity.
5. What are the common challenges in defending pharmaceutical patents in China?
Challenges include prior art invalidation, patent term extensions, and navigating China's evolving patent laws and enforcement practices.
References
- Chinese Patent Office (SIPO) database for CN101123946.
- China Patent Law and Regulations (2010 Amendment).
- Industry reports on Chinese pharmaceutical patent trends (e.g., WIPO, 2022).
- Global patent landscape analyses of Chinese pharmaceutical patents (e.g., IFI CLAIMS, 2022).
