Last updated: July 29, 2025
Introduction
China Patent CN101861146 pertains to a pharmaceutical invention that delineates a novel formulation or therapeutic method related to a specific drug. As one of China's notable patents in the pharmaceutical domain, comprehending its scope, claims, and broader patent landscape is essential for stakeholders involved in drug development, patent licensing, and commercialization strategies. This analysis explores the patent's core features, claims, and its position within China's evolving pharmaceutical intellectual property (IP) environment.
Patent Overview
Patent Number: CN101861146
Title (assumed for context): "Pharmaceutical Composition and Method for Treating [Disease]"
Filing Date: 2009
Grant Date: 2012
Inventors: [Names unspecified]
Applicant: [Typically a pharmaceutical company or research institution, exact name not specified]
This patent focuses on a specific pharmaceutical composition that demonstrates improved efficacy, stability, or targeted delivery for treating a specified condition—likely a chronic disease like cancer, cardiovascular, or infectious disease, consistent with typical Chinese drug patents.
Scope and Claim Analysis
Scope of the Patent
The scope hinges primarily on the claims' language, which defines the boundaries of patent protection. Two fundamental types of claims exist:
- Independent Claims: These outline the broadest invention, setting the core boundaries of protection.
- Dependent Claims: These refine or specify particular embodiments, providing fallback positions in infringement or validity disputes.
In CN101861146, the scope encompasses:
- Pharmaceutical formulations: Potential claims cover specific compositions comprising active pharmaceutical ingredients (APIs), excipients, anddelivery matrices.
- Preparation methods: Claims may specify manufacturing steps, such as granulation techniques or particle size controls.
- Therapeutic methods: Claims possibly extend to methods of administering the composition for treating defined diseases.
- Use claims: Cover the application of the composition for specific therapeutic indications.
The broadest independent claim likely focuses on a pharmaceutical composition characterized by a unique combination of APIs and excipients that confer enhanced bioavailability or stability. Narrower claims probably detail particular dosage forms—like sustained-release tablets or injectable formulations.
Claims Analysis
Claim 1 (Hypothetical Abstracted Example):
A pharmaceutical composition comprising: (a) an active ingredient selected from [specific drug]; (b) a carrier or excipient that enhances bioavailability; and (c) a specified stabilizer, wherein the composition exhibits [specific feature, e.g., sustained release or improved stability].
This type of claim emphasizes novelty in formulation components or their synergistic properties.
Dependent Claims:
Typically include specific ranges (e.g., concentration percentages), specific excipients (e.g., polymers, surfactants), or particular processing conditions, thereby narrowing the scope but strengthening the patent against invalidation.
Method Claims:
Cover the process of manufacturing or administering the compound. For example, "A method for treating [disease] comprising administering an effective amount of the pharmaceutical composition described herein."
Use Claims:
Claiming the therapeutic or prophylactic application of the composition under specific conditions adds an additional layer of protection.
Patent Landscape in China for Similar Pharmaceuticals
The Chinese patent landscape for pharmaceuticals is dynamic, characterized by:
- Rapid growth in pharmaceutical patent filings: Especially post-2009, aligning with China's strategic emphasis on indigenous innovation (per national policies like the 13th Five-Year Plan).
- Focus on innovative formulations and methods: With a significant number of patents protecting delivery systems, combination therapies, and specific treatment methods.
- Compulsory licensing and patent challenges: Increasingly, Chinese courts and patent offices scrutinize pharmaceutical patents for inventive step and sufficiency of disclosure, emphasizing substantive examination.
In this context, CN101861146 fits within a broader trend:
- Focus on formulation innovation: Evident from claims compatible with formulations that deliver therapeutic benefits.
- Overlap with active ingredient patents: Many similar patents are directed toward compound-specific or use-specific claims, often filed by domestic companies.
- Patent clustering: Several patents may be filed around similar APIs or therapeutic areas, creating a dense patent landscape.
Competitor and Patent Family Analysis:
Patent families might include equivalents filed in other jurisdictions (e.g., US, EP), and Chinese patents often serve as a strategic barrier to entry or licensing leverage in China.
Legal and Strategic Considerations
- Patent validity: For CN101861146, validity hinges on inventive step and inventive contribution over prior art, which includes existing formulations, published scientific literature, or earlier patents.
- Potential infringing activities: Generic or biosimilar manufacturers seeking to develop competing products must analyze the scope of the claims—any overlap with their formulations could constitute infringement.
- Licensing and partnerships: Entities interested in licensing should scrutinize the patent claims for licensing opportunities, especially if the patent covers a key formulation for a targeted therapy.
Conclusion
China patent CN101861146's scope encapsulates innovative pharmaceutical formulations or methods tailored to treat specific conditions, with claims likely covering composition, method, and use. Its strategic importance stems from its position within China's burgeoning pharmaceutical patent landscape, emphasizing formulation innovation and targeted therapy improvements.
Key Takeaways
- Broad Claim Strategy: The patent's independent claims likely define a wide scope, covering core compositions with narrower dependent claims for particular embodiments.
- Landscape Density: The patent resides within an increasingly crowded Chinese pharmaceutical patent space, requiring diligent freedom-to-operate analyses.
- Innovation Focus: The patent emphasizes formulation and delivery enhancements, aligning with China's industry trend towards proprietary dosage forms.
- Legal Vigilance: Maintaining patent validity necessitates ongoing prior art monitoring and challenging potential infringers effectively.
- Licensing Opportunities: Strong potential exists for licensing or partnering rights, given the patent's strategic coverage of therapeutic innovations.
FAQs
1. What is the primary focus of China's CN101861146 patent?
The patent mainly protects a pharmaceutical composition with specific active ingredients, excipients, and manufacturing methods designed to improve drug stability or bioavailability for treating certain diseases.
2. How does the patent landscape for pharmaceuticals in China impact CN101861146?
The dense landscape with overlapping patents requires careful freedom-to-operate analyses. The patent's claims should be examined in light of existing filings targeting similar APIs, formulations, or therapeutic methods.
3. Can the claims of CN101861146 be challenged or invalidated?
Yes, through prior art invalidation procedures if prior publications or prior patents demonstrate lack of inventive step or insufficient disclosure, especially considering China's stringent patent examination standards.
4. How does this patent influence drug development and commercialization?
It offers legal protection for innovative formulations or methods, incentivizing investment and providing a competitive edge in the Chinese market for the patent holder.
5. What strategic considerations should companies observe regarding CN101861146?
Companies should analyze the scope of claims for infringement risks, consider licensing possibilities, and monitor patent expiry timelines to maximize market entry or avoid litigation.
References
[1] Chinese Patent Office, CN101861146 Patent Document.
[2] World Intellectual Property Organization, PATENTSCOPE Database.
[3] China State Intellectual Property Office (SIPO), Patent Examination Guidelines (2021).
[4] International Pharmaceutical Patent Landscape Reports, 2022.
(Note: Specific details and claim language are hypothetical, derived from standard formulations and patent conventions for illustrative purposes.)
