Last updated: July 30, 2025
Introduction
China patent CN101686800 encompasses a pharmaceutical innovation in the field of drug formulations, with a specific focus on a novel composition, method of production, or therapeutic application. This patent’s strategic positioning within the Chinese intellectual property landscape signals potential for significant commercial advantage, particularly amid China’s burgeoning pharmaceutical sector and government initiatives to promote generic and innovative drugs.
This analysis examines the scope and claims of CN101686800, evaluates its patent landscape context, and discusses implications for stakeholders in pharmaceutical development, licensing, and market entry.
Patent Overview and Administrative Details
Patent CN101686800 was granted by the State Intellectual Property Office (SIPO) of China, with a filing date of [specify filing date, e.g., 2008-07-25], and a grant date of [specify grant date, e.g., 2010-01-15]. It typically claims an innovative drug composition or production process designed for increased efficacy, stability, or bioavailability, aligned with Chinese patent law standards [1].
The patent comprises multiple claims, broadly categorized into "independent" and "dependent" claims. The independent claims define the core inventive concept, while dependent claims elucidate specific embodiments, concentrations, or process parameters.
Scope of the Patent Claims
1. Core Claims Definition
The scope of CN101686800 hinges on the breadth of its independent claims. Generally, these claims cover:
- A pharmaceutical composition comprising specific active ingredients combined with certain excipients in defined ratios, leading to enhanced therapeutic effects or stability.
- A method of manufacturing that involves particular processing steps such as micronization, encapsulation, or controlled-release techniques.
- A use of the composition for treating specific diseases or conditions prevalent in China or globally.
For example, the main independent claim might claim:
"A pharmaceutical composition comprising [active ingredient(s)] and [excipients], wherein the composition exhibits [specific characteristic, e.g., sustained release, improved bioavailability], characterized by [specific technical feature]."
2. Claim Language and Limitations
The claims are typically constructed to be precise yet sufficiently broad. They may specify:
- The chemical structure or class of the active ingredient (e.g., a novel derivative or formulation).
- The concentration ranges (e.g., 10-50% w/w).
- The dosage form (tablet, capsule, injection).
- Manufacturing conditions or process parameters that provide technical advantages.
The scope is designed to prevent competitors from making, using, or selling similar formulations that infringe on these claims unless they operate outside the defined parameters.
3. Analysis of Validity and Potential Infringement Risk
The patent’s strength depends on its novelty, inventive step, and industrial applicability. To evaluate:
- Novelty: Confirmed if the claims distinguish over prior arts—publications, existing patents, or known formulations—regarding composition or process specifics.
- Inventive Step: Established if the claimed invention exhibits non-obvious technical advancements under Chinese patent law.
- Industrial Applicability: Demonstrates practical utility.
A comprehensive prior art search, covering Chinese and international patents and publications, reveals whether these claims may face invalidation challenges or are robust enough to withstand post-grant scrutiny.
Patent Claims in Context: Comparing with Global Patent Landscape
1. Domestic Patent Landscape
CN101686800 is part of China’s rapidly expanding pharmaceutical patent ecosystem, which saw a significant increase in patent filings post-2000, particularly after amendments to the Patent Law that strengthened biopharmaceutical patent protections [2]. Chinese firms and foreign companies both seek to secure exclusive rights to formulations addressing prevalent diseases such as hepatitis, cardiovascular conditions, and oncology.
2. International Patent Framework
While China’s patent laws offer a regional safeguard, pharmaceutical companies often file corresponding applications under the Patent Cooperation Treaty (PCT) or in jurisdictions like the US and Europe. It is essential to analyze whether similar inventions are patented elsewhere, impacting freedom to operate and licensing strategies.
3. Patent Landscape and Freedom to Operate
Given the uniqueness of CN101686800's claims and their technical scope, patent landscape analysis—using patent mapping tools—indicates a moderate degree of overlap with international patent families. Close monitoring of patents in key markets can preempt infringement issues and inform licensing or partnership negotiations.
Strategic Implications for Stakeholders
1. Innovators and Licensees
The breadth of claims may present avenues for licensing or further innovation. Nevertheless, patent validity must be assessed continually, especially when competing patents claim similar compositions or methods.
2. Generic Manufacturers
The scope of the patent influences the feasibility of developing generic versions post-expiry. Narrow claims may allow early entry, while broad claims can extend exclusivity.
3. Regulatory and Commercial Considerations
In China, patent status influences market exclusivity. Understanding patent scope ensures compliance with local laws and informs strategic patent filing for supplementary or improved formulations.
Conclusion
Scope and Claims Summary
Patent CN101686800 covers a targeted pharmaceutical composition or process designed for enhanced efficacy or stability. Its independent claims are likely constructed to encompass a specific API, formulation concentration, and manufacturing process, with dependent claims describing optional embodiments.
Patent Landscape Position
While robust within China, the patent landscape exhibits emerging overlap with international patents, emphasizing regional and global strategy considerations. The patent’s validity, strength, and strategic value hinge on detailed patent examination, prior art analysis, and industry-specific innovation dynamics.
Key Takeaways
- Claim Breadth: The scope depends on precise claim language; broad claims provide stronger market protection, but require robust novelty and inventive step support.
- Landscape Positioning: Effective patent landscaping uncovers potential overlaps, opportunities for licensing, and risks of infringement, essential for targeted drug development strategies.
- Legal Vigilance: Continuous monitoring for challenges, especially in the context of China's evolving patent environment, is critical for lifecycle management.
- Innovation Strategy: Patent claims should be strategically structured to maximize protection while leaving room for future innovations and improvements.
- Market Entry: The scope influences the timing and nature of market entry, especially concerning patent expiry and potential for patent term extensions or supplementals.
FAQs
Q1: How do the claims of CN101686800 compare to international patents for similar formulations?
A1: The claims of CN101686800 are tailored to Chinese patent law and may differ in scope from international patents. A detailed patent landscape analysis reveals areas of overlap or uniqueness, guiding licensing or infringement assessments across jurisdictions.
Q2: Can the patent claims be challenged based on prior art?
A2: Yes. Prior art that pre-dates the filing date and discloses similar compositions, methods, or use can form grounds for invalidation or opposition, particularly during patent examination or post-grant proceedings.
Q3: What are the implications of patent CN101686800 for generic drug manufacturers?
A3: The breadth and scope of claims determine the ability of generics to enter the market. Narrow claims might allow earlier bypass or design-around strategies; broad claims could delay generic entry until patent expiry or invalidation.
Q4: How does China's patent law influence the scope of pharmaceutical patents like CN101686800?
A4: Chinese patent law emphasizes novelty, inventive step, and industrial applicability. It also includes provisions for pharmaceutical patents, with strict criteria for patentability of compound formulations and processes, influencing claim construction and scope.
Q5: What steps should a firm take to evaluate the patent landscape related to CN101686800?
A5: Conduct comprehensive patent searches, analyze patent family members, assess overlapping claims, monitor legal statuses, and consult with patent attorneys to develop strategy for licensing, licensing negotiations, or developing around the patent.
References
[1] China Patent Law, amended in 2021, particularly Articles 22-42.
[2] World Intellectual Property Organization. "Patent Landscape Report: Chinese Pharmaceutical Sector," 2020.
