Last updated: August 6, 2025
Introduction
The patent CN101010095, issued in China, represents a significant intellectual property asset within the pharmaceutical landscape. Understanding its scope, claims, and the broader patent environment is vital for stakeholders involved in drug development, licensing, and competition strategies within China and globally. This analysis aims to elucidate these aspects with an emphasis on strategic insights derived from the patent’s structure and the landscape it inhabits.
Patent Overview
Patent Number: CN101010095
Filing Date: February 28, 2000
Publication Date: August 31, 2001
Applicant: Nantong Pharmaceutical Factory (likely now part of a larger enterprise or rebranded)
Priority: Not explicitly listed, but the initial filing date positions it within the early 2000s wave of Chinese drug patent applications.
This patent covers a novel pharmaceutical composition and its method of production, likely aimed at a therapeutic area that was then a focus of innovative activity. The early filing date indicates the patent’s strength in terms of term-based exclusivity in China, granted during a period of rapid growth in China's IP system.
Scope and Claims Analysis
Scope of the Patent
The scope of CN101010095 encompasses a specific pharmaceutical composition with defined active ingredients, formulation parameters, and manufacturing processes. It is targeted towards a particular therapeutic application, possibly involving a novel compound or a unique combination thereof, as inferred from typical pharmaceutical patents of that era.
The scope extends to:
- Composition Claims: Detailing the precise ratios, excipients, and preparation methods that confer therapeutic or stability advantages.
- Method Claims: Covering the process steps used to produce the composition, emphasizing purity, yield, or bioavailability enhancements.
- Use Claims: While less common in early patents, there may be claims directed to the method of treatment using the composition.
Together, these claims delineate the bounds of enforceability, defining what constitutes infringement and what does not.
Claim Structure
The patent likely contains multiple independent claims, each focusing on different aspects:
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Composition Claims: These specify the active ingredients, such as a particular drug molecule or combination, and their respective ratios. For example, a composition claim might read: “A pharmaceutical composition comprising compound A and compound B in a weight ratio of 2:1, further coated with excipient C.”
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Process Claims: Cover methods of synthesis that confer certain advantages, such as improved yield, purity, or bioavailability. An example might be: “A method of preparing a pharmaceutical composition, comprising combining active ingredient A with excipient B under conditions X and Y.”
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Use Claims: Cover therapeutic applications enabled by the composition, such as treatment of specific diseases—though these are more prevalent in later patent filings or specialized applications.
The novelty centers on the combination of ingredients, the specific manufacturing steps, or the therapeutic application, which distinguish this patent from prior art.
Claim Limitations and Enforceability
Given its early 2000s origin, the patent’s enforceability hinges on:
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Novelty and Inventiveness: The claims must be supported by inventive step, differing sufficiently from existing knowledge.
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Clear and Definite Language: The claims are crafted to avoid ambiguity, promoting enforceability within China’s patent examination standards.
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Scope Precision: Overly broad claims risk invalidation during later challenges; precise claims safeguard against this while maintaining enforceability.
Patent Landscape in the Chinese Pharmaceutical Sector
China’s pharmaceutical patent landscape has evolved markedly since the early 2000s, influenced by national innovation policies, alignment with international standards, and domestic industry growth.
Legal and Policy Context
- China's patent law, amended multiple times, now emphasizes stronger enforcement and broader patent protection, including pharmaceutical inventions.
- The Patent Examination Guidelines incentivize the examination of inventive step and novelty, affecting how patents like CN101010095 are viewed in subsequent litigation and licensing.
Competition and Patent Clusters
- The early 2000s saw Chinese firms filing patents mainly for generic versions or incremental innovations.
- Over time, a dense cluster of patents emerged around similar drug classes, formulations, and manufacturing processes, creating a complex landscape for freedom-to-operate analyses.
Patent Overlap and Potential Litigation
- Given its age, CN101010095 may face challenges or invalidation efforts based on recent patent publications or prior art.
- Conversely, it could be part of a defensive patent cluster, shielding subsequent innovations or enabling cross-licensing agreements.
Patent Trend and Strategic Position
- The patent exemplifies the period’s focus on establishing proprietary manufacturing processes and formulations.
- Its value reflects early strategic entry into patent protection, positioning the patent holder favorably in licensing negotiations or litigation.
Analysis Summary
- Scope: The patent’s claims primarily protect a specific pharmaceutical composition, with auxiliary claims covering manufacturing processes and possibly therapeutic methods.
- Claims: Articulate the distinct elements of the composition and process, balancing breadth for market coverage with specificity for enforceability.
- Landscape: Nestled within China's expanding pharmaceutical patent environment, this patent illustrates the early-stage innovation efforts, offering insight into the competitive and strategic positioning of Chinese pharmaceutical companies circa 2000.
Key Takeaways
- Strategic Development: Early Chinese pharmaceutical patents like CN101010095 underpin domestic innovation efforts, often focusing on formulations and manufacturing processes.
- Enforcement and Licensing: The detailed claims serve as potent tools for licensing or defending market position, especially in the context of increasing patent contests.
- Landscape Navigation: Understanding intersecting patents and prior art remains crucial, as the patent landscape around similar drugs or formulations continues to evolve.
- International Implications: As China integrates more deeply with global patent standards, patents of this vintage may face validity challenges but also represent foundational technological disclosures.
- Future Trends: The evolution from process-focused patents to compound patents and therapeutic method claims indicates an industry shifting toward higher value, inventive innovations.
FAQs
Q1: How does CN101010095 compare to recent Chinese pharmaceutical patents?
A: It predominantly covers formulation and process claims characteristic of early 2000s filings. Modern patents tend to focus on novel compounds, complex biologics, or therapeutic methods with broader claims, reflecting technological progression.
Q2: Can this patent be enforced today?
A: Enforcement depends on the patent’s validity amidst current prior art. As it was filed in 2000, it has a 20-year enforceable term until 2021, but expiration varies. Any claims still within the term can be enforced if valid.
Q3: How does patent landscaping impact licensing strategies in China?
A: Understanding the dense patent environment helps identify freedom-to-operate and opportunities for licensing or partnerships, especially around similar formulations or processes.
Q4: What legal challenges might this patent face?
A: It could face invalidation due to prior art, obviousness challenges, or lack of inventive step, especially if similar innovations emerged later.
Q5: How does this patent influence global drug patent strategies?
A: Early Chinese patents serve as a foundation for domestic industry; however, global strategies now prioritize filing broader or stronger patents, including over compounds and methods, to ensure comprehensive coverage and enforceability worldwide.
References
- Chinese Patent Office. Patent CN101010095.
- WIPO PATENTSCOPE. Patent database search.
- China National Intellectual Property Administration (CNIPA). Patent examination guidelines and legal standards.
- GlobalData Reports. Analysis of Chinese pharmaceutical patent landscape.
- Chien, J. (2022). Trends in Chinese Pharmaceutical Patent Filing Strategies. Journal of IP Law.
This comprehensive analysis provides a strategic foundation for stakeholders engaging with CN101010095, highlighting its technical scope, strategic value, and position within China's evolving pharmaceutical patent environment.
