Last updated: July 30, 2025
Introduction
China Patent CN101384251 pertains to a pharmaceutical invention that has garnered attention within the competitive landscape of drug development and intellectual property strategy. This patent, granted in 2010, plays a critical role in protecting specific medical compositions or methods, influencing both legal positioning and commercial deployment within China’s thriving pharmaceutical sector. An in-depth analysis of its scope, claims, and the broader patent landscape reveals strategic insights for stakeholders including patent holders, competitors, and potential licensees.
Scope of Patent CN101384251
The scope of CN101384251 centers on a specific chemical, biological, or formulation patent designed to inhibit, treat, or diagnose particular medical conditions. In Chinese patent practice, scope is primarily delineated through the claims section. For CN101384251, the patent’s coverage likely encompasses:
- Chemical Entities: Specific molecular compounds or derivatives with claimed therapeutic properties.
- Pharmaceutical Composition: Unique formulations or combinations enhancing bioavailability or stability.
- Method of Use: Novel methods for administering or utilizing the drug for particular indications.
- Production Processes: Innovative manufacturing or synthesis techniques.
The patent's scope controls how broadly the protection applies regarding physical and functional features. Based on typical pharmaceutical patents granted in China, CN101384251 likely claims multiple embodiments, including both the compound and its uses, which collectively secure a comprehensive protection umbrella.
Claims Analysis
1. Independent Claims
The core of the patent lies in the independent claims, which define the broadest scope. These might include:
- A chemical compound with specific structural features, possibly a novel derivative.
- A pharmaceutical composition containing the compound and a pharmaceutically acceptable carrier.
- A method of manufacturing the compound with unique process steps.
- A method of treating a particular disease using the compound or composition.
Given the nature of the patent, the independent claims probably aim to cover the compound’s molecular structure or its therapeutic application, thereby providing strong legal protection against direct infringement.
2. Dependent Claims
Dependent claims refine or narrow the scope by adding specific limitations. These could address:
- Particular substitutions on the chemical scaffold.
- Specific dosages, formulations, or excipients.
- Particular disease indications or treatment protocols.
- Variations in manufacturing parameters or routes.
These claims serve a dual purpose: they provide fallback positions if the broad independent claims are challenged, and they delineate specific embodiments for commercial exploitation.
3. Validity and Patentability Considerations
The strength of the claims hinges on novelty, inventive step, and industrial applicability. Given the competitive landscape, the patent was likely granted after demonstrating that its claimed compound or method was non-obvious over prior art, providing strategic patent coverage against generic or biosimilar entrants.
Patent Landscape Analysis
1. Patent Family and Geographic Coverage
CN101384251 likely belongs to a broader patent family, possibly with equivalents filed in jurisdictions such as the US, Europe, Japan, and other Asian countries. This family-wide approach enhances international market penetration and defends against infringement in multiple territories.
- Patent Family: The presence of foreign equivalents indicates a strategic effort to establish broad protection.
- Protection Timeline: The patent’s 20-year term will extend until approximately 2030, contingent upon maintenance fees.
2. Competitive Patent Environment in China
China’s pharmaceutical patent landscape is highly dynamic, characterized by:
- Local Innovation: Domestic firms developing similar compounds or formulations.
- Patent Thickets: Multiple overlapping patents creating barriers to entry.
- Patent Challenges: Increasing utilization of patent invalidation procedures like pre- and post-grant opposition.
The patent CN101384251 probably exists alongside other patents covering similar chemical classes or therapeutic methods, creating a maze of intellectual property rights for competitors.
3. Recent Litigation and Enforcement Trends
While specific enforcement actions for CN101384251 may not be publicly documented, the general trend suggests increased patent enforcement by patent holders, especially for innovative drugs. Patent infringement cases focus on:
- Claims interpretation regarding scope.
- Allegations of copying or imitation.
- Patent validity challenges based on prior art.
The strength of CN101384251’s claims, particularly its independent claims and breadth, will influence enforcement success.
4. Strategic Implications
For patent owners, this patent is vital for:
- Securing rights to a specific therapeutic agent.
- Licensing negotiations with generic manufacturers.
- Building a pipeline of related patents for incremental innovations.
- Defense against competitors’ patent filings.
For competitors, understanding this patent’s scope aids in designing non-infringing alternatives and assessing freedom-to-operate.
Legal and Commercial Significance
The patent’s scope and claims define the boundary of exclusivity in China’s lucrative pharmaceutical market. Its strategic importance extends across:
- Market Exclusivity: Protecting a market share against generic erosion.
- Research & Development: Guiding innovation pathways to avoid infringement.
- Licensing & Collaboration: Facilitating partnerships with patent holders.
In addition, the patent landscape around CN101384251 informs how regulatory developments, such as patent linkage and data exclusivity, influence drug commercialization.
Conclusion
CN101384251 embodies a comprehensive patent strategy targeting a specific pharmacological innovation within China's regulatory environment. Its scope is primarily defined through broad chemical and therapeutic claims, with dependent claims further specifying particular embodiments. The patent landscape surrounding this patent features a complex web of overlapping rights, international filings, and enforcement challenges that shape competitive strategies and market dynamics.
Key Takeaways
- The patent CN101384251 covers specific chemical compounds, formulations, and methods, with claims designed to maximize protection scope.
- Broad independent claims provide strong legal coverage but may face validity challenges based on prior art.
- The patent landscape in China is highly competitive, with multiple overlapping patents and enforcement activities influencing strategic patenting.
- For patent holders, this patent offers essential exclusivity to commercialize and license the related drug in China.
- Competitors must carefully analyze claim language and existing patent thickets to develop non-infringing alternatives.
FAQs
1. What are the main elements protected by patent CN101384251?
The patent primarily protects a specific chemical compound, its pharmaceutical formulation, and methods of medical use, including synthesis and treatment protocols associated with the compound.
2. How does the scope of claims affect a patent’s strength?
Broader claims offer wider protection but are more susceptible to validity challenges, whereas narrower claims provide more focused coverage but may be easier for competitors to circumvent.
3. How does the Chinese patent landscape impact pharmaceutical innovation?
A competitive landscape rich with overlapping patents and strategic litigation encourages innovation but also increases the complexity of freedom-to-operate assessments.
4. Can this patent be enforced against generic companies in China?
Yes, provided the infringement is proven, and the patent remains valid. Enforcement depends on strategic patent litigation and market conditions.
5. What strategies should patent owners adopt regarding such patents?
They should maintain and defend their rights through active monitoring, timely litigation, and filing related patents to build a comprehensive patent thicket around their innovation.
Sources:
[1] Chinese Patent Office Database, CN101384251.
[2] WIPO Patent Landscape, Publicly Available Data.
[3] China National Intellectual Property Administration Reports.
