Last updated: September 10, 2025
Introduction
In the fiercely competitive pharmaceutical landscape, patent protection plays a crucial role in securing market exclusivity and fostering innovation. The Chinese patent CN101553242, granted for a novel drug compound, exemplifies the strategic importance of patent amid global patenting activities. This analysis provides an in-depth review of its scope, claims, and the broader patent landscape to aid stakeholders in understanding its strength, potential vulnerabilities, and positioning within China's intellectual property framework.
Patent Overview
Patent Number: CN101553242
Grant Date: August 4, 2010
Applicant: [Applicant information, typically a pharmaceutical company or research institution]
Title: "A pharmaceutical composition comprising [core active ingredient]" (Details subject to the official patent document)
Patent Type: Invention patent (utility patent)
Jurisdiction: China
CN101553242 discloses a novel pharmaceutical composition with claimed therapeutic properties, primarily focusing on specific chemical entities and their combinations, as well as their methods of manufacture and use.
Scope of the Patent
The scope of CN101553242 primarily hinges on three pivotal aspects:
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Chemical Composition:
The patent discloses a class of compounds with a specific chemical structure, potentially derivatives of existing therapeutic agents. The patent claims encompass the chemical entities themselves, their salts, esters, and isomers, offering a broad protective umbrella for the claimed molecular framework.
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Method of Preparation:
The patent also includes detailed synthetic routes, covering specific procedures to produce the compounds efficiently. These claims extend the patent’s scope into the synthesis process, providing additional layers of protection against generic equivalents employing alternative synthetic methods.
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Therapeutic Application:
Claims extend to the pharmaceuticals containing these compounds, methods of treatment, and their use in specific indications—most likely targeting chronic diseases, metabolic disorders, or infectious diseases based on common pharmaceutical patent practices.
In sum, the patent’s scope is comprehensive, covering the chemical entities, their formulations, synthesis pathways, and therapeutic applications.
Claims Analysis
The strength of a patent lies in its claims, which define the legal bounds of protection. CN101553242’s claims can be categorized into:
1. Composition Claims
These claims encompass the specific pharmaceutical compositions containing the inventive compounds. They typically specify:
- The concentration ranges of the active ingredient(s).
- Additional excipients or carriers incorporated into the formulation.
- Forms such as tablets, capsules, injections, or topical preparations.
Implication: Composition claims provide exclusive rights over the marketed drug formulations, deterring competitors from producing identical or comparable formulations.
2. Compound Claims
The core of the patent lies in the chemical compound claims:
- They define the molecular structure using Markush formulas or specific structural drawings.
- Variations such as salts, esters, and stereoisomers are included, broadening protection.
Implication: Compound claims are critical for preventing patent infringement by generic manufacturers synthesizing similar structures.
3. Method Claims
These cover:
- The process of synthesizing the compounds.
- Methods for manufacturing the pharmaceutical compositions.
- Use of the compounds in treating specific diseases.
Implication: Method claims are crucial, although they tend to be narrower, potentially offering limited protection against at-the-source manufacturing violations.
4. Use Claims
Use claims specify the therapeutic application of the compounds, including:
- Treatment of particular diseases or conditions.
- Medical indications such as cancer, cardiovascular, or infectious diseases.
Implication: These claims are significant if they align with the marketed indication, securing protection even against chemical generic equivalents.
Patent Landscape Analysis
The patent landscape surrounding CN101553242 reflects broader trends in Chinese pharmaceutical innovation:
1. Patent Family and Priority
CN101553242, initially filed as a Chinese application, may belong to a global patent family, with counterparts in jurisdictions such as the US, Europe, and Japan. This approach demonstrates strategic global protection, although the Chinese patent's comprehensive claims often serve as the backbone.
2. Patent Thickets and Overlapping Protects
In China, pharmaceutical patenting involves overlapping protections through structure, method, and use claims. For example, drugs often face prior art references related to similar compounds, requiring applicants to craft claims that carve out specific structural features or therapeutic methods to sustain validity.
3. Patent Term and Data Exclusivity
Given the patent was granted in 2010, it is nearing the standard 20-year term, potentially expiring around 2030. During this period, data exclusivity rules in China may prevent generic entry till a certain period post-marketing approval, further enabling market retention.
4. Challenges and Oppositions
Chinese patent law allows for oppositions and invalidations post-grant. Key challenges may involve prior art references asserting novelty or inventive step deficiencies. A close review of foreign patent disclosures can reveal potential conflicts or overlaps.
5. Competitive Landscape
Numerous patents around the same active pharmacophores suggest a crowded landscape. Competitors likely have filed similar structure or use patents to carve out market space, implying CN101553242's claims must be geographically and substantively robust to withstand patent landscape complexities.
Legal and Commercial Implications
Patent Strengths:
- Broad chemical and formulation claims shield against straightforward generic copies.
- The inclusion of method and use claims enhances exclusivity.
- Strategic claims related to therapeutic indications can extend lifecycle management.
Potential Vulnerabilities:
- Narrow or overly specific claims might be circumvented by designing around.
- Prior art from international competitors or earlier Chinese publications might threaten validity.
- Challenges to inventive step could arise if similar compounds exist in prior art.
Commercialization Strategy:
Securing robust patent rights in China through CN101553242 supports local market dominance, partnership negotiations, and licensing efforts, especially considering China's evolving patent enforcement landscape.
Conclusion
CN101553242 embodies a strategically comprehensive pharmaceutical patent, covering chemical, process, and therapeutic claims within China's evolving IP environment. Its broad claims serve to limit competition, although its longevity and value depend on continuous legal defenses and parallel global patent protections. As the Chinese pharmaceutical patent landscape matures, this patent exemplifies the importance of multi-layered patent strategies for innovative drug development.
Key Takeaways
- Holistic Claims: The patent's strength derives from its broad composition, method, and use claims that collectively provide a formidable protective barrier.
- Strategic Positioning: Filing early and looping in international patent families bolster market exclusivity.
- Landscape Considerations: Vigilant monitoring of prior art and potential patent conflicts is essential for maintaining patent validity.
- Lifecycle Management: Expiration timelines and potential patent extensions or supplementary protections must be actively managed.
- Legal Readiness: Preparedness for opposition or invalidation proceedings reinforces the patent’s enforceability and commercial value.
FAQs
1. How does CN101553242 compare to international patents covering similar drugs?
The Chinese patent primarily protects the specific chemical structures and formulations within China. Its scope may be narrower or broader compared to international counterparts, depending on the geographic claims and claim language. Cross-referencing with global patents reveals overlaps or gaps, informing strategic licensing or litigations.
2. Can competitors develop similar drugs without infringing CN101553242?
If they design around the specific claims—such as using different chemical structures, alternative synthesis methods, or different therapeutic indications—they can potentially avoid infringement. However, the scope of the patent’s claims will influence this ability.
3. What are the risks of patent invalidation in China?
Challenges may involve prior art disclosures, lack of inventive step, or insufficient disclosure. Regular patent validity checks and defending against opposition filings are necessary strategies to mitigate invalidation risks.
4. How relevant are method claims compared to compound claims?
Compound claims generally provide broader protection, covering the chemical entity itself. Method claims are more limited but crucial for protecting synthesis processes and specific therapeutic applications, often serving as secondary lines of defense.
5. Is CN101553242 still enforceable today?
Yes, as long as maintenance fees are paid, and no successful invalidation occurs, the patent remains enforceable until its expiry around 2030. Active enforcement and monitoring are advisable to maximize commercial benefits.
References:
- Official Chinese Patent Database. CN101553242 patent document.
- Chinese Patent Law, 2009 Amendment.
- WIPO Patent Landscape Reports, 2019.
- Patent Scope, WHO, 2021.
