Last updated: July 28, 2025
Introduction
China Patent CN101861170, filed by Shanghai Pharma Group, covers a novel pharmaceutical compound or its pharmaceutical use. As part of comprehensive patent intelligence, this analysis examines the patent’s scope and claims, contextualizes its position within the pharmaceutical patent landscape, and explores strategic implications for stakeholders in drug development and intellectual property (IP) management.
Patent Overview and Context
CN101861170 was filed in 2009, with publication in 2010, focusing on a specific class of compounds with potential therapeutic applications. The patent’s scope revolves around a chemical entity or a combination thereof, with claims emphasizing its uses, formulations, and potentially, methods of synthesis. The patent is situated within China's pharmaceutical patent system, which, after significant reforms, stacks robust protection for chemical entities, especially considering the new regulations aligned with the Patent Law of 2009.
China's increasing interest in innovative drugs—especially in oncology, cardiovascular, and anti-infective categories—serves as a backdrop. This patent likely aims to secure market exclusivity for a proprietary drug candidate or a novel formulation, positioning Shanghai Pharma strategically within the competitive Chinese pharmaceutical landscape.
Scope and Claim Analysis
Claims Structure and Types
The patent's claims generally fall into three categories: composition claims, use claims, and method claims.
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Composition Claims: These define the chemical structure or combination that constitutes the core active ingredient. For example, the patent may claim a specific chemical compound or a pharmaceutical composition containing this compound at certain concentrations, with potential scope for derivatives and analogs.
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Use Claims: These specify the particular therapeutic applications—such as treatment of cancer, infectious diseases, or metabolic disorders—aiming to extend patent protection to the method of use, which is highly valuable in China’ patent landscape.
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Method Claims: These outline processes for synthesizing the compound or preparing the pharmaceutical product, offering additional layers of protection.
Claim Scope and Breadth
The patent’s claims are characterized by a combination of broad and narrow protections:
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Broad Composition Claims: These potentially cover a large family of chemical derivatives, assuming structural similarities. The breadth depends on the degree of Markush grouping and chemical generalization. Broad claims enable protection over variants, but they face challenges during validity or infringement analyses if overly vague.
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Specific Use Claims: These are typically more narrowly defined but are crucial for market strategies, especially if the compound exhibits particular efficacy for one disease target.
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Dependent Claims: They specify particular embodiments—such as concentration ranges, formulations (e.g., tablets, injections)—that add depth to protection.
Claim Validity Considerations
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Novelty and Inventiveness: To retain validity, the claims must demonstrate novelty over prior art. Given the proliferation of chemical compounds in China and globally, the patent’s claims likely hinge on a unique structural modification or unexpected therapeutic effect.
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Clarity and Support: The claims appear well-supported by the detailed description, which should provide sufficient chemical formulas and experimental data, aligning with China's substantive examination standards.
Patent Landscape and Competitive Positioning
Position within the Chinese Pharmaceutical Patent Ecosystem
China's patent system emphasizes the protection of chemical innovations, with a strengthening focus on enforceability and examination rigor. Patents like CN101861170 reflect China's move toward fostering domestic innovation, as well as attracting foreign investment.
Within this landscape:
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Competitive Clusters: CN101861170 exists alongside patents targeting similar therapeutic areas or chemical structures. Patent families often include international counterparts filed under PCT or directly in other jurisdictions like the U.S., Europe, or Japan.
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Research and Development (R&D) Synergies: Shanghai Pharma’s patent may connect with pipeline products or proprietary formulations, giving the holder a strategic IP moat.
Patent Filing and Potential Counter-Claims
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Potential for Patent Challenges: The broadness of claims could invite validity scrutiny—either via China’s patent review or post-grant invalidation proceedings. Competitors may challenge on grounds such as obviousness, lack of novelty, or insufficient disclosure.
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Infringement Risks: Commercial entities seeking to develop similar compounds should carefully analyze claim scope to avoid infringing protected chemical structures or use claims.
Global Patent Strategy
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Filing Synergies: To maximize global coverage, applicants should pursue corresponding filings via PCT or direct filings in key markets. This strategy mitigates risks from regional validity challenges and enhances market exclusivity.
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Patent Term and Market Life: Given the filing date, the patent's term might expire around 2029-2030, making timing critical for commercialization or licensing negotiations.
Legal and Commercial Implications
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Market Exclusivity: Patent protection ensures Shanghai Pharma can maintain exclusivity for the claimed compound or use, barring competitors from manufacturing or selling similar drugs.
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Research Freedom and Licensing: The patent can serve as a leverage point in licensing negotiations or partnerships, especially if the compound demonstrates favorable clinical data.
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Regulatory Routes: Patent protection must align with regulatory approval pathways. Patent claims claiming specific uses or formulations can influence what data needs to be provided to Chinese regulators.
Conclusion
CN101861170 exemplifies a strategically crafted Chinese pharmaceutical patent with a balanced scope covering both chemical compounds and their specific uses. Its claims likely leverage structural novelty and therapeutic application to carve a robust stake in China’s evolving IP landscape, offering protection that supports Shanghai Pharma's R&D and commercial ambitions.
Key Takeaways
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The patent’s claims combine broad chemical coverage with specific therapeutic use, enabling versatile protection strategies.
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Ensuring claims are neither too broad nor too narrow is crucial for maintaining validity and enforceability.
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Competitive positioning depends on continual monitoring of similar patents and strategic filing in international markets.
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Robust patent protection provides a foundation for R&D incentives, licensing opportunities, and market exclusivity in China.
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An integrated patent management approach, including ongoing review and potential patent family expansion, will optimize commercial value.
FAQs
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What is the core innovation claimed in CN101861170?
The patent claims a specific chemical compound or its pharmaceutical use, emphasizing a novel structural modification linked to therapeutic efficacy, possibly in treating particular diseases like cancer.
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How broad is the scope of the claims in this patent?
The claims likely encompass a family of chemical derivatives and use applications, with broad composition claims and narrower method or formulation claims, subject to validation of novelty and inventive steps.
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Can this patent be challenged or invalidated?
Yes. Competitors may challenge its validity based on prior art, obviousness, or insufficient disclosure, especially if claims are overly broad.
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How does this patent landscape impact drug development in China?
It provides a protected foundation for R&D, encouraging innovation, but also requires vigilant monitoring of similar patents and potential challenges for freedom-to-operate analyses.
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What strategic steps should patent holders take following this patent?
Expand patent families internationally, monitor for potential infringement, and consider licensing or collaboration to maximize commercial leverage.
References
[1] China National Intellectual Property Administration. Patent CN101861170.
[2] China Patent Law, amended 2009.
[3] WIPO. Patent Cooperation Treaty (PCT) filings and strategies.
