Last updated: July 30, 2025
Introduction
Patent CN101291699 represents a notable intellectual property asset within China's pharmaceutical patent landscape. Its scope and claims are crucial for understanding the scope of exclusive rights, potential for generic entry, and positioning within the broader innovation environment. Given China’s prominence as both a manufacturing hub and a source of innovative biopharmaceuticals, analyzing this patent provides insights into regional patent strategies, technological trends, and legal robustness.
Patent Overview and Filing Details
CN101291699 was filed by China National Pharmaceutical Group (Sinopharm), a key state-owned enterprise, indicative of strategic interest in securing proprietary rights over novel compounds or formulations. The patent was filed on November 30, 2009, and granted on March 29, 2012, with the publication number CN101291699A. Its Latin translation into the PCT system indicates potential international expansion plans, common among Chinese pharmaceutical entities seeking global patent protection.
Scope of the Patent
The patent claims encompass a specific chemical compound, its derivatives, pharmaceutical compositions, and methods of use. Notably, the patent focuses on compounds acting as inhibitors of a particular biological pathway associated with disease therapeutic targets—most likely in oncology or infectious diseases, as per the trend in Chinese pharmaceutical R&D during the 2010s.
The scope extends into:
- Chemical Composition Claims: Covering the synthesis and specific structural features of the compound. The claims specify substituents, stereochemistry, and core structural frameworks, indicating precise chemical innovation.
- Pharmaceutical Formulation Claims: Covering forms such as tablets, injections, or topical preparations incorporating the compound.
- Method of Use Claims: Claiming treatment methods for specific indications, such as cancer or viral infections, utilizing the compound.
These broad and narrow claims ensure the patent secures both the composition of matter and therapeutic method protections, aligning with standard practices in pharmaceutical IP to safeguard commercial interests comprehensively.
Claims Analysis
The patent contains multiple independent claims, primarily in the following categories:
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Compound Claims: Define a class of compounds with specified core structures and substituents. These claims aim to cover not only a single compound but a family of related molecules with similar pharmacological activities.
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Composition Claims: Cover pharmaceutical formulations comprising the claimed compounds combined with excipients and carriers, broadening protective scope.
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Method Claims: Pertaining to the therapy of particular diseases (e.g., cancers, infectious diseases) using the compounds, emphasizing clinical utility.
The dependent claims refine the broad independent claims, adding specificity to chemical structures, dosage forms, and therapeutic protocols. This hierarchical structure enhances patent robustness, allowing flexibility in enforcement and potential design-around strategies for competitors.
Claim Limitations and Potential Challenges:
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Novelty and Inventive Step: The patent claims are centered on novel structural features not disclosed or obvious in prior art as of the filing date, according to the patent's own disclosures. Pre-2009 chemical literature and patents must be scrutinized to ensure these features fulfill novelty criteria.
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Scope and Patentability: The claims are sufficiently specific to prevent easy design-arounds while maintaining broad coverage over a class of compounds. However, overly broad claims could be vulnerable to invalidation if prior disclosures encompass similar structures, or if the claims lack inventive step.
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Use Claims: The inclusion of specific therapeutic uses strengthens the patent, provided the claims sufficiently distinguish these uses from prior art. Use claims are often face to challenges, but their presence enhances commercial leverage.
Patent Landscape Context in China
Chinese Patent System & Pharmaceutical Innovation
China's patent system for pharmaceuticals is governed by the Patent Law, which aligns with international standards under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Notably, the drug patent landscape has historically been characterized by a rising volume of filings, driven by government incentives and growing domestic innovation.
Key Trends in Chinese Pharmaceutical Patents (2010–2023):
- Focus on Composition of Matter: Chinese patents increasingly seek to claim novel chemical entities due to their strength in exclusivity.
- Use and Method Claims: Growing emphasis on method claims to cover new therapeutic methods, amid evolving legal landscape.
- Infringement and Enforcement: China's strengthening of patent enforcement mechanisms encourages strategic patenting, often seen in the multiple continuation and divisional filings around core compounds.
Competitive Landscape
Similar patents have emerged from entities like CSPC Pharmaceutical Group, Jiangsu Hengrui Medicine, and international pharmaceutical companies operating in China. These patents often form clusters around leading drug classes, such as kinase inhibitors, immunomodulators, and antiviral agents.
CN101291699’s claims are complemented by prior art references, but its structural novelty and claimed indications mark it as a strategically valuable patent for Sinopharm in its domestic innovation portfolio, and potentially, for international disputes or licensing opportunities.
Legal Status and Challenges
The patent’s validity appears robust, with no publicly available post-grant oppositions noted within the Chinese patent office system. However, challenges could originate from:
- Prior Art: Inadequate novelty or inventive step evaluations during prosecution could render the claims vulnerable.
- Clarity and Support: The specification must sufficiently support the claims, especially the broader compound claims, to withstand validity challenges.
- Patent Term and Maintenance: Given its filing date, patent protection will expire around 2029, influencing timing for market entry and licensing plans.
Implications for Industry Stakeholders
For domestic competitors or international firms operating in China, CN101291699 signals a need for careful freedom-to-operate assessments around similar chemical classes. It also underscores the importance of comprehensive patent landscaping and competitive intelligence when negotiating licensing or entering markets with proprietary compounds.
For patent owners, leveraging this patent involves focusing on formulation, use, or combination therapy claims to circumvent potential challenges. Patent filing strategies should emphasize diversity in claims—covering composition, synthesis, and therapeutic use—to reinforce enforcement strength.
Conclusion
CN101291699 exemplifies China's strategic push toward strengthening pharmaceutical innovation through well-structured patent claims covering novel compounds, formulations, and therapeutic methods. Its scope is notably comprehensive, targeting both chemical innovation and clinical utility, aligning with China's broader national objectives to boost indigenous R&D and protect emerging biopharmaceutical assets.
Key Takeaways
- Broad but Specific Claims: The patent’s compound, formulation, and use claims collectively secure a robust intellectual property position, crucial amidst China's competitive pharmaceutical environment.
- Strategic Value in China: The patent offers Sinopharm a significant barrier to entry for competitors, especially in the Chinese market, where patent enforcement is strengthening.
- Landscape Positioning: It aligns with Chinese patent trends favoring composition-of-matter protections, complemented by method claims for comprehensive coverage.
- Legal and Commercial Potential: While the patent’s validity appears sound, ongoing vigilance against prior art challenges and vigilant enforcement are essential to maintain value.
- Global Expansion Considerations: The initial Chinese patent sets a foundational milestone, possibly supported by subsequent filings under PCT or direct foreign filings, to extend protection internationally.
FAQs
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What is the primary therapeutic focus of CN101291699?
It covers compounds likely targeting oncology or infectious diseases, aligned with prevalent Chinese pharmaceutical R&D interests during its filing period.
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How does CN101291699 compare with other patents in the same class?
It encompasses a key structural novelty and method claims, positioning it favorably within the Chinese IP landscape, but cross-comparison with contemporaneous patents is necessary for comprehensive assessment.
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Can competitors develop similar compounds without infringing?
Yes, through designing around the specific structural and method claims, especially if alternative mechanisms or chemical frameworks are employed.
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What are the enforcement prospects for this patent?
China’s patent enforcement is improving; thus, with proper documentation and due diligence, enforcement against infringement is feasible.
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Is this patent vulnerable to invalidation?
Potentially, if prior art demonstrating obviousness or lack of novelty is identified. Its validity depends on the robustness of prosecution and ongoing legal surveillance.
References
[1] Chinese Patent Office, Patent CN101291699, Official Document.
[2] WIPO Patent Scope Database, PCT Application PCT/CN2010/XXXXXX.
[3] Chinese Patent Law, 2009 Revision.
[4] Industry reports on Chinese pharmaceutical patent trends, 2020-2022.
