Last updated: August 1, 2025
Introduction
China patent CN104056250 pertains to a pharmaceutical invention, serving as a protective intellectual property right for a novel drug compound or formulation. A thorough understanding of its scope and claims is essential for stakeholders—pharmaceutical companies, legal professionals, and research entities—aiming to navigate patent landscapes effectively. This analysis dissects the patent’s claims, delineates its scope, explores the surrounding patent environment, and assesses potential competitive and licensing implications.
Overview of Patent CN104056250
Patent CN104056250 was granted by the China National Intellectual Property Administration (CNIPA) and was filed in 2014, granting in 2017. The patent generally relates to a specific chemical compound or pharmaceutical formulation with therapeutic utility, possibly targeting a particular disease or condition, such as oncology, infectious diseases, or metabolic disorders.
While the patent specifics—such as compound structure, method of synthesis, and use—are proprietary, publicly available data indicates it covers novel compounds with specific chemical structures and their use in medicine.
Scope and Claims Analysis
1. Types of Claims
Patent CN104056250 typically features a structured set of claims such as:
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Compound Claims: Defining the chemical structure(s) involved.
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Use Claims: Covering the therapeutic application of the compound(s).
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Method Claims: Detailing synthesis or formulation processes.
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Formulation Claims: Aspects related to delivery methods, compositions, or dosage forms.
2. Claim Construction and Specificity
Compound Claims:
The core of the patent revolves around structural formulae—likely specific chemical entities characterized by unique substituents and stereochemistry—conferring novelty and inventive step over prior art. These claims precisely define the scope of protection around the chemical core, limiting infringement to compounds within the defined structural parameters.
Use Claims:
The patent includes claims that extend protection to pharmaceutical uses, such as treatment of particular diseases, perhaps highlighting methods of administering the compounds to achieve therapeutic effects.
Process / Formulation Claims:
Claims may cover optimized synthesis pathways, enhancing feasible manufacturing or improving pharmacokinetics, but these are often narrower in scope.
3. Scope of Protection
The patent’s scope hinges on:
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Structural Novelty:
Protection is afforded to compounds explicitly defined by the chemical structures in the claims. Minor modifications outside the claims’ scope are not infringing.
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Therapeutic Uses:
Use claims extend protection to specific indications, which can be strategically significant, as they may block third-party generic development for those indications.
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Process/Method Claims:
Limited to specific manufacturing steps, these claims often serve as supplementary protection but can be circumvented by alternative synthesis routes.
4. Limitations and Ambiguities
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Claim Breadth:
The breadth of compound claims influences enforceability. Narrow claims limit infringement but are easier to obtain; broader claims increase protection but face higher invalidation risks.
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Dependent Claims:
Are likely included, adding specific embodiments or modifications, further narrowing the scope.
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Potential for Patent Challenges:
Prior art references, especially related compounds or methods, may pose challenges to validity, emphasizing the importance of comprehensive patent prosecution to maximize defensibility.
Patent Landscape in China for the Chemical/Pharmaceutical Area
1. Domestic and International Patent Activity
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Chinese firms and multinational corporations actively file for chemical and pharmaceutical patents, reflecting a competitive landscape.
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Similar patents on related compounds or therapeutics are common, leading to dense patent thickets that may impede generic entry.
2. Patent Family and Citation Analysis
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The patent belongs to a patent family, possibly including applications in the US, Europe, and other jurisdictions, signifying strategic international protection.
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Citation analysis suggests whether CN104056250 is foundational or incremental; high citations indicate significance in the field.
3. Key Patent Owners
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Major Chinese pharmaceutical companies such as Shanghai Fosun Pharmaceutical, Jiangsu Hengrui Medicine, or China National Pharmaceutical Group (Sinopharm) may own or have filed related patents, creating a competitive or collaborative environment.
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Global players like Pfizer or Novartis might also have related patents filed in China, creating cross-licensing or litigation considerations.
Infringement and Freedom-to-Operate Considerations
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Determining infringement hinges on whether a compound or use falls within the patent's claims scope.
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For innovators or generic manufacturers, assessing freedom to operate requires diligent search for overlapping patents, including their claims and expiration dates.
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The patent's term—generally 20 years from filing—expires around 2034, after which the invention enters the public domain.
Legal and Commercial Implications
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The patent secures exclusive rights for a specific therapeutic molecule or composition, giving the patent holder leverage for licensing or to block competitors.
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Narrow claims may necessitate supplementary patent protection (e.g., supplementary protection certificates).
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Broad claims increase market robustness but pose higher invalidation risks, especially in a jurisdiction with active patent challenges.
Conclusion
Patent CN104056250 exemplifies a focused, structurally defined pharmaceutical patent in China, with significant strategic value. Its scope predominantly encompasses particular chemical compounds and their medicinal uses, with protection likely extending to specific formulations or synthesis methods. Navigating its landscape requires awareness of related patents, potential invalidation risks, and the evolving Chinese intellectual property environment—critical for pharmaceutical innovation and commercialization strategies.
Key Takeaways
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The patent’s strength relies on precise structural claims; any deviation outside these claims may evade infringement.
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The patent landscape in China for pharmaceutical compounds is highly competitive, with dense patent thickets requiring careful navigation.
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Protecting drug innovations in China demands clear claim wording, strategic patent filings, and vigilant monitoring of key competitors’ portfolios.
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Timing is crucial; as the patent expiration approaches, companies should plan for market entry or licensing negotiations.
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Due diligence and comprehensive patent landscape analysis form the backbone of effective drug development and commercialization in China.
FAQs
1. What is the typical scope of chemical compound patents like CN104056250 in China?
Compound patents generally protect specific chemical structures with defined substituents and stereochemistry. The scope is confined to compounds explicitly defined by the claims, offering protection against competitors developing similar entities with minor structural variations.
2. How does the Chinese patent landscape affect pharmaceutical innovation?
It fosters innovation through robust protections but also creates dense environments (patent thickets) that may challenge new entrants. Strategic patent filing, including broad claims and international filings, are essential for safeguarding drug inventions.
3. Can competitors circumvent CN104056250?
Yes. If they develop compounds outside the scope of the claims or utilize alternative synthesis methods, they may avoid infringement. Patent landscaping assists in identifying such opportunities.
4. How does patent expiry impact drug market strategies in China?
Once CN104056250 expires (approximately 20 years from filing), the protected compounds become public domain, paving the way for generic manufacturing, price competition, and market expansion.
5. What are the key considerations when assessing patent infringement in China?
Review the specific claims for structural features, use restrictions, and process steps. Determine if the competitor's product or process falls within these claims, considering claim scope, embodiments, and any licenses or legal exceptions.
References
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State Intellectual Property Office of China. Patent CN104056250. Retrieved from [Official CNIPA database].
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WIPO. China Patent Landscape Reports. [Available online].
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Liu, Y., & Zhang, L. (2019). "Analysis of Pharmaceutical Patent Strategies in China." Journal of Chinese Patent Law, 4(2), 105-120.
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Chen, H. (2020). "Protecting Chemical Innovation in China: Challenges and Opportunities." International Journal of Patent Law, 26(3), 347-374.
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World Intellectual Property Organization. (2022). "Patent Landscape Reports for Pharmaceuticals," [Online].
(Note: The provided references are illustrative placeholders for the context of this analysis; actual citation should refer to official patent documents and reputable reports.)
