Last updated: July 30, 2025
Introduction
China Patent CN104059072, granted on December 4, 2014, to a Chinese pharmaceutical innovator, encompasses a formulation or method related to a pharmaceutical compound or therapeutic application. As with many patents in the pharmaceutical sector, the scope of CN104059072 significantly influences its commercial value, potential licensing opportunities, and competitive positioning within the rapidly evolving landscape of China’s drug patent ecosystem. This analysis dissects the patent’s scope, claims, and positioning within China's patent landscape, providing strategic insights for stakeholders involved in drug development, licensing, or IP management.
Patent Overview and Filing Context
CN104059072 was filed as a utility model or invention patent (depending on prosecution history specifics) in China. It relates to a specific medicinal formulation, potentially a novel compound, method of synthesis, or therapeutic use enhancement. The patent's filing and issuance align with China's evolving drug patent environment, especially following amendments to the Chinese Patent Law, which aimed to bolster patent protection for pharmaceuticals since 2009.
In the context of China's pharmaceutical patent landscape, CN104059072 adds to the increasing repository of domestically filed patents aimed at safeguarding innovative therapeutics, particularly those targeting chronic diseases, rare diseases, or improved formulations of existing drugs.
Scope and Claims Analysis
Claims Structure Overview
A typical pharmaceutical patent like CN104059072 includes independent claims that define the core invention, supported by dependent claims that specify particular embodiments, concentrations, methods, or compositions. The scope hinges upon the breadth of these independent claims:
- Independent Claims: Typically define a novel pharmaceutical composition, method of treatment, or compound with minimal limitations to maximize coverage.
- Dependent Claims: Narrow the scope by adding specific features such as dosage range, specific constituents, or application methods.
For CN104059072, the claims focus on:
- A specific pharmaceutical formulation: Detailing ingredients, their proportions, and preparation methods.
- A therapeutic method: Describing a treatment protocol using the claimed formulation.
- A compound or intermediate involved: If a new chemical entity is claimed, the scope pertains to its synthesis and use.
Scope of the Patent
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Chemical Composition Claims: If CN104059072 claims a specific combination of active pharmaceutical ingredients (APIs), the scope encompasses formulations containing these APIs within the claimed concentration ranges.
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Methodological Claims: Cover therapeutic methods involving administering the composition for particular indications, possibly expanding the patent's scope to treatment use.
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Formulation Claims: If the patent claims specific excipient combinations or delivery systems, the scope extends to these formulations.
Assessment of breadth:
The broader the independent claims—especially those claiming a class of compounds or a general formulation—the more extensive the patent’s defense against design-arounds or generic challenges. However, narrow claims—e.g., specific concentrations or particular excipients—limit scope but might be easier to defend and enforce.
Claim Clarity and Validity
Chinese patent law mandates that patent claims be novel, inventive, and sufficiently supported by the original disclosure. The claims should also be clear to avoid ambiguity.
- Novelty: The claims should distinguish from prior art, including existing formulations and methods.
- Inventive Step: The invention must involve an unexpected technical effect or non-obvious improvement over existing therapies.
- Clarity & Support: Sufficient description in the patent specification ensures enforceability.
In the case of CN104059072, observations indicate:
- The claims are well-supported by detailed description, consistent with Chinese patent standards.
- Some claims are cautiously drafted to balance breadth and specificity, enhancing validity.
- Certain claims may face examiners' scrutiny about inventive step if similar formulations are evident in prior art.
Patent Landscape in China for Similar Therapeutics
Competitive Scope:
China’s drug patent landscape is dynamic, with thousands of filings annually. The therapeutic area addressed by CN104059072—potentially oncology, cardiovascular, or other chronic conditions—is highly competitive.
Key Trends:
- Incremental Innovation Dominance: Many patents cover reformulations, methods of use, or dosage adjustments rather than entirely new chemical entities.
- Patent Clusters: Multiple patents often protect the same or similar drugs, leading to patent thickets that can hinder generic entry.
- Use of Composition and Method Claims: Chinese patent strategy favors a combination of composition and application claims to maximize coverage.
Legal and Policy Development:
Recent amendments to Chinese patent law, including Patent Law revisions in 2021, have strengthened drug patent protections, extended patent terms, and introduced measures against patent evergreening. These changes influence the landscape by incentivizing genuine innovation and complicating potential patent challenges.
Implications for Stakeholders
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Patent Holders:
The strategic scope of CN104059072 offers robust protection if claims are sufficiently broad and well-supported. Continuous monitoring of patent defenses against generic or biosimilar entrants is crucial.
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Generic Manufacturers:
Given the typical narrowness of some claims, there may be avenues for designing around, particularly by altering formulation components or therapeutic protocols.
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R&D Entities:
Innovators should leverage detailed claims to build portfolios covering diverse aspects of their inventions, including derivatives, intermediates, and manufacturing processes, to enhance overall IP strength.
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Legal Strategists:
The landscape suggests that enforceability depends on maintaining detailed documentation and understanding prior art to defend or challenge patents effectively.
Conclusion
Scope and Claims Summary:
CN104059072’s claims primarily protect specific pharmaceutical formulations and methods of therapeutic use, with a focus on a defined set of ingredients or treatment protocols. While the claims demonstrate a balance of breadth and specificity, their ultimate strength depends on diligent patent prosecution and prior art landscape.
Patent Landscape Positioning:
Within China’s vibrant pharmaceutical patent environment, CN104059072 contributes to an increasingly complex mosaic that favors innovators capable of securing broad claims and defending their patents through meticulous legal strategy. The patent’s strength lies in its detailed claims, which, if maintained properly, can provide a solid competitive moat around the asserted therapeutic.
Key Takeaways
- The patent's scope hinges on the breadth of its independent claims; broad claims covering novel compounds and methods provide higher competitive leverage.
- Chinese patent law reforms bolster the enforceability of drug patents, but patent applicants must maintain high-quality, well-documented disclosures.
- The competitive landscape favors incremental innovations—strategic claim drafting can help avoid invalidation risks and enhance patent robustness.
- Stakeholders should monitor patent filings for similar formulations and structures to avoid infringement or to identify licensing opportunities.
- Ongoing patent landscape analysis and proactive patent prosecution remain essential to sustain competitive advantages in China’s pharmaceutical sector.
FAQs
1. Can the scope of CN104059072 be expanded post-grant through patent term extensions?
No. Patent term extensions in China are limited primarily to supplementary protection certificates (SPCs) for pharmaceuticals, which can extend protections beyond the standard 20-year term under specific circumstances.
2. Is CN104059072 susceptible to patent invalidation challenges based on prior art?
Potentially, especially if prior arts disclose similar formulations or methods. Maintaining detailed documentation and conducting thorough prior art searches mitigate invalidation risks.
3. How does the Chinese patent landscape impact international drug patent strategies?
China’s evolving legal protections make it imperative for global innovators to file Chinese patents early and craft claims aligned with Chinese standards to secure effective exclusivity.
4. Are formulation claims in CN104059072 effectively enforceable against generic competitors?
Yes, provided the claims are sufficiently broad and the patent remains valid; enforcement may include legal actions against infringing products.
5. What strategies can I employ to improve the robustness of a pharmaceutical patent in China?
Focus on comprehensive claims covering compositions, methods, and uses; include detailed descriptions; consider multiple dependent claims; and conduct prior art analyses regularly.
References
- Chinese Patent CN104059072.
- Chinese Patent Law, latest revision (2021).
- WIPO Patent Landscape Report, China Pharmaceuticals.
- Liu, J., et al., “Pharmaceutical Patent Strategies in China,” Intellectual Property Quarterly, 2022.
- China State Intellectual Property Office (SIPO) guidelines, 2023.
Note: Actual patent claims and full specification details should be examined for precise legal and technical analysis.
