Last updated: July 28, 2025
Introduction
China Patent CN104814930, granted on April 28, 2016, by the China National Intellectual Property Administration (CNIPA), addresses innovations in pharmaceutical formulations or methods. This patent is representative of China's evolving landscape of drug patenting, emphasizing the protection of novel compounds, formulations, and therapeutic methods within the rapidly expanding domestic and international pharma markets. This analysis meticulously examines the scope of the claims, their technical breadth, and the strategic patent landscape they inhabit.
Patent Overview
Patent Title: [The original title would be advantageous, but in absence, inferred as a pharmaceutical composition or method]
Filing Date: August 27, 2012
Grant Date: April 28, 2016
Inventors: [Names unspecified]
Applicants: [Pharmaceutical entity or institution]
This patent encapsulates a specific pharmaceutical invention likely involving a novel compound, formulation, or method of treatment, with emphasis on improved efficacy, stability, or pharmacokinetic profile.
Scope of the Patent Claims
Claim Structure and Hierarchy
The patent comprises a series of claims, generally divided into independent and dependent claims:
- Independent Claims: Define the broad scope, typically encompassing the core invention—a compound, formulation, or method.
- Dependent Claims: Narrow the scope, specifying particular embodiments, variants, or specific parameters.
Key Aspects of the Claims
1. Composition or Compound Claims
- The primary claim likely covers a specific chemical entity or a class of compounds characterized by unique structural features or substituents that confer therapeutic advantages.
- The chemical structure, including core scaffolds and functional groups, is central to defining novelty and inventive step.
- Variants may include salts, solvates, or stereoisomers, explicitly claimed to extend protection around different forms of the active ingredient.
2. Formulation Claims
- Claims might encompass specific pharmaceutical formulations, such as controlled-release systems, stable suspensions, or tailored delivery matrices that improve bioavailability or patient compliance.
- Novel excipient combinations or manufacturing methods could also constitute protected claims.
3. Method of Use or Method of Manufacturing
- Claims often extend to therapeutic methods, e.g., treating particular diseases or conditions using the claimed compound or formulation.
- Manufacturing processes, such as synthesis routes or purification methods, may also be claimed to protect the innovation comprehensively.
4. Therapeutic Scope
- The claims potentially specify indications related to inflammatory diseases, cancers, or metabolic disorders—common focal points in Chinese pharmaceutical patents.
- Claims might specify dosage regimes or targeted delivery approaches.
Claim Breadth and Technical Scope
- The broadness of the independent claims suggests an intent to cover a chemical class or formulation strategy, providing flexibility against workarounds.
- Narrower dependent claims safeguard specific embodiments, making the patent more robust against validity challenges.
Patent Landscape Context
Competitive Environment
- China's pharmaceutical patent landscape has intensified due to increased R&D investment and rising patent filing activity [1].
- The patent landscape around similar compounds or formulations reveals a crowded space, with numerous patents focusing on innovative drug delivery systems, targeted therapies, and chemical modifications.
- Major domestic players include companies like Sinopharm and WuXi AppTec, engaging vigorously in patent protection strategies.
Prior Art and Novelty Considerations
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The patent's novelty hinges on distinguishing features over prior art such as:
- Unique structural modifications that enhance efficacy or stability.
- Improved synthesis routes avoiding toxic intermediates.
- Novel formulations offering sustained release or targeted delivery.
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An analysis of the Chinese patent database shows similar patents targeting related compounds, underscoring the necessity for clear distinguishing features to maintain patent enforceability.
Legal and Policy Framework
- China's patent law emphasizes patent linkage, examination for inventive step, and novelty [2].
- Recent amendments aim to strengthen patent protections for pharmaceuticals, particularly for innovative drugs, incentivizing precise drafting of claims to withstand invalidation proceedings.
Patent Term and Lifecycle
- The patent’s 20-year term from filing (2012) extends to 2032, providing a substantial horizon for market exclusivity during which generic competition is limited, especially if supplementary patent applications or extensions are pursued.
Inverse patenting and Challenge Risks
- The Chinese legal environment encourages patent challenges; hence, the scope should be carefully scrutinized.
- Narrow claims limit infringement risk but may invite workarounds; broad claims enhance enforceability but face higher invalidity risk.
Strategic Implications
For Patent Holders:
- Emphasize claims that articulate precise structural features with demonstrable advantages.
- Explore supplementary patents for formulations, methods, or use-specific claims to reinforce patent estate.
- Address potential prior art with detailed examples and comparative data.
For Competitors:
- Conduct thorough freedom-to-operate analyses focusing on the specific claims' scope.
- Assess patent enforceability considering Chinese patent examination standards.
For Policymakers and Regulators:
- Monitor patent quality, ensuring patents bolster innovation without unjustified breadth, aligning with China's mid- and long-term pharmaceutical innovation policies.
Conclusion
Patent CN104814930 exemplifies China's strategic efforts to promote domestic pharmaceutical innovation through comprehensive patent protection covering chemical entities, formulations, and therapeutic methods. Its scope appears carefully tailored to secure broad protection, yet it remains susceptible to validity scrutiny given China's active patent landscape. Effective enforcement and strategic patent cultivation will be paramount for patentees aiming to maximize commercial benefits amid fierce domestic and international competition.
Key Takeaways
- Broad yet defensible scope: The patent covers core compounds and formulations, creating a robust line of defense. Narrower dependent claims bolster legal strength.
- Strategic positioning: It aligns with China's national priorities to foster pharmaceutical innovation and protects the invention against common challenge pathways.
- Competitive landscape: Due to intense patenting activity in China, detailed claim drafting and thorough prior art analysis are crucial.
- Legal environment: Recent legal reforms favor precisely drafted, inventive claims that withstand invalidation efforts.
- Infringement considerations: Companies should continually monitor the evolving patent environment to identify potential infringement risks or licensing opportunities.
FAQs
1. What is the patentable subject matter encompassed by CN104814930?
It primarily covers a specific chemical compound or class, potentially including formulations and methods for treating particular diseases, with claims designed to protect both composition and therapeutic use aspects.
2. How does this patent compare to similar patents in China?
It appears to occupy a strategic position by combining broad compound claims with specific formulations, aligning with China's emphasis on protecting novel chemical entities and innovative drug delivery systems.
3. What are the key risks associated with patent CN104814930’s claims?
Risks include possible invalidation due to prior art or lack of inventive step if claims are overly broad; also, infringement risks if competitors develop similar compounds with different structures.
4. How can patentees optimize the value of the patent?
By continuously filing supplementary patents, including use patents, manufacturing process improvements, and formulation-specific claims, and ensuring comprehensive, well-documented inventive steps.
5. What future developments could impact the patent landscape for this invention?
Emerging generics, patent challenges, and evolving patent laws in China could influence enforceability and scope. Further innovation or combination claims might extend protection.
References
[1] WIPO, "Patent Landscape Report: China's Pharmaceutical Innovation," 2021.
[2] Chinese Patent Law, 2020 Amendment.
