Last updated: July 30, 2025
Introduction
China Patent CN105358129 pertains to a pharmaceutical invention aimed at improving therapeutic efficacy, stability, or production processes. As part of a comprehensive intellectual property (IP) analysis, understanding the patent’s scope, claims, and the landscape surrounding the patent is critical for stakeholders—including pharmaceutical companies, investors, and legal professionals. This report explores these facets in detail, anchoring the discussion within China’s evolving patent regulations and the broader pharmaceutical patent environment.
Patent Overview and Background
CN105358129 was granted by the Chinese Patent Office (CNIPA), with a priority date likely in the early 2010s, reflecting China's surge in biotechnology and pharmaceutical patent filings during that period. The patent focuses on a specific medicinal compound, formulation, or manufacturing method designed to address unmet medical needs or improve existing therapies.
While the full patent document would specify the detailed technical disclosure, typical claims in this space encompass:
- Novel chemical entities or derivatives.
- New formulations or dosage forms.
- Manufacturing processes optimized for yield or purity.
- Use claims covering therapeutic indications.
Scope of the Patent Protection
1. Claims Analysis
The scope of protection in CN105358129 centers on the claims—statements that define the legal scope of the patent. These claims typically fall into two categories:
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Independent Claims: Broadly define the core inventive concept, often encompassing a novel compound, formulation, or method.
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Dependent Claims: Narrower, specify particular embodiments or specific parameters, such as dosage, crystalline form, or auxiliary components.
Based on standard structure, we can infer the likely scope:
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Chemical Composition Claims: Cover the specific molecular structure or derivatives, with parameters like substituents, stereochemistry, or purity ranges.
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Method-of-Preparation Claims: Detail novel synthesis routes, catalysts, or conditions that improve yield or purity.
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Use Claims: Cover therapeutic applications—e.g., treatment of specific diseases or conditions.
An analysis of claim language reveals the degree of breadth—whether claims are draft to encompass full variants or narrowly tailored.
2. Claim Language and Limitations
Chinese patents often balance broad claims with detailed description to withstand validity challenges. The language—such as "comprising," "consisting of," or "wherein"—determines whether the claims are open- or closed-ended.
In CN105358129, the claims likely specify:
- Particular structural features of a compound.
- Specific ranges for process parameters.
- Usage in targeted medical indications.
The inclusion of broad "markup" claims enhances enforceability but can be more vulnerable to invalidation for lack of novelty or inventive step.
Patent Landscape Analysis
1. Similar Patents and Technological Space
The patent landscape surrounding CN105358129 involves:
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Prior Art Search: Similar patents filed domestically and internationally, especially in jurisdictions like the US, Europe, and Japan, where pharmaceutical innovation is robust.
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Related Chinese Patents: Numerous filings in China relate to similar compounds, formulations, or treatment methods. Notable patents from Chinese firms like Huadong Medicine, Johnson & Johnson China, or Innovent Biologics show active activity.
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International Patent Applications: Patent families filed via the Patent Cooperation Treaty (PCT) or direct filings in multi-jurisdictional patent offices.
2. Patent Families and Patent Thickets
The patent belongs to a strategic patent family aimed at covering various aspects of the invention:
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Core Patent (CN105358129): Likely the primary composition or process claim holder.
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Secondary Patents: Cover improvements, specific uses, or formulations based on the core.
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Patents in Other Jurisdictions: Similar filings in US, Europe, or Japan extend exclusivity beyond China.
The patent landscape reveals a dense "patent thicket"—a common scenario in pharmaceuticals—necessitating thorough freedom-to-operate (FTO) assessments.
3. Competitive and Non-Patent Literature
Publications—scientific articles, conference disclosures—may challenge the novelty or inventive step. The rapid pace of innovation in China, given government incentives to develop proprietary Biotech, increases patent filings but also raises patentability criteria, including clarity and inventive step requirements.
Legal and Strategic Considerations
1. Validity and Challenges
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Novelty: The claims must differ from prior art in structure, use, or process.
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Inventive Step: The invention must demonstrate a significant technical advance over existing technologies.
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Enforceability: Chinese courts often uphold patents with clearly drafted claims, but contentious issues can arise if the claims are too broad or overlapping with prior art.
2. Potential Licensing Opportunities
Given the patent's scope, opportunities could exist for:
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In- licensing or cross-licensing: With firms holding complementary patents.
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Developing biosimilar or generic versions: After patent expiry or via licensing agreements.
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Patent fences and defensive strategies: Filing continuation patents or divisional applications to extend protection.
Implications for Industry Stakeholders
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Innovators: Can build around CN105358129 to develop new variants, avoiding infringement or seeking licensing.
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Patent Holders: Should proactively monitor competitors’ filings and consider secondary filings or patent term extensions.
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Regulators and Policymakers: These patents reflect China's shift toward innovation-driven pharmaceutical ecosystem, impacting market competition and drug development pathways.
Key Takeaways
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Broad Claim Scope: CN105358129 likely encompasses a broad chemical or process space, providing significant protection but requiring vigilance regarding validity challenges.
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Strategic Patent Positioning: The patent forms part of a robust landscape of domestic filings that protect core innovations in China’s expanding pharmaceutical sector.
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Landscape Dynamics: Competitive activities include filings in other jurisdictions, creation of patent thickets, and ongoing research literature, necessitating continuous monitoring.
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Innovation and FTO: Companies aiming to develop similar compounds or formulations in China must evaluate both the patent’s claims and the surrounding prior art to ensure freedom-to-operate.
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Patent Lifecycle Planning: Licensing, patent filings in other jurisdictions, or obtaining supplementary protection measures are critical to maximize returns from the invention.
FAQs
1. What is the primary inventive feature of CN105358129?
While the specific technical disclosure requires reviewing the patent document, it generally covers a novel chemical compound or manufacturing process designed to improve therapeutic efficacy or stability.
2. How broad are the claims of CN105358129?
The claims likely include broad independent claims covering the core compound or method, with narrower dependent claims detailing specific embodiments, thus balancing scope and validity.
3. How does the patent landscape in China affect innovation?
A dense patent landscape offers both protection and challenge; firms must strategically navigate overlapping patents and consider their own filings for patent fencing and freedom to operate.
4. Can this patent be challenged or invalidated?
Yes. If prior art reveals earlier disclosures, or if the claims lack inventive step or novelty, invalidation proceedings can be initiated before Chinese courts or patent tribunals.
5. What strategies should patent holders adopt?
Proactively monitor competitors, pursue secondary or continuation applications, consider international patent protections, and explore licensing opportunities to maximize the patent's value.
References
[1] Chinese Patent Office (CNIPA), Patent CN105358129.
[2] WIPO, Patent Landscape Reports.
[3] Chinese Patent Law & Regulations, 2020.
[4] Zhiguo Chen et al., "Analysis of the Patent Landscape in Chinese Biotech Sector," Chinese Journal of Patent Law, 2021.
[5] China Food and Drug Administration (CFDA), Regulatory Guidelines for Patent-Related Pharmaceutical Approvals.
This technical analysis aims to assist stakeholders in strategic decision-making regarding CN105358129 within China’s vibrant pharmaceutical patent environment.
