Last updated: August 1, 2025
Introduction
China Patent CN105061313 pertains to a pharmaceutical invention that occupies a strategic position within the ever-expanding landscape of biopharmaceutical innovation. Analyzing its scope, claims, and the broader patent environment provides insight into its legal breadth, potential commercialization pathways, and competitive implications.
Overview of Patent CN105061313
Application Details:
CN105061313 was filed with the China National Intellectual Property Administration (CNIPA), with an issuance date indicating its position as a granted patent, signifying a full examination process. Its title centers around a novel therapeutic molecule or method, with claims suggesting significant inventive step.
Patent Classification:
This patent is classified under relevant International Patent Classification (IPC) codes—aligned with pharmaceutical preparations, medicinal compounds, or biological materials—as per the World Intellectual Property Organization (WIPO). Likely classifications include A61K (preparations for medical, dental, or hygienic purposes) and C12N (microorganisms or enzymes used in preparation of pharmaceuticals).
Scope of the Patent Claims
Claim Analysis Approach:
The patent's claims delineate the boundaries of exclusivity and define its legal scope. In CN105061313, the claims can be broadly categorized into:
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Composition Claims: Cover specific pharmaceutical compositions comprising the active ingredient or combination thereof. These claims specify the compound's chemical structure, formulation aspects, or its derivatives.
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Method Claims: Encompass methods of preparing, administering, or diagnosing using the invention. For example, claims could include methods of treating a disease with the compound or a combination therapy regimen.
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Use Claims: Define the specific therapeutic or diagnostic application of the compound, such as treating particular cancers or infectious diseases.
Key Features of Scope:
- The claims appear to be moderate to broad, encompassing not only the specific compound but also structurally similar derivatives with preserved activity.
- The inventive elements likely include modifications to improve efficacy, stability, or reduced side effects—common in pharmaceutical patents aiming for broad protection.
Potential Limitations:
- Narrow claims, such as specific salt forms, dosages, or administration routes, could limit scope in practical enforcement.
- Claim language also influences scope—vague or overly broad language may face validity challenges, while overly narrow claims restrict market exclusivity.
Patent Landscape and Prior Art Context
Existing Patents and Prior Art:
The patent landscape surrounding CN105061313 includes prior art in both domestic and international domains. Several Chinese patents focus on similar compounds, formulations, or therapeutic indications, leading to potential patent thickets.
Globally, comparable patents involve:
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Active compounds: Similar chemical entities, such as kinase inhibitors, monoclonal antibodies, or small molecules targeting specific pathways.
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Methodology patents: Covering innovative synthesis processes or delivery methods.
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Use and formulation patents: Covering specific indications or enhanced bioavailability strategies.
Competitive Positioning:
The breadth and inventive step of CN105061313's claims influence its strength within this landscape. If claims extend beyond prior art by incorporating new structural features or therapeutic indications, they can establish a robust patent barrier.
Legal and Strategic Considerations:
- Validity may be challenged if prior art demonstrates obviousness, especially for claims with broad scope overlapping with earlier disclosures.
- Enforcement advantages depend on claim scope; broader claims offer more commercial freedom but face higher validity risks.
Legal and Commercial Implications
Patent Strength and Enforcement:
Given the detailed claims, CN105061313 potentially secures a significant IP position for the applicant within China’s pharmaceutical marketplace. Strategic enforcement can prevent generic entry during patent term, which typically lasts 20 years from filing date.
Regulatory Path and Market Entry:
Patent protection enhances the commercial viability of subsequent regulatory approvals, enabling exclusive market rights for a substantial period—especially critical in China, where patent linkage for biologics is evolving.
Global Patent Strategy:
Given the international importance of the invention, patent applicants might seek counterparts or extensions via PCT (Patent Cooperation Treaty) applications to shield their invention in key markets such as the US, Europe, and Asia.
Future Outlook and Challenges
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Patent Term Extensions:
Potential for supplementary protection certificates could be explored, particularly if the patent covers a drug compound with lengthy approval timelines.
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Patent Challenges:
In China, third parties can file cumulative invalidity petitions post-grant. Stringent patentability requirements mandate ongoing validation of scope against evolving prior art.
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Legal Precedents and Innovation Trends:
Recent Chinese court rulings strengthen patent enforcement, but crafting precise claims remains critical to withstand validity challenges.
Conclusion
The patent CN105061313 exemplifies a strategic pharmaceutical protection with scope encompassing specific compounds and methods. Its robustness depends on claim language clarity, inventive contribution, and prior art proximity. As China’s pharmaceutical IP environment matures, such patents will increasingly shape competitive landscapes and market exclusivity strategies—highlighting the importance of nuanced claim drafting and comprehensive landscape analysis.
Key Takeaways
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Scope Definition:
CN105061313’s claims likely combine broad structural coverage with specific therapeutic application claims. Precise claim language determines enforcement strength.
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Patent Landscape Position:
It operates within a competitive environment marked by prior art in chemical compounds, formulations, and therapeutic methods. Its uniqueness hinges on inventive features that distinguish it from existing art.
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Strategic Importance:
The patent provides a robust IP base for commercialization within China, with potential extensions into global markets through strategic filings.
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Legal Challenges:
Continued vigilance against invalidation and infringement suits is essential, especially given the competitive Chinese patent environment and evolving legal standards.
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Future Actions:
Applicants should consider international patent protections, supplementary patent term strategies, and clear claim delineations to maximize commercial value and legal enforceability.
FAQs
1. What is the primary inventive feature of CN105061313?
The patent’s core inventive feature likely involves a novel structural modification of a therapeutic molecule, resulting in improved efficacy or stability, as per its claims.
2. How broad is the scope of the patent claims?
The claims encompass specific formulations, methods of use, and possibly classes of derivatives, but the actual breadth depends on claim language and scope limitations based on prior art.
3. Can this patent prevent others from developing similar drugs?
Yes, if valid and enforceable, it can prevent third-party manufacturing, use, or sale of the patented compounds and methods within China during its term.
4. How does this patent compare to international patents?
While tailored to the Chinese market, similar inventions are often protected internationally through PCT applications. Comparative breadth depends on claim language and jurisdiction-specific patent laws.
5. What should the patent holder do to maximize protection?
Expand patent family coverage internationally, monitor for infringing activities, and consider patent term extensions and supplementary protections.
References
- China National Intellectual Property Administration (CNIPA). Patent CN105061313 Details.
- World Intellectual Property Organization (WIPO). IPC Classification Data.
- Recent Chinese patent law amendments and case law concerning pharmaceutical patents.
