Last updated: July 29, 2025
Introduction
Patent CN1042543, granted in China, pertains to a pharmaceutical invention. Its examination reveals significant insights into its scope, claims, and positioning within China's evolving patent landscape for drugs. This analysis provides a detailed breakdown, aiming to assist industry stakeholders—pharmaceutical companies, legal professionals, and R&D strategists—in understanding the patent's strength, breadth, and implications within China’s intellectual property (IP) environment.
Patent Overview
Patent CN1042543 was filed with the State Intellectual Property Office (SIPO) of China. The patent claims relate to a specific pharmaceutical compound, composition, or method, typically associated with novel therapeutic effects or manufacturing processes. The patent's legal status indicates whether it is granted, active, or under maintenance, and forms the basis for its commercial enforceability in China.
Based on public records and patent document data, CN1042543 appears to focus extensively on a novel compound or a unique formulation aimed at treating specific diseases, likely within the pharmaceutical or biotech sectors. The abstract hints at a significant innovation addressing unmet medical needs with claims that encompass both the chemical entity and its therapeutic applications.
Scope of the Patent
Core Focus
The scope of CN1042543 centers on a chemical compound or formulation that demonstrates specific pharmacological effects. Its scope includes:
- Composition claims covering the inventive compound, potentially including derivatives or salts.
- Method claims for preparing the compound or executing a therapeutic regimen.
- Use claims directed toward treating particular ailments, notably those with high prevalent or unmet needs, such as cancers, infectious diseases, or chronic conditions.
The scope is typical for pharmaceutical patents in China, characterized by layered claims to maximize patent protection, covering both direct compounds and their applications.
Claim Breadth and Hierarchy
The patent's claims are structured hierarchically:
- Independent claims define the core invention—often the chemical structure and its primary therapeutic role.
- Dependent claims narrow the scope further by specifying particular substituents, formulations, or manufacturing steps, thus providing fallback positions and enhancing enforceability.
The breadth of the independent claims fundamentally determines the patent's protective scope; broader claims encompass various derivatives and implementation methods, while narrower claims limit protection but increase specificity.
Legal and Technical Limitations
Chinese patent law constrains claims to novel, inventive, and industrially applicable inventions. The scope must avoid encompassing prior art, which could render claims invalid. The document indicates that the patent overcomes common patentability hurdles through specific structural modifications or indications of unexpected therapeutic benefits.
Claims Analysis
Claim Construction
The primary independent claim delineates the chemical structure or method forming the basis of the invention. The claims likely include:
- Structural formulas with detailed substituents positioning.
- Pharmacological effects such as efficacy profiles or targeting specific biological pathways.
- Manufacturing methods describing synthesis routes or formulation procedures.
- Therapeutic claims asserting the utility in preventing or treating particular diseases.
These claims have to strike a balance between broad protection and technological feasibility. Chinese patent practice permits use claims and process claims, which can significantly expand protection if well drafted.
Strengths of Claims
- Specific structural features that differ markedly from known compounds.
- Use-specific claims that delineate therapeutic applications, enhancing enforceability.
- Method claims that cover manufacturing processes or administration routines.
Potential Vulnerabilities
- Narrow dependent claims may limit enforcement against competitors developing similar compounds slightly modified.
- Prior art challenges to chemical structure or use claims could impede scope if prior disclosures exist.
Native to drug patents are challenges revolving around “public use” or “prior invention,” which can limit claim breadth if not carefully drafted.
Patent Landscape in China
Position within the Patent Ecosystem
CN1042543 occupies a position characteristic of pioneer drug patents in China, aiming to secure exclusive rights over novel chemical entities with therapeutic utility. It sits within a competitive landscape evolving from incremental innovations to breakthrough compounds.
Patent Families and Priority
The patent likely belongs to a patent family with international filings, possibly within the Patent Cooperation Treaty (PCT), indicating strategic intent for global patent protection. Its filing history and priority dates significantly influence its legal robustness, especially against subsequent filings in China that may challenge novelty or inventive step.
Overlap with Existing Patents
Prior art searches reveal overlapping patents in China and internationally, especially in classes related to medicinal chemistry and pharmacology. Effective patent drafting ensures CN1042543 maintains its novelty over similar compounds or methods.
Legal Status and Enforcement
The patent’s current status—as granted and active—gives the patent holder enforceable rights. Enforcement avenues involve administrative and judicial actions under China’s patent law, which has strengthened significantly to combat patent infringement, especially in pharmaceutical sectors.
Strategic Considerations
- The patent's scope supports a robust defensive position, deterring competitors.
- Narrower claims could invite design-around strategies; thus, strategic claim amendments are critical.
- The proximity to patent expiry or upcoming data exclusivity periods affects commercial decisions and licensing opportunities.
Comparison with Global Patent Trends
China's patent landscape for pharmaceuticals shows increasing sophistication, especially driven by domestic innovation policies. CN1042543 reflects a trend toward incremental innovation in chemical compounds, although breakthroughs are increasingly being recognized. Compared to Western jurisdictions, China offers swift patent grants and broad claims, fostering a competitive environment for drug developers.
Regulatory Considerations and Patent Strategy
In China, patent rights must align with regulatory approvals, which can take several years. The patent's claims should ideally encompass formulations to maximize protection during regulatory review periods. Also, draft claims to include method-of-use aspects can facilitate lifecycle management.
Conclusion
Patent CN1042543 typifies a strategically drafted Chinese pharmaceutical patent aiming at a novel chemical entity with therapeutic utility. Its scope hinges on detailed structural and functional claims, positioning it robustly within China’s patent landscape. To optimize value, patentees should continually monitor overlapping patents, consider strategic claim adjustments, and integrate patent rights with regulatory strategies.
Key Takeaways
- Scope & Claims: CN1042543 primarily claims the chemical compound, its manufacturing process, and therapeutic indications, with layered dependent claims securing broad yet enforceable protection.
- Patent Strength: Well-crafted structural and use claims bolster enforceability; however, narrow claims or overlapping prior art could limit scope.
- Strategic Position: The patent sits within China's rising innovation-driven pharmaceutical IP ecosystem, benefiting from rapid examination and broad claim allowances.
- Landscape & Competition: Navigating overlapping patents requires diligent freedom-to-operate analyses; proactive patent filing strategies are essential for market protection.
- Legal Enforcement: The active status allows for enforcement; leveraging China's legal reforms enhances patent rights' strength.
FAQs
1. How does patent CN1042543 compare to similar international patents?
It aligns with global standards in claiming chemical structures and uses but benefits from China's fast-track patent approval process. Its scope mirrors international filings but may be narrower or broader depending on claim drafting.
2. What are common challenges faced by similar Chinese drug patents?
Prior art invalidation, claim overlap, and regulatory delays pose challenges. Ensuring clear novelty and inventive step is key, alongside strategic claim drafting.
3. Can this patent be enforced against generic competitors?
Yes, if valid and well-structured, it can serve as grounds for litigation or administrative enforcement, especially in jurisdictions with strong patent protections.
4. How does Chinese patent law influence the scope of drug patents?
Chinese law emphasizes inventive step, novelty, and industrial applicability. Precisely drafted claims that demonstrate unexpected advantages are favored, impacting scope and enforceability.
5. What strategies should patent holders consider to maximize protection?
Diversify claims to cover derivatives, use methods, and manufacturing processes; file continuation or divisional applications; monitor overlapping patents and enforce rights proactively.
References:
[1] SIPO Patent Database, CN1042543 Patent Document, 2015.
[2] Chinese Patent Law, 2020 Revision.
[3] World Intellectual Property Organization (WIPO), Patent Landscape Reports on Pharmaceutical Patents.
