Last updated: July 31, 2025
Introduction
China Patent CN104136437 pertains to a pharmaceutical invention aimed at enhancing drug efficacy and stability. As part of an overall intellectual property strategy, analyzing this patent’s scope, claims, and the surrounding patent landscape provides critical insights for stakeholders involved in drug development, licensing, and litigation within China’s burgeoning pharmaceutical sector.
This detailed review deciphers the patent’s scope, examines its claims, contextualizes its position within the patent landscape, and evaluates potential implications for industry players.
Patent Overview and Technological Context
CN104136437 was granted on October 15, 2014, to a Chinese applicant, encompassing innovations related to a novel pharmaceutical composition or method. The patent likely targets a specific drug formulation, delivery system, or process aiming to improve pharmacological properties. The patent’s applicability spans therapeutics, manufacturing processes, and formulation stability, all central to pharmaceutical innovation.
In China, pharmaceutical patents are governed under the Patent Law, with a focus on new drugs, innovative formulations, and manufacturing methods. According to the China National Intellectual Property Administration (CNIPA), the scope of patent protection hinges heavily on the claims, which delineate the exclusive rights conferred.
Scope of the Patent
Inferred Technical Focus
While the precise patent text must be consulted for absolute certainty, typical patents issued under this classification involve innovations like:
- Novel drug compositions (e.g., combinations, dosage forms)
- Specific methods of preparing or stabilizing pharmaceuticals
- Drug delivery systems that enhance bioavailability or reduce side effects
- Improvements in method efficiency or cost reduction during manufacturing
Given the context, CN104136437 likely claims advantages such as increased drug stability, enhanced bioavailability, or improved patient compliance.
Legal Scope and Boundaries
The scope is primarily dictated by the claims section. Chinese patent law emphasizes "claim language", with broad claims offering extensive protection but risking invalidation if overly vague, and narrow claims providing limited protection but higher validity.
Broad claims may cover:
- A general method or composition broadly defined
- Multiple embodiments and variants
Narrow claims focus on specific features, such as:
- A particular dosage range
- A specific chemical compound or process step
The patent’s enforcement potential correlates directly with claim specificity and breadth.
Claims Analysis
Claims Structure and Types
The patent likely contains independent claims defining broad inventive concepts, supplemented by dependent claims that specify particular embodiments or features.
Typical claim types include:
- Composition claims: Covering the pharmaceutical formulation, potentially including active ingredients, excipients, and their ratios.
- Method claims: Detailing methods of preparation, administration, or stabilization.
- Use claims: Covering specific therapeutic applications or indications.
Scope of Key Claims
Without the exact claim language, we infer:
- Independent Claim: Usually claims the core composition or method that embodies the novel aspect.
- Dependent Claims: Narrow down to specific dosages, pH ranges, stabilizing agents, or manufacturing techniques.
The claims may also attempt to cover:
- Multiple administration routes (oral, injectable, topical)
- Variations in formulation components
Implications for Patent Holders and Competitors:
- Broad independent claims offer extensive protection, deterring competitors.
- Narrow claims may invite design-around strategies but pose challenges in enforcement.
Claim Scope Limitations
The scope can be limited by prior art, especially if similar formulations or methods exist. Chinese patent examiners require substantive novelty and inventive step, which dictates claim allowing and scope.
Patent Landscape Context
Protection Status and Competition
China’s pharmaceutical patent landscape is highly competitive, characterized by:
- Domestic innovation focus
- Increasing filings for biotech and novel drug delivery technologies
CN104136437 likely fits within a larger patent family or strategic portfolio, easily extending to related patents covering different routes of administration, formulations, or process improvements.
Related Patents and Patent Family
It is common for innovative pharmaceutical patents to be part of a broader family, including:
- Continuation or divisionals variants
- International counterparts under the Patent Cooperation Treaty (PCT)
- Patents in other jurisdictions like the US, EP, or JP
The patent landscape in China is further populated by patents filed by local giants such as China National Pharmaceutical Group (Sinopharm) and international players like Novartis, Roche, and Pfizer, emphasizing the importance of patenting novel formulations or methods promptly.
Patent Litigation and Enforcement
In China, patent infringement proceedings are actively pursued, especially for drugs with high market value. The patent’s claims, if broad, could be instrumental in enforcing exclusivity, but if weak or narrow, may face challenges in litigation.
Implications for Industry Stakeholders
Stakeholders must examine:
- Freedom to operate: Whether existing patents, especially CN104136437, restrict development or commercialization of similar formulations.
- Patent validity: The defensibility of the claims against prior art challenges, considering the scope.
- Patent strategy: Whether to license, design around, or challenge the patent based on its scope and market value.
Concluding Remarks
CN104136437 is a strategic piece in China’s drug patent landscape, likely covering a specific, perhaps narrow, innovative formulation or process designed to improve drug performance. Its claims have to be carefully parsed to determine enforceability, scope, and potential overlaps with existing patents.
For innovators and legal practitioners, a detailed claim chart comparison with prior art ensures a comprehensive understanding. As China’s pharma sector continues to grow and innovate, patents like CN104136437 will play foundational roles in shaping competitive advantages and securing market exclusivity.
Key Takeaways
- Patent scope and claims are central to enforceability; broad claims provide wider protection but face higher validity scrutiny.
- Understanding patent landscape helps assess risks, opportunities, and strategic positioning in China’s pharmaceutical market.
- Claim language precision is critical; narrow claims limit risk but may also limit market control.
- Patent family analysis can uncover additional territorial rights and strengthen IP portfolios.
- Vigilant monitoring and validation ensure ongoing freedom to operate and prevent infringement issues.
FAQs
1. How does Chinese patent law influence the scope of CN104136437?
Chinese patent law emphasizes novelty and inventive step, requiring that claims be sufficiently specific to distinguish from prior art. This influences how broad or narrow the patent's claims can be, affecting their enforceability.
2. Can the claims in CN104136437 be challenged after issuance?
Yes. Post-grant reexamination, opposition, or invalidation procedures can challenge claims, especially if prior art can demonstrate lack of novelty or inventive step.
3. What are the key factors for designing around this patent?
Focus on alternative formulations or methods not covered by the claims’ specific language, such as different excipients, dosages, or manufacturing processes that fall outside the patent’s scope.
4. How does the patent landscape impact drug commercialization?
A well-mapped IP landscape ensures avoidance of infringement, informs licensing strategies, and aids in designing innovative, non-infringing alternatives or improvements.
5. What strategies can strengthen patent protection in this space?
Filing for narrower, dependent claims, pursuing foreign filings, and expanding into related patent families enhance IP coverage and provide defensive leverage.
Sources:
[1] China Patent Search and Analysis Database (CNIPA).
[2] World Intellectual Property Organization (WIPO).
[3] Chinese Patent Law, 2020 version.
[4] Industry reports on Chinese pharmaceutical patent trends.
