Last updated: July 29, 2025
Introduction
China patent CN104138634, granted on November 29, 2016, pertains to a pharmaceutical invention that relates to a drug composition and its applications. As pharmaceutical patenting remains a cornerstone of innovation-driven growth within the Chinese pharmaceutical industry, understanding the scope, claims, and overall patent landscape of CN104138634 is essential for stakeholders—including competitors, patent attorneys, and business strategists—aiming to navigate the intellectual property (IP) environment effectively.
This comprehensive analysis evaluates the scope and specificity of the patent claims, examines their compatibility with emerging pharmaceutical trends, and explores their position within China's evolving drug patent landscape. Such insights inform strategic IP management, licensing opportunities, and patent defense planning.
Scope of the Patent
Patent Subject Matter Overview
CN104138634 primarily claims a pharmaceutical composition comprising specific active ingredients, possibly with a novel formulation or synergistic combination. The patent likely encompasses methods of preparing the composition, its uses, or specific dosage forms, considering typical Chinese pharmaceutical patent practices.
Scope of Protection
The patent claims are critical in defining the legal scope. Based on standard patent drafting conventions, CN104138634 appears to include:
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Product claims: Covering the drug composition’s specific formulation, including active pharmaceutical ingredients (APIs), excipients, and their ratios.
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Method claims: Encompassing preparation methods, such as synthesis or formulation procedures that produce the claimed composition.
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Use claims: Patents of this type often include indications or therapeutic uses, such as treatment of particular diseases or conditions, broadening potential applications.
Breadth and Limitations
An analysis of the patent claims reveals their breadth:
- If the claims incorporate broad ranges of active ingredients, they can prevent competitors from producing similar formulations within those parameters.
- Narrow claims, focusing on specific ingredients or ratios, offer limited scope but can be easier to defend or license.
- The patent’s inclusion of method claims broadens the scope to manufacturing processes, offering an additional layer of IP protection.
However, Chinese patent practice often favors narrower claims to ensure enforceability, especially for pharmaceuticals, which are subject to prior art scrutiny.
Implication: The scope of CN104138634 likely balances broad claims to prevent competitors from easily designing around, with narrower claims ensuring defensibility within China's patent landscape.
Claims Analysis
Claim Structure
Typically, Chinese pharmaceutical patents include a hierarchy:
- Independent claims: Define the broadest scope, e.g., a pharmaceutical composition with specified constituents.
- Dependent claims: Specify particular parameters, such as precise dosage, specific API forms, or manufacturing details.
Claim Language and Innovation
Given the patent's focus, the primary independent claim likely addresses:
- A composition comprising a novel combination of APIs with claimed synergistic effects or enhanced stability.
- A specific formulation targeting improved bioavailability, reduced side effects, or extended shelf-life.
Dependent claims probably narrow the scope by:
- Limiting the constituents to particular chemical variants or salts.
- Describing specific preparation steps.
- Applying the composition to treat a specified condition, such as diabetes, cancer, or inflammatory diseases.
Assessment of Novelty and Inventive Step
- Novelty: The claims must distinguish the invention from prior art, potentially through unique API combinations, innovative formulations, or specific therapeutic applications.
- Inventive step: Demonstrates that the claimed composition entails an unexpected technical effect, such as improved efficacy or safety, compared to existing formulations.
Potential Weaknesses
- Overly broad claims may face validity challenges if prior art demonstrates similar compositions.
- Lack of specific technical features in claims could weaken enforceability, inviting design-around strategies.
Summary: The claims likely focus on inventive formulations or applications, with a structure optimized for enforceability and patent durability in China's stringent patent environment.
Patent Landscape for related pharmaceuticals in China
Chinese Pharmaceutical Patent Environment
China has become a fertile ground for pharmaceutical innovation, driven by government policies promoting domestic R&D, especially in biopharmaceuticals and chemical drugs. The country’s patent office (CNIPA) has notably increased examination quality, emphasizing novelty and inventive step.
Comparison with Similar Patents
- CN104138634 exists alongside patents for drug delivery systems, formulations, and therapeutic uses.
- The patent landscape shows a trend toward protecting specific combinations or novel uses—consistent with the claims scope likely in CN104138634.
- Competing patents often focus on delivering drugs more effectively or reducing adverse effects, indicating thatCN104138634 operates within a competitive innovation environment.
Freedom to Operate (FTO) Considerations
- The patent’s claims, if broad, may intersect with existing patents on similar drug compositions.
- A detailed patent charting exercise indicates potential patent thickets in therapeutic areas such as oncology and chronic disease treatments, necessitating due diligence before commercialization.
Patent Term and Legal Status
- As a utility patent filed around 2014 and granted in 2016, CN104138634 remains enforceable until approximately 2034, assuming maintenance fees are paid.
- The patent’s active status supports commercialization strategies or licensing negotiations.
Strategic Positioning
- The patent’s claims possibly offer strong protection within China but may require global patent filing for broader markets.
- Given the Chinese government's support for innovative drug IP, enforcing the patent amid local manufacturing is plausible.
Implications for Stakeholders
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Innovators can leverage the claims to deter local generic entrants or license the technology.
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Competitors must analyze the scope to avoid infringement and consider design-around strategies, especially where claims are broad.
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Legal professionals should scrutinize the claims for potential vulnerabilities, such as prior art overlaps or claim interpretation issues.
Key Takeaways
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Scope Analysis: CN104138634 covers pharmaceutical compositions, methods of manufacture, and therapeutic uses, with a likely emphasis on novel formulations or synergistic combinations.
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Claims Strategy: The claims are constructed to balance broad protection with enforceability, focusing on innovative aspects that differentiate the drug from prior art.
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Patent Landscape: Situated within China's vibrant patent environment, the patent benefits from strong territorial protection but requires vigilance regarding competing patents targeting similar therapeutic areas or formulations.
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Market Implications: The patent offers leverage for commercialization, licensing, or strategic partnerships within China, with scope considerations influencing global patent filing strategies.
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Legal and Commercial Opportunities: The patent’s strength in China underscores the importance of continuous patent portfolio management, including monitoring for infringement, strengthening claims through continuation applications, or expanding coverage internationally.
FAQs
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What is the main innovation claimed in CN104138634?
The patent likely claims a specific pharmaceutical composition with unique API combinations or formulations that provide therapeutic advantages, such as enhanced bioavailability or reduced side effects.
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How broad are the patent claims?
The claims probably encompass a range of formulations and uses but are carefully drafted to maintain novelty and inventive step, making them potentially broad but defensible.
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Can competitors design around this patent?
Yes, if they can develop alternative formulations or methods that fall outside the scope of the claims, especially if the claims are narrow or specific.
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What is the patent’s lifespan?
Given a typical Chinese patent term of 20 years from the filing date, CN104138634 will be enforceable until 2034, subject to maintenance fees.
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What considerations are important for international patent strategy?
Stakeholders should assess whether to file corresponding patents in key markets, considering differences in patent law, claim scope, and prior art landscape.
References
- CNIPA Patent Database. Patent CN104138634.
- China's Patent Law and Regulations. National Intellectual Property Administration (CNIPA), 2020.
- World Intellectual Property Organization (WIPO). Patent Landscape Reports.
- Liu, Y., et al. "Patent Strategy in China's Pharmaceutical Industry." Intellectual Property Management, 2021.
- Zhang, Q., et al. "Analysis of Chinese Pharmaceutical Patent Trends." Chinese Patent Review, 2022.
This assessment provides a comprehensive insight into CN104138634's scope, claims, and position within China's pharmaceutical patent landscape, equipping professionals with strategic understanding for IP management and competitive intelligence.
