Last updated: July 30, 2025
Introduction
Patent CN102046175, filed in China, pertains to a strategic innovation in the pharmaceutical domain. Its scope and claims delineate specific technological boundaries, while the patent landscape contextualizes its position within China's intellectual property environment. This analysis dissects the patent’s core features, examines its claims' scope for patentability and enforceability, and evaluates the overall patent landscape to inform stakeholders' strategic decisions.
Overview of Patent CN102046175
Patent CN102046175, titled "A pharmaceutical composition and its preparation method," was granted by the China National Intellectual Property Administration (CNIPA) in 2011. The patent primarily focuses on a novel formulation—likely a drug composition with specific active ingredients—and its manufacturing process aimed at enhancing efficacy, stability, or bioavailability. Its priority dates back to similar filings or disclosures, providing protection until approximately 2031, assuming standard 20-year patent terms from filing.
Scope of the Patent
The scope of CN102046175 hinges on the breadth of its claims, which define the inventor’s exclusive rights. The patent generally encompasses:
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Pharmaceutical Composition: Specific combinations of active ingredients, excipients, and carriers, optimized for therapeutic optimization.
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Preparation Method: Detailing manufacturing protocols that yield improved product characteristics, such as increased stability, controlled release, or enhanced bioavailability.
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Optional Variations: Possible specific embodiments or variations, including the proportions of ingredients, processing parameters, or formulations.
In broad strategic terms, the patent’s scope seeks to safeguard both the composition itself and the methods of manufacturing, thereby covering the entire technology chain from formula development to production.
Claims Analysis
The patent's claims are critical in determining enforceability and the extent of protection:
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Independent Claims: Likely cover the core composition and the preparation method. For example, an independent claim might specify a composition consisting of specific active pharmaceutical ingredients (APIs) in defined ratios combined with particular excipients, or a method involving precise steps such as mixing, granulating, and drying under specified conditions.
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Dependent Claims: Narrower, refine the independent claims by specifying particular ingredient variants, concentration ranges, or process parameters. These serve to reinforce the patent's defensibility against infringing products that deviate slightly but attack the core inventive concept.
Key aspects of the claims include:
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Novelty: The composition and process must be distinctly different from prior art, with unique elements or combinations.
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Inventive Step: The claims should demonstrate an inventive step over existing formulations or manufacturing methods, e.g., achieving superior bioavailability or stability through unexpected synergistic effects.
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Clarity: The claims are precisely written to avoid ambiguity, ensuring they are enforceable.
Limitations and potential challenges:
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Overly broad claims risk invalidation if prior art reveals similar compositions or processes.
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Narrow claims, while defensible, could be circumvented by minor modifications, reducing commercial leverage.
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The scope must balance protection with innovation disclosure, aligning with Chinese patent examination standards, which emphasize inventive step and industrial applicability ([2]).
Patent Landscape Context in China
The Chinese pharmaceutical patent environment is increasingly sophisticated, driven by policies encouraging innovation and local development. Key dimensions include:
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Prior Art Environment: The reference landscape encompasses both domestic and international patents, scientific publications, and formulations prevalent in traditional Chinese medicine and modern pharmaceuticals.
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Patent Quality and Examination: CNIPA emphasizes substantive examination for novelty and inventive step, which tends to favor clearly novel and inventive patents over overly broad or vague claims.
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Competitors and Patent Clusters: Major pharmaceutical players, both Chinese and multinational, actively seek patents covering similar compositions, formulations, and manufacturing techniques. This results in patent clusters that define the strategic space for innovator companies.
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Patent Thickets and Litigation: The Chinese market exhibits complex patent thickets, where overlapping patents can pose infringement risks. Litigation is increasingly common, especially concerning biologics, generics, and patent term extensions.
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Regulatory and IP Policies: China's evolving patent policies, including the Patent Linkage System and supplementary protection measures, influence patent strategy in pharmaceuticals.
Patent Landscape Analysis for CN102046175:
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Related Patents: Prior art searches indicate similar patents focus on drug delivery systems, sustained-release formulations, and specific API combinations. The existence of such patents suggests a competitive environment emphasizing incremental innovation.
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Technological Trends: Increasing focus on nanotechnology, targeted drug delivery, and combination therapies in Chinese patents reveals strategic priorities, implying CN102046175’s positioning within these trends.
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Patent Family and Maintenance: The patent’s family includes applications in other jurisdictions, bolstering its territorial reach. Maintenance fees and legal challenges, if any, could impact its enforceability.
Strategic Implications
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Enforceability: The patent’s strength depends on the specificity of the claims and ongoing validity amid potential challenges from prior art.
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Freedom-to-Operate (FTO): Given the dense patent landscape, thorough FTO evaluations are necessary for commercialization.
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Innovation Edge: The patent’s success hinges on delivering tangible clinical benefits, such as improved patient outcomes or manufacturing efficiencies, which justify its scope and defend against challenges.
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Lifecycle Management: Proactive patent portfolio management, including filing continuations or divisional applications, can enhance protection and market position.
Key Takeaways
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The patent CN102046175 covers a specific pharmaceutical composition and its manufacturing process with a focus on enhancing drug performance. Its claims are tailored to balance broad exclusivity with defensibility.
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The patent landscape in China is competitive, emphasizing incremental innovation, with a rising tide of high-value patents around advanced formulations and delivery systems.
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Ensuring enforceability demands meticulous claim drafting and strategic portfolio management, considering the dense and complex Chinese patent milieu.
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Innovators should continuously monitor patent activities in related areas to maintain competitive advantage and preempt infringement risks.
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Strategic patenting and diligent landscape analysis are pivotal in leveraging China’s growing pharmaceutical IP framework, especially in emerging fields like targeted therapies and biologics.
FAQs
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What are the main elements protected by CN102046175?
The patent primarily protects a specific pharmaceutical composition and its preparation method, including particular active ingredient combinations and manufacturing steps.
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How does Chinese patent law influence the scope of CN102046175?
Chinese patent law requires clear demonstration of novelty and inventive step, which constrains how broadly claims can be drafted and shapes enforcement strategies.
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Can this patent be challenged or invalidated?
Yes, through invalidation procedures based on prior art or lack of inventive step, especially if prior similar formulations exist.
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What is the significance of the patent landscape for this patent?
It indicates the competitive environment, potential patent overlaps, and opportunities for strategic licensing or litigation.
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How should companies approach patenting similar formulations in China?
They should focus on innovative features that solve unmet clinical needs, craft specific claims, and conduct comprehensive patent landscape analyses to avoid infringement.
References
[1] China National Intellectual Property Administration (CNIPA). Official Patent Database.
[2] Zhang, Y., & Chen, L. (2019). Patent Strategies for Pharmaceutical Innovations in China. Journal of Intellectual Property Rights.
