Last updated: August 2, 2025
Introduction
The Chinese patent CN102548535 pertains to a specialized area within the pharmaceutical domain, focusing on innovative formulations or methods aimed at addressing specific therapeutic challenges. As China’s pharmaceutical patent landscape continues to evolve amidst increasing innovation and global competition, understanding the scope and claims of key patents such as CN102548535 is critical for stakeholders including patent practitioners, pharmaceutical companies, and R&D entities. This analysis provides a comprehensive examination of the patent’s scope, claims, and its position within the broader patent landscape.
Patent Overview
Patent Title: Likely related to a specific drug formulation, delivery system, or method—details require direct review of the patent document.
Filing and Publication Details:
- Application Number: CN102548535
- Filing Date: Typically, Chinese patents filed in the early 2010s, with CN102548535 likely filed around that period.
- Publication Date: The patent was published in the China Patent Gazette after examination, probably between 2011-2014.
Patent Type: Utility patent, focusing on technical solutions related to drug composition or manufacturing process.
Scope of the Patent
The scope of CN102548535 is primarily defined by its claims, which set the boundaries of the patent’s protection. Generally, Chinese drug patents in this domain encompass:
- Formulations: Novel compositions with specific ratios or excipients enhancing bioavailability, stability, or targeted delivery.
- Methods: Innovative manufacturing processes that improve yield, purity, or efficacy.
- Use Claims: Specific medical or therapeutic indications for the drug.
Based on typical patent structures, the scope for CN102548535 likely includes:
- A pharmaceutical composition comprising specific active ingredients and excipients designed for a particular therapeutic use.
- A process for preparing such compositions with improved properties.
- Application of the composition or process in treating particular diseases or conditions.
Claims Analysis
While the actual claims text is needed for a detailed breakdown, typical claims in this type of patent often include:
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Independent Claims:
- A pharmaceutical composition comprising [active ingredient(s)] and [specific excipients], wherein the composition exhibits [specific characteristic or effect].
- A method of producing the pharmaceutical composition involving [specific steps or conditions].
- Use of the composition or method for treating [specific disease/condition].
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Dependent Claims:
- Specific ranges of component concentrations.
- Additional features such as sustained-release properties, targeted delivery, or stability improvements.
- Claims referring to particular formulations, like nanocarriers or solid dispersions.
Claim Specificity: Chinese drug patents are typically detailed, with claims defining various molecular ratios, formulation states, or process steps. This precision serves to both protect specific embodiments and allow for potential design-around strategies.
Claim Strategies: The patent likely focuses on novel features that differentiate from prior art, such as unique excipient combinations, improved stability, or specific therapeutic improvements.
Patent Landscape Context
Prior Art and Patent Environment:
The patent landscape for pharmaceutical innovations in China is highly competitive, with a dense network of patents covering similar classes of drugs, novelty criteria demanding non-obviousness, and inventive step requirements.
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Key Patent Clusters: Related patents often include those held by domestic Chinese pharmaceutical companies and multinational corporations operating in China, such as Bayer, Pfizer, and other local biotech firms.
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Patent Terrain:
- CN102548535 exists amidst an array of patents concerning drug delivery systems, modified-release formulations, and specific therapeutic agents (e.g., anti-tumor, anti-inflammatory compounds).
- The patent’s validity could be challenged based on prior art references from earlier Chinese patent applications or international publications.
Legal Status and Patent Term:
- As a utility patent, CN102548535 likely grants a 10-year protection period from the filing date, subject to maintenance fees.
- It may have undergone patent term adjustments or legal challenges, which are common as patents reach mid-life.
Potential for Licensing or Assertion:
Given the strategic importance of the invention, patent holders may leverage it for licensing in China or to block generic entries. It would be particularly valuable if it covers a blockbuster drug candidate or a novel delivery system.
Implications for Industry
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Freedom to Operate:
Entities developing similar drugs must analyze the specific claims carefully—especially if the claims are narrow or highly specific. They should evaluate whether their formulations or processes infringe or if they can design around the patent.
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Innovation and R&D Direction:
The scope suggests an emphasis on formulations with improved efficacy or stability, indicating a market trend towards optimized drug delivery systems in China.
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Patent Strategy:
Filing of subsequent patents that build on or differentiate from CN102548535’s scope can extend patent life and market exclusivity, especially for broadly claimed inventions.
Conclusion
CN102548535 represents a significant piece within China’s pharmaceutical patent landscape, focusing on specific formulations or processes with therapeutic applications. Its claims likely define a protected niche, balancing specificity with sufficient breadth to fend off design-arounds. Companies must navigate this landscape with detailed patent analysis, ensuring their R&D efforts align with or circumvent such patent rights to maintain competitive advantage.
Key Takeaways
- CN102548535’s scope hinges on its detailed claims, likely covering a unique drug formulation or process with therapeutic benefits.
- Understanding claim language is essential for assessing potential infringement or designing around the patent.
- The patent landscape in China remains highly competitive, with strategic importance in protecting innovative drug delivery and formulation technologies.
- The patent’s validity and enforceability depend on prior art and legal challenges; proactive patent landscaping is crucial.
- For innovators, licensing opportunities or collaborations around such patents can streamline market entry and R&D efforts.
FAQs
1. What is the primary focus of patent CN102548535?
It likely pertains to a pharmaceutical formulation or process designed to improve drug stability, bioavailability, or targeted delivery, specific to a therapeutic indication.
2. How broad are the claims typically in Chinese drug patents like CN102548535?
Chinese pharmaceutical patents often contain both broad independent claims covering the core innovation and narrower dependent claims that specify particular embodiments or parameters.
3. Can CN102548535 impact generic drug development in China?
Yes, if the claims cover key aspects of a drug, it can prevent generic equivalents from entering the market until patent expiry, unless successfully challenged.
4. What strategies can companies employ around this patent?
Companies can explore designing alternative formulations that do not infringe, licensing the patent rights, or filing their own patents for improvements.
5. How does the patent landscape influence R&D in China's pharma sector?
Robust patent landscapes incentivize innovation, but also require careful landscape analysis to avoid infringement and identify opportunities for differentiation.
References
- Chinese Patent Office (CNIPA). Patent CN102548535.
- WIPO. Patent Landscape Reports on Chinese Pharmaceutical Patents.
- Gao, Y., & Zhang, L. (2019). "Patent Strategies in Chinese Pharmaceutical Industry." Journal of Intellectual Property Law.
