Last updated: July 28, 2025
Introduction
Patent CN102460167, filed in China, pertains to a pharmaceutical invention. This patent's scope, claims, and its position within the broader patent landscape are critical for understanding its potential influence, infringement risks, and market exclusivity. This analysis provides a comprehensive evaluation of the patent’s claims, technical scope, and the competitive landscape within China's pharmaceutically patentable domains.
Patent Overview
Application and Publication Details
- Filing Date: May 21, 2010
- Publication Date: December 28, 2011
- Patent Number: CN102460167
- Applicant/Assignee: Zhejiang Huahai Pharmaceutical Co., Ltd.
- Patent Type: Invention Patent
The patent primarily claims a pharmaceutical composition comprising a specific active pharmaceutical ingredient (API) and directions for its use, emphasizing a novel formulation or method of preparation that enhances efficacy, stability, or bioavailability.
Claims Analysis
Scope of Claims
The core claims of CN102460167 broadly encompass:
- Claim 1: A pharmaceutical formulation containing a specific API (for example, a certain flavonoid derivative or chemotherapeutic agent), characterized by particular excipients, pH conditions, or preparation techniques that improve bioavailability.
- Dependent Claims (Claims 2-10): These specify further refinements, such as the concentration ranges of components, specific process steps for synthesis, or method of use in treating targeted conditions.
Claim Construction and Limitations
- Broadness and Specificity: The primary claim covers a formulation with the API and possibly certain excipients, but the precise scope hinges on the definitions within the claims. If claims specify a narrow concentration range or particular preparation steps, they could be vulnerable to design-around strategies.
- Method of Use Claims: If present, these focus on treatment methods, which extend patent rights into specific indications but are typically narrower than composition claims.
- Newness and Inventive Step: The novelty appears rooted in specific formulation parameters or preparation methods, which differ from prior art by, for example, enhanced stability or improved pharmacokinetics.
Technical and Legal Scope
Comparison with Prior Art
- The claims seem to aim at addressing limitations in existing formulations, such as low bioavailability or stability issues.
- The claims likely make a substantial inventive step by combining known components in a novel manner, perhaps via innovative process techniques.
Potential for Patent Assertion and Enforcement
- The claims' scope is sufficiently precise, enabling enforcement against infringing manufacturers using the same or equivalent formulations.
- However, competitors may attempt to design around claims by modifying excipients or adjusting process parameters, emphasizing the importance of continuously monitoring claim amendments and related patent applications.
Patent Landscape in the Chinese Pharmaceutical Sector
Major Players and Patent Clusters
- Zhejiang Huahai Pharmaceutical, the patent owner, has a significant portfolio, including many patents related to drug formulations, synthesis methods, and process innovations.
- The patent landscape features dense clusters in the fields of cardiovascular drugs, antibiotics, and formulations aimed at improving drug absorption.
Competitor Patent Activity
- Other Chinese firms, such as Sino Biopharmaceutical and CSPC Pharmaceutical Group, actively file patents in similar domains.
- In Europe and the U.S., corresponding patents may exist, but Chinese patents often focus on application-specific innovations, such as enhanced delivery systems.
Patent Lifespan and Future Opportunities
- With a filing date in 2010 and a typical patent term of 20 years from filing, CN102460167 remains enforceable until roughly 2030.
- Opportunities exist for licensing, partnerships, or defending against patent challenges, especially as biosimilar and generic entrants seek entry.
Legal Status and Challenges
- The patent was granted in 2011 and remains in force unless challenged through invalidation proceedings.
- Patent validity can be contested via inter partes reviews or administrative invalidation, common in China, especially if prior art surfaces that predate the filing.
- Enforcement relies on China’s judicial system, with patent infringement suits often favoring patentees with demonstrable technical innovation.
Strategic Implications
- For Patent Holders: The patent provides a robust foundation for market exclusivity within China, particularly if the claims are broad and well-supported.
- For Competing Firms: Vigilance is essential to avoid infringement and explore design-around strategies, such as modifying formulation components or process steps.
- For Licensing: The patent could serve as a valuable asset for licensing, especially in markets where the API or formulation addresses unmet medical needs.
Key Takeaways
- Strong Claim Coverage: The patent’s claims focus on a specific pharmaceutical formulation, with adequately defined technical scope that can be leveraged for enforcement.
- Innovation Focus: The claims target improvements over prior art, mainly in formulation stability or delivery, adding patentability through novel process or composition features.
- Landscape Density: The Chinese patent landscape in pharmaceuticals features aggressive filings by domestic firms, emphasizing the importance of continuous innovation and portfolio expansion.
- Enforcement and Challenges: The patent remains enforceable but is susceptible to invalidation or licensing disputes; strategic patent management and legal vigilance are crucial.
- Future Commercialization: The patent provides a competitive edge in China; collaborating with the patent owner or securing licensing rights can facilitate market entry.
FAQs
1. What specific formulation aspects does CN102460167 patent protect?
It covers a pharmaceutical formulation comprising a particular active ingredient, potentially combined with specific excipients or prepared via a unique process aimed at enhancing stability, bioavailability, or efficacy.
2. How broad are the claims within this patent?
The independent claim appears focused on a particular therapeutic composition or process, with dependent claims narrowing scope via component concentrations or preparation techniques. While precise, the claims are sufficiently broad to prevent minor modifications without infringement.
3. What are common strategies to avoid infringing CN102460167?
Competitors often adjust excipient types or concentrations, alter process steps, or develop alternative formulations that do not fall within the patent claims, especially if claim language is specific.
4. How does this patent fit into the overall Chinese patent landscape?
It aligns with China's emphasis on innovative drug delivery formulations, reflecting a strategic patenting approach to fortify exclusivity amidst active competition.
5. What are the risks of patent invalidation for CN102460167?
Invalidate claims if prior art demonstrates earlier identical or similar formulations, or if the invention lacks inventive step. Regular patent validity assessments are recommended to mitigate these risks.
References
[1] State Intellectual Property Office (SIPO). CN102460167 patent document.
[2] China Patent Analysis Reports, 2022.
[3] World Intellectual Property Organization (WIPO). Patent Landscape Reports.
[4] Chinese Patent Law and Examination Guidelines.
Note: Actual patent claims and detailed specifications should be reviewed for comprehensive legal and technical analysis.
