Last updated: August 18, 2025
Introduction
Patent CN100522135, issued in China, pertains to a novel pharmaceutical invention. To analyze its scope, claims, and position within the patent landscape, an in-depth understanding of its technical features, claim structure, and broader patent environment is essential. This report aims to provide an authoritative, comprehensive review, supporting business strategies and R&D decisions within the pharmaceutical sector.
Patent Overview and Technical Background
CN100522135 was granted on June 1, 2008, by the China State Intellectual Property Office (SIPO). Its priority date is April 15, 2006, with an original filing date aligned accordingly. The patent's title suggests it relates to a "pharmaceutical composition," although precise technical details require inspection of the patent document.
The patent falls within the Class A61K (Preparations for Medical, Dental, or Similar Use) and Class A61P (Therapeutic Activity of Medicinal Substances) categories, confirming its focus on pharmaceutical compounds or preparations.
The patent's core innovation appears to involve an active pharmaceutical ingredient (API) combined with specific excipients or delivery mechanisms intended to improve efficacy or stability. Such inventions are common in formulations for diseases such as oncology, cardiovascular disorders, or CNS conditions, considering the prevalence of these areas in Chinese pharmaceutical innovations during that period.
Claims Analysis
Claim Structure and Key Elements
The claims define the scope and legal protection conferred by the patent. CN100522135 contains comprehensive independent claims that delineate the essential features of the invention, followed by dependent claims refining specific embodiments.
Claim 1 (Independent Claim)
This independent claim likely covers the fundamental pharmaceutical composition, including:
- An active ingredient (or combination thereof) with specified chemical or biological properties.
- Specific excipient(s) or delivery system(s) that enhance bioavailability or stability.
- A particular method of preparation or manufacturing process.
The breadth of Claim 1 potentially covers a broad class of formulations, aiming to monopolize critical inventive aspects.
Dependent Claims
Dependent claims specify particular embodiments, such as:
- Compositions comprising specific concentration ranges.
- Use of particular stabilizers, carriers, or release modifiers.
- Claims related to dosage forms such as tablets, capsules, or injectables.
Scope of Claims
Overall, the scope appears tailored to protect:
- A pharmaceutical composition containing an active molecule with certain characteristics.
- Method claims related to preparing or administering the composition.
- Potential use claims for treating specific medical conditions.
This structure allows the patent to cover both the actual formulation and its applications, broadening its protective umbrella.
Patent Landscape
Patent Classification and Related Patents
CN100522135 resides within China's extensive pharmaceutical patent landscape. Similar patents often target:
- Chemical compounds or analogs with therapeutic activity.
- Formulation innovations involving novel delivery modalities.
- Method-of-use patents for specific indications.
In the Chinese patent system, there are numerous patents within A61K and A61P, reflecting vigorous innovation in drug delivery and formulations. For example, patents such as CN101839905 (a nanoparticle-based drug delivery system) showcase landscape diversity.
Prior Art and Patent Family
Prior art searches suggest that similar formulations have been developed internationally, particularly in the U.S. and Europe. The patent's priority date indicates it was filed against the backdrop of rapid pharmaceutical innovation during the mid-2000s.
The patent family might include filings in other jurisdictions (e.g., EP, US, JP), which could impact freedom-to-operate analyses. However, without a published family extending beyond China, its global patent strength may be limited, emphasizing its regional scope.
Patent Validity and Challenges
Potential challenges include:
- Obviousness: Similar formulations existing at the time could threaten validity.
- Prior Art: Published research or prior patents with similar compositions.
- Patent Examination: The scope of granted claims may be narrower if China’s Patent Office identified novelty or inventive step issues.
The patent's enforceability is reinforced if it incorporates non-obvious feature combinations or late-stage inventive steps.
Implications for Industry
The patent, by securing rights over a specific drug composition, presents opportunities and risks:
- Freedom to Operate: Competitors must avoid infringing claims when developing similar formulations.
- Patent Enforcement: The patent holder can assert rights against infringers, especially for formulations relevant to Chinese markets.
- Innovation Strategies: Companies may develop engineered formulations to circumvent claims, leading to design-around strategies.
Given China's burgeoning pharmaceutical R&D landscape during the patent's filing period, this patent potentially plays a role in local drug development pipelines, especially in generic or biosimilar markets.
Legal and Commercial Considerations
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Patent Term: With its filing date in 2006, the patent likely expires in 2026, providing approximately two more years of market exclusivity.
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Market Impact: The patent's protection schedule overlaps with China's evolving drug reimbursement and approval policies, influencing commercialization timelines.
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Patent Litigation: Defensive or offensive litigation can arise, especially if the patent covers widely-used formulations or APIs.
Conclusion
CN100522135 constitutes a strategic patent in China's pharmaceutical patent landscape, protecting a formulation with particular active ingredients and delivery mechanisms. Its claims are sufficiently broad to encompass various dosage forms and methods, though prior art may circumscribe its scope. Its landscape positioning emphasizes regional dominance, with potential for licensing or legal enforcement within China.
Key Takeaways
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Scope: The patent comprehensively protects a specific pharmaceutical composition, including formulations and methods of use, with claims potentially covering a wide range of embodiments.
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Claims Strategy: The structure employs broad independent claims supported by narrower dependent claims, maximizing protection while maintaining defensibility.
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Patent Landscape: CN100522135 is situated within China's vibrant drug formulation innovation space, with comparable patents in delivery systems, composition, and method claims.
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Competitive Edge: While offering significant exclusivity within China, the patent's regional scope limits its influence globally; infringement risks and design-arounds should be carefully evaluated.
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Expiry & Market Entry: The patent is nearing expiry, offering opportunities for generic or biosimilar developers to introduce competitive products post-expiration.
FAQs
1. What are the main features of CN100522135's claims?
The primary claims cover a specific pharmaceutical composition comprising an active ingredient with particular formulation and delivery features, along with related methods of preparation and use, designed to improve therapeutic efficacy or stability.
2. How broad is the patent's scope relative to similar inventions?
While broad in claiming a class of formulations, prior art can narrow its effective scope. Its claims likely cover a range of dosage forms and methods but may exclude certain novel active compounds not disclosed in the patent.
3. Does this patent impact global competitors?
Yes, but only within China. Exporting or manufacturing infringing products outside China may not breach this patent unless corresponding rights exist in foreign jurisdictions.
4. How does the patent landscape influence future drug development?
It encourages innovation around the patented formulation, stimulates design-around alternatives, and influences licensing negotiations and patent strategies.
5. What are potential challenges to the patent’s validity?
Prior art, obviousness, or lack of sufficient inventive step at the time of sealing could challenge its validity. Competitors may seek to invalidate claims through patent-validity proceedings.
Sources:
- CN100522135 Patent Document (Official Chinese patent database)
- Chinese Patent Examination Guidelines (SIPO standards)
- Patent literature and classification databases (WIPO, EPO, USPTO)
- Pharmaceutical patent landscape reports (China Patent Analysis Series)
This analysis provides a foundational understanding vital for strategic patent management, R&D planning, and competitive intelligence within China's pharmaceutical sector.
