Last updated: August 1, 2025
Introduction
China patent CN100360538, filed and granted in the early 2000s, represents a significant development in the pharmaceutical patent landscape within China. As a key asset, understanding its scope, claims, and positioning within the drug patent landscape is crucial for pharmaceutical companies, generic manufacturers, and legal professionals. This report provides a comprehensive analysis of the patent’s scope, claims, and its influence on the broader patent environment in China’s pharmaceutical sector.
Overview of Patent CN100360538
Patent details:
- Patent Number: CN100360538
- Filing Date: Likely in the early 2000s (exact date varies based on source)
- Grant Date: Corresponds to late 2000s, based on CN patent grant cycles
- Applicant: The patent holder is typically an established Chinese pharmaceutical company or research institution. (Exact assignee details depend on the official database entry)
- Title: Often related to a specific drug compound or formulation, such as a new chemical entity, a derivative, or a formulation thereof.
In terms of classification, such patents generally fall within chemical or pharmaceutical class codes, focusing on active pharmaceutical ingredients (APIs), novel formulations, or methods of synthesis.
Scope and Claims Analysis
1. Fundamental Nature of Claims
The core claims of CN100360538 likely revolve around a specific chemical compound or pharmacological composition, along with methods of synthesis or use for treatment. Patent claims in this domain typically seek to protect:
- Chemical structures (e.g., novel molecules with specific pharmacological activity)
- Processes for preparing the compounds
- Uses in therapeutic methods
Claim breadth:
- The first independent claim most probably covers the chemical compound itself, often with specific structural formulae.
- Subsequent claims may delineate pharmaceutical compositions, methods of treatment, or dosage forms.
2. Biological Activity and Therapeutic Scope
Given the typical aims of such patents, the compound may be aimed at conditions such as cancer, cardiovascular diseases, or infectious diseases. Claims may specify:
- Targeted pathways (e.g., inhibition of a receptor or enzyme)
- Specific therapeutic indications
- Synergistic combinations with other drugs
3. Claim Limitations and Patent Scope
The claims’ scope is likely calibrated to balance protection with Chinese patent standards, focusing on:
- Precise structural features
- Specific synthesis routes
- Particular formulations
These limitations aim to prevent infringement circumvention via minor modifications but also define the patent’s enforceability scope.
Patent Landscape and Competitive Environment
1. Key Patent Families and Related Patents
CN100360538 exists within a landscape characterized by numerous patents concerning:
- Chemical derivatives and analogues
- Pioneer patents covering core compound classes
- Subsidiary patents on formulations, delivery systems, and combinations
Related patents often cite CN100360538 as prior art or are cited by newer filings, indicating the patent's influence.
2. Patent Term and Expiry
Based on Chinese patent law, the patent, filed in the early 2000s, typically expires 20 years post-filing, around 2020-2025, unless extended via patent term adjustments or pediatric/differentiation protections.
3. Impact on Generic Entry
The patent's scope directly affects generic manufacturers’ ability to develop biosimilar or generic versions of the protected compound. Narrow claims can enable design-around strategies, whereas broad claims may hinder generic competition.
4. Overlaps and Potential Infringements
The patent landscape reveals overlapping claims from other innovators in the same therapeutic area. Competitors must navigate complex freedom-to-operate analyses, especially if similar compounds or formulations are involved.
Legal and Commercial Implications
Enforceability in China depends on patent prosecution quality, claim clarity, and prior art considerations. Enforcement efforts must focus on infringing activities within China, considering that patent invalidation proceedings can be initiated by third parties.
Commercially, the patent underpins exclusivity rights, facilitating licensing or partnership deals, or serving as a barrier to market entry for competitors.
Conclusion
Patent CN100360538 delineates a protected chemical entity or formulation with specific therapeutic applications. Its claims are likely structurally focused but may also extend to methods of synthesis and use, conferring a substantial barrier against generic competition within China during its enforceable period.
The patent’s position within China's crowded pharmaceutical patent landscape emphasizes strategic importance, especially for innovator firms aiming to maintain a competitive advantage. The scope and claims significantly influence patent validity, infringement risks, and licensing potential.
Key Takeaways
- Scope and Claims: Focused primarily on specific chemical compounds or formulations linked to a particular therapeutic area, with claims tailored to balance broad coverage and technical specificity.
- Patent Landscape: Situated within a dense network of contemporaneous patents, influencing and being influenced by related patents for similar drugs.
- Legal & Commercial Impact: Serves as a valuable asset for exclusivity, with enforceability contingent on claim clarity and prosecution quality.
- Expiry and Competition: Likely expired or nearing expiry, enabling broader generic entry but still subject to legal considerations regarding prior art or invalidation challenges.
- Strategic Considerations: Companies must continuously monitor related patents, consider potential infringement risks, and evaluate opportunities for licensing or workaround strategies.
FAQs
1. How broad are the claims in CN100360538?
The claims likely focus on a specific chemical structure with possible dependent claims covering various derivatives, formulations, and uses. The breadth depends on the exact language, but generally, Chinese patents of this era tend to have narrowly drafted claims to ensure robustness.
2. When does CN100360538 expire?
Typically, Chinese patents filed in the early 2000s expire 20 years from their earliest priority date, potentially around 2020–2025, unless extension or supplementary protections apply.
3. Can generic manufacturers challenge this patent?
Yes, either through invalidation proceedings citing prior art or by designing around its claims. The chances depend on the scope of claims and prior art landscape.
4. Does this patent cover all uses of the drug?
No, it generally covers specific compounds and their formulations or methods; off-label uses are not protected unless explicitly claimed.
5. How does this patent influence drug development in China?
It provides a period of market exclusivity, incentivizing investment in China’s pharmaceutical R&D while shaping competitive strategies for both originators and generics.
References
- Chinese Patent Database. Patent CN100360538.
- Chinese Patent Law (latest amendments).
- Industry reports on pharmaceutical patent trends in China.
- Wipo PATENTSCOPE and Derwent Innovation for related patent family analysis.
Note: For precise legal advice or detailed patent claims analysis, consulting the original patent document and professional patent attorneys is recommended.
