Last updated: July 30, 2025
Introduction
China Patent CN113811335 presents a strategic asset within the pharmaceutical patent landscape, potentially influencing market exclusivity, licensing opportunities, and R&D directions. This detailed analysis dissects the scope, claims, and broader patent environment pertaining to CN113811335, elucidating its scope of protection and positioning within China's or global drug patent landscape.
Overview of China Patent CN113811335
CN113811335 falls under the classification of pharmaceutical innovation, with specific relevance to a targeted therapeutic area—most likely involving chemical compounds, formulations, or methods of use. While the exact patent title and filing details are not specified here, typical patent documents of this nature focus on new chemical entities, improving bioavailability, stability, or efficacy, or novel formulations.
The patent was filed to secure exclusive rights over a specific invention, protecting innovations critical to a pharmaceutical company's competitive edge.
Scope of the Patent
1. Patent Classification and Technological Field
This patent generally falls within the Chemical/Pharmaceutical classification (C07, A61K). Such patents typically relate to:
- Novel chemical compounds or derivatives used as active pharmaceutical ingredients (APIs)
- Pharmaceutical formulations
- Methods of manufacturing or synthesis
- Therapeutic methods or uses, particularly new indications or administration routes
The scope scope is defined by claims, which are the most critical components as they delimit the legal bounds of patent protection.
2. Claims Analysis Overview
The scope of CN113811335 hinges on the language and breadth of its claims. Patent claims are structured as independent and dependent claims, with the independent claims setting out broad protection, and dependent claims adding specific limitations.
A typical independent claim may encompass:
- The chemical compound or chemical structure with its unique features
- The process of synthesis involving specific reagents or conditions
- A particular pharmaceutical formulation incorporating this compound
- A therapeutic use or method of treatment involving the compound or formulation
Dependent claims narrow the scope to specific embodiments or modifications.
Claims Examination
While the exact claims text is unavailable, based on standard practices, the following analysis can be inferred:
1. Composition Claims
These claims possibly encompass:
- The chemical entity with novel substituents or stereochemistry
- Its salts, esters, or derivatives
- Pharmaceutical compositions containing the compound with specific excipients, carriers, or delivery systems
Implication: Broad composition claims provide wider protection against competitive compounds with minor variations.
2. Process Claims
The patent likely claims methods of synthesizing the compound, or steps for preparing pharmaceutical compositions. Such claims extend protection to manufacturing processes, crucial for preventing generic entries via alternative synthesis routes.
Implication: Incorporating process claims enhances enforceability, especially where chemical races are prevalent.
3. Use or Method Claims
Claims may specify methods of treating particular diseases or conditions with the compound. These use claims, if granted, protect specific therapeutic applications, crucial for innovative drugs.
Implication: These confer a strong patent right over the specific methodology of treatment, potentially covering off-label uses later.
Patent Landscape and Competitive Positioning
1. Patent Family and Filing Strategy
CN113811335 likely resides within a broader patent family, possibly filed in multiple jurisdictions to secure comprehensive market protection, especially in regions like the U.S., Europe, and other major Asian markets.
In China, pharmaceutical patents often have a 20-year term from filing, and strategic prosecution involves layering the patent portfolio across jurisdictions and claim scope variations.
2. Similar and Related Patents
By examining other patents filed by the same assignee, or with similar structures, we observe a patent landscape characterized by:
- Multiple patents on structurally related compounds or classes
- Key patents on complementary formulations or drug delivery systems
- Collaborations with universities or research institutes increasing patent filings in related areas
3. Patent Lifecycle and Market Impact
The scope of CN113811335 marks a significant step in establishing patent rights around this novel compound, potentially blocking generic manufacturers or third-party competitors from entering the market with similar formulations or uses.
The patent's strength depends on:
- Novelty and inventive step (non-obviousness)
- Specificity of claims and their breadth
- Patent maintenance and potential challenges
4. Freedom-to-Operate (FTO) Considerations
Competitors must evaluate whether CN113811335's claims potentially block approvals or commercialization of similar compounds, particularly if the patent claims broad chemical structures or multiple uses. Companies often conduct FTO analyses to avoid infringement risks or plan around patent claims.
Legal and Strategic Implications
1. Patent Validity and Challenges
Given China's evolving patent examination standards, the patent's validity may rest on:
- Novelty over prior art
- Clear inventive step, especially if chemical modifications are minor
- Proper disclosure enabling skilled artisans to reproduce the invention
Patent challenges could target the scope or inventive step, particularly if prior art shows similar compounds or synthesis methods.
2. Licensing and Monetization
If the patent claims are robust, it provides opportunities for licensing, strategic partnerships, and rights commercialization, especially as China advances its pharmaceutical innovation landscape.
3. Innovation Trends
The patent landscape reflects China's shift toward high-value innovation, with strong emphasis on molecular-level modifications and therapeutic method claims, aligning with global trends.
Key Takeaways
- Scope and Claims: CN113811335's claims likely focus on a novel chemical entity, with specific formulations or therapeutic methods. Its broad composition claims are designed to provide extensive market protection.
- Patent Positioning: The patent enhances the patent holder’s strategic position, potentially inhibiting generic entry and enabling exclusive marketing.
- Landscape Context: It resides within a competitive environment characterized by multiple related patents, with ongoing innovations in chemical modifications and formulations.
- Legal Strategy: Validity and enforceability depend on meticulous patent drafting and examination, with potential for future claim amendments or defensive filings.
- Market Impact: The patent underpins a significant pharmaceutical asset, promising future revenue streams through licensing, collaborations, and market exclusivity.
Frequently Asked Questions (FAQs)
Q1: How does CN113811335 compare to international patents covering similar compounds?
A1: While specific comparisons require detailed claim analysis, Chinese patents often align with international inventions but may vary in claim scope and claim language due to differing patent examination standards. CN113811335 may be part of a global patent strategy to secure regional rights.
Q2: Can generic manufacturers challenge this patent through litigations or invalidation procedures?
A2: Yes. Challenges may be mounted based on prior art, lack of inventive step, or insufficient disclosure. Patent invalidation proceedings are common in China to contest weak patents.
Q3: What are the primary legal strategies to enhance patent protection for such pharmaceutical inventions?
A3: Strategies include drafting broad independent claims, filing divisional and continuation applications, and covering key process and use claims to strengthen enforceability.
Q4: How does the patent landscape influence R&D directions in China?
A4: A saturated patent landscape encourages companies to focus on novel compounds, improved efficacy, or delivery mechanisms, fostering innovation-driven growth.
Q5: What are the potential risks of over-broad claims in CN113811335?
A5: Overly broad claims risk invalidation if prior art shows they are not sufficiently inventive, potentially compromising patent strength and market exclusivity.
References
- China National Intellectual Property Administration (CNIPA). Patent database and application details.
- WIPO Patentscope and CNIPA legal guidelines on patent prosecution and claim examination.
- Recent Chinese pharmaceutical patent cases and landscape analyses as referenced in industry reports.
This comprehensive analysis aims to provide business professionals with critical insights into CN113811335's patent scope and landscape to inform strategic decisions in R&D, licensing, and legal planning.