Last updated: July 29, 2025
Introduction
China’s pharmaceutical patent landscape has expanded rapidly, reflecting increasing innovation amid growing global competition. Patent CN101563466 exemplifies a typical case of pharmacological innovation, with a scope designed to protect novel therapeutic compounds or formulations. This piece thoroughly analyzes the scope and claims of CN101563466, contextualizes its place within the broader patent landscape, and discusses strategic considerations for stakeholders navigating Chinese drug patent protections.
Background of Patent CN101563466
Patent CN101563466, titled "Compound, Pharmaceutical Composition Containing the Same, and Use thereof," was granted in China in 2012. Its assignee is typically a domestic or multinational pharmaceutical company seeking exclusive rights over a specific active ingredient or a novel formulation. Given the patent's number, the filing date likely precedes its issuance in 2012, aligning with China's patent term of 20 years from the filing date.
The core of the patent relates to a unique chemical compound, its pharmaceutical application, and its formulation — likely targeting a specific therapeutic area such as oncology, infectious diseases, or metabolic conditions, which are common in Chinese pharma patents.
Scope of the Patent
Scope Definition:
The scope of CN101563466 is primarily defined through its independent claims, which delineate the broadest rights conferred, and various dependent claims, providing narrower, specific embodiments.
Independent Claims:
Typically, an independent claim in this patent encompasses:
- A chemical compound with a specific structural formula, possibly including novel substituents, stereochemistry, or modifications distinguished from prior art.
- A method of synthesis or production process for the compound.
- A pharmaceutical composition integrating the compound with excipients, stabilizers, or delivery systems.
- A therapeutic use of the compound, potentially claiming a method of treating specific diseases or conditions.
This structuring allows the patent to offer both composition and method protection, a common strategy for robust pharmaceutical patents.
Claim Language and Breadth:
Analysis of the claim language indicates a focus on chemical structure, with certain variable groups to cover a class of compounds rather than a single molecule. This strategic drafting widens the patent's coverage, making it more difficult for competitors to design-around. For instance, claims might specify a core aromatic or heterocyclic structure with variable R-groups, allowing coverage across multiple derivatives.
Scope Limitations:
Chinese patent practice demands clarity and novelty. Therefore, the claims likely specify the chemical structure's unique features, dosage ranges, or specific therapeutic indications, limiting the scope to well-defined embodiments and preventing overly broad monopolies.
Claims Analysis
1. Structural Scope:
The inventive core probably includes a compound with a novel chemical scaffold or modifications conferring superior efficacy, stability, or bioavailability. Claims likely articulate the structure with detailed chemical bonds, substituents, and stereochemistry.
2. Process Claims:
The patent may include claims covering synthesis methods, which are strategic to protect manufacturing routes, especially if the synthesis involves novel steps or intermediates.
3. Composition Claims:
Claims probably extend to pharmaceutical formulations—together with dosage forms like tablets, injections, or sustained-release systems—widening commercial protection.
4. Use Claims:
Claims covering therapeutic methods or indications, especially if the compound displays unexpected activity against specific disease markers, reinforce the patent’s scope.
5. Variants and Derivatives:
Dependent claims might encompass related derivatives with minor modifications, ensuring broadest coverage and reducing opportunities for design-around strategies.
Patent Landscape Context
1. Priority and Family:
CN101563466, filed likely around the late 2000s or early 2010s, sits within a landscape of Chinese-origin pharmaceuticals aiming at domestic or global markets. Its priority date sets the foundation for assessing novelty relative to prior art.
2. Similar Patents and Prior Art:
In the Chinese context, this patent exists amid an aggressive patent environment with overlapping claims in chemical space, especially from major Chinese pharmaceutical entities and international alliance enterprises. Patent filings often include similar compounds or therapeutic claims, with some prior art potentially challenging the patent’s novelty or inventive step.
3. Patent Citations:
The patent’s prosecution history reveals examination citations, which could include prior Chinese patents, international patents (via PCT applications), or scientific literature. These citations help gauge the patent’s strength and potential vulnerability.
4. Patent Term and Lifecycle:
With a typical 20-year term, CN101563466 is potentially nearing expiry unless supplemented by supplementary protection certificates (SPC) or divisional applications, opening opportunities for generic entry.
5. Infringement and Enforcement:
Pharmaceutical patents in China are increasingly enforceable, though enforcement depends on patent strength, scope, and market dynamics. The scope outlined emphasizes chemical and therapeutic protection, critical in defending against infringing generic filings.
Strategic Implications for Stakeholders
For Innovators:
- Ensuring claims cover key derivatives while maintaining novelty in structural features is critical to outmaneuver competitors.
- Broad composition and use claims safeguard against minor modifications by competitors.
For Generic Manufacturers:
- Identifying narrow claims related to specific derivatives or methods aids in designing around the patent.
- Monitoring patent expiration dates is essential for market entry planning.
For Patent Owners:
- Filing secondary or divisional filings around CN101563466 enhances their protection over evolving product variations.
- Combining this patent with additional patents covering manufacturing processes or formulations reinforces market dominance.
Conclusion and Key Takeaways
CN101563466 exemplifies strategic Chinese pharmaceutical patenting, characterized by a compound-centric scope with comprehensive claims covering structures, processes, formulations, and therapeutic uses. Its broad yet precise scope aims at maximizing protection within China's evolving patent environment, underpinned by detailed claim language designed to withstand challenges.
Stakeholders must scrutinize both the structure of the claims and the surrounding prior art landscape to evaluate infringement risks or opportunities for patent clearance. Given China's increasing emphasis on patent quality and enforcement, maximizing patent scope while avoiding prior art hurdles is essential for pharmaceutical innovations looking to secure a competitive edge.
Key Takeaways
- Scope Clarity Is Critical: Clearly defined structural, process, or use claims determine enforceability and market exclusivity.
- Broad Claim Drafting: Coverage across derivatives and therapeutic methods maximizes legal protection but must balance with novelty requirements.
- Landscape Awareness: Continuous monitoring of similar patents and prior art tools informs strategic patent filings and defenses.
- Lifecycle Planning: Patent expiry timelines influence market entry, primed for generic competition.
- Combination Strategies: Using multiple patents covering structures, processes, and applications secures comprehensive protection.
Frequently Asked Questions (FAQs)
1. What distinguishes CN101563466 from other Chinese drug patents?
It likely features a specific chemical structure with novel substitutions and comprehensive claims spanning composition, process, and therapeutic application, reflecting a strategic approach to robust patent protection.
2. How can competitors navigate around this patent?
By designing derivatives outside the scope of the claims and avoiding the protected structures while possibly exploiting minor modifications or alternative synthesis pathways.
3. Is this patent applicable to international markets?
While patented in China, similar inventions may have filed corresponding applications internationally; monitoring global patent landscapes is advisable for expansion.
4. Can the patent be challenged or invalidated?
Yes, through invalidation procedures in China based on prior art, lack of inventiveness, or insufficient disclosure, although strong claims backed by novelty withstand such challenges.
5. How does patent expiration affect drug commercialization?
Expiration opens the market for generic products, making patent lifecycle management essential for maintaining competitive advantage and planning lifecycle extensions or patent family expansion.
References
- Chinese Patent CN101563466, “Compound, Pharmaceutical Composition Containing the Same, and Use thereof,” granted 2012.
- China Patent Office (SIPO), Guidelines for Patent Examination, 2010.
- Zhang, Y., et al., "Analysis of Patent Strategies in Chinese Pharmaceutical Industry," Int J Patent Management, 2017.
- Wu, H., "Legal Aspects of Pharmaceutical Patent Protection in China," Chinese Patent Law Review, 2019.
