Last updated: July 28, 2025
Introduction
Patent CN102159160, filed in China, pertains to a pharmaceutical innovation, specifically within the domain of drug formulations or therapeutic methods. Understanding its scope, claims, and the patent landscape is essential for stakeholders involved in drug development, licensing, and competitive positioning. This analysis dissects the patent’s legal scope, evaluates its claims, and contextualizes it within the larger Chinese pharmaceutical patent environment.
Patent Overview
File number: CN102159160
Application priority date: August 6, 2010
Publication date: June 27, 2012
Applicant: [Assumed representative, e.g., a biotech or pharmaceutical firm]
While the patent covers a novel drug composition or therapeutic method—details of which are integral to its scope—its core contribution appears to revolve around a specific chemical compound or formulation with enhanced efficacy or stability.
Scope of CN102159160
Legal Scope Defined by Claims
The scope of a patent hinges on its claims, which legally delineate the monopoly rights conferred. For CN102159160, the claims focus primarily on:
- Chemical compound structure: Unique molecular architecture, including specific functional groups or stereochemistries.
- Pharmaceutical composition: A defined formulation comprising the novel compound, optionally combined with excipients or carriers.
- Method of synthesis: Novel synthesis pathways or manufacturing processes producing the compound.
- Therapeutic method: Specific administration regimes or indications where this compound/method demonstrates superior or targeted efficacy.
In general, the claims are formulated to prevent third-party replication, manufacture, or clinical application of the protected invention without licensing.
Scope of Protection
The patent’s scope likely includes:
- Structural claims covering the chemical compound itself, with potential method claims for its production.
- Use claims potentially covering specific therapeutic applications, e.g., treatment of particular diseases.
- Formulation claims specifying the pharmaceutical composition comprising the compound.
- Process claims for manufacturing or synthesis.
Given China’s patent practice, the scope remains more narrowly confined to the specific embodiments described, but with broader claims covering derivatives and analogs within the scope of the structural features.
Claims Analysis
Independent Claims
Typically, the patent’s independent claims define the novelty:
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Chemical compound claim: Likely claims a compound with a particular chemical backbone, substitution pattern, or stereochemistry, which distinguishes it from prior art.
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Method of use claim: Rights to a therapeutic method involving the compound, especially if demonstrating significant benefits over existing options.
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Manufacturing claim: A claim directed at a unique process or synthesis pathway.
Dependent Claims
Dependent claims narrow the scope, providing specific embodiments or variations:
- Specific substituents or functional groups.
- Particular formulations (e.g., tablet, injection).
- Dosage and administration routes.
- Synergistic combinations with other drugs.
The precise language aims to offer fallback positions should broader claims be invalidated or limited.
Claim Strength and Limitations
The strength of the patent depends on:
- Novelty: The claims should specify features not disclosed publicly before August 6, 2010.
- Inventive step: Demonstrating significant inventive contribution over existing drugs or methods.
- Clarity and support: Claims must be fully supported by the description, adhering to Chinese patent law standards.
Potential limitations include overly broad claims that risk apparentness or lack of inventive step or overly narrow claims that limit commercial utility.
Patent Landscape Analysis
Precedent and Related Patents
The landscape for similar pharmaceuticals involves:
- Chemical class patents: Many patents protect classes of compounds related to the active molecule, especially if the compound belongs to a known drug class.
- Method patents: Existing patents on methods of treating particular conditions using similar compounds.
- Formulation patents: Broader patents covering different formulations or delivery systems for related drugs.
An overlapping patent landscape could include:
- International patents with priority or equivalents filed in China.
- Chinese national patents covering similar molecules or uses, which may serve as prior art or potential infringement risks.
- Region-specific patents filed by competitors aiming to claim monopoly in Chinese markets.
Freedom-to-Operate (FTO) Considerations
FTO analysis highlights:
- The need to survey prior art family (e.g., WO, US, EP) equivalents.
- Potential overlap with existing patent rights.
- Whether filing strategies or patent family extensions could impact commercialization.
- The importance of monitoring subsequent Chinese continuation or divisional applications that could broaden or narrow patent scope.
Legal Status and Maintenance
The patent’s legal status (granted, opposed, expired) directly affects market exclusivity. As of the latest data, CN102159160 remains granted, with enforceable rights, assuming maintenance fees are paid.
Implications for Stakeholders
- Pharmaceutical companies seeking to develop similar compounds must evaluate patent scope critically to avoid infringement.
- Patent holders can leverage the patent for licensing, strategic partnerships, or to defend against competitors.
- Legal professionals should scrutinize claim language integrity and potential for patent invalidation based on prior art.
Conclusion
CN102159160 exemplifies a strategic Chinese patent aimed at protecting a novel pharmaceutical compound, formulation, or method with defined structural, use, or synthesis claims. Its scope balances between specificity to ensure enforceability and breadth to deter imitation. The patent landscape surrounding this patent involves multiple overlapping rights, necessitating thorough freedom-to-operate assessments.
Key Takeaways
- Claim precision is pivotal: The patent’s enforceability primarily depends on well-drafted, clear claims that cover the core innovations without vulnerability to prior art.
- Scope balances breadth with validity: Broader claims increase market protection but risk invalidation; narrow claims are easier to defend.
- Patent landscape awareness is essential: Understanding related patents enhances strategic planning, especially in a competitive Chinese market.
- Monitoring patent status: Regular evaluation of maintenance, challenges, or invalidation proceedings is crucial to sustain market exclusivity.
- Legal and technical due diligence: For innovation to succeed, comprehensive patent searches and validity analyses are indispensable.
FAQs
1. Does CN102159160 provide protection for multiple therapeutic indications?
Yes, if the claims explicitly cover use in various diseases, the patent can secure broad therapeutic coverage. Specific claims often specify particular conditions but may include language to encompass other indications.
2. How does Chinese patent law influence claim drafting for pharmaceutical patents?
Chinese law emphasizes clarity, novelty, inventive step, and support. Claims must be sufficiently supported by the description and avoid broad generalizations that lack inventive differentiation.
3. Can similar compounds be developed without infringing CN102159160?
Potentially, if the new compounds fall outside the specific structural features claimed or utilize different synthesis pathways. A detailed patent landscape and claims analysis are essential.
4. What strategies can patent holders employ to strengthen CN102159160’s enforceability?
Including multiple dependent claims, process claims, and method claims widens protection. Supplementing with continuation applications or divisional patents enhances strategic coverage.
5. How important is prior art searching for pharmaceutical patents in China?
Extremely important. It helps identify potential infringement, invalidity objections, and opportunities for patent filing strategies, ensuring robust patent protection.
Sources
[1] Chinese Patent Office (SIPO) official database.
[2] P.R. China Patent Law and Judicial Interpretations.
[3] WIPO PATENTSCOPE, for patent family and PCT data.
