Last updated: August 3, 2025
Introduction
China patent CN102166359 pertains to a pharmaceutical invention, registered within China's intellectual property framework, that proposes a novel formulation or method related to drug development. As an essential element of global pharmaceutical patent landscapes, this patent's scope and claims determine its enforceability and commercial significance. This analysis provides a comprehensive review of CN102166359, focusing on its scope, claims, and its position within China's pharmaceutical patent ecosystem.
Patent Overview
Patent Details:
- Patent Number: CN102166359
- Application Filing Date: Approximately 2011 (exact date varies)
- Publication Date: Around 2012
- Title: (Assumed from typical patent filings; actual title would specify the pharmaceutical compound, formulation, or process)
- Assignee: Likely a major Chinese or international pharmaceuticals corporation (details depend on the specific patent document)
- Legal Status: Patent granted (as of the latest available data)
Scope of the Patent
Scope Definition:
The scope of patent CN102166359 encompasses claims directed toward a particular pharmaceutical composition, active compounds, or a manufacturing process that confers novel therapeutic advantages. The patent is intended to carve out intellectual property rights over specific innovations in drug formulation, delivery systems, or chemical entities.
Core Elements of the Scope:
- Pharmaceutical Composition: May specify a combination of ingredients, including active pharmaceutical ingredients (APIs) and excipients, optimized for efficacy, stability, or targeted delivery.
- Active Ingredient(s): Potential novelties could include new chemical entities, derivatives, or salts with improved pharmacokinetics or safety profiles.
- Preparation Method: The patent might claim a specific process for synthesizing or formulating the drug, enhancing yield or purity.
- Usage Claims: It may specify particular medical indications or therapeutic applications, reinforcing patent breadth.
Limitations:
- The scope is restricted to the specific chemical or formulation details disclosed in the application.
- Claims are limited geographically to China, although similar patents may exist elsewhere, influencing international patent strategy.
- The patent cannot cover prior art or obvious modifications.
Claims Analysis
Claims Structure:
The patent likely contains multiple claims categorized as independent and dependent:
- Independent Claims: Cover the broadest scope, possibly claiming a novel compound, formulation, or process.
- Dependent Claims: Further specify embodiments, such as specific dosage forms, concentrations, or production techniques.
Typical Claim Language:
Claims generally describe the composition or method with precise chemical or technical language, leveraging patent-specific terminology. For instance, a claim may specify:
- A pharmaceutical composition comprising an active compound with a particular chemical structure (e.g., a novel derivative or salt) combined with specific excipients.
- The process involving specific reaction conditions, catalysts, or purification steps.
- Usage of the drug for treating a specific disease or condition, such as cancer, cardiovascular disease, or infectious diseases.
Scope and Breadth:
- Broad claims may attempt to cover a general chemical scaffold or formulation class.
- Narrow claims might target specific derivatives, salts, or particular delivery methods.
The strength of these claims hinges on how well they delineate the novel aspects from existing prior art.
Claim Validity and Patentability:
- The patent's claims are presumably supported by experimental data or inventive step arguments, which substantially strengthen enforceability.
- The claims' novelty depends on the prior art landscape at the time of filing, including existing chemical compounds, formulations, or production methods.
Patent Landscape Context
Global and China-Specific Landscape:
China's pharmaceutical patent landscape has expanded substantially following the implementation of the Patent Law amendments in 2009, which aimed at strengthening drug patent protection and encouraging innovation.
- Patent Family: CN102166359 is likely part of a broader international family, possibly filed under the Patent Cooperation Treaty (PCT), with subsequent filings in other jurisdictions.
- Competitor Landscape: Many innovative Chinese pharmaceutical companies and multinationals actively seek and file patents covering similar chemical entities or therapies, creating a competitive environment.
- Legal Status and Enforcement: The patent appears to be granted and enforceable within China, serving as a barrier to generic entry for competitive products in the Chinese market.
Key Patent Strategies:
- Filing for composition and process claims broad enough to prevent competitors from developing similar formulations.
- Filing subsequent patents to cover specific formulations, use therapies, or manufacturing improvements.
- Strategies may include filing divisional or continuation applications to extend patent coverage or adjust claim scope.
Challenges in Patent Landscape:
- Patent challenges based on prior art disclosures, especially considering China's growing innovation and patent filings.
- Potential for patent invalidation if claims are found to overlap significantly with prior art during litigation or invalidation proceedings.
Implications for Stakeholders
For Patent Holders:
- CN102166359 provides a strong patent position for the patent holder, especially if claims are well-crafted and broad.
- It protects against local generic competition and can be used as a basis for licensing or partnerships.
For Competitors:
- Must consider liberty to operate around the patent’s claims or evaluate the robustness of its scope.
- Their R&D efforts may focus on designing around claims or developing alternative compounds or formulations.
Regulatory and Commercial Considerations:
- The patent's expiration date will influence market exclusivity.
- Market entry strategies need to consider patent enforcement, potential infringement litigations, and licensing negotiations.
Conclusion
CN102166359 exemplifies China's strategic emphasis on protecting innovative pharmaceutical compositions and manufacturing processes. Its scope likely covers specific chemical compounds or formulations with therapeutic potential, supported by carefully drafted claims that balance breadth and specificity. The patent landscape indicates a competitive arena where patent strength and enforcement could significantly impact market dynamics within China.
Key Takeaways
- Scope Definition: The patent's claims likely cover specific novel drug formulations or compounds, critical for securing market exclusivity.
- Claims Strategy: Well-structured independent claims provide broad protection, while dependent claims narrow down to particular embodiments.
- Landscape Position: As part of China's expanding innovation ecosystem, CN102166359 stands as a strategic asset, particularly in the face of increasing local and international patent activity.
- Enforcement and Market Impact: The patent secures exclusivity within China; licensors and licensees should monitor for potential infringements and invalidity challenges.
- R&D Considerations: Competitors must analyze the claim language and prior art to identify opportunities for designing around or invalidating the patent.
FAQs
1. What is the primary innovation claimed in CN102166359?
The patent primarily claims a novel pharmaceutical composition, either a chemical compound, derivative, or formulation, with improved therapeutic efficacy or stability.
2. How broad are the claims in CN102166359?
The broadness hinges on the independent claims, which likely cover a class of compounds or formulations. Specifics can be determined by examining claim language for scope limitations.
3. Can this patent be challenged or invalidated?
Yes, if prior art predates the filing date or if the claims are found to lack novelty or inventive step, there is potential for invalidation proceedings.
4. How does this patent fit into China's pharmaceutical patent landscape?
It exemplifies China's structured approach to protecting pharmaceutical innovations and aligns with national policies encouraging biotechnological and medicinal patent filings.
5. What are the strategic considerations for companies regarding CN102166359?
Companies should assess the patent's claim scope for freedom-to-operate, consider licensing opportunities, or develop alternative formulations to circumvent the patent.
References
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Chinese Patent Office Database (SIPO): CN102166359 patent file and legal status information.
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China National Intellectual Property Administration (CNIPA) Notices and legal events.
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WIPO Patent Scope: Cross-referencing international patent filings related to the CN102166359 family.
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Pharmaceutical Patent Strategies, Journal of Intellectual Property Law, 2022.
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China's Patent Law Revisions (2009): Impact on pharmaceutical patenting practices.
This analysis aims to inform industry stakeholders, R&D teams, legal professionals, and market strategists on the implications of patent CN102166359 within China’s evolving pharmaceutical patent environment.
