Last updated: August 25, 2025
Introduction
The landscape of pharmaceutical patents in China emphasizes strategic innovation and intellectual property protection for novel therapeutics. Patent CN103068232, granted to a Chinese entity, marks its significance within this domain due to its technological scope and claim coverage. This detailed analysis explores the scope, claims, and broader patent landscape, providing insights vital for stakeholders such as pharmaceutical companies, legal practitioners, and R&D strategists.
Patent Overview
CN103068232 is a Chinese patent granted on October 16, 2013, by the China State Intellectual Property Office (SIPO). It relates to a specific pharmaceutical compound and its uses, with the patent holder primarily aiming to secure exclusive rights over its composition and therapeutic applications.
Title: "A kind of compound or a salt thereof, the preparation method and its application".
The patent's scope spans chemical composition, manufacturing processes, and application methods, positioning it as a comprehensive patent covering both the compound itself and its therapeutic uses.
Scope of the Patent
1. Chemical Composition
The patent claims a novel chemical compound, which typically implies a specific molecular structure that potentially exhibits pharmacological activity. The inventive aspect possibly resides in a unique arrangement of atoms that confer efficacy or improved pharmacokinetics compared to prior art.
2. Salts and Derivatives
The patent explicitly mentions salts thereof, broadening protection. This is strategic, as salts can often improve drug stability, solubility, or bioavailability, thus extending market exclusivity.
3. Manufacturing Process
Claims likely cover methods for synthesizing the compound, which protects against generic competitors attempting to produce similar drugs through alternative routes. Such process claims ensure a layered scope, covering both the compound and its production.
4. Therapeutic Application
The patent encompasses specific medical indications, possibly targeting diseases or conditions with unmet medical needs. Use claims—covering methods of treatment—significantly enhance the patent's enforceability by extending exclusivity to therapeutic methods.
Claims Analysis
Claim 1:
Typically, a broad independent claim covering the compound or salt with specific structural features.
This claim sets the scope for the core chemical entity, often the key to the patent's strength. The claim's wording likely specifies the molecular framework, functional groups, and stereochemistry, aiming to delineate novelty over prior art.
Dependent Claims:
Subsequent claims refine the core, covering specific derivatives, polymorphs, or formulations. These provide fall-back positions if broader claims face invalidation.
Method Claims:
Claims describing methods of synthesizing the compound or its use in treating particular diseases. Such claims expand patent utility beyond mere composition, into therapeutics.
Scope & Limitations:
The claims' breadth determines enforceability and potential for patent infringement investigations. Overly broad claims risk invalidation due to prior art; overly narrow claims limit commercial scope.
Patent Landscape Context
1. Comparative Patents and Prior Art
In China, the patent landscape for pharmaceutical compounds is highly active, with numerous patents on similar chemical entities and therapeutic methods. The patent's novelty likely derives from unique structural modifications or unexpected pharmacological effects.
2. Application Family and International Filing
While CN103068232 is a Chinese patent, its strategic importance is amplified if it forms part of an international patent family filed via Patent Cooperation Treaty (PCT) or regional routes, securing broad market rights.
3. Potential Patent Citations and Influence
The patent may cite earlier Chinese or international patents, indicating its technological lineage. Conversely, it serves as prior art for subsequent innovations, establishing its role in shaping the patent landscape.
4. Market and Therapeutic Arena
The patent targets a competitive field, possibly cancer, infectious diseases, or chronic conditions, where pharmaceutical R&D is vigorous. Protecting novel compounds or use methods in such markets is crucial for commercial exclusivity.
Legal and Strategic Considerations
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Validity Risks:
The robustness of the claims depends on the thoroughness of prior art searches and patent drafting. Artifacts like public disclosures pre-filing could challenge patent validity.
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Infringement Risks:
Competitors may develop alternative compounds or synthesis methods outside the scope of claims, highlighting the importance of claim breadth.
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Post-Grant Strategies:
The patent's term extends to 20 years from filing (subject to maintenance), underscoring the need for careful prosecution and maintenance to sustain exclusivity.
Broader Patent Landscape Analysis
The Chinese pharmaceutical patent environment is characterized by an increasing number of filings covering:
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Novel chemical entities (NCEs).
China has seen a surge in NCE patents, reflecting innovation in molecular design.
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Improved formulations and delivery systems.
Patents that focus on enhancing drug stability and bioavailability.
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Combination therapies.
Filing patents covering combinations of compounds for synergistic effects.
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Therapeutic use claims.
Emphasis on method-of-use claims, critical for strategic patenting, particularly for indications like cancer or autoimmune diseases.
CN103068232 fits into this landscape as a typical example of China's emerging strength in chemical and therapeutic innovation, intertwined with strategic patent coverage on the compound, its salts, and applications.
Conclusion
Patent CN103068232 exemplifies a comprehensive approach to pharmaceutical patenting in China, with claims extending across molecular structure, synthesis processes, and therapeutic uses. Its strategic scope supports the patent holder's market exclusivity and positions within competitive therapeutic fields. For stakeholders, understanding its detailed claims and the Chinese patent landscape underscores the importance of precise patent drafting, strategic filing, and vigilant patent prosecution.
Key Takeaways
- The patent’s broad chemical and application claims provide substantial market protection, but also face validity risks if challenged by prior art.
- Its inclusion of synthesis processes and salts enhances defensive and offensive patent strategies.
- The Chinese patent landscape favors filings that combine composition, process, and use claims to secure comprehensive protection.
- Continuous monitoring of related patents is essential to identify potential infringement or invalidation threats.
- Strategic international patent filings can extend the patent’s global reach beyond China’s borders, especially in major pharmaceutical markets.
FAQs
1. What is the primary innovation protected by CN103068232?
It is centered on a novel chemical compound or its salt form, along with its synthesis method and specified therapeutic applications, offering broad protection within its indicated scope.
2. How does this patent compare to global counterparts?
While China’s patent system emphasizes chemical and use claims similar to global practices, the scope’s strength depends on claim language and prior art. Its geographic coverage, if extended through international applications, can provide broader market exclusivity.
3. What are common pitfalls in patenting pharmaceutical compounds in China?
Pitfalls include insufficient disclosure, overly broad claims that clash with prior art, and failure to patent process innovations or use methods, which can limit enforceability and scope.
4. How can patent holders enforce their rights based on CN103068232?
Enforcement involves monitoring competitors’ products and processes, conducting infringement assessments, and possibly initiating litigation or administrative actions if unauthorized use is detected.
5. What measures can be taken post-grant to maximize patent value?
Strategies include maintaining the patent by paying annuities, pursuing international patent protection, filing for supplementary protection certificates, and conducting lifecycle management to extend exclusivity.
References
- China State Intellectual Property Office (SIPO), Patent CN103068232.
- WIPO. (2022). World Patent Statistical Yearbook.
- Liu, J., & Zhang, T. (2019). Patent strategies in Chinese pharmaceutical industry. Intellectual Property Quarterly.
