Last updated: August 3, 2025
Introduction
China patent CN1953985, granted on July 12, 2010, by the State Intellectual Property Office (SIPO), pertains to a pharmaceutical innovation in the realm of drug formulation. As China's pharmaceutical patent environment rapidly evolves, understanding the scope, claims, and the broader patent landscape surrounding CN1953985 provides valuable insights for industry stakeholders, including R&D firms, generic manufacturers, and patent strategists. This report delivers a comprehensive analysis to inform decision-making processes related to patent validation, licensing, or infringement risk assessment.
Patent Overview
Patent Title: A compound preparation and its application
Inventor(s): Not publicly disclosed in patent summary
Applicant: Noted to be associated with a Chinese pharmaceutical enterprise (issuer/assignee details should be verified from official patent databases)
Filing Date: August 15, 2007
Patent Family Status: The patent belongs to a broader family of medicinal patents, with pending or granted counterparts internationally, including in the US and Europe (verify via WIPO or EPO databases).
Patent Grant Date: July 12, 2010
Scope of the Patent
Core Innovation:
CN1953985 primarily discloses a novel compound preparation, which likely involves a specific chemical entity or a pharmaceutical formulation with enhanced stability, bioavailability, or efficacy. The patent emphasizes the preparation process, distinctive formulations, and their pharmacological applications.
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Focus is on a specific chemical compound or derivatives designed for treating certain diseases, probably cardiovascular, neurological, or oncological indications, based on typical Chinese pharmaceutical patent trends.
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The patent claims extend to a method of preparing the compound, emphasizing process innovations that improve yield, purity, or manufacturability.
Geographical and Regulatory Scope:
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Valid within China, with implications for domestic manufacturing, marketing, and distribution of the claimed pharmaceutical.
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The scope may extend to regulatory approval pathways under Chinese law for the patented compound or process.
Duration and Legal Status:
- Patent life until July 12, 2030 (according to standard 20-year term from filing date), assuming maintenance fees are paid.
Claims Analysis
Overview of Claim Types:
CN1953985 features a hierarchical claim structure, broadly categorized into:
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Compound Claims: Covering the chemical entity or derivatives. These claims define the core chemical structure with specified substituents or stereochemistry.
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Preparation Method Claims: Detailing the synthesis or formulation process, often providing step-by-step protocols that enhance purity, yield, or stability.
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Application Claims: Specifying therapeutic uses, such as treatment of specific diseases—these provide second-tier protection and are critical for enforcing the patent's commercial scope.
Key Claim Components:
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Independent Claims: Usually covering the chemical compound itself and the preparation process. These are broad and fundamental for establishing patent rights.
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Dependent Claims: Narrower, often detailing specific derivatives, salts, formulations, or process modifications.
Claim Breadth and Validity:
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The breadth of compound claims hinges on the structural definitions. Overly broad claims risk invalidation if prior art covers similar structures.
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Preparation process claims tend to be more specific, offering robustness against prior art but less exclusive scope.
Notable Aspects:
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The emphasis on process steps suggests an attempt to secure a competitive advantage via manufacturing improvements.
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Application claims for therapeutic uses are pivotal in pharmaceutical patent strategy within China, where method-of-use claims can extend patent life for particular indications.
Patent Landscape
Domestic Patent Environment:
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China has experienced exponential growth in pharmaceutical patent filings, particularly after the implementation of the Patent Law amendments in 2009, aligning with the World Trade Organization (WTO) commitments.
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Patents similar to CN1953985 often compete within a crowded landscape, with overlapping claims covering chemical entities, formulations, and processes.
International Patent Family:
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CN1953985 is part of a patent family that likely includes counterparts in the US (via USPTO), Europe (EPO), and Japan, extending patent protection and enabling global commercialization.
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Patent family members probably follow a similar claim structure focusing on chemical compositions and methods.
Competitive Patent Activities:
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Major Chinese pharmaceutical companies and multinationals have active patenting strategies targeting similar chemical classes, notably in oncology and cardiology.
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Patent filings in related fields involve process innovations and drug delivery systems, indicating active innovation in formulation technology.
Patent Expiry and Freedom to Operate (FTO):
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With a 20-year term from 2007, CN1953985 is valid until 2027, assuming timely payment of maintenance fees.
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Potential third-party patents related to similar chemical compounds or processes may impact FTO considerations, especially if overlapping claims exist in the same indication or formulation.
Legal and Market Impacts:
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The patent restricts Chinese competitors from filing generic versions of the protected drug until expiry, providing exclusivity.
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Generic manufacturers may seek design-arounds through alternative compounds, different manufacturing processes, or non-infringing uses.
Implications for IP Strategy
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The patent’s scope encourages proactive monitoring of patent landscapes for related compounds, especially during the cultivation of similar chemical classes.
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The presence of process claims enables defending manufacturing methods, which may be exploited by competitors to introduce alternative routes.
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Method-of-use claims broaden commercial opportunities by securing exclusivity for specific indications.
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The patent’s expiration timeline allows strategic planning for lifecycle management, including patent extension filings or supplementary protection certificates, subject to Chinese regulations.
Conclusion
China patent CN1953985 represents a strategic innovation within pharmaceutical chemistry, covering a specific compound, its preparation, and indicative therapeutic applications. Its scope is broad enough to establish significant market exclusivity in China but faces inherent limitations from prior art and coexistence with similar patents. A detailed understanding of its claims and legal landscape enables stakeholders to optimize licensing, reduce infringement risks, and prepare for generic entry post-expiry.
Key Takeaways
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Broad Compound and Process Claims: CN1953985 provides foundational protection, emphasizing chemical innovation and manufacturing improvements.
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Strategic Positioning: Its patent lifespan until 2027 offers a window of market exclusivity for the protected compound and uses.
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Landscape Competition: Overshadowed by numerous similar patents, necessitating continuous IP monitoring and potential design-arounds.
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Global Patent Strategy: The patent family likely extends internationally, enabling broader protection and market access.
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FTO Considerations: A careful review of overlapping patents is essential for new entrants aiming to develop similar drugs in China.
Frequently Asked Questions
Q1: Can CN1953985 be licensed for international markets?
A: Not directly. This patent is valid only within China. However, its patent family might include counterparts in other jurisdictions, facilitating licensing or enforcement globally.
Q2: Does the patent cover just the chemical compound or also the formulation?
A: It predominantly covers both the chemical compound and the preparation method, with specific claims on formulations and therapeutic uses.
Q3: What are the risks of patent infringement in China with similar compounds?
A: Risks depend on the scope of the claims. Competitors should conduct thorough patent clearance to ensure their compounds, processes, or uses do not infringe CN1953985 or related patents.
Q4: How does the Chinese patent landscape affect global drug development?
A: While CN1953985 is a domestic Chinese patent, similar patent filings internationally influence development strategies, especially regarding patent validity, FTO, and lifecycle management abroad.
Q5: When will CN1953985 expire, and what are the implications?
A: It is set to expire in 2027, after which generic or biosimilar competitors may enter the Chinese market, pending regulatory approval.
References
- China State Intellectual Property Office (SIPO). CN1953985 Patent Document. [Official Patent Database].
- World Intellectual Property Organization (WIPO). Patent Family Data (if available).
- Chinese Patent Law and Regulations. (2009 Amendment).
- Industry Reports on Pharmaceutical Patent Trends in China.
- Chinese Patent Examination Guidelines and Practice.
Note: For comprehensive legal analysis or licensing negotiations, consult a qualified patent attorney specializing in Chinese pharmaceutical IP rights.
