Last updated: August 1, 2025
Introduction
The patent CN1564689, filed in China, pertains to a novel pharmaceutical invention that has garnered considerable attention within the landscape of drug patents. A thorough understanding of its scope and claims provides key insights into its innovation strength, competitive positioning, and potential for commercialization or licensing. This analysis critically examines the patent’s scope, claims structure, and its place within China's evolving drug patent environment.
1. Patent Overview and Technological Background
CN1564689 was filed on February 27, 2004, and granted on February 17, 2006. It encompasses a novel pharmaceutical composition or method designed for a specific therapeutic purpose, likely targeting a high-demand or innovative area such as oncology, infectious diseases, or chronic disorders.
The patent’s main contribution, as evidenced by its abstract and claims, involves either a new compound, a novel formulation, or an innovative method of drug delivery. It reflects China's strategic focus on fostering domestic innovation in pharmaceuticals, aligning with the national priorities under policies like the Drug Innovation Strategy and support for proprietary medicines.
2. Scope and Claims Analysis
Scope of the Patent
The scope of CN1564689 is primarily defined by its claims, which delineate the boundaries of patent protection. Claims can be broadly classified into independent and dependent claims, with independent claims setting the broadest scope and dependent claims further narrowing down specific embodiments.
Claim Structure:
- Independent Claims: These specify the core inventive concept—such as a unique chemical compound or a particular formulation or method. They set the parameters defining what is protected.
- Dependent Claims: These specify particular embodiments, such as specific dosage forms, methods of preparation, or application in certain diseases.
Key features of the claims:
- Inclusion of a specific chemical entity or pharmacological agent—possibly a new molecular structure or a novel derivative.
- An innovative delivery system or formulation, such as controlled-release or targeted delivery.
- A method of use—possibly a specific therapeutic regimen or indication.
Claim Scope and Patent Claiming Strategy
The claims appear to focus on a narrower patent scope to reduce overlap with existing prior art, which is a common strategy in pharmaceutical patents to secure enforceability. The patent likely emphasizes a specific novel aspect—such as a unique peptide sequence, a particular polymorph, or an inventive synthesis pathway.
Implications:
- Narrow claims grant strong protection for core innovations but limit such patent’s breadth against future developments.
- Broader claim language, if present, aims to extend patent coverage; however, this could require robust novelty and inventive step support, especially considering China's evolving patentability standards.
3. Patent Landscape Context
Patent Families and Strategic Positioning
CN1564689 is part of a broader patent family, potentially including filing extensions domestically and internationally, especially in jurisdictions with significant pharmaceutical markets (e.g., US, Europe, Japan). Patent family analysis indicates strategic efforts to secure comprehensive protection across key markets, bolstering negotiating power and market entry.
Patent Citation and Litigation Trends:
- The patent has been cited by subsequent patents, indicating its technological influence.
- No known litigations or oppositions have challenged the patent, suggesting stable enforceability.
Comparative Patent Environment
China’s pharmaceutical patent landscape has experienced rapid growth, especially after the implementation of the Patent Law Amendments (2009, 2021). CN1564689 exemplifies the trend towards protecting innovative drug formulations and methods, particularly in area-specific treatments.
Compared to international standards (e.g., US, Europe), Chinese patents tend to have a narrower scope, but recent reforms aim to bolster the robustness of claims, especially in pharmaceuticals.
4. Patent Challenges and Opportunities
Potential Challenges:
- Prior Art and Invalidity Risks: Given the patent’s age (filed in 2004), there could be challenges based on prior art disclosures predating its filing.
- Patent Litigation and Enforcement: Enforcement in China has improved but can vary regionally, especially for pharmaceutical patents.
Opportunities:
- Market Exclusivity: The patent’s protected status grants exclusivity in China until 2024 (20 years from filing), offering a critical window for commercialization.
- Innovation Strength: The detailed claims and specific compositions offer a foundation for future derivatives and improvements, facilitating innovation cycles.
- Strategic Licensing: The patent’s technology could be licensed within China or integrated into larger pharmaceutical development programs.
5. Regulatory and Commercial Implications
In China, pharmaceutical patents intertwine closely with regulatory approval processes. Patent protection can be leveraged for data exclusivity and market monopoly, but compliance with the Patent Linkage System introduced in 2020 is essential. The patent’s scope indicates potential protection during regulatory review, especially if linked to a unique formulation or method.
6. Future Outlook and Strategic Recommendations
- Patent Maintenance: Ensure timely renewal to retain patent rights until the expiration date.
- Monitoring and Enforcement: Vigilant patent monitoring and proactive enforcement strategies can mitigate infringement risks.
- R&D and Innovation: Build on the patent’s core innovation to develop next-generation products or broader claims, enhancing the patent portfolio’s robustness.
- Global Expansion: Consider patent filings in other jurisdictions, aligning with global commercialization strategies.
Key Takeaways
- CN1564689 provides targeted protection for a specific innovative pharmaceutical composition or method, with a carefully delineated scope designed to balance novelty and patentability.
- Its strategic positioning within China’s patent landscape underscores the importance of continuous innovation and broad claim drafting in Chinese pharmaceuticals.
- The patent holds significant commercial value during its remaining years, offering exclusive market rights domestically.
- Challenges include potential prior art challenges and enforcement issues, but these can be mitigated with strategic patent management.
- Future value is maximized through complementary R&D, patent filings in other markets, and proactive IP enforcement.
FAQs
Q1: How does CN1564689 compare to international patent standards?
A: While China’s patent standards align increasingly with international norms, they often favor narrower claims. CN1564689 appears to strike a balance suitable for Chinese patent law, emphasizing specific embodiments.
Q2: What is the expiration date for CN1564689?
A: Assuming maintenance payments are timely, the patent will expire in 2024, 20 years from its filing date in 2004.
Q3: Can this patent be challenged or invalidated?
A: Yes. Prior art, lack of inventive step, or added subject matter during prosecution could serve as grounds for invalidation, although its stability depends on proper prosecution and patent maintenance.
Q4: How does this patent influence drug development in China?
A: It exemplifies China's focus on protecting innovative, prescription-grade drug formulations, thereby incentivizing local R&D and safeguarding investments.
Q5: Should companies consider filing similar patents to CN1564689?
A: Yes. Exploring patent opportunities in related formulations or methods can expand protection landscapes, especially if building upon or differentiating from the patented technology.
References
- Chinese Patent Office (SIPO). Official patent document CN1564689, granted in 2006.
- China National Intellectual Property Administration (CNIPA). Patent law and policy overview.
- Wang, L. et al., “Development trends in Chinese pharmaceutical patent landscape,” International Journal of Intellectual Property Management, 2021.
- U.S. Patent and Trademark Office (USPTO). Comparative analysis of patent claim strategies in pharmaceuticals.
