Last updated: August 1, 2025
Introduction
China’s drug patent CN1355693 represents a significant element within the pharmaceutical patent landscape, reflecting strategic efforts to secure exclusive rights over innovative pharmaceutical compounds and formulations. This patent, filed and granted within China’s evolving intellectual property framework, exemplifies the country’s push to enhance domestic pharmaceutical innovation and meet regulatory requirements to foster a more robust patent ecosystem. This analysis offers a comprehensive review of the patent’s scope, claims, and the broader patent landscape, providing insights vital for stakeholders including pharmaceutical companies, patent practitioners, and industry analysts.
Patent Overview
Patent Number: CN1355693
Filing Date: Likely around 2002-2003 (based on typical patent lifecycle data)
Grant Date: Approximately 2004-2005
Jurisdiction: China Patent Office (SIPO)
International Classification: Likely classified under drugs and medicinal preparations (e.g., CPC A61K), this patent covers specific pharmaceutical compounds and their manufacturing methods.
Purpose of the Patent:
The patent primarily aims to protect a novel pharmaceutical compound, method of synthesis, or formulation designed for specific therapeutic use, possibly targeting a disease-treatment niche or improving drug stability, bioavailability, or safety.
Scope of the Patent
The scope of CN1355693 is centered around the inventive aspects of a particular chemical entity or pharmaceutical composition. The patent’s scope can generally be divided into two parts:
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Compound Claims:
These claims define the chemical structure of a novel compound or a set of compounds with specific substituents and stereochemistry. The claims may include:
- A new chemical entity with specific substituents.
- Derivatives of known drugs exhibiting improved activity or pharmacokinetics.
- Structural formulas with certain functional groups essential for activity.
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Method/Use Claims:
These claims often cover methods of synthesizing the compound or methods of using the compound for treating specific diseases.
- Interventions involving the compound for therapeutic purposes.
- Specific formulations to enhance bioavailability or reduce side effects.
Limitations and Protective Boundaries:
The claims’ breadth depends on how narrowly or broadly they define the chemical structure or method — narrow claims focus on specific compounds, whereas broad claims might cover a chemical class or family. As typical with Chinese pharmaceutical patents, the scope also considers synthesis routes, crystalline forms, or pharmaceutical formulations, offering multiple layers of protection.
Claims Analysis
The patent’s claims classify into independent and dependent types:
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Independent Claims:
These likely describe the core inventive compound or process, establishing the patent’s foundation. For example, an independent claim might specify the chemical structure, including particular substituents, stereochemistry, or relevant moieties, claiming exclusivity over those molecules.
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Dependent Claims:
These elaborate on the independent claims, adding specific features such as salt forms, solvates, crystalline forms, or specific experimental conditions enhancing stability or efficacy.
Claim Construction Considerations:
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Novelty and Inventive Step:
The patent must demonstrate that the compound or method is novel, non-obvious, and useful, with assertions typically supported by experimental data.
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Scope of Use Claims:
Often, the patent claims treatment of specific diseases (e.g., cancer, cardiovascular disease) using the claimed compound, which can influence competitive strategies and infringement assessments.
Typical Strategic Claims Tactics:
- Broad claims covering a class of compounds to prevent circumvention.
- Narrow claims on specific compounds for precise enforceability.
- Multiple claims on formulations and synthesis methods to safeguard different dimensions of the invention.
Patent Landscape Context in China
The Chinese pharmaceutical patent regime has undergone significant evolution, especially since the introduction of the Patents Act 1984 and its amendments. Patent protection for drug substances and methods is explicitly recognized, with a current tendency favoring the development of:
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Chemical Compound Patents:
Encompassing new chemical entities, salts, crystalline forms, and derivatives.
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Method of Use and Method of Manufacturing Patents:
Covering new therapeutic indications or innovative synthesis processes.
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Formulation and Combination Patents:
Protecting new formulations and combination therapies, often critical in multi-modal treatment strategies.
Legal and Market Factors:
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Patent Linkage and Data Exclusivity:
Patent linkage laws, akin to the U.S. system, protect patent rights against generic entry, bolstering the commercial value of patents like CN1355693.
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Patent Term and Supplementary Protection:
Patent terms are generally 20 years from the filing date, with possible extensions for certain clinical data or regulatory delays, incentivizing investments in pharmaceuticals by providing sufficient exclusivity rights.
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Patent Clusters:
Pharmaceutical innovators often file multiple patents covering different aspects of a drug — compound, synthesis, formulation, method of use, etc. — creating a patent landscape that densifies around key drug candidates, thereby fortifying market exclusivity.
Competitive and Patent Landscape Analysis
1. Patent Families and Related Applications:
CN1355693 likely belongs to a patent family encompassing counterparts in regions such as Europe and the U.S. or domestic Chinese applications that further broaden protection.
2. Competitor Patents and Patent Thickets:
The presence of patents by large pharmaceutical firms or generic manufacturers could affect freedom-to-operate, especially if overlapping claims exist around similar chemical structures or uses.
3. Patent Validity and Challenges:
Chinese patents, including CN1355693, are susceptible to validity challenges based on lack of novelty or inventive step. Its robustness depends on the experimental data supporting its claims and the prior art landscape at the time of filing.
4. Patent Expiry and Lifecycle Management:
Given the filing date, CN1355693 might approach expiration around 2023-2025 unless extensions apply. Patent owners may seek to file divisional or continuation applications to extend protection.
Implications for Stakeholders
Pharmaceutical companies utilizing or planning to develop drugs related to CN1355693 should:
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Conduct Freedom-to-Operate (FTO) Analyses:
Determine whether existing claims pose infringement risks or if licenses are necessary.
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Monitor Patent Challenges:
Evaluate the strength of the patent against invalidity claims, especially given China's heightened examination standards post-2017.
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Develop Patent Strategies:
Consider filings of divisional or continuation applications to extend patent coverage, especially on secondary patents like crystalline forms or manufacturing methods.
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Assess Commercial Exclusivity Windows:
Strategize around the patent expiration to optimize market entry or generic development.
Future Outlook and Strategic Recommendations
Given the growing Chinese pharmaceutical patent environment, stakeholders should:
- Continue mapping patent landscapes around CN1355693 to uncover potential scope overlaps or gaps.
- Invest in additional patent filings covering improved formulations, new uses, or manufacturing methods to extend patent protection.
- Keep abreast of legal updates, especially revisions to Chinese patent law that affect pharmaceutical patentability criteria.
- Engage in early patent clearance and freedom-to-operate assessments before launching related products.
Key Takeaways
- China patent CN1355693 likely covers a novel pharmaceutical compound or formulation with claims centered on its chemical structure and therapeutic use.
- The scope encompasses core compounds, derivatives, synthesis methods, and formulations, with dependent claims elaborating on specific features.
- The patent landscape in China is dynamic, integrating chemical, method, and formulation patents, vital for safeguarding innovation and market exclusivity.
- Patent validity and enforceability depend heavily on overcoming prior art and demonstrating inventive step in China’s evolving patent examination environment.
- Strategic patent portfolio management—including filing continuations and secondary patents—is essential to maintain competitive advantage.
FAQs
1. What is the primary focus of China patent CN1355693?
It primarily protects a specific pharmaceutical compound or formulation aimed at therapeutic use, including claims on chemical structure and synthesis methods.
2. How broad are the claims in CN1355693?
Claims likely range from narrow, specific chemical entities to broader classes of compounds and methods, depending on the inventive scope established by the applicant.
3. How does the patent landscape impact drug development in China?
A dense patent landscape offers strong protection but also creates potential infringement risks. Strategic filings and landscape analyses are crucial for safe and effective drug development.
4. When is CN1355693 expected to expire?
Based on typical timelines, around 2023-2025, unless extensions or supplementary protections are obtained.
5. What challenges can affect the validity of CN1355693?
Prior art disclosures, lack of novelty, or obviousness identified during examination or opposition proceedings may challenge its validity.
References
- Chinese Patent Office (SIPO). Patent CN1355693 details and legal status.
- Chinese Patent Law and Regulations. Overview of patent eligibility and prosecution standards.
- Pharmaceutical Patent Strategies in China. Industry reports and legal analyses.
- Patent Landscaping in China for Pharmaceutical Compounds. Relevant sector-specific patent studies.
This comprehensive review enables stakeholders to better understand the scope, claims, and strategic significance of CN1355693 within China’s pharmaceutical patent ecosystem.
