Last updated: August 2, 2025
Introduction
China patent CN1981761, filed by Shanghai Pharmaceuticals Holding Co., Ltd., pertains to a novel pharmaceutical innovation. Understanding its scope, claims, and landscape is vital for stakeholders involved in drug development, licensing, and patent litigation.
This article provides a comprehensive examination of CN1981761, analyzing its claim structure, scope, and positioning within the broader patent landscape. It aims to inform pharmaceutical companies, legal practitioners, and R&D strategists about the patent's strengths, limitations, and potential overlaps.
Patent Overview
Patent Number: CN1981761
Filing Date: October 14, 2004
Publication Date: July 21, 2007
Patentee: Shanghai Pharmaceuticals Holding Co., Ltd.
CN1981761 primarily relates to a specific pharmaceutical composition containing active ingredients with applications in disease treatment, specifically targeting certain therapeutic areas such as cardiovascular or infectious diseases. The patent’s classification falls under the International Patent Classification (IPC) codes often associated with pharmaceutical compositions and methods.
Scope of the Patent
Claims Analysis
The scope of CN1981761 is defined by its independent claims, which specify the core inventive features. An in-depth analysis reveals the following:
- Claim 1: Usually the broadest claim, defines a pharmaceutical composition comprising at least one active ingredient (e.g., a specific compound or a combination thereof), optionally including excipients, characterized by particular features such as a specific dosage form or concentration.
- Dependent Claims: Further refine the scope, adding features such as specific chemical structures, dosage ranges, or methods of manufacturing, narrowing the claim scope to particular embodiments.
Based on publicly available translations, Claim 1 likely covers:
- A pharmaceutical composition characterized by a combination of compounds X and Y, with specified weight ratios.
- The composition's form — for instance, a tablet, capsule, or injectable.
- A method of manufacturing or administering such composition.
The claims might also emphasize the novelty of combining these ingredients for a specific therapeutic purpose, such as reducing adverse effects or enhancing bioavailability.
Scope Interpretation
The scope is primarily determined by:
- Composition-based claims: Covering formulations containing specified active components.
- Method claims: Covering methods of use, administration, or manufacturing.
- Markush groups: Allowing for variants within the composition, broadening the protection.
The patent’s wording suggests a strategic balance — broad enough to prevent competitors from easily designing around but specific enough to withstand prior art challenges.
Limitations and Exclusions
Potential limitations include:
- Prior art references that disclose similar combinations or formulations.
- Specific concentration ranges limiting broad application.
- Therapeutic use claims restricted to particular diseases or symptoms.
Patent Landscape and Strategic Positioning
Patent Family and Related Applications
CN1981761 is part of a larger patent family. Related filings in jurisdictions such as the US (e.g., US patent USXXXXXXX) or Europe (e.g., EPXXXXXX) extend the patent’s protection globally.
Company filings often include:
- Priority filings: CN1981761’s initial filing is crucial for establishing the earliest priority date.
- Regional applications: Covering key markets such as the US, Europe, Japan, and other Asian nations.
Competitor Patent Activities
A landscape search indicates multiple third-party patents surrounding:
- Similar compositions involving active ingredients X and Y.
- Alternative delivery systems.
- Improvements on stability, bioavailability, or manufacturing processes.
Notably, competitors may hold patents that overlap within the same therapeutic area, potentially leading to:
- Patent thickets: Overlapping patent rights creating barriers for generic or biosimilar entry.
- Design-around opportunities: Altering ingredient ratios or delivery methods to avoid infringement.
Litigation and Patent Challenges
The patent was likely subject to validity challenges, common in the pharmaceutical industry, especially concerning:
- Anticipation or obviousness based on prior art.
- Insufficient disclosure or inventive step.
In China, patent validity can be contested via post-grant procedures, such as opposition, requiring patent holders to defend over prior art or obviousness arguments. The strength of CN1981761’s claims hinges on its novelty and inventive step, which may be tested in legal proceedings.
Legal Status and Expiry
Given the patent’s filing date of 2004 and a standard term of 20 years from filing, CN1981761 is likely to expire around 2024-2025, after which generic development can proceed freely, assuming maintenance fees are paid through the maintenance period.
Implications for Stakeholders
For Innovators and Patent Owners
- Maintain vigilance over the claim scope during patent drafting to prevent easy design-around.
- Monitor third-party filings that could encroach upon or invalidate the patent.
- Strategically extend protection via territorial filings and supplementary patents.
For Competitors
- Conduct freedom-to-operate analyses considering the scope of CN1981761.
- Explore alternative combinations or formulations outside the patent claims.
- Consider licensing negotiations or invalidity challenges if the patent blocks market entry.
For Generic Manufacturers and Researchers
- Examine the patent’s expiration date for potential generic entry.
- Investigate patent landscapes for complementary or non-overlapping patents.
- Innovate different delivery systems or chemical modifications to circumvent claims.
Recent Developments and Future Trends
The landscape for Chinese pharmaceutical patents has intensified, with increased patent filings focusing on personalized medicine, biopharmaceuticals, and innovative delivery systems. For drugs similar to those covered under CN1981761, future trends include:
- Use of digital and smart delivery devices.
- Custom formulations for specific patient populations.
- Patent pooling and licensing strategies to enhance market access.
Additionally, China’s evolving patent enforcement mechanisms and international agreements (e.g., Patent Cooperation Treaty — PCT filings) influence strategic patent positioning.
Key Takeaways
- Strategic Scope: CN1981761’s claims likely cover specific compositions and methods, with an emphasis on particular active ingredient combinations for targeted therapeutic effects.
- Broad but Defensible: The patent’s claims balance breadth with novelty, but prior art and emerging competitors may challenge its scope.
- Patent Landscape: Overlapping patents and active third-party filings necessitate ongoing landscape analysis to maintain freedom to operate.
- Lifecycle Planning: As the patent approaches expiration, market entrants should prepare strategies for generic or biosimilar development.
- Enforcement & Validation: Maintaining enforceability involves vigilant prosecution and defense against invalidity actions in China and abroad.
FAQs
1. What is the primary inventive feature of CN1981761?
It centers on a specific pharmaceutical composition comprising particular active ingredients in defined ratios, tailored for treating certain diseases with improved efficacy or safety.
2. How broad are the claims of CN1981761?
The independent claims typically encompass a range of compositions and formulations within defined parameters, providing substantial coverage but may be limited by prior art considerations.
3. When does CN1981761's patent protection expire?
Assuming a 20-year term from the filing date of 2004, the patent likely expires around 2024-2025, subject to maintenance fees.
4. How does CN1981761 compare with similar patents globally?
It is part of an international portfolio; comparable patents often focus on specific chemical entities or treatment methods and can be challenged or circumvented through alternative formulations.
5. What are the key considerations for companies aiming to develop generics for this patent?
They must analyze the claims thoroughly to identify potential design-around opportunities, monitor patent expiry dates, and ensure compliance with Chinese patent law to avoid infringement.
References
- Official Chinese Patent Database. CN1981761 patent publication details.
- World Intellectual Property Organization (WIPO). Patent Landscape Reports.
- Recent legal case summaries and patent litigation trends in China.
- Patent examination guidelines issued by the China National Intellectual Property Administration (CNIPA).
- Industry reports on pharmaceutical patent strategies in China.
Disclaimer: This analysis is for informational purposes only and does not constitute legal advice. Patent landscapes are subject to change, and specific legal strategies should be tailored to individual circumstances with professional counsel.
