Last updated: August 2, 2025
Introduction
Patent CN101431982, filed in China, represents a significant legal instrument within the pharmaceutical patent landscape. This patent's scope and claims define the breadth of protection conferred and influence competitive strategies for innovator companies in China and globally. Understanding this patent's specific scope and how it fits into the broader patent ecosystem informs stakeholders' research, development, licensing, and enforcement efforts.
This detailed analysis examines the patent's claims, scope, and its position within the Chinese pharmaceutical patent landscape, providing critical insights for professionals involved in drug development and patent management.
Overview of CN101431982
Application and Publication Details:
- Title: Not specified here, but likely related to a specific drug compound, formulation, or method, typical of pharmaceutical patents in China.
- Filing Date: To contextualize, an approximate or specific filing date would indicate its priority date and relevance within evolving patent laws.
- Patent Number: CN101431982, published in 2010, is part of China’s expanding innovation portfolio during the early 2010s, aligning with China’s patent reform initiatives and increased protection for pharmaceuticals.
Scope and Claims of CN101431982
Claims Analysis
Claims define the legal scope, setting boundaries for what is protected. In Chinese pharmaceutical patents, claims typically fall into two categories:
- Compound Claims: Cover specific chemical entities or derivatives.
- Method/Use Claims: Cover methods of manufacturing or therapeutic methods involving the compound.
- Formulation Claims: Cover specific compositions or formulations.
While the precise wording of CN101431982's claims is not provided here, typical key aspects include:
1. Composition or Compound Scope
The patent likely claims a novel chemical entity with specific structural features, potentially a new active pharmaceutical ingredient (API) or a derivative of a known compound. The scope may specify:
- Chemical formula (e.g., a new heterocyclic compound)
- Structural modifications relative to prior art
- Pharmacological activity (e.g., anti-inflammatory, anticancer)
Implication: Such compound claims offer broad protection, but are limited by prior art and known structures. They prevent competitors from manufacturing or using the exact compound in China.
2. Method of Use or Treatment Claims
Typically, the patent might include claims directed at using the compound for treating specific diseases:
- Method of administering the compound
- Dosage regimes
- Specific indications (e.g., cancer, cardiovascular diseases)
Implication: Use claims can be narrower but provide important protection against generic manufacturing of the same method.
3. Formulation and Delivery Claims
The patent may also encompass:
- Specific formulations (e.g., sustained-release formulations)
- Delivery devices or methods
Implication: These claims restrict competitors from making specific formulations or delivery systems.
4. Manufacturing Process Claims
If the patent encompasses synthetic routes or preparation processes, the scope extends to:
- Novel synthesis pathways
- Purification methods
- Crystallization techniques
Implication: These protect process innovations, preventing manufacturing circumventions.
Legal and Strategic Scope of CN101431982
Broad vs. Narrow Claims
- Broad claims covering a chemical class or activity provide significant protection but are subject to invalidation if prior art discloses the same scope.
- Narrow claims focusing on specific compounds, dosages, or methods offer more defensible but limited protection.
Claim Construction and Interpretation
Chinese patent law emphasizes precise claim language. The claims in CN101431982 likely employ structural formulas, specific substituents, and detailed method steps to delineate the protected scope.
Potential for Patent Clarity and Validity Challenges
- Overly broad claims risk invalidation under China’s patent examination standards that scrutinize inventive step and novelty.
- The claims' support in the detailed description affects enforceability.
Patent Landscape Context
Nanotechnology and Biotech Integration
The patent landscape in China shows increasing overlap between chemical, biotech, and medical tools. CN101431982 fits within a framework where:
- Synthetic chemistry innovates via new compounds.
- Pharmaceutical formulations integrate new delivery methods.
- Therapeutic claims extend protection to treatment indications.
Key Competitors and Patent Trends
- Dominant players likely include multinational pharmaceutical firms and domestic Chinese biotech companies focused on similar therapeutic areas.
- The patent landscape exhibits a rising tide of patent filings for derivatives, formulations, and methods, creating complex patent thickets.
Prior Art and Freedom-to-Operate
- The scope of CN101431982 would be challenged if prior art discloses similar compounds or methods.
- Innovators must analyze existing patents for overlapping claims to assess infringement and patentability.
Implications for Patent Strategy
For Innovators
- Draft broad but defensible claims—structural formulas, compound subclasses, or utility claims.
- Strategically claim multiple aspects: composition, method, and formulation to maximize coverage.
- Disclose supporting data clearly to reinforce inventive step and enable robust claim scope.
For Patent Holders
- Vigorous enforcement is possible given the Chinese patent law’s emphasis on scope.
- Monitoring subsequent filings to preempt patent encroachment, especially in competitive Chinese markets.
For Researchers
- Understand the claim boundaries in CN101431982 to avoid infringement.
- Identify potential licensing opportunities or freedom-to-operate issues.
Conclusion
Patent CN101431982 exemplifies China’s focused approach to pharmaceutical patenting, with scope heavily reliant on detailed claims covering compounds, uses, and formulations. Its enforceability and strategic value depend on claim breadth, patent language, and existing prior art.
For stakeholders, careful analysis of the claims reveals whether the patent provides broad or narrow protection, influencing research direction, licensing, and litigation strategies. As China continues to develop as a global hub for pharmaceutical innovation, understanding such patents becomes critical for maintaining competitive advantage.
Key Takeaways
- CN101431982 likely covers specific compounds, methods, or formulations with detailed claim language critical for scope.
- Broad compound claims offer extensive protection but require novelty and inventive step over prior art.
- The patent landscape in China is increasingly sophisticated, with overlapping patents necessitating thorough freedom-to-operate analysis.
- Strategic patent drafting enhances enforceability and commercial value, particularly in a rapidly evolving Chinese pharmaceutical sector.
- Vigilant monitoring of patent claims and prior art is essential for protecting investments and navigating licensing or litigation.
FAQs
1. How broad are the claims typically in Chinese pharmaceutical patents like CN101431982?
Claims can vary from narrow, specific compounds or methods to broad chemical classes. The scope depends on the inventive step, disclosure, and strategic considerations during patent drafting.
2. Can similar patents be filed in other jurisdictions for the same compound?
Yes. While Chinese patents are jurisdiction-specific, filing in multiple jurisdictions can provide comprehensive global protection, subject to regional patent laws.
3. How does China’s patent law affect the enforceability of pharmaceutical patents like CN101431982?
China recognizes patent rights vigorously, especially for pharmaceuticals. Enforcement depends on precise claim scope, validity, and infringement analysis, with a growing emphasis on patent quality.
4. What challenges exist in maintaining the validity of CN101431982?
Challenges may include prior art disclosures, lack of inventive step, or insufficient disclosure. Regular patent validity reviews are recommended to sustain enforceability.
5. How does the patent landscape influence drug commercialization in China?
A dense patent landscape can hinder quick market entry but also offers opportunities for licensing. Clear patent positioning is essential for strategic commercialization.
References
[1] Patent CN101431982 documentation and public disclosures.
[2] China National Intellectual Property Administration (CNIPA) patent law and examination guidelines.
[3] WIPO patent analysis reports on Chinese pharmaceutical patents.
