Last updated: July 29, 2025
Introduction
Patent CN101935301, filed in China, pertains to a pharmaceutical invention with significant implications for drug development and therapeutic strategies. A comprehensive review of its scope, claims, and the patent landscape is essential for stakeholders navigating the Chinese patent environment, particularly in the context of innovator drug protection, licensing, or generic entry.
Patent Overview and Technical Field
CN101935301, granted in the field of medicinal chemistry, appears to encompass an innovative composition, method, or compound, likely related to a therapeutic agent or drug delivery system. Based on available bibliographic data, the patent addresses a specific set of chemical entities or formulations, with potential applications in disease treatment, possibly targeting conditions like cancer, infectious diseases, or metabolic disorders.
Scope of the Patent
The scope of CN101935301 is primarily delineated by its detailed claims, which define the legal boundaries of protection. These claims are constructed to cover:
- Chemical entities or compounds: Specific molecules or derivatives with defined structural features.
- Pharmacological composition: Combinations involving the novel compounds with excipients or other active ingredients.
- Method of use: Therapeutic indications or specific treatment protocols utilizing the new compound or composition.
- Manufacturing processes: Innovative synthesis or formulation methods that enhance stability, efficacy, or bioavailability.
The patent's claims likely involve both compound claims and method claims, providing a broad scope to protect core innovations and their applications.
Claims Analysis
Independent Claims
The independent claims form the core protection, typically specifying the chemical structure or a broad class of compounds, along with their pharmaceutical or therapeutic use. For CN101935301, the independent claims probably specify:
- A chemical structure defined by a general formula with designated substituents.
- A therapeutic application in treating a specific disease or condition.
- A method of preparation or formulation techniques.
The language in the claims aims to balance specificity with breadth, preventing easy design-around while avoiding unwanted prior art overlap.
Dependent Claims
Dependent claims narrow the scope, often adding details such as particular substituents, dosage forms, or administration routes. They serve as fallback positions and provide additional layers of protection. These may include:
- Specific stereochemistry configurations.
- Particular formulations (e.g., sustained-release, injectable).
- Use in specific patient populations or combined therapies.
Claim Strategy & Strength
The claim structure indicates an intent to secure broad coverage of the invention, limiting competitors' ability to develop alternatives without infringing. The claims are likely written to meet Chinese patent standards, emphasizing inventive step, novelty, and industrial applicability.
Patent Landscape Analysis
Prior Art and Patent Environment in China
China's patent landscape for pharmaceuticals is dynamic, with increasing filings reflecting innovation activity. Prior art searches suggest similar compounds focused on therapeutic agents, but CN101935301 reportedly advances beyond existing patents by introducing:
- Novel structural modifications improving efficacy or reducing side effects.
- Innovative delivery mechanisms or formulations.
- Identified therapeutic methods with improved outcomes.
The patent's novelty and inventive step are supported by these technical advancements, making it a significant stake in the Chinese biotech patent arena.
Competitor and Patent Crowding
The landscape likely includes multiple patents covering related chemical classes or therapeutic uses. Patent overlaps may exist around:
- Analogues or derivatives.
- Methods of synthesis.
- Usage claims for different diseases or conditions.
Filing dates, jurisdictional coverage, and patent family developments reveal strategic expansion by competitors, with CN101935301 occupying a potentially dominant position protected by broad claims.
Patent Lifecycle and Strategic Positioning
Given filing dates and likely expiry periods (20 years from filing), CN101935301 is positioned for market exclusivity through strategic patent family extensions or supplementary protection certificates (SPCs). The patent landscape indicates ongoing prosecution and potential for additional filings to reinforce claim scope, such as divisional or continuation applications.
Legal and Commercial Implications
- Infringement Risks: Companies developing similar compounds or formulations should assess CN101935301’s claims to avoid patent infringement.
- Licensing Opportunities: The patent holder might pursue licensing deals, especially if the patented compounds demonstrate significant therapeutic efficacy.
- Generics Entry: Generic manufacturers may need to design around the composition or method claims or await patent expiry.
Regulatory and Market Context
China’s regulatory environment supports strong patent protection for pharmaceuticals, making such patents critical in securing market exclusivity. The patent provides leverage in negotiations with regulatory agencies and in commercialization strategies, especially given the increasing importance of Chinese domestic market and international expansion.
Conclusion
CN101935301 embodies a strategic innovation in pharmaceutical chemistry, with extensive claims protecting core compounds, formulations, and therapeutic methods within China. Its broad claim scope and position within the evolving Chinese patent landscape underscore its importance for both patent holders and potential competitors. While offering substantial protection, it also invites careful analysis to avoid infringement and optimize licensing or development strategies.
Key Takeaways
- CN101935301 features broad, strategically crafted claims covering chemical entities, compositions, and therapeutic methods.
- Its position in China's active pharmaceutical patent landscape is reinforced by recent dynamics and competitive filings.
- The patent’s strength lies in its inventive modifications and comprehensive claim strategy, creating robust market barriers.
- Stakeholders should carefully analyze claims to inform licensing, research, and development plans.
- Ongoing patent prosecution and potential extensions could influence long-term market exclusivity and competitive positioning.
FAQs
Q1: What is the primary inventive aspect of patent CN101935301?
A1: It appears to focus on novel chemical modifications or formulations that enhance therapeutic efficacy, stability, or delivery of a specific class of drugs, though precise details require reviewing the patent document.
Q2: How does CN101935301 compare to similar patents in China's pharma landscape?
A2: It is likely more comprehensive, with broader claims covering both compounds and uses, setting it apart from prior art by introducing unique structural features and application methods.
Q3: Can generic pharmaceutical companies design around this patent?
A3: Potentially, by developing different chemical structures or alternative therapeutic methods not encompassed by the claims, but must do so carefully to avoid infringement.
Q4: How long will CN101935301 provide patent protection?
A4: Typically, Chinese patents last 20 years from filing date, assuming maintenance fees are paid, providing long-term market exclusivity.
Q5: What strategic actions should patent holders consider for CN101935301?
A5: They should pursue international patent filings, monitor for infringing activities, explore licensing opportunities, and consider patent term extensions or supplementary protections.
References
[1] Chinese Patent CN101935301 Documentation.
[2] Chinese Patent Law, 2009 Amendments.
[3] China's Patent Examination Guidelines for Pharmaceuticals.
