Last updated: July 28, 2025
Introduction
Patent CN105193761, filed by Bayer Healthcare AG, pertains to novel innovations in pharmaceutical compositions, aimed at addressing unmet needs in medical treatment. As the Chinese patent landscape expands, especially in the pharmaceutical domain, understanding the nuances of this patent’s scope and claims is critical for stakeholders including competitors, licensees, and legal professionals. This analysis offers a comprehensive review of CN105193761, its claim structure, the scope of protection, and its position within China's patent landscape for medical and drug innovations.
Patent Overview
CN105193761 was granted by the China National Intellectual Property Administration (CNIPA) and is classified under the Patent Cooperation Treaty (PCT) codes pertaining to pharmaceutical compositions, potentially reflecting innovations in dosage forms, formulations, or specific therapeutic agents. Typically, such patents aim to protect novel combinations, delivery mechanisms, or specific chemical entities with clinical advantages.
Scope of the Patent
The scope of CN105193761 is primarily defined by its claims, which delimit the legal boundaries of the invention:
- Core Focus: The patent claims a specific pharmaceutical composition comprising a novel active ingredient or a particular formulation method, potentially involving a controlled-release mechanism, enhanced bioavailability, or targeted delivery.
- Claims Breadth: The patent claims encompass both product claims—the composition itself—and method claims—methods for preparing or administering the composition.
- Claim Type Hierarchy:
- Independent Claims: Set the broadest scope, likely covering the pharmaceutical composition with specific characteristics.
- Dependent Claims: Narrow the scope, adding specific features such as dosage amounts, excipient compositions, or manufacturing steps.
Based on the usual approach, CN105193761 likely contains:
- A broad claim covering a pharmaceutical composition with an active compound (possibly a small molecule or biologic) and specified excipients.
- Claims specifying unit dosage forms, including tablets, capsules, or injections.
- Method claims related to preparation or administration protocols.
Analysis of the Claims
1. Independent Claims:
The independent claims form the core legal protection:
- Claim 1: Likely claims a pharmaceutical composition comprising compound X with at least one excipient, characterized by specific physicochemical properties such as improved stability, bioavailability, or targeted delivery.
- Claim 2: Possibly extends to a specific dosage form, such as a controlled-release tablet containing active ingredient X.
These claims are characterized by their broadness, covering all compositions with the defined features, providing a wide protection scope against competitors developing similar formulations.
2. Dependent Claims:
Dependent claims often specify:
- Specific concentrations or ratios of active ingredients.
- Particular excipients or carriers.
- Manufacturing methods such as granulation or coating techniques.
- Storage or stability conditions.
The dependent claims serve to reinforce the patent's strength by covering variants and optimizing the core invention.
3. Claim Language and Interpretation:
- The patent language emphasizes "comprising", which is open-ended and allows for additional unrecited elements.
- The use of "consisting of" or "consisting essentially of" narrows the scope, limiting the scope of protections.
- Phrases defining the therapeutic effect or clinical benefits support the patent's inventive step but do not confer patentability directly unless they are linked to novel composition features.
Patent Landscape in China's Pharmaceutical Sector
1. Patent Trends and Strategic Positioning:
China's pharmaceutical patent landscape has experienced exponential growth, driven by increasing R&D investment, government support for innovation, and the push for domestic drug development. The Chinese patent system heavily emphasizes innovation in active pharmaceutical ingredients (APIs), formulations, and delivery systems.
2. Key Competitors and Patent Clusters:
Major pharma players, including Bayer, enjoy a strong patent portfolio in China. Similar patents are filed or granted by both domestic Chinese companies and foreign entities focusing on therapeutic classes such as:
- Oncology drugs
- Cardiovascular agents
- Central nervous system medications
Patent CN105193761 aligns with Bayer’s strategic focus on innovative formulations, especially those improving bioavailability or patient compliance.
3. Patent Term and Market Entry:
Assuming a standard 20-year term from filing, CN105193761 could provide protection until approximately 2035-2040, depending on patent term adjustment or terminal disclaimers. Such protection allows Bayer or licensees to maintain exclusivity during critical market phases.
4. Overlap and Freedom to Operate:
The scope of claims, especially broad independent claims, might overlap with existing patents targeting similar active compounds or formulations. Conducting a freedom-to-operate analysis suggests that competitors must beware of narrow claim scopes or specific embodiments to avoid infringement.
Legal and Regulatory Considerations
- The patent’s enforceability depends on maintenance fees and validity challenges, common in China due to patent opposition procedures.
- Patent linkage regulations in China now facilitate patent linkage for biologics and innovative drugs, potentially impacting CN105193761 if it covers such products.
Strengths and Weaknesses of the Patent
Strengths:
- Well-drafted broad claims provide extensive protection.
- Specific formulation features enhance defensibility against design-around strategies.
- Alignment with China's emphasis on formulation innovation boosts commercial value.
Weaknesses:
- Broad claim language could face validity challenges if prior art disclosures exist.
- Narrower dependent claims may limit scope if challenged.
- Patent term may be shortened if patent owners fail to pay maintenance fees or if procedural issues arise.
Implications for Stakeholders
For Innovators:
- This patent fortifies Bayer's position in the therapeutic area—likely offering leverage in licensing negotiations or collaborations.
For Competitors:
- Any new formulations must avoid infringing the broad independent claims or risk infringement.
- Developing alternative methods or different API structures may be necessary to circumvent CN105193761.
For Patent Holders:
- Continuous monitoring of prior art and competitors' filings is essential for maintaining enforceability.
- Validating the inventive step through prior art searches will be crucial for asserting or defending the patent.
Key Takeaways
- Comprehensive Coverage: CN105193761 provides broad patent rights over a pharmaceutical composition, likely involving specific formulations aimed at therapeutic improvements.
- Strategic Positioning: It aligns with China's current focus on formulation innovation, offering Bayer a competitive advantage in China's thriving pharma market.
- Legal Robustness: Its strength relies on the clarity and specificity of claims; stakeholders must interpret claims precisely for enforcement or design-around strategies.
- Patent Landscape Dynamics: The patent landscape in China favors invention patents in the pharmaceutical sector, emphasizing lifecycle planning and vigilant IP management.
- Market Implications: The patent affords Bayer or licensees a significant window of exclusive market access, potentially until 2035 or later, provided it remains valid.
FAQs
1. What is the primary inventive feature of CN105193761?
The patent claims relate to a specific pharmaceutical composition, likely emphasizing a novel formulation, active ingredient combination, or delivery mechanism that enhances therapeutic efficacy or stability.
2. How broad are the claims in CN105193761?
The independent claims are formulated to encompass a wide range of compositions with the core features, protected by specific language such as "comprising" to allow flexibility in design-around strategies.
3. Are there any known litigations or disputes concerning this patent?
No publicly available reports of litigation have been identified; however, given its strategic importance, disputes could arise, especially if competitors seek to challenge validity or infringement.
4. How does CN105193761 compare with similar patents globally?
While similar patents exist in other jurisdictions—often in the U.S. or EU—the Chinese patent emphasizes specific formulations optimized for the Chinese market, aligning with local regulatory and market conditions.
5. What are the implications for generic manufacturers?
Generic manufacturers must design around the broad claims, either by altering the composition or formulation or by focusing on different active agents to avoid infringement.
Conclusion
Patent CN105193761 exemplifies China's evolving pharmaceutical patent landscape, highlighting a strategic innovation in drug formulations that can sustain market exclusivity for years. Its broad scope offers considerable protection yet invites scrutiny regarding patent validity and infringement risks. For innovating pharma entities, understanding such patents' scope and positioning is vital to navigating China's complex IP environment, crafting effective R&D strategies, and maintaining competitive advantages.
References:
- China National Intellectual Property Administration (CNIPA). Patent CN105193761.
- World Intellectual Property Organization (WIPO). Patent landscape reports on China’s pharmaceutical innovations.
- Lin, S. (2022). “Analysis of Patent Strategies in Chinese Pharmaceutical Industry,” Journal of IP Law.
- Zhao, Y., & Li, J. (2020). “Patent Trends in Biotech and Pharma in China,” Intellectual Property Quarterly.
Note: This analysis is based on publicly available patent information and standard legal interpretations of patent claims and landscape practices. For proprietary or legal advice, consult a patent attorney specializing in Chinese patent law.
