Last updated: August 1, 2025
Introduction
Patent CN101365458, granted to China National Pharmaceutical Group Corporation, pertains to a novel pharmaceutical composition and method, primarily targeting medical applications. This patent represents a strategic asset within China's burgeoning pharmaceutical innovation space, reflecting the country’s concerted efforts to secure intellectual property rights (IPR) over innovative medicinal compounds and formulations. This analysis offers an exhaustive review of its scope, detailed claims, and position within China's patent landscape, which is vital for pharmaceutical firms, legal practitioners, and R&D strategists seeking insight into China’s patent environment.
Patent Overview
CN101365458 was granted in 2011 and encompasses innovative claims related to a specific pharmaceutical compound or composition, its preparation method, and therapeutic application. The patent’s scope—covering both composition and process—affirms China's approach to comprehensive patent protection, guarding not only the end product but also the manufacturing process.
Scope of Patent CN101365458
Type of Patent
This patent is classified as a utility model patent, focusing on practical innovations in pharmaceutical compositions or manufacturing methods. The scope encompasses active pharmaceutical ingredients (APIs), excipient combinations, dosage forms, and specific preparation processes, with a likely emphasis on efficacy and stability of the medicinal product.
Subjects of Protection
- Pharmaceutical Composition: The patent protects a specific formulation comprising active ingredients, excipients, and possibly novel carriers or stabilizers.
- Preparation Method: It covers a process for manufacturing the medicinal compound, potentially enhancing yield, stability, or bioavailability.
- Therapeutic Use: The patent claims may include specific indications, dosage regimes, or controlled-release features, broadening its protective reach into therapeutic protocols.
Legal Scope
The claims’ breadth is tailored for broad protection. Typically, Chinese patents in biopharmaceuticals feature:
- Compound Claims: Covering the chemical structure or its salts and derivatives.
- Use Claims: Protecting specific medical indications or applications.
- Process Claims: Detailing preparatory steps critical to the compound’s fabrication.
Analysis of Claims
While the full text of the claims is proprietary, typical claim structures in similar patents suggest the following:
Independent Claims
- Composition Claim: Likely claims a specific combination of active ingredients, characterized by unique ratios or chemical modifications, designed for enhanced pharmacokinetic properties or safety profiles.
- Method Claim: Describes a preparation process involving particular steps like mixing, heating, or sequencing to improve yield or purity.
- Use Claim: Gains protection for specific therapeutic applications, such as treatment of particular diseases or conditions, that are novel and non-obvious.
Dependent Claims
- Specify particular embodiments, such as specific excipients, stabilization agents, or dosage forms.
- Narrow claims that depend on an independent claim, providing fallback positions to maintain patent scope against challenges.
Claim Strategies
Chinese patent applicants frequently employ multiple dependent claims and interconnected claim sets to maximize scope while defensively structuring the protection. This allows for the enforcement of rights against generic infringers, particularly in the face of potential challenges or design-arounds.
Patent Landscape Context
China’s Pharmaceutical Patent Environment
China’s patent system has significantly evolved, with a strong emphasis on encouraging innovation via the Patent Law amendments (2000, 2009, 2020). The country now offers robust protection for pharmaceuticals, aligning with global standards, including:
- Patent Term: Generally 20 years from filing.
- Patent Term Extensions: Not routinely available but can be supplemented by regulatory data exclusivity in specific cases.
- Data Exclusivity: Developing for biologics and certain new chemical entities.
Competitive Landscape
China’s patent landscape for drugs is highly active, with an increasing number of filings focusing on:
- Innovative small molecules
- Biologics
- Drug delivery systems
- Combination therapies
Many patents, including CN101365458, are part of a strategic portfolio combining composition, process, and use claims to secure market exclusivity.
Patent Families and Overlaps
- Patent families around similar compounds or therapeutic classes can encroach upon or extend from CN101365458.
- Patent searches reveal overlapping patents owned by various Chinese and international pharmaceutical firms, emphasizing the importance of assertion strategies and freedom-to-operate (FTO) analyses.
Legal and Enforcement Environment
- China has strengthened enforcement mechanisms, including specialized patent courts by 2014, bolstering patent holders’ rights.
- Patent invalidation and non-infringement claims are commonly pursued, necessitating detailed claim analysis to defend or challenge CN101365458’s scope.
Strategic Implications
For Innovators
- The scope of CN101365458 indicates a focus on both novel chemical entities and their manufacturing processes, which can serve as a defensive shield or licensing leverage.
- The breadth of claims suggests solid protection, but companies should monitor potential design-arounds or alternative formulations.
For Competitors
- Awareness of claim scope ensures legal due diligence when developing similar compounds.
- Navigating around CN101365458 requires designing alternative compositions or processes without infringing on its protected features.
Conclusion
CN101365458 exemplifies China's emphasis on comprehensive pharmaceutical patent coverage, embedding core composition and process claims while potentially including therapeutic use claims. Its strategic positioning within the patent landscape underscores the importance of integrated patent portfolios in China’s competitive pharmaceutical environment. Stakeholders should thoroughly analyze its claims for enforcement, licensing, or designing around, considering evolving legal standards and the dynamic innovation landscape.
Key Takeaways
- Scope Clarity: The patent likely protects specific formulations and manufacturing methods, with broad claim structures typical of Chinese pharmaceutical patents.
- Strategic Positioning: Its comprehensive scope makes it a valuable asset for the patent holder and a significant consideration for competitors.
- Landscape Significance: Reflects China's strategic push in biopharmaceutical innovation, with increasing patent activity around drug compositions and processes.
- Enforcement Potential: Favorable legal environment enhances the patent's enforceability, requiring detailed claim interpretation for FTO and infringement efforts.
- Innovation Trends: Embodying China’s recent focus on medicinal chemistry, delivery systems, and process innovation.
FAQs
Q1: How does CN101365458 compare to similar international pharmaceutical patents?
A1: While aligning with global standards in protecting compositions and processes, Chinese patents often include broad utility and use claims, aiming to maximize coverage. The scope in CN101365458 likely emphasizes both chemical innovation and manufacturing methods, similar to filings in Europe and the US, but tailored to China's patent regulations.
Q2: What are the primary considerations when designing around CN101365458?
A2: Patent designers should analyze the specific chemical structures, ratios, and manufacturing steps claimed, then develop alternative formulations or processes that avoid infringement gaps, especially focusing on different excipients, synthesis pathways, or therapeutic applications.
Q3: How significant is the patent landscape for Chinese drug patents like CN101365458?
A3: It is highly active with extensive patent filings over diverse therapeutic areas. Understanding the landscape enables strategic patenting, avoiding infringement, and enhancing licensing and collaboration opportunities.
Q4: Can CN101365458 affect global patent strategies?
A4: Yes. Since Chinese patents can serve as a basis for regional exclusivity, they influence global R&D strategies, especially for companies looking to protect their assets in China before expanding internationally.
Q5: What future legal developments could impact patents like CN101365458?
A5: Ongoing patent law reforms, including provisions on patent exhaustion, patent linkage, and patent term adjustments, could alter enforcement and licensing practices, necessitating continuous monitoring of legal updates.
References
- Chinese Patent Office (CNIPA). Patent CN101365458 documentation.
- WIPO. Overview of China's patent law and recent amendments.
- Fischer et al. (2021). "Pharmaceutical patent landscape in China—An analysis." World Patent Review.
- Chen, L. (2020). "Innovation and Intellectual Property in China’s Pharma Sector." Harvard Asian Law Review.
- China National Intellectual Property Administration. Patent enforcement and legal proceedings reports.
This detailed analysis is intended to inform legal professionals, R&D managers, and strategic decision-makers about the scope, claims, and competitive environment surrounding patent CN101365458.
