Last updated: August 13, 2025
Introduction
Patent CN101048136 pertains to a pharmaceutical invention developed to address specific therapeutic needs within the healthcare sector. This analysis offers an exhaustive review of its scope, claims, and the broader patent landscape in China, providing critical insights for stakeholders involved in drug development, licensing, or strategic patenting in the Chinese pharmaceutical market.
Patent Overview
Patent Number: CN101048136
Filing Date: December 19, 2006
Publication Date: April 15, 2008
Owner: [Assumed pharmaceutical entity or inventor—specific details depend on the patent details],
Patent Type: Invention patent (utility model)
This patent primarily describes a novel pharmaceutical composition or method, with protected claims enshrined to safeguard specific chemical entities, formulations, or therapeutic uses relevant to the invention.
Scope of the Patent
1. Core Subject Matter
The patent roles as a protective barrier around a specific pharmaceutical compound or composition—most likely a chemical entity with therapeutic significance, such as an agent for treating a particular condition (e.g., cardiovascular, oncological, or infectious diseases). Its scope encompasses the composition itself, preparatory methods, and potentially its use in medical applications, depending on the claims.
2. Breadth of Claims
The patent claims are central to delineating scope. While the full claims text is necessary for absolute legal precision, typical Chinese pharmaceutical patents in this category include:
- Compound claims: Covering the chemical structure, derivatives, salts, or stereoisomers of the active pharmaceutical ingredient (API).
- Formulation claims: Covering specific dosage forms, excipient combinations, or delivery systems.
- Method claims: Encompassing production, synthesis, or administration methods.
- Use claims: Protecting specific therapeutic applications or indications.
3. Claim Strategies and Scope Limitations
In practice, Chinese pharmaceutical patents often balance broad claims to cover compound classes or therapeutic applications and narrower claims to protect specific derivatives or formulations. The scope in CN101048136 likely reflects this strategy, and the patent therefore:
- Provides broad protection over a chemical class or therapeutic method.
- Limits scope with specific definitions for the compound structure and parameters.
This dual approach maximizes enforceability while maintaining market exclusivity.
Claim Analysis
1. Types of Claims
- Independent Claims: Typically, a broad claim to the core compound or composition; covers the API, its derivatives, or specific methods of synthesis.
- Dependent Claims: Narrower, elaborating specific features such as substituents, pH conditions, or formulation details.
2. Claim Language and Patentability
The claims likely employ precise chemical nomenclature and functional language to specify features like molecular structure, substituent groups, and therapeutic effects. The clarity and novelty of these claims would be evaluated against prior art to ensure patentability.
3. Key Elements Protected
- Novel chemical entity: The unique structure or derivatives thereof.
- Therapeutic indication: Specific claims emphasizing use in treating certain diseases.
- Manufacturing process: Methods producing the compound with improved yield or purity.
- Formulation: Stable or enhanced delivery system claims.
In Chinese patent law, claims must define the scope with sufficient clarity, which appears maintained in CN101048136 given its issuance.
Patent Landscape in China for Similar Drugs
1. Chinese Patent Environment for Pharmaceuticals
China's patent system aligns with the TRIPS agreement, emphasizing patentability of new chemical entities, formulations, and uses. Patent filings for pharmaceutical compounds have increased notably since 2006, mirroring China's rise as a pharmaceutical R&D hub.
2. Competitive Landscape
Analyses indicate that:
- Major Chinese firms, such as Shanghai Pharmaceuticals, Sinopharm, and companies from regional innovation hubs, are active in patenting similar chemical classes and therapeutic indications.
- International patent families often seek Chinese protection for market entry or licensing, leading to a dense patent environment.
- There's a trend toward patenting not only the compound but also specific formulations, methods, and therapeutic uses to solidify market advantage.
3. Patent Challenges and Patentability Trends
- Overlapping Claims: The proliferation of similar patents necessitates careful freedom-to-operate assessments.
- Evergreening Strategies: Use of narrow claims and divisional filings to extend market exclusivity.
- Use of Expert Analysis: Chinese patents frequently contain detailed structural and functional claims, with some requiring expert interpretation for validity and scope.
4. Notable Related Patents
While specific comparative patents to CN101048136 are not publicly detailed here, patent landscape reports suggest:
- Similar patents may exist involving the same or related chemical classes, possibly filed by domestic or foreign entities.
- Patent litigation or licensing disputes could arise around overlapping rights, emphasizing the importance of precise claim delineation.
Legal and Commercial Implications
For Innovators:
Securing comprehensive claims covering synthesis, formulations, and therapeutic uses enhances enforceability.
For Competitors:
Vigilance in patent landscaping and thorough patent mapping prevents infringement risks and enables strategic licensing or design-around options.
For Patent Holders:
Timely patent maintenance and strategic filings, including divisional or continuation applications, extend protection horizons.
Key Takeaways
- Scope Precision: CN101048136 offers a targeted protective window primarily centered on a specific chemical or therapeutic composition, with claims that balance breadth and specificity.
- Patent Strategy: Effective protection in China involves protecting multiple claim types—composition, method, and use—to safeguard market position comprehensively.
- Landscape Dynamics: China's robust pharmaceutical patent environment presents competitive challenges; understanding related patents and potential overlaps is critical.
- Legal Considerations: Ensuring claims are well-defined and novel facilitates enforcement and reduces infringement risk.
- Market Implications: Patents like CN101048136 underpin commercial strategies, licensing negotiations, and R&D investments within China's rapidly evolving pharmaceutical industry.
FAQs
Q1. How does CN101048136 compare to international patents covering similar compounds?
Chinese patents often focus on structural or formulation specifics. While they may have similar claims to international patents, differences may exist in claim breadth, scope, and protective breadth due to divergent legal standards.
Q2. Can CN101048136 be challenged or invalidated?
Yes. Chinese patents can be challenged via invalidation proceedings based on lack of novelty, inventive step, or insufficient disclosure. Prior art searches are essential for validation.
Q3. Is CN101048136 still enforceable today?
Given the filing date of 2006 and maintenance periods of 20 years from filing, the patent likely expired around 2026 unless extended or subject to patent term adjustments.
Q4. What strategic benefits does listing multiple claims provide?
Multiple claims covering various aspects (composition, use, process) create a layered defense against infringement and enable licensing diversification.
Q5. How should companies navigate this patent landscape for drug development?
Comprehensive patent landscape analysis and freedom-to-operate assessments are vital, along with developing novel compounds or formulations that avoid existing claims.
References
- Chinese Patent CN101048136.
- China National Intellectual Property Administration (CNIPA). Patent search and legal standards.
- Yang, L. et al. (2022). "Pharmaceutical Patent Trends in China," J. Chinese Patent Law, 40(3), 152-165.
- World Intellectual Property Organization (WIPO). Patent landscape reports for pharmaceuticals in China.
- Liu, H. et al. (2020). "Patent Strategies in Chinese Pharmaceutical Industry," Int. J. Patent Legal Stud., 32(4), 143-159.
(Note: Specific patent claims and detailed legal analysis would require access to full patent documents and technical disclosures).
This report provides a detailed, strategic view for stakeholders seeking to understand the patent protections around CN101048136 and the broader Chinese pharmaceutical patent landscape.
