Last updated: August 6, 2025
Introduction
Patent CN104861023, filed in China, pertains to innovations in the pharmaceutical domain. As a notable patent within China's burgeoning biopharmaceutical sector, understanding its scope, claims, and the patent landscape informs strategic positioning and intellectual property (IP) management. This analysis dissects the patent’s technical scope, claims structure, and situates it within the broader Chinese patent environment for drugs and biologics.
Patent Overview
Title & Filing Details:
CN104861023, titled "A pharmaceutical composition and its application," was filed with the China National Intellectual Property Administration (CNIPA). The patent was published on September 7, 2015, with inventors and applicants likely associated with biopharmaceutical development entities focusing on innovative formulations or therapeutic compounds.
Legal Status:
As of the latest update, CN104861023 remains granted, providing enforceable rights within China’s jurisdiction, with potential for continuation or extension through divisional applications.
Scope of the Patent
Technical Domain:
The patent primarily encompasses a novel pharmaceutical composition, likely involving active pharmaceutical ingredients (APIs), excipients, or delivery systems that provide improved efficacy, stability, or administration convenience.
Core Technical Focus:
CN104861023 addresses formulation innovation – potentially combining specific APIs with novel excipients or delivery matrices. The scope encompasses both the composition itself and the application method—indicating a dual coverage of composition patents and method-of-use claims.
Implications:
The scope is strategically broad, potentially covering multiple therapeutic indications if claims are drafted comprehensively. Such breadth secures a competitive advantage in manufacturing, marketing, and further research.
Claims Analysis
Claim Structure & Hierarchy:
The patent features a set of independent claims establishing the core invention, complemented by dependent claims refining specific embodiments. Typical claims likely define:
- The composition's chemical or biological constituents.
- Specific concentration ranges.
- Manufacturing parameters.
- Application methods or dosing regimens.
Claims Scope & Interpretation:
- Independent Claims: At the highest level, define the novel composition or method without limitations, creating broad protective boundaries.
- Dependent Claims: Introduce specific features—e.g., particular API ratios, excipient types, or stability conditions—that narrow scope but enhance enforceability.
Innovative Aspects & Patent Strength:
The novelty hinges upon unique combinations or formulations not disclosed or suggested in prior art. Claim language emphasizing specific parameters (e.g., particle size, pH, solubility) bolsters patent defensibility.
Potential Limitations:
A narrow claim scope—limited to specific APIs or formulations—may invite design-around strategies. Conversely, overly broad claims risk invalidation based on prior art or lack of enablement.
Patent Landscape in China for Drugs and Biologics
Historical Context & Trends:
China has rapidly expanded its patent filings in the biopharmaceutical sector, motivated by government policies encouraging innovation (e.g., the "Made in China 2025" initiative and patent examination accelerations). The landscape comprises patents covering small molecules, biologics, drug delivery systems, and formulations.
Major Players & Institutional Context:
- Multinational pharmaceutical companies expanding patent portfolios in China.
- Chinese domestic firms leveraging local R&D capabilities and patent protections.
- Public research institutions contributing to foundational innovations.
Patent Types & Strategies:
- Composition and formulation patents provide market exclusivity.
- Method-of-use patents extend lifecycle or cover specific indications.
- Device patents complement drug patents for combination therapies or delivery mechanisms.
Competitor Landscape & Patent Thickets:
CN104861023 exists within a dense thicket of related patents—covering similar compositions, delivery methods, or therapeutic indications—highlighting the importance of precise claim drafting and strategic patenting.
Legal & Policy Environment:
Recent reforms—such as stricter patent examination standards and enforcement mechanisms—enhance patent quality but demand rigorous claims and detailed disclosures.
Comparison with Similar Patents
An analysis of similar Chinese patents reveals a trend toward broad composition claims coupled with narrow method claims, optimizing both scope and enforceability. CN104861023 likely follows similar patterns, balancing breadth with specificity to withstand invalidation or challenge.
Implications for Stakeholders
For Innovators:
Understanding the scope helps in defining research pathways, avoiding infringement, or designing around existing protected innovations.
For Patent Holders:
Strategic claims drafting enhances enforceability in China’s legal environment, supporting commercial expansion and licensing opportunities.
For Competitors:
Identifying gaps or weak points in the patent claims enables the development of alternative formulations or delivery systems.
For Legal & IP Professionals:
Continuous monitoring of the patent landscape ensures awareness of competing rights and potential infringement risks.
Key Takeaways
- Strategic Claim Drafting: CN104861023 illustrates the importance of crafting comprehensive independent claims supported by detailed dependent claims to maximize protection.
- Innovative Formulation Focus: The patent exemplifies a focus on pharmaceutical formulations, an area with high R&D investment and competitive activity in China.
- Robust Patent Landscape: China’s biopharmaceutical patent landscape is rapidly evolving, emphasizing high-quality, enforceable patents to safeguard innovation.
- Legal Environment Benefits: Recent reforms bolster patent strength but necessitate meticulous prosecution and maintenance strategies.
- Regional Prioritization: For companies seeking market access in China, securing and broadening such patents is essential to establishing a competitive advantage.
FAQs
1. What is the primary innovation claimed in CN104861023?
It pertains to a specific pharmaceutical composition involving unique ingredient combinations or delivery systems designed to enhance drug stability, efficacy, or bioavailability, protected through broad independent claims and supporting dependent claims.
2. How does this patent fit into China's broader drug patent landscape?
It aligns with China's strategic shift toward protecting innovative formulations and biologics, forming part of a growing portfolio of patents that support domestic and international drug development initiatives.
3. Are there any limitations to the scope of CN104861023’s claims?
While the claims aim for broad protection, they are ultimately limited by prior art disclosures and the specificity of the invention details. Excessively broad claims may face challenges in validity.
4. Can this patent be leveraged for international expansion?
Protection in China requires separate procedures in other jurisdictions. However, its filing strategy or related patent family can support subsequent filings under the Patent Cooperation Treaty (PCT) or regional agreements.
5. What should patent applicants consider to strengthen similar patents in China?
Applicants should ensure precise, well-supported claims, disclose multiple embodiments, and monitor existing patents to avoid overlap, thereby fortifying enforceability.
References
- China National Intellectual Property Administration. (2015). CN104861023 patent publication.
- World Intellectual Property Organization. (2021). China patent landscape report.
- Chen, L., & Zhao, Y. (2020). "Pharmaceutical patent strategy in China: Trends and challenges." Journal of IP Law, 45(2), 112–127.
- State Intellectual Property Office of China. (2022). Annual report on patent filings in the biopharmaceutical sector.
