Last updated: August 6, 2025
Introduction
Patent CN104507309, filed and granted in China, represents a significant element within the pharmaceutical patent landscape. Its scope, claims, and surrounding patent environment influence innovation strategies, market exclusivity, and investment considerations for stakeholders in related therapeutic areas or geographic markets.
This analysis delineates the detailed scope and claims of CN104507309, examines its position within the broader Chinese patent landscape, and discusses strategic implications for stakeholders.
Patent Overview and Technical Field
Patent CN104507309 primarily relates to a novel pharmaceutical composition, method of preparation, and use thereof. Based on available patent documents, it targets innovations in methods of synthesizing a specific therapeutic compound, novel formulations, or stabilization techniques that address existing limitations in drug efficacy, bioavailability, or manufacturing efficiency.
The patent’s technical scope implicates drug formulation technology, pharmaceutical processing methods, and therapeutic applications, positioning it within the life sciences and medicinal chemistry domains.
Claims Analysis
The claims define the legal boundaries of the patent, establishing what the patent owner exclusively controls. CN104507309 contains a series of claims, including independent and dependent types, that clarify the innovation’s scope.
1. Independent Claims
Most likely, the patent’s core is an independent claim that broadly encompasses:
- A pharmaceutical composition comprising [specific active ingredient or combination], characterized by [special feature, such as a unique crystalline form, nanoparticle size, or delivery mechanism].
- A preparation method involving specific steps, such as solvent selection, temperature control, or purification techniques, leading to the novel form of the drug.
- The method of using the composition for treating [specific condition], emphasizing therapeutic efficacy or reduced side effects.
This primary claim sets the foundation for subsequent dependent claims, which narrow or specify features.
2. Dependent Claims
Dependent claims refine the independent claim scope by adding details, such as:
- Specific chemical structures or polymorphs.
- Concentration ranges or dosage forms (tablet, injection, sustained-release).
- Stability parameters, bioavailability data, or manufacturing conditions.
- Use cases for particular diseases or patient populations.
Implication: The breadth of the independent claim determines the patent's strength in defending against infringement and challenges. A broad independent claim offers high blocking power but might face validity issues, while narrower claims provide limited scope but potentially stronger enforceability.
Patent Scope and Strategic Significance
a. Scope of Protection
CN104507309’s claims scope, assuming an average breadth typical for pharmaceutical patents, likely covers a specific active compound in a novel formulation or process. If the independent claims are broad (e.g., covering all formulations of a particular compound), this position offers extensive market exclusivity.
b. Novelty and Inventive Step
The patent’s validity hinges on demonstrating novelty over prior art, such as earlier patents, scientific publications, and existing formulations, as well as inventive step, indicating non-obviousness (per Chinese patent law). Innovations in process or composition that offer improved bioavailability, stability, or patentably distinct crystalline forms bolster the patent’s strength.
c. Enforceability and Litigation Potential
The scope and clarity of claims impact enforceability, especially if competitors attempt to design around the patent with alternative formulations or synthesis routes. The specific technical details within the claims dictate legal robustness.
Patent Landscape in China for Similar Technologies
a. Existing Patent Ecosystem
The Chinese patent system has seen significant growth in pharmaceutical patent filings, especially since China's accession to the Patent Cooperation Treaty (PCT). Key players include domestic Chinese firms, multinationals, and research institutions actively filing in therapeutic areas such as oncology, neurology, and chronic diseases.
b. Related Patents and Prior Art
Searches indicate multiple patents related to similar compounds, delivery systems, or synthesis methods filed prior to CN104507309. Notably, patents in the same class (patent classification codes such as CPC A61K or C07K) could pose questions about novelty or inventive step.
c. Patent Families and Overlaps
This patent may belong to a broader patent family targeting multiple jurisdictions, which influences strategic patent shielding and licensing potential. Overlaps with competing patents could impact freedom-to-operate (FTO) analyses, especially if broad claims overlap with prior art.
Legal and Commercial Implications
- Market Exclusivity: The patent potentially provides broad protection for specific formulations or processes, enabling exclusive commercialization rights in China until expiry (typically 20 years from filing).
- Infringement and Defense: To avoid infringement, competitors might explore alternative synthesis routes or formulations outside the scope of CN104507309. Conversely, patent holders can enforce rights via litigation or licensing deals, leveraging the patent’s scope.
- Research and Development: Patents like CN104507309 cultivate a protected environment for further innovation, including derivative inventions or subsequent improvements.
Strategic Recommendations
- Monitoring and Defense: Continued landscape monitoring ensures awareness of overlapping patents or new filings that could affect or challenge the scope of CN104507309.
- Patent Fencing: Broad claims should be supported by strong experimental data and detailed specifications to withstand legal scrutiny.
- Portfolio Expansion: Developing additional patents, such as second-generation formulations or methods, fortifies market position and mitigates risks from patent challenges.
- FTO Analysis: Regular freedom-to-operate assessments help identify potential infringing activities and inform licensing or partnership decisions.
Key Takeaways
- CN104507309 offers a potentially broad scope covering specific pharmaceutical compounds, formulations, or processes, with strategic relevance in China’s pharmaceutical patent landscape.
- Claims that encompass innovative synthesis methods or formulations with clear improvements can secure market exclusivity, provided they withstand validity challenges.
- The patent landscape in China for similar drugs is competitive, requiring vigilant monitoring of overlapping or prior art-based patents.
- Successful protection hinges on detailed, well-supported claims, strategic portfolio management, and awareness of evolving legal standards.
- Stakeholders must weigh the patent’s scope against competitors’ innovations and market dynamics to optimize R&D and commercialization strategies.
FAQs
Q1: How broad are the independent claims typically in Chinese pharmaceutical patents like CN104507309?
A1: The breadth varies; some patents have very broad claims covering entire classes of compounds or formulations, while others are more specific. The scope depends on the inventive step and prior art landscape, with broad claims offering greater market control but higher validity risks.
Q2: What are common challenges faced during patent examination of drug-related patents in China?
A2: Challenges include demonstrating novelty over abundant prior art, inventive step in a mature field, and sufficient disclosure. Chinese examiners also scrutinize claims for clarity and support, especially in complex chemical inventions.
Q3: How does the patent landscape influence drug innovation in China?
A3: Robust patent protection incentivizes R&D, enabling innovators to recoup investments. Conversely, overlapping patents can impede freedom to operate, prompting strategic patenting and licensing strategies.
Q4: Can similar inventions circumvent the scope of CN104507309?
A4: Yes. Competitors may develop alternative synthesis methods, different formulations, or use different therapeutic indications within the scope of their patents to avoid infringement.
Q5: What strategic considerations should companies pursue surrounding CN104507309?
A5: Companies should monitor patent activity, consider filing patent families for improved or related innovations, and assess potential infringement risks versus licensing opportunities to optimize market position.
References
- Chinese Patent Office, CN104507309—a comprehensive patent database entry.
- World Intellectual Property Organization, PATENTSCOPE.
- Fenech, M., et al. "Pharmaceutical Patent Trends in China." Intellectual Property Quarterly, 2022.
- World Trade Organization, TRIPS Agreement and Chinese patent law specifics.
- Chinese Patent Law and Examination Guidelines (latest editions).
Disclaimer: This analysis is based on publicly available information and reasonable assumptions concerning typical patent structures. For a precise legal opinion or patent validity assessment, consult patent attorneys with access to full patent documents and prior art searches.
