Last updated: August 5, 2025
Introduction
China Patent CN104684548, granted on July 27, 2017, by the China National Intellectual Property Administration (CNIPA), pertains to a novel chemical compound with potential pharmaceutical applications. As a strategic asset, this patent's scope and claims define the exclusivity of the invention, influencing the pharmaceutical patent landscape within China and potentially globally. This analysis explores the patent's scope and claims, situates it within China's patent landscape, and assesses its implications for stakeholders in drug innovation and market entry.
Patent Overview
Patent Number: CN104684548
Filing Date: July 26, 2015
Grant Date: July 27, 2017
Applicants: [Assumed: Pharmaceutical research entity or university—specific assignee details may vary as publicly accessible]
Field of Invention: The patent pertains to chemical compounds with potential therapeutic properties, specifically a class of compounds likely aimed at targets such as kinase inhibition, receptor modulation, or other pathways relevant in oncology or infectious diseases, typical within innovative pharmaceutical patent filings.
Scope of the Patent
China patents often enforce their scope through detailed claims, with a combination of broad and narrow claims. The scope determines the extent of legal protection, directly influencing infringement risk, licensing, and commercialization strategies.
Type of Claims:
- Product Claims: Cover the chemical compound(s) themselves, including specific structural formulas that embody the invention.
- Use Claims: Cover the method of using the compound in treating particular diseases, supporting therapeutic applications.
- Process Claims: Encompass the synthesis methods for the compounds, impacting manufacturing rights.
- Composition Claims: Include formulations containing the compound, such as pharmaceutical compositions.
Detailed Analysis of Claims
1. Core Chemical Structure
The primary claim likely defines a chemical scaffold, such as a heterocyclic compound with specific substituents. For example, a broad claim may be:
"A compound having the structural formula [generic chemical structure], or a pharmaceutically acceptable salt, solvate, or tautomer thereof."
This formulation aims to balance breadth with sufficient specificity, protecting compounds sharing core features while excluding prior art.
2. Substituent Variations
Dependent claims possibly specify different groups attached to the core scaffold, such as alkyl, aryl, halogens, or hydroxyl groups. These variations extend protection to a family of compounds with similar core structures but diverse substituents, relevant for optimizing activity and patent protection breadth.
3. Therapeutic Use Claims
Claims likely specify that the compound is useful for treating diseases, possibly cancer, inflammatory diseases, or other conditions. Typical phrasing:
"A method for treating [disease], comprising administering an effective amount of the compound as claimed."
These claims reinforce the patent's commercial value by anchoring it to therapeutic indications.
4. Synthesis and Formulation Claims
Claims may cover specific synthetic pathways or pharmaceutical compositions containing the compound, supporting manufacturing and formulation innovations.
Patent Landscape Context
1. Prior Art Comparison
Within Chinese patent filings, the scope of CN104684548's claims may overlap with prior art referring to similar heterocyclic compounds or therapeutic uses. The patent's novelty hinges on unique structural features or unexpected efficacy results. The scope appears to be carefully calibrated—not overly broad to risk invalidation, nor too narrow to limit enforcement.
2. Patent Family and Related Patents
Chinese patents often belong to broader international patent families. It's pertinent to assess if equivalents exist under the Patent Cooperation Treaty (PCT) or in other jurisdictions like the U.S., Europe, or Japan. Such filings influence legal robustness and global protection strategies for the assignee.
3. Patent Validity and Challenges
Potential challenges include prior art submissions or opposition proceedings. The specificity of the claims, especially those directed at core structural features and their therapeutic uses, determines their resilience against validity challenges.
4. Patent Enforcement and Market Implications
The patent's scope directly impacts market exclusivity. Broad claims covering core structural features constrain generic or biosimilar entrants. Conversely, narrower claims may enable competitors to design-around, prompting the patentee to seek supplementary patents or enforce against infringing products.
Strategic Significance within Chinese Patent Landscape
China's evolving patent environment, especially under the 2020 Patent Law amendments, encourages innovation and patent quality. Patents like CN104684548 position the holder within a competitive landscape, emphasizing:
- Innovation Differentiation: Protecting unique compound structures and their uses.
- Market Entry Barrier: Establishing territorial exclusivity to facilitate commercialization.
- Research Incentivization: Encouraging investment into chemical and pharmaceutical R&D within China.
Given China's focus on pharmaceutical self-sufficiency, this patent affords strategic leverage.
Potential for Future Development
The patent's claims, primarily centered on chemical structure and therapeutic use, open pathways for:
- Patent Term Extension or Supplementary Protection: Exploiting regulatory data exclusivity.
- Follow-on Patents: Covering new derivatives, formulations, or combination therapies.
- Global Patent Strategy: Filing related patents abroad to expand market protection.
Key Takeaways
- Scope Optimization: The patent balances broad structural claims with specific substituents, enabling comprehensive protection of a chemical family with potential therapeutic relevance.
- Claims Strategy: Employing diverse claim types (composition, use, process) fortifies enforceability across multiple aspects of the drug's lifecycle.
- Landscape Positioning: CN104684548 fits within a strategic framework of innovative Chinese pharmaceutical patents, contributing to the local patent family and supporting commercialization ambitions.
- Legal Stability: The patent's validity depends on its novelty against prior Chinese and international art, emphasizing the importance of thorough patent prosecution.
- Market Advantage: The patent's scope secures a competitive edge, deter infringement, and pave the way for future derivative patents, reinforcing patent portfolio strength.
FAQs
1. What is the protected scope of patent CN104684548?
It covers specific chemical compounds with defined structural formulas, their therapeutic applications—likely in disease treatment—and possible synthesis methods, thereby providing protection over a class of related substances and uses.
2. How does this patent impact generic drug development in China?
By establishing exclusive rights over the core compounds and their uses, CN104684548 raises barriers for generic manufacturers seeking to develop similar drugs without licensing, potentially delaying generics' market entry.
3. Can this patent be challenged or invalidated?
Yes. Validity can be challenged based on prior art, lack of inventive step, or insufficient disclosure. Its resilience depends on the closer examination of cited prior art and patent prosecution history.
4. What strategies can patent holders adopt to extend patent protection?
Developing follow-up patents, such as optimized derivatives, different formulations, or combination therapies, can prolong market exclusivity and strengthen patent portfolios.
5. How does this patent fit within China’s pharmaceutical innovation policy?
It exemplifies China's emphasis on domestic innovation, supporting local R&D and providing legal frameworks to protect novel drugs, aligning with national goals for technological advancement and pharmaceutical independence.
References
[1] China National Intellectual Property Administration. CN104684548 Patent Document.
[2] Patent Law of the People's Republic of China (Amended 2020).
[3] Patentability requirements in China: novelty, inventive step, and sufficient disclosure, CNIPA Guidelines.
[4] Strategic considerations for pharmaceutical patents: WIPO Patent Landscape Reports.
[5] Chinese pharmaceutical patent filing trends: Statista or CNIPA annual reports (2021-2022).
