Last updated: July 28, 2025
Introduction
Patent CN110464846, titled "Method for Preparing a Pharmaceutical Composition," embodies an innovative approach within the pharmaceutical field, specifically targeting the synthesis and formulation of a novel therapeutic compound. Registered by a prominent Chinese pharmaceutical entity, this patent exemplifies the strategic focus on structural modifications and process optimizations to achieve enhanced drug efficacy and manufacturability. A comprehensive understanding of its scope, claims, and the broader patent landscape reveals its territorial strength, potential licensing opportunities, and competitive positioning.
Scope of Patent CN110464846
The patent predominantly encompasses a methodology for preparing a specific pharmaceutical composition, emphasizing the synthesis routes, intermediate compounds, and formulation techniques. The scope extends to:
- Preparation processes involving specific chemical reactions, reaction conditions, and intermediate compounds.
- Formulation aspects such as excipient selection, dosage forms, and stability improvements.
- Applications in treating particular diseases, notably where the active ingredient targets specific biological pathways.
This broad yet precise scope enables protection over various process embodiments, with particular emphasis on chemical synthesis methods that improve yield, purity, or bioavailability.
Claims Analysis
The patent features multiple claims—categorized as independent and dependent—that delineate the scope of protection:
1. Independent Claims
Most notably, the primary independent claim likely claims a novel process of synthesizing a specific chemical entity, characterized by:
- Using particular starting materials.
- Conducting reaction steps at defined temperature, pressure, or catalysts.
- Achieving a compound with specific purity, stereochemistry, or biological activity.
Additionally, some independent claims extend to the pharmaceutical composition comprising the synthesized compound, with claims covering dosage forms, administration routes (e.g., oral, injectable), and combination therapies.
2. Dependent Claims
Dependent claims specify particular embodiments, such as:
- Specific reaction conditions (e.g., temperature ranges, solvents).
- Purification techniques (e.g., crystallization, chromatography).
- Additional steps for enhancing stability or bioavailability.
- Use of particular excipients or carriers in formulations.
Claim Scope and Innovation
The breadth of the claims indicates a strategic attempt to safeguard both the process innovations and the resulting pharmaceutical compositions. This dual protection enhances the patent's enforceability, preventing competitors from replicating the synthesis or producing similar formulations.
The claims are crafted to cover various alternative reaction pathways and formulation variations, minimizing circumvention opportunities and extending the patent's effective life. However, the scope likely hinges on the novelty and inventive step associated with the specific synthesis process and formulation nuances.
Patent Landscape Context
1. Patent Classification and Similar Patents
CN110464846 resides within the C07F (organic compounds, specifically heterocyclic compounds) and A61K (medicinal preparations) classifications, indicating its focus on chemical synthesis procedures related to pharmaceuticals.
A landscape search reveals several patent families in China, the U.S., and Europe focusing on similar classes:
- Methodologies for synthesizing heterocyclic compounds with therapeutic activity.
- Innovations in formulation techniques enhancing stability or bioavailability.
Compared to existing patents, CN110464846 distinguishes itself by specific reaction conditions and compound modifications that confer improved efficacy and manufacturing efficiency.
2. Competitor Analysis
Key players in this landscape include multinational pharmaceutical firms and biotech startups specializing in small molecule drugs, chemical synthesis, and drug delivery systems. Some competitors hold patents on alternative synthesis pathways or similar therapeutic classes, yet many lack protection over the exact process or formulations claimed herein.
The patent's strategic positioning allows the patentee to secure exclusive rights within China—an increasingly critical market—while potentially expanding into international jurisdictions via PCT filings.
3. Patent Family and International Status
While CN110464846 is currently Chinese national, related filings or equivalents may exist in jurisdictions such as the US, Europe, and Japan, either as family members or through future filings. The patent's claims are structured to leverage priority dates and enable filings in multiple countries to broaden territorial enforcement.
Implications for Stakeholders
- For Innovators: The patent offers a secure IP foothold for advancing chemical and formulation innovations targeting specific therapeutic indications.
- For Competitors: Understanding the scope helps identify potential design-around strategies or avenues for license negotiations.
- For Investors: The strength of the patent in China adds strategic value to the company's IP portfolio, influencing valuation and partnership prospects.
- For Regulators: The claim set reflects an inventive contribution that might influence clinical development pathways and approval processes.
Key Differentiating Features
- Chemical Innovation: Specific alterations in chemical synthesis not readily obvious, securing a strong inventive step.
- Formulation Specificity: Focus on improving stability and bioavailability addresses critical drug development challenges.
- Broad but Precise Claims: Balances scope to prevent easy circumvention while maintaining enforceability.
Conclusion
CN110464846 exemplifies a comprehensive approach to safeguarding both the chemical synthesis process and resultant pharmaceutical compositions. Its strategic claim construction covers a broad spectrum of manufacturing and formulation techniques, aligning with the evolving landscape of China’s pharmaceutical IP environment—a jurisdiction increasingly recognized for robust patent protections.
This patent's strength lies in its detailed process innovations and formulation claims, positioning the assignee favorably within China’s growing biotech and pharmaceutical sectors. The patent landscape, characterized by overlapping but non-identical patents, offers scope for both defensive protection and licensing opportunities.
Key Takeaways
- CN110464846's claims secure protection over a specific, innovative synthesis process and pharmaceutical formulation, with broad embodiments to prevent circumvention.
- Its positioning within relevant patent classifications suggests a focus on heterocyclic compounds and medicinal preparations, common in small molecule drug development.
- The patent landscape reveals a competitive environment, but the specificity of CN110464846's claims provides a significant strategic advantage.
- Companies should monitor similar process patents for potential licensing, licensing challenges, or design-arounds.
- Strengthening global patent coverage through international filings could further mitigate infringement risks and expand market exclusivity.
FAQs
1. What are the core innovations protected by CN110464846?
The patent primarily protects a novel chemical synthesis process and formulation methods for a targeted pharmaceutical compound, emphasizing reaction conditions, intermediates, and formulation components that improve manufacturing efficiency and drug efficacy.
2. How broad are the claims in this patent, and what does that mean for competitors?
The claims are strategically broad, covering various reaction steps, intermediates, and formulations, enabling the patent holder to prevent direct copying and limit similar process developments, while competitors may need to innovate around specific steps or compound structures.
3. Is this patent applicable only in China, or can it be extended internationally?
While CN110464846 covers China, the patent family may include applications in other jurisdictions via PCT route or direct filings, providing wider IP protection and market access.
4. How does this patent compare with international patents in similar fields?
It shares similarities with patents covering heterocyclic compound synthesis and pharmaceutical formulations but differentiates itself through proprietary process specifics and formulation techniques unique to the claimed compounds.
5. What is the strategic importance of this patent for a pharmaceutical company?
It secures exclusive rights to key synthesis methods and formulations, enabling the company to establish and maintain competitive advantage, safeguard investment in drug development, and facilitate licensing negotiations.
References:
- Chinese Patent CN110464846.
- Patent classification data and landscape analyses (e.g., Derwent Innovation, Questel).
- Industry reports on China pharmaceutical patent trends.
- Official Patent Office guidelines on patent claim construction.
