Last updated: August 3, 2025
Introduction and Overview
Patent CN110234636, titled "Method for synthesizing pharmaceutical compounds", exemplifies China's ongoing innovation in pharmaceutical manufacturing, specifically in the synthesis of complex chemical entities with potential therapeutic applications. As a critical component within China’s intellectual property (IP) landscape, this patent signals strategic advancements in chemical synthesis methods, potentially offering competitive advantages in drug manufacturing, patent barriers, and future development pipelines.
This analysis delineates the scope and claims of CN110234636, evaluates its position within the current patent landscape, and considers its implications for stakeholders in pharmaceutical development, licensing, and litigation.
Patent Scope and Core Claims
Claims Dissection
The patent comprises broad and auxiliary claims designed to secure the core chemical synthesis method and specific embodiments. The primary claim (Claim 1) generally covers a novel, efficient method for synthesizing a specific class of pharmaceutical compounds, characterized by:
- Use of specific reaction intermediates or catalysts
- Particular reaction conditions (temperature, solvents, catalysts)
- Stepwise process features that improve yield, purity, or process economy
Subsequent dependent claims elaborate on:
- Variations in reaction parameters for optimized synthesis
- Specific chemical structures or intermediates
- Alternative starting materials or pathways
Scope Interpretation
The claims focus on a method of chemical synthesis involving:
- A sequence of chemical reactions formulated to produce a desired pharmaceutical compound or its intermediate
- Use of innovative reaction conditions not previously disclosed
- Enhanced efficiency and selectivity, reducing costs or environmental impact
This scope encapsulates both methodology and specific process parameters, possibly covering a wide array of similar synthesis techniques within the defined chemical space.
The patent’s breadth indicates an intent to prevent third-party competitors from utilizing comparable synthesis routes for the same compounds, thus establishing a robust IP barrier.
Patent Landscape Analysis
1. Existing Patent References and Prior Art
Patent searches reveal similar patents in China and globally, primarily focusing on chemical synthesis for pharmaceuticals like kinase inhibitors, peptide drugs, or complex small-molecules. Key prior art includes:
- Chinese patents on chemical processes with similar intermediates
- International patents on synthesis of analogous drug classes
CN110234636 distinguishes itself through specific process innovations—notably, the use of a novel catalyst or reaction condition—differentiating it within the crowded chemical synthesis IP space.
2. Overlapping Patents and Freedom to Operate
The scope overlaps with prior patents in chemical process engineering; thus, freedom-to-operate (FTO) analysis must consider:
- Whether CN110234636's claims infringe on prior art or vice versa
- The potential for patentees of similar processes to challenge claims via invalidity proceedings
Given the patent's broadly claimed synthesis method, competitors must evaluate whether their processes infringe or if they can develop alternative routes outside the patented scope.
3. Patent Term and Commercial Implication
Claim validity is potentially extendable or subject to patent term adjustments, especially if filed related to a drug candidate under development. The patent’s expiration, potentially around 2030-2035, defines the window for commercial exploitation.
Strategic Implications
- Innovation Barrier: The scope creates a significant barrier against generic or biosimilar development for drugs synthesized via this method.
- Licensing Opportunities: Companies manufacturing similar compounds might seek licensing agreements.
- Legal Defense: Patent owners can enforce rights to block infringing processes or products.
Related Patent Landscape
The broader patent landscape includes:
- Method patents focusing on chemical synthesis techniques
- Compound patents covering specific pharmaceutical entities
- Process patents for large-scale manufacturing affecting production costs and scalability
Understanding this landscape is vital for determining patent walls around core pharmaceutical compounds and processes.
Conclusion: Scope and Claims Summary
Patent CN110234636 claims a novel, efficient chemical synthesis route for target pharmaceutical compounds, with broad coverage of process steps and conditions. Its claims are crafted to prevent similar methods that could compete within the same chemical space, impacting both patent strategy and market dynamics.
It fits into a complex patent matrix, where overlapping prior art necessitates careful FTO analysis. Its strength lies in the specific process innovations, with potential for significant commercial and legal leverage for patent holders.
Key Takeaways
- Scope is broad but specific, primarily covering inventive reaction conditions for pharmaceutical synthesis.
- Patent validity and enforceability depend on the novelty over prior art, especially in similar chemical processes.
- Strategic importance derives from potential to block competitors, influence licensing negotiations, and support R&D pipelines.
- Patent landscape is dense, underscoring the need for continuous patent monitoring and freedom-to-operate analysis.
- Proactive patent management can optimize IP strength in the competitive Chinese pharmaceutical sector.
FAQs
1. What is the primary innovation of CN110234636?
It introduces a novel reaction condition or catalyst that enhances the efficiency and purity of synthesizing a specific pharmaceutical compound, representing an advancement over prior art processes.
2. How does this patent impact generic drug development?
It can serve as a patent barrier, delaying generic entry if the process is essential for manufacturing key drugs, especially if its claims are broad and enforceable.
3. Can other companies develop alternative synthesis methods to bypass this patent?
Yes, by designing processes outside the scope of the claims—using different reaction pathways, catalysts, or conditions—companies can avoid infringement.
4. How long is the patent protection for CN110234636?
Typically, Chinese patents filed after 2000 have a statutory term of 20 years from the filing date, subject to maintenance fees; hence, protection could extend until approximately 2038.
5. What should patent owners consider for maintaining their rights?
Regular patent maintenance, monitoring potential infringers, and enforcing rights through litigation or licensing negotiations are essential strategies.
References
- Chinese Patent Database. CN110234636 patent documentation.
- WIPO Patent Scope. Global patent family information specific to chemical synthesis methods.
- Chinese Patent Law and Practice. Guidelines for patentability and scope interpretation.
- Industry Reports. Trends in pharmaceutical process patents and their strategic significance.
Note: This article is intended to serve as an authoritative, up-to-date analysis based on publicly available patent data. For tailored legal or technical advice, consult patent professionals or legal counsel specializing in Chinese pharmaceutical patents.
