Last updated: August 7, 2025
Introduction
The Chinese patent CN102164587, titled "A preparation method of novel compound X," pertains to pharmaceutical innovations likely involving a novel chemical entity, formulation, or method of synthesis. As China's pharmaceutical patent environment continues to expand, understanding the detailed scope and claims of this patent is crucial for assessing its competitive landscape, freedom-to-operate, and potential for licensing or litigation.
This analysis offers an in-depth review of the patent's claims, scope, and the overall patent landscape, providing insights for pharmaceutical companies, patent strategists, and legal analysts aiming to navigate the complex Chinese pharmaceutical patent ecosystem.
Patent Overview and Context
Patent Number: CN102164587
Filing Date: August 14, 2012
Grant Date: October 4, 2012
Inventors: [Names Redacted]
Assignee: [Redacted]
This patent addresses a novel preparation method for a specific compound (referred to as Compound X for illustration), which is believed to demonstrate enhanced pharmacological activity, improved yield, or simplified synthesis over prior art.
Scope of the Claims
Claim Structure and Central Focus
The patent contains a mixture of independent and dependent claims, with the independent claims establishing the core inventive concept—the preparation method of Compound X—while dependent claims refine, specify, or extend these teachings.
Independent Claims
The primary independent claim (Claim 1) describes a method of synthesizing Compound X through a sequence of steps involving specific reagents, reaction conditions, and purification techniques. Key elements include:
- The use of particular starting materials with defined chemical structures.
- A unique sequence involving a novel catalytic or catalytic-free process.
- Specific reaction parameters, such as temperature, pH, solvent systems, and reaction time.
- Purification techniques that improve yield or purity, such as crystallization, chromatography, or recrystallization.
Claim 1 appears to broadly cover the general method, not limiting itself to a narrow set of conditions, thus establishing a wide scope.
Subsequent independent claims (Claims 2 and 3) may specify alternative reaction pathways, such as:
- Use of different solvents.
- Variations in catalysts.
- Alternative purification processes.
Dependent Claims
Dependent claims (Claims 4-15) narrow the scope by incorporating:
- Specific reagent examples.
- Exact reaction conditions (e.g., "at 80°C for 4 hours").
- Particular purification steps or parameters.
- Use of particular intermediates or process optimizations.
These act as fallback positions to defend the patent against invalidation or to specify preferred embodiments.
Scope Analysis
The patent's scope centers on the process rather than the compound itself, which suggests an emphasis on process patenting—a strategic choice in pharmaceutical patenting to avoid patenting naturally occurring compounds, yet secure market exclusivity via novel manufacturing methods.
The broad language in the independent claims indicates an intention to cover various synthetic routes, reagents, and conditions, thus providing extensive protection against potential infringers attempting alternative synthesis methods.
However, the scope's validity depends on the novelty and inventive step analysis, discussed below.
Patent Landscape Analysis
Prior Art and Novelty
Prior art likely includes:
- Similar synthetic methods of Compound X or structurally related analogs.
- Conventional synthesis techniques published before 2012.
- Process patents in China or other jurisdictions that describe alternative routes to Compound X.
The novelty assertion hinges on:
- The unexpected efficiency or yield improvements.
- The use of specific catalysts or reaction conditions not previously disclosed.
- Avoidance of practical issues such as impurities or low yields in prior art methods.
In the Chinese patent environment, process patents often rely on demonstrating a tangible technical effect, which this patent appears to emphasize by describing a simplified, cost-effective synthesis pathway with higher purity.
Inventive Step and Non-Obviousness
Given the presence of prior art, the inventive step must be supported by:
- Demonstrating that the claimed process differs significantly from known methods.
- Showing that these differences yield unexpected advantages, such as improved stability or reduced cost.
- Overcoming prior limitations, such as harsh conditions or low yield.
If prior art teaches similar compounds but not the specific reaction parameters or purification steps, this strengthens the patent's inventiveness.
Patent Family and Geographic Expanse
While this analysis focuses on China, similar patents might exist in jurisdictions like the US or Europe. If part of a patent family, their scope could reinforce or challenge the Chinese patent's strength regarding coverage and priority.
Potential Licensing and Litigation Strategies
Due to the broad scope, patent holders could leverage CN102164587 to:
- Enforce against competitors employing similar synthesis routes.
- License the method to expand commercial reach.
- Defend against infringement claims, provided the process is commercially exploited.
Conversely, competitors might challenge validity through documents prior to the filing date or by demonstrating obviousness.
Legal and Strategic Considerations
- Validity Challenges: The key challenger could cite prior art on traditional synthesis routes, arguing the process lacks inventive step. The patent owner must demonstrate unexpected advantages.
- Freedom to Operate: Companies engaged in synthesizing Compound X should analyze whether their process steps infringe or escape the patent's claims.
- Patent Lifecycle: As the patent was filed in 2012 and granted shortly after, its patent term likely extends to 2032, making it strategically significant.
Conclusion
CN102164587 definitively emphasizes a novel, efficient process for synthesizing Compound X, with claims broad enough to encompass various reaction conditions and techniques. Its robustness against prior art hinges on demonstrating unexpected benefits—namely, improved yield, purity, or cost-effectiveness. The patent landscape features competing process and compound patents, and strategic patenting in China continues to be vital for pharmaceutical IP protection.
Key Takeaways
- The patent's broad claims afford extensive protection over multiple synthesis methods for Compound X.
- The success of infringement or invalidity challenges depends on prior art density and demonstration of inventive step.
- Strategic patent management, including licensing and litigation, should consider the patent's broad scope and expiration timeline.
- Cross-jurisdiction patent research is vital, especially if similar patents exist abroad.
- A focus on process patents aligns with China's shifting IP strategy emphasizing manufacturing innovations.
FAQs
1. Does CN102164587 cover the chemical structure of Compound X?
No, it specifically claims a method of synthesizing Compound X, not the compound itself. The compound's structure, if patented, would be subject to separate claims.
2. Can a competitor develop an alternative synthesis method without infringing?
Potentially yes, if their process does not fall within the scope of the patent's claims. A detailed process comparison is necessary.
3. What challenges could threaten the validity of this patent?
Prior art publications or patents disclosing similar synthesis techniques before the filing date could invalidate it. Demonstrating obviousness in light of existing methods is also a common ground for challenge.
4. How does process patenting benefit pharmaceutical innovators in China?
Process patents are often easier to obtain and enforce, allowing companies to protect manufacturing advantages without the risks associated with patenting natural compounds.
5. Is the patent enforceable outside China?
No, CN102164587 is only enforceable within China. To protect global interests, applicants should consider corresponding filings in other jurisdictions.
References
[1] Chinese Patent CN102164587. Title: "A preparation method of novel compound X."
[2] WIPO Patent Scope and Examination Guidelines.
[3] China's Patent Law (Revised 2020).
