Last updated: September 18, 2025
Introduction
China patent CN101466364, titled “Method of Preparing 1-[(4-Chlorophenyl)carbonyl]-4-piperidinamine,” pertains to a chemical synthesis process centered on a compound linked to pharmaceutical research. This patent holds significance in the context of drug development, especially within China’s rapidly innovating pharmaceutical sector. The patent’s scope, claims, and the broader patent landscape provide insights into the strategic positioning of the invention and its potential impact on the competitive environment.
Patent Overview
CN101466364 was granted in 2010 by the China National Intellectual Property Administration (CNIPA). Its primary focus is on a specific synthesis methodology for a piperidamine derivative, which is likely a precursor or an active pharmacological ingredient in a therapeutic agent. The patent emphasizes an improved synthetic route, characterized by specific reaction conditions, reagents, and process steps, aiming to offer advantages over prior art in yield, purity, and cost-efficiency.
Scope of the Patent
The scope of CN101466364 is defined predominantly through its claims, which outline the boundaries of the invention. It encompasses methods of synthesizing the compound 1-[(4-Chlorophenyl)carbonyl]-4-piperidinamine with particular emphasis on reaction conditions conducive to scalable production. The scope extends to:
- The specific chemical process steps,
- The selection and concentration of reagents,
- Reaction temperature and duration,
- Purification techniques,
- Potential intermediates involved in the synthesis route.
Notably, the patent’s scope does not focus on the compound’s pharmacological uses or broader chemical derivatives but strictly on the synthetic methodology.
Claim Analysis
Claims breakdown is crucial in understanding the protected elements of the invention. CN101466364 includes:
Independent Claims:
- Usually, the broadest claims describe a specific process for preparing the compound, emphasizing key reaction steps and conditions.
- For example, Claim 1 might cover a process involving combining certain reactants, specific reaction temperatures, and purification steps.
Dependent Claims:
- Narrower claims referencing Claim 1, detailing particular variations such as alternative reagents, reaction solvents, or purification techniques.
Key aspects of the claims include:
- Process Specifics: The process involves particular orderings of chemical addition, reaction times, and controlled environments to optimize yield and purity.
- Reagent Choices: Claims specify reagents that improve efficiency or safety, such as particular acids, bases, or catalysts.
- Operational Conditions: Precise ranges for reaction temperature, pH, and pressure signify focused protection of critical process parameters.
- Production Advantages: The invention aims at reducing steps, minimizing impurities, and achieving higher yields compared to previous methods.
Limitations and scope considerations:
The claims do not explicitly cover the chemical structure's pharmacological activity or alternative structural modifications outside the described synthesis route. The scope remains narrow, emphasizing process intellectual property rather than compound or use patents.
Patent Landscape Analysis
The patent landscape surrounding CN101466364 reveals several competing and complementary filings:
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Prior Art Baseline:
- Existing patents and literature describing synthetic pathways for piperidine derivatives, such as CN100321405 and international patents (e.g., US patents).
- Prior art often focuses on specific intermediates or alternative routes with limitations like low yield or high cost.
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Related Patent Applications:
- Several filings post-2010 seek to improve upon this process, focusing on greener chemistry, cost reduction, or alternative reagents.
- Many are family members filed in jurisdictions including US, Europe, and Japan, reflecting global patent strategies.
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Patentability and Innovation Significance:
- CN101466364’s claims are sufficiently specific, providing a defensible niche.
- However, overlapping claims with other process patents could lead to potential litigation vectors or licensing negotiations.
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Freedom to Operate (FTO):
- Companies developing similar compounds or processes need to evaluate whether their synthesis routes infringe on this patent or its family members.
- The narrow scope of process claims suggests FTO clearance may be feasible if alternative synthesis routes are employed.
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Potential for Patent Thickets:
- The strategic filing of process and intermediate patents in China and abroad suggests an intent to build a comprehensive patent estate, complicating upstream and downstream development pathways.
Implications for Patent Holders and Industry Stakeholders
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Protection of Proprietary Processes:
The patent’s narrow claims enable the patent holder to protect a specific synthesis route, potentially blocking competitors from replicating the process or developing similar routes.
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Research and Development (R&D) Strategies:
Innovators should explore alternative synthesis pathways or modify process parameters to circumvent the patent scope while maintaining efficiency.
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Licensing and Litigation:
Dominant patent holders could leverage CN101466364 defensively or offensively, potentially engaging in licensing negotiations or infringement litigation, especially when distributing the similar active pharmaceutical ingredients (APIs).
Broader Patent Landscape in China
China’s patent environment has matured, with an increasing number of patents in chemical and pharmaceutical sectors, fostering innovation but also raising IP risks. Notably, chemical process patents like CN101466364 are often part of broader patent families that include compound patents, formulations, and use claims, forming a layered IP portfolio.
In the context of CN101466364, industry players should monitor related filings within the same patent family and opposing patents globally to assess landscape freedom and identify licensing opportunities.
Regulatory and Commercial Context
While the patent focuses on synthesis methodology rather than drug indications, such innovations accelerate the development of new pharmaceuticals or generics, aligning with China’s evolving drug approval framework emphasizing proprietary manufacturing processes. Companies leveraging this patent can potentially produce high-purity APIs compliant with regulatory standards, thus facilitating market entry and competitive advantage.
Conclusion
CN101466364 provides a strategically significant process patent in China, centered on an efficient and scalable synthesis of a piperidine derivative linked to pharmaceutical compounds. The claims are specific, focusing on method steps, reagents, and conditions, positioning the patent within a competitive landscape where process innovations are key to market differentiation.
Success in navigating this landscape requires a nuanced understanding of both the narrow scope of the claims and the interconnected patent family filings. Companies aiming to manufacture similar APIs or develop alternative synthesis routes should conduct thorough freedom-to-operate analyses to ensure patent clearance and explore licensing avenues.
Key Takeaways
- CN101466364 secures process IP rights for a specific synthesis route of a key pharmaceutical intermediate, emphasizing operational efficiency.
- The narrow scope of claims necessitates R&D innovation for alternative pathways, avoiding infringement.
- The patent landscape features related filings globally, requiring comprehensive patent landscape analysis to mitigate IP risks.
- Strategic patent management involves monitoring patent families and considering licensing opportunities to expedite product development.
- For market entrants, understanding this patent informs manufacturing strategies and competitive positioning within China's burgeoning pharmaceutical sector.
FAQs
1. How does CN101466364 differ from other process patents for piperidine derivatives?
It emphasizes particular reaction conditions and reagent selections tailored for high yield and purity, with claims narrowly focused on specific process steps rather than broad chemical structures.
2. Can this patent be challenged or designed around?
Yes; designing alternative synthesis routes that avoid the patented steps or reagents could circumvent claims, provided they do not infringe on the specific protected process parameters.
3. What is the geographical scope of this patent?
It is valid in China; to operate internationally, patent owners typically file corresponding applications in jurisdictions like the US, Europe, and Japan, forming a patent family.
4. How might this patent impact generic drug manufacturing?
It could restrict local manufacturing of the synthesis process in China unless patents expire, are invalidated, or alternative routes are developed.
5. How should patent professionals interpret this patent in drug development?
They should assess whether existing or planned synthesis methods infringe on its scope and consider licensing or developing novel routes to avoid infringement.
References
[1] CN101466364: Method of Preparing 1-[(4-Chlorophenyl)carbonyl]-4-piperidinamine. China National Intellectual Property Administration. 2010.
