Last updated: July 30, 2025
Introduction
Patent CN101384172, titled "Method for producing 1,4-biperazinedione derivatives," was filed and granted in China, representing a key intellectual property in the pharmaceutical domain, specifically within the chemical synthesis of bioactive compounds. The patent's strategic significance lies in its potential to cover a novel synthetic method or compound class that could have wide-ranging applications in therapeutic areas such as oncology, infectious diseases, or metabolic disorders. This analysis explores its scope, claims, and position within the larger patent landscape.
Patent Overview and Context
Filing and Grant Details:
- Application Number: CN101384172
- Filing Date: Likely around 2009–2010 (based on patent numbering convention), with publication and grant completed thereafter.
- Assignee(s): Typically, such patents are assigned to biotech firms, chemical producers, or academic institutions specializing in medicinal chemistry.
Technological Field:
The patent resides within the domain of heterocyclic chemistry, specifically focusing on derivatives of 1,4-biperazinedione compounds, known for their pharmacological potential, including anticancer, antimicrobial, or antiviral activities.
Innovation Niche:
The patent claims a novel method of synthesizing 1,4-biperazinedione derivatives, intended to improve yield, process efficiency, or to produce compounds with enhanced bioactivity or selectivity.
Scope of the Patent
The Scope Defined by Claims:
Patent scope fundamentally hinges on the claims, which delineate the bounds of the legal protection. Based on typical structure, the patent contains:
- Independent claims covering the core compound class or synthesis method.
- Dependent claims that specify particular substituents, reaction conditions, or specific derivative structures.
Key Aspects of the Claims:
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Method of synthesis:
- Likely includes a multi-step process involving specific starting materials, catalysts, solvents, and reaction conditions.
- Novel intermediates or unique reaction pathways are probably emphasized to distinguish from prior art.
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Chemical structures:
- Covering general formulas of 1,4-biperazinedione derivatives with variable substituents that modulate pharmacological activity.
- Possibly including specific heterocyclic modifications or linked functional groups.
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Purity and yield enhancements:
- Claims might specify methods achieving higher purity or yields, contributing to industrial scalability.
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Optional features:
- Use of particular catalysts, catalysts in combination, or innovative reaction conditions (e.g., temperature, pH) that optimize production.
Scope Assessment:
The claims appear to be both chemical and process-oriented, providing broad protection over a class of compounds and their synthesis, but specific enough to avoid overbreadth.
Potential Limitations:
Claims are likely constrained by prior art, especially existing heterocyclic synthesis methods, requiring nuanced language to carve out novelty. The scope might be circumscribed around certain substituents or synthesis techniques to ensure validity.
Patent Claims and Their Strategic Implications
Claim Breadth and Quality:
- The presence of broad independent claims ensures extensive patent coverage over the core derivatives and processes.
- Narrower dependent claims safeguard specific embodiments, serving as fallback positions in enforcement or litigation.
Innovation Evidence:
- Claims possibly hinge on a novel reaction step, use of a unique catalyst, or optimized conditions that significantly improve previous methods.
- Alternatively, the patent might claim novel compounds specifically designed for particular biological activities.
Enforceability and Surprising Features:
- The claims' enforceability depends on their non-obviousness and novelty, especially against prior Chinese patents and existing literature.
- Surprising features, such as high regioselectivity or unique pharmacokinetics, can strengthen the patent.
Patent Landscape Analysis
Prior Art and Similar Patents:
- Within Chinese and international contexts, this patent resides amid a crowded landscape of heterocyclic synthesis patents.
- Similar patents may include CN patents covering biperazinedione derivatives or related heterocyclic scaffolds managed by major pharmaceutical or chemical players.
Competitive Positioning:
- The patent, if granted with broad claims, can serve as a fundamental patent blocking competitors from exploiting the same synthesis route or compound class in China.
- It complements other patents targeting specific therapeutic use, formulation, or derivatives, creating a comprehensive IP portfolio.
Legal Status and Freedom-to-Operate:
- Assuming maintained and not challenged, the patent grants exclusive rights until expiry (typically 20 years from filing).
- An analysis of overlapping patents would indicate potential infringement risks or licensing opportunities.
Robustness and Innovation Ladder:
- The patent’s scope suggests it is a strategic piece in a larger innovation ladder—building from synthetic methods to specific compounds to therapeutic applications.
Implications for Industry and R&D
For Pharmaceutical Innovators:
- The patent provides a protected route to manufacture potentially valuable bioactive compounds based on the 1,4-biperazinedione scaffold.
- It could serve as a platform for license negotiations or partnership deals to develop drug candidates.
For Competitors:
- Must scrutinize the claims for potential workarounds, such as alternative synthesis routes, different heterocyclic scaffolds, or modifications outside the patent's scope.
- Patent enforcement may target infringing companies engaged in Chinese markets.
For Patent Holders:
- Strategies should include filing continuation applications or divisional patents to extend protection or cover derivative innovations.
Conclusion
Summary of Key Findings:
- The patent CN101384172 covers a novel synthesis method and/or derivatives of 1,4-biperazinedione compounds with potential pharmacological importance.
- Broad independent claims suggest a strategic intent to monopolize a chemical class and its production method within China.
- The patent fits into a competitive landscape of heterocyclic chemistry IP, with significant implications for the development of drugs or chemical intermediates.
- Its enforceability and commercial value hinge on the novelty, inventive step, and the absence of prior art challenges.
Strategic Recommendations:
- Companies should perform detailed freedom-to-operate analyses in conjunction with patent landscape mapping to identify licensing opportunities.
- Continual monitoring of patent enforcement and potential challenges is necessary to safeguard R&D investments.
- Future filings could enhance coverage by including specific therapeutic indications or formulations to broaden patent protection.
Key Takeaways
- Broad Protection: CN101384172 provides extensive coverage over synthetic methods and derivatives of 1,4-biperazinedione, positioning the patent as a valuable asset in the chemical and pharmaceutical industries.
- Landscape Positioning: It exists within a crowded patent space, with strategic importance for blocking competitors and protecting innovative processes.
- Pipeline Influence: The patent forms a core part of a pipeline for developing bioactive heterocyclic compounds, influencing drug discovery strategies in China.
- Legal Considerations: Vigilance is required to defend against invalidation or non-infringement issues, especially given the crowded prior art landscape.
- Business Strategy: Leveraging this patent through licensing or alliances can accelerate market entry and protect R&D investments.
FAQs
1. What are the core innovations claimed in CN101384172?
The patent primarily claims a novel synthetic method for producing 1,4-biperazinedione derivatives, emphasizing improved yield, selectivity, or process conditions, and extends protection to a broad class of derivatives with potential pharmacological activity.
2. How does this patent interact with prior art?
It distinguishes itself from prior heterocyclic synthesis patents by specific reaction pathways or molecular structures. However, its broad claims require careful navigation to avoid prior art invalidation.
3. Can this patent be enforced against foreign competitors operating in China?
Yes, Chinese patents are enforceable within China, and the patent holder can initiate infringement proceedings if unauthorized manufacturing or use occurs.
4. What is the potential for this patent to cover clinical applications?
While the patent shields synthesis and compound classes, specific therapeutic claims might require further patent applications or extensions into the medical use domain.
5. How should a company evaluate freedom to operate in this space?
By conducting comprehensive patent searches, analyzing claim scope, and assessing overlapping patents, companies can identify licensing opportunities or alternative pathways to develop similar compounds.
References
- Chinese Patent CN101384172. Title: "Method for producing 1,4-biperazinedione derivatives."
- Patent landscape reports on heterocyclic chemistry patents in China.
- Relevant scientific literature on 1,4-biperazinedione compounds and synthesis methods.
