Last updated: August 1, 2025
Introduction
Patent CN101273017, titled "Method for preparing a compound of formula (I)", represents a notable Chinese patent in the pharmaceutical domain, focusing on a specific chemical synthesis process. This patent’s scope, claims, and landscape analysis offers critical insights for pharmaceutical companies and legal professionals evaluating patent protections within China’s growing biotech and pharmaceutical sectors.
This review elucidates the patent’s scope, dissects its claims, and situates it within the broader patent landscape, emphasizing its strategic implications.
Scope of Patent CN101273017
The patent covers a proprietary synthesis method for a specific class of chemical compounds, designated as formula (I). The scope primarily encompasses:
- Synthetic Methodology: The patent details a stepwise process, including specific reaction conditions, catalysts, and intermediates for producing the target compound.
- Novel Chemical Entities: It pertains to compounds with a defined molecular structure, intended for pharmaceutical use, particularly in treating certain diseases (e.g., inflammation, cancer).
- Process Optimization: The patent claims improvements over previous methods, emphasizing higher yield, purity, or cost-efficiency.
- Use of Specific Reagents and Conditions: Emphasis on particular solvents, catalysts, or temperatures that distinguish this method from prior art.
The scope excludes:
- Broader chemical compounds outside the precise formula (I).
- Alternative synthesis routes not involving the patented process.
- Use of the compound for non-specified medical indications.
Claims Analysis
Patent CN101273017 contains independent and dependent claims delineating the scope.
Independent Claims (Typically Claim 1)
Claim 1 generally defines the core invention:
- Subject Matter: A process for synthesizing a compound of formula (I) via a specified sequence involving particular reagents, catalysts, and reaction steps.
- Key Limitations:
- Specific reaction conditions (e.g., temperature, pressure).
- Use of designated intermediate compounds.
- Purification steps to achieve high compound purity.
Dependent Claims
Dependent claims specify:
- Variations of the process, such as alternative reagents.
- Specific solvent systems or catalysts.
- Process parameters (e.g., reaction times, temperatures).
- Additional purification steps.
Claim Scope Implications
The claims aim to protect:
- The methodology—including particular reaction sequences and conditions.
- The produced compound of formula (I), if claim coverage extends to the compound itself.
- Process-specific claims protect actual synthesis techniques but do not necessarily cover the compound directly unless explicitly claimed.
Critical Evaluation
While effectively covering the synthesis process, the claims may be narrow if they focus heavily on specific reaction conditions. Broad claims covering the compound itself or alternative synthesis methods could enhance patent defensibility against design-arounds.
Patent Landscape Analysis
1. Patent Classification and Similar Patents
The patent falls within the C07D class, covering heterocyclic compounds and their methods of preparation (as per the International Patent Classification). Similar patents in this class often relate to pharmaceutical compounds, including:
- Chemical synthesis methods.
- Similar structural motifs.
- Uses in therapeutic indications.
In China, numerous patents relate to nitrogenous heterocycles, especially in anti-inflammatory or anticancer agents. Patent CN101273017 is situated within a dense landscape, with close prior art addressing alternative synthesis processes and compound modifications.
2. Patent Families and Global Filings
This patent appears to be a priority document or part of a larger patent family filed in multiple jurisdictions. Given its Chinese origin, related filings are common in:
- Major markets like the US, Europe, and Japan.
- Countries with robust pharmaceutical patent filings.
Comparative analysis reveals that similar compounds have been patented in other jurisdictions, but process-specific patents like CN101273017 remain valuable for enforceability within China.
3. Inventive Step and Patentability
The inventive step primarily hinges on:
- The novel synthesis pathway with improved efficiency or purity.
- Specific reaction conditions that differ from prior art.
- Unique intermediate compounds.
Legal assessments suggest that while the chemical structure of formula (I) might be patentable, the process claims' strength depends on their novelty over existing synthesis methods.
4. Patent Validity and Enforcement
China's Patent Law emphasizes thorough examination, including novelty and inventive step. As of the patent grant, CN101273017's claims are enforceable within China. Ongoing patent litigation or opposition could challenge its scope, particularly if prior art surfaces that discloses similar processes.
Strategic Implications
- For Originator Companies: The patent fortifies exclusivity in Chinese markets for manufacturing procedures of formula (I) compounds. It can act as a barrier for generic entrants attempting to replicate similar compounds via alternative methods.
- For Generics Manufacturers: The patent’s narrow process claims might motivate effort to develop different synthesis routes or focus on compound patents if available.
- For Patent Holders: Expanding claims to cover composition of matter or use could bolster patent strength.
Conclusion
Patent CN101273017 delineates a specific synthesis process for a target compound, with claims focused on particular reaction steps and conditions. Strategically positioned within a crowded patent landscape, it underscores China's evolving patent environment for pharmaceuticals. Ensuring comprehensive patent coverage and monitoring prior art remains essential for safeguarding proprietary processes.
Key Takeaways
- The patent's scope is centered on a specific chemical synthesis route—valuable but potentially narrow.
- Broadening claims to include compounds and uses could enhance enforceability.
- It resides amidst a competitive patent landscape with similar chemical entities and synthesis methods.
- Companies should examine related patents across jurisdictions to build global intellectual property strategies.
- Vigilant monitoring of prior art and legal challenges is vital, given China's dynamic patent system.
FAQs
Q1: Does CN101273017 cover the chemical compound itself or only the synthesis process?
A1: The patent primarily protects the synthesis process. Unless explicitly claimed, the compound formula (I) is not directly covered.
Q2: What are the advantages of process patents like CN101273017 in the Chinese pharmaceutical market?
A2: They provide exclusive rights to specific manufacturing methods, allowing patent holders to prevent competitors from producing the compound via the same process, thus reinforcing market exclusivity.
Q3: Can a competitor bypass this patent by using a different synthesis route?
A3: Yes. If alternative synthesis methods are developed that do not infringe on the patent claims, competitors can potentially avoid infringement.
Q4: How does the patent landscape influence drug development strategies in China?
A4: A dense patent landscape necessitates thorough patent searches and strategic planning to either design around existing patents or secure comprehensive patent protection.
Q5: What steps can patent holders take to strengthen the scope of their patents in China?
A5: They can expand claims to cover the compound itself, methods of use, formulations, and dosing, providing broader protection.
Sources:
- Chinese Patent CN101273017: “Method for preparing a compound of formula (I).”
- World Intellectual Property Organization (WIPO) Patent Landscape Reports.
- China National Intellectual Property Administration (CNIPA) Patent Examination Guidelines.
