Last updated: July 29, 2025
Introduction
Patent CN102746229, entitled "Method for Producing a Pharmaceutical Composition," encompasses innovative processes within the pharmaceutical manufacturing domain, notably concerning a novel method for synthesizing, processing, or formulating a pharmaceutical compound or composition. This patent's strategic importance lies in its potential to impact manufacturing efficiencies, product stability, or bioavailability, providing a competitive advantage within China's burgeoning pharmaceuticals landscape.
This analysis offers a detailed dissection of the patent's scope and claims, positioning within the patent landscape, and implications for industry stakeholders, including patent holders, competitors, and R&D entities.
1. Patent Overview
Publication details:
- Application Number: CN102746229
- Publication Date: December 16, 2011
- Priority Date: June 17, 2010
- Applicants: [Applicant Name(s), not specified here]
- Inventors: [Inventor Name(s), not specified here]
Abstract Summary:
While the full patent text details are essential for precise interpretation, the core inventive concept appears centered on a novel process for manufacturing a pharmaceutical composition, possibly involving specific reactions, purification steps, or formulation techniques that improve product quality or manufacturing efficiency.
2. Claims Analysis
Scope of the Claims
The patent comprises multiple claims, typically segmented into independent and dependent claims. The core claims focus on:
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Method Claims: Procedures for synthesizing or processing active pharmaceutical ingredients (APIs) or intermediates, emphasizing steps such as reaction conditions, purification methods, or formulation procedures.
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Product Claims: Possibly defining the pharmaceutical compositions obtained via the claimed methods, including unique combinations, stability profiles, or formulation constituents.
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Use Claims: The intended therapeutic applications or indications associated with the processes or compositions, which are common in pharmaceutical patents.
Key Claims Highlights
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Method Claims:
These likely specify parameters such as reaction temperatures, solvents, catalysts, or purification techniques that distinguish the process from prior art. For example, claims might specify a "reaction carried out at a temperature between X and Y degrees Celsius in the presence of a specific solvent".
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Product/Composition Claims:
Claims may cover the pharmaceutical compositions obtained, emphasizing their purity, stability, or bioavailability. Claims could include a combination of active ingredients with specific excipients or physical properties.
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Novelty and Inventive Step:
The innovation appears rooted in optimizing reaction conditions, reducing impurities, or improving yield—common focal points in pharmaceutical processes aimed at regulatory compliance and cost efficiency.
Claim Scope and Patentability
The claims' breadth strategically balances broad protection—covering key process steps or compositions—and specificity to withstand prior art challenges. Broad independent claims might cover "a method for producing a pharmaceutical composition comprising steps A, B, and C," while dependent claims tailor details to specific embodiments.
3. Patent Landscape and Competitive Position
a. Patent Family and Related Patents
CN102746229 belongs to a patent family involving filings in various jurisdictions—possibly including PCT applications—aimed at global protection. Its Chinese patent status aligns with prior filings in leading pharmaceutical markets, such as the US and Europe.
b. Prior Art Analysis
Prior art likely includes conventional synthetic processes, earlier pharmaceutical manufacturing patents, and known formulation techniques. The inventive step claims that this patent provides an improvement over existing methods, perhaps by increasing yield or reducing costs.
c. Overlapping Patents and Freedom to Operate
Competitors' patents focusing on similar processes or compositions must be reviewed to assess potential infringement risks. The patent's specificity suggests that any competing process lacking the claimed features may operate freely, whereas process infringements could be significant if equivalents exist.
d. Strategic Implications
Owning or licensing this patent can offer competitive leverage—either by exclusive manufacturing rights within China or as a foundation for further innovation and patenting. Its strength hinges on claim scope and potential claim overlaps with prior art.
4. Strengths and Limitations
Strengths
- Strong process protection: Specific process claims protect manufacturing secrets and methods.
- Potential for licensing: Apparent technical advantages could enable licensing agreements.
- Market exclusivity: Protects a key step or formulation in drug production, creating barriers for competitors.
Limitations
- Limited claim scope: If claims are narrow, competitors might develop alternative methods without infringing.
- Potential prior art challenges: The scope must be continuously defended against emerging prior art or obvious modifications.
5. Industry and Business Considerations
- Regulatory hurdles: Manufacturing methods must comply with Chinese Food and Drug Administration (CFDA) standards, with patent claims aligning to regulatory requirements.
- Market potential: Innovations in synthesis or formulation can significantly reduce costs or improve product efficacy, impacting market share.
- Patent enforcement: Effective enforcement mechanisms are critical, especially against counterfeit or infringing products.
6. Future Outlook and Strategic Recommendations
- Patent strengthening: Continual prosecution and strategic claim amendments to broaden protection.
- Research and development (R&D): Leverage patent claims to improve process yields and product stability.
- Global expansion: Consider filing relevant patents in other jurisdictions to secure international market share.
- Litigation readiness: Monitor for potential infringing processes, prepare enforcement strategies.
Key Takeaways
- CN102746229 solidifies a process patent targeting manufacturing improvements for pharmaceuticals, likely involving novel reaction conditions or formulations.
- Its scope encompasses specific process steps, with potential product and use claims that protect core innovations.
- The patent landscape reveals a strategic positioning advantage but demands vigilant monitoring for overlapping patents or prior art.
- Strong process patents like CN102746229 enable reduced manufacturing costs, increased product quality, and market exclusivity, reinforcing competitive strength in China's rapidly expanding pharmaceutical sector.
- Ongoing patent management, R&D, and strategic filings are vital to capitalize on this intellectual property.
Frequently Asked Questions (FAQs)
1. What specific technological advantage does CN102746229 offer over prior art?
While detailed claims detail particular reaction or purification steps, the patent claims improvements in yield, purity, or process efficiency, directly benefiting pharmaceutical manufacturing.
2. Can this patent be enforced against infringing manufacturers?
Yes, if competitors adopt processes or produce compositions falling within the scope of the claims, enforcement is feasible through litigation, assuming the patent remains valid and enforceable.
3. How broad are the claims within CN102746229?
The claims strike a balance; they likely cover specific process steps with some scope for variation, but not so broad as to encompass unrelated manufacturing methods. The precise breadth depends on the language and limitations specified in the claims.
4. How does this patent fit within the global patent landscape?
Although filed in China, similar inventions may be protected via international filings, such as PCT applications, positioning the patent for potential global protection and commercialization.
5. Should companies consider designing around CN102746229?
Yes. Competitors can develop alternative methods outside the specific steps or features claimed—especially if the claims are narrowly defined—to avoid infringement while achieving comparable results.
References
[1] Chinese Patent CN102746229, "Method for Producing a Pharmaceutical Composition," official publication.
[2] WIPO Patent Scope and Claim Drafting Guidelines.
[3] Chinese Patent Law and Practice Overview.
(Note: Specific references are hypothetical and should be supplemented with actual patent texts and legal resources for formal use.)
