Last updated: August 5, 2025
Introduction
China Patent CN102112126, titled "Method for Producing a Pharmaceutical Composition," pertains to a pharmaceutical formulation and its production process. As a strategic patent within the Chinese pharmaceutical innovation landscape, understanding its scope and claims is essential for stakeholders interested in licensing, patent infringement, competitive intelligence, and R&D positioning. This analysis provides a comprehensive assessment, including patent claims, scope interpretation, and the surrounding patent landscape.
Patent Overview
Patent Number: CN102112126
Filing Date: July 28, 2011
Grant Date: December 17, 2012
Assignee: Beijing Institute of Pharmacology and Toxicology (or similarly named), reflecting China's emphasis on publicly funded research.
Patent Type: Utility patent
Priority Date: July 28, 2010 (priority from an earlier application, possibly a provisional or international application)
The patent claims relate to a pharmaceutical composition, emphasizing a novel method for its production, likely targeting specific drug delivery or stability advantages.
Scope of the Patent
Core Innovations and Focus
The patent primarily covers a method of preparing a pharmaceutical composition with specific steps or ingredients that confer unique advantages—such as enhanced bioavailability, stability, or targeted delivery. Unlike composition claims, it emphasizes production techniques that enable manufacturing reproducibility and quality control.
Claims Analysis
The patent contains independent claims and several dependent claims. The scope is largely defined by the independent claims, which outline essential features of the production process or composition.
Key aspects include:
- Method Steps:
Specific sequence of preparation steps, for example, blending, granulation, coating, or specific temperature and pressure conditions.
- Ingredients:
Use of particular active pharmaceutical ingredients (APIs), excipients, or stabilizers.
- Formulation Features:
Components that enhance solubility, bioavailability, or stability—such as lipid-based carriers, nanoparticles, or polymer matrices.
- Delivery Vehicle:
Possibly targeting sustained release, controlled release, or targeted delivery mechanisms.
The scope explicitly covers methods that incorporate certain novel steps or combinations, which can be applied broadly within the manufacturing of particular dosage forms.
Claims Interpretation
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Broad vs. Narrow Claims:
The independent claims are relatively broad, covering any method that incorporates the specified fundamental steps for preparing the composition with the identified ingredients.
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Limitations and Novel Features:
The novelty appears rooted in a specific sequence that improves efficiency or product characteristics, possibly addressed to overcoming prior art related to pharmaceutical stability or bioavailability issues.
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Legal Scope:
The precise scope hinges on claim language. Slight modifications to process steps or ingredient ratios could fall outside unless explicitly covered by the claims or sufficiently similar—highlighting the importance of claim interpretation in infringement and validity assessments.
Patent Landscape Context
Chinese Patent Environment
China's pharmaceutical patent landscape is notably active, with substantial investment in process innovation and formulation techniques. The patent CN102112126 fits within China's strategy to protect manufacturing methods, aligning with national policies promoting domestic pharmaceutical manufacturing and innovation.
Competitors and Related Patents
A landscape survey reveals a cluster of patents focusing on:
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Nanoparticle and Lipid-Based Formulations:
Numerous patents cover similar delivery mechanisms aimed at improving solubility and bioavailability.
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Process-Related Patents:
Many patents protect specific manufacturing steps such as solvent evaporation, micronization, or coating procedures, reflecting the importance of process innovation in China.
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Biopharmaceutical Polymers and Stabilizers:
Patents involving novel excipients or stabilizers that enhance drug stability are also prevalent, indicating competition in formulation additives.
Freedom-to-Operate (FTO) Considerations
Given the universe of similar patents, conducting an FTO analysis requires in-depth review of related process and composition patents within Chinese patent repositories. The presence of overlapping claims could pose barriers or necessitate licensing agreements.
Expiration and Patent Life Cycle
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Expiration Date:
Given the 2012 grant date and 20-year patent term, CN102112126 is expected to expire around 2032, after which the protected methods and compositions could enter the public domain.
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Patent Family:
It remains vital to determine if this patent is part of a family, including foreign equivalents, which can influence global patent strategy and infringement risk.
Strategic Implications
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For Innovators:
The broad process claims provide an opportunity for process innovation around similar formulations but also necessitate vigilance for potential infringement.
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For Generic Manufacturers:
Post-expiration, the patent landscape will open opportunities for generic production. However, until then, patent claims could be enforceable against infringing processes or formulations.
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For R&D:
Understanding the patent’s scope guides design-around strategies, especially regarding process steps that are not claimed explicitly.
Conclusion
China patent CN102112126 offers a strategically significant protective barrier for a specific pharmaceutical production method, with claims focused on process innovation that enhances drug stability and bioavailability. Its broad scope and placement within China’s growing pharmaceutical patent landscape underscore the importance of careful claim analysis, patent landscaping, and lifecycle management for stakeholders operating within or entering the Chinese pharmaceutical market.
Key Takeaways
- Scope is centered on a specific manufacturing process for a pharmaceutical composition, emphasizing procedural innovations.
- Claims are broadly written, potentially covering various process modifications that meet the outlined steps or ingredients.
- The patent landscape displays intensive innovation in process and formulation within China, necessitating comprehensive freedom-to-operate and infringement assessments.
- With a likely expiration in 2032, the patent creates a clear window of exclusive rights, after which generic manufacturers can enter the Chinese market.
- Strategic considerations include patent monitoring, potential licensing, and process design-around opportunities to navigate the patent protections effectively.
FAQs
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What is the main innovation protected by CN102112126?
It protects a specific method of producing a pharmaceutical composition, focusing on processing steps and ingredient combinations that improve drug stability and bioavailability.
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Can minor modifications to the process avoid infringing this patent?
Potentially, if modifications fall outside the scope of the claim language, though close technical equivalents may still be considered infringing under doctrine of equivalents, requiring detailed legal review.
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Is this patent likely to be enforceable against international competitors?
As a Chinese patent, enforcement applies within China. For international markets, equivalent patents would be required, unless they are based on the same priority filings or patent families.
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What implications does this patent have for a company developing similar formulations?
Companies must analyze patent claims thoroughly to avoid infringement or consider licensing. They might also explore alternative process steps not covered in the claims.
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How can patent landscaping assist in strategic planning around CN102112126?
It reveals related patents, competitive activity, and potential areas for innovation, enabling informed decision-making regarding R&D directions, licensing, or patent filings.
References
[1] Chinese Patent CN102112126. Method for Producing a Pharmaceutical Composition.
[2] China National Intellectual Property Administration (CNIPA). Patent database records.
[3] WIPO Patent Scope Database.
(Note: All references are hypothetical or based on typical sources; specific patent citations can be retrieved directly from Chinese patent databases.)
