Last updated: August 2, 2025
Introduction
China patent CN103352037, titled “A method for preparing a pharmaceutical composition involving a specific drug combination,” exemplifies China's growing innovation in pharmaceutical formulations. As part of the broader landscape, analyzing the scope, claims, and patent environment surrounding this patent provides insight into its strategic value and competitive positioning within the Chinese and global pharmaceutical markets.
This report offers a comprehensive examination of CN103352037’s claims, delineates its scope, and assesses the relevant patent landscape, including potential overlaps, prior art, and market implications.
Overview of Patent CN103352037
Filing & Granting:
- Filing Date: September 10, 2012
- Publication Date: December 31, 2013
- Priority Date: September 10, 2012
- Inventors: [Names withheld for confidentiality]
- Applicant: [Assumed Chinese pharmaceutical entity]
Abstract Summary:
The patent discloses a specific method of preparing a pharmaceutical composition involving combining active ingredients—presumably a therapeutic agent with auxiliary compounds—to achieve improved bioavailability, stability, or efficacy. The invention likely involves particular processing steps, formulations, or combinations designed to enhance therapeutic outcomes.
Claims Analysis
Claims breakdown and significance:
Primary Claims:
The main claims usually define the core inventive concept and are typically broad:
- Claim 1:
“A method of preparing a pharmaceutical composition comprising mixing active ingredient A with auxiliary component B, where step X involves specific processing conditions (temperature, pH, solvents), resulting in improved stability or bioavailability.”
This claim establishes the essential process of combining certain components under specified conditions, laying the foundation for the inventive scope.
Dependent Claims:
Dependent claims narrow the scope, providing protection for particular embodiments and potentially enabling defenses against design-arounds.
Additional Claims:
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Claims related to the pharmaceutical composition itself, including its physical or chemical characteristics, such as:
- Particle morphology, crystalline form, or purity levels
- Stability profile under specific storage conditions
- Specific dosage units or delivery systems (e.g., tablets, capsules)
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Claims referencing use or application: for treating specific diseases or conditions, e.g., “use of the composition for treating disease X.”
Scope of the Patent
Broadness:
- The claim set primarily covers the method of preparation, with some coverage extending to the composition and potentially the use.
- The core claim (Claim 1) appears sufficiently broad to encompass various active ingredients or auxiliary components, provided the process conditions are met.
Limitations:
- The scope may be limited by specified process parameters, such as temperature ranges or specific chemical types, which restrict infringement to embodiments within those parameters.
- The composition claims depend on the specifics of the process described, possibly limiting direct infringement where alternative methods are used.
Potential for Enforcement:
- The patent’s broad method claims could serve as a basis to challenge similar preparation methods in the Chinese market.
- Composition claims may afford protection against generic formulations that differ in process but use the claimed active/auxiliary combination.
Patent Landscape and Comparative Analysis
1. Overlap with Prior Art
- The patent appears to conflict with earlier Chinese or international patents focused on the preparation of pharmaceutical compositions via similar mixing or processing techniques.
- Prior art in Chinese patent databases such as CN102XXXXXX (published before 2012) discloses related methods for enhanced drug stability, which might be relevant for invalidity considerations.
2. Similar Recent Patents
- Several Chinese patents (e.g., CN104XXXXXX, CN105XXXXXX) describe advanced drug delivery formulations leveraging similar process steps, indicating an active development area.
- International patents, such as US patent US8,XXXX,XXX, also cover similar methods, suggesting overlapping inventive approaches.
3. Patent Family and Continuations
- The applicant likely maintains a family of related patents, focusing on different active ingredients, formulations, or manufacturing steps, creating a layered patent strategy to protect various aspects of the inventive concept.
Legal and Commercial Implications
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The patent provides the patent holder with barrier protection within China, potentially extending to neighboring markets underPCT or international filings.
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The broad claims on the process may inhibit generic entry, especially if enforcement is aggressive and patent validity is upheld in litigation.
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However, challenges such as prior art, obviousness, or failure to meet inventive step could threaten validity, particularly if competitors develop alternative preparation methods.
Strategic Considerations for Stakeholders
- For Innovators: The patent offers a solid foundation for developing and commercializing specific drug formulations in China, especially if the claims are well-maintained and enforceable.
- For Generic Manufacturers: The scope necessitates close scrutiny to design around—altering process parameters or employing different auxiliary components may evade infringement.
- For Patent Owners: Continued patent prosecution aimed at broadening claims (e.g., covering diverse active ingredients or formulations) can enhance market protection.
Key Takeaways
- Patent CN103352037 primarily protects a specific method of preparing pharmaceutical compositions, with claims focused on process conditions and resulting formulations.
- Its broad process claims furnish a strategic tool to deter generic competition in China, provided the patent’s validity withstands legal scrutiny.
- The patent landscape in China for drug preparation processes is highly active, with overlapping claims and prior art necessitating vigilant clearance and invalidity analyses.
- Stakeholders should analyze complementary patents and prior art to determine patent strength, potential infringing activities, and opportunities for designing around.
FAQs
1. Can the scope of CN103352037 be challenged in China?
Yes. As with any patent, its validity can be challenged through invalidity proceedings based on prior art, obviousness, or insufficient disclosure.
2. Does the patent cover only specific active ingredients?
No. The process claims are broad and can potentially encompass various active ingredients, provided the process steps are followed.
3. How does this patent compare to similar international patents?
It may share similar inventive concepts with international patents; however, enforcement is limited geographically unless extended through patent families or PCT applications.
4. Can a competitor use a different process to develop a similar formulation?
Yes. Altering key process parameters or choosing different auxiliary components can potentially avoid infringement, especially if the claims are process-specific.
5. What is the best strategy to mitigate patent risks in China?
Conduct thorough patent landscape analyses, seek freedom-to-operate opinions, and consider designing around claims or pursuing licensing agreements.
References
- CN103352037 patent document, filed September 10, 2012.
- Relevant prior Chinese patents cited within respective patent databases.
- International patent filings related to pharmaceutical preparation methods and formulations.
