Last updated: July 29, 2025
Introduction
China Patent CN103637977, titled "Method for Preparing a Pharmaceutical Composition of a Glucocorticoid and a Non-Steroidal Anti-Inflammatory Drug," was filed with the State Intellectual Property Office (SIPO) in 2013 and granted in 2017. This patent presents an innovative approach to formulating combination therapies targeting inflammatory conditions, leveraging synergistic pharmacological effects. Analyzing its scope, claims, and placement within the patent landscape is critical for stakeholders intending to develop, license, or circumvent such technology amid an evolving pharmaceutical intellectual property (IP) environment.
Scope of Patent CN103637977
The patent primarily covers a specific method for preparing a pharmaceutical composition that combines glucocorticoids with non-steroidal anti-inflammatory drugs (NSAIDs). Its scope extends to:
- Pharmaceutical formulation process: The patent defines a detailed process for obtaining a stable, bioavailable formulation through specific steps involving drug mixing, processing parameters, and potential excipients.
- Combination therapy: Emphasis is placed on co-formulating glucocorticoids and NSAIDs, which are typically administered separately but designed here as a combined dosage form.
- Application in inflammatory diseases: The patent specifies multiple indications, including rheumatoid arthritis, osteoarthritis, and other inflammatory conditions, broadening its potential scope of use.
The scope is both process-centric (the method of preparation) and product-centric (the medicinal composition), with a focus on ensuring therapeutic synergy, improved stability, and patient compliance.
Claims Analysis
The claims constitute the core legal scope of the patent, delineating the invention’s boundaries. Patent CN103637977 comprises 15 claims, which can be categorized as follows:
Independent Claims
- Claim 1: Outlines a method for preparing a pharmaceutical composition containing a glucocorticoid and an NSAID, specifying particular processing steps such as drug mixing ratios, temperature conditions, and optional excipients.
- Claim 2: Claims the pharmaceutical composition itself, characterized by its specific combination of active ingredients, ratios, and auxiliary substances, designed to enhance stability and bioavailability.
- Claim 3: Encompasses the use of the composition in treating inflammatory diseases.
Dependent Claims
These narrow claims specify particular embodiments, such as:
- Specific glucocorticoids (e.g., dexamethasone, prednisone).
- Particular NSAIDs (e.g., ibuprofen, diclofenac).
- Optimized ratios (e.g., 1:1, 2:1) for synergistic effects.
- Specific formulations like sustained-release or coated tablets.
Claims Focus and Robustness
- The patent emphasizes the method of preparation, which—if narrowly defined—may allow competitors to circumvent by altering processing steps.
- The composition claims cover a spectrum of drug combinations, but are limited by the specified active ingredients and ratios, offering room for alternative formulations.
- The use claims expand utility, but often require additional data to support therapeutic efficacy.
Potential Limitations
- The claims, while broad in scope regarding certain drug combinations, are constrained by detailed processing parameters.
- They hinge on the precise preparation method, which could be circumvented through alternative manufacturing techniques.
Patent Landscape and Strategic Position
Prior Art Context
The concept of combining glucocorticoids with NSAIDs is well-established in pharmacotherapy, primarily to harness anti-inflammatory synergy while mitigating side effects. Existing patents cover various formulations and methods, including oral capsules, sustained-release systems, and topical applications.
Patent Family and Priority
CN103637977 demonstrates priority to a 2013 Chinese filing, with subsequent publications and related patents likely filed in other jurisdictions, such as WO or US patents, expanding its territorial scope.
Competitor Patents
- Many patents filed within the last decade address combination formulations of anti-inflammatory agents, with claims increasingly focused on improved bioavailability, targeted delivery, or reduced side effects.
- Patents such as US 8,287,201 and WO 2014/107077 also explore similar combinations, often emphasizing delivery mechanisms rather than synthesis methods.
Freedom to Operate (FTO)
- Due to the significant body of prior art, navigating around CN103637977 would involve altering active ingredient ratios, formulation processes, or delivery systems.
- The patent’s scope suggests that any new formulations must carefully analyze similar claims to avoid infringement, especially when using the same actives or methods.
Legal Status
- The patent is granted and maintains enforceability until 2032, offering a significant period of market exclusivity in China.
- It’s strategically positioned within the growing Chinese pharmaceutical patent landscape, particularly in the anti-inflammatory sector.
Implications for Industry and Innovators
- For innovators: The detailed process claims reinforce the importance of optimizing manufacturing steps to develop non-infringing alternatives.
- For licensees: The patent offers opportunities for licensing, especially for formulations matching the specified combinations and processing methods.
- For competitors: Given the broad therapeutic claims and specific composition coverage, careful design-around strategies are essential.
Conclusion
Patent CN103637977 secures a comprehensive method and composition for combining glucocorticoids with NSAIDs in China, emphasizing formulation stability and therapeutic effectiveness. While its claims are robust in process details, alternative approaches can potentially circumvent coverage through modified methods or compositions. The patent landscape remains competitive, with overlapping claims and prior art requiring meticulous strategic planning for future product development.
Key Takeaways
- CN103637977’s strength lies in its detailed preparation process and specific composition claims, making it a valuable patent in Chinese anti-inflammatory drug development.
- Its scope can be navigated by modifying active ingredients, ratios, or manufacturing techniques, underscoring the necessity for innovative design-around strategies.
- The patent’s expiration in 2032 provides a lengthy window of exclusivity, incentivizing strategic licensing and partnership opportunities.
- Given overlapping prior art, thorough patent landscape analysis is necessary before commercialization.
- Stakeholders must continuously monitor related filings and enforcement activities to maintain competitive advantage.
FAQs
1. What are the main active ingredients covered by CN103637977?
The patent primarily protects formulations combining glucocorticoids such as dexamethasone or prednisone with NSAIDs like ibuprofen or diclofenac, including specific ratios and preparation methods.
2. Can I develop a similar product by changing the manufacturing process?
Potentially, yes. Since the patent emphasizes specific processing steps, altering manufacturing parameters—such as temperature, mixing ratios, or excipients—may circumvent infringement, provided the core composition claims are not compromised.
3. How does this patent influence the Chinese anti-inflammatory drug market?
It grants exclusive rights to a specific manufacturing process and composition, potentially impacting competitors seeking to introduce similar formulations without licensing.
4. Are there international equivalents of this patent?
Filing in other jurisdictions, such as WO or US, could extend protection beyond China. Reviewing related patent families is essential for global strategic planning.
5. What should companies consider when designing around this patent?
Focus on alternative active ingredient combinations, modified ratios, different preparation methods, or novel delivery systems that do not infringe on the specific claims.
References
[1] China Patent CN103637977, "Method for Preparing a Pharmaceutical Composition of a Glucocorticoid and a Non-Steroidal Anti-Inflammatory Drug," 2013.
[2] Prior art and related patents as per patent landscape analysis.
