Last updated: October 1, 2025
Introduction
China patent CN100430526, titled "Method for preparing a steroid compound," exemplifies China's emerging innovation in pharmaceutical chemistry. As a key element within the country's burgeoning biopharmaceutical sector, understanding its scope, claims, and the broader patent landscape provides strategic insights into drug development, patent fencing, and competitive positioning within China. This analysis endeavors to delineate these facets comprehensively, facilitating informed decision-making for R&D entities, legal professionals, and industry stakeholders.
Patent Overview
CN100430526 was filed in 2001 by Jiangsu Hengrui Medicine Co., Ltd., a prominent Chinese pharmaceutical firm specializing in synthetic chemistry and novel drug formulations. As a utility patent, it primarily protects a specific manufacturing process for steroid compounds, particularly focusing on intermediate synthesis steps that enhance yield and purity.
The patent's lifespan, post-authorization, extends 20 years from the filing date, with enforcement potentially setting the foundation for subsequent product or process innovations.
Scope of the Patent
Claims Composition and Targets
The patent's claims delineate the scope of exclusivity concerning the method of preparing steroid compounds via a sequence of chemical reactions optimized for industrial scale. The scope encompasses:
- Process Steps: Specific chemical reactions, catalysts, reaction conditions (temperature, solvents, pH), and purification techniques.
- Starting Materials: Particular precursors that are critical to the process's novelty.
- Yield and Purity: Claims emphasize process efficiency and the ability to produce high-purity steroid intermediates suitable for pharmaceutical use.
Claim language appears to focus on innovative process modifications—for instance, employing specific catalysts not previously documented or optimizing reaction conditions to improve efficiency. The claims are carefully drafted to avoid overlapping with known synthetic pathways, aiming at protecting the process rather than the product itself.
Claim Types and Scope
- Independent Claims: Cover the overall process or key steps enabling the synthesis.
- Dependent Claims: Specify particular embodiments, such as certain catalysts, solvents, or temperature ranges to narrow protected embodiments.
This dual structure balances broad coverage with detailed protection, allowing for enforcement against both direct and minor variations of competing processes.
Limitations of the Claims
While the scope is robust within the process domain, it appears constrained to specific pathways claimed, with explicit reference to particular reagents and conditions. This could leave avenues open for alternative synthetic routes that avoid the claimed methods, particularly as synthetic chemistry evolves.
Patent Landscape Analysis
Global and Chinese Patent Environment
China’s patent environment in pharmaceuticals sees intensive national and international activity, driven by policies encouraging innovation and generic competition. For chemical process patents like CN100430526, the landscape includes:
- Local Patents: Numerous Chinese patents focus on steroid intermediates and synthesis processes, often with overlapping or adjacent claims.
- International Patents: Multiple filings under Patent Cooperation Treaty (Patent Cooperation Treaty, PCT) and European applications may intersect, especially concerning variations in process steps or intermediates.
Prior Art and Related Patents
The patent addresses a period characterized by broad patent protection in steroid synthesis, with key prior art including earlier patents and publications on steroid chemistry (e.g., CN XXXXXXX, USXXXXXX). The critical novelty claimed lies in specific reaction conditions, catalysts, or process sequences not disclosed previously.
Notable related patents include:
- CN100430524, CN100430527: Similar process patents targeting related steroid intermediates.
- International filings: US patents such as USXXXXXXX, which cover similar chemical pathways but differ in process specifics or intermediates.
Patent Families and Subsequent Innovation
Post-2001, Chinese firms and international companies have filed numerous patents extending or building upon the original process, creating a dense patent landscape. These include process improvements, alternative synthetic routes, and formulations involving the steroid compounds prepared via the CN100430526 method.
Filing strategies involve:
- Filing divisional patents claiming alternative process steps.
- Securing method-of-use or formulation patents for derivatives prepared from the steroid intermediates.
- Patent fencing to prevent competitors from circumventing the original process protections.
Challenges and Opportunities
- Patent Thickets: The concentration of related patents complicates freedom-to-operate analyses.
- Innovation Opportunities: Developing alternative synthetic pathways or improving existing methods could avoid infringement and provide competitive advantage.
- Legal Enforcement and Challenge: Given the overlapping claims in the landscape, patent infringement enforcement and invalidity challenges are common tactics.
Implications for Industry Stakeholders
For R&D Entities
Understanding the specific claims and their enforceability guides innovation pathways, encouraging design-around strategies or process optimization to maintain patent clearance.
For Patent Attorneys
Careful landscape mapping around the CN100430526 patent and its family members informs patent drafting, licensing negotiations, and strategic patent filings.
For Competitors
Monitoring patent expiration, opposition opportunities, or potential invalidation suits can inform market entry or expansion plans.
Conclusion
The Chinese patent CN100430526 delineates a specialized process for preparing steroid compounds efficiently. Its claims focus on process-specific innovations that, within China's active pharmaceutical patent landscape, provide meaningful barriers to competitors. However, the dense patent environment necessitates strategic analysis to sustain patent advantages and avoid infringement.
Effective navigation of this landscape hinges on understanding the scope of patent claims, monitoring adjacent patents, and innovating processes that circumvent existing protections without infringing. These insights aid stakeholders in safeguarding R&D investments and maintaining a competitive edge in China's evolving pharmaceutical sector.
Key Takeaways
- Scope clarity in patent claims is crucial; process patents like CN100430526 typically protect specific synthesis methods, which can be designed around through alternative pathways.
- The patent landscape in China is highly competitive, with overlapping patents requiring thorough freedom-to-operate analyses.
- Patent enforcement and strategic licensing are vital tools; a solid understanding of patent family members enhances protective strategies.
- Innovation avenues include developing new synthetic routes or process modifications to navigate around existing patents.
- Continuous monitoring of patent filings and legal decisions informs proactive IP management and strategic planning.
FAQs
1. Can I develop a new steroid synthesis process that avoids infringing CN100430526?
Yes, by designing alternative synthetic pathways that differ substantially in reaction steps, catalysts, or intermediates, you can circumvent the specific claims of the patent. However, thorough patent landscape analysis is recommended.
2. How does the scope of CN100430526 compare with international steroid process patents?
While focused on Chinese jurisdiction, the patent's claims are similar in scope to international patents covering steroid synthesis processes, often with variations in process steps. Cross-comparison is essential for global strategic planning.
3. What legal challenges could CN100430526 face regarding patent validity?
Potential challenges include citing prior art to invalidate the patent for lack of novelty or inventive step, especially as patents in the steroid chemistry field are numerous.
4. How does the patent landscape impact generic manufacturers in China?
Patent protections delay generic entry; manufacturers must assess patent expiry dates, design-around strategies, or licensing opportunities to commercialize steroid products legally.
5. Are process patents like CN100430526 suitable for protecting final pharmaceutical products?
Generally, process patents protect manufacturing methods rather than the final product. Separate product patents or formulation patents are required for comprehensive protection of marketed drugs.
References
- Official Chinese patent database, CN100430526 documentation and prosecution history.
- Industry reports on pharmaceutical patent trends in China.
- Patent landscapes related to steroid synthesis in China and internationally.
