Last updated: August 1, 2025
Introduction
Patent CN101594871, titled "Preparative method for semi-synthetic penicillin antibiotics," was granted to Shandong Shuangrun Pharmaceutical Co., Ltd. It addresses the field of pharmaceutical manufacturing, specifically methods for producing semi-synthetic penicillin antibiotics. Its scope, claims, and position within the patent landscape are critical for competitors, licensors, and legal practitioners navigating the burgeoning Chinese pharmaceutical patent environment.
This analysis dissects the patent’s scope, claims, and its technological and legal landscape, providing insights into its strategic significance.
Overview of Patent CN101594871
Publication Details:
- Application Number: 200610169439.3
- Grant Date: February 21, 2012
- Priority Date: August 30, 2006
- Filing Office: China National Intellectual Property Administration (CNIPA)
Assignee: Shandong Shuangrun Pharmaceutical Co., Ltd.
Technical Field:
The patent falls within the chemical and pharmaceutical manufacturing domain, specifically the synthesis and preparation of semi-synthetic penicillin antibiotics, such as amoxicillin and ampicillin derivatives.
Scope and Claims Analysis
1. Claiming Strategy and Structuring
The patent contains independent and dependent claims focused primarily on the preparative process. This strategy distinguishes itself by emphasizing specific process steps for enhancing efficiency, yield, or purity, reflecting a typical approach in pharmaceutical process patents.
2. Core Claims and Technological Focus
Main Independent Claims:
The independent claims specify a novel process for preparing semi-synthetic penicillin antibiotics, involving:
- Use of specific raw materials or intermediates (e.g., penicillin nuclei or intermediates with defined purity).
- Particular reaction conditions such as temperature, pH, and reaction time.
- Specific catalysts or reagents that facilitate chemical transformations.
- Steps for purification and isolation of the target antibiotics with defined parameters to improve yield and purity.
Scope of Claims:
The scope is narrow, focusing on particular process parameters, which creates high specificity but limits broader patenting protection beyond the exact process steps. This narrow scope aims to shield against straightforward design-arounds while enabling coverage of incremental process innovations.
Dependent Claims:
Dependent claims specify details such as reagent concentrations, reaction atmospheres, solvent selections, and process sequences, reinforcing the process's proprietary aspects.
3. Interpretations and Implications
- Narrow Claiming: The patent emphasizes specific process parameters, aligning with Chinese patent practice favoring detailed process disclosures. This may limit opposition but also reduces the breadth of protection.
- Innovation Focus: The claims highlight improvements over prior art in process efficiency, purity, and cost-effectiveness rather than new compound structures.
4. Prior Art and Patentability
- The patent’s strategic filing during the mid-2000s coincided with prolific patenting activity in Chinese biopharmacology.
- Prior art such as WO2003/093951 and CN100482484 (methods for penicillin modifications) serve as background; the claimed process distinguishes itself via unique reaction conditions or steps.
- The patent’s narrow claims likely reduce risks of invalidation but may face challenges if broader, prior art-based novelty arguments arise.
Patent Landscape and Competitive Position
1. Surrounding Patents and Overlap
- Several Chinese patents cover antibiotics synthesis, including CN101587945 (method of amoxicillin production) and CN102062244 (penicillin intermediate manufacturing). The analyzed patent operates in a crowded space but emphasizes the incremental process aspect.
- Internationally, patents like US7,144,852 (methods for penicillin) might have overlapping inventive concepts but differ in jurisdiction and scope.
2. Enforcement and Commercial Utility
The patent’s utility hinges on the commercial importance of semi-synthetic penicillin production in China. Given China's large pharmaceutical manufacturing base, strengthening patent protection in this niche is strategically vital for protecting market share against generic competitors.
3. Patent Litigations and Challenges
No prominent litigations or oppositions are publicly recorded for CN101594871, but ongoing patent filings in China and globally could influence its enforceability and freedom to operate.
4. Impact on Innovation and R&D
The patent exemplifies incremental innovation typical in chemical process patents; it complements existing IP portfolios, facilitating licensing, technology transfer, or defensive measures.
Legal and Strategic Insights
- The process-centric claims support a robust patent protection where process improvements are key differentiators.
- Enforcing narrow claims requires vigilant monitoring to prevent design-arounds.
- Broader claims or combinations with compound patents could enhance strategic protection.
- The patent’s focus aligns with China's emphasis on process patents, especially in manufacturing-intensive sectors.
Conclusion
Patent CN101594871 exemplifies a typical Chinese pharmaceutical process patent, emphasizing specific, incremental steps for synthesizing semi-synthetic penicillin antibiotics. Its narrow scope limits but also robustly protects the specific process innovations introduced.
Understanding its claims and landscape positioning enables stakeholders to better evaluate licensing opportunities, potential infringement risks, and R&D directions in the competitive Chinese pharmaceutical patent arena.
Key Takeaways
- The patent’s narrow claims focus on specific process parameters, which provide targeted protection but may face challenges against broader prior art or alternative processes.
- Its strategic importance derives from the critical role of penicillin antibiotics in China’s pharmaceutical landscape.
- Potential licensors or licensees must scrutinize the patent’s claims and competing patents for freedom-to-operate analyses.
- Incremental process patents like CN101594871 remain vital in China’s patent system for safeguarding manufacturing innovations.
- Continuous monitoring of related patent filings and legal developments is essential to maintaining patent strength and leveraging licensing opportunities.
FAQs
Q1: Can the process described in CN101594871 be directly used in manufacturing?
A1: Yes, assuming the patent is in force and the claims are broad enough to cover the process, manufacturers can implement the described steps. However, they must verify claim scope and freedom-to-operate.
Q2: How does the patent landscape influence the enforcement of CN101594871?
A2: The landscape, especially competing patents, can affect enforceability. Narrow claims reduce infringement risk but may be easier for competitors to circumvent.
Q3: What are the advantages of process patents over compound patents?
A3: Process patents can protect manufacturing methods, improving product purity, yield, and cost-efficiency, often without requiring new compound structures.
Q4: Is CN101594871 still enforceable, and what factors could affect its validity?
A4: Typically, patents are enforceable for 20 years from the filing date unless invalidated by prior art or legal challenges.
Q5: How does Chinese patent law influence the scope of claims in pharmaceuticals?
A5: Chinese law favors detailed, specific claims, particularly in chemical processes, to clearly define the invention and avoid overlaps with prior art.
References
[1] CN101594871 patent document.
[2] Relevant prior art references: WO2003/093951, CN100482484, CN101587945.
[3] Chinese patent law and practice guidelines.
