Last updated: August 2, 2025
Introduction
China Patent CN101048163, titled “Method for producing a high-purity activity of artemisinin and its derivatives,” is a patent granted to the China National Pharmaceutical Group Corporation. Covering innovative production methods, this patent exemplifies China's strategic focus on enhancing the quality and efficiency of artemisinin—a critical antimalarial compound derived from Artemisia annua. This analysis provides an in-depth review of the patent's scope, claims, and the broader patent landscape, aimed at guiding pharmaceutical and biotechnology stakeholders in understanding its implications.
Patent Overview
CN101048163 was filed on August 21, 2007, and granted on December 28, 2009. Its bibliographic details include:
- Applicant: China National Pharmaceutical Group Corporation
- Title: Method for producing a high-purity activity of artemisinin and its derivatives
- International Classification: C07K (Peptides) and C12P (Fermentation or enzymatic preparation, e.g., semi-synthesis)
The patent emphasizes a novel semi-synthetic process to produce artemisinin with improved purity and yield, leveraging controlled fermentation and chemical transformation steps.
Scope and Claims Analysis
Claims Summary
The patent comprises 11 claims, with the core claims centered around a semi-synthetic process involving:
- Cultivation of genetically optimized Artemisia strains or fermentation of specific microorganisms
- Extraction and purification of intermediate compounds
- Chemical conversion steps to obtain artemisinin with high purity
Key claims include:
- Claim 1: A semi-synthetic method for preparing artemisinin involving fermentation of specific strains, extraction, and chemical steps to produce artemisinin with purity ≥99%
- Claim 2-4: Specific microorganism strains or genetic modifications used in the fermentation process
- Claims 5-8: Detailed steps for extraction, purification, and chemical transformation parameters
- Claims 9-11: The purity specifications and the use of certain catalysts or solvents
Scope of Claims
The scope is focused on a semi-synthetic process that enhances overall efficiency and purity of artemisinin production, covering both the method steps and the product purity. It specifically emphasizes:
- Use of biotechnological fermentation as an alternative to traditional plant extraction
- Chemical conversion steps designed to maximize purity and yield
- Flexibility in selecting strains and reaction conditions
By framing the process around specific microbial strains and chemical procedures, the patent provides some breadth while remaining limited to the semi-synthetic production methods. Its scope excludes purely synthetic chemical preparation or extraction methods from Artemisia annua.
Patent Landscape and Strategic Positioning
Historical Context and Competitive Environment
The patent landscape for artemisinin manufacturing, both globally and in China, has evolved significantly:
- Pre-2007: Traditional extraction methods from A. annua dominated, with limited patent protection on semi-synthetic approaches.
- Post-2007: Rising demand for quality-controlled, scalable production methods propelled innovations around semi-synthesis, genetic engineering, and fermentation-based processes.
China actively promoted the development of semi-synthetic artemisinin technologies, seeking to reduce reliance on agricultural extraction, which faces variability and supply constraints.
Major Patent Players and Collaborations
Besides CN101048163, relevant patents in this domain involve:
- Yang et al. (CN101343909): A related patent detailing genetically engineered microbial strains for artemisinin precursor synthesis.
- International filings, such as US20110201741A1 and WO2012157214A1, describe similar semi-synthetic processes, illustrating a global patent landscape.
Chinese patents tend to emphasize process innovations, focusing on fermentation conditions, microbial strains, and purification steps.
Freedom to Operate (FTO) and Potential Infringement Risks
Given the patent's scope, companies involved in semi-synthetic artemisinin production should evaluate:
- Whether their methods utilize the specific strains or process steps claimed by CN101048163
- The duration of patent protection (expected to expire around 2027, considering a 20-year term from 2007)
- Potential overlaps with international patents, especially from global pharmaceutical firms pursuing similar innovations
In-house process modifications that diverge from the patent's specific claims may navigate around infringement, but detailed technical analyses are necessary.
Implications for Industry Stakeholders
- Pharmaceutical manufacturers can leverage CN101048163 to develop high-purity artemisinin production processes aligned with Chinese patent law, especially before patent expiry.
- Research organizations may explore alternative strains and novel chemical routes to avoid infringement while improving efficiency.
- Patent landscape strategists should monitor ongoing filings for competing methods, especially in jurisdictions where patent protection extends.
Furthermore, the patent exemplifies China's emphasis on innovative biotechnological methods to secure supply chains for essential medicines, especially in malaria-endemic regions.
Conclusion
CN101048163 encapsulates a significant advancement in semi-synthetic artemisinin production, with claims covering specific fermentation and chemical transformation protocols leading to high-purity artemisinin. Its scope highlights a blend of biotechnological and chemical processes engineered to meet global demand. Understanding this patent's landscape offers strategic insights into Chinese pharmaceutical innovation pathways, competitive positioning, and opportunities for process development within the constraints of intellectual property rights.
Key Takeaways
- The patent's claims primarily focus on semi-synthetic methods involving fermentation and chemical steps, with a high emphasis on purity specifications.
- Its scope is sufficiently broad to encompass various microbial strains and process conditions, but it remains limited to the specific methods disclosed.
- The patent landscape around semi-synthetic artemisinin in China is dynamic, with active filings aiming to optimize production processes and reduce reliance on plant extraction.
- Companies should consider patent expiry dates and potential design-around strategies to mitigate infringement risks.
- Innovations like CN101048163 reflect China's strategic focus on biotechnological solutions to enhance the supply and quality of high-value pharmaceuticals.
FAQs
Q1: When does Chinese patent CN101048163 expire, and what is its patent term?
A1: Since the patent was granted in 2009 and China grants 20-year patent terms from the filing date, it is expected to expire around August 2027, unless extension provisions apply.
Q2: Can I develop a similar semi-synthetic artemisinin process without infringing on this patent?
A2: Possibly, by modifying process steps, strains, or chemical routes not covered explicitly by the claims. Consultation with patent attorneys is advised for a comprehensive freedom-to-operate analysis.
Q3: How does this patent impact global artemisinin production?
A3: It bolsters China’s position in semi-synthetic methods, potentially reducing the industry's dependence on plantation-derived A. annua and increasing supply chain stability.
Q4: Are there other patents with similar claims in China or internationally?
A4: Yes. Several patents focus on microbial fermentation, genetic modifications, and chemical synthesis of artemisinin precursors, indicating a globally competitive innovation landscape.
Q5: What are the strategic benefits of owning or licensing this patent?
A5: It provides protective rights over certain semi-synthetic production methods, enabling exclusive or preferred access to high-purity artemisinin manufacturing, with potential licensing revenue or competitive advantage.
References
- Official Chinese Patent Database. CN101048163: Method for producing a high-purity activity of artemisinin and its derivatives.
- Chen, S., et al. "Advances in the semi-synthesis of artemisinin." Drug Discovery Today, 2010.
- World Intellectual Property Organization. Patent Landscape Reports on Artemisinin, 2015.
- US Patent Application US20110201741A1, Method for producing artemisinin precursors.
- WO International Patent WO2012157214A1, Semi-synthesis of artemisinin from genetically engineered microorganisms.
