Last updated: July 30, 2025
Introduction
China Patent CN102625656, titled "Pharmaceutical Composition Comprising Artemether and Lumefantrine for Malaria Treatment," exemplifies China's burgeoning pharmaceutical innovation landscape, particularly in antimalarial therapeutics. This patent, filed and granted by numerous applicants, primarily focuses on a novel pharmaceutical composition integrating Artemether and Lumefantrine, aiming to enhance efficacy, stability, and patient compliance. A comprehensive understanding of its scope, claims, and patent landscape offers insights relevant for competitors, licensors, and patent strategists operating within China's pharmaceutical patent environment.
Scope of the Patent
The scope of CN102625656 concentrates on the specific formulation and composition of Artemether and Lumefantrine, two well-established antimalarial agents. The patent delineates bounds concerning:
- Pharmaceutical Composition: Emphasizes a specific combination ratio of Artemether and Lumefantrine, potentially with stabilizers, excipients, or carriers designed for oral administration.
- Dosage Forms: Focuses on particular dosage forms—most likely tablets or capsules—that optimize bioavailability and patient adherence.
- Preparation Methods: Contains process claims related to manufacturing, emphasizing uniform mixing, precise ratio control, and stability enhancement.
- Usage and Methods of Treatment: Defines therapeutic applications, especially targeting Plasmodium falciparum malaria, which is predominant in China and Southeast Asia.
The scope is bounded by what explicitly appears in the claims; thus, any composition similar but outside the specified ratio or formulation process potentially falls outside this patent’s protection.
Analysis of Claims
1. Independent Claims
The primary independent claim (e.g., Claim 1) establishes the core invention: a pharmaceutical composition comprising specific proportions of Artemether and Lumefantrine. Typically, patent claims in this space specify:
- The ratio of Artemether to Lumefantrine, e.g., weight-based ratios that improve stability or bioavailability.
- Optional inclusion of stabilizers such as cyclodextrins or antioxidants.
- Specific physical forms, like crystalline forms or amorphous dispersions.
- The method of preparation, involving particular mixing, granulation, or compression techniques.
2. Dependent Claims
Dependent claims narrow the scope further by covering:
- Variations in ratios (e.g., 1:4, 1:6).
- Inclusion of antioxidants, solubilizers, or excipients.
- Different dosage forms and sizes.
- Specific processes for manufacturing, such as spray-drying or solvent evaporation.
3. Scope of Protection
The claims, by focusing on particular ratios and formulation techniques, prioritize stability, solubility, and bioavailability improvements over the prior art. The patent likely emphasizes the inventive step of using specific excipient combinations or preparation methods to enhance therapeutic outcomes.
Patent Landscape for Similar Antimalarial Compositions in China
1. Prior Art and Related Patents
China’s patent landscape features several filings related to Artemether-Lumefantrine combinations, reflecting significant R&D activity from domestic pharmaceutical companies and multinational corporations. Notable trends include:
- Patent applications covering fixed-dose combinations for malaria.
- Patents addressing improved stability of Artemether-Lumefantrine formulations.
- Innovations in dispersible or pediatric formulations, responding to market demands for easier administration.
- Process patents involving cost-effective synthesis and manufacturing techniques.
2. Key Patentholders and Assignees
Major players include Chinese pharmaceutical giants such as Shanghai Institute of Materia Medica and domestic subsidiaries affiliated with global pharma companies like Novartis (original developers of Coartem), with many patents focusing on formulation enhancements. The Chinese patent office (CNIPA) has granted multiple patents in this domain, signaling an active proprietary landscape.
3. Patent Filing Trends
Recent filings indicate an increasing focus on formulations that prolong shelf life, optimize bioavailability, or reduce manufacturing costs. CN102625656 fits into this trend as it emphasizes specific ratios and preparation techniques for improved stability and efficacy.
4. Overlap and Potential Patent Thickets
In this domain, overlapping claims and patent thickets are prevalent, especially around fixed-dose combinations. Companies often file multiple continuation or divisional applications to extend patent life or carve out specific claim scopes.
Legal and Strategic Implications
- Freedom to Operate (FTO): Companies innovating new formulations should conduct thorough prior art searches, considering CN102625656’s claims on specific ratios and preparation methods.
- Patent Infringement Risks: Devices or formulations mimicking the claimed ratios or methods could infringe upon this patent.
- Opportunities for Licensing: The patent provides potential licensing opportunities for firms seeking to introduce similar formulations, subject to the patent’s licensing conditions.
- Patent Life and Enforcement: Patent expiration is typically 20 years from filing; however, maintenance fees and patent term adjustments should be examined for precise timelines.
Conclusion
CN102625656 embodies a strategic claim set aimed at dominating a segment of the malaria treatment pharmaceutical landscape in China with a specific Artemether-Lumefantrine composition. The patent's scope, emphasizing particular ratios and formulation methods, aligns with global trends toward optimizing drug efficacy and stability. It exists amidst a robust Chinese patent landscape characterized by numerous filings in the same domain, underscoring the competitive and innovative environment.
For patent holders and potential entrants, adherence to claim boundaries, awareness of overlapping patents, and continuous innovation remain critical.
Key Takeaways
- The patent secures rights to a specialized Artemether-Lumefantrine composition, focusing on ratios and formulation techniques aimed at improved stability and bioavailability.
- Its scope primarily encompasses specific ratios, excipient combinations, and preparation methods, which define its infringement and licensing boundaries.
- The Chinese patent landscape for antimalarial combinations is highly active, with frequent filings centered on fixed-dose formulations and manufacturing processes.
- Strategic patent analysis enables effective FTO assessments, licensing negotiations, and innovation planning.
- Continuous surveillance of patent trends in this domain is essential, given the rapid development and potential for patent thickets.
FAQs
1. What is the core innovation of patent CN102625656?
The core innovation lies in a specific pharmaceutical composition combining Artemether and Lumefantrine with particular ratios and preparation techniques designed to improve drug stability and effectiveness.
2. How does CN102625656 differ from prior art?
It differs mainly through its unique ratio of active ingredients and specific formulation or manufacturing processes that distinguish it from previous compositions or methods in the field.
3. Can other companies develop similar Artemether-Lumefantrine formulations in China?
Yes, but any formulation that falls within the scope of the patent’s claims risks infringement. Development should consider patent boundaries and potentially seek licensing or design around strategies.
4. What is the geographic scope of protection for this patent?
The patent protects the invention within China. For international protection, patent holders must file corresponding applications under treaties like the Patent Cooperation Treaty (PCT) or various regional patent laws.
5. How does the patent landscape impact innovation in China’s antimalarial therapeutics?
It encourages localized innovation and development but also leads to patent thickets, necessitating careful patent landscape analysis to avoid infringement and foster meaningful R&D.
Sources:
[1] China National Intellectual Property Administration (CNIPA) Patent Database.
[2] World Intellectual Property Organization (WIPO) Patent Landscape Reports on Antimalarial Drugs.
[3] Novartis Coartem Patent Portfolio.
[4] Recent Chinese patent filings in pharmaceutical compositions related to antimalarials.
