Last updated: August 1, 2025
Overview of WIPO Patent WO2005028443
The patent application WO2005028443, filed under the auspices of the World Intellectual Property Organization (WIPO), pertains to the use, formulation, and treatment methods involving Miltefosine—originally developed as an anticancer agent and later recognized for its antileishmanial properties. Although specific bibliographic data for this patent indicates its publication date around March 10, 2005, the patent family and subsequent national phase entries reflect a broad strategic interest in protecting Miltefosine's use for parasitic diseases, notably leishmaniasis.
The invention’s primary focus is on novel pharmaceutical formulations and treatment regimens that leverage Miltefosine’s antiparasitic activity, including methods for its administration in the context of visceral and cutaneous leishmaniasis.
Scope of the Patent: Key Aspects
1. Technical Field and Purpose
The patent broadly addresses pharmaceutical compositions containing Miltefosine, emphasizing improved formulations for oral or topical administration and methods for treating parasitic infections caused by Leishmania species. It also covers novel dosages, treatment regimens, and combination therapy approaches aimed at enhancing efficacy and reducing side effects.
2. Core Innovations and Claims
The scope extends across:
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Pharmaceutical formulations: Novel dosage forms, such as sustained-release formulations, liposomal carriers, or specific excipient combinations that optimize bioavailability.
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Treatment methods: Specific regimens involving dosages, timing, or combination with other antiparasitic agents, aiming to optimize therapeutic outcomes while mitigating toxicity.
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Use claims: The application of Miltefosine for the treatment of leishmaniasis, both visceral and cutaneous, including pediatric and immunocompromised patients.
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Stability and bioavailability enhancements: Claims related to improved stability under storage conditions and enhanced absorption profiles through targeted delivery systems.
3. Claims Analysis
The patent’s claims are structured to provide broad coverage over methods and compositions, with particular emphasis on:
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Method of administering Miltefosine in a way that improves tolerability, for example, via specific dosages over defined treatment periods.
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Pharmaceutical compositions comprising Miltefosine combined with specific carriers, liposomes, or excipients.
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Use of Miltefosine in the preparation of medicaments for treating Leishmania infections.
Claim hierarchy typically begins with broad 'use' or 'composition' claims, followed by narrower claims defining specific formulations, dosages, or treatment regimens.
Patent Landscape Analysis
1. Prior Art and Related Patents
Miltefosine's journey from an oncology candidate to an antiparasitic drug resulted in various patent filings focusing on formulations, uses, and combination therapies. The WO2005028443 patent intersects with patents from major pharmaceutical companies, including:
- The initial patenting of Miltefosine's antiparasitic use in India and other jurisdictions (e.g., Indian Patent Nos. 198733, 264672).
- Patent applications from pharmaceutical companies such as Zentiva (now part of Sanofi) and others targeting liposomal or topical formulations.
2. Patent Family and Geographic Coverage
The patent family for WO2005028443 covers multiple jurisdictions via national phase entries, including the US, EP (Europe), India, and Brazil. These regions mirror the high prevalence of leishmaniasis and represent strategic markets for anti-parasitic drugs.
3. Freedom-to-Operate and Competition
While the core patent provides broad claims, several subsequent patents and patent applications focus on specific formulations, such as liposomal Miltefosine (e.g., WO2014182454), or combination therapies. Companies operating in the antiparasitic space must navigate around these patents through alternative formulations, dosage claims, or by licensing arrangements.
4. Patent Challenges and Validity
Given the age of the patent application, legal challenges based on prior art often emerge in jurisdictions like India and the US. The patent's scope could be scrutinized regarding novelty and inventive step, especially as Miltefosine itself was known for its antileishmanial activity prior to this patent's filing.
Implications for Pharmaceutical Development and Business
Regulatory and Commercial Outlook
The patent landscape underscores a crowded environment where innovation tends to focus on drug delivery systems, combination therapies, and specific treatment protocols, rather than the compound’s core use. Companies investing in patenting delivery technology or novel treatment regimens can secure a competitive edge in markets with significant leishmaniasis burden, such as India, Brazil, and Southeast Asia.
Potential for Patent Expiry and Generics
As many patents related to Miltefosine expire or face patent challenges, the market is increasingly open to generics, particularly in endemic regions. However, nuanced formulations or uses still present patenting opportunities.
Key Takeaways
- The WO2005028443 patent broadens the patent protection scope of Miltefosine by covering formulations and treatment methods, reinforcing its strategic importance in antiparasitic therapies.
- Robust claims cover various pharmaceutical compositions, including sustained-release and lipid-based carriers, addressing bioavailability and tolerability issues.
- The patent landscape is characterized by a mix of broad patents and narrow, technology-specific patents—companies must navigate this landscape carefully by innovating around existing claims or securing licensing deals.
- Patent challenges based on prior art, especially in jurisdictions like India, necessitate continuous innovation and strategic patent prosecution.
- The evolving landscape presents both risks (patent cliffs, patent validity issues) and opportunities (formulation innovation, combination therapies).
FAQs
1. What is the main medical use covered by WIPO patent WO2005028443?
It primarily covers the use of Miltefosine for treating leishmaniasis, including formulations and administration methods designed to improve efficacy and tolerability.
2. How broad are the claims of this patent?
The claims encompass various formulations of Miltefosine, treatment methods, dosages, and use in combination therapies, enabling broad protection over pharmaceutical compositions and treatment protocols.
3. What are key strategic considerations for companies regarding this patent?
Competitors must analyze the patent's claims to avoid infringement and explore alternative formulations or regimens. Licensing or patent litigation might also be plausible strategies.
4. How does this patent fit within the patent landscape of antiparasitic drugs?
It complements prior patents on Miltefosine’s use, focusing on formulation and method claims, thereby shaping the patent space for innovative delivery systems and treatment approaches.
5. Will patent expirations impact the availability of Miltefosine?
Potentially. As patents expire or are challenged, generic manufacturing increased, which could influence pricing and accessibility, especially in endemic regions.
References
[1] WIPO patent publication WO2005028443.
[2] Indian Patent No. 198733 (Miltefosine use).
[3] Indian Patent No. 264672 (Miltefosine formulations).
[4] WO2014182454 (Liposomal Miltefosine formulations).
[5] Clinical and Regulatory Data on Miltefosine, WHO Reports.
