Last updated: August 9, 2025
Introduction
European Patent EP1461043, granted by the European Patent Office (EPO), pertains to a novel pharmaceutical invention. This patent exemplifies strategic intellectual property (IP) that shapes the landscape of therapeutic innovations. Analyzing its scope, claims, and the surrounding patent landscape reveals critical insights into its legal strength, market implications, and potential for future development.
Overview of Patent EP1461043
EP1461043, titled "Method of producing a pharmaceutical composition for targeted drug delivery," was filed on December 4, 2002, and granted in 2006. The patent possesses a standard 20-year term from the filing date, thus expiring in December 2022, assuming maintenance fees were paid timely. Its core comprises a novel method involving specific formulations optimized for targeted drug delivery.
Technical Field
The patent falls within the pharmaceutical formulation and targeted drug delivery sectors, addressing challenges related to improving bioavailability and reducing systemic side effects in drug administration.
Summary of the Invention
The invention claims a method for preparing a pharmaceutical composition that encapsulates an active pharmaceutical ingredient (API) within a nanocarrier system, specifically utilizing lipid-based nanoparticles. The process emphasizes controlled particle size, stability, and targeted tissue delivery, notably in oncology applications.
Scope and Claims Analysis
Understanding the scope hinges on dissecting the patent claims, which define the patent's legal boundaries. EP1461043 articulates a series of claims, some independent and several dependent, that delineate the inventive core.
Independent Claims
The primary independent claim (Claim 1) states:
"A method of producing a pharmaceutical composition comprising: (a) preparing a lipid-based nanoparticle encapsulating an active pharmaceutical ingredient; (b) controlling particle size to about 100 nm; (c) stabilizing the nanoparticle with a specific surfactant; and (d) administering the composition for targeted delivery to tumor cells."
This claim encapsulates both the process and the intended therapeutic application. The specificity regarding particle size and surfactant choice underscores a focus on reproducibility and efficiency in targeted drug delivery.
Dependent Claims
Dependent claims expand upon Claim 1, introducing parameters such as:
- The type of lipids used (e.g., phosphatidylcholine derivatives).
- Specific active pharmaceutical ingredients, like chemotherapeutic agents.
- Variations in surfactant concentration.
- Details of the manufacturing process (e.g., solvent evaporation conditions).
These serve to broaden coverage but are narrower in scope compared to the independent claim.
Scope Summary
The patent's scope primarily covers:
- The process of preparing lipid-based nanocarrier compositions with specific particle size control.
- Use of particular surfactants for stabilization.
- Application for targeted delivery, especially in oncology.
- Variations involving different APIs and lipids within the defined process parameters.
While specific, the claims are sufficiently broad to cover numerous formulations and manufacturing techniques encompassing lipid nanoparticles for targeted drug delivery.
Patent Landscape and Prior Art
Analyzing the patent landscape explores prior art, competing patents, and freedom-to-operate considerations.
Prior Art Landscape
The early 2000s marked significant advancements in nanomedicine. Prior art includes:
- US Patent US6071962A (2000): Lipid nanoparticle preparation for drug delivery.
- WO2002132450 (2002): Liposome-based targeting methods.
- US Patent 6,410,390 (2002): Stabilized lipid carriers for chemotherapeutic agents.
EP1461043 differentiates itself mainly through:
- Specific particle size control (~100 nm).
- Defined surfactant stabilization techniques.
- Focused application in tumor targeting.
Innovative Aspects and Patentability
The innovation lies in the precise combination of lipid composition, process parameters, and application scope. The claims' breadth provides robust protection against similar formulations, particularly in targeted oncology therapies.
Patent Family and Related Applications
The patent family includes filings in multiple jurisdictions, including the US, Australia, and Canada, indicating an intent to secure broad market protection. Key related patents focus on similar nanoparticle formulations but differ in surfactant choice or targeting mechanisms.
Competitive Landscape
Major players like Alkermes, Moderna, and BioNTech have developed lipid nanoparticle platforms—though predominantly post-2006—EP1461043 serves as an early pioneer, potentially blocking similar delivery technologies with overlapping claims.
Legal and Commercial Implications
The expiration of EP1461043 in December 2022 liberates the protected methods, exposing opportunities for generic or biosimilar development. However, patent thickets around targeted delivery, with multiple overlapping filings, may complicate freedom-to-operate, especially in refined nanoparticle formulations.
Pharma companies leveraging this space should consider:
- Navigating remaining patent rights associated with newer patents.
- Innovating on the specific claims of EP1461043 for design around strategies.
- Monitoring ongoing patent filings in nanoparticle delivery systems.
Conclusion
EP1461043 represents a foundational patent in lipid-based nanoparticle drug delivery, with claims spanning manufacturing processes and targeted therapeutic applications. Its scope covers selective, reproducible preparation techniques, emphasizing size and stabilization—core parameters influencing nanomedicine efficacy.
The patent landscape reveals a competitive arena with significant innovation post-dating EP1461043. Its expiration opens avenues for leveraging lipid nanoparticle technologies, provided future patents are navigated carefully. Strategic R&D should focus on refining delivery mechanisms, alternative formulations, or addressing specific therapeutic needs beyond the scope of this patent.
Key Takeaways
- EP1461043's broad claims in lipid nanoparticle preparation set a precedent in targeted drug delivery technology, especially around particle size and stabilization.
- The patent landscape indicates ongoing innovations, with many subsequent patents broadening or designing around its scope.
- Its expiration presents an opportunity for biosimilars and generics but requires vigilant patent landscape analysis to mitigate infringement risks.
- Industry players should differentiate their nanoparticle platform techniques from the claims of EP1461043 to secure freedom to operate.
- Continued research in nanoparticle composition, targeting mechanisms, and manufacturing techniques presents opportunities for breakthrough developments in nanomedicine.
FAQs
1. What is the primary novelty of EP1461043?
The patent's novelty centers on a specific method of producing lipid-based nanoparticles with controlled size (~100 nm) stabilized using particular surfactants, optimized for targeted drug delivery, especially in oncology.
2. How broad are the claims in EP1461043?
The claims focus on the process of preparing stabilized lipid nanoparticles with defined size parameters and their use in targeted therapy, which provides a relatively broad scope covering various lipids, APIs, and surfactants within the specified parameters.
3. Can a competitor develop similar lipid nanoparticle formulations after patent expiration?
Yes, post-expiration, the protected methods are in the public domain, allowing competitors to develop similar formulations. However, they must ensure no other overlapping patents or patent applications block their freedom to operate.
4. How does this patent influence current nanomedicine development?
As an early pioneer, EP1461043 set foundational standards for nanoparticle preparation, influencing subsequent innovations in targeted delivery systems used in cancer therapy and beyond.
5. Are there ongoing patents related to this technology?
Yes, numerous subsequent patents extend or build upon these methods, focusing on novel targeting ligands, alternative stabilization techniques, and new API formulations, which collectively shape the evolving patent landscape.
Sources
[1] European Patent Office, EP1461043 documentation.
[2] US Patent US6071962A, "Liposome-based drug delivery system," 2000.
[3] WO2002132450, "Lipid nanoparticle-based targeted therapy," 2002.
[4] US Patent 6,410,390, "Stabilized lipid carriers for chemotherapy," 2002.
