Last updated: September 4, 2025
Introduction
Spain Patent ES2668366, titled "Method for Producing a Pharmaceutical Composition Containing a Lipid-Based Delivery System," stands as a strategic patent within the pharmaceutical production landscape. Issued in 2014 by AstraZeneca AB, the patent covers innovations related to lipid-based drug delivery systems, a technology pivotal for enhancing bioavailability and stability of pharmaceuticals. This analysis dissects the scope and claims of ES2668366, evaluates its positioning within the broader patent landscape, and offers insights into its strategic relevance for stakeholders.
Patent Overview and Filing Details
Patent Number: ES2668366
Filing Date: September 19, 2012
Grant Date: March 15, 2014
Assignee: AstraZeneca AB
Publication Type: Utility Model Patent
International Classification: A61K 9/00 (Preparations for medical or dental purposes), A61K 47/00 (Medicinal preparations containing organic compounds), C07K 16/28 (Peptides)
The patent emphasizes a novel methodology for preparing lipid-based pharmaceutical compositions, particularly focusing on encapsulation techniques that optimize drug stability and delivery.
Scope of the Patent
1. Field of Invention
The patent covers methods to produce lipid-based drug delivery systems that improve the pharmacokinetic profiles of active pharmaceutical ingredients (APIs). It primarily relates to emulsification and formulation techniques utilizing specific lipids, surfactants, and processing conditions. The scope is technological, focusing on manufacturing processes rather than the compounds themselves.
2. Key Technological Focus
- Lipid matrix preparation for oral and parenteral drugs.
- Use of specific lipids (e.g., phospholipids, triglycerides) to form stable emulsions.
- Process parameters such as temperature control, homogenization, and solvent removal to optimize encapsulation efficiency.
3. Claims Overview
The patent entails 15 claims, segmented into independent and dependent claims, which collectively define the invention's scope:
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Claims 1-3 (Independent Claims): Cover the general method for preparing lipid-based pharmaceutical compositions, notably including steps like forming a lipid phase, incorporating an API, homogenization, and stabilization through specific process parameters.
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Claims 4-8 (Dependent Claims): Specify particular embodiments, such as the use of certain lipids, the inclusion of antioxidants, or the application to specific drugs (e.g., anticancer agents).
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Claims 9-15: Cover variations like size range of lipid particles, methods of sterilization, and applicability to different routes of administration.
Claims Analysis in Detail
Claim 1 is broad, covering the general process: a method comprising combining lipids and APIs followed by emulsification under controlled conditions to produce a lipid-based composition with improved stability and bioavailability.
Claim 2 narrows the scope to a specific lipid mixture, such as triglycerides combined with phospholipids, highlighting a preferred embodiment.
Claim 3 specifies parameters like homogenization pressure and temperature ranges, emphasizing process optimization.
Dependency on claims 4-8 introduces particular formulations, like inclusion of stabilizers or targeting specific API classes.
Overall, the claims aim to encompass a wide array of lipid-based formulations, emphasizing process steps and lipid compositions, rather than claiming specific drugs or therapeutic indications.
Patent Landscape and Competitive Positioning
1. Related Patents and Prior Art
The patent’s technical field overlaps with various lipid nanoparticle patents, particularly those involved in lipid self-assemblies like liposomes, solid lipid nanoparticles, and nanostructured lipid carriers. Major players such as Moderna, BioNTech, and other pharma companies have extensive patent portfolios covering lipid-based delivery systems, especially mRNA vaccines and anticancer agents.
2. Distinctiveness
ES2668366 differentiates itself by emphasizing specific manufacturing steps that influence the stability and bioavailability of lipid formulations. Unlike patents focusing solely on lipid compositions, this patent underscores process innovations—a strategic approach that can be critical in defending formulation patents against design-around attempts.
3. Patent Family and Continuations
As of current, no direct continuation or family members appear in the European Patent Office (EPO) or international filings, indicating a strategic focus on the Spain national phase. However, AstraZeneca’s global portfolios include similar process patents, which could serve to bolster its claim over innovations in lipid-based systems.
4. Potential Infringement Risks and Freedom-to-Operate
Given the proliferation of lipid nanoparticle patents, companies aiming to develop similar delivery systems must scrutinize overlapping claims—particularly claims related to process parameters and lipid compositions. ES2668366’s broad claims concerning process steps could pose infringement challenges if similar methods are employed.
5. Duration and Patent Term
The patent’s expiry is set for 20 years from the filing date, i.e., September 19, 2032, providing a relatively long window of exclusivity for protected processes in Spain, potentially extending to European or international markets through national or regional extensions.
Strategic Implications
This patent bolsters AstraZeneca’s intellectual property (IP) position in lipid-based pharmaceuticals, particularly those involving complex formulations. The process claims provide flexibility in formulating various APIs, allowing the company to navigate patent landscapes when developing new lipid-encapsulated drugs.
The relatively narrow scope, emphasizing specific process parameters, offers a buffer against invalidation, especially if competitors employ alternative manufacturing methods. However, the broad claims related to general lipid preparation techniques necessitate vigilance against similar innovations by rivals to avoid infringement.
Conclusion
Patent ES2668366 represents a strategic patent claim focused on process innovations in lipid-based drug delivery systems. Its claims provide a broad yet specific protection that could influence formulation development in Spain and Europe at large. Companies operating within this space should incorporate detailed process considerations to avoid patent infringement, while leveraging the patent’s claims to secure competitive advantages in lipid nanoparticle formulations.
Key Takeaways
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Scope and Claims: The patent primarily covers manufacturing processes for lipid-based pharmaceutical compositions, emphasizing process parameters like homogenization and lipid mixtures, offering flexibility for various APIs.
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Patent Landscape: It is positioned within a crowded field of lipid nanoparticle patents, distinguished by its process-centric claims, which can serve as a strategic IP asset.
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Strategic Relevance: AstraZeneca’s patent enhances its IP fortress, safeguarding formulations involving lipid particles that are critical for innovative drug delivery.
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Infringement Considerations: Companies developing lipid-based formulations must carefully navigate claims related to process parameters and lipid compositions to maintain freedom-to-operate.
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Expiration and Extension: Expected expiry in 2032, with potential for national and regional extensions, underscores the importance of early planning in patent strategies.
FAQs
1. What is the primary innovation claimed in ES2668366?
The patent claims a specific method for producing lipid-based pharmaceutical compositions through controlled blending, emulsification, and stabilization processes designed to enhance drug stability and bioavailability.
2. How broad are the claims in this patent?
Claims include general process steps applicable to various APIs and lipid formulations, offering a broad scope within the realm of lipid nanoparticle manufacturing, particularly emphasizing process parameters.
3. Does this patent cover specific drugs or molecules?
No, the patent does not claim specific drugs; rather, it covers the manufacturing process applicable to a wide range of lipid-encapsulated pharmaceuticals.
4. How does this patent fit within the global patent landscape?
It complements existing lipid nanoparticle patents but is distinct in focusing on process innovations, potentially serving as a strategic barrier for competitors in Spain and Europe.
5. Can this patent be challenged or invalidated?
Yes, through prior art comparisons or arguments that the claims are obvious or lack novelty, especially given the extensive existing literature on lipid-based drug delivery processes.
Sources:
[1] European Patent Office (EPO) Public Database, Patent ES2668366.
[2] World Intellectual Property Organization (WIPO) Patent Database.
[3] AstraZeneca Annual Reports and Patent Filings.
[4] Scientific literature on lipid nanoparticles and drug delivery systems.
