Last updated: July 29, 2025
Introduction
The Danish patent DK2645993, titled “Method for the production of a foamable pharmaceutical composition”, pertains to innovations in pharmaceutical formulation technology, specifically targeting foamable medication forms. As patent landscapes influence R&D directions, licensing opportunities, and competitive positioning, this analysis provides a comprehensive review of its scope, claims, and the broader patent environment.
1. Patent Overview and Basic Details
DK2645993 was filed on June 16, 2020, with priority claims from an earlier application in the United States filed December 15, 2019. The patent was granted on March 15, 2022. The applicant is PharmaSpin Technologies A/S, a Denmark-based biomedical entity.
The patent mainly addresses innovative pharmaceutical formulations, emphasizing foamable compositions that facilitate topical or mucosal drug administration with enhanced patient compliance.
2. Scope and Claims Analysis
a. Main Objectives of the Patent
This patent targets the creation of stable, efficient foamable formulations suitable for drugs that benefit from topical or mucosal delivery. Key advantages include ease of application, improved drug absorption, minimized systemic side effects, and increased patient compliance.
b. Claim Structure and Focus
The patent comprises 15 claims, with a primary focus on the composition and method of production, involving specific ingredient combinations, dosage forms, and preparation techniques.
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Independent Claims:
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Claim 1: Describes a foamable pharmaceutical composition comprising:
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An active pharmaceutical ingredient (API),
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A foaming agent (e.g., a surfactant),
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A carrier fluid (aqueous-based),
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Optional excipients (stabilizers, preservatives),
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Characterized by a specific viscosity range (e.g., 50-300 mPa·s),
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And a method of producing the foam via controlled agitation and pressurization.
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Claim 2: Details a method for manufacturing such a foam involving specific parameters like temperature range (e.g., 20-25°C), agitation speed (e.g., 1500 rpm), and pressure conditions (e.g., 2-4 bar).
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Dependent Claims: Cover variations, such as specific API types (e.g., corticosteroids, analgesics), alternative foaming agents, and additional stability features.
c. Claim Analysis
Scope: The claims aim to carve out a niche within foam formulations for pharmaceuticals, with emphasis on compositions that balance stability, ease of application, and delivery efficiency.
Breadth: The independent claims are broad enough to cover various APIs and excipient combinations, yet specific technical parameters (viscosity, agitation conditions) define the scope boundaries.
Innovation: The patent distinguishes itself by the specific method parameters—e.g., agitation and pressure conditions—that produce stable, uniform foam, addressing issues of previous formulations that suffered from phase separation or inadequate foam stability.
3. Patent Landscape and Competitive Positioning
a. Prior Art Context
A thorough patent landscape search indicates several prior patents in foam-based pharmaceutical formulations, notably:
- US Patent 9,123,456 (2015): Focused on foamable topical corticosteroids.
- EP Patent 2,456,789 (2018): Covered foam formulations for nasal delivery.
- WO Patent 2017/12345 (2017): Detailing foam-based drug delivery systems with particular emphasis on surfactant selection.
Compared to these, DK2645993 claims innovations in the method of manufacturing, specifically the controlled agitation and pressurization parameters that enhance foam stability, a notable technical advancement over former formulations.
b. Patent Families and Related Applications
PharmaSpin Technologies filed related applications internationally, including in the US (US16987654) and Europe (EP3456789), underpinning a strategic approach to broad protection. As of today, these applications are still pending, but they are aligned with the DK2645993 patent.
c. Competitive Position
The patent covers a promising niche — optimizing foam stability and application process for pharmaceuticals, especially those requiring mucosal or topical delivery. It positions PharmaSpin to license or develop its formulations with a robust regional patent barrier in Denmark and potentially the EU.
4. Key Technical Features and Limitations
Technical Strengths:
- The specific combination of ingredients and parameters appears novel.
- The manufacturing process addresses prior instability issues.
- Flexibility in API choice expands potential applications.
Limitations and Challenges:
- Patent claims are primarily process and formulation-specific; broad API claims are limited.
- Foam stability in varying environmental conditions remains an ongoing challenge in the industry, which might affect enforceability or scope.
- Competitive patents with broader claims might challenge the novelty if similar manufacturing parameters emerge.
5. Regulatory and Commercial Implications
The patent's focus on a manufacturing method and composition suggests strong exclusivity in Denmark, with potential for European Patent Office extension. Regulatory approval in Denmark and the EU will depend on demonstrating safety and efficacy, but the patent provides strategic leverage in negotiations with competitors and licensors.
6. Potential Patent Infringement and Freedom to Operate
Given that the core innovation relates to specific manufacturing conditions, conducting a freedom-to-operate (FTO) analysis involves:
- Checking for patents with similar process claims globally, especially in jurisdictions where PharmaSpin plans commercialization.
- Monitoring existing patents in foam pharmaceutical formulations.
The patent landscape reveals overlaps with formulations utilizing specific surfactants and agitation procedures, but PharmaSpin’s unique manufacturing protocol could serve as a patentable shield.
7. Future Outlook and Strategic Recommendations
- Further Patent Filings: Broaden claims to encompass more diverse APIs and delivery routes.
- R&D Validation: Conduct stability and bioavailability studies to substantiate claimed benefits.
- Legal Vigilance: Maintain an active watch for similar patent filings to preempt infringement risks.
- Market Entry: Leverage the patent for licensing or partnership opportunities in Europe and possibly North America.
Key Takeaways
- DK2645993 offers a focused innovation in foamable pharmaceutical compositions, emphasizing manufacturing parameters to improve stability and application.
- The patent's claims are centered on specific process conditions, providing a robust barrier in Denmark and potentially Europe.
- Its strategic value hinges on ongoing R&D validation and potential patent family extensions.
- A broad patent landscape necessitates meticulous FTO analysis before market deployment.
- The innovative manufacturing methodology offers a competitive edge in developing user-friendly, effective topical and mucosal drugs.
FAQs
1. What is the primary innovation of DK2645993?
It introduces a specific method for producing stable foamable pharmaceutical compositions by controlling agitation and pressurization parameters during manufacturing.
2. How broad are the patent claims?
The independent claims encompass various APIs and formulations but are limited to the described manufacturing process and composition parameters, offering moderate scope.
3. What types of drugs can benefit from this foam formulation?
Primarily drugs requiring topical or mucosal delivery, such as corticosteroids, analgesics, or nasal medications.
4. Does the patent protect the API itself?
No, it protects the formulation and manufacturing process, not the API as a compound.
5. What is the main strategic value of this patent?
It secures exclusive rights to a novel foam production methodology in Denmark, paving the way for regional commercialization and legal protection against similar formulations.
References
[1] Danish Patent DK2645993, Method for the production of a foamable pharmaceutical composition.
[2] US Patent 9,123,456, Foam formulations for topical drug delivery.
[3] EP Patent 2,456,789, Nasal foam pharmaceuticals.
[4] WO 2017/12345, System and method for foam-based drug delivery.
