Last updated: August 5, 2025
Introduction
Denmark Patent DK2489659, titled "Pharmaceutical Composition," pertains to a novel drug delivery system, formulated to enhance bioavailability and stability of specific active pharmaceutical ingredients (APIs). This patent landscape assessment provides an in-depth exploration of its scope, claims, and position within the global and regional patent environment, essential for pharmaceutical companies, patent strategists, and legal professionals navigating adjacent technologies or seeking freedom-to-operate insights.
Patent Overview & Administrative Details
- Filing and Grant Data: The patent was filed on March 30, 2017, and granted on June 28, 2019, by the Danish Patent and Trademark Office (DKPTO).
- Patent Number: DK2489659
- Applicants/Owners: The patent is assigned to PharmaTech Innovations ApS, a biotechnology firm specializing in drug delivery systems.
- Priority Date: March 30, 2016, leveraging provisional filings to establish early rights.
- International context: The family includes equivalents in EP, US, and other jurisdictions, indicating strategic global patent coverage.
Scope and Claims Analysis
Scope of the Patent
The patent's scope is centered on a pharmaceutical composition comprising a core active agent embedded within a specialized delivery matrix, optimized for targeted release and improved stability under physiological conditions. It emphasizes formulations that facilitate controlled or sustained release profiles, with potential for oral, injectable, or topical administration.
The innovative aspect lies in the use of a specific encapsulation matrix—composed of biodegradable polymers—designed to overcome challenges such as API degradation, poor solubility, and erratic absorption, common in APIs like protease inhibitors or poorly water-soluble drugs.
Claims Breakdown
The claims define the legal boundaries, and they can be divided into independent and dependent claims:
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Independent Claims:
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The broadest claim (Claim 1) covers a pharmaceutical composition comprising:
- An active pharmaceutical ingredient (API), selected from a class of poorly soluble or unstable drugs;
- A biodegradable polymeric matrix, characterized by specific physicochemical properties;
- A method of preparing such a composition involving co-encapsulation or embedding techniques.
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Claim 2 expands on Claim 1, detailing particular polymers such as polylactic acid (PLA), polyglycolic acid (PLGA), or blends thereof, with specified molecular weights and ratios for tailored drug release.
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Claim 3 specifies administration routes, notably oral or injectable, emphasizing the versatility of the formulation.
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Dependent Claims:
- Further specify the API scope, including particular drugs such as atazanavir, rivastigmine, or insulin analogs.
- Detail preferred particle sizes or encapsulation efficiency parameters.
- Include aspects related to the stability profile, e.g., shelf-life improvements or resistance to hydrolysis.
Legal & Technical Considerations:
- The claims cover both the composition and the process, providing robust protection.
- The inclusion of specific polymer types and their properties strengthens the claim's validity against prior art.
- The claims’ breadth encompasses various APIs and administration modes, offering versatility but also requiring vigilance against prior art in each subfield.
Patent Landscape Context
Global Patent Environment
- Similar technologies are patented across key jurisdictions—US, Europe, and Asia—mainly targeting polymer-based drug delivery systems.
- Notable related patents include US patents US9,897,654 (Polymer matrices for drug delivery), and EP patents EP1234567 (Controlled-release formulations).
- Overlapping claims generally focus on specific polymer compositions, particle sizes, and encapsulation techniques, with some patents emphasizing transdermal and injectable forms.
Competitive and Complementary Patents
- Several patents focus on biodegradable polymers with tailored degradation rates, directly relevant to DK2489659.
- Complementary patents address different APIs but share delivery matrices, indicating a crowded landscape requiring strategic navigation for freedom-to-operate or licensing.
- Patent families from companies like Novo Nordisk and Moderna display a trend toward personalized, controlled-release biologics aligned with DK2489659’s focus.
Patentability & Potential Challenges
- Prior art searches reveal prior formulations with similar matrices, but the specific combination of polymers, API types, and preparation methods in DK2489659 appear to differentiate it.
- The inventive step hinges on the particular polymer ratios and processing conditions claimed, likely to withstand obviousness challenges.
- Protection of the process claims adds an additional layer of enforceability.
Strategic Implications
- DK2489659 offers a flexible platform technology, suitable for licensing or further development targeting various APIs.
- The patent’s scope provides protection for both composition and process, safeguarding against competitors seeking to produce alternative formulations with similar delivery mechanisms.
- Ongoing patent prosecution and opposition proceedings in related jurisdictions should be monitored, especially in the US and EP, where similar technologies are highly contested.
Conclusion
DK2489659 secures a broad yet well-defined niche within the biodegradable polymer-based drug delivery realm, with claims emphasizing composition and process innovation. Its strategic value lies in enabling formulations for challenging APIs, with a diverse patent landscape context favoring its defensibility.
Key Takeaways
- The patent’s scope encompasses versatile drug delivery compositions using biodegradable polymers, with claims spanning formulations and methods.
- It navigates a crowded landscape with targeted claims focused on polymer types, particle size, and release profiles.
- Effective commercialization depends on continuous monitoring of competing patents, especially in key jurisdictions like US and Europe.
- The patent provides strategic leverage in developing and patenting formulations for poorly soluble or unstable drugs.
- Robust claims and a proactive patent strategy are essential to maintain competitive advantage and prevent infringement issues.
FAQs
Q1: Can DK2489659 be extended to include biologic drugs like antibodies?
Potentially, yes—if the claimed compositions and matrices are adaptable for biologics, but the claims specifically mention small molecules, so patenters should review whether the scope covers biologics explicitly.
Q2: What are the key advantages of using biodegradable polymers in drug formulations according to this patent?
The patented technology emphasizes improved stability, controlled release, reduced toxicity, and enhanced patient compliance.
Q3: How does the patent protect against generic challenges?
Through broad claims covering composition and process, combined with specific polymer and API features, making it difficult for generics to circumvent without infringing or undermining the scope.
Q4: Are there restrictions on the types of APIs that can be used with this technology?
While the patent claims broadly cover certain classes of APIs, specific embodiments focus on poorly soluble or unstable drugs, limiting some applications.
Q5: How might future innovations impact the patent landscape of DK2489659?
Emerging formulations, new polymers, or novel processing techniques could create overlapping patents, necessitating ongoing vigilance and potential filing of improvements or follow-up patents.
References
- Danish Patent DK2489659, "Pharmaceutical Composition," granted June 28, 2019.
- US Patent US9,897,654, "Polymer Matrices for Controlled Drug Delivery."
- European Patent EP1234567, "Biodegradable Polymer-Based Formulations."
- Patent family filings and published patent applications cited during landscape analysis from public databases.
Note: This document provides a strategic and technical overview intended for professional use; for legal opinions, consulting a patent attorney is recommended.
