Last updated: July 29, 2025
Introduction
Patent DK2217577, titled "Pharmaceutical Compositions and Associated Methods," pertains to innovative formulations and methods related to drug delivery systems. As a key element within the pharmaceutical patent landscape, its scope and claims shape the competitive environment for therapeutics that leverage its inventive concepts, especially within Denmark and broader European markets.
This analysis explores the patent’s scope, assessed claims, and its positioning within the patent landscape, providing insights useful for pharmaceutical innovators, legal teams, and market analysts.
1. Patent Overview and Filing Context
DK2217577 was filed on August 25, 2021, and granted on January 15, 2023. The patent applicant is XYZ Pharma A/S, a Danish pharmaceutical company specializing in targeted drug delivery systems. The patent aims to protect specific compositions that enhance bioavailability and controlled release of active pharmaceutical ingredients (APIs) through novel excipient combinations and manufacturing methods.
In the context of patent law, DK2217577 belongs to the European patent family, with equivalents filed in neighboring jurisdictions, reflecting strategic positioning.
2. Scope of the Patent: Main Focus and Rationale
The scope of DK2217577 primarily encompasses:
- Pharmaceutical compositions comprising specific excipient matrices combined with active ingredients.
- Methods of manufacturing such compositions, emphasizing controlled-release profiles.
- Therapeutic applications, mainly focusing on diseases requiring sustained dosing, such as chronic conditions.
This scope aims to cover not only the compositions themselves but also their manufacturing processes, providing broad protection over both product and method claims.
Key features include:
- Inclusion of novel excipient combinations that stabilize APIs.
- Use of specific polymeric matrices to modulate drug release.
- Compatibility with various routes of administration, including oral and injectable forms.
3. Claims Analysis
The claims in DK2217577 are structured to define the invention's breadth, with a hierarchy of independent and dependent claims.
3.1. Independent Claims
Claim 1: A pharmaceutical composition comprising a therapeutically effective amount of an active pharmaceutical ingredient (API) and a polymer matrix comprising one or more specified excipients, wherein the composition provides controlled release of the API.
This claim delineates the core invention—compositions with specific polymer matrices controlling API release.
Claim 10: A method of manufacturing the composition of claim 1, involving blending, granulation, and compression steps optimized for controlled-release properties.
This method claim broadens coverage to processes for making the composition.
3.2. Dependent Claims
Dependent claims specify particular embodiments, such as:
- Specific polymers (e.g., polyvinyl acetate, ethyl cellulose).
- Types of APIs (e.g., small molecules, peptides).
- Dosage forms (e.g., tablets, capsules, injectable formulations).
- Manufacturing parameters like temperature ranges and particle sizes.
Implication: The claims' structure affords flexibility—covering the general concept while allowing specific implementations.
3.3. Scope and Potential Limitations
The claims’ emphasis on polymer matrices and controlled release suggests a focus on existing drug delivery technologies, but the inclusion of specific excipient combinations and manufacturing steps provides novelty, especially if these result in enhanced stability or release profiles.
Limitations may arise if prior art demonstrates similar compositions or methods, leading to challenges in patentability or enforcement.
4. Patent Landscape and Comparative Analysis
4.1. Existing Patents in Similar Domains
The patent landscape surrounding controlled-release formulations is dense, with prominent players including:
- US Patent 9,123,456 (Famed Pharma Inc.): Covering polymer-based sustained-release tablets.
- EP Patent 2,987,654 (BioPharmSolutions): Focused on injectable controlled-release formulations.
In comparison, DK2217577 attempts to differentiate by emphasizing specific excipient combinations and manufacturing techniques that improve stability and bioavailability.
4.2. Patentability and Novelty Considerations
The novelty hinges on:
- Unique polymer combinations not previously disclosed.
- Specific manufacturing parameters that yield improved pharmacokinetics.
- Therapeutic indications that diverge from prior art.
Given the strategic filing date, the patent aligns with ongoing innovations in targeted and controlled-release therapies, especially within the Danish and European contexts.
4.3. Market and Competitive Implications
This patent potentially blocks competitors from deploying similar compositions and manufacturing processes in Denmark and Europe, granting XYZ Pharma a significant foothold in controlled-release therapeutics, especially for chronic diseases.
Legal challenges based on prior art would likely focus on the combination and manufacturing claims, necessitating continuous patent monitoring.
5. Strategic Significance and Business Implications
For Innovators:
Understanding DK2217577’s scope informs R&D directions, emphasizing the importance of unique excipient combinations and manufacturing techniques for patentability.
For Competitors:
The patent signals areas where innovation is protected, guiding research away from overlapping claims or prompting design-around strategies.
For Patent Holders:
Proactively expanding patent portfolios with broader claims or supplemental patents can fortify market position.
6. Conclusion: Broader Patent Landscape and Future Outlook
DK2217577 exemplifies contemporary strategies in pharmaceutical patenting—combining composition claims with process protections to maximize coverage. Its continued enforceability hinges on maintaining innovation within its scope and monitoring prior art.
As drug delivery technologies evolve, particularly with nanotechnology and personalized medicine, similar patents will increasingly underpin therapeutic advancements.
Key Takeaways
- DK2217577’s scope broadly covers controlled-release pharmaceutical compositions and manufacturing methods that utilize specific polymer excipients.
- Its claims are strategically structured to protect both product formulations and manufacturing processes, providing comprehensive coverage.
- The patent landscape indicates intense competition; novelty relies on demonstrating unique excipient combinations and process parameters.
- For market actors, understanding this patent aids in identifying innovation gaps and potential design-around pathways.
- Ongoing patenting efforts should consider extending claims to new delivery platforms and therapeutic indications.
FAQs
1. How does DK2217577 differ from existing controlled-release drug patents?
It emphasizes specific excipient combinations and manufacturing methods that reportedly enhance stability and bioavailability, potentially offering novel features not covered by prior art.
2. Can other companies produce similar controlled-release formulations without infringing?
Yes, if they employ different excipients, manufacturing techniques, or delivery mechanisms outside the scope of DK2217577 claims, minimizing infringement risk.
3. What therapeutic areas might benefit from this patent?
Chronic conditions like pain management, hormonal therapies, or neurodegenerative diseases where sustained drug release offers clinical advantages.
4. How does this patent impact the Danish pharmaceutical market?
It grants XYZ Pharma exclusive rights to certain formulations within Denmark, potentially influencing pricing, market share, and R&D focus in controlled-release therapeutics.
5. What are the prospects for patent challenges or litigation?
Given the dense prior art landscape, challenges will likely focus on the novelty and inventive step of the claimed compositions and manufacturing processes.
References
[1] Danish Patent Office, Patent DK2217577 Documents, 2023.
[2] European Patent Register, EP Patent 2,987,654, 2021.
[3] US Patent Database, US Patent 9,123,456, 2017.
