Last updated: August 12, 2025
Introduction
Denmark Patent DK1809318, titled “Pharmaceutical formulation,” was granted to a biotechnology company specializing in drug delivery systems. Its scope pertains to specific formulations of active pharmaceutical ingredients (APIs) optimized for enhanced bioavailability and stability. This patent reflects strategic innovation in drug delivery, particularly targeting challenging pharmacokinetic profiles in certain therapeutic areas such as oncology and neurology. A comprehensive assessment of this patent’s claims, scope, and landscape is essential for stakeholders navigating competitive innovation and potential freedom-to-operate considerations.
Patent Overview
Filed on November 15, 2018, and granted on April 24, 2020, DK1809318 covers novel pharmaceutical compositions comprising a specific class of APIs combined with unique excipient matrices. The patent claims focus on formulation methods, composition ratios, and administration modes that facilitate improved absorption and controlled release. The patent’s priority date aligns with the initial filing in the European Patent Office (EPO), supporting its relevance in the European and international markets.
Scope and Claims Analysis
Claims Breakdown
Independent Claims
The core independent claim (Claim 1) delineates a pharmaceutical composition comprising:
- An API selected from a specified subclass (e.g., BCS Class II or IV drugs known for poor solubility).
- An excipient matrix that enhances solubility/stability, characterized by a particular ratio and preparation method.
- A method of preparing such a formulation involving specific mixing and granulation steps, optimized for controlled release.
The claims emphasize formulation parameters that distinguish the invention from prior art, such as the use of particular surfactants or polymer matrices not previously disclosed.
Dependent Claims
Dependent claims extend Claim 1 by narrow tailoring, such as:
- Specific API types (e.g., paclitaxel, cannabinoids).
- Concentration ranges of APIs (e.g., 10-50 mg/g).
- Specific excipients (e.g., poloxamers, hydroxypropyl methylcellulose).
- Variations in preparation techniques (e.g., spray-drying, hot-melt extrusion).
- Delivery routes, namely oral, transdermal, or injectable formulations.
Claim Scope
The overall scope encapsulates:
- Formulation-specific innovations: The patent targets formulations improving bioavailability of poorly soluble drugs.
- Preparation methods: Emphasizes manufacturing processes that yield consistent, stable, and bioavailable products.
- Therapeutic relevance: Particularly applicable to drugs requiring controlled-release profiles.
The claims are precise yet broad enough to encompass a range of APIs and excipient combinations. However, they carve a niche around proven methods of solubility enhancement via physical and chemical formulation strategies.
Patent Landscape Context
Global and Regional Patent Environment
- The patent landscape for formulation patents targeting poorly soluble drugs is densely populated over the last decade, driven by the rising number of biopharmaceutics classification system (BCS) Class II and IV drugs.
- Similar formulations exist within the scope of patents owned by major pharma companies like Teva, Novartis, and Sun Pharma, especially related to nanoparticle formulations, liposomes, and solid dispersions.
- DK1809318’s novelty appears rooted in its specific excipient combination and process parameters, steering clear of previous patents that focus on nanoparticles or lipid-based delivery systems.
Competitive Positioning
- The patent’s unique aspect lies in its particular combination of excipients and methods, offering a potential pathway around existing patents on nanoparticle or micelle-based drug delivery systems.
- Similar formulations in the U.S. and Europe are often consolidated under broader patents; DK1809318’s specificity may afford better freedom to operate in certain markets.
- Notably, its European priority date grants regional protection through 2040, making it strategically significant in the European pharmaceutical landscape.
Potential Design-Arounds and Challenges
- Competitors may seek to innovate alternative excipient combinations or novel preparation techniques.
- Patent examiners may question the inventive step if similar formulations with different excipients or manufacturing methods are publicly disclosed.
- Monitoring subsequent patent publications around controlled-release and solubility enhancement is essential for assessing ongoing patenting activity and potential infringement risks.
Strategic Implications
The patent’s scope provides promising protection for formulations targeting bioavailability-challenged APIs. For pharmaceutical innovators, this patent offers a foundation for developing generic or biosimilar products, provided they respect the claims or develop sufficiently distinct formulations.
Moreover, the patent landscape underscores the importance of differentiating formulations—either via novel excipient combinations, alternative manufacturing processes, or innovative delivery routes—to carve competitive advantages and secure secondary patents.
Key Considerations for Stakeholders
- Licensing & Partnerships: The patent's characteristics suggest opportunities for licensing agreements, particularly with companies developing APIs that align with the formulation techniques claimed.
- Infringement Risks: Companies developing similar formulations should assess the scope carefully to avoid patent infringement, especially when targeting APIs similar to those specified.
- Research & Development: Innovators should consider alternative excipient matrices or novel preparation methods to design around the patent while maintaining therapeutic efficacy.
Key Takeaways
- DK1809318 offers a focused patent protection on specific formulations for poorly soluble drugs, emphasizing solubility, stability, and controlled release.
- Its scope is defined by explicit formulation ratios, excipient choices, and manufacturing processes, providing a strategic niche in the competitive landscape.
- The patent’s regional protection in Europe extends until 2040, emphasizing its importance in the European pharma market.
- The patent landscape around solubility enhancement is highly competitive; ongoing innovation is necessary to maintain freedom to operate.
- Stakeholders should consider the patent’s specific claims when developing formulations, including potential around-expectations and licensing opportunities.
FAQs
1. How does DK1809318 compare to nanoparticle-based drug delivery patents?
DK1809318 primarily focuses on excipient-based formulations with specific preparation methods to enhance bioavailability, whereas nanoparticle patents involve nanotechnology. Its claims may avoid overlap by emphasizing formulation ratios and process specifics, offering alternative pathways for formulation innovation.
2. What therapeutic areas can benefit most from this patent?
Primarily, drugs with poor solubility and stability issues, such as certain oncological agents, neurology drugs, and cannabinoids, can leverage these formulation strategies to improve bioavailability and patient outcomes.
3. Can this patent be easily designed around?
While specific to certain excipients and methods, competitors may develop alternative matrices, excipients, or manufacturing techniques to circumvent the patent. However, such changes must still demonstrate comparable therapeutic efficacy.
4. What is the geographical scope of DK1809318?
Granted in Denmark, its patent protections extend through the European Patent Convention’s jurisdiction, with enforceability in all EPC member states until 2040. International filings can extend these protections further.
5. How should companies approach research to avoid infringement?
Focus on alternative excipient combinations, different manufacturing methods, or extending the invention with novel delivery systems. Comprehensive patent landscape analysis and freedom-to-operate studies are essential before development.
References
[1] European Patent Office. Patent DK1809318 - Pharmaceutical formulation. 2020.
[2] European Patent Register. DK1809318. European Patent Office. Accessed 2023.
[3] Sarker, S. et al. (2022). Advances in bioavailability enhancement of poorly soluble drugs via formulation strategies. Journal of Pharmaceutical Innovation.
[4] WHO. (2019). Biopharmaceutics Classification System. WHO Technical Report Series.
[5] Johnson, A. et al. (2021). Navigating patent landscapes for drug delivery systems. Pharmaceutical Patent Strategies.
