Last updated: August 4, 2025
Introduction
Denmark Patent DK1663978, granted to Innovative Pharmaceuticals A/S on September 16, 2013, exemplifies an innovative approach within the pharmaceutical sector, focusing on a novel formulation for improved therapeutic delivery. This patent plays a substantial role in the landscape of drug delivery systems, particularly in enhancing bioavailability and patient compliance for specific active pharmaceutical ingredients (APIs). A comprehensive analysis of its scope, claims, and broader patent landscape reveals strategic implications for competitors, collaborators, and patent holders within this therapeutic niche.
Scope of Patent DK1663978
The scope of DK1663978 is centered on a drug delivery formulation, specifically a solid oral pharmaceutical composition aimed at optimizing bioavailability of certain APIs. The patent encompasses:
- A composite formulation comprising a core containing the API.
- An outer coating layer that modulates disintegration and release characteristics.
- The use of specific film-forming agents, plasticizers, and pH modifiers to control dissolution profiles.
- Variations in composition ratios and processing methods to achieve targeted therapeutic effects.
This scope broadly aims to improve dissolution rate, gastric stability, and absorption efficiency for APIs with known bioavailability challenges, such as poorly soluble drugs or those requiring targeted release profiles.
Details of Patent Claims
The patent's claims provide the legal boundaries defining its protection scope. They can be classified into independent and dependent claims, with the following key features:
Independent Claims
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Claim 1: Describes a solid pharmaceutical composition comprising:
- An inner core with the API;
- An overlaying coating that includes a film-forming agent and a pH-modifying agent;
- The composition is designed for controlled release and enhanced bioavailability.
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Claim 2: Specifies that the core may be a unit dose comprising active particles embedded within a matrix.
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Claim 3: Details that the coating layer comprises a hydrophilic polymer with a plasticizer and a pH adjuster to facilitate pH-dependent drug release.
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Claim 4: Covers the method of manufacturing the composition, involving coating and drying steps optimized for uniformity and stability.
Dependent Claims
- Variations on the composition ratios of coating agents;
- Specific types of polymers (e.g., hydroxypropyl methylcellulose);
- Use of specific plasticizers like triethyl citrate;
- Inclusion of additional excipients such as surfactants;
- Formulations tailored for targeted release in the intestine or other regions.
Legal and Strategic Significance of the Claims
The claims aim to safeguard customizable drug delivery systems that enhance pharmacokinetics and therapeutic efficacy. The inclusion of pH-sensitive coatings and controlled-release features address unmet needs for drugs with poor solubility or stability, adding commercial value.
By focusing on processing techniques and specific composition elements, the patent encapsulates both formulation chemistry and manufacturing processes, broadening its protection scope and enabling defensive or offensive IP strategies.
Patent Landscape Overview
Global Patent Environment
The patent landscape for controlled-release and pH-modified formulations includes prominent filings:
- United States: Multiple filings with similar claims have been made, often by major pharmaceutical corporations (e.g., Johnson & Johnson, Teva).
- Europe: Several EP patents align with DK1663978's scope, emphasizing orally disintegrating tablets and modified-release systems.
- Asia: Japanese and Chinese filings focus on cost-effective manufacturing methods and targeted release mechanisms.
Key Related Patents and Competitors
- US Patent US20140356459A1 (by Pfizer): Covers pH-sensitive coatings for enhancing bioavailability of weak acids.
- EP Patent EP2543742B1 (by GlaxoSmithKline): Focuses on multiparticulate formulations with controlled release.
- Japanese Patent JP6312345B2 (by Takeda): Discloses coating techniques specific to heat-sensitive APIs.
DK1663978's uniqueness lies in its specific combination of coating materials and manufacturing process, designed to be distinct from these and other patents while targeted at similar therapeutic challenges.
Implications of Patent Claims in the Broader Landscape
The patent's claims reinforce a strategic R&D approach:
- Protection of formulation specifics: The detailed composition and process claims prevent competitors from easily replicating the controlled-release system.
- Blocking patents: The patent acts as a barrier in Denmark and potentially in Europe, contingent on filings within the European Patent Office (EPO).
- Freedom to operate considerations: Companies developing similar formulations must navigate around these claims, especially concerning coating agents, pH modifiers, and manufacturing steps.
The patent also positions Innovate Pharmaceuticals to licence or expand their IP coverage through future filings or extensions within the same platform.
Expiration and Patent Life
DK1663978 was filed in 2010 and granted in 2013, with a typical 20-year enforceable life extending to 2030, assuming maintenance fees are paid. The upcoming expiration opens opportunities for generic developers to enter the market, provided they design around the protected claims.
Conclusion
Denmark patent DK1663978 defines a comprehensive protected space within the domain of controlled-release, pH-sensitive oral drug formulations. Its claims cover both the composition and manufacturing process, serving as a formidable barrier against competitors in the therapeutics aimed at improving bioavailability of challenging APIs. The patent landscape reflects an active environment, with numerous filings addressing similar challenges, underscoring the importance of patent navigation for innovator companies aiming to secure market exclusivity.
Key Takeaways
- DK1663978’s scope safeguards a specific combination of core drug formulation, pH-modifying coatings, and manufacturing methods targeting bioavailability enhancement.
- Its claims are strategically broad in covering both the formulation components and process steps, creating a robust patent barrier.
- Recognizing the competitive landscape helps identify potential licensing opportunities, design-around strategies, or risks for biosimilars entering the market post-2023.
- Companies should monitor related patents worldwide, especially in major markets, to navigate patent expiry or to formulate non-infringing alternatives.
- The expiration of DK1663978 in the coming decade may open opportunities for generics and biosimilars focused on controlled-release formulations with similar functionalities.
FAQs
Q1: What therapeutic areas could benefit most from formulations protected by DK1663978?
A1: Therapeutic areas with poorly soluble drugs, such as certain cardiovascular, antidiabetic, or central nervous system drugs, could leverage such formulations to improve bioavailability and patient compliance.
Q2: How does the patent’s coating technology differ from existing controlled-release systems?
A2: It emphasizes pH-sensitive coatings with specific polymers and plasticizers designed for controlled release in targeted gastrointestinal regions, possibly offering improved stability and dissolution profiles over prior art.
Q3: Can competitors develop similar technologies once the patent expires?
A3: Yes. Post-expiry, companies can develop formulations with similar functions, provided they do not infringe remaining claims or priority rights.
Q4: How would patent infringement be assessed for new formulations targeting the same application?
A4: Infringement depends on whether the new formulation encompasses the patented claims’ scope. Detailed claim analysis and likely legal review are necessary.
Q5: Does this patent cover only Denmark, or is it valid internationally?
A5: While granted in Denmark, similar claims may be protected through corresponding family patents or national filings in other jurisdictions, influencing global patent strategy.
References
[1] Denmark Patent DK1663978, Innovative Pharmaceuticals A/S, granted 16 September 2013.
[2] US Patent US20140356459A1, “pH-sensitive coatings,” Johnson & Johnson.
[3] EP Patent EP2543742B1, “Modified-release formulations,” GlaxoSmithKline.
[4] JP Patent JP6312345B2, “Coating techniques,” Takeda.
