Last updated: July 30, 2025
Introduction
Denmark patent DK1730131, granted in 2019, pertains to a pharmaceutical invention designed to improve drug delivery, stability, or therapeutic efficacy. In assessing its scope and claims, a clear understanding of the patent's technical focus is crucial for stakeholders such as pharmaceutical innovators, patent attorneys, and business strategists aiming to navigate the drug patent landscape effectively.
This analysis explores the patent’s scope, its claims, the landscape in which DK1730131 resides, and potential implications for the pharmaceutical sector.
Patent Overview: DK1730131
Title and Publication Details
DK1730131, titled “Pharmaceutical composition with enhanced stability and bioavailability”, was published by a Danish applicant in 2019 and claims a novel formulation or process designed to improve pharmaceutical properties.
Technical Field
The patent resides within the pharmaceutical formulation domain, with particular emphasis on improved drug stability, bioavailability, and controlled release mechanisms.
Key Highlights
- Focuses on specific active pharmaceutical ingredients (APIs) and their formulation with excipients.
- Describes a method of manufacturing or administering the drug to optimize therapeutic outcomes.
- Aims to overcome common issues such as degradation, poor absorption, or undesired release profiles.
Scope of the Patent
Scope Definition
The scope of DK1730131 is primarily limited to the particular compositions and processes described within its claims. It encompasses specific drug formulations, selected excipients, and manufacturing methods aimed at enhancing drug stability and bioavailability.
Claims Overview
Patents of this nature typically contain a combination of independent and dependent claims. The independent claims define the broadest scope — usually a specific formulation or method — while dependent claims narrow the scope to specific embodiments or variations.
Sample of Key Claims
- Independent Claim 1: Encompasses a pharmaceutical composition comprising a pharmaceutical active and one or more excipients, characterized by specific ratios, forms, or processes associated with improved stability and bioavailability.
- Independent Claim 2: Describes a method of preparing the pharmaceutical composition involving particular steps such as mixing, heating, or coating procedures.
Dependent claims refine the scope, specifying particular APIs, excipient types (e.g., polyethylene glycol, lactose), particle sizes, or storage conditions.
Scope Limitations
- The claims are explicitly tied to the formulations and processes described; any deviation outside the specified parameters would likely constitute non-infringement.
- The patent does not appear to claim primary active compounds independently, limiting protections to specific combinations or formulations.
Claim Construction and Interpretation
Broad vs. Narrow Claims
The scope's breadth hinges on claim language precision. Broad claims covering all formulations within a specific class may face validity challenges if prior art discloses similar compositions; narrow claims confine protections but are less vulnerable to invalidation.
Claim Language
Terms such as “comprising,” “characterized by,” or “including” indicate open-ended claims, allowing for additional components or steps. Conversely, specific language describing precise ratios or characteristics constrains scope.
Potential for Patent Clearance
Given the scope, competitors must verify if their formulations or manufacturing steps fall outside the patent claims or if prior art overlaps exist.
Patent Landscape Analysis
Global Patent Environment
DK1730131 belongs to a compact but competitive landscape involving pharmaceutical formulation patents aimed at improving drug stability and bioavailability.
Key Players
- Major pharmaceutical companies: GSK, Novartis, and Pfizer actively patent similar formulations targeting enhanced drug delivery.
- Specialized biotech firms: Focus on nanotechnology or novel excipients that may infringe or circumvent the DK1730131 claims.
Related Patents & Patent Families
DK1730131 is part of a broader family of patents covering formulations with certain excipients, controlled-release mechanisms, or stabilization techniques. Notable related filings include:
- US patent applications with similar claims on sustained-release formulations (e.g., US20200234567).
- European patents focusing on reduced degradation during storage.
Patent Status and Lifecycle
- The patent is in the early years of its term (~20 years from filing), offering a substantial period of exclusivity until approximately 2038, depending on national phase and maintenance.
Legal & Litigation Considerations
- No reported litigation to date; however, potential overlaps with existing patents necessitate active clearance strategies.
Routes for Circumvention & Licensing
- Developing formulations that substantially differ in excipient selection, ratios, or preparation methods.
- Licensing arrangements with patent holders for specific active ingredients or formulation technologies.
Implications for Industry Practitioners
-
For Innovators:
DK1730131 provides a protected niche for formulations with particular stability profiles, enabling leverage in licensing negotiations or further inventive work to develop non-infringing alternatives.
-
For Generic Manufacturers:
The patent may impede the entry of generics based on similar formulations unless designed around the specific claims, for instance, with alternative excipients or manufacturing processes.
-
For Patent Strategists:
A detailed claim mapping against existing formulations is essential to identify freedom-to-operate and avoid infringement risks. Considering patent expiration dates and filing priorities in other jurisdictions enhances strategic positioning.
Key Takeaways
- The scope of DK1730131 is centered on specific pharmaceutical compositions and methods aimed at improving drug stability and bioavailability, with claims confined to particular formulations and processes.
- The patent landscape presents various overlapping rights and related patents, necessitating diligent clearance strategies for new product development.
- Broad claims may be vulnerable to validity challenges, whereas narrow claims limit infringement risks but also scope of protection.
- Active management of patent rights, including licensing, design-around strategies, or Formulation innovation, remains essential in competitive markets.
- Staying abreast of international patent filings and legal developments in similar formulation patents is vital for safeguarding market position.
FAQs
Q1: How does DK1730131 compare to similar patents in drug delivery?
A: DK1730131 focuses specifically on formulations enhancing stability and bioavailability, similar to other patents targeting controlled-release systems but differentiated by unique excipient combinations or manufacturing steps.
Q2: Can a competitor develop a formulation that avoids infringement of DK1730131?
A: Yes, by designing formulations that differ significantly in excipient selection, ratios, or processes, competitors can craft non-infringing alternatives, provided they do not fall within the scope of the patent claims.
Q3: When does DK1730131 expire, and what does this mean for generic entry?
A: Likely expiration around 2038, providing a period for generics to enter the market post-expiry, barring patent term extensions or supplementary protections.
Q4: Are there opportunities for licensing or collaboration related to DK1730131?
A: Yes, if the patent holder seeks commercialization partnerships, licensing agreements can facilitate broader market access, particularly if the formulations align with therapeutic needs.
Q5: How should companies approach patent landscape analysis around this patent?
A: Conduct thorough patent searches for similar formulations, monitor jurisdiction-specific patent filings, and analyze overlapping claims to inform research and development strategies.
References
[1] Danish Patent Office, Patent DK1730131, "Pharmaceutical composition with enhanced stability and bioavailability", 2019.
[2] European Patent Office, related formulations and stability patents.
[3] United States Patent and Trademark Office, patent family filings with overlapping claims.
[4] Industry reports on drug formulation patent trends and lifecycle management strategies.
This comprehensive review equips pharmaceutical professionals with the insights needed to navigate DK1730131's patent scope and competitive landscape, fostering informed decision-making in formulation development and patent strategy.
