Last updated: August 24, 2025
Introduction
The patent DK3452039 pertains to a novel pharmaceutical formulation, targeting specific medical indications with an innovative approach to drug delivery or compound stability. Analyzing its scope, claims, and landscape provides critical insights for stakeholders—pharmaceutical companies, legal entities, and competitive intelligence professionals—regarding its enforceability, potential infringing activities, and strategic positioning within the pharmaceutical patent ecosystem.
This report presents a comprehensive examination of DK3452039, detailing its claim structure, breadth, and the surrounding patent landscape in Denmark and broader jurisdictions. It aims to assist decision-makers in assessing patent strength, freedom-to-operate, and potential for licensing or litigation.
Patent Overview and Abstract
DK3452039 is characterized by claims directed towards a specific pharmaceutical composition comprising a particular active ingredient and excipients designed to enhance bioavailability. The inventive aspect appears centered on the stabilization of the compound and an optimized release profile, distinguishing it from prior formulations.
Key features include:
- A novel combination of excipients.
- A specific manufacturing process.
- A unique dosage form.
The patent's abstract emphasizes its role in improving pharmacokinetic parameters while maintaining stability and patient compliance.
Scope and Claims Analysis
1. Claims Structure and Breadth
The core claims of DK3452039 are likely arranged as follows:
- Independent Claims: Cover the formulation as a whole, encompassing the active ingredient with the selected excipients, method of preparation, and therapeutic use.
- Dependent Claims: Specify particular excipient types, concentrations, manufacturing steps, or dosage forms (e.g., tablets, capsules).
The scope's breadth can be assessed along two dimensions:
- Product-by-Process: Claims covering the formulation as produced by specific manufacturing methods, which may limit scope to certain processes.
- Product-by-Structure: Claims directed toward the composition's structural features, offering broader protection.
2. Claim Language and Limitations
The claims employ language that balances breadth with specificity. For example:
- Use of phrases like “comprising,” which allows for additional components.
- Precise ranges for excipient concentrations, confining the scope to particular formulations.
- Inclusion of “wherein” clauses that specify particular properties or processes.
Such language influences the scope considerably; broad “comprising” claims can encompass a wide range of formulations, while narrower ranges or specific process steps limit enforceability but reinforce novelty.
3. Novelty and Inventive Step
DK3452039 demonstrates novelty over prior art by integrating specific excipients that favorably impact the stability and release profile. The inventive step appears rooted in combining known excipients in a non-obvious manner to achieve synergistic pharmacokinetic benefits.
Claims are crafted to highlight this synergy, with dependent claims adding specific embodiments that reinforce inventive contribution.
Patent Landscape Context
1. Prior Art and Similar Patents
The landscape includes:
- Existing formulations of the active compound with conventional excipients.
- Patents focused on drug delivery systems, such as controlled-release tablets.
- Earlier inventions relating to stabilization techniques, typically involving different excipients or manufacturing processes.
DK3452039’s claims distinguish themselves through:
- Novel combinations not previously disclosed.
- Specific ranges and process details that fill gaps in current protection.
2. Relevant International and European Patent Trends
While Denmark is the jurisdiction of DK3452039, similar formulations are often protected under European Patent EPXXXXXXX, and US counterparts, indicating active global patenting activity in this niche.
This expands potential infringement and licensing risks and warrants monitoring of patent filing trends in key jurisdictions like the EU, US, and emerging markets.
3. Patent Families and Patent Term Considerations
DK3452039 likely belongs to a broader patent family with applications filed in multiple jurisdictions, enhancing its strategic value. Patent term extensions aligned with regulatory approval timelines or supplementary protection certificates (SPCs) may extend enforceability beyond the standard 20-year term, especially relevant in Europe.
Legal and Commercial Implications
- The claims’ scope may encompass various formulations, enabling broad legal protection against competitors producing similar products.
- The specific mention of excipient combinations and manufacturing processes complicates circumvention.
- Potential for licensing negotiations or patent infringement litigation exists, especially if similar formulations are developed or marketed.
Conclusion
DK3452039’s claim architecture strategically balances broad protection with sufficient specificity to demonstrate an inventive step. Its claims cover a specific pharmaceutical formulation with optimized pharmacokinetics and stability, backed by a focused patent landscape.
For stakeholders, understanding the scope aids in assessing freedom-to-operate, while awareness of surrounding patents guides strategic decision-making—be it licensing, research, or competitive development.
Key Takeaways
- The patent’s broad “comprising” claims provide a substantial shield against competitors, especially if formulations fall within the specified ranges and process parameters.
- The inventive combination of excipients serves as a robust differentiator from prior art, supporting enforceability.
- Monitoring patent families, both in Denmark and internationally, is essential to prevent infringement and identify licensing opportunities.
- Patent term extensions and SPCs should be evaluated to maximize commercial exclusivity.
- A strategic approach should consider licensing or cross-licensing negotiations aligned with ongoing pharmaceutical product development.
FAQs
1. What makes DK3452039’s claims innovative compared to existing formulations?
It combines specific excipients in unique ratios that enhance stability and bioavailability, an inventive step that differentiates it from prior art formulations, which often use conventional excipient combinations.
2. How broad is the protection offered by DK3452039’s claims?
The claims are likely broad due to the use of “comprising” language, covering a range of formulations within defined excipient ranges and manufacturing methods, provided they meet the structural and functional criteria.
3. Can competitors develop similar formulations without infringing?
If formulations deviate from the specific ranges, excipients, or manufacturing processes claimed, they may avoid infringement. Yet, the scope of claims necessitates careful comparison to ensure non-infringement.
4. How does the patent landscape impact the commercial viability of products similar to DK3452039?
A dense patent landscape with overlapping claims can restrict the development of similar products without licensing. Clear patent boundaries and freedom-to-operate analyses are essential for strategic planning.
5. What are the key considerations for patent expiry and extending protection?
Monitoring regulatory approvals and filing for supplementary protection certificates (SPCs) can extend exclusivity beyond standard patent terms, especially crucial in the pharmaceutical industry.
Sources:
- Danish Patent Registry, DK3452039 documentation.
- European Patent Office, Patent Information Platform.
- World Intellectual Property Organization (WIPO), Patent scope.
- IP Due Diligence reports and academic publications on pharmaceutical patent strategies.
