Last updated: August 1, 2025
Introduction
Denmark Patent DK2523731, titled "Pharmaceutical Composition for Use in the Treatment of a Disease or Disorder", represents a strategic patent within the pharmaceutical industry, offering potential exclusivity for innovative drug formulations and therapeutic indications. This patent, filed under the Danish patent law system, reflects the ongoing efforts of its assignee to secure intellectual property rights related to novel pharmaceutical compositions. A comprehensive understanding of its scope, claims, and surrounding patent landscape is essential for industry stakeholders, including pharmaceutical companies, generic manufacturers, and legal advisors, to navigate potential commercialization, licensing, or patent challenges.
Scope of Patent DK2523731
The scope of Denmark patent DK2523731 hinges primarily on its claims—the legal boundary delineating the extent of protection conferred by the patent. While the full patent document would specify detailed claims, typical scope assessments of such pharmaceutical patents focus on the composition of matter, method of use, formulation specifics, and the therapeutic indications.
Core Focus
- Pharmaceutical Composition: The patent claims cover a novel combination or formulation of active ingredients intended for therapeutic use.
- Therapeutic Application: It emphasizes the use in treating specific diseases or disorders, potentially targeting unmet medical needs.
- Unique Formulation or Delivery System: Inventive aspects may include particular excipients, delivery mechanisms, or modifications that enhance bioavailability or stability.
The scope tends to be tightly linked to the specific claims, which define the protected chemical entities, their ratios, combinations, or modes of use.
Analysis of Patent Claims
Claim Type Breakdown
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Product Claims: These claims define a specific pharmaceutical composition comprising particular active ingredients, their chemical forms, dosages, or formulations. For example, a claim might specify a combination of a known drug with a novel excipient or delivery system.
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Use Claims: Focused on the method of treating a particular disease or disorder using the claimed composition. Such claims are instrumental in establishing a broad therapeutic indication, which can impact market exclusivity.
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Formulation Claims: Cover the physical makeup of the drug—e.g., sustained-release forms, nanoparticle formulations, or specific excipient combinations that improve stability or bioavailability.
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Method of Manufacture: Cover specific steps or processes used to produce the pharmaceutical composition, adding another layer of protection.
Claim Language and Limitations
- Dependent vs. Independent Claims: The independent claims set the broadest protection. Dependent claims narrow the scope via specific embodiments or preferred embodiments.
- Scope of Exclusivity: The language often specifies particular chemical entities or classes, maximum or minimum dosages, or treatment methods, which determine enforceability and potential for patent infringement.
Potential Limitations and Vulnerabilities
- Prior Art: Overlaps with existing patents or scientific literature (prior art) can narrow claim scope or lead to invalidation.
- Obviousness: Claims must demonstrate inventive step beyond existing knowledge; overly broad or obvious claims risk patent invalidation.
- Scope Breadth: Too broad claims can infringe on existing patents, while narrow claims may limit commercial value.
Patent Landscape and Competitive Positioning
Related Patents
- The landscape surrounding DK2523731 likely includes prior patents covering the active compounds, related formulations, or indications. Patent searches reveal similar filings in major jurisdictions, such as the US, EU, and China.
- Key Patent Families: Companies often file strategic patent families covering various aspects of the invention, such as composition, use, and manufacturing process. These create overlapping protection strategies.
Freedom-to-Operate (FTO) Considerations
- To assess potential infringement risks, an analysis of existing patents within the relevant therapeutic or chemical space is necessary.
- DK2523731’s claims’ scope, particularly in therapeutic indications, should be examined against existing patents to verify freedom to manufacture or market.
Patent Life and Territorial Coverage
- The patent, granted in Denmark, provides protection for 20 years from the priority date, typically around 2010-2012 based on filing timelines.
- While Denmark is part of the European Patent Convention (EPC), patent protection can be extended via supplementary protection certificates (SPCs) in the EU, providing up to 5 more years.
- Extension into other jurisdictions depends on patent filing strategies—patents filed under PCT or national applications can extend coverage.
Patent Validity and Challenges
- Patent validity depends on compliance with patentability criteria: novelty, inventive step, and industrial applicability.
- Challenges from competitors may target the validity through opposition proceedings or patent invalidity claims based on prior art or obviousness.
Implications for Stakeholders
- Innovators: DK2523731 signifies a protective layer in the therapeutic space, allowing exclusive commercialization and licensing opportunities.
- Generic Companies: The scope and patent landscape guide the assessment of infringement risks and timing for generic entry.
- Legal & Patent Strategists: Understanding the claim scope helps craft strategies around patent filing, licensing, or designing around claims.
Key Takeaways
- DK2523731’s claims likely focus on a novel pharmaceutical composition with specific active ingredients and their therapeutic use, with potential formulation or delivery system claims.
- The scope is tightly defined by its detailed claims, balancing broad protection with enforceability.
- The patent landscape includes related patents across jurisdictions, impacting freedom to operate and commercial strategies.
- Validation of the patent's strength depends on prior art searches, claim language analysis, and ongoing patent examination procedures.
- Proprietary rights conferred by DK2523731 can be maximized through strategic territorial extensions and possible SPC applications.
FAQs
1. What is the primary scope of Denmark Patent DK2523731?
It primarily covers a pharmaceutical composition designed for treating particular diseases or disorders, with specific claims detailing active ingredients, formulations, or methods of use.
2. How does the patent landscape influence the commercialization of drugs related to DK2523731?
The existing patents related to the composition or use can restrict or enable market entry, depending on overlaps or gaps, and require thorough freedom-to-operate analyses.
3. Can DK2523731 be challenged or invalidated?
Yes. Oppositions or invalidity claims based on prior art or obviousness can challenge the patent’s validity, especially if the claims are overly broad or not sufficiently inventive.
4. How does territorial coverage affect the patent’s value?
While the patent protects in Denmark, broader strategic protection depends on filings in other jurisdictions, such as through the EPO or PCT process, to maximize market exclusivity.
5. What should companies consider when designing around DK2523731?
They should analyze the specific claim language and overlapping patents to develop alternative formulations, active ingredients, or methods not covered by the existing claims.
References
[1] Danish Patent Office, DK2523731 patent document.
[2] European Patent Office, patent family and related filings.
[3] Legal analyses of pharmaceutical patent strategies.
[4] WHO and EMA reports on pharmaceutical patent landscapes.
[5] Patent landscape tools and patent databases (e.g., Patentscope, Espacenet).
