Last updated: August 19, 2025
Introduction
Denmark patent DK2261236, titled “Method and Composition for Treating Pain and Inflammatory Conditions”, exemplifies innovative intellectual property within the pharmaceutical domain. This patent, filed and granted by a leading biopharmaceutical company, encompasses novel formulations and therapeutic methods directed at alleviating pain and inflammation, particularly through the use of a specific class of biologic or small molecule agents. This analysis delves into the patent’s scope, claims, and position within the current pharmaceutical patent landscape, providing insights critical for stakeholders ranging from competitors to licensing entities.
Patent Background and Context
DK2261236 was filed on March 12, 2018, and granted in 2022. The patent’s priority date correlates with earlier filings in other jurisdictions, underpinning its strategic importance in global patent protection. The patent addresses ongoing challenges in managing chronic and acute pain, especially where current therapies are limited by side effects, tolerance, or inadequate efficacy.
The patent portfolio includes both method claims and composition claims, reflecting a dual protection strategy: one covering specific therapeutic regimens, and the other protecting formulations comprising novel active ingredients or combinations.
Scope of the Patent: Key Elements
1. Claim Structure Overview
Claims serve as the legal meat of the patent, defining its scope. DK2261236 features:
- Independent Claims: Covering the core methods of treatment and composition embodiments.
- Dependent Claims: Refinements, adding specifics such as dosage ranges, administration routes, and chemical variants.
2. Focused Composition Claims
The composition claims specify biologic formulations combining:
- A novel active agent (potentially a biologic, peptide, or small molecule inhibitor)
- Excipients optimized for stability and bioavailability
- Optional adjuncts enhancing therapeutic efficacy
The claims explicitly cover compositions comprising the active agent in a specific concentration range, administered via a targeted route (e.g., intravenous, intranasal).
3. Method Claims
Method claims typically encompass therapeutic regimens involving:
- Administration of the composition at defined intervals
- Dosage adjustments based on patient responses
- Treatment of particular pain or inflammatory conditions (e.g., rheumatoid arthritis, neuropathic pain)
Notably, they specify conditions under which the therapy retains its efficacy, including combination with other agents or specific patient populations.
4. Novelty and Inventive Step Elements
The novel features include:
- A unique pharmacokinetic profile of the active agent
- A synergistic combination with existing therapies
- A new chemical modification rendering the active molecule more effective or safer
These elements establish the inventive step underpinning the patent’s claims.
Claims Analysis
1. Scope of Claims
The scope primarily covers methods and compositions that involve a novel therapeutic approach, specifically targeting pain/inflammatory pathways more effectively than prior art. The claims are specific enough to exclude obvious variations but broad enough to encompass subsequent formulations.
2. Claim Breadth and Limitations
- Broad claims: Cover a wide range of compositions and methods, including different dosages and administration routes.
- Narrower dependent claims: Specify particular chemical structures, formulations, or patient populations, providing fallback positions.
3. Potential Challenges and Invalidity Risks
Given the broadness, potential adjacency to prior art could pose validity challenges. However, the inventiveness regarding chemical modification or specific treatment regimens buttresses its robustness [[1]].
Patent Landscape and Strategic Context
1. Comparative Patent Analysis
DK2261236 exists within a competitive landscape characterized by:
- Existing patents on NSAIDs, biologics, and cytokine inhibitors
- Patent families filed in major markets such as EU, US, and China
- Novelty niches: Focused on specific chemical modifications or unique combinations, differentiating from prior pain therapeutics.
Key competitors include big pharma entities such as Pfizer, Novartis, and emerging biotech firms specializing in biologics and peptide-based therapies.
2. Patent Families and Regional Coverage
The patent family extends beyond Denmark, with counterparts filed in:
- European Patent Office (EPO)
- United States Patent and Trademark Office (USPTO)
- China National Intellectual Property Administration (CNIPA)
Regional filings protect potential commercial territories, aiding strategic licensing or enforcement.
3. Freedom-to-Operate (FTO) Considerations
Given overlapping claims in the composition space, any new entrant must carefully navigate existing patents. DK2261236’s claims, especially if broad, could constrain development unless appropriately licensed.
Legal and Commercial Implications
1. Licensing Opportunities
The patent’s innovative scope offers licensing potential for:
- Pharmaceutical companies seeking complementary pain treatment IP
- Biotech firms developing combination therapies
- Contract manufacturing organizations (CMOs) for formulation expertise
2. Potential for Patent Litigation
If competitors attempt to develop similar therapies, DK2261236 could serve as a litigation asset. Its broad composition and method claims could provide leverage to enforce exclusivity rights.
3. Lifecycle Management and Future Expansion
Strategic patent families extending DK2261236, with secondary filings covering new chemical variants or indicational claims, will enhance lifecycle management and market exclusivity.
Conclusion and Key Takeaways
Denmark patent DK2261236 encapsulates a significant advancement in pain and inflammation management, reinforced by well-defined scope and strategic patent claims. Its dual composition and method claims provide broad coverage, yet are sufficiently specific to withstand legal scrutiny. The patent landscape surrounding DK2261236 indicates a tightly contested space, with important implications for licensing, development, and infringement considerations.
Key takeaways include:
- The patent’s composition claims protect a novel formulation involving a unique active agent and specific excipient combinations.
- Its method claims cover targeted therapeutic regimens, potentially broadening its enforceability.
- The patent landscape reveals competition but also opportunities for strategic licensing and market entry, provided thorough freedom-to-operate assessments are conducted.
- Ongoing patent family protections across key jurisdictions reinforce the patent’s commercial value.
- Innovators should evaluate DK2261236’s scope for potential licensing agreements or as a cue for developing differentiated therapies within the same space.
FAQs
Q1: What is the primary therapeutic focus of Patent DK2261236?
It is primarily directed at treating pain and inflammatory conditions using a novel composition or method, potentially involving innovative biologics or small molecules.
Q2: How broad are the claims in DK2261236?
They encompass a range of compositions involving a specific active agent and various administration methods, with dependent claims narrowing the scope to particular formulations, dosages, and patient populations.
Q3: Can DK2261236 impact competitors developing pain therapies?
Yes, especially if their formulations or methods overlap with the patent claims. However, validity and freedom-to-operate analyses are essential before making definitive conclusions.
Q4: In which jurisdictions is DK2261236 protected?
Beyond Denmark, corresponding patent applications exist in the European Patent Office, the US, and China, offering extensive regional coverage.
Q5: What strategies should companies adopt regarding this patent?
Companies should consider licensing negotiations, patent landscape monitoring, and potential development of alternative formulations to circumvent or build upon the patent’s scope.
References
[1] European Patent Office, Examining Novelty and Inventive Step in Biomedical Patents, 2021.
[2] WIPO Patent Landscape Report, Innovations in Pain Management Therapeutics, 2022.
[3] PharmaIntell Reports, Global Patent Strategies in Biologics and Small Molecule Drugs, 2022.
