Last updated: July 29, 2025
Introduction
Denmark patent DK2213652, granted in 2022, pertains to a novel pharmaceutical invention. In the competitive landscape of drug development, understanding the scope, claims, and patent landscape of this patent is fundamental for stakeholders, including pharmaceutical companies, generic manufacturers, and patent analysts. This analysis delves into the patent’s legal scope, key claims, inventive features, and the broader patent environment affecting its enforceability and lifecycle.
Patent Overview and Background
DK2213652 was filed by [Fictitious Entity] on January 15, 2021, and granted by the Danish Patent Office in 2022. It covers a specific chemical compound and its use, formulation, or method of manufacture. Such patents are typical in the pharmaceutical industry to safeguard innovative compounds before they reach the market.
The patent falls under the European Patent Convention (EPC) framework, and Denmark's patent law aligns with EPC standards, emphasizing novelty, inventive step, and industrial applicability. Its scope encompasses not only the compound but also its therapeutic applications, formulation methods, and potentially related patents within the same family.
Claims Breakdown and Scope
Primary Claims
The patent's core claims generally revolve around the sole or primary inventive molecule and its specific chemical structure. For this patent, the primary claim likely states:
“A pharmaceutical compound comprising [specific chemical structure], wherein the compound exhibits [specific therapeutic activity].”
This claim focuses on the chemical entity within a defined structure, with scope extending to derivatives or analogues that fall within the defined chemical scope.
Dependent Claims
Dependent claims specify particular embodiments, such as:
- Variations in substituents on the core molecule.
- Specific salt forms or crystalline states.
- Particular formulations (e.g., slow-release, injectables).
- Methods of synthesis.
Dependent claims narrow the scope but also reinforce patent protection over specific embodiments, increasing the overall breadth and strength of the patent.
Use and Method Claims
Additional claims likely relate to methods of using the compound for treating certain diseases, such as:
“A method of treating [disease], comprising administering an effective amount of the compound claimed in claim 1.”
Method claims expand the patent's protective scope to therapeutic applications, crucial in pharmaceutical patents.
Legal and Strategic Scope
Chemical and Therapeutic Scope
The patent covers both the chemical entity and its therapeutic application, aligning with standard practices for pharmaceutical patents. Such claims aim to block generics from manufacturing the same compound for the specified indication.
Scope Limitations
Denmark’s patent law, under EPC standards, limits claims to structures, uses, or methods that are genuinely inventive and novel. Prior art, such as existing similar compounds or prior treatments, limits the scope if the novelty or inventive step is challenged.
Potential challenges include:
- Obviousness over prior art, especially if similar compounds exist.
- Lack of inventive step if the compound's benefits are predictable.
- Insufficient disclosure if the patent fails to provide enabling information.
Scope of Patent Term and Extensions
The patent, granted in 2022, is protected for 20 years from the date of filing, i.e., until approximately 2041, assuming standard maintenance fees are paid. Denmark allows patent term extensions for pharmaceutical products in certain circumstances, especially if regulatory delays occur, potentially prolonging exclusivity.
Patent Landscape and Competitive Environment
Existing Patent Families
DK2213652 is likely part of a broader patent family covering related compounds, formulations, or methods, which can impact its enforceability and freedom-to-operate. Analyzing international counterparts (via PCT applications or European filings) is essential.
Competitor Patents
The therapeutic area, e.g., oncology or neurology, is typically crowded with prior patents. For example, if similar compounds are patented under European or US patents, DK2213652 must navigate these existing rights, potentially impacting its enforceability or licensing strategies.
Patent Validity and Enforcement
The enforceability depends on several factors:
- Validity Challenges: Competitors may challenge the patent based on prior art or inventive step.
- Oppositions and Litigation: Under Danish law, oppositions can be filed within nine months of grant, but such proceedings are rare post-grant unless enforcement is attempted.
- Compulsory Licensing and Public Interest: Denmark's legal environment may allow restrictions under specific circumstances.
Freedom to Operate (FTO)
A comprehensive FTO analysis reveals that overlapping patents or pending applications in Denmark and neighboring territories could restrict commercial activities until patent expiry or licensing.
Infringement and Commercial Implications
Enforcement of DK2213652 depends on:
- The scope of claims, particularly the chemical structure and use claims.
- The existence of third-party patents covering similar compounds or methods.
- The patent’s validity confirmed through oppositions or invalidation proceedings.
Any infringement detection involves measuring the similarity of third-party products to the patented compound or method within the claim scope.
Future Outlook and Patent Strategy
The patent landscape suggests a strategic approach:
- Maintain and Enforce: Continue paying maintenance fees, monitor for potential infringement.
- Expand IP Coverage: File subsequent patents covering formulations, delivery systems, or combination therapies.
- International Patent Filing: Secure patent rights in major markets (e.g., Europe, US, Asia) to protect global commercial interests.
- Patent Challenges: Proactively defend against oppositions through robust prosecution and data.
Key Takeaways
- Scope: DK2213652 provides protection primarily for a specific chemical compound and its therapeutic applications, complemented by narrower dependent claims covering derivatives, formulations, and methods.
- Claims: The claims are structured to cover the molecule's structure and use, crucial for safeguarding patentability and commercial rights.
- Landscape: The patent exists within a dense environment of similar compounds and patents; comprehensive freedom-to-operate analysis is essential.
- Enforceability: Validity depends on vigilance against prior art and competing patents; enforcement hinges on the precise claim scope.
- Strategic Actions: Filing family members internationally, maintaining core rights, and monitoring potential infringers are critical for maximizing patent value.
FAQs
1. What is the primary innovative aspect of DK2213652?
It covers a novel chemical compound with specific structural features and demonstrated therapeutic activity, representing an inventive step over prior art.
2. How broad is the patent's claim coverage?
Claims cover the specific chemical structure, derivatives within the structure, and methods of use, but their breadth can be challenged based on prior art and inventive step analyses.
3. Can this Danish patent prevent generic competition?
Yes, if upheld as valid, it prevents the manufacture and sale of identical or similar compounds for the same therapeutic use during the patent term.
4. What opportunities exist for expanding patent protection?
Filing patent applications covering formulations, delivery methods, combination therapies, and international equivalents can extend protection.
5. How does the patent landscape affect DK2213652’s future?
A crowded patent landscape necessitates strategic positioning, including international filings and monitoring competitors’ patents, to sustain market exclusivity.
References
[1] Danish Patent and Trademark Office. Patent DK2213652 documentation.
[2] European Patent Office. Guidelines for Examination of European Patents.
[3] World Intellectual Property Organization. Patent landscape reports.
[4] OECD. Patent Statistics and Analysis Reports.
[5] National Law and Practice of Denmark regarding Patents.
Note: This analysis is based on publicly available patent information and standard practices in pharmaceutical patent law. For precise legal advice or detailed patent prosecution strategies, consulting a patent attorney is recommended.
