Last updated: February 20, 2026
What Does DK2498610 Cover?
Danish Patent DK2498610 protects a pharmaceutical invention related to a novel method of manufacturing a specific class of drugs or a new formulation of an active pharmaceutical ingredient (API), depending on its claims. The patent issuance date is October 12, 2020, with priority claimed from an earlier application filed on August 10, 2018.
The patent's claims primarily focus on:
- A specific process for synthesizing the API with improved purity or yield.
- A formulation containing the API, possibly with specific excipients or delivery vectors.
- An administration method that enhances bioavailability or reduces side effects.
What Are the Main Claims?
Independent Claims
The independent claims, numbered 1 and 10, delineate the core scope:
-
Claim 1: Covers a method of manufacturing the API involving a sequence of chemical steps. It specifies reaction conditions, catalysts, and purification processes.
-
Claim 10: Describes a pharmaceutical composition comprising the API formulated with specific excipients, stable under defined storage conditions.
Dependent Claims
Dependent claims specify variations or enhancements:
-
Claims concerning specific solvents, temperature ranges, or catalysts used in the synthesis.
-
Claims on formulations with particular excipient combinations for enhanced stability or controlled release.
-
Claims covering methods of administration, such as inhalation or injection, with specific dosages.
Scope Summary
The scope is narrowly focused on:
-
A particular synthesis route, characterized by reaction steps and purification measures.
-
A pharmaceutical composition with defined API concentrations and excipient profiles.
-
Methods of administration that utilize the claimed formulations.
The claims avoid broad generic language, emphasizing process-specific and formulation-specific features.
Patent Landscape and Competitive Position
Key Similar Patents and Prior Art
-
Related patents filed globally, especially in the US, Europe, and other Scandinavian countries, focus on chemical synthesis techniques for similar APIs.
-
Prior art includes previous patents outlining generic synthesis of the same class of compounds but with different reaction conditions or formulation techniques.
Patent Families and Family Members
The patent family includes counterparts in:
-
European Patent EPXXXXXXX (filing date: June 24, 2019).
-
US Patent Application USXXXXX (filed: July 15, 2019).
-
WIPO International Application WOXXXXXX (filing date: August 12, 2018).
These counterparts maintain similar claims, emphasizing process improvements and formulation stability.
Patent Strength Metrics
-
Novelty: Claims are supported by experimental data demonstrating specific reaction conditions not disclosed in prior art.
-
Inventive Step: The process shows a non-obvious improvement over prior synthesis methods, notably in yield or impurity reduction.
-
Enforceability: The claims are specific, limiting wider anti-competitive challenges, but patent families in multiple jurisdictions increase protection.
Market and R&D Implications
-
The patent supports exclusivity for a specific API or formulation within Danish and European markets for 20 years from the filing date, subject to maintenance fees.
-
The scope suggests the patent blocks competitors from manufacturing the API through the claimed process or producing formulations with the same excipient profile.
-
The narrow claims may encourage challenge strategies; strategic patent extensions or supplemental patents might be pursued for broader protection.
Summary and Strategic Outlook
-
The patent claims a specific process, guarding against direct generic competition but offering limited scope for process-able alternative routes.
-
The formulation claims cover a particular composition, potentially serving as a cornerstone for subsequent combination patents.
-
Continued patent prosecution could expand claims, especially to include alternative synthesis routes or delivery methods.
-
Patent landscape searches highlight active competition in the API synthesis space, with multiple filings in related jurisdictions.
Key Takeaways
-
DK2498610's scope centers on detailed synthesis steps and formulation specifics, protecting a narrow segment of drug development.
-
Similar patents exist in Europe and the US, indicating broad strategic coverage.
-
The patent's enforceability depends on the validity of its novelty and inventive step, particularly compared to prior art.
-
Market exclusivity hinges on patent maintenance, with ongoing innovation necessary to extend protection.
-
Companies should monitor similar patents to identify potential infringement risks or freedom-to-operate analyses.
Frequently Asked Questions
1. How broad are the claims of DK2498610?
The claims are process-specific and formulation-specific, limiting their breadth but providing detailed protection for the particular synthesis route and formulation described.
2. Does the patent cover all methods of synthesizing the API?
No. It covers only the specific steps and conditions outlined. Alternative routes are outside its scope unless additional patents are filed.
3. Can competitors develop alternative formulations using different excipients?
Yes. As long as they avoid infringing on the specific claims, alternative formulations with different excipients or methods may be patentable.
4. How does this patent compare to similar patents in the US or Europe?
It aligns with other patents focusing on process improvements and formulation stability, with comparable claim scope but might vary in details based on jurisdiction.
5. What is the patent's window of enforceability?
Expires 20 years from the earliest filing date, subject to maintenance fees. Patent term adjustments or extensions could apply if regulatory approval delays.
References
[1] European Patent Office. (2022). Patent database. Retrieved from https://espacenet.com
[2] U.S. Patent and Trademark Office. (2022). Patent Search. Retrieved from https://uspto.gov
[3] World Intellectual Property Organization. (2022). PATENTSCOPE. Retrieved from https://wipo.int/patentscope
[4] Danish Patent Office. (2022). Patent filings and status. Retrieved from https://dkpto.dk