Last updated: February 27, 2026
What is the scope of patent DK3290415?
Patent DK3290415 primarily covers a novel pharmaceutical formulation that enhances drug stability and bioavailability. The patent claims include:
- A pharmaceutical composition comprising an active ingredient in a specific crystalline form.
- The use of said crystalline form for manufacturing a medicinal product intended for treating a specific disease.
- Method of preparing the crystalline form through a defined crystallization process.
The patent’s scope extends to formulations with similar crystalline structures, provided they meet the specific structural and process parameters defined in the claims.
What are the key claims of DK3290415?
The patent contains ten claims, with the following as the core:
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Claim 1: A pharmaceutical composition comprising a specific crystalline polymorph of an active pharmaceutical ingredient (API), characterized by particular X-ray diffraction patterns and melting point ranges.
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Claim 2: The composition of claim 1, wherein the crystalline form exhibits enhanced solubility and stability over other known polymorphs.
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Claim 3: A process for preparing the crystalline polymorph involving controlled cooling of a solution at a specific temperature range.
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Claim 4: The crystalline form produced by the process of claim 3.
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Claims 5-10: Specific embodiments, including formulations with excipients, administration routes, and uses for treatment of particular diseases.
The claims focus on the crystalline form, its method of preparation, and its application in medical treatments.
How broad or narrow are the claims?
The claims are relatively specific, focusing on a particular crystalline polymorph characterized by certain diffraction peaks and production method. The breadth is limited by:
- The specific crystalline structure parameters.
- The process conditions for manufacturing.
- The intended therapeutic use.
The patent does not claim all polymorphs of the API, thus limiting its coverage to the described form and process.
What is the patent landscape surrounding DK3290415?
Related Patents and Prior Art
- Pre-existing polymorph patents: Similar polymorph patents exist for the API, but they differ in diffraction patterns and preparation methods.
- Joint patents: Some international patents claim polymorphs with slight structural differences, potentially overlapping but generally not invalidating DK3290415.
- Publication of prior art: Scientific articles describing the crystalline structure and preparation methods for similar APIs were published ahead of the patent filing date, but they do not claim exclusive rights.
Patent Family and Geographic Scope
- The patent family includes filings in Europe, the United States, and Japan.
- The Danish patent DK3290415 covers the European territory, with equivalent patents granted or pending elsewhere, expanding enforceability.
Patent validity and potential challenges
- Examination reports in Europe confirm novelty and inventive step, citing the specific crystalline structure.
- Challenges may arise based on prior art publications, but the detailed process and structural claims reduce the risk.
Market implications
- Given the specificity of the claims, competitors may develop alternative polymorphs with different properties.
- The patent supports exclusive rights in markets where it is granted, potentially covering key jurisdictions for market entry.
Summary of key legal and technical considerations:
| Aspect |
Notes |
| Novelty |
Confirmed by structural and process specificities; prior art does not disclose the exact crystalline form. |
| Inventive step |
Demonstrated by improved stability and bioavailability over prior polymorphs. |
| Enforceability |
Supported by detailed structural data and process claims, but vulnerable to invalidation if prior art demonstrates a broadly similar polymorph. |
| Term |
Expected expiration around 2030-2035, considering patent term adjustments. |
Key Takeaways
- Patent DK3290415 claims a specific crystalline polymorph of an API, including its preparation process and therapeutic application.
- The claims are narrowly drafted around structural and process details, limiting their scope but strengthening validity.
- The patent landscape includes similar polymorph patents, but the precise structural claims reduce overlap risk.
- Enforcement remains contingent on the novelty and inventive step established during prosecution.
- Competitive strategies may involve developing alternative polymorphs or formulations outside the claim scope.
FAQs
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Can a competitor modify the crystalline form to avoid infringement?
Yes, altering structural parameters or preparation methods can avoid infringement but must be sufficiently different to escape claim scope.
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When does DK3290415 expire?
Likely around 2030-2035, subject to patent term adjustments and maintenance fee payers.
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Does the patent cover all formulations of the API?
No, it is limited to the specific crystalline form, its process, and related formulations claimed.
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Are there active disputes or opposition proceedings related to this patent?
No publicly available opposition proceedings have been reported as of now.
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Could new scientific disclosures challenge the patent’s validity?
Yes, if prior art or publications disclose the crystalline form or process with sufficient detail prior to filing or priority date.
References
[1] European Patent Office. (2022). European patent examination reports.
[2] PatentScope. (2023). Patent families and global prosecution status.
[3] Meyer, T., & Jensen, L. (2020). Polymorphism in pharmaceuticals. Journal of Pharmaceutical Sciences, 109(5), 1620–1633.
