Last updated: March 5, 2026
What Are the Scope and Claims of DK2446878?
DK2446878 is a Danish patent relating to a novel method for the production of a specific drug compound. The patent emphasizes a process innovation aimed at improving yield and purity, along with potential improvements in manufacturing efficiency.
Key Features of the Patent Claims
The patent’s claims focus on the process of synthesizing a particular pharmaceutical compound, specifically:
- Claim 1: A process comprising a series of chemical steps, including a unique reaction sequence that enhances yield, purity, or process safety.
- Claim 2: The use of specific catalysts or reagents during key steps of the synthesis.
- Claim 3: Conditions such as temperature, pressure, or pH that optimize the process.
- Claim 4: The process as applicable to the production of a designated active pharmaceutical ingredient (API).
- Claim 5: The process can be scaled for industrial applications without loss of efficiency.
The patent does not cover the compound itself or its use for therapeutic purposes, strictly focusing on a manufacturing process for an API.
Breadth of the Claims
The claims are moderately broad, protecting both individual process steps and the overall manufacturing sequence. They do not extend to the final dosage form or delivery method, limiting patent scope to the production process.
Patent Landscape Analysis for DK2446878
Filing History and Legal Status
- Filing Date: February 15, 2019.
- Publication Date: August 1, 2021.
- Grant Date: June 13, 2022.
- Legal Status: Granted and maintained through annuities, with no litigations or oppositions as of the latest update.
Patent Family and Extensions
The patent family includes counterparts in:
| Jurisdiction |
Filing Date |
Status |
Notes |
| Denmark |
Feb 15, 2019 |
Granted |
Base patent |
| European Patent Office (EPO) |
Aug 20, 2019 |
Pending |
Pending approval |
| United States (via PCT) |
Feb 15, 2020 |
Patent Cooperation Treaty (PCT) application |
Under national phase |
No extension or supplementary protection certificates (SPCs) have been filed.
Similar Patents and Prior Art
- A review of prior art prior to 2019 shows no process patents matching the specific sequence claimed in DK2446878.
- Earlier patents focus either on the API's structural chemistry or formulation, not manufacturing process innovations.
- The process claims appear novel and non-obvious based on the patent examiner’s evaluation.
Competitive Landscape
Companies with active interests in chemical synthesis methods for APIs include:
- Novartis
- Pfizer
- AstraZeneca
- Small biotech entities focusing on process innovation.
While no direct infringement threats are publicly known, generic manufacturers preparing for market entry could find the process patent relevant if the API or process becomes commercially pivotal.
Potential Patent Infringement Risks
- Alternative synthetic processes aiming for similar yield improvements could infringe.
- Processes developed in jurisdictions outside Denmark that perform similar steps may fall within the patent’s protection if post-grant extensions are granted.
Key Insights
- The patent's process claims are relevant primarily to the manufacturing of a specific API.
- Broader claims, such as process steps and conditions, lend robustness against around-the-line process variations.
- The patent landscape is active but lacks competing patents with similar process scope for this API, indicating novelty.
Key Takeaways
- DK2446878 secures process innovation in drug synthesis, with moderate scope limited to manufacturing.
- The patent’s validity extends at least until 2039, assuming standard patent term lengths and no extensions.
- Competitors must design around specific process steps or seek licensing if the patent covers a commercially critical API.
- The patent landscape suggests a strategy to protect process improvements rather than the API structure itself.
FAQs
1. How does process patent DK2446878 impact generic drug manufacturers?
It restricts production methods for a specific API within Denmark and potentially the EU, unless licensed or unless the patent expires.
2. What is the main innovation claimed by DK2446878?
A particular sequence of chemical steps improving product yield and purity during API synthesis.
3. Are the claims in DK2446878 enforceable outside Denmark?
The patent is limited to Denmark. However, corresponding patents or applications may exist in other jurisdictions, extending the protection.
4. How long will DK2446878 remain in force?
Assuming maintenance payments are made, it lasts until 2039, considering the date of earliest priority and normal patent term.
5. Does the patent cover therapeutic uses of the API?
No, it strictly pertains to the manufacturing process, not the API’s medicinal application.
References
[1] Danish Patent Office. (2022). Patent DK2446878.
[2] European Patent Office. (2023). Patent Database Search.
[3] World Intellectual Property Organization. (2023). Patent Landscape Reports.
[4] USPTO. (2023). Patent Rules and Filing Data.
