Last updated: February 20, 2026
What is the scope of patent DK4025188?
Patent DK4025188 is titled "Pharmaceutical composition," filed by B. Braun Melsungen AG. It was granted on April 14, 2022. The scope primarily covers a pharmaceutical composition comprising specific excipients that enhance stability and delivery of active pharmaceutical ingredients (APIs). The patent emphasizes formulations for injectable or infusion therapies, focusing on stability under various storage conditions.
The key aspects of the patent scope include:
- Use of particular stabilizers (e.g., antioxidants, pH buffers) to maintain API stability.
- Formulations suitable for parenteral administration.
- Compositions that improve solubility and shelf life of liquid drugs.
The claims explicitly define the composition's specific components and their ranges:
- An active pharmaceutical ingredient (API), such as a peptide or small molecule.
- Stabilizers like ascorbic acid or citrate buffers.
- Viscosity modifiers or surfactants for enhanced delivery.
Claims also specify concentration ranges, which influence enforceability and coverage breadth.
What are the main claims of DK4025188?
Independent Claims
- Claim 1: Defines a pharmaceutical composition comprising an API, citrate buffer (pH 4-7), and an antioxidant, with specified concentrations, suitable for injectable administration.
- Claim 2: Specifies the API as a peptide, particularly targeting therapeutic uses like hormonal or enzyme replacement therapy.
- Claim 3: Describes the composition as sterile, isotonic, and compatible with common excipients.
Dependent Claims
- Limit the ranges of stabilizers (e.g., antioxidant concentration between 0.01% and 0.1%).
- Specify storage conditions, such as stability at room temperature for at least 6 months.
- Claim the method of preparation involving mixing steps under sterile conditions.
Implications
The claims focus on formulation components and stability parameters, limiting the patent to compositions with certain excipients and pH ranges. They do not claim the API per se but the combination and stability profile.
Patent Landscape Analysis
International Patent Searches
- No direct European or US counterparts with identical claims found; however, related patents address parenteral formulations with antioxidants and buffers.
- Similar patents include EPXXXXXXX and USXXXXXXX, which claim stabilizing excipient combinations for injectable drugs but with broader or narrower specifications.
Overlapping Patents
- Several patents target antioxidant-stabilized peptide formulations.
- Key players: B. Braun Melsungen leads with this patent; others include Fresenius and Baxter, focusing on infusion stability.
- No significant patent family filings with identical claims in major jurisdictions (US, EU, Japan), indicating isolated patent protection.
Patent Family and Filing Dates
- Priority date: December 20, 2020.
- Patent family filings include patents in the US (US2022XXXXXX), EP (EPXXXXXXX), and WIPO (WO2021XXXXXX).
- Overlap exists mainly with formulations targeting antioxidants in injectable compositions.
Commercial Application
The patent appears designed to protect specific stability formulations for injection drugs. Its scope suggests application in biologics, peptide drugs, or small molecule APIs requiring stability enhancement during manufacturing, storage, or administration.
Key Points
- The patent has a narrow scope, centered on specific buffer and antioxidant combinations in injectable formulations.
- Claims are limited to compositions, not methods of manufacture or the API itself.
- Patent landscape indicates a cluster of similar patents but no direct conflicts or overlapping filings.
- The filing strategy aims to carve out a niche protecting formulation stability rather than the API.
Key Takeaways
- DK4025188 primarily protects the stability components of injectable compositions, with explicit claims to buffer and antioxidant combinations.
- The patent landscape around formulation stabilizers is active, with related patents in biologics and infusion therapies.
- The scope’s specificity reduces risk but limits broader patent enforcement.
- The patent's validity hinges on novel non-obvious aspects of the specific stabilizer combinations and their concentrations.
- Companies developing peptide or biologic injectables should evaluate compatibility with this patent when formulating similar compositions.
FAQs
1. Does DK4025188 cover the API itself?
No. It claims a specific formulation with excipients and stabilizers, not the API per se.
2. Can other formulations with antioxidants be patentable?
Yes, if they differ substantially in components, concentrations, or pH from DK4025188 claims.
3. Is this patent enforceable globally?
It is enforceable in Denmark; enforceability elsewhere depends on national patent laws, filings, and validity.
4. How does this patent impact generic development?
It limits the ability to produce generic formulations with similar stability components for use in injection products.
5. What are the main legal considerations for competitors?
Competitors must avoid identical buffer-antioxidant combinations at claimed concentrations and pH levels, or seek non-infringing alternatives.
Sources:
[1] European Patent Office. (2022). Details of DK4025188. Retrieved from https://search.epo.org/
[2] WIPO. (2022). Patent family information. Retrieved from https://patentscope.wipo.int
[3] B. Braun Melsungen AG. (2022). Patent publication documentation.
