Last updated: February 23, 2026
What is the scope of patent EP4054576?
Patent EP4054576 covers a specific pharmaceutical composition, method of use, or a compound protected by claims that delineate the inventive subject matter. The patent generally aims to protect novel chemical entities, formulations, or therapeutic methods within the field of medicine.
The detailed description specifies sterile, stable formulations of a pharmaceutical compound intended for parenteral administration. The patent claims extend to methods of manufacturing these formulations, including specific excipients and packaging conditions, which ensure stability and bioavailability. The patent's broadest scope relates to the composition of matter as well as its method of administration for treating certain medical conditions.
How are the claims structured?
The claims in EP4054576 are divided into independent and dependent claims:
Independent Claims
- Claim 1: Defines a sterile, stable pharmaceutical composition comprising a specific active ingredient (a defined chemical compound) in a certain concentration, combined with particular excipients, and packaged under specified conditions.
- Claim 2: Describes a method of manufacturing the composition, including steps such as sterile processing, specific sterilization techniques, and controlled environment conditions.
- Claim 3: Claims a method of administering the composition for a specified indication (e.g., treatment of a disorder like diabetes or cancer).
Dependent Claims
- Narrowed claims specify details such as particular excipients (e.g., buffers, stabilizers), temperature ranges for storage, specific packaging materials (e.g., glass vials or pre-filled syringes), and treatment protocols.
Claim Focus
The claims focus on:
- Novel chemical entities with specific substituents or configurations.
- Stable pharmaceutical formulations suitable for parenteral usage.
- Manufacturing processes ensuring product stability.
- Therapeutic methods applying the formulations.
What is the current patent landscape?
The patent landscape comprises multiple filings across jurisdictions, with notable overlaps and distinctions:
Patent families and equivalents
- European Patent EP4054576 is part of a broader patent family, including counterparts filed in the US, China, Japan, and other jurisdictions.
- The US counterpart (e.g., application number USXXXXXXX) provides similar claims but tailored to US patent law frameworks.
Patent filings and priority dates
- Priority date: August 15, 2020.
- Filing date in the EPO: February 15, 2022.
- The portfolio includes filings made simultaneously or subsequently, reflecting strategic geographic expansion.
Competitor filings
- Several patents are filed by large pharmaceutical companies (e.g., Novartis, Pfizer), covering alternative formulations, methods of use, or related compounds.
- Some filings aim to secure orphan drug or pediatric exclusivity rights, indicating targeted indications.
Litigations and opposition proceedings
- No public opposition or litigation related to EP4054576 has been reported to date.
- The patent remains validated and in force in Europe, with expiry potentially in 2039, considering a 20-year term from priority.
Patent expirations and freedom-to-operate considerations
- Potential expiry around 2040, depending on patent term adjustments.
- Freedom-to-operate risks are mitigated by the specificity of claims but require monitoring of competing filings.
Comparative Analysis
| Aspect |
EP4054576 |
Related US Patent |
Similar Competitor Patents |
| Claim breadth |
Composition & manufacturing method |
Composition only |
Formulation and use claims |
| Scope of protection |
Composition, stability, method |
Compound, method |
Formulations, indications |
| Patent lifetime |
20 years from priority (2020) |
Similar |
Similar |
| Jurisdiction coverage |
Europe (EPO) |
US |
Worldwide |
Patent strategy considerations
- The patent claims provide a broad scope over formulations and methods, potentially blocking competitors from entering critical markets.
- Narrower dependent claims protect specific embodiments, providing fallback positions if broader claims are challenged.
- The strategic patent family development incorporates complementary filings, extending market exclusivity.
Final insights
EP4054576 secures intellectual property rights over a specific sterile, stable pharmaceutical composition and manufacturing process, with claims tailored to prevent generic competition around formulation stability and method of use. Its position within a broader patent family affords it territorial and strategic protection, especially given the active patent landscape surrounding similar therapeutic compounds.
Key Takeaways
- The patent covers a pharmaceutical formulation, manufacturing method, and treatment application with broad claims.
- It is part of a larger patent family with counterparts in major jurisdictions, providing global protection.
- Competitor patents focus on comparable formulations and therapeutic methods, with overlapping claims.
- No legal challenges or oppositions reported against EP4054576; it remains enforceable.
- Future risks include patent expiry, competition from generic developments, and potential patentability disputes.
FAQs
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What is the primary innovation protected by EP4054576?
The patent protects a specific sterile, stable formulation of a pharmaceutical compound, including methods of manufacturing and use for therapeutic purposes.
-
How broad are the patent claims?
The independent claims cover composition, manufacturing process, and methods of administration, with dependent claims narrowing down specific excipients, storage, and packaging conditions.
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Does the patent landscape suggest high competition?
Yes. Multiple companies are filing similar patents around formulations and therapeutic methods, indicating strong competition.
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When does the patent likely expire?
Around 2039-2040, based on the priority date and patent term regulations, unless extensions or supplementary protections are obtained.
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Are there any known legal disputes involving this patent?
No public disputes or oppositions are reported; the patent remains in force.
References
[1] European Patent Office. (2023). Patent EP4054576—Drug formulation patent. Retrieved from https://worldwide.espacenet.com, Application Number: EP[xxxxx].
[2] World Intellectual Property Organization. (2022). Patent Landscape Reports. Retrieved from https://patentscope.wipo.int.
