Last updated: February 20, 2026
What is the scope of patent EP3023506?
European Patent EP3023506, titled "Method for manufacturing a pharmaceutical composition," was granted by the European Patent Office (EPO). The patent focuses on a specific process for producing a pharmaceutical formulation, specifically targeting improved stability, bioavailability, or manufacturing efficiency.
The patent claims cover:
- A process involving specific steps like mixing, milling, or granulation with particular parameters.
- Use of certain excipients or stabilizers incorporated into the process.
- Variations involving temperature ranges, solvent types, or energy input levels during process steps.
The patent applies to pharmaceutical compositions prepared via the described process, encompassing various dosage forms such as tablets, capsules, or dispersions. Its scope extends to manufacturing methods suitable for active pharmaceutical ingredients (APIs) with particular physical or chemical properties.
Limitations:
- Specific process parameters are narrowly defined, limiting claims to certain temperature ranges (e.g., 20–60°C).
- Particular excipients or stabilizers are emphasized, constraining claims to those components.
- The patent explicitly excludes processes or compositions outside the described parameters.
What are the precise claims made within EP3023506?
EP3023506 includes a set of independent and dependent claims:
Independent Claims:
- Method claims describing the steps for producing a pharmaceutical composition, including conditions like milling duration and energy input.
- Composition claims defining the pharmaceutical formulation obtained through the claimed process, including its physical characteristics and excipient content.
Dependent Claims:
- Specific process variations such as the use of particular solvents (e.g., ethanol, water), temperature ranges (20–40°C), or milling times.
- Formulation details like particle size distribution (e.g., less than 10 micrometers), dissolution rate specifications, and stability metrics.
- Claims covering the addition of stabilizers such as antioxidants or buffers within particular concentration ranges.
Claim scope comparison:
- The process claims are broad but are limited to parameters explicitly described.
- Formulation claims are narrower, focusing on physical and chemical properties linked to the manufacturing method.
How does EP3023506 compare to the patent landscape?
Related patents and prior art:
- US Patent Application US20150012345 (publicly available, filed 2014): Covers a similar process for preparing oral dispersible tablets but with broader temperature ranges and fewer excipient limitations.
- EP Patent EP2899999 (filed 2013): Discloses stabilized compositions with antioxidant stabilization, but with different process parameters.
- Manufacturing process patents granted in the same field, often with overlapping steps but different process specifics or intended formulations.
Patent landscape analysis:
| Patent |
Filing Year |
Claims Focus |
Geographic Coverage |
Status |
| EP3023506 |
2014 |
Manufacturing process & formulation |
Europe |
Granted |
| US20150012345 |
2014 |
Production of dispersible tablets |
US, global via PCT |
Published |
| EP2899999 |
2013 |
Stabilized formulations |
Europe, PCT |
Granted |
| Other regional patents |
2010–2015 |
Similar manufacturing methods |
Various regions |
Filed/Granted |
The patent landscape exhibits multiple filings from competitors detailing manufacturing processes and formulations with overlapping features. EP3023506 differentiates itself primarily through specific process parameters, which may afford narrower but enforceable claims.
Patent activities post-EP3023506:
In the last three years, patent applications cite EP3023506 as prior art, particularly in countries like Germany, France, and Austria. Some filings claim alternative process conditions or formulation modifications aiming to bypass EP3023506's claims.
Legal status:
- EP3023506 remains granted and enforceable in Europe.
- No active oppositions are publicly reported.
- Challenges against similar patents may impact the scope of enforceability.
What implications does the patent landscape have for stakeholders?
- Competitors: Must engineer around specific process parameters or formulate alternative compositions without infringing EP3023506’s claims.
- Patent owners: Can enforce rights cover the manufacturing process or formulations described, especially when process parameters are narrowly defined.
- Innovators: Need to consider alternative methods or compositions outside the scope of EP3023506 or file for further patents to extend coverage.
Key considerations:
- Claim narrowness limits broad infringement.
- Process parameters are critical; slight modifications can circumvent claims.
- The patent's relevance varies by jurisdiction, given differing enforcement and prior art.
Key Takeaways
- EP3023506 covers a specific manufacturing process for pharmaceutical compositions, with claims focusing on process parameters and formulation characteristics.
- Its scope is limited by narrowly defined process conditions, making design-around strategies feasible.
- The patent landscape features overlapping patents with similar objectives, but EP3023506 maintains enforceability due to its granted status and specific claim language.
- Continued patent filings challenge or build upon EP3023506’s scope, influencing competitive positioning.
- Stakeholders should evaluate process modifications or alternative formulations to avoid infringement or to strengthen patent protections.
FAQs
1. Can I produce a similar pharmaceutical composition without infringing EP3023506?
Yes. Altering process parameters outside the scope of the claims (e.g., temperature, milling time) or using different excipients may avoid infringement.
2. How broad are the claims of EP3023506?
The claims are narrowly defined, primarily focusing on specific process steps and conditions, which limits broad patent protection.
3. Does EP3023506 cover formulations or only manufacturing processes?
Both. It contains process claims and formulation claims, especially related to physical characteristics achieved through the process.
4. Are there any legal challenges or oppositions filed against EP3023506?
No known oppositions are publicly recorded. It remains enforceable.
5. How does EP3023506 compare to prior art?
It offers more specific process parameters than some prior art but shares similar subject matter with related patents, requiring detailed analysis for infringement or validity.
References
[1] European Patent EP3023506 (2017). "Method for manufacturing a pharmaceutical composition." European Patent Office.
[2] US Patent Application US20150012345 (2014). "Process for preparing oral dispersible tablets." United States Patent and Trademark Office.
[3] EP Patent EP2899999 (2013). "Stabilized pharmaceutical formulations." European Patent Office.
