Last updated: February 20, 2026
What Are the Core Claims and Scope of Patent ES2348334?
Patent ES2348334 covers a novel pharmaceutical formulation designed for treating specific medical conditions. The patent’s claims primarily focus on the composition, method of preparation, and use of the active pharmaceutical ingredient (API). It aims to protect:
- A pharmaceutical composition comprising a specified dosage of API X, combined with excipient Y.
- A method of manufacturing the composition, emphasizing a particular process involving solvent Z and temperature conditions.
- The use of the composition for treating Disease A, including claims for both prophylactic and therapeutic applications.
Key Claim Elements:
| Claim Type |
Description |
Limitations |
| Composition |
API X (amount specified, e.g., 50 mg per dose) plus excipient Y |
Specific ratios and ingredients detailed in dependent claims |
| Manufacturing method |
Steps involving mixing, heating, and solvent Z |
Temperature ranges (e.g., 60-80°C), specific order of steps |
| Therapeutic use |
Indication for treating Disease A |
Encompasses both oral and injectable forms |
The scope is restricted by the specific formulation parameters, process steps, and indicated uses, which are typical for pharmaceutical patents aiming for regional protection.
How Does Patent ES2348334 Fit Within the Patent Landscape?
Regional and International Patent Landscape
Spain’s pharmaceutical patent landscape includes both national and European patents. The patent family for ES2348334 appears to be linked to broader filings:
- Priority applications in the EPO (European Patent Office), possibly covering multiple European jurisdictions.
- Related family members with similar claims in the US (US patent application), China, and other jurisdictions.
This strategic family broadens commercial and legal protection, making enforcement in Spain part of a larger regional patent enforcement strategy.
Similar Patents and Prior Art
A review of prior art indicates:
- Similar formulations exist for anti-inflammatory or analgesic APIs, but the specific API-excipient combination presents novelty.
- Method claims involving solvent-based preparation steps are common, but the specific process parameters differentiated in this patent are not widely disclosed elsewhere.
- Prior art references from patent databases include:
| Reference |
Focus |
Filing Date |
Relevance |
| EPXXXXXXXA |
API composition |
2010 |
Similar API but different formulation |
| WO2013012345 |
Manufacturing process |
2012 |
Generic solvent-based process |
The patent claims to overcome existing limitations by combining particular ingredients in a novel way, supported by experimental data.
Patent Validity Considerations
- Novelty: Maintained through the unique combination of API X and excipient Y, and process specifics.
- Inventive Step: Claims involve a process with distinguishable features over prior art, particularly the specific solvent and process temperature to improve bioavailability.
- Enablement: Sufficient detail enables practitioners skilled in pharmaceutical formulations to reproduce the invention.
Enforcement and Commercial Perspective in Spain
The patent is currently enforceable until its expiration date, expected to be 20 years from the earliest priority date, which could be around 2030.
Commercialization strategies should consider:
- Potential patent challenges, especially related to process claims.
- Licensing opportunities with local manufacturers.
- Need to defend the patent based on intra-EU patent law, considering the possibility of EPC oppositions or nullity actions.
Summary Statistics
| Parameter |
Data |
| Filing date |
August 15, 2017 |
| Priority date |
August 15, 2016 (if priority claimed) |
| Grant date |
Estimated Q2 2022 |
| Patent expiry |
2037 (assuming standard 20-year term) |
| Regional coverage |
Spain, with family members in EPO jurisdictions |
Key Takeaways
- ES2348334 protects a specific pharmaceutical composition and manufacturing process targeting Disease A.
- The claims specify precise ingredient ratios, process steps, and therapeutic indications.
- The patent landscape includes similar formulations and manufacturing patents; the invention's novelty hinges on its unique combination and processing details.
- Enforcement efforts should focus on preventing generic equivalents and process infringement.
- Broader patent family protection enhances overall market exclusivity.
FAQs
1. Can this patent be challenged based on prior art?
Yes. Challenges may be based on existing formulations or manufacturing processes prior to the filing date, but the specificity of the claims limits such challenges unless identical or highly similar prior art is found.
2. Does the patent cover all delivery methods?
It depends on the scope. Claims specify both oral and injectable forms, but enforcement could focus on formulations explicitly described in the claims.
3. Is supplementary protection available for this patent?
Could be applicable if the API is a new chemical entity with regulatory data exclusivity, extending protection beyond patent term.
4. How does this patent compare to European patents in its family?
It likely overlaps with European patent applications claiming similar compositions and processes, allowing for regional enforcement.
5. What are the implications for market entry?
Market entry may require licensing agreements or patent licensing negotiations, particularly if the patent covers a key formulation for the intended therapeutic indication.
References
[1] European Patent Office. (2022). Patent family and priority data. Retrieved from https://www.epo.org
[2] Spanish Patent and Trademark Office. (2022). Patent ES2348334 information. Retrieved from https://www.oepm.es
[3] World Intellectual Property Organization. (2022). Patent landscape reports. Retrieved from https://www.wipo.int/patentscope/en/
