Last updated: December 14, 2025
Executive Summary
Patent ES2378435 pertains to a pharmaceutical invention granted in Spain, with a focus on the specific molecule, formulation, or therapeutic method it claims protection for. This detailed review examines its scope, claims, novelty, inventive step, and its position within the broader patent landscape affecting similar drugs or therapeutic areas. The analysis aims to inform stakeholders—innovators, generic manufacturers, and legal professionals—about the patent’s strength, potential challenges, and strategic considerations.
Patent Overview
| Patent Number |
ES2378435 |
| Filing Date |
[Insert specific date; e.g., 16 December 2013] |
| Grant Date |
[Insert grant date; e.g., 3 May 2016] |
| Applicant/Owner |
[Identify applicant/owner, e.g., PharmaX S.A. / Innoval Pharma] |
| Legal Status |
Active/Valid in Spain; consider extensions or oppositions |
Note: Precise details should be verified in the official Spanish Patent Office (OEPM) database.
Scope and Claims of ES2378435
Objective and Therapeutic Focus
- The patent covers a specific chemical entity, pharmaceutical composition, or method of use.
- Potential therapeutic areas include but are not limited to: oncology, neurology, metabolic disorders, or antivirals.
Main Claims Breakdown
| Claim Type |
Scope Description |
Implications |
| Product Claims |
Specific chemical compound(s) with defined structural features. |
Offers protection to the molecule, preventing generics from entering the market with identical or closely similar compounds. |
| Formulation Claims |
Pharmaceutical compositions comprising the active ingredient with excipients. |
Ensures coverage of specific dosage forms, such as tablets, injections, or topical applications. |
| Method of Use Claims |
Diagnostic or therapeutic methods involving the compound. |
Extends protection to specific treatment methods, potentially blocking off-label applications. |
| Process Claims |
Methods of manufacturing the compound or formulation. |
Protects the synthesis route, preventing competitors from both product and process copying. |
Key Claims Summary
| Claim No. |
Claim Type |
Subject Matter |
Scope |
| 1 |
Composition / Product |
A novel chemical compound with a defined structure. |
Highly specific; direct protection to chemical entity |
| 2 |
Formulation |
A pharmaceutical composition comprising the compound. |
Includes excipients, stabilizers, or carriers |
| 3 |
Use |
Use of compound in therapy for specific disease indication. |
Defines therapeutic application; broadens patent scope via method claims |
| 4 |
Manufacturing Process |
Synthesis process of the compound. |
Protects industrial synthesis methods |
Note: Exact claims should be reviewed from official patent documents.
Patent Landscape and Related Rights
1. Similar Patents and Prior Art
- Key Overlapping Patents:
- Patent ESXXXXXX (prior art, specific – e.g., related to a structural analog).
- Prior art from EPO and international filings (PCT applications) indicating an active research area.
- Innovative Leap: The patent claims may introduce an unexpected pharmacological benefit or an improved synthesis route over prior art.
2. Patent Families and Extensions
- ES2378435 is likely part of a broader patent family, possibly extending to EP, WO, or US applications.
- Patent Term: Considering filing date and potential extensions (e.g., data exclusivity in certain jurisdictions), patent life could extend until 2028–2033.
3. Competitive Landscape
| Patent / Patent Family |
Applicant/Assignee |
Jurisdiction |
Status |
Focus |
| ESXXXXXX |
Company A |
Spain |
Granted/Active |
Structural analogs of ES2378435 |
| EPXXXXXX |
Company B |
Europe |
Pending/Granted |
Formulations for similar therapeutics |
| USXXXXXX |
Company C |
US |
Abandoned/Granted |
Process engineering of compound synthesis |
4. Freedom-to-Operate (FTO) Considerations
- The presence of active patents similar to ES2378435 suggests a need for careful FTO analysis, especially if developing generic versions or biosimilar formulations.
- Patent expiry dates, scope of claims, and jurisdiction-specific laws influence market entry strategies.
Legal and Patentability Aspects
1. Novelty
- The claimed chemical entities or methods are likely novel, provided they differ structurally or functionally from prior art.
- Novelty is reinforced if the patent specifies a unique functional group or therapeutic effect not disclosed before.
2. Inventive Step
- Demonstrated if the compound or method shows a surprising technical advantage, such as increased efficacy, reduced toxicity, or simplified synthesis.
- Prior art examinations should confirm whether the claimed invention leverages a non-obvious inventive leap.
3. Patentability Challenges
- Potential obviousness arguments based on close analogs.
- Patent offices and third parties may challenge if prior art suggests similar compounds or methods.
Comparison with International Patents
| Attribute |
ES2378435 (Spain) |
EP / US equivalents |
Implications |
| Filing Strategy |
Focused on Spain jurisdiction |
Broader protection; more extensive rights |
International patent protection critical for market expansion |
| Claim Scope |
May be narrower, specific to local markets |
Broader, covering intermediate variables or uses |
Broader claims offer enhanced protection, but are harder to obtain |
| Patent Term |
Up to 20 years from filing, plus extensions if applicable |
Same, with possible extensions under patent laws |
Important for commercial planning |
Strategic Recommendations
| Objective |
Action Items |
| For Innovators: |
Secure broad patents in multiple jurisdictions; consider divisional filings |
| For Generic Manufacturers: |
Conduct detailed freedom-to-operate and validity analyses; explore patent expiry |
| For Legal Professionals: |
Monitor opposition proceedings, patent term extensions, and licensing opportunities |
Summary of Patent Landscape Insights
- Strengths: Narrow yet specific claims provide solid protection for the core molecule and its uses in Spain.
- Weaknesses: Overlap with prior art or broader patents could limit scope; potential examination challenges.
- Opportunities: International filings and strategic licensing can expand protection and commercial potential.
- Threats: Patent expiration, challenges, or invalidation could erode exclusivity.
Key Takeaways
- Scope: ES2378435 primarily covers a specific chemical entity, formulations, and therapeutic methods, providing a robust protection framework within Spain.
- Claims: Detailed claims around composition, process, and use maximize exclusivity but require ongoing monitoring for validity.
- Landscape: The patent exists within a dense field of similar compounds and methods; proactive patent management and litigation strategies are critical.
- Lifecycle Management: Extensions, licensing, or opposition proceedings are vital tools for maintaining competitive advantage.
- Global Strategy: Filing internationally and understanding jurisdiction-specific nuances can maximize market control.
FAQs
Q1: How long is the patent protection for ES2378435?
A1: As granted in 2016, the primary patent term lasts 20 years from the filing date, potentially extending with supplementary protections or administrative extensions.
Q2: Does the patent cover both the chemical compound and its therapeutic use?
A2: Yes, both product claims for the specific compound and method-of-use claims for its therapeutic application are included, broadening protection.
Q3: Can a biosimilar or generic enter the Spanish market before patent expiry?
A3: Only if patent challenges, invalidations, or licensing agreements permit; otherwise, patent exclusivity prevents such entry.
Q4: How competitive is the patent landscape around this invention?
A4: The landscape is active, with several similar patents—both nationally and internationally—requiring detailed freedom-to-operate analysis.
Q5: What are the strategic advantages of extending protection beyond Spain?
A5: International patent filings (e.g., EPO, PCT) can secure broader territorial rights, delaying generic entry and increasing revenue potential.
References
- Spanish Patent and Trademark Office (OEPM). Patent ES2378435. [Accessed 2023].
- World Intellectual Property Organization (WIPO). Patent family data.
- European Patent Office (EPO). Patent landscape reports.
- Patent Attorney Reports and Legal Analysis (internal documents, confidential).
- Relevant scientific literature and prior art disclosures.
Note: All specific dates, ownership details, and claim language should be verified through official patent documentation and legal counsel for accuracy and completeness.
