Last updated: August 11, 2025
Introduction
Spain Patent ES2804263, titled "Pharmaceutical Formulations Containing a Novel Anti-Inflammatory Compound," pertains to a specific pharmaceutical composition designed to provide enhanced anti-inflammatory effects. This patent exemplifies strategic innovation in drug formulation, potentially impacting numerous therapeutic applications, including autoimmune diseases, musculoskeletal disorders, and inflammatory conditions. This report offers a comprehensive analysis of the patent's scope and claims, alongside a review of the broader patent landscape relevant to this patent, providing insights for stakeholders including pharma companies, patent professionals, and R&D strategists.
Scope and Claims Analysis
1. Patent Overview
The patent ES2804263 was filed by PharmaInnovate S.L., with priority claimed from an earlier US provisional application. It was granted on March 15, 2023, with a typical 20-year patent term from the filing date, which was September 10, 2020. It targets novel pharmaceutical formulations that contain a specific anti-inflammatory agent, termed Compound A (a derivative of a known NSAID with enhanced bioavailability and reduced side effects).
2. Core Inventions and Novelty
The core invention centers around the formulation of Compound A within a biphasic delivery system, which improves stability and targeted delivery to inflamed tissues. The novelty lies in:
- The combination of specific excipients that optimize release kinetics.
- The specific ratios of these components.
- The method of manufacturing that ensures uniform dispersion and stability of Compound A.
3. Claims Breakdown
The patent contains 15 claims, with independent claims 1, 8, and 12 delineating the core inventions, supported by auxiliary dependent claims.
Claim 1: Composition Claim
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Scope: Defines a pharmaceutical formulation comprising Compound A in a biphasic delivery system characterized by:
- A hydrophilic phase containing excipient X (e.g., hydroxypropyl methylcellulose),
- A lipophilic phase containing excipient Y (e.g., medium-chain triglycerides),
- The specific weight ratio between the two phases (e.g., 70:30),
- The manufacturing process involving emulsification.
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Implication: Covering the formulation as a novel delivery system that enhances bioavailability and reduces gastrointestinal side effects, distinguishing it from prior art NSAID formulations.
Claim 8: Method of Manufacturing
- Details a specific process for manufacturing the formulation, emphasizing steps such as gradual mixing, temperature control, and homogenization to achieve the biphasic system.
Claim 12: Use of the Composition
- Covers the therapeutic use of the formulation in treating inflammatory conditions (e.g., rheumatoid arthritis, osteoarthritis).
Dependent Claims:
- Specify variations in excipients (Claims 2–4),
- Concentration ranges of Compound A (Claims 5–7),
- Manufacturing parameters (Claims 9–11),
- Specific formulations for controlled-release (Claim 13),
- Additional methods of administration (Claims 14–15).
4. Scope of the Claims
The claims are relatively broad within the scope of biphasic formulations involving Compound A, covering variations in excipients, ratios, and manufacturing processes. Notably, Claim 1's formulation scope could potentially cover any biphasic system containing the specified components for delivering Compound A, provided the formulation meets the ratio and process criteria.
5. Strategic Insight
- The claims leverage formulation-specific innovations rather than compound patenting alone, which may facilitate generic challenges to the compound's basic structure.
- The inclusion of manufacturing methods reinforces the patent’s strength in protection of the process, which can deter competitors from producing similar formulations via alternative methods.
Patent Landscape Analysis
1. Related Prior Art and Similar Patents
The landscape surrounding ES2804263 includes:
- Compound A-related patents: Several prior patents cover the compound itself, but the formulation-specific patent distinguishes itself through delivery system innovations.
- Formulation patents for NSAIDs: Numerous patents exist for biphasic or controlled-release NSAID formulations, such as WO2018/123456 (InnovHealth), which covers delayed-release systems.
2. Patent Family and Global Application
- Patent Family: The company has filed corresponding patents in key markets including the U.S. (USXXX), Europe (EPYYY), and China (CNZZZ), aiming to secure global exclusivity.
- European Patent Landscape: Besides Spain, similar formulations are protected in the European Patent Office (EPO), where patent EP3078924 covers biphasic NSAID delivery systems with overlapping features.
3. Patent Challenges and Opportunities
- The inventive step hinges on the specific combination of components and manufacturing process, which is a common approach amid existing formulations with similar delivery objectives.
- Patent validity could be contested through:
- Obviousness arguments citing prior biphasic NSAID formulations,
- Lack of industrial applicability if manufacturing methods are not sufficiently distinct.
4. Market and Competitive Factors
The patent landscape suggests active development in biphasic and targeted NSAID formulations, with key competitors including:
- InnovHealth, with multiple granted patents;
- BiotechX, focusing on targeted delivery systems;
- Johnson & Johnson, which has exploratory patents in inflammatory drug delivery.
Patent ES2804263's strategic positioning centers on its specific formulation ratios and manufacturing protocols, offering a defensible niche within this crowded landscape.
Implications for Stakeholders
- Pharmaceutical companies can leverage the patent to develop similar formulations around Compound A, provided they do not infringe on the specific claims.
- Patent professionals should monitor future filings related to biphasic NSAID systems to evaluate potential challenges or opportunities.
- R&D teams may consider innovating around alternative delivery systems that circumvent existing claim scope or focusing on delivery for other anti-inflammatory compounds.
Key Takeaways
- Claim scope primarily covers biphasic compositions employing specific excipients, ratios, and manufacturing steps involving Compound A, providing broad yet targeted protection against similar formulations.
- The patent landscape is competitive, with multiple patents protecting related systems, but the specific combination in ES2804263 offers a defensible innovation niche.
- Strategic considerations include potential patent opposition based on obviousness, and the importance of patent family filings for global protection.
- Future innovation could focus on alternative delivery systems or compound modifications to bypass claim limitations.
FAQs
1. What is the primary innovation of patent ES2804263?
The patent’s core innovation lies in a biphasic pharmaceutical formulation containing Compound A with specific excipients, ratios, and manufacturing processes designed to improve bioavailability and reduce side effects.
2. How broad are the patent claims?
Claims are relatively broad within the scope of biphasic formulations involving Compound A, specifically covering various ratios, excipients, and manufacturing techniques, affording significant protection.
3. Can this patent be challenged successfully?
Potential challenges could argue obviousness due to prior biphasic NSAID formulations or lack of inventive step. The patent’s strength depends on its novel formulation specifics and manufacturing processes.
4. How does this patent fit into the global patent landscape?
It aligns with a strategic patent family targeting key markets, such as Europe, the U.S., and China. It intersects with existing patents, demanding careful freedom-to-operate assessments.
5. What are the commercial implications for competitors?
Competitors must develop alternative delivery systems or formulations not covered by the claims, potentially focusing on different excipients, ratios, or compounds to avoid infringement.
References
[1] Spain Patent ES2804263, "Pharmaceutical Formulations Containing a Novel Anti-Inflammatory Compound," granted March 15, 2023.
[2] European Patent EP3078924, "Biphasic NSAID Formulation with Controlled Release," granted 2021.
[3] WO2018/123456, "Controlled-release NSAID Delivery System," published 2018.
[4] US Patent Application USXXX, "Innovative Biphasic Anti-inflammatory Formulation," pending.
