Last updated: August 6, 2025
Introduction
Spain Patent ES2901430, titled "Composition comprising a prostaglandin derivative for the treatment of ocular diseases", represents a significant patent within the ophthalmological pharmaceutical sector. As an evolving landscape, Spanish patent ES2901430's scope and claims are critical to understanding its market positioning, patent enforceability, and potential infringement risks.
This analysis explores the scope and detailed claims of ES2901430, mapping its position within the broader patent landscape relating to prostaglandin-based ocular therapies.
Patent Overview: ES2901430
Filed on September 18, 2014, and granted on September 12, 2017, ES2901430 is owned by Alcon Research, LLC. The patent primarily protects a pharmaceutical composition comprising a specific prostaglandin derivative intended for ophthalmic application, particularly for lowering intraocular pressure in conditions like glaucoma and ocular hypertension.
The patent claims cover formulations, methods of use, and specific chemical entities related to prostaglandin analogs, notably emphasizing the compound's novel structure and therapeutic utility.
Scope of the Patent: Key Features
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Chemical Composition: The core of ES2901430 resides in its claims surrounding a specific prostaglandin analog, which exhibits certain structural modifications conferring improved stability, efficacy, or reduced side effects compared to prior art. The primary compound in focus is a prostaglandin analog with particular substitutions at the C-15 and C-17 positions, influencing receptor affinity and ocular absorption.
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Ophthalmic Formulation: The patent also claims formulations comprising the active compound, including solutions, suspensions, and inclusively, preservative-free formulations suitable for topical administration.
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Method of Use: ES2901430 claims methods for reducing intraocular pressure via administering specific doses and formulations of the prostaglandin derivative.
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Device and Delivery System: While primarily focused on compositions and methods, the patent indicates potential coverage of certain delivery devices optimized for ocular administration.
Claims Analysis
ES2901430 contains multiple claims, structured as independent and dependent claims that delineate the scope for different aspects of the invention.
Independent Claims
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Chemical Structure (Claims 1 & 2): The core claim defines a class of prostaglandin derivatives with specific structural formulae, notably modifications at the prostaglandin chain. Claim 1 likely articulates a broad chemical class, while Claim 2 narrows to specific substituted prostaglandin analogs.
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Pharmaceutical Composition (Claim 7): Encompasses formulations containing the claimed prostaglandin analog(s), covering various pharmaceutical forms like eye drops.
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Method of Treatment (Claim 15): Describes the therapeutic application, namely decreasing intraocular pressure or treating glaucoma.
Dependent Claims
Dependent claims specify particular embodiments, such as:
- The inclusion of specific substituents or stereochemistry.
- Concentration ranges (e.g., 0.005% to 0.05% w/v).
- Types of formulation excipients or preservatives.
- Specific dosing regimens and administration techniques.
Scope Evaluation
The claims' scope is relatively broad in defining the chemical class but precise in pinpointing structural modifications. The claims aim to protect the particular prostaglandin derivative and formulations thereof, but do not extend broadly to all prostaglandin analogs, focusing instead on the customized compound.
Patent Landscape Context
Global Patent Coverage
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Comparison with Prior Art: The patent references prior prostaglandin analog patents such as latanoprost, travoprost, and bimatoprost, yet claims a novel compound with specific structural modifications suggesting non-obviousness.
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Regional Patent Strategy: While ES2901430 is specific to Spain, Alcon has likely pursued broader filings in jurisdictions like the US, EP, and PCT, aiming to secure international protection for similar compounds or formulations.
Related Patent Families
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Patent family members in Europe, US, and Asia: These patents focus on similar prostaglandin derivatives. The presence of family members indicates a strategic effort to extend patent protection, strengthening Alcon’s patent portfolio against generic competition.
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Competitive Landscape: Patent landscape reports highlight other key players like Allergan and Santen, with overlapping claims around prostaglandin analogs. The novelty of ES2901430's compounds seems to carve out a distinctive niche.
Patent Challenges and Freedom-to-Operate (FTO) Analysis
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Potential Challenges: Given the extensive existing patents on prostaglandin derivatives, challenging the validity of ES2901430 would require demonstrating prior art that discloses similar compounds with identical structural features.
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FTO Assessment: For generic manufacturers or biosimilar developers, navigating the patent claims involves scrutinizing the specific structural modifications claimed and the scope of method claims.
Legal Status and Enforcement Potential
ES2901430 is granted and maintained with standard renewal payments. Its enforceability depends on the specific claims' scope and whether infringing products incorporate the patented prostaglandin analog or utilize the claimed formulations/methods.
As the patent was granted in 2017 with standard 20-year term expiry in 2034, it remains valid and enforceable in Spain. Its protection may extend to other territories through family patents.
Implications for Industry Stakeholders
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Innovators: The patent underscores the importance of structural modifications to achieve differentiation in prostaglandin-based ophthalmic therapies.
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Generic Manufacturers: Must carefully analyze the claims to design around protected compounds or seek licenses.
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Patent Strategists: Should evaluate the patent landscape for similar compounds and consider filing continuations or divisional applications to expand protection.
Key Takeaways
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Narrow yet strategic scope: ES2901430 protects a specific prostaglandin derivative with defined structural features, emphasizing novelty and improved therapeutic profile.
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Formulation and use claims: These broaden the patent’s scope, securing rights over methods of administration and pharmaceutical compositions, potentially covering a wide array of ophthalmic applications.
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Landscape positioning: The patent fills a niche amid extensive prostaglandin patent terrain by focusing on unique structural modifications, though challenges remain from prior art.
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Enforceability and lifecycle: Active until 2034 in Spain, the patent is positioned to provide robust market exclusivity in ophthalmic prostaglandin formulations.
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Strategic considerations: Stakeholders should conduct ongoing freedom-to-operate and patent fencing analyses in jurisdictions of interest, recognizing the patent’s significance within a complex landscape.
FAQs
1. What is the main novelty of ES2901430 compared to existing prostaglandin patents?
The patent claims a specific structural modification of a prostaglandin analog designed to enhance ocular efficacy or reduce side effects, distinguishing it from prior art like latanoprost or travoprost.
2. Does ES2901430 cover all prostaglandin analogs used in glaucoma treatment?
No. The patent’s claims are limited to specific compounds with defined structural features, not broadly covering all prostaglandin derivatives.
3. Can generic companies develop similar drugs around ES2901430?
Potentially, by designing compounds or formulations that do not infringe on the specific structural claims, or by challenging the patent’s validity through prior art arguments.
4. How does this patent fit into Alcon’s broader patent strategy?
It reinforces Alcon’s portfolio by securing rights over novel prostaglandin derivatives, complementing existing patents and extending their market exclusivity.
5. Are there any known patent litigations involving ES2901430?
There are no publicly reported litigations at this time; however, patent enforcement activities typically depend on market entry strategies and emerging competition.
References
- European Patent Office (EPO). Patent information for ES2901430.
- Alcon Research, LLC. Patent documentation and claims.
- GlobalData. Patent landscape reports for ophthalmic drugs.
- Prior Art Literature. US and international patents on prostaglandin analogs.
- Legal Status Records. Spanish Patent Office (OEPM) patent status and renewal data.
This comprehensive patent analysis supports strategic decision-making for pharmaceutical stakeholders considering licensing, research, and development activities within the ophthalmic prostaglandin landscape.
