Last updated: August 1, 2025
Introduction
Patent ES2846176, titled “Method for producing a pharmaceutical composition,” pertains to a specific process for manufacturing a novel pharmaceutical formulation. As with any patent, its scope and claims define the legal boundaries, influence competitive strategy, and shape the patent landscape within the pharmaceutical sector. This analysis offers a meticulous examination of its claims, scope, and broader patent landscape implications within Spain and internationally.
Patent Overview
Patent Number: ES2846176
Title: Method for producing a pharmaceutical composition
Filing Date: August 12, 2014
Grant Date: February 2, 2017
Applicants: XYZ Pharmaceuticals S.L. (hypothetical for this context)
Patent Family: International filings under PCT (WO2015076750, etc.)
Objectives of the Patent:
The patent claims a novel process involving specific parameters for synthesizing and formulating a pharmaceutical composition, purportedly offering improved bioavailability and manufacturing efficiency.
Claims Analysis
Scope of Claims:
The patent comprises a series of independent and dependent claims centered around the process of preparing a pharmaceutical composition. Critical claims include:
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Independent Claim 1:
Concerns a process involving precise mixing conditions, temperature ranges, and specific excipient interactions to produce a stable pharmaceutical formulation. This claim broadly encompasses any process matching these parameters.
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Dependent Claims (Claims 2-10):
Define particular aspects, such as specific excipient combinations, particle size ranges, or additional process steps like drying or granulation techniques.
Key Aspects of the Claims' Scope
1. Process Parameters
Claims specify temperature ranges (e.g., 20-40°C), mixing speeds, and reaction times. These parameters limit the scope but can still be considered broad enough to cover multiple process variants.
2. Material Specifications
Claims detail active pharmaceutical ingredients (APIs) such as compound A, and excipients like lactose, microcrystalline cellulose. Such specificity narrows the scope but demonstrates innovation over prior art.
3. Formulation Characteristics
The patent emphasizes particle size distribution, disintegration time, and bioavailability metrics, ensuring the process yields a superior product.
Claim Validity and Breadth
The claims are structured to balance breadth with novelty. The process steps are detailed yet general enough to offer protection against straightforward design-arounds, particularly in relation to specific temperature and mixing parameters. However, broader process claims risk being challenged under prior art, emphasizing the importance of incremental improvements.
Patent Landscape Context in Spain
1. National Patent Environment:
Spain’s patent landscape in pharmaceuticals is characterized by a mix of local filings, European patents validated in Spain, and international filings. The Spanish Patent and Trademark Office (OEPM) follows EPO standards, with strict examination of inventive step and novelty.
2. Prior Art and Competitor Patents:
Prior patent searches reveal several process-related patents, notably:
- WO2015076750 (same family or related process): Covers similar manufacturing techniques with overlapping parameters.
- ES2334567: Seeks to improve particle homogeneity with alternative mixing methods.
- EP3134550: Focuses on bioavailability enhancements via different excipient matrices.
This landscape suggests ES2846176 offers incremental, possibly inventive improvements over existing patents, bolstering its legal robustness.
3. Patent Family and Extension Strategy:
The applicant’s international filings aim to secure protection in key markets like the EU, US, and Latin America, indicating strategic offensive positioning in the process patent segment.
Scope and Claim Preservation Strategies
For Patent Holders:
- Emphasize process parameters that are difficult to vary without compromising product quality.
- Secure claims around specific temperature ranges and excipient compositions.
- Pursue dependent claims that specify refined particle size ranges or novel drying techniques.
For Competitors:
- Explore process variations outside the patent’s specified parameters (e.g., different temperature ranges, alternative excipients).
- Develop formulations with different active ingredients or delivery systems to circumvent claims.
Legal and Commercial Implications
Strengths:
- The patent’s specific process claims can shield manufacturing techniques, especially in Spain and Europe.
- Its strategic family expansion provides geographical scope, deterring entry by competitors.
Risks and Challenges:
- Potential prior art in process optimization might threaten enforceability.
- The narrowness of some claims could be circumvented by subtle process modifications.
Commercial Relevance:
Securing a process patent like ES2846176 offers exclusive rights that could translate into market differentiation, especially if the process improves bioavailability or reduces manufacturing costs. This patent could underpin a proprietary manufacturing method, strengthening competitive positioning.
Concluding Remarks
ES2846176 embodies a well-defined process patent that, through its specific claims, offers a meaningful border around proprietary pharmaceutical manufacturing techniques in Spain. Its success depends on the enforceability of its claims against prior art and its integration within a broader patent strategy. The evolving landscape demands continuous monitoring to guard against design-arounds and to reinforce patent strength through strategic claim drafting and family extensions.
Key Takeaways
- The patent’s scope centers on specific manufacturing parameters, balancing breadth with patentability.
- Its claims target process steps that can be protected against straightforward variations, especially in key physical and chemical parameters.
- Competitors can may attempt circumvention via process innovations outside the defined ranges, underscoring the need for robust claim drafting.
- The patent landscape includes overlapping prior art, demanding careful claim differentiation and strategic prosecution.
- Protecting process patents like ES2846176 in Spain enhances market exclusivity and secures manufacturing control.
FAQs
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What makes the process claims in ES2846176 novel?
The claims specify unique temperature ranges, excipient interactions, and process steps that distinguish it from prior techniques, focusing on improved bioavailability and stability.
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Can competitors develop alternative production methods?
Yes, by varying process parameters such as temperature, mixing sequences, or excipients outside the patent’s scope, competitors can potentially circumvent protections.
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What is the value of this patent in the broader European market?
Its strategic family filings extend protection to the EU, enabling market exclusivity and licensing opportunities across multiple European countries.
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How does prior art affect the enforceability of ES2846176?
Overlapping prior art—particularly similar process patents—may challenge the patent’s novelty or inventive step unless the process introduces significant improvements.
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Should companies consider filing similar process patents?
Yes, especially if their manufacturing processes differ substantially or offer clear advantages, as process patents remain vital in pharmaceutical manufacturing exclusivity strategies.
References
- Spanish Patent ES2846176. Available at OEPM database.
- WO2015076750. International patent application related to manufacturing processes.
- ES2334567. Prior art process patent in Spain focusing on particle homogeneity.
- EP3134550. European patent covering alternative bioavailability-enhancing methods.
