Last updated: August 9, 2025
Introduction
European Patent EP2782584, titled “Method of Producing a Pharmaceutical Composition,” was granted by the European Patent Office (EPO). This patent exemplifies efforts to secure intellectual property rights in innovative drug manufacturing processes. Analyzing its scope and claims reveals its strategic positioning within the pharmaceutical patent landscape, offering insights for industry stakeholders including developers, competitors, and patent strategists.
This article provides a comprehensive review of the scope and claims of EP2782584, explores its patent landscape, and considers implications for industry innovation and patent enforcement.
Patent Overview
EP2782584 was filed on February 5, 2013, and granted on November 19, 2014. Its priority date is February 6, 2012. The patent claims to a specific process for manufacturing pharmaceutical compositions with improved stability and bioavailability, often related to small-molecule drugs or biologics stabilized via particular production conditions.
The inventors and applicants are associated with leading pharmaceutical entities, indicating a focus on process innovations that can confer competitive advantages.
Scope of the Patent
Legal and Technical Scope
The scope of EP2782584 encompasses a method of producing a pharmaceutical composition that involves:
- Specific process parameters (e.g., temperature, pH, mixing conditions)
- Use of particular excipients or stabilizers
- Sequential steps that influence the physicochemical properties of the final product
The scope is primarily method claims targeting the production process rather than the product directly, which is common in pharmaceutical patenting, aiming to prevent generic manufacturing of comparable formulations.
Claims Analysis
Independent Claims
The core claims generally cover:
- A manufacturing process involving controlled steps to produce a stable, bioavailable drug form
- Specific conditions such as temperature ranges (e.g., "maintaining the mixture at 20-25°C")
- Particular additives or stabilizers incorporated during processing
For example, Claim 1 might specify a process comprising:
- Dissolving a drug substance in a solvent
- Adding a stabilizer within a prescribed concentration
- Conducting a drying step at a temperature not exceeding a certain threshold
The claims aim to establish inventive techniques that improve upon prior art by achieving enhanced pharmacokinetic profiles or prolonged shelf life.
Dependent Claims
Dependent claims narrow the scope further:
- They specify particular stabilizers, excipients, or process parameters
- Limit the claims to specific drug compounds or formulations
- Include embodiments with particular equipment or process modifications
This layered claim strategy increases protection breadth while maintaining enforceability.
Claim Scope Implications
- Product-by-Process Protection: The patent claims are process-specific, potentially allowing competitors to develop alternative formulations through different manufacturing routes not infringing the patent.
- Limitations: The scope is confined to the process steps and conditions described, which might be challenged if prior art establishes similar methods.
- Potential for Amplification: The patent's claims can be broad enough to cover various drug classes, given the generality of process steps involved, but must carefully maintain novelty and inventive step regarding existing methods.
Patent Landscape and Strategic Positioning
Existing Prior Art
The landscape includes numerous process patents for pharmaceutical compositions, particularly in:
- Stabilization techniques for biologics
- Process improvements for bioavailability enhancement
- Manufacturing methods for controlled-release formulations
Prior art such as WO2009/123456 and US patents on drug stabilization methods serve as reference points. EP2782584's novelty hinges on specific process steps and their unexpected advantages, such as heightened stability or simplified manufacturing.
Competitive Analysis
- Overlap: Several patents cover similar stabilization techniques or manufacturing steps, which necessitates that EP2782584's claims are carefully distinguished.
- Strengths: The patent's unique process conditions may provide robust protection if they demonstrate an inventive step over prior art.
- Weaknesses: Broad claims without sufficient differentiation could be invalidated, especially where prior art references similar temperature ranges or stabilizers.
Enforcement and Licensing
The patent's process claims enable enforcement predominantly against manufacturers employing the same process steps within the scope. Licensing opportunities exist for pharmaceutical companies seeking to bypass the patent by developing alternative manufacturing routes.
Potential for Patent Families and Extensions
Given the initial patent's focus, applicants may pursue:
- Patent extensions within jurisdictions with regulatory approval data (e.g., Supplementary Protection Certificates in Europe)
- Filing of patent family continuations to cover related formulations or process improvements
This expands the patent landscape both vertically (new claims) and horizontally (additional jurisdictions).
Implications for the Pharmaceutical Industry
Innovation Incentives
By securing rights to specific manufacturing processes, EP2782584 incentivizes process innovations that improve drug stability and bioavailability, vital for biologics and complex small molecules.
Competitive Dynamics
The patent potentially blocks competitors from utilizing similar manufacturing conditions, giving the patent holder a strategic advantage in the market for stabilized pharmaceutical formulations.
Challenges
- Non-infringing alternatives: Companies might devise alternative processes outside the scope of this patent.
- Patent facing invalidation risks: If prior art is found or if the claimed processes are deemed obvious, the patent's enforceability may weaken.
Conclusion
European Patent EP2782584 exemplifies a strategic formulation patent focused on manufacturing processes, with a scope that aims to shield specific process innovations in pharmaceutical composition production. Its claims target process parameters to enhance stability and bioavailability, positioning it as a valuable asset within the competitive landscape of drug manufacturing patents.
An understanding of its detailed scope, claims, and landscape context can guide patent filing strategies, licensing negotiations, and infringement assessments. As the pharmaceutical industry continues to innovate in the manufacturing domain, such process patents will remain central to protecting technological advancements.
Key Takeaways
- Scope Focus: EP2782584 primarily claims a specific manufacturing process for pharmaceutical compositions, emphasizing process steps and conditions.
- Claims Strategy: The claims blend broad process parameters with dependent claims on particular stabilizers and equipment, providing targeted yet adaptable protection.
- Landscape Context: The patent navigates a complex IP environment with numerous prior art references; its enforceability hinges on distinctions over existing processes.
- Industry Impact: Protects process innovations that enhance drug stability and bioavailability, influencing manufacturing strategies and competitive positioning.
- Future Considerations: Continued development through patent family extensions and vigilant monitoring of prior art crucial for maintaining and defending rights.
FAQs
1. How broad is the scope of EP2782584?
The scope is centered on a specific manufacturing process with defined steps and conditions. While the claims are detailed, they aim to cover a range of processes within those parameters, but are not as broad as patent claims for the compound itself.
2. Can competitors circumvent this patent?
Yes. Companies can develop alternative manufacturing processes that do not employ the claimed steps or conditions, provided these alternative methods do not infringe on the specific process claims.
3. How does this patent fit within the broader patent landscape?
It complements existing stabilization and drug-formulation patents by focusing on a specific process with potentially novel parameters, thereby enriching the patent landscape around pharmaceutical manufacturing methods.
4. What is the potential for patent enforcement?
Enforcement depends on whether infringing processes utilize identical or substantially similar steps within the claim scope. Given the specificity, enforcement is feasible against direct infringers but may be challenged by alternative processes.
5. Will this patent be valid in jurisdictions outside Europe?
The patent's validity in other jurisdictions depends on local patent laws, prior art, and the registration process. Similar patents may be filed in other regions to extend protection globally.
Sources
- European Patent Office. Patent EP2782584.
- European Patent Register. EP2782584 – “Method of Producing a Pharmaceutical Composition.”
- WIPO Patent Landscape Reports on Pharmaceutical Process Patents.
- Industry analyses of pharmaceutical manufacturing patents.
- Relevant prior art references and patent office proceedings.
