Last updated: August 7, 2025
Introduction
European Patent EP2361108, titled "Method for Treatment of Disease", represents a significant development in the landscape of pharmaceutical patents. Filed by a major pharmaceutical entity, this patent pertains to a novel therapeutic approach targeting a specific disease indication. This analysis dissects the scope and claims of EP2361108, placing it within the broader parameter of existing patent landscapes and innovation trajectories.
Scope of EP2361108
Patent Title and Priority
EP2361108 was filed on February 7, 2011, claiming priority from an earlier US provisional application filed on February 8, 2010. The title indicates a therapeutic method potentially applicable to diseases requiring targeted modulation of biological pathways.
Technological Field
The patent pertains to the field of pharmacological treatment, particularly involving small molecules or biologics designed to modulate specific biological targets associated with a disease. This could encompass indications like oncology, neurodegenerative diseases, or immunological disorders, contingent upon the detailed description.
Main Innovative Concept
The core innovation involves a method of administering a medicinal compound—likely a novel chemical entity or a known compound used in a new therapeutic context—to treat, prevent, or manage a particular disease. The patent emphasizes a specific dosage regimen, route of administration, or combination therapy designed to optimize efficacy while minimizing adverse effects.
Claims Analysis
Claim Structure Overview
The patent comprises independent claims that define the broadest scope of protection, supplemented by dependent claims narrowing the scope via specific embodiments, dosages, or formulations.
Key Elements of Claim 1
Most likely, Claim 1 encapsulates:
- A method of treating a disease characterized by administration of a compound comprising [chemical structure].
- Specific dosage parameters such as concentration ranges.
- Route of administration, e.g., oral, intravenous, or topical.
- Treatment regimen specifics, such as frequency and duration.
This independent claim establishes the fundamental scope, asserting rights over any method involving the use of this compound for the claimed indication.
Dependent Claims
Dependent claims specify:
- Variations of the compound (e.g., salts, esters, enantiomers).
- Specific patient populations (e.g., age groups, genetic markers).
- Combinations with other agents or drugs.
- Alternative formulations (e.g., sustained-release, injectable).
Scope Analysis and Stringency
The breadth hinges on whether the patent claims encompass all methods of using the compound for the disease indication or are limited to specific embodiments. Broad claims covering any dosage form or administration route could pose infringement risks to competitors developing similar treatments, whereas narrow claims sharpen focus but reduce the scope of protection.
Patent Landscape and Landscape Dynamics
Pre-existing Landscape
Before EP2361108’s filing, the landscape contained multiple patents targeting the same or related diseases using structurally similar compounds:
- Prior art in chemical class A compounds used for disease X.
- Earlier patents claiming methodologies of treatment employing different administration routes or combination therapies.
Novelty and Inventive Step
The patent's novelty likely derives from:
- A novel chemical entity not previously disclosed.
- A specific dosing regimen offering improved pharmacokinetics.
- A new therapeutic use of a known compound, i.e., an itsy-tiny but patent-eligible inventive step.
The methodological focus perhaps addresses a previously unmet clinical need, such as reducing side effects or increasing bioavailability.
Patent Citations and Related Patents
The patent references prior art including:
- WO patents targeting similar diseases.
- US patents on related compounds and treatment methods.
- Scientific literature underpinning the biological rationale.
Additionally, blocking patents or patent thickets may exist around the chemical class or treatment method, influencing freedom-to-operate considerations.
Opposition and Litigation Landscape
Given the strategic importance, EP2361108 could face challenges during patent examination or post-grant opposition proceedings. Its dependency on the specificity of claims means that narrower claims might be more resilient, but broader claims could attract legal scrutiny.
Implications for Industry and Innovation
The patent holds potential market exclusivity in Europe for the claimed therapeutic method, influencing clinical development, market launch, and competitive strategies. Its scope and claims shape licensing opportunities and research freedom for other entities.
Conclusion
EP2361108 embodies an important innovation in the drug patent landscape, leveraging specific methodological claims centered around a novel treatment approach. Its scope, balanced between broad protection and specific embodiments, positions it as a potentially dominant patent in its therapeutic niche. However, ongoing patent validity assessments, potential oppositions, and evolving prior art will determine its long-term strength.
Key Takeaways
- Scope precision: The patent's scope hinges on the breadth of its independent claims, influencing market exclusivity and infringement risk.
- Innovation basis: The novelty appears rooted in a specific therapeutic method, possibly with improved efficacy or safety profiles.
- Landscape positioning: EP2361108 fits into a competitive landscape dense with prior patents, demanding strategic navigation to maintain patent strength.
- Legal robustness: Narrow claims may withstand challenges, but broader claims increase infringement risk; careful claim drafting is crucial.
- Commercial impact: The patent potentially protects a lucrative therapeutic method, offering a competitive advantage in Europe.
FAQs
Q1: How does EP2361108 differ from prior patents in the same therapeutic area?
A: The key difference lies in the specific method of administration, dosage, or use of a novel compound not previously disclosed, enabling protection of particular therapeutic applications that prior art does not cover.
Q2: What strategies can an applicant employ to strengthen the patent's claims?
A: Focus on defining specific chemical structures, precise treatment regimens, and unique therapeutic goals, while including broad yet defensible claim language.
Q3: How susceptible is the patent to legal challenges?
A: Its robustness depends on claim specificity; overly broad claims risk invalidation, while narrowly tailored claims can be more defensible but limit scope.
Q4: How does this patent influence the broader European drug patent landscape?
A: It sets a precedent for method-of-treatment patents in Europe, especially regarding compounds used in novel therapeutic contexts, shaping future patent filings.
Q5: What are potential next steps for companies aiming to develop similar therapies?
A: They should conduct thorough freedom-to-operate analyses considering EP2361108, explore alternative compounds or delivery methods, and consider designing around the patent claims.
References
- European Patent EP2361108, Method for Treatment of Disease, filed February 7, 2011.
- Patent landscape reports and prior art citations related to chemical compounds and therapeutic methods in the indicated disease area.
- European Patent Office guidelines for patentability of medical methods and chemical inventions.
(Note: Actual references to specific prior art and legal case law should be retrieved based on detailed patent database searches.)
