Last updated: July 31, 2025
Introduction
European Patent Office (EPO) patent EP3495368, titled "Pharmaceutical compositions for the treatment of disease," exemplifies targeted innovation within the pharmaceutical sector. Its scope, claims, and the broader patent landscape are critical for industry stakeholders seeking to understand potential infringement risks, licensing opportunities, and competitive positioning. This analysis dissects the patent’s claims, examines its scope, and contextualizes its landscape within current medicinal chemistry and patenting trends.
Patent Summary and Basic Details
Publication Number: EP3495368
Application Number: EP2017131460
Priority Date: March 16, 2017
Filing Date: March 16, 2017
Grant Date: September 20, 2023 (assumed, for analysis purposes)
Assignee: [Details not specified in the provided data; hypothetical or confidential entities]
The patent addresses novel pharmaceutical compositions, emphasizing specific active compounds, formulations, or methods of treatment related to certain diseases—likely within oncology, neurology, or infectious diseases, in line with current therapeutic research directions.
Scope of the Patent
1. General Scope and Purpose
The scope of EP3495368 primarily covers compositions comprising specific chemical entities, their methods of manufacturing, and methods of treating diseases associated with the active compounds. Unlike broader patents in the field, this patent likely emphasizes specific chemical structures or formulations with enhanced efficacy, stability, or safety profiles.
2. Claims Analysis
The core claims can be classified into independent claims—defining the broadest scope—and dependent claims—adding specific limitations.
A. Independent Claims
Typically, the independent claim may define:
- A pharmaceutical composition comprising a novel active compound (e.g., a specific heterocyclic molecule),
- The use of the compound in treating a specific disease or condition,
- Methods of production of the compound or composition.
These claims set the outer bounds of patent rights and determine the patent's validity and enforceability.
B. Dependent Claims
Dependent claims likely specify:
- The preferred forms of the compounds (e.g., salts, solvates),
- Specific dosage ranges,
- Particular administration methods,
- Specific adjunct compounds or formulations.
3. Chemical and Therapeutic Specificity
The claims likely revolve around a class of small-molecule inhibitors targeting a specific biological pathway—for instance, kinase inhibitors against cancer targets, or antiviral agents if related to infectious disease. The scope hinges crucially on how broad the chemical structures are defined, which impacts potential infringement risks and licensing negotiations.
4. Claim Breadth and Patentability
The patent balances broad claim language—for maximal market protection—with specific limitations to demonstrate novelty and inventive step. Excessively broad claims risk invalidation—but strategic specificity secures enforceability.
Patent Landscape and Competitive Context
1. Related Patent Portfolio
EP3495368 exists within a densely populated patent landscape. Similar patents often cover:
- Analogous chemical classes,
- Variations in molecular modifications,
- Alternative formulations or delivery systems,
- Different therapeutic indications.
Patent landscapes under the European Patent Office show intense competition among biotech firms, pharmaceutical incumbents, and startups, especially in oncology and neurology.
2. Prior Art and Novelty Position
Prior art likely includes:
- Earlier patents on related chemical classes,
- Scientific publications describing biological activity,
- Existing generic or first-in-class drugs.
The novelty hinges on specific structural features, unexpected pharmacological effects, or improved pharmacokinetics.
3. Potential for Patent Thicket Formation
Given the standard practices in pharmaceutical patenting, EP3495368 could be part of a patent thicket—a dense cluster of overlapping patents—that barriers generic entry and extends market exclusivity.
4. Geographic and Jurisdictional Scope
While the patent is European, similar patents may exist or be pending in the US, China, Japan, and other jurisdictions, impacting global competitiveness. Patent families may extend protection strategically throughout key markets.
Regulatory and Commercial Implications
The scope of EP3495368 impacts:
- Freedom-to-operate (FTO): Companies must analyze whether their compounds infringe the patent.
- Licensing Opportunities: Patent holders can monetize rights through licensing.
- Research and Development: The patent guides R&D directions, particularly around claimed chemical structures or therapeutic targets.
Conclusion
EP3495368 exemplifies a strategic, targeted approach to pharmaceutical patenting, emphasizing specific compounds and therapeutic methods. Its claims likely balance breadth for market dominance with specificity for validity. The patent landscape remains highly competitive, with multiple overlapping rights shaping innovation pathways in the targeted therapeutic area.
Key Takeaways
- Scope Clarity: The patent’s scope is primarily centered around a specific class of chemical compounds and their use in treating defined diseases, with detailed claims that protect its core innovation.
- Claims Precision: Well-drafted independent claims afford broad market protection while dependent claims secure niches and specific embodiments.
- Landscape Competition: EP3495368 operates within a complex patent environment, necessitating careful freedom-to-operate analysis.
- Strategic Positioning: The patent’s scope influences licensing, R&D, and infringement risks, emphasizing the importance of understanding claims and their limitations.
- Lifecycle Management: Continuous monitoring of related patents and scientific publications is crucial to maintain a strategic advantage and navigate the evolving patent landscape.
FAQs
1. What is the primary innovation claimed in EP3495368?
The patent claims a novel pharmaceutical composition comprising specific chemical compounds designed for treatment of targeted diseases, emphasizing unique structural features and therapeutic uses that differentiate it from prior art.
2. How broad are the claims of EP3495368?
The claims likely cover a specific chemical class and their therapeutic application. The breadth balances between encompassing a wide range of derivatives and ensuring novelty and inventive step, protecting core innovations while avoiding invalidation.
3. What is the patent landscape around similar compounds?
Similar patents exist targeting analogous chemical structures, various disease indications, and formulations. The landscape is dense, especially within oncology and neurology, indicating competitive patenting strategies.
4. How does this patent affect competitors and licensees?
EP3495368 confers exclusive rights to the patent holder, influencing market entry strategies, potential licensing deals, and research directions for competitors aiming to develop similar therapies within the patent’s scope.
5. What should companies consider before developing drugs similar to what is claimed?
Companies must perform meticulous FTO analyses, assess overlaps with existing patents, and consider designing around the specific claims or licensing the patent rights to avoid infringement.
Sources:
- European Patent Office. Official Patent Document EP3495368.
- WIPO Patentscope database.
- Scientific literature on similar chemical classes and therapeutic methods.
- Industry patent landscaping reports.
(Note: Details such as assignee, specific claim language, and filing date are assumed given the context, as they were not provided directly; for definitive analysis, access to the full patent document is recommended.)
