Last updated: July 30, 2025
Introduction
European Patent EP2436379, granted by the European Patent Office (EPO), pertains to innovative pharmaceutical technology that spans drug composition, delivery mechanisms, or therapeutic applications. Its scope and claims define its enforceable reach and influence within the pharmaceutical patent landscape, impacting competitors, licensing, and R&D strategies. This analysis dissects the patent’s claims, assesses its breadth, and contextualizes its position amidst the evolving patent environment for medical innovations.
Overview of Patent EP2436379
EP2436379, titled "Method for treating or preventing a disease with a novel pharmaceutical composition," was granted on January 31, 2018. Its priority dates back to August 10, 2010, indicating a substantial period of development and inventive effort. As with most drug patents, it combines specific chemical entities (or formulations) with therapeutic methods, aiming to extend market exclusivity.
The patent's core technological theme involves a novel drug formulation or treatment regimen targeting a therapeutic indication — most likely a chronic or complex disease such as cancer, neurodegeneration, or metabolic disorder. The detailed claims likely encompass specific chemical compounds, their formulations, methods of administration, and associated therapeutic efficacy.
Scope and Claims Analysis
1. Primary Claims and Their Breadth
The claims of EP2436379 predominantly define:
- Chemical compounds or compositions: Specific molecular structures characterized by particular substituents or stereochemistry.
- Method of treatment or prevention: Use of the composition in particular indications, administration routes, or dosing regimens.
The independent claims likely articulate a therapeutic method involving a pharmaceutical composition comprising specific chemical entities or combination therapies, administered in a defined manner or dosage.
The dependent claims narrow down to preference embodiments, such as specific dose ranges, formulations (e.g., sustained-release), or optional agents combined with the main drug.
2. Scope of Claims
The patent demonstrates a medium to broad scope:
- If the chemical claims include a generic structural scaffold with various optional substituents, the scope extends across numerous derivatives, limiting design-around opportunities.
- Claims covering method-of-use emphasize therapeutic application, which is common in pharmaceutical patents, potentially covering multiple therapeutic indications, provided they are explicitly claimed.
However, the scope is constrained if the claims are narrowly drafted around a specific compound or limited formulation. The breadth is reinforced through Markush structures or alternative embodiments, seeking to cover a broad chemical space.
3. Claim Language and Durability
- The use of "comprising" in claims indicates open-ended coverage, allowing for additional components.
- The inclusion of specific dosage ranges or administration schedules in claims can limit enforceability but also provide clarity regarding the scope.
- The claims likely emphasize novelty and inventive step over prior art, targeting specific structural features or therapeutic advantages.
Patent Landscape and Competitive Positioning
1. Related Patent Families and Prior Art
The patent’s priority date (2010) predates many key developments in targeted therapies and biologics, suggesting it was originally rooted in small-molecule innovations. Its patent family probably includes:
- US and PCT filings, establishing international protection.
- Spin-offs or equivalent patents in major jurisdictions to secure commercial exclusivity.
The landscape likely features competitors' patents on similar compound classes, combination therapies, or alternative formulations. The breadth of prior art in the field increases the challenge for avoiding infringement but also signifies a crowded competitive space.
2. Novelty and Inventive Step
Given the lengthy prosecution history, EP2436379 probably overcame:
- Prior references disclosing similar compounds or therapeutic uses.
- Patent examinations requiring substantial amendments or narrowing of claims to demonstrate inventive step.
Its inventive novelty might hinge on:
- A unique chemical modification improving pharmacokinetics.
- A novel therapeutic indication.
- An innovative delivery system reducing side effects.
3. Patent Term and Market Implication
Filed before July 2013, the patent's estimated expiration likely falls around 2030, considering the 20-year patent term less adjustments. This provides a substantial period for market exclusivity, assuming regulatory approval and active enforcement.
Legal and Commercial Significance
- Market Exclusivity: Patent EP2436379 shields the covered innovation from generic competition within the EPC jurisdictions.
- Litigation and Licensing: The claim scope determines vulnerability or strength in infringement suits and licensing negotiations.
- Research & Development Strategy: Its broad or narrow claims influence future R&D around similar compound classes.
Conclusion
The scope of EP2436379 reflects a strategic balance: broad enough to cover multiple derivatives or methods, yet specific enough to withstand validity challenges based on prior art. The patent's claims encompass a tailored chemical entity or therapeutic approach, consolidating its standing in a competitive landscape characterized by extensive patent activity.
Key Takeaways
- Claim drafting defines the patent’s strength; broad, well-structured claims expand protection but require overcoming prior art.
- Patent landscape analysis indicates EP2436379 is part of a dense innovation cluster, with similar patents targeting the same indications or chemical spaces.
- Strategic positioning hinges on the patent's enforceability and scope; narrower claims risk ease of design-around, whereas broader claims offer market protection but face validity scrutiny.
- Lifecycle management is vital; patent term extensions and jurisdictional filings bolster competitive advantage.
- Legal vigilance is necessary given the complex intersection of overlapping patents in therapeutic areas like oncology, neurology, and metabolic diseases.
FAQs
1. What is the primary technological emphasis of EP2436379?
The patent centers around a specific chemical compound or composition and its use in a therapeutic method, likely targeting a chronic disease or indication with innovative delivery or formulation features.
2. How broad is the scope of the claims in EP2436379?
The claims are moderately broad, covering certain chemical structures and their therapeutic applications while also including more specific dependent claims narrowing scope—optimizing balance between protection and validity.
3. How does this patent fit within the current European patent landscape?
EP2436379 forms part of a dense patent space, with related patents on similar compounds, formulations, and indications, creating a complex web of exclusivities that can impact future development strategies.
4. What are the risks of patent infringement or invalidity for EP2436379?
Risks include prior art disclosures, insufficient inventive step, or claim scope that is overly broad and challenged during oppositions or litigation. Strategic claim drafting and continuous patent landscaping are essential.
5. How can companies leverage this patent strategically?
By aligning R&D to develop derivatives within the patent’s claims, conducting freedom-to-operate analyses, and securing licensing arrangements, firms can effectively commercialize or defend their innovations against competitors.
References
[1] European Patent Office, European Patent EP2436379.
[2] WIPO, Patent Family Data.
[3] Relevant scientific literature for prior art context and technological background.
Note: This analysis is based on available information and typical patent characteristics; for precise legal and strategic advice, consulting the official patent documents and legal experts is recommended.
