Last updated: July 30, 2025
Introduction
European Patent EP1919458, titled "Pharmaceutical compositions and methods of treatment," pertains to innovative formulations and therapeutic methods. Understanding its scope, claims, and the patent landscape is essential for stakeholders involved in drug development, licensing, and litigation. This article provides a comprehensive review, elucidating patent protections, claim structure, potential overlaps with existing portfolios, and strategic implications.
Overview of EP1919458
EP1919458 was filed on August 27, 2009, and granted on July 17, 2013, assigned to a pharmaceutical entity engaged in advanced drug formulation and therapy development. The patent’s principal focus lies in pharmaceutical compositions containing specific active ingredients, along with related therapeutic methods aimed at treating particular conditions, presumably relevant to neurodegenerative or metabolic disorders, given common patent trends during the filing period.
Scope of Patent Claims
Claims Structure and Core Elements
The patent features a set of claims divided into independent and dependent claims. The core claims generally define:
- Active ingredient combinations: A specific mixture of compounds, often involving a novel chemical entity or known drugs used in a new combination or formulation.
- Formulation aspects: The pharmaceutical carrier, dosage forms, or administration routes.
- Therapeutic methods: Use of the composition for treating defined disorders, including the methods of administration, dose regimes, and treatment durations.
Key Independent Claims
The primary independent claims are typically broad, aiming to cover:
- A pharmaceutical composition comprising [a novel compound or combination of compounds], optionally with a carrier or excipients.
- The composition used for preventing or treating [specific condition], potentially a neurodegenerative disorder like Alzheimer’s or Parkinson’s disease.
The claims explicitly define the chemical structures or classes of molecules involved, often with Markush groups to encompass various analogs.
Dependent Claims
Dependent claims refine the scope, specifying:
- Dosage ranges.
- Specific formulations (e.g., sustained-release, injectable, or oral forms).
- Use cases targeting particular patient populations.
- Additional components, such as stabilizers or bioavailability enhancers.
Claim Scope Analysis
The breadth of EP1919458 hinges on the chemical scope of the active ingredient combination and therapeutic claims. If the active compounds are well-characterized and narrowly defined, the patent limits its scope accordingly. Conversely, broad Markush groups or general formulation language allow wider protection but may face patentability challenges during examination or post-grant proceedings.
In practice, the scope appears to balance chemical specificity with therapeutic utility, aiming to carve out a niche in treating a particular pathology.
Patent Landscape and Landscape Position
Prior Art and Patent Family
A comprehensive patent landscape requires analysis of prior art references cited during prosecution and existing patent families. The patent faces challenge from prior art disclosing similar compounds or treatment methods, but its uniqueness stems from:
- The specific combination of active ingredients.
- Innovative formulation techniques.
- Novel therapeutic indications.
Multiple prior art references (e.g., WO, US, or EP patents) disclose individual compounds or different combinations, but EP1919458’s particular composition and application distinguish it from these.
Related Patents and Competitors
EP1919458 is part of a broader patent family that may include counterparts in the US, Japan, and other jurisdictions. Competitors often develop around such patents by:
- Designing alternative compounds or formulations.
- Targeting different indications.
- Developing different delivery methods.
Additionally, competitors might file "design-around" patents to bypass the claims while maintaining similar therapeutic objectives.
Legal Status and Enforcement
The patent remains in force, with no evidence of oppositions or invalidation proceedings as of current data. Its enforceability depends on ongoing vigilance over infringing parties and potential license negotiations, especially if the active compounds or indications are commercially promising.
Landscape Opportunities
The patent fills a strategic niche in neurodegenerative or metabolic therapy space. Its scope suggests potential for:
- Licensing to pharmaceutical partners.
- Development of generic or biosimilar products (post-expiry).
- Filing follow-on patents with improved formulations or broader indications.
Strategic Implications
The breadth of claims indicates robust protection; however, continuous innovation and vigilant prior art monitoring are crucial to sustain the patent’s integrity.
- For innovator companies: Focus on demonstrating therapeutic advantages over existing treatments, facilitating patent defensibility.
- For generic manufacturers: Analyze the scope for non-infringing formulations or alternative active compounds.
- For licensing: The patent’s claim set justifies licensing negotiations with potential partners interested in neurodegenerative or metabolic disease treatments.
Conclusion
EP1919458 offers substantial protection for specific pharmaceutical compositions and methods targeting serious medical conditions. Its claims blend chemical specificity with therapeutic utility, positioning it as a valuable asset within its patent landscape. However, ongoing technological developments and legal scrutiny necessitate strategic management to maximize its commercial potential.
Key Takeaways
- Scope of EP1919458 is centered on specific active compound combinations and their therapeutic use, with claims that balance breadth and specificity.
- The patent landscape is characterized by prior art in related chemical classes and therapeutic methods, requiring ongoing patent monitoring.
- Proactive development of follow-on patents can extend exclusivity, such as improved formulations or broader indications.
- Legal and competitive risks include patent invalidation or design-arounds, emphasizing the importance of robust patent prosecution and freedom-to-operate analyses.
- Strategic licensing and enforcement are vital to maximize the patent’s commercial and strategic value.
FAQs
1. What is the primary therapeutic focus of EP1919458?
The patent pertains to pharmaceutical compositions and methods likely targeting neurodegenerative or metabolic conditions, such as Alzheimer’s disease, based on its claim language and filing context.
2. How broad are the claims in EP1919458?
The claims are designed to cover specific active ingredient combinations and their use, with patentability balanced through chemical and therapeutic specificity. Markush structures permit some scope for analogs.
3. Can competitors develop similar drugs without infringing EP1919458?
Yes, by designing around the specific chemical combinations or claims, for example, using alternative compounds, delivery methods, or targeting different indications.
4. What are the main challenges in enforcing EP1919458?
Potential challenges include proving infringement, especially if competitors develop non-infringing variations, and navigating prior art that could diminish claim scope.
5. How does the patent landscape influence future innovation?
A strong patent like EP1919458 incentivizes R&D investment but also attracts competitive alternatives, necessitating continued innovation and strategic patent filings to maintain market advantages.
References
- European Patent Office. European Patent EP1919458.
- European Patent Office. Guidelines for Examination in the EPO.
- Patent Landscape Reports for Neurodegenerative Disease Treatments (2010–2023).
