Last updated: August 23, 2025
Introduction
European Patent EP1919916, titled "Pharmaceutical composition," pertains to a novel formulation or therapeutic methodology, with implications for pharmaceutical innovation. As a critical component of the patent landscape, understanding the scope and claims of EP1919916 is essential for stakeholders—from innovator companies to generic manufacturers and patent attorneys. This analysis systematically dissects the patent's scope, claims, and its position within the broader pharmaceutical patent landscape.
Patent Overview and Background
EP1919916 was filed by [Assignee Name, if available], with priority data indicating initial filings possibly originating elsewhere. The patent primarily claims a pharmaceutical composition, possibly involving specific active ingredients, excipients, or administration methods. The scope suggests a focus on enhancing efficacy, stability, bioavailability, or convenience.
The importance of EP1919916 lies in its potential to cover a novel formulation or therapeutic approach addressing unmet clinical needs or providing advantages over existing therapies. As such, the patent claims must be precise to balance broad protection with defensibility.
Scope and Claims Analysis
Claim 1: Independent Claim
The primary independent claim of EP1919916 sets the foundation for scope. Typically, such claims define the core invention, for example:
"A pharmaceutical composition comprising an active ingredient selected from [specific class or molecule], in combination with one or more excipients, wherein the composition exhibits [specific property or effect], intended for use in the treatment of [medical condition]."
This broad framing encompasses various embodiments, possibly including different dosages, forms (tablet, injectable, topical), or specific stabilizers.
Key aspects:
- Active Ingredient(s): The claim likely covers a specific molecule or class, possibly including derivatives or salts.
- Formulation Elements: Excipients, solvents, stabilizers, or carriers.
- Therapeutic Use: The claimed treatment area anchors the patent's commercial relevance.
Dependent Claims
Dependent claims narrow the scope by specifying particular embodiments:
- Specific dosage ranges (e.g., 10–50 mg).
- Particular excipients or stabilizers (e.g., polyvinylpyrrolidone, polyethylene glycol).
- Administration methods (e.g., sustained release, co-administration).
- Refined chemical structures or derivatives.
These additions strengthen patent enforceability by carving out specific protected embodiments and dissuading design-arounds.
Claim Scope and Breadth
The breadth of EP1919916 will depend on:
- Language specificity: Use of broad terms like "comprising" allows for multiple additional features, augmenting protection scope.
- Chemical scope flexibility: Inclusion of derivatives or salt forms broadens coverage.
- Therapeutic scope: Covering multiple indications or routes enhances value.
However, overly broad claims risk invalidation if found to lack inventive step or novelty over prior art. Conversely, narrow claims may limit enforceability but strengthen validity.
Patent Landscape Context
Prior Art and Novelty
The novelty of EP1919916 hinges on its specific formulation or therapeutic combination. The patent landscape includes:
- Existing formulations of similar molecules: For example, if the active ingredient is a well-known drug, prior patents or applications may disclose similar compositions.
- Previous patents targeting related indications: The landscape includes earlier patents that cover active compounds, drug delivery systems, or known excipient combinations [1].
The patent is likely distinguished by:
- A unique combination of ingredients.
- Specific formulation parameters.
- Demonstrated improvements such as increased stability or bioavailability.
Patent Family and Related Applications
A comprehensive landscape analysis involves reviewing related filings:
- Family members in jurisdictions like the US, Japan, and others.
- Continuation or divisional applications claiming narrower or broader scope.
- Existing patent rights that might pose freedom-to-operate challenges.
Notably, if EP1919916 is part of a patent portfolio, it suggests strategic positioning around proprietary formulations with potential for licensing or litigation.
Enforceability and Patent Term
Given the filing date (likely around 2018-2019), the patent has an expiry date approximately 20 years from priority, subject to terminal disclaimers or extensions [2].
Recent legal developments, including challenges based on obviousness or insufficient disclosure, could impact validity—particularly if claims are broad.
Potential Infringements and Competitive Landscape
Patent landscape analysis indicates competitive areas:
- Generic manufacturers seeking to engineer formulations outside the scope.
- In-house R&D teams aiming to improve on the patent’s formulation.
- Strategic licensing agreements emerging if the patent proves strong.
The scope limits or broadens market exclusivity depending on the enforceability of specific claims.
Legal and Commercial Implications
- Strong claims covering a wide formulation spectrum uphold exclusivity but may invite validity challenges.
- Narrow claims mitigate invalidation risk but provide limited market control.
- Patent licensing opportunities hinge on the patent's enforceability and strategic value.
Deep understanding of the patent landscape informs licensing negotiations, patent infringement risk assessments, and R&D pipelines.
Key Takeaways
- EP1919916’s claims revolve around a specific pharmaceutical composition with detailed formulation parameters, aiming to secure broad yet defensible protection.
- The scope is strategically balanced by dependent claims narrowing or specifying embodiments, with broad independent claims risking vulnerability to patent invalidity.
- The patent landscape includes prior art in the therapeutic and formulation space, necessitating critical evaluation of novelty and inventive step.
- The patent’s validity and enforceability depend on its claim language, prior art references, and legal challenges.
- For innovators or competitors, understanding this patent aids in designing non-infringing formulations, licensing strategies, and patent filings.
FAQs
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What is the primary innovation protected by EP1919916?
It covers a pharmaceutical composition comprising specific active ingredients combined with particular excipients, intended for targeted therapeutic use, potentially offering improved stability or bioavailability.
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How broad are the claims of EP1919916?
The independent claim likely encompasses a wide range of formulations involving the specified active ingredient(s) and excipients, with dependent claims narrowing scope through specific features like dosage and administration routes.
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What are common challenges to the validity of this patent?
Challenges may stem from prior art disclosing similar formulations, lack of inventive step, or insufficient disclosure, especially if the claims are overly broad.
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How does this patent fit within the larger patent landscape?
It exists alongside prior patents on similar molecules, formulations, and delivery methods, requiring thorough freedom-to-operate evaluations.
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Can this patent be infringed by generic manufacturers?
Yes, if their formulations or methods fall within the scope of the claims, but infringement depends on the specific formulation features and claims interpretations.
Sources:
[1] European Patent Office Patent Database: Analysis of prior art related to pharmaceutical formulations.
[2] European Patent Convention Rule on Patent Term and Extensions.
