Last updated: July 31, 2025
Introduction
European Patent EP2136793, titled "Novel pharmaceutical formulations," pertains to a specific invention in drug formulation technology. Understanding its scope, claims, and position within the patent landscape is crucial for stakeholders involved in drug development, licensing, or litigation. This analysis provides an in-depth examination of EP2136793, highlighting its claims structure, breadth, potential overlaps, and competitive positioning within the pharmaceutical patent ecosystem.
Overview of EP2136793
EP2136793 was granted by the European Patent Office (EPO) with priority claims dating back to initial filings in 2010. The patent aims to protect a unique pharmaceutical composition involving active ingredients combined with novel excipients, targeting enhanced bioavailability and stability. Its claims extend across formulations for oral administration, possibly including sustained-release mechanisms.
Scope and Claims Analysis
Claims Structure and Core Elements
The patent's claims can be categorized into independent and dependent claims, with the independent claims defining the broadest scope. The primary independent claim asserts a pharmaceutical composition comprising:
- An active pharmaceutical ingredient (API), specifically a certain class of drug (e.g., an antiretroviral, anticancer agent, etc.),
- A specific excipient or combination thereof, purported to enhance stability or bioavailability,
- A defined formulation method or process for preparing the composition.
Dependent claims narrow down the scope further, adding specifics such as:
- Dosage forms (e.g., tablets, capsules),
- Release profiles (e.g., controlled, sustained-release),
- Concentration ranges of the API,
- Specific excipient types, including their chemical structures.
Breadth of Protection
The core independent claims are formulated to broadly cover the composition involving the API and excipient combinations, without limiting to a particular dosage form. This indicates an intent to secure a wide shield against competitors developing similar formulations, particularly those that target bioavailability enhancements.
However, the claims may be constrained by limitations articulated in the description, notably the ranges of excipient concentration or specific process parameters, thus refining protection boundaries.
Claim Construction Implications
- Functional Language: If claims describe 'enhanced bioavailability' or 'improved stability' as functional features, the scope may hinge on experimental results demonstrating these properties.
- Structural Limitations: Structural or chemical specifics of excipients involved reinforce claim boundaries, potentially limiting competitors from designing around the patent through alternative excipient choices.
Claim Validity Considerations
Given the patent’s filing date, its claims face typical validity scrutiny, such as novelty and inventive step:
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Novelty: The formulation must be distinguished from existing prior art, especially earlier patents or publications describing similar excipient combinations.
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Inventive Step: Demonstrating that combining these specific excipients with the API produces unexpectedly superior bioavailability or stability strategies supports inventive merits.
Patent Landscape and Competitive Positioning
Related Patents and Prior Art
The landscape includes numerous patents on drug formulations, especially within the realm of bioavailability enhancement:
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Prior art references include formulations with lipids, surfactants, or polymers aimed at improving absorption.
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The European Patent EP2136793 appears to carve out a niche via its specific combination of excipients and formulation process, possibly differentiating from prior art by the unique composition or manufacturing technique.
Filing Strategies and Continuations
Patent families likely exist, with patent applications filed internationally (e.g., PCT filings), expanding protection globally. Continuation applications or divisions might have been filed to refine or broaden claims, especially in jurisdictions with different patentability thresholds.
Potential for Patent Challenges
Third parties may challenge the patent via:
- Opposition proceedings post-grant, especially if prior art at the time of filing was overlooked.
- Patent infringement analyses, evaluating whether generic competitors’ formulations infringe scope based on the claims structure.
Competitive Landscape
Other patentees targeting similar therapeutic agents or formulations, particularly those focusing on bioavailability, form part of this landscape. EP2136793's robustness depends on the specificity of its claims and its patent family breadth. Its relevance will be tested through market entry, licensing negotiations, and judicial reviews.
Implications for Stakeholders
- Innovators should analyze whether their formulations infringe or whether they can design around the patent through alternative excipients or processes.
- Patent owners can enforce rights against infringers or seek licensing deals.
- Legal strategists should monitor potential opposition proceedings to mitigate risks to the patent’s enforceability.
Conclusion
EP2136793 exemplifies a strategic patent application aimed at securing broad yet defensible protection for a specific pharmaceutical formulation involving active ingredients combined with novel excipients. Its claims' scope balances breadth with specificity, designed to prevent competitors from producing similar formulations while maintaining novelty and inventive step.
Key Takeaways
- The independent claims cover a broad class of formulations, centered on a specific API-excipient combination.
- Validity depends heavily on the distinction over prior art, emphasizing the importance of detailed characterization.
- The patent landscape reveals active competition around bioavailability and stability enhancements, with potential overlaps requiring careful freedom-to-operate analysis.
- Enforcement strategies should focus on claim scope and potential design-arounds.
- Continuous patent monitoring and possible patent family expansion are advisable for maintaining competitive advantage.
FAQs
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What is the primary innovation protected by EP2136793?
It secures a pharmaceutical composition involving a specific API combined with certain excipients designed to improve bioavailability and stability, along with the process for preparing such a formulation.
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How broad are the claims in EP2136793?
The independent claims are broadly drafted to encompass various dosage forms and release profiles, though specific embodiments and ranges narrow protection.
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What are typical challenges to the validity of this patent?
Challenges usually relate to prior art that discloses similar compositions, and whether the claimed invention demonstrates an unexpected technical effect supporting inventive step.
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How does the patent landscape affect strategies for drug formulation development?
It informs companies about potential infringement risks, encourages designing around existing patents, and highlights areas where innovation can secure strong patent protection.
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Can EP2136793 be enforced against biosimilar or generic entrants?
Yes, if those competitors develop formulations falling within the scope of the claims, enforcement actions are viable, subject to the validity and strength of the patent.
Sources:
[1] European Patent Office, "European Patent EP2136793," 2023.
