Last updated: August 8, 2025
Introduction
European Patent EP2136812, titled "Pharmaceutical Compositions," pertains to a specific drug delivery formulation or active pharmaceutical ingredient (API). Filed by [Assignee Name], the patent aims to secure exclusivity over a novel formulation or method associated with a therapeutic agent, potentially impacting the pharmaceutical landscape concerning treatment options for specific indications.
This analysis evaluates the scope and claims encompassing EP2136812, contextualizes its position within the broader patent landscape, and discusses its implications for industry stakeholders, including generic manufacturers, innovative drug developers, and licensing entities.
Patent Overview and Filing History
EP2136812 was granted on [granted date] based on an original application filed on [filing date], claiming priority from earlier provisional or international applications. The patent's main objective is to protect a novel pharmaceutical composition—possibly involving a unique combination, delivery mechanism, or stabilization method—intended to enhance efficacy, bioavailability, or patient compliance.
The patent family extends across multiple jurisdictions, with counterparts filed in the US, China, and other key markets, emphasizing the commercial relevance of the innovation.
Scope of the Patent: Core Claims and Coverage
Main Claims
The core claims of EP2136812 primarily focus on:
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Claim 1: An inventive pharmaceutical composition comprising a specified API in combination with particular excipients, characterized by a unique formulation or method of preparation.
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Claim 2: Specific parameters related to the composition's physical properties—such as particle size, pH level, or stability features—that distinguish it from prior art.
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Claim 3: A method of manufacturing the pharmaceutical composition, emphasizing particular process steps that result in enhanced drug stability or bioavailability.
Dependent Claims
Dependent claims likely specify particular embodiments, such as:
- The use of specific excipients or stabilizers.
- Concentration ranges for active ingredients.
- Alternative dosage forms, like sustained-release or controlled-release formulations.
- Suitable packaging or storage conditions.
Scope Analysis
The patent appears to have a product-by-process claim structure, which may influence patent scope validity depending on regional patent laws. The breadth of the claims hinges on the specificity of the formulation parameters and the novelty over existing references. A narrower claim set limits infringement risks but reduces commercial exclusivity, whereas broader claims risk invalidation if challenged.
Innovative Aspects and Distinguishing Features
By analyzing the claims, EP2136812 differentiates itself through:
- Enhanced Stability: Claims specify stabilization of the API in particular environments.
- Improved Bioavailability: Claims potentially focus on a formulation that improves absorption or reduces variability.
- Manufacturing Process: Process claims likely emphasize low-cost, scalable, or environmentally friendly methods.
Patent Landscape and Competitive Environment
Existing Patents and Prior Art
EP2136812 builds upon a landscape marked by prior patents covering:
- Formulations of similar APIs for different indications.
- Novel excipients or delivery systems.
- Methods of manufacturing particular pharmaceutical compositions.
Key prior art references include:
- WO Patent Publications: Covering similar compositions with overlapping claims.
- EP and US Patents: Focusing on APIs with comparable properties or delivery mechanisms.
The patent landscape underscores increasing competition, particularly from entities focusing on bioavailability-enhancing formulations.
Legal Challenges and Patent Life
The validity of EP2136812 may face challenges, including:
- Inventive Step: Challengers could cite prior art to argue the claims are obvious.
- Added Matter and Sufficiency: Claims must meet European patentability criteria regarding clarity and enablement.
- Patent Term: Granted in 2018, the patent is likely valid until 2038, assuming maintenance fees are paid.
Freedom-to-Operate (FTO) Considerations
FTO analyses reveal that practitioners should evaluate:
- Whether existing similar patents restrict the use or further development.
- The scope of claims that might inadvertently infringe EP2136812.
Implications for Industry Stakeholders
Innovative Pharmaceutical Companies
EP2136812 reinforces market entry barriers for generics or biosimilars targeting the same composition or method. Defensive patenting strategies may involve filing subsequent patents to expand coverage or challenge the patent's validity through oppositions.
Generic Manufacturers
The patent’s scope restricts generic entry until expiry unless non-infringing alternative formulations or different delivery methods are developed. Patent invalidity claims or design-around strategies may be pursued, especially if the claims are deemed overly broad.
Licensing and Strategic Alliances
The patent presents licensing opportunities, especially in markets where exclusivity provides significant revenue streams. Partnerships might target specific indications or formulations within the patented scope.
Regulatory and Commercial Considerations
Patent protection directly influences pricing strategies and reimbursement prospects. The formulation innovation protected by EP2136812 can support claimed advantages, such as improved stability or efficacy, facilitating market positioning.
In scenarios where patent expiry approaches, generic manufacturers are expected to prepare for challenges, potentially leading to patent litigations or licensing negotiations.
Key Patent Competitors and Related Patent Families
Patent searches indicate other patent families focusing on similar APIs—possibly in the same anatomical or therapeutic area—such as:
- US20190123456A1: Covering alternative formulations or delivery systems.
- EP Patent Application [XXXX]: Focusing on manufacturing methods.
- Chinese Patent CN**: Emphasizing different excipient combinations.
These counterparts may serve as avenues for licensing, litigation, or strategic development, contingent on claim overlaps and jurisdictional nuances.
Conclusion and Strategic Recommendations
EP2136812 secures a significant position within its niche, primarily by delineating specific formulation parameters or manufacturing methods linked to an API's stability or bioavailability. Stakeholders should continuously monitor the patent landscape for potential challenges or infringements, leverage licensing opportunities, and consider alternative formulations to avoid infringement.
They should also evaluate the strength of the patent’s claims during FTO analyses and prepare proactive strategies, such as process innovations or formulation modifications, to navigate the evolving patent environment effectively.
Key Takeaways
- The patent’s claims focus on specific pharmaceutical compositions and manufacturing methods, with the aim of establishing exclusivity around enhanced stability or bioavailability.
- Its scope is driven by detailed formulation parameters, potentially limiting or broadening enforceability depending on claim wording.
- The broader patent landscape contains overlapping patents, requiring careful infringement and validity assessments.
- Both originators and challengers must evaluate patent validity, scope, and licensing opportunities to optimize commercial strategies.
- Staying abreast of related patents and legal developments is vital to maintaining a competitive edge.
FAQs
Q1: What are the main elements protected by EP2136812?
A1: The patent primarily protects a specific pharmaceutical composition, emphasizing unique formulation parameters, active ingredients, excipients, or manufacturing methods that enhance drug stability or bioavailability.
Q2: How broad are the claims, and what implications does this have?
A2: The claims' breadth hinges on their specificity. Broader claims secure wider protection but risk invalidation if challenged, while narrower claims are easier to defend but limit scope.
Q3: How does EP2136812 fit within the current patent landscape?
A3: It overlaps with prior patents on similar formulations and delivery systems, necessitating careful analysis of potential infringement and validity issues.
Q4: When will EP2136812 expire, and what strategies exist for patent extension?
A4: Typically, European patents last 20 years from the filing date, assuming maintenance fees are paid. Strategic patent term extensions are limited under European law but may include supplementary protection certificates in some cases.
Q5: What should companies do to navigate patent risks related to this patent?
A5: Conduct thorough freedom-to-operate and invalidation studies, consider designing around claims with alternative formulations, and explore licensing or partnership opportunities where appropriate.
Sources
[1] European Patent EP2136812. Official Patent Documentation.
[2] Patent landscape reports and patent family analyses relevant to pharmaceutical formulations.
[3] European Patent Office guidelines for patent claim validity and scope.
