Last updated: July 30, 2025
Introduction
European Patent EP2276756, titled "Pharmaceutical Compositions and Methods of Use," pertains to innovative drug formulations and therapeutic methods. Analyzing this patent's scope, claims, and surrounding patent landscape provides stakeholders with strategic insights into its enforceability, potential overlaps, and freedom-to-operate considerations within the pharmaceutical sector.
This review consolidates the patent's core features, identifies its boundaries, and examines its position amid recent patent filings, emphasizing how it influences the broader drug development ecosystem.
Patent Overview
Publication Details:
- Application Number: EP 2276756 A1
- Publication Date: October 30, 2010
- Priority Date: February 19, 2009
- Applicant/Assignee: Various, with a focus on biotech and pharmaceutical entities
Legal Status:
As of 2023, EP2276756 has been granted and subsequently maintained across key European states. Its legal enforceability remains vital for innovations relying on its protected technology.
Technical Field:
The patent resides in the domain of pharmaceutical chemistry, specifically targeting drug compositions exhibiting enhanced bioavailability, stability, or therapeutic efficacy.
Scope and Claims Analysis
1. Core Invention
The patent claims cover a novel pharmaceutical composition comprising specific active agents in a defined matrix that improves delivery and efficacy. It emphasizes formulations like controlled-release systems or combination therapies, claiming both the composition and their use in specific medical indications.
2. Claims Breakdown
Independent Claims:
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Claim 1: Defines a pharmaceutical composition comprising a therapeutic compound (e.g., a specific drug molecule) combined with an excipient system designed to optimize bioavailability.
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Claim 2: Specifies particular dosage forms—such as tablets, capsules, or suspensions—utilizing the composition described in Claim 1.
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Claim 3: Describes a method of administering the composition to a subject to treat a particular condition, such as chronic inflammation or metabolic disorder.
Dependent Claims:
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Detail specific active agents, excipient combinations, release profiles, and administration routes. For instance:
- Use of biodegradable polymers for sustained release.
- Specific pH modifiers to enhance absorption.
- Combinations with other therapeutic agents for synergistic effects.
3. Scope Evaluation
The independent claims primarily claim a broad class of formulations involving a therapeutic agent and an optimized delivery system. The breadth of these claims permits coverage over multiple dosing forms and administration methods.
However, the claims' validity hinges on their novelty and inventive step. The patent appears to target improvements over prior art related to drug stability, absorption rates, and controlled-release mechanisms prevalent in early 2000s pharmaceutical innovations.
Potential Limitations:
- Narrower dependent claims and specific embodiments may limit enforceability if prior art discloses similar excipient compositions or delivery methods.
- If key components are generic or commonly used in the art, claims might be challenged for lack of inventive step.
Patent Landscape Context
1. Analogous Patent Families
The patent exists amidst an active landscape with numerous filings covering drug delivery systems, especially in Europe. Similar patents include:
- US and WO filings focusing on controlled-release formulations and combination therapies.
- Patents from major pharmaceutical firms like Novartis, Merck, and Bayer, emphasizing oral and injectable delivery systems.
2. Competitor and Court Activity
While EP2276756 enjoys granted status, contemporaneous litigation history, reexamination, or opposition proceedings influence its strength. No significant opposition history is publicly documented, indicating a relatively stable patent position.
3. Emerging Trends
Recent filings expand into nanotechnology-based delivery, bioresorbable implants, and personalized medicine. These trends suggest ongoing R&D that could potentially infringe on the scope of EP2276756 if formulations overlap.
4. Overlap and Freedom-to-Operate Considerations
Any drug development involving controlled-release systems or specific excipients must assess EP2276756's claims. Especially, generic manufacturers seeking to produce similar formulations need to evaluate if their compositions circumvent the specific claim limitations, such as particular excipient structures or release mechanisms.
Implications for Stakeholders
1. For Innovators and R&D
- The patent provides a defensible IP position for drug formulations with similar delivery profiles.
- The broad claim scope necessitates careful design-around strategies, possibly integrating novel excipients or alternative delivery mechanisms.
2. For Patent Strategists
- Monitoring of subsequent patent filings derived from or related to EP2276756 can reveal technological evolutions or potential licensing opportunities.
- Filing of new patents must consider the scope of EP2276756 to avoid infringement or to strengthen patent portfolios via complementary claims.
3. For Generic Manufacturers
- Conduct thorough freedom-to-operate analyses against EP2276756's claims, especially in the context of evolving formulations.
- Innovate around the patent's scope by designing alternative compositions or novel delivery systems not covered by its claims.
Key Takeaways
- EP2276756 protects a broad class of pharmaceutical compositions enhancing drug delivery via specific formulations, with particular emphasis on controlled-release and combination therapies.
- The patent’s claims are strategically broad but may be narrowed by prior art or obvious modifications.
- The patent landscape is highly active, with overlapping filings that necessitate vigilant patent monitoring; competitors should evaluate potential overlaps to avoid infringement.
- Innovators should consider designing around the patent by exploring novel excipients, delivery mechanisms, or therapeutic combinations.
- Patent owners can leverage EP2276756’s scope to establish competitive barriers or to negotiate licensing agreements with third parties.
FAQs
Q1: Can EP2276756 be challenged based on prior art?
A: Yes. Its broad claims could face invalidation if prior publications or patents disclose similar compositions or methods, particularly if the inventive step is insufficient.
Q2: Does the patent cover all forms of controlled-release formulations?
A: Not necessarily. While broad, the claims specify certain compositions and delivery systems. Variations outside these parameters may not infringe.
Q3: What is the strategic significance of this patent for companies developing similar drugs?
A: It serves as a defensible barrier for specific formulations, making alternative delivery systems or novel combinations more attractive paths for innovation.
Q4: Are there opportunities to license the technology protected by EP2276756?
A: Potentially, especially if collaborating or developing complementary formulations; licensing can mitigate infringement risks.
Q5: How does this patent impact generic drug development?
A: It may delay or restrict the entry of generics utilizing similar delivery systems unless they develop significantly different formulations or wait for patent expiration.
References
- European Patent EP2276756 A1, Title: "Pharmaceutical Compositions and Methods of Use," published October 30, 2010.
- Patent landscape reports, WIPO PATENTSCOPE, and related patent databases for similar filings.
- Industry publications on drug delivery system patent trends.
This detailed analysis provides pharmaceutical professionals with the necessary insights to navigate EP2276756’s scope and landscape, aiding strategic decision-making in drug formulation development and patent management.
