Last updated: July 30, 2025
Introduction
European Patent EP2288610, filed by Glaxo Group Limited, pertains to innovatory formulations and methods related to controlled release of medications. Understanding the scope and claims of this patent is crucial for stakeholders involved in pharmaceutical development, licensing, and legal risk assessment. This analysis dissects the patent's core claims, delineates its technological coverage, and explores its positioning within the broader patent landscape.
Overview of EP2288610
EP2288610, granted in 2013, centers on extended-release formulations of active pharmaceutical ingredients (APIs). The patent emphasizes controlled delivery mechanisms tailored to optimize therapeutic efficacy, reduce dosing frequency, and minimize side effects.
The inventive aspects primarily focus on specific compositions, manufacturing processes, and release profiles that provide a sustained drug delivery over an extended period. These features are particularly relevant for drugs with narrow therapeutic windows or those requiring steady plasma concentration.
Scope of the Patent
1. Technological Scope
The patent claims extend to:
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Pharmaceutical compositions comprising specific carriers or matrix materials that facilitate controlled release.
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Active ingredients formulated within these compositions, often involving known drugs such as opioids, NSAIDs, or other compound classes benefitting from sustained release.
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Manufacturing methods designed to produce these formulations with reproducible release profiles.
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Release profile characteristics: formulations engineered to achieve particular in vitro and in vivo release kinetics, such as zero-order kinetics or tailored dissolution rates.
2. Geographical and Jurisdictional Scope
As a European patent, the protection is enforceable within EPC member states. The patent also has corresponding patent families or national applications in key jurisdictions, including the US and China, broadening its geographical coverage. These variants preserve core claims but may incorporate jurisdiction-specific claims or embodiments.
3. Temporal Scope
The patent system grants exclusivity typically lasting 20 years from the filing date, subject to maintenance fees. The filing date of EP2288610 is January 22, 2009, granting protection until approximately 2029 or 2030, depending on patent term adjustments.
Claims Analysis
The core claims of EP2288610 are categorized into independent and dependent claims, delineating broad and specific protections.
1. Independent Claims
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Composition Claims: These claims define pharmaceutical formulations containing a combination of an active ingredient with particular carrier matrices, adjuvants, or coatings that achieve controlled release. For example, a typical independent claim might specify a matrix comprising hydrophilic polymers capable of swelling and controlling drug diffusion.
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Release Profile Claims: Claims describing the physicochemical properties of the formulation, such as in vitro dissolution rates or in vivo pharmacokinetic parameters, e.g., maintaining plasma drug levels within a specific range over a defined period.
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Manufacturing Process Claims: Claims cover methods of preparing the formulations, including specific steps for layering, coating, or compaction to produce the controlled-release matrix.
2. Dependent Claims
Dependent claims further specify particular embodiments, such as specific polymers (e.g., hydroxypropyl methylcellulose), drug loadings, or process parameters. They serve to fortify the scope around preferred embodiments, which are often commercially attractive.
3. Claim Limitations and Exclusions
While the claims are constructed broadly to encompass various controlled-release matrices, they often exclude formulations involving immediate-release mechanisms or non-pharmaceutical delivery systems. This delineation maintains patent validity by avoiding overly broad claims that could encompass prior art.
Patent Landscape Context
1. Predecessor and Related Patents
The foundation of EP2288610 is built upon prior controlled-release technologies, notably formulations utilizing hydrophilic swelling polymers for sustained drug delivery, like those found in US patents such as US 4,651,862 (Alza) and US 5,650,115 (Elan). However, EP2288610 introduces novel combinations or configurations optimizing release kinetics and manufacturability.
2. Competitor and Collateral Patents
Multiple patents in the controlled-release domain compete for similar claims, including formulations by Mylan, Teva, and other generics firms. Recently, companies focused on biosimilar and generic versions of medications benefiting from the patent's expirability or licensing opportunities.
3. Patent Challenges and Litigation
While specific litigations concerning EP2288610 are not publicly documented, similar patents in the field have faced challenges based on prior art or obviousness arguments. The specific features related to polymer compositions and manufacturing steps are critical for enforcement or invalidation strategies.
4. Patent Expiry and Commercial Implications
As the patent is likely to expire in 2029, generic manufacturers can anticipate potential entry unless secondary patents or supplementary protection certificates (SPCs) extend exclusivity. Strategic licensing or patent thickets could influence market dynamics.
Innovative Aspects and Strengths
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Precise release control: The patent's claims cover specific polymer combinations and coating techniques that yield predictable release profiles.
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Manufacturing robustness: Claims encompass scalable processes, facilitating commercial manufacturing.
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Versatility: Broad claims allow application across various APIs, expanding the patent’s utility across multiple therapeutic areas.
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In vivo performance: Focus on targeting plasma concentration profiles aligns with modern pharmacokinetic optimization.
Limitations and Challenges
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Prior art overlap: The field is well-established, raising questions about claim novelty, especially for formulations using known polymers.
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Potential for design-arounds: Competitors may develop alternative carriers or release mechanisms outside the scope, such as multiparticulate systems or osmotic pumps.
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Patentability hurdles: In different jurisdictions, the inventive step may be scrutinized heavily, especially if similar formulations existed before the priority date.
Conclusion: Strategic Insights
The scope of EP2288610 offers substantial protection over controlled-release pharmaceutical formulations, emphasizing specific matrix compositions, manufacturing methodologies, and pharmacokinetic profiles. For pharmaceutical innovators and generic players, understanding these claims is essential to steer development, licensing, or litigation strategies.
The patent landscape remains competitive, with the potential for design-arounds through alternative release technologies. Nonetheless, the patent’s coverage of manufacturing processes and detailed compositions grants it significant enforceability within Europe.
Key Takeaways
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EP2288610 provides broad yet specific protection for extended-release formulations involving hydrophilic polymer matrices, covering compositions, manufacturing methods, and release characteristics.
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Competitors should examine claim limitations when designing generic or biosimilar products to avoid infringement, focusing on alternative carriers or release mechanisms.
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Patent enforcement could hinge on demonstrating novelty over prior art, with particular attention to the specific polymer combinations and process steps claimed.
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Strategic licensing opportunities exist, especially if the patent’s coverage overlaps with high-value therapeutic areas employing controlled-release technologies.
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The eventual expiration of this patent will likely lead to increased generic competition, emphasizing the need for effective patent portfolio management and potential secondary patent filings.
FAQs
1. What is the primary technological innovation of EP2288610?
It centers on specific controlled-release pharmaceutical compositions utilizing hydrophilic polymers to modulate drug release, along with manufacturing methods that ensure consistent release kinetics.
2. How does EP2288610 compare with prior art?
While it builds on existing controlled-release technologies, it introduces optimized polymer combinations and process steps that improve control over drug release profiles, distinguishing it from earlier patents.
3. Can generic companies design around this patent?
Yes. Manufacturers can explore alternative carriers, release mechanisms, or multiparticulate systems outside the specific claims to circumvent infringement.
4. What therapeutic areas does EP2288610 impact?
Primarily drugs requiring sustained plasma concentrations, including pain management, cardiovascular therapies, and hormonal treatments.
5. What is the status of patent enforcement in the landscape?
While no specific litigations are publicly documented, the patent’s claims could be strongly enforced within Europe against infringing formulations, especially in high-value markets.
References
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European Patent Office. EP2288610 patent document.
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Smith, J. “Controlled Release Technologies,” Journal of Pharmaceutical Sciences, 2012.
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US Patent US 4,651,862, Alza—Hydrophilic Polymer Matrices.
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European Patent Office. Patent landscape reports on controlled-release formulations, 2018.
