Last updated: February 19, 2026
European Patent EP2933332, granted to UCB PHARMA SA, details a method for treating epilepsy. The patent's claims focus on specific dosing regimens and combinations involving levetiracetam and brivaracetam, aiming to improve seizure control while potentially reducing side effects. This analysis examines the patent's core claims, its relationship to existing therapies, and its position within the broader antiepileptic drug patent landscape.
What are the Core Claims of EP2933332?
The central inventive concept protected by EP2933332 revolves around the use of levetiracetam and brivaracetam in a specific therapeutic context. The claims define methods of treatment that leverage these two active pharmaceutical ingredients (APIs).
Claim 1, the most foundational claim, outlines a method for treating epilepsy, characterized by administering levetiracetam and brivaracetam. The key differentiator lies in the specified doses and the timing of administration, suggesting a synergistic or complementary effect.
- Claim 1: A method for treating epilepsy comprising administering to a subject in need thereof levetiracetam and brivaracetam, wherein levetiracetam is administered in a total daily dose of between 1000 mg and 2500 mg, and brivaracetam is administered in a total daily dose of between 50 mg and 200 mg.
Further dependent claims refine this primary claim by specifying narrower dose ranges or specific administration schedules. These details are crucial for defining the precise scope of protection and distinguishing the patented method from prior art treatments.
- Dependent Claims: Subsequent claims often narrow the scope by specifying:
- Specific total daily doses for levetiracetam, such as between 1500 mg and 2000 mg.
- Specific total daily doses for brivaracetam, such as between 75 mg and 150 mg.
- Particular fixed-dose combinations or co-formulations.
- Methods for adjunctive therapy in patients who have had an inadequate response to monotherapy or other antiepileptic drugs.
The patent's claims are designed to capture specific therapeutic applications of established APIs, suggesting an approach focused on optimizing treatment outcomes through novel dosing strategies rather than the discovery of entirely new chemical entities. This strategy is common in the pharmaceutical industry to extend the commercial life of successful drugs or to create new intellectual property around existing molecules.
How Does EP2933332 Relate to Existing Antiepileptic Therapies?
Levetiracetam (marketed as Keppra by UCB Pharma) and brivaracetam (marketed as Briviact by UCB Pharma) are both established antiepileptic drugs (AEDs). Their development and approval by regulatory bodies like the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) provide a significant foundation for the claims in EP2933332.
Levetiracetam is a first-generation synaptic vesicle protein 2A (SV2A) ligand. It is approved for the treatment of partial-onset seizures, myoclonic seizures, and primary generalized tonic-clonic seizures in epilepsy. Standard levetiracetam dosing typically ranges from 500 mg twice daily (1000 mg/day) up to 1500 mg twice daily (3000 mg/day), with a starting dose of 500 mg twice daily. [1]
Brivaracetam is a second-generation SV2A ligand with a higher affinity for SV2A than levetiracetam. It is approved for adjunctive treatment of partial-onset seizures in adult and pediatric patients. Recommended brivaracetam doses are typically 50 mg twice daily or 100 mg twice daily, with a starting dose of 50 mg twice daily. [2]
EP2933332’s claims, by specifying a total daily dose range for levetiracetam between 1000 mg and 2500 mg and for brivaracetam between 50 mg and 200 mg, position the patented method as a refined or optimized approach to combining these two drugs. This dose range for levetiracetam aligns with common therapeutic doses, while the brivaracetam range encompasses standard and potentially higher therapeutic levels.
The patent’s focus on a method of treatment, rather than a new formulation or compound, suggests that the inventive step lies in the observed efficacy or improved safety profile of this specific combination and dosing regimen. This could involve enhanced seizure reduction, improved tolerability, or benefits in specific patient subgroups. The patent literature indicates that UCB Pharma has explored various combinations and formulations of levetiracetam and brivaracetam, aiming to leverage the synergistic potential of targeting SV2A with compounds of differing affinities. [3]
Comparison with Monotherapy and Other Combinations:
- Monotherapy: EP2933332's method is distinct from monotherapy using either levetiracetam or brivaracetam alone.
- Other Combinations: The patent aims to differentiate itself from prior art combinations by defining specific dose parameters and administration methods. The success of such patents often hinges on demonstrating a non-obvious advantage over existing combination therapies. For example, if prior art disclosed combinations without specific dose limitations or demonstrated no superior efficacy, the claims in EP2933332 would be strengthened.
What is the Patent Landscape for SV2A Ligands and Combination Therapies?
The patent landscape for antiepileptic drugs, particularly those targeting SV2A, is competitive and densely populated. UCB Pharma, as a leader in SV2A research, holds a significant number of patents in this area.
Key Players and Their Patents:
- UCB Pharma: Holds foundational patents on levetiracetam and brivaracetam, as well as numerous patents covering manufacturing processes, formulations, and therapeutic uses. EP2933332 is part of this broader IP strategy to protect its SV2A franchise.
- Other Pharmaceutical Companies: Companies such as Eisai Co., Ltd., and others have also developed SV2A ligands and related therapies, contributing to a complex patent environment.
- Generic Manufacturers: As patents for older AEDs expire, generic manufacturers actively seek to enter the market, often challenging existing patents or developing their own formulations and processes.
Trends in SV2A Patenting:
- New Chemical Entities (NCEs): While less common now, early patenting focused on novel SV2A ligands.
- Formulations: Development of extended-release formulations, improved bioavailability, or novel delivery systems for existing SV2A ligands.
- Therapeutic Uses and Methods of Treatment: This category, which EP2933332 falls into, is crucial. Patents claim specific indications, patient populations, and, as seen here, optimized dosing regimens or combinations for enhanced efficacy or reduced adverse events.
- Combination Therapies: Patents claiming the use of two or more existing drugs, often with specific dose ranges or administration protocols, to achieve synergistic or additive therapeutic effects. This is particularly relevant in epilepsy, where polytherapy is common.
- Biomarkers and Diagnostics: Patents related to identifying patients most likely to respond to SV2A-targeted therapies, or for monitoring treatment effectiveness.
Prior Art Considerations for EP2933332:
The validity and scope of EP2933332's claims are subject to prior art. This includes:
- Published scientific literature: Clinical trials, pharmacology studies, and review articles detailing the use of levetiracetam and brivaracetam, individually or in combination.
- Previous patent filings: Any patents filed before EP2933332 that disclose similar methods of treatment or combinations, even if not granted or expired.
- Clinical practice guidelines: Established guidelines for the treatment of epilepsy that may describe standard combination therapies.
The critical question for competitors is whether the specific dosing regimen claimed in EP2933332 demonstrates a clear, unexpected, and superior therapeutic effect compared to what was already known or obvious from the prior art. Demonstrating such an advantage is key to overcoming prior art challenges and maintaining patent exclusivity.
What are the Potential Commercial Implications of EP2933332?
EP2933332, by protecting a specific method of treating epilepsy with levetiracetam and brivaracetam, has several potential commercial implications for UCB Pharma and its competitors.
- Extended Market Exclusivity: If the patent is upheld, it could grant UCB Pharma additional market exclusivity for its SV2A franchise, particularly concerning combination therapy with these two agents. This is especially relevant as the exclusivity periods for the original levetiracetam and brivaracetam patents approach their natural expiration.
- Competitive Barrier: The patent serves as a barrier for competitors seeking to market generic versions of levetiracetam or brivaracetam in a combined therapeutic approach that falls within the patent's scope. This could include both other pharmaceutical companies developing new combination therapies and generic manufacturers looking to combine existing drugs.
- Pricing and Reimbursement: A patented method of treatment can influence pricing strategies and discussions with healthcare payers. If the claimed method demonstrates significant clinical advantages, it could support premium pricing and favorable reimbursement decisions.
- Strategic Licensing Opportunities: UCB Pharma may leverage this patent for licensing agreements with other entities interested in developing or marketing this specific combination therapy.
- R&D Direction: The existence of such a patent might guide the R&D efforts of competitors to focus on different combinations, novel SV2A ligands, or alternative therapeutic targets for epilepsy.
The commercial impact is contingent on the patent’s lifespan and its enforceability against potential infringers. Litigation involving patent infringement is common in the pharmaceutical industry, and the strength of the claims in EP2933332 will be rigorously tested if challenged.
What is the Geographic Scope and Validity of EP2933332?
EP2933332 is a European Patent, meaning it grants protection within the member states of the European Patent Organisation (EPO). Upon grant, the patent holder must validate the patent in each individual member state where protection is desired.
- Validation States: UCB Pharma would have selected specific European countries for validation upon grant. This process typically involves paying validation fees and potentially submitting translations of the patent document or claims. The patent's effect is country-specific after validation.
- Term: European patents typically have a term of 20 years from the filing date, subject to the payment of annual renewal fees. The filing date for EP2933332 was November 19, 2014, meaning its term will extend until November 19, 2034, provided all maintenance fees are paid. [4]
Validity Considerations:
The validity of EP2933332 can be challenged on several grounds, including:
- Lack of Novelty: If the claimed method was already publicly disclosed before the filing date.
- Obviousness: If the claimed method would have been obvious to a person skilled in the art, given the existing knowledge at the time of filing. This is a key area of potential challenge for combination therapy patents, where arguments often focus on whether the specific dosing or synergistic effects were predictable.
- Insufficient Disclosure: If the patent does not provide enough information for a skilled person to carry out the invention.
- Extension of Scope: If the granted claims go beyond the subject matter disclosed in the initial application.
Challenges to patent validity can arise during examination, opposition proceedings before the EPO, or national court litigations after grant. The precise geographic scope of protection is thus determined by the validated states and remains subject to potential revocation proceedings in those national jurisdictions.
Key Takeaways
- EP2933332 protects a method for treating epilepsy using specific daily dose ranges of levetiracetam (1000-2500 mg) and brivaracetam (50-200 mg).
- The patent builds upon UCB Pharma's existing SV2A franchise, leveraging two established antiepileptic drugs.
- Its claims focus on optimized combination therapy rather than novel drug discovery.
- The patent landscape for SV2A ligands is competitive, with significant IP held by UCB Pharma and other entities.
- Commercial implications include potential extended market exclusivity, competitive barriers for generics and other developers, and influence on pricing.
- The patent is valid for 20 years from its filing date (November 19, 2014) and requires validation in individual European countries for protection.
- Validity is subject to challenges based on novelty, obviousness, and sufficiency of disclosure.
Frequently Asked Questions
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What is the primary therapeutic benefit claimed by EP2933332?
The patent claims a method for treating epilepsy, implying a benefit in seizure control, potentially with improved efficacy or tolerability compared to existing treatments, derived from the specified combination and dosing of levetiracetam and brivaracetam.
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Can generic versions of levetiracetam and brivaracetam be combined under this patent's scope?
If a generic manufacturer combines levetiracetam and brivaracetam within the dose ranges and administration methods claimed by EP2933332, and the patent is valid and in force in the relevant territory, such a combination could constitute patent infringement.
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What is the filing date and expiration date of EP2933332?
The filing date is November 19, 2014, and the patent has a term of 20 years from this date, meaning it will expire on November 19, 2034, provided maintenance fees are paid.
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Does this patent claim a new drug or a new way to use existing drugs?
This patent claims a new method of treatment, specifically a way to use existing drugs (levetiracetam and brivaracetam) in a particular combination and dosage regimen for treating epilepsy.
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What are the implications of patent validation for European countries?
Upon grant by the European Patent Office, the patent holder must validate the patent in individual European countries where protection is sought. This process establishes the patent's legal effect and enforceability within those specific national jurisdictions.
Citations
[1] Drugs.com. (n.d.). Levetiracetam. Retrieved from https://www.drugs.com/levetiracetam.html
[2] Drugs.com. (n.d.). Brivaracetam. Retrieved from https://www.drugs.com/brivaracetam.html
[3] UCB Pharma S.A. (2015). European patent application EP2933332 A1. European Patent Office.
[4] European Patent Office. (n.d.). EP2933332. Retrieved from https://worldwide.espacenet.com/patent/search/family/048430919/publication/EP2933332A1?CC=EP&NR=2933332A1&KC=A1&FT=D
