United States Patent 11,364,247: A Detailed Analysis of Scope and Claims
Overview of the Patent
The United States Patent 11,364,247, titled "Methods of treatment of partial onset seizures using eslicarbazepine acetate," is a significant patent in the field of neurology and pharmacology. This patent is held by Bial-Portela & CA SA and Sunovion Pharmaceuticals Inc., and it pertains to the use of eslicarbazepine acetate, an anticonvulsant agent, for the treatment of partial-onset seizures.
Background of Eslicarbazepine Acetate
Eslicarbazepine acetate is a medication used as an adjunctive therapy to treat partial-onset seizures in patients who have not responded adequately to other treatments. It is known by the brand name Aptiom and has undergone extensive clinical trials to establish its efficacy and safety[1][4].
Scope of the Patent
Therapeutic Use
The patent primarily focuses on the methods of treating partial-onset seizures using eslicarbazepine acetate. It outlines various dosing regimens and administration methods to optimize the therapeutic effect of the drug. This includes once-daily and twice-daily dosing, which are critical for maintaining therapeutic plasma concentrations and minimizing side effects[4].
Pharmacokinetics
The patent delves into the pharmacokinetic properties of eslicarbazepine acetate, including its absorption, distribution, metabolism, and excretion. It provides detailed data on parameters such as the area under the plasma concentration versus time curve (AUC), peak plasma concentration (Cmax), and terminal half-life (t1/2). These parameters are essential for understanding the drug's bioavailability and how it is metabolized in the body[4].
Claims of the Patent
Key Claims
The patent includes several key claims that define the scope of protection:
- Method of Treatment: The patent claims methods for treating partial-onset seizures using eslicarbazepine acetate, including specific dosing regimens and administration routes.
- Pharmacokinetic Profiles: Claims related to the pharmacokinetic profiles of eslicarbazepine acetate, ensuring that the drug's bioavailability and metabolism are within specified ranges.
- Therapeutic Efficacy: Claims that establish the therapeutic efficacy of eslicarbazepine acetate in reducing the frequency and severity of partial-onset seizures[4].
Dependent Claims
The patent also includes dependent claims that further specify the conditions under which the method of treatment is effective. These claims may include:
- Dosing Regimens: Specific dosing schedules, such as once-daily or twice-daily administration.
- Patient Populations: Claims that specify the patient populations for which the treatment is effective, such as adults or children with epilepsy.
- Combination Therapies: Claims that cover the use of eslicarbazepine acetate in combination with other antiepileptic drugs[4].
Patent Landscape
Litigation and Settlements
The patent has been involved in several litigation cases, particularly in the context of generic drug approvals. For instance, Bial-Portela & CA SA has been involved in lawsuits against generic manufacturers like Aurobindo Pharma Ltd. to protect the patent rights of eslicarbazepine acetate. These settlements often involve agreements that prevent generic manufacturers from infringing the patents until the expiration dates or under specific conditions[2].
Expiration Dates
The patent has multiple expiration dates due to various extensions and settlements. For example, some of the patents related to eslicarbazepine acetate are set to expire between 2025 and 2032, depending on the specific claims and extensions[1][2].
Competitor Activity
Other pharmaceutical companies are closely monitoring the patent landscape for eslicarbazepine acetate. This includes tracking the expiration dates of key patents and assessing opportunities for generic or biosimilar versions of the drug. Companies like Aurobindo Pharma Ltd. have been actively involved in ANDA (Abbreviated New Drug Application) litigation related to this patent[2].
Patent Analytics and Claim Coverage
Claim Coverage Matrix
To understand the full scope of protection provided by this patent, a Claim Coverage Matrix can be used. This matrix categorizes the patents and claims by their scope concepts, helping to identify which claims are actively protecting the intellectual property and where gaps or opportunities exist. This tool is particularly useful for managing large numbers of patent claims and ensuring comprehensive coverage[3].
Interactive Claim Charts
Interactive claim charts generated by software like ClaimScape® can facilitate the review of patent coverage with technical experts. These charts help in determining whether specific scope concepts are applicable to target products or methods, thereby identifying gaps in current coverage and highlighting future design opportunities[3].
Key Takeaways
- Therapeutic Use: The patent covers the use of eslicarbazepine acetate for treating partial-onset seizures.
- Pharmacokinetics: Detailed pharmacokinetic data is provided to ensure optimal dosing and therapeutic efficacy.
- Litigation and Settlements: The patent has been involved in several litigation cases to protect its rights against generic manufacturers.
- Expiration Dates: Multiple expiration dates apply due to extensions and settlements.
- Competitor Activity: Other pharmaceutical companies are closely monitoring the patent landscape for opportunities.
FAQs
What is the primary use of eslicarbazepine acetate as described in the patent?
Eslicarbazepine acetate is used as an adjunctive therapy to treat partial-onset seizures in patients with inadequate clinical response to other treatments.
What are the key pharmacokinetic parameters discussed in the patent?
The patent discusses parameters such as AUC, Cmax, and terminal half-life (t1/2) to understand the drug's bioavailability and metabolism.
How does the patent protect its claims against generic manufacturers?
The patent holders have been involved in several litigation cases and settlements to protect their patent rights against generic manufacturers.
What is the significance of the Claim Coverage Matrix in patent analytics?
A Claim Coverage Matrix helps in categorizing patents and claims by their scope concepts, identifying gaps or opportunities in intellectual property protection.
What is the expected expiration date range for the patents related to eslicarbazepine acetate?
The patents are set to expire between 2025 and 2032, depending on the specific claims and extensions.
Sources
- DrugBank: Eslicarbazepine acetate: Uses, Interactions, Mechanism of Action.
- Robins Kaplan LLP: ANDA Litigation Settlements | Hatch-Waxman.
- Schwegman: Patent Analytics.
- Google Patents: Methods of treatment of partial onset seizures using eslicarbazepine acetate.
