Details for Patent: 9,763,954

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Which drugs does patent 9,763,954 protect, and when does it expire?

Patent 9,763,954 protects APTIOM and is included in one NDA.

This patent has twenty-eight patent family members in twenty-five countries.

Summary for Patent: 9,763,954

Title:	Therapeutical uses of eslicarbazepine
Abstract:	New applications of eslicarbazepine and eslicarbazepine acetate in the treatment of intractable conditions.
Inventor(s):	Patricio Manuel Vieira Araújo Soares Da Silva
Assignee:	Bial Portela and Cia SA
Application Number:	US14/134,843
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,763,954
Patent Claim Types: see list of patent claims	Use; Composition;

United States Patent 9,763,954: Scope, Claims, Expiration Risk, and Eslicarbazepine Patent Landscape

US Patent 9,763,954 protects the use of eslicarbazepine or eslicarbazepine acetate to treat intractable, refractory, or pharmacoresistant epilepsy in patients previously treated with oxcarbazepine. Its broadest commercial relevance is a treatment-selection claim directed to patients who failed or became less responsive to oxcarbazepine. Claim 21 separately covers monotherapy.

The patent is issued and enforceable subject to maintenance-fee status, terminal-disclaimer issues, prosecution history, and any applicable patent-term adjustment. The patent does not protect eslicarbazepine acetate as a chemical compound generally. It protects a defined clinical use.

What does US Patent 9,763,954 cover?

US Patent 9,763,954 covers a method comprising:

1. Identifying a patient with an intractable epilepsy condition.
2. Confirming that the patient was previously treated with oxcarbazepine.
3. Administering a therapeutically effective amount of eslicarbazepine or eslicarbazepine acetate.

Claim 1 is the principal independent claim. Claim 21 is a second independent claim that adds administration as monotherapy.

The patent’s central distinction is the treatment sequence: prior oxcarbazepine exposure followed by treatment with eslicarbazepine or its acetate prodrug.

Claim group	Subject matter	Commercial significance
Claim 1	Treatment of intractable epilepsy after prior oxcarbazepine treatment	Broadest treatment-use protection
Claims 2 and 18	Patients under 2 years of age; temporal lobe epilepsy	Narrow patient and disease subgroups
Claims 3, 4, 14, 20, 22, 23	P-glycoprotein or multidrug-resistance-protein conditions and inhibitor status	Mechanistic and treatment-context limitations
Claims 5-13	Pharmacoresistant, refractory, relapsed, frequent-seizure, or multidrug-failure patients	Defines clinical severity
Claims 15-17	Oxcarbazepine as the prior substrate; acetate or active eslicarbazepine	Narrows the agent and active form
Claim 19	Adjunctive therapy	Relevant to the FDA-approved Aptiom treatment model
Claims 21-28	Monotherapy after prior oxcarbazepine treatment	Separate protection for monotherapy use

How should the independent claims be construed?

Claim 1: prior oxcarbazepine treatment

Claim 1 contains several elements that must be present for infringement:

• A method for treating an intractable epilepsy condition.
• A subject in need of treatment.
• Administration of eslicarbazepine or eslicarbazepine acetate.
• Prior treatment of the subject with oxcarbazepine.

The claim does not require that oxcarbazepine caused treatment failure. It requires that the patient previously received oxcarbazepine. Claims 4, 14, and 15 add the mechanistic relationship involving P-glycoprotein, multidrug-resistance proteins, or oxcarbazepine as a transporter substrate.

A generic product administered to a patient who previously received oxcarbazepine could meet the core treatment sequence, even if the generic label does not expressly recommend that sequence. The practical infringement analysis would depend on the approved label, promotional conduct, prescribing patterns, and the scope of any Section viii carve-out.

Claim 21: monotherapy

Claim 21 covers the same prior-oxcarbazepine treatment sequence but requires eslicarbazepine or eslicarbazepine acetate to be administered as monotherapy.

This claim is narrower than claim 1 in one respect and commercially more significant in another. It excludes adjunctive therapy, but a monotherapy indication could create a separate barrier to a generic applicant seeking to market the product for that use.

The FDA-approved Aptiom label has historically centered on adjunctive treatment of partial-onset seizures. That makes claim 19 more closely aligned with the approved product than claim 21, although the actual relevance depends on the current label and any approved monotherapy indication. FDA approval and patent scope are separate inquiries. A patented use does not become an FDA-approved indication merely because it appears in a patent.

What patient populations are protected?

The dependent claims create a layered set of patient definitions.

Refractory and pharmacoresistant epilepsy

Claims 5 and 6 cover patients with pharmacoresistant or refractory epilepsy. Claims 9 and 10 identify patients who remain seizure-free despite treatment with at least two antiepileptic drugs, including treatment at maximum tolerated doses.

Claim 13 addresses drug-resistant epilepsy patients who have tried at least three or four other antiepileptic drugs. Claim 12 requires at least four seizures per week despite treatment with at least one antiepileptic drug.

These limitations are clinically specific but may create proof issues. In litigation, the patent owner would need evidence that the patient met the applicable condition and that the defendant’s conduct caused or encouraged the claimed administration.

Relapsed or progressively less responsive patients

Claim 7 covers a patient who relapsed after treatment with at least one pharmaceutical composition. Claim 11 covers a patient who became increasingly less responsive to medication and experienced an increasing number of seizures.

These claims expand the patent beyond a fixed numerical treatment-failure threshold. Their enforcement value depends on how the terms are construed and documented in medical records.

Pediatric patients

Claim 2 covers subjects under 2 years of age. The claim is potentially valuable if eslicarbazepine acetate is studied or approved for very young children, but it does not itself establish pediatric safety, efficacy, dosing, or FDA approval.

The FDA label and pediatric exclusivity record must be reviewed separately. A patent claim directed to children under 2 years of age has limited commercial effect if the approved label excludes that population.

What role do P-glycoprotein and multidrug-resistance proteins play?

Claims 3, 4, 14, 20, 22, and 23 address P-glycoprotein and multidrug-resistance proteins, referred to in the claims as “Multiple Resistant Protein” or “Multiple Resistant Proteins.”

The claims use these concepts in three ways:

• Treatment without a P-glycoprotein or multidrug-resistance-protein inhibitor.
• Treatment of epilepsy allegedly caused by overexpression of these proteins.
• Prior treatment with a pharmaceutical composition containing an inhibitor of those proteins.

Claim 15 identifies oxcarbazepine as the relevant P-glycoprotein or multidrug-resistance-protein substrate.

These limitations appear intended to distinguish eslicarbazepine treatment from approaches that attempt to overcome drug resistance by co-administering transporter inhibitors. They may also be vulnerable to evidentiary disputes. A patent owner would need to show that “overexpression” or the applicable transporter relationship is satisfied where the limitation is asserted.

What is the legal strength of US Patent 9,763,954?

The patent has meaningful commercial breadth because claim 1 does not require:

• A particular dose.
• A specific dosage form.
• A specific administration frequency.
• A particular concomitant antiepileptic drug.
• A specific biomarker test.
• A defined duration of prior oxcarbazepine therapy.

The main limiting elements are prior oxcarbazepine treatment and intractable epilepsy.

Strength factor	Assessment
Product coverage	Does not cover the molecule generally; covers use of the molecule
Patient-selection scope	Broad if “previously treated” is interpreted broadly
Clinical severity	Limited to intractable, refractory, pharmacoresistant, or similarly defined patients
Dose protection	None stated in the supplied claims
Formulation protection	None stated in the supplied claims
Monotherapy protection	Present in claim 21
Adjunctive-therapy protection	Present in claim 19
Biomarker dependence	Present only in selected dependent claims
Design-around potential	Possible through indication carve-outs, patient selection, or non-promotional use
Proof burden	Significant for prior therapy and intractable disease status

The claims are stronger against conduct expressly targeting oxcarbazepine failures than against a generic product marketed for broad epilepsy treatment with a carved-out label.

When does US Patent 9,763,954 lose exclusivity?

The patent issued on September 19, 2017. Its expiration is determined under the US patent-term statute, generally 20 years from the earliest effective nonprovisional or international filing date, subject to patent-term adjustment, patent-term extension, terminal disclaimers, and maintenance fees (35 U.S.C. § 154).

The patent’s statutory expiration date should be taken from the USPTO Patent Center record and any FDA Orange Book listing. The issue date alone does not determine expiration.

The patent does not receive a separate biologic exclusivity period because eslicarbazepine acetate is a small-molecule drug. FDA small-molecule exclusivity, if applicable, is distinct from patent protection and does not extend the patent term.

What is the Orange Book status of Aptiom and this patent?

Aptiom is the US brand for eslicarbazepine acetate. The reference product is associated with Sunovion Pharmaceuticals, a subsidiary of Sumitomo Pharma, while BIAL developed and licensed eslicarbazepine acetate technology.

The Orange Book determines whether US Patent 9,763,954 is listed against a specific Aptiom NDA, the listed use code, and the date on which the patent blocks approval of an ANDA. A patent can be enforceable without being listed in the Orange Book, but an unlisted patent generally does not trigger the same ANDA certification process.

Key regulatory questions are:

• Whether the patent is listed for Aptiom.
• Whether it has a method-of-use code.
• Whether the listed use matches prior oxcarbazepine treatment.
• Whether the patent covers all approved indications or only a subset.
• Whether the FDA listing has been delisted, expired, or corrected.

The FDA Orange Book and the current Aptiom labeling are the controlling sources for those questions (FDA, 2024a, 2024b).

What Paragraph IV challenges and generic entry risks exist?

A generic applicant seeking approval for eslicarbazepine acetate could face several routes:

Paragraph IV certification

The applicant may certify that an Orange Book-listed patent is invalid, unenforceable, or not infringed. A Paragraph IV notice can trigger Hatch-Waxman litigation and a 30-month stay of approval under applicable statutory conditions (FDA, 2024c).

Section viii statement

If the listed patent covers only a method of use that the generic applicant does not seek to market, the applicant may submit a Section viii statement and carve the patented use from its labeling.

For this patent, the commercial viability of a carve-out depends on whether the generic label can exclude:

• Treatment after prior oxcarbazepine use.
• Monotherapy.
• Refractory or pharmacoresistant patients.
• Any specific adjunctive-use language linked to the patent.

Induced-infringement exposure

Even with a carved-out label, litigation risk can remain if the label, marketing materials, distribution strategy, or physician-directed communications encourage the patented treatment sequence. A generic company is more exposed if it promotes eslicarbazepine for oxcarbazepine nonresponders.

What formulations are protected by this patent?

The supplied claims do not recite a formulation, dosage form, release profile, particle-size distribution, salt form, coating, or manufacturing process.

Accordingly, US Patent 9,763,954 does not, based on the supplied claims, protect:

• Immediate-release tablets as a formulation class.
• Extended-release tablets.
• Oral suspensions.
• Specific excipient combinations.
• Tablet hardness or dissolution profiles.
• Eslicarbazepine acetate crystal forms.
• Manufacturing processes.
• Packaging or stability systems.

Those protections, if they exist, must be located in separate composition, formulation, polymorph, or process patents in the Aptiom family and related BIAL or Sunovion portfolios.

How does this patent compare with other eslicarbazepine patents?

The eslicarbazepine patent estate can be divided into four technical groups.

Patent category	Typical protection	Relevance to generic entry
Compound patents	Eslicarbazepine, eslicarbazepine acetate, related derivatives	Usually earliest-expiring rights
Formulation patents	Tablets, release characteristics, excipients, stability	Can delay or complicate product development
Method-of-use patents	Epilepsy treatment, dosing, monotherapy, adjunctive therapy, patient selection	Relevant to ANDA labeling and inducement
Manufacturing patents	Synthesis, purification, stereochemical control, crystallization	Can create process barriers without blocking all products

US Patent 9,763,954 is a patient-selection and treatment-sequence patent. It is distinct from a basic compound patent and should be analyzed with the FDA-listed use code rather than as a general Aptiom composition patent.

Which companies are relevant to the eslicarbazepine competitive landscape?

The primary commercial parties are:

• BIAL-Portela & Ca., S.A., the originator associated with eslicarbazepine development.
• Sunovion Pharmaceuticals, the US commercial partner for Aptiom.
• Sumitomo Pharma, Sunovion’s parent company.
• Generic manufacturers pursuing ANDA approval for eslicarbazepine acetate.
• Competing antiseizure-drug companies marketing oxcarbazepine, carbamazepine, lacosamide, perampanel, cenobamate, and other treatments.

Eslicarbazepine acetate competes most directly with oxcarbazepine because both are dibenzazepine-related sodium-channel antiseizure therapies. Lacosamide and cenobamate compete for patients with focal or drug-resistant epilepsy but rely on different mechanisms and patent estates.

Are biosimilar risks relevant?

No. Eslicarbazepine acetate is a chemically synthesized small-molecule drug, not a biologic. Biosimilar approval under the Public Health Service Act is not the relevant pathway.

The relevant regulatory pathway is an ANDA under section 505(j) of the Federal Food, Drug, and Cosmetic Act. Generic applicants must address listed patents through Paragraph IV certifications, Paragraph III certifications, or Section viii statements, depending on the patent and proposed label.

What patent litigation and settlement issues should be reviewed?

A complete freedom-to-operate assessment should review:

1. Any Paragraph IV notice involving Aptiom.
2. District-court complaints under 35 U.S.C. § 271(e)(2).
3. Federal Circuit appeals.
4. Hatch-Waxman settlement agreements.
5. FTC submissions concerning generic-delay settlements.
6. Patent-term adjustment and maintenance-fee records.
7. Orange Book listing and delisting history.
8. Any covenant not to sue or license agreement involving BIAL, Sunovion, or a generic applicant.

The supplied claims do not establish that US Patent 9,763,954 has been litigated, invalidated, disclaimed, or settled. Those matters are separate from claim construction and require review of the USPTO, FDA, PACER, and FTC records.

What licensing deals affect the patent estate?

BIAL and Sunovion have been the principal commercial parties associated with US eslicarbazepine acetate commercialization. The licensing relationship is commercially relevant because patent ownership, NDA ownership, manufacturing rights, and enforcement authority may be divided among affiliates or licensees.

A license does not change claim scope. It can change who has standing to sue, who controls Orange Book submissions, and who may authorize generic entry or a settlement.

Key Takeaways

• US Patent 9,763,954 is a method-of-use patent, not a broad compound patent.
• Claim 1 targets treatment of intractable epilepsy after prior oxcarbazepine treatment.
• Claim 21 separately protects monotherapy after prior oxcarbazepine treatment.
• Claims 3, 4, 14, 15, 20, 22, and 23 add transporter-related limitations involving P-glycoprotein and multidrug-resistance proteins.
• Claims 9, 10, 12, and 13 define treatment-resistant populations using drug-failure and seizure-frequency thresholds.
• The patent contains no formulation, dose, release-profile, crystal-form, or manufacturing limitations in the supplied claims.
• Generic entry risk depends heavily on Orange Book listing, use-code language, label carve-outs, and inducement theories.
• Biosimilar law is irrelevant; ANDA and Hatch-Waxman rules control generic competition.
• Patent expiration cannot be determined from the September 19, 2017 issue date alone. USPTO patent-term data and any Orange Book listing control.
• The most commercially important infringement question is whether a generic label or marketing program directs treatment of patients who previously failed oxcarbazepine.

FAQs

Does US Patent 9,763,954 cover Aptiom itself?

No. The supplied claims cover administering eslicarbazepine or eslicarbazepine acetate for specified epilepsy patients. They do not claim the active compound in all uses.

Can a generic manufacturer avoid this patent by removing monotherapy from its label?

Potentially, but removal of monotherapy would address claim 21 and its dependents only. Claim 1 and claim 19 may still matter if the proposed label supports adjunctive treatment after prior oxcarbazepine use.

Does prior oxcarbazepine treatment have to be unsuccessful?

Claim 1 requires prior treatment but does not expressly require failure. Other claims impose treatment resistance, relapse, seizure-frequency, or multidrug-failure limitations.

Does the patent cover eslicarbazepine acetate administered with other antiepileptic drugs?

Yes, claim 19 expressly covers adjunctive therapy. Claim 1 itself is not limited to monotherapy or adjunctive therapy.

Is oxcarbazepine patent protection still the main barrier to eslicarbazepine generic entry?

No. Oxcarbazepine and eslicarbazepine acetate have separate patent estates. A generic eslicarbazepine applicant must assess Aptiom compound, formulation, method-of-use, and process patents independently.

References

1. United States Patent and Trademark Office. (2017). U.S. Patent No. 9,763,954.
2. United States Code. (2024). 35 U.S.C. § 154: Contents and term of patent; provisional rights.
3. U.S. Food and Drug Administration. (2024a). Approved drug products with therapeutic equivalence evaluations: Orange Book.
4. U.S. Food and Drug Administration. (2024b). Aptiom (eslicarbazepine acetate) prescribing information.
5. U.S. Food and Drug Administration. (2024c). Abbreviated new drug application regulations and patent certifications.

Drugs Protected by US Patent 9,763,954

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Sumitomo Pharma Am	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-001	Nov 8, 2013	AB	RX	Yes	No	9,763,954					TREATMENT OF PARTIAL-ONSET SEIZURES IN PATIENTS WITH EPILEPSY WHO HAVE BEEN PREVIOUSLY TREATED WITH OXCARBAZEPINE
Sumitomo Pharma Am	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-002	Nov 8, 2013	AB	RX	Yes	No	9,763,954					TREATMENT OF PARTIAL-ONSET SEIZURES IN PATIENTS WITH EPILEPSY WHO HAVE BEEN PREVIOUSLY TREATED WITH OXCARBAZEPINE
Sumitomo Pharma Am	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-003	Nov 8, 2013	AB	RX	Yes	No	9,763,954					TREATMENT OF PARTIAL-ONSET SEIZURES IN PATIENTS WITH EPILEPSY WHO HAVE BEEN PREVIOUSLY TREATED WITH OXCARBAZEPINE

Foreign Priority and PCT Information for Patent: 9,763,954

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	0700773.5	Jan 15, 2007

International Family Members for US Patent 9,763,954

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	064898
Australia	2008205712
Brazil	PI0806568