Details for Patent: 10,709,671

Which drugs does patent 10,709,671 protect, and when does it expire?

Patent 10,709,671 protects EPIDIOLEX and is included in one NDA.

This patent has seventeen patent family members in nine countries.

Summary for Patent: 10,709,671

Title:	Use of cannabinoids in the treatment of epilepsy
Abstract:	The present invention relates to the use of cannabidiol (CBD) in the treatment of focal seizures. In one embodiment the patients suffering from focal seizures are children and young adults. CBD appears particularly effective in reducing focal seizures in patients suffering with etiologies that include: Lennox-Gastaut Syndrome; Tuberous Sclerosis Complex; Dravet Syndrome; CDKL5; Neuronal ceroid lipofuscinoses (NCL); febrile infection related epilepsy syndrome (FIRES); Aicardi syndrome and brain abnormalities in comparison to other seizure types. Significantly CBD additionally is very effective in the reduction of a sub-type of focal seizures, focal seizures with impairment.
Inventor(s):	Geoffrey Guy, Stephen Wright, Orrin Devinsky
Assignee:	Jazz Pharmaceuticals Research UK Ltd
Application Number:	US15/183,947
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,709,671
Patent Claim Types: see list of patent claims	Use; Composition;

United States Patent 10,709,671: CBD Dravet Syndrome Claims, Expiration, Orange Book Status and Generic Risk

US Patent 10,709,671 protects specific methods of treating focal seizures associated with Dravet syndrome using highly purified cannabidiol at 15 to 20 mg/kg/day, including the 20 mg/kg/day dose used in the second independent claim. The patent also reaches CBD supplied as a purified cannabis extract or synthetic compound, used with specified antiepileptic drugs, and administered in an oral formulation containing sesame oil, ethanol, sucralose and strawberry flavoring.

The patent is a method-of-use and formulation-linked patent. It does not claim cannabidiol as a molecule, a general CBD product, or every use of CBD in epilepsy. Its commercial significance is tied to Epidiolex, Jazz Pharmaceuticals' purified cannabidiol oral solution.

What does US Patent 10,709,671 cover?

The patent covers a treatment method with four principal elements:

Claim element	Scope
Disease	Dravet syndrome
Seizure type	Focal seizures; dependent claims specify focal seizures with impairment
Active ingredient	Cannabidiol
Purity	At least 98% w/w CBD
THC limit	No more than 0.15% w/w Δ9-THC
Dose	15 to 20 mg/kg/day in claim 1; exactly 20 mg/kg/day in claim 16
Product source	Highly purified cannabis extract or synthetic CBD
Optional ingredients	CBDV up to 1%
Concomitant therapy	Listed antiepileptic drugs and non-drug interventions
Oral formulation	CBD, solvent, co-solvent, sweetener and flavoring
Narrow formulation	Sesame oil, ethanol, sucralose and strawberry flavor

Claim 1 is the broadest independent claim in the first claim group. Claim 16 creates a second independent method claim limited to exactly 20 mg/kg/day. Claims 2 through 15 depend from claim 1. Claims 17 through 24 depend from claim 16.

The claims use "Δ9-tetrahydrocannabidiol," but the relevant cannabinoid impurity is ordinarily identified as Δ9-tetrahydrocannabinol, or Δ9-THC. The patent and related regulatory materials should be reviewed for the precise issued terminology and any certificate of correction.

How do the claims differ from one another?

Claims 1 and 16: overlapping independent dose claims

Claim 1 covers a dose range from 15 to 20 mg/kg/day. Claim 16 covers exactly 20 mg/kg/day. Because 20 mg/kg/day falls within the claim 1 range, the two independent claims substantially overlap.

Claim 16 may have been retained as a separate claim to preserve a focused legal position around the highest dose, which corresponds to the upper end of Epidiolex's commonly used dosing range for Dravet syndrome. The separate claim can also provide a distinct fallback position if the broader range is challenged.

Claims 2 and 17: focal seizures with impairment

These claims narrow the seizure type to focal seizures with impairment. The limitation may be difficult to establish from commercial labeling alone because Dravet syndrome is characterized primarily by severe, treatment-resistant seizures with multiple seizure types. Medical records and clinical documentation would be important in an infringement analysis.

Claims 3 and 18: treatment-resistant Dravet syndrome

These claims require treatment-resistant disease. Dravet syndrome patients commonly receive multiple antiseizure medicines, but treatment resistance cannot automatically be assumed for every patient. The claimant would likely need evidence of inadequate control despite prior or concomitant therapy.

Claims 4 and 19: concomitant antiepileptic treatment

These claims require CBD to be administered with one or more listed AEDs. The list includes clobazam, valproic acid, stiripentol, levetiracetam, topiramate, lamotrigine, fenfluramine-related alternatives are not listed, and several other medicines and interventions.

The presence of clobazam is commercially important. Epidiolex is frequently used with clobazam in severe developmental epileptic encephalopathies, and CBD can affect exposure to the active clobazam metabolite N-desmethylclobazam.

Claims 5, 6, 7, 20, 21 and 22: source and composition

These claims preserve coverage for two manufacturing routes:

1. A highly purified cannabis extract.
2. Synthetic cannabidiol.

Claims 6 and 21 permit up to 1% CBDV in a cannabis-derived product. The source limitations do not eliminate infringement if the CBD is synthetic, because claims 7 and 22 expressly cover synthetic CBD.

Claims 9 through 15 and claim 24: oral formulation

Claim 9 requires an oral composition containing:

• CBD
• A solvent
• A co-solvent
• A sweetener
• A flavoring

Claims 10 through 13 identify sesame oil, ethanol, sucralose and strawberry flavoring. Claim 14 covers CBD concentrations from 25 to 100 mg/mL. Claim 15 narrows the formulation to the following concentrations:

Component	Claimed amount
CBD	25 to 100 mg/mL
Ethanol	79 mg/mL
Sucralose	0.5 mg/mL
Strawberry flavor	0.2 mg/mL
Sesame oil	Quantity sufficient to 1.0 mL

Claim 15 is materially narrower than claim 9. A competing product could avoid that claim by using a different solvent system, sweetener, flavoring, or excipient concentration while still potentially falling within the broader method claims.

What FDA product is associated with US Patent 10,709,671?

Epidiolex is the principal commercial product associated with the patent estate.

Regulatory event	Date or status
FDA approval for Lennox-Gastaut syndrome and Dravet syndrome	June 25, 2018
Initial labeled population	Patients aged 2 years and older
Dosage form	Oral solution
CBD concentration	100 mg/mL
FDA approval for tuberous sclerosis complex	2020
Active ingredient	Highly purified cannabidiol
Controlled-substance status	FDA and DEA scheduling changes removed CBD products meeting applicable requirements from Schedule V controls in 2020

The FDA-approved Epidiolex label identifies a 100 mg/mL oral solution and dosing that can reach 20 mg/kg/day for Dravet syndrome and Lennox-Gastaut syndrome. The product is administered with other antiseizure medicines in many patients. The label therefore creates a potential factual overlap with claims 1, 4, 9, 14 and 15, although the approved indications and the patent's focal-seizure language are not identical.[1]

FDA approval is not itself proof of patent infringement. Patent liability depends on the product, prescribing or use instructions, patient population, dosage, formulation, and the legal standards applicable to direct, induced or contributory infringement.

What patents protect Epidiolex and purified CBD?

Epidiolex is protected by a layered patent estate rather than a single patent. Relevant US patent families associated with purified cannabidiol include method-of-use, formulation, dosing and manufacturing claims.

Public patent and Orange Book records identify US Patent 10,709,671 as part of the GW Pharmaceuticals cannabidiol estate. Related patents in the broader estate include US Patent 9,730,911 and later patents addressing additional uses, formulations or dosing concepts. The exact Orange Book listing and expiration date should be checked against the current FDA Orange Book and USPTO Patent Center record because listings and terminal-disclaimer information can change.

Patent 10,709,671 legal profile

Attribute	Assessment
Patent type	Method of treatment
Core product	Purified cannabidiol
Core disease	Dravet syndrome
Core use	Focal seizure treatment
Dose	15 to 20 mg/kg/day and exactly 20 mg/kg/day
Formulation coverage	Yes, through dependent claims
Composition claim to CBD itself	No
Manufacturing method claim	No
Biosimilar relevance	None in the conventional biologic sense
Main commercial product	Epidiolex
Patent owner lineage	GW Pharmaceuticals, now within Jazz Pharmaceuticals

The patent's likely expiration is in the mid-2030s based on its priority and US patent-term calculations. A definitive expiration date should be taken from the USPTO record, including any patent-term adjustment, terminal disclaimer, patent-term extension or correction. The patent does not appear to be a biologic patent, so the regulatory concept of biosimilar interchangeability does not apply.

When does cannabidiol and Epidiolex lose exclusivity?

Epidiolex had FDA orphan-drug exclusivity for Dravet syndrome and Lennox-Gastaut syndrome beginning with its June 25, 2018 approval. Orphan exclusivity generally lasts seven years for the approved indication, subject to statutory exceptions. That period is separate from patent protection.

The commercial exclusivity timeline is therefore layered:

Exclusivity layer	Timing
FDA approval	June 25, 2018
Orphan exclusivity for original indications	Generally through June 2025
Pediatric exclusivity	May add six months if granted and applicable
Patent protection	Expected to extend into the mid-2030s for relevant families
Generic entry	Depends on ANDA approval, certifications, litigation and settlement terms

Orphan exclusivity does not necessarily block every generic cannabidiol application. A generic applicant may pursue a carve-out for protected indications or submit a Paragraph IV certification against listed patents. Patent expiration, regulatory exclusivity and labeling strategy must be assessed separately.

What is the Orange Book status of US Patent 10,709,671?

The patent has been associated with the Epidiolex Orange Book patent estate. Orange Book listings typically identify patents that the NDA holder asserts cover the approved drug or an approved method of using it.

For a generic applicant, the relevant questions are:

1. Is US 10,709,671 currently listed against the applicable Epidiolex NDA?
2. What claims does the NDA holder identify as covering the product or method?
3. Has the applicant submitted a Paragraph IV certification?
4. Did the NDA holder file an infringement action within 45 days?
5. Is there a settlement or consent judgment affecting the earliest launch date?

Orange Book listing does not establish validity or infringement. It triggers regulatory and litigation consequences under the Hatch-Waxman framework.

Are there Paragraph IV challenges to Epidiolex patents?

A Paragraph IV challenge would require an ANDA applicant to assert that a listed patent is invalid, unenforceable or not infringed. The most important attack vectors against US 10,709,671 are likely to be:

• Lack of written description for the specific focal-seizure population.
• Obviousness based on prior CBD epilepsy studies and disclosed dosing.
• Anticipation by prior publications describing purified CBD, Dravet syndrome and 20 mg/kg/day dosing.
• Indefiniteness involving "focal seizures," "treatment-resistant," or impurity terminology.
• Non-infringement based on a different indication, dose, formulation or CBD source.
• Enablement challenges directed to the full scope of the method claims.

The patent's strongest features are the combination of disease, seizure type, purity and dose limitations. Its narrower claims also benefit from the specific oral formulation and listed excipients. Its vulnerabilities arise from the overlap between the claims and publicly known CBD epilepsy research, particularly where the prior art disclosed high-purity CBD and doses approaching 20 mg/kg/day.

No verified conclusion on a particular Paragraph IV case or settlement should be drawn solely from the patent number. The current ANDA litigation docket and Orange Book listing control the practical entry analysis.

How strong is the patent estate for Epidiolex?

Strengths

• The claims combine multiple limitations rather than claiming CBD broadly.
• The 20 mg/kg/day dose aligns with an important clinical dose.
• The patent reaches both plant-derived and synthetic CBD.
• The formulation claims may cover the marketed oral solution or close substitutes.
• Dependent claims preserve narrower positions around clobazam and other concomitant therapies.
• The patent estate extends beyond the original FDA orphan-exclusivity period.

Weaknesses

• The focal-seizure limitation may not map cleanly to the FDA label.
• The claims are method claims, making patient-specific use evidence important.
• A generic may avoid infringement through a label carve-out or different dosing instructions.
• Purity and THC content may be readily met by pharmaceutical CBD products, reducing the commercial distinction between products.
• Prior-art epilepsy studies may create obviousness and anticipation issues.
• Claim 15 is narrow because it requires a specific excipient system and concentrations.

Overall, US 10,709,671 is commercially meaningful but narrower than a composition-of-matter patent. Its practical value depends on whether a generic product is labeled for Dravet syndrome, recommends 15 to 20 mg/kg/day, supplies a formulation matching the claimed excipients, and is used with the listed AEDs.

Which companies are challenging the Epidiolex market?

The competitive market includes generic-drug manufacturers developing cannabidiol oral solutions and branded antiseizure products used in Dravet syndrome. Key branded alternatives include fenfluramine, sold as Fintepla by UCB, stiripentol, sold as Diacomit by Biocodex, clobazam, valproic acid and other antiseizure medicines.

These products do not necessarily challenge US 10,709,671 directly because they do not contain CBD. They compete for the same treatment population and can reduce Epidiolex revenue without creating literal product infringement.

Generic cannabidiol applicants present the direct patent risk. Their strategies may include:

• Paragraph IV invalidity or non-infringement certifications.
• Section viii labeling carve-outs for protected indications.
• Alternative concentrations or excipient systems.
• Dosing instructions outside the 15 to 20 mg/kg/day range.
• Different labeling for epilepsy indications not covered by the patent.

What generic launch scenarios exist?

Scenario 1: Full-label generic launch

A generic applicant seeks approval for Dravet syndrome, includes the relevant dose instructions, and challenges the listed patents. This creates the highest litigation exposure and could produce a 30-month stay if the statutory conditions are met.

Scenario 2: Carved-out labeling

The applicant removes Dravet syndrome, focal seizures or other protected use information from its label. This can reduce induced-infringement risk but may limit commercial uptake.

Scenario 3: Formulation workaround

The applicant uses a different solvent, sweetener or flavoring. This may avoid claims 9 through 15 and 24 but would not necessarily avoid claims 1 or 16.

Scenario 4: Dose workaround

The product label avoids 15 to 20 mg/kg/day. This strategy may avoid the patent but could reduce clinical substitution where physicians use the approved high-dose regimen.

Scenario 5: Settlement or licensed entry

Jazz and an ANDA applicant may agree to an entry date before patent expiration. The commercial result depends on the settlement's launch date, authorized-generic provisions and any license restrictions.

Does US 10,709,671 cover biosimilars?

No. CBD is a small-molecule active ingredient, not a biologic. The relevant competitors are ANDA-based generic-drug applicants, not biosimilar applicants under the Public Health Service Act.

A generic cannabidiol oral solution may still face bioequivalence, formulation, labeling and patent certification issues. Those regulatory questions are distinct from biosimilar interchangeability.

What licensing deals affect the patent landscape?

GW Pharmaceuticals developed Epidiolex and was acquired by Jazz Pharmaceuticals in 2021. The acquisition transferred the commercial value of the Epidiolex product and associated intellectual-property portfolio to Jazz.

The patent itself is not a license to use CBD. Commercial access may require rights relating to:

• The listed patents.
• Know-how for purified CBD.
• Manufacturing specifications.
• Product trademarks.
• Regulatory data.
• Supply arrangements.

No generally recognized third-party license can be inferred from the claims alone. Any settlement license, authorized-generic arrangement or confidential commercial agreement would need to be confirmed through court filings, SEC disclosures or regulatory records.

Key Takeaways

• US 10,709,671 is a method-of-treatment patent centered on purified CBD for focal seizures in Dravet syndrome.
• The principal dose scope is 15 to 20 mg/kg/day, with a separate independent claim to exactly 20 mg/kg/day.
• The patent covers CBD from purified cannabis extracts and synthetic CBD.
• Dependent claims add treatment resistance, focal seizures with impairment, concomitant AEDs, CBDV and a defined oral formulation.
• Epidiolex is the principal product implicated by the patent estate.
• The patent does not claim CBD itself and does not cover every CBD epilepsy treatment.
• Orphan-drug exclusivity for the original indications began in 2018 and was generally exhausted in 2025, subject to applicable pediatric exclusivity.
• Patent protection is expected to continue into the mid-2030s, subject to the official USPTO expiration calculation.
• Generic risk will depend on Orange Book listings, Paragraph IV certifications, label carve-outs, formulation design and litigation settlements.
• Biosimilar analysis is inapplicable because cannabidiol is a small molecule.

FAQs

Does US Patent 10,709,671 cover Epidiolex for Lennox-Gastaut syndrome?

Not on the face of the supplied claims. The claims expressly recite Dravet syndrome. Epidiolex's Lennox-Gastaut indication may be covered by separate patents or claims in the broader cannabidiol patent estate.

Can a generic CBD product avoid US 10,709,671 by using synthetic cannabidiol?

Not necessarily. Claims 7 and 22 expressly cover synthetic CBD. A generic would need to assess the disease, dose, purity, THC limit, labeling and other claim elements independently of the CBD source.

Does the patent cover CBD products below 25 mg/mL?

Claims 9 through 15 and claim 24 impose concentration or formulation limitations, but claims 1 and 16 do not require a particular concentration. A product below 25 mg/mL could still raise method-claim issues if the other limitations are met.

Is clobazam required for infringement?

No. Claims 1 and 16 do not require concomitant AED treatment. Clobazam and other AEDs appear in dependent claims 4, 8, 19 and 23. A use without an AED could still fall within an independent claim if all other limitations are satisfied.

Does FDA approval prove that the patent claims are valid?

No. FDA approval and patent validity are separate legal questions. A patent can be listed in the Orange Book and challenged through Paragraph IV litigation on grounds including invalidity, unenforceability or non-infringement.

References

1. U.S. Food and Drug Administration. (2018). Epidiolex (cannabidiol) oral solution prescribing information. FDA.
2. U.S. Food and Drug Administration. (2025). Approved drug products with therapeutic equivalence evaluations: Orange Book. FDA.
3. U.S. Patent and Trademark Office. (2025). Patent Center: U.S. Patent No. 10,709,671. USPTO.
4. U.S. Patent and Trademark Office. (2025). Patent term adjustment and patent expiration resources. USPTO.
5. Jazz Pharmaceuticals plc. (2021). Annual report and acquisition disclosures relating to GW Pharmaceuticals. SEC.

Drugs Protected by US Patent 10,709,671

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Jazz Pharms Res	EPIDIOLEX	cannabidiol	SOLUTION;ORAL	210365-001	Sep 28, 2018		RX	Yes	Yes	10,709,671					USE FOR THE TREATMENT OF FOCAL SEIZURES IN PATIENTS WITH DRAVET SYNDROME

Foreign Priority and PCT Information for Patent: 10,709,671

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	1510664.4	Jun 17, 2015

International Family Members for US Patent 10,709,671

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2016278088
Australia	2021269374
Canada	2989779
European Patent Office	3310390
European Patent Office	3984531