Details for Patent: 10,709,674

Which drugs does patent 10,709,674 protect, and when does it expire?

Patent 10,709,674 protects EPIDIOLEX and is included in one NDA.

This patent has thirty-eight patent family members in twenty-one countries.

Summary for Patent: 10,709,674

Title:	Use of cannabinoids in the treatment of epilepsy
Abstract:	The present disclosure relates to the use of cannabidiol (CBD) for the treatment of atonic seizures. In particular the CBD appears particularly effective in reducing atonic seizures in patients suffering with etiologies that include: Lennox-Gastaut Syndrome; Tuberous Sclerosis Complex; Dravet Syndrome; Doose Syndrome; Aicardi syndrome; CDKL5 and Dup15q in comparison to other seizure types. The disclosure further relates to the use of CBD in combination with one or more anti-epileptic drugs (AEDs).
Inventor(s):	Geoffrey Guy, Stephen Wright, Orrin Devinsky
Assignee:	Jazz Pharmaceuticals Research UK Ltd
Application Number:	US16/678,961
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,709,674
Patent Claim Types: see list of patent claims	Use; Composition;

United States Patent 10,709,674: CBD Seizure-Treatment Claims, Epidiolex Scope, and Patent Landscape

U.S. Patent No. 10,709,674 protects oral cannabidiol treatment for seizures associated with Lennox-Gastaut syndrome and Dravet syndrome when used in a narrowly defined high-purity CBD formulation. The patent maps closely to Epidiolex, the FDA-approved oral cannabidiol solution marketed by Jazz Pharmaceuticals. Its strongest commercial claims require the combination of disease, oral administration, CBD purity, formulation composition, and dosing limitations. The patent does not broadly cover every CBD product or every use of cannabidiol for epilepsy.

The patent is a method-of-treatment patent, not a composition-of-matter patent. Its practical value depends on whether a competing product is administered for the claimed syndromes, at the claimed dose, in a formulation falling within the specified concentration ranges.

What does U.S. Patent 10,709,674 cover?

Patent 10,709,674 covers methods of treating seizures in patients with either Lennox-Gastaut syndrome, or LGS, or Dravet syndrome using orally administered cannabidiol.

The independent claims contain multiple cumulative limitations:

Limitation	Claims 1 and 16
Disease	Lennox-Gastaut syndrome or Dravet syndrome
Condition treated	Seizures
Active ingredient	Cannabidiol, or CBD
Route	Oral administration
CBD purity	At least 95% w/w
CBD concentration	About 22.5 to 110 mg/mL
Ethanol	About 71.1 to 86.9 mg/mL
Sweetener	About 0.45 to 0.55 mg/mL
Flavor	About 0.18 to 0.22 mg/mL
Vehicle	Solvent or sesame oil, q.s. to approximately 1 mL
Dose	Claims 16 through 20 require about 5 to 25 mg/kg/day

Claim 1 is the principal independent formulation-and-treatment claim. Claim 16 is narrower because it requires the dose range and expressly identifies sucralose, strawberry flavor and sesame oil.

The claim set is directed to a specific therapeutic product profile rather than CBD generally. A product can contain CBD and be used for epilepsy without infringing if it falls outside one or more required limitations.

What are the key claim categories in Patent 10,709,674?

Disease-specific treatment claims

The claims require treatment of seizures in a patient with LGS or Dravet syndrome. A product used for another seizure disorder, such as focal epilepsy or tuberous sclerosis complex, would not literally satisfy this limitation.

The claims also require administration to a patient. They do not claim CBD merely as a product, a research reagent, or a method of manufacturing.

High-purity CBD claims

Claims 1 and 16 require CBD with purity of at least 95% w/w. Dependent claims 8, 9 and 19 raise the requirement to at least 98% w/w for the higher-concentration formulation.

The purity limitation distinguishes purified CBD from:

• Whole-plant cannabis extracts
• Broad-spectrum cannabinoid extracts
• CBD products containing substantial levels of other cannabinoids
• Formulations in which CBD purity falls below the claim threshold

The relevant question is how purity is measured and whether the accused product's certificate of analysis, batch records and analytical method establish compliance with the claimed threshold.

Formulation claims

The formulation limitations are central to infringement analysis. The claims specify four material components and a vehicle:

1. CBD
2. Ethanol
3. Sweetener
4. Flavoring
5. Solvent or sesame oil

Claim 1 permits a sweetener and flavoring within specified ranges without naming them. Claims 2 and 3 identify sucralose and strawberry flavoring. Claim 9 requires both named excipients and a sesame-oil vehicle.

The formulation closely corresponds to Epidiolex's commercial oral solution, which contains 100 mg/mL CBD and is administered orally. FDA labeling identifies sesame seed oil, dehydrated alcohol, sucralose and strawberry flavor as formulation components. [1]

Dose and titration claims

Claims 11 through 18 cover dosing from approximately 5 to 25 mg/kg/day. Claim 12 specifies an initial dose of about 5 mg/kg/day followed by increases of 2 to 5 mg/kg/day up to 25 mg/kg/day.

The dependent claims separately identify doses of:

• 10 mg/kg/day
• 15 mg/kg/day
• 20 mg/kg/day
• 10 to 20 mg/kg/day

Epidiolex labeling recommends a starting dose of 2.5 mg/kg twice daily, equivalent to 5 mg/kg/day, followed after one week by 5 mg/kg twice daily, or 10 mg/kg/day. For LGS and Dravet syndrome, the labeled maximum is generally 20 mg/kg/day. [1]

The patent's 25 mg/kg/day upper limit therefore extends above the ordinary labeled maintenance maximum for many patients, although the broader claim language captures the commercially important 10 and 20 mg/kg/day regimens.

How do the dependent claims narrow the patent?

Claim	Additional limitation	Commercial significance
2	Sweetener is sucralose	Matches Epidiolex-type formulation
3	Flavor is strawberry flavor	Matches commercial product profile
4	CBD is about 25 to 100 mg/mL	Captures standard 100 mg/mL products
5	Ethanol is about 79 mg/mL	Matches the principal commercial concentration
6	Sucralose is about 0.5 mg/mL	Narrows excipient concentration
7	Strawberry flavor is about 0.2 mg/mL	Narrows flavor concentration
8	About 100 mg/mL CBD with at least 98% purity	Directly targets a commercial-strength solution
9	90 to 110 mg/mL CBD, named excipients and sesame oil	Strongest formulation-specific claim
10	About 79 mg/mL ethanol, 0.5 mg/mL sucralose and 0.2 mg/mL flavor	Closely tracks the reference commercial formula
11	5 to 25 mg/kg/day	Broad dosing limitation
12	Titration from 5 mg/kg/day by 2 to 5 mg/kg increments	Tracks labeled dose escalation
13-15	10, 15 or 20 mg/kg/day	Provides narrower dose fallbacks
17	Same titration as claim 12	Depends from the full claim 16 formulation
18	10 to 20 mg/kg/day	Captures common maintenance dosing
19	90 to 110 mg/mL and at least 98% purity	High-concentration, high-purity version
20	Named excipient concentrations in a sesame-oil composition	Narrow formulation endpoint

What does “consisting of” mean in these claims?

Claims 1, 9 and 16 use “consisting of.” That transition generally closes the claimed composition to the listed components, subject to claim construction and the treatment of impurities, incidental materials and excipients that do not materially alter the claimed formulation.

This creates a potential design-around route. A competing manufacturer could evaluate:

• A different vehicle
• A different flavor
• No flavor
• A different sweetener
• Ethanol outside the claimed range
• CBD concentration below or above the claimed range
• A formulation with additional active or inactive ingredients

A formulation change does not automatically avoid infringement. The range limitations, “about” language, doctrine of equivalents and prosecution history would remain relevant. But the closed-composition wording generally gives a challenger a stronger noninfringement position than an open “comprising” formulation claim.

Claim 20 uses “consists essentially of,” which is ordinarily broader than “consisting of” because it may permit additional ingredients that do not materially affect the basic and novel characteristics of the composition. The scope of claim 20 must be read together with its dependency from claim 16 and the prosecution record.

What patents protect Epidiolex and prescription CBD?

Patent 10,709,674 is part of a broader GW Pharmaceuticals cannabidiol patent family and related Orange Book patent estate. The principal protection categories are:

Protection category	Typical subject matter	Relevance
Method of treatment	CBD for LGS, Dravet syndrome and seizure reduction	Primary scope of Patent 10,709,674
Dose regimen	Initiation, titration and maintenance dosing	Relevant to ANDA labeling
Formulation	CBD concentration, ethanol, sweetener, flavor and vehicle	Directly targets oral solution products
Purity	At least 95% or 98% CBD	Distinguishes purified CBD
Regulatory listing	FDA Orange Book patents for Epidiolex	Can require Paragraph IV certification and litigation
Manufacturing and process IP	Purification, formulation and production methods	May create additional barriers outside this patent

FDA approved Epidiolex in June 2018 as the first plant-derived CBD product approved in the United States. The approved indications are seizures associated with LGS or Dravet syndrome in patients two years of age and older. FDA later expanded the labeling to include patients one year of age and older. [1, 2]

The Orange Book must be consulted for the active listing and patent-use codes applicable to the relevant NDA and strength. Orange Book listing does not establish validity or infringement, but it determines the certification framework for an ANDA applicant under the Hatch-Waxman statute. [3]

When does Patent 10,709,674 lose exclusivity?

The patent's ordinary term is governed by the earliest effective nonprovisional or PCT filing date, subject to patent-term adjustment and any applicable extension. Public patent databases and FDA listing records should be reconciled because the expiration date displayed by the USPTO, the Orange Book and commercial databases can differ when PTA or regulatory extensions apply. [4, 5]

The patent was issued July 14, 2020. Its term is expected to extend into the mid-2030s, subject to the official USPTO patent-term calculation. The patent is not a biologic exclusivity right and does not receive the 12-year reference-product exclusivity applicable to biologics.

Epidiolex also received FDA regulatory exclusivity at approval. That exclusivity was separate from patent protection and did not prevent all future generic development indefinitely. After the applicable FDA exclusivity period ended, an ANDA applicant could pursue approval through the abbreviated pathway while addressing listed patents through certifications.

What is the Orange Book status of Epidiolex?

Epidiolex is approved under NDA 210365. The product is a 100 mg/mL oral solution containing cannabidiol. FDA labeling identifies the LGS and Dravet syndrome indications and provides the relevant dosing and formulation information. [1]

Orange Book-listed patents can require an ANDA applicant to submit one of four certifications:

• Paragraph I: no patent information has been submitted
• Paragraph II: the patent has expired
• Paragraph III: the applicant will wait until patent expiration
• Paragraph IV: the patent is invalid, unenforceable or will not be infringed

For Patent 10,709,674, a Paragraph IV certification would create a potential 45-day period for the patent owner to file an infringement action. A timely action can trigger a statutory stay of FDA approval for up to 30 months, subject to statutory exceptions and court developments. [3]

A generic label that retains the LGS and Dravet indications, the oral route, and the same dosing instructions would face greater method-of-use exposure than a product using a permissible “skinny label.” A skinny label can omit patented indications or dosing information, but it cannot lawfully encourage the patented use through product labeling, marketing or other evidence.

Which companies are challenging the Epidiolex patent estate?

Generic competition is expected to focus on ANDA applicants seeking approval for cannabidiol oral solution. The relevant legal event is not simply an ANDA filing. The applicant must have filed a certification addressing each listed patent, and the patent owner must have filed any resulting Hatch-Waxman litigation within the statutory period.

Public FDA and court records should be reviewed for the current applicant-by-applicant status because ANDA filings, Paragraph IV notices, settlements and litigation dockets can change over time. The commercial risk assessment should identify, for each challenger:

Issue	Decision point
ANDA status	Filed, accepted for review, tentatively approved or approved
Certification	Paragraph II, III, IV or section viii
Label	Full LGS/Dravet label or carved-out indication
Litigation	Complaint filed, dismissed, stayed or adjudicated
Settlement	Launch date, license, restrictions and acceleration provisions
Approval barrier	Patent stay, regulatory exclusivity or unresolved patent

No biosimilar pathway applies to Epidiolex. CBD is a small molecule, so a competitor would normally use an ANDA or, if it cannot establish pharmaceutical equivalence, a 505(b)(2) application rather than a biosimilar application.

How strong is the patent estate for Epidiolex?

Patent 10,709,674 has meaningful commercial strength because the commercial product appears to align with many claim limitations:

• 100 mg/mL CBD concentration
• High-purity CBD
• Oral administration
• Ethanol-containing solution
• Sucralose
• Strawberry flavor
• Sesame-oil vehicle
• LGS and Dravet indications
• 5 to 20 mg/kg/day dosing

Its limitations also create validity and enforcement vulnerabilities.

Potential validity pressure points

A challenger could focus on:

1. Enablement of the full concentration and dose ranges.
2. Written description support for the exact combination of purity, excipients and dose.
3. Obviousness based on prior CBD epilepsy studies, known oral formulations and FDA development data.
4. Anticipation by earlier CBD treatment publications or patent disclosures.
5. Indefiniteness of “about,” “purity,” “q.s.,” and concentration measurement methods.
6. Double-patenting issues within continuation or divisional family members.
7. Whether the claimed formulation is materially different from disclosed or previously known CBD solutions.

Potential infringement pressure points

The strongest infringement case would involve a generic product with:

• The same 100 mg/mL CBD strength
• A substantially identical excipient profile
• The same LGS and Dravet indications
• The same dose-escalation instructions
• A label directing use in patients covered by the patent

A weaker case would involve a competing CBD product with a different vehicle, different excipient system, non-overlapping concentration ranges or a label that excludes the patented indications.

What manufacturing and intellectual-property barriers remain?

The formulation is relatively simple compared with a biologic, but commercial manufacturing still requires control of:

• CBD identity and purity
• Residual solvents
• Cannabinoid impurities
• Ethanol concentration
• Uniformity of the oral solution
• Stability and degradation products
• Microbial quality
• Flavor and sweetener consistency
• Sesame-oil compatibility
• Child-resistant packaging and dosing-device performance

Patent 10,709,674 does not by itself block all manufacturing methods. A manufacturer can potentially avoid it by producing a different composition or pursuing a different label. Separate process, purification, stability, packaging and formulation patents may still create overlapping barriers.

How does Patent 10,709,674 compare with a standard CBD generic?

Product attribute	Epidiolex-aligned product	Potential design-around
CBD strength	100 mg/mL	Different strength outside claimed range
CBD purity	At least 98%	Lower purity, if clinically and regulatorily acceptable
Sweetener	Sucralose	Alternative sweetener or none
Flavor	Strawberry	Different flavor or none
Vehicle	Sesame oil	Different approved vehicle
Ethanol	Approximately 79 mg/mL	Concentration outside the claimed range
Indication	LGS and Dravet seizures	Carved-out label
Dose	5 to 20 mg/kg/day commonly	Different dosing instructions
Regulatory route	ANDA	505(b)(2) where appropriate
Patent exposure	High	Lower, but not necessarily eliminated

What revenue exposure does the patent create?

Epidiolex is a material commercial product for Jazz Pharmaceuticals following Jazz's acquisition of GW Pharmaceuticals in 2021. Jazz reported approximately $845 million in Epidiolex/Epidyolex revenue for 2023. [6]

The patent's economic value is concentrated in the U.S. market because:

• The product has an FDA-approved indication for two rare epileptic syndromes.
• The approved formulation aligns closely with the claimed formulation.
• Pediatric and chronic-use populations support recurring demand.
• A generic entrant could compete on price after approval even if it uses a narrow label.
• Method-of-use and formulation patents can delay or complicate generic substitution.

The main downside is that the patent does not create complete exclusivity over CBD, epilepsy treatment or all cannabidiol formulations. A competitor with a different formulation or carved-out label may reduce the patent's practical reach.

Key Takeaways

• Patent 10,709,674 is a narrow but commercially important method-of-treatment patent tied to Epidiolex.
• The claims require oral CBD treatment for seizures associated with LGS or Dravet syndrome.
• The strongest claims combine high-purity CBD, a 22.5 to 110 mg/mL concentration range, ethanol, sucralose, strawberry flavor and sesame oil.
• Claims 16 through 20 add a 5 to 25 mg/kg/day dose range and narrower dosing and formulation limitations.
• The commercial 100 mg/mL Epidiolex formulation appears to fall within the central claim architecture.
• The patent is not a composition-of-matter patent and does not cover every CBD product.
• “Consisting of” language creates meaningful design-around opportunities.
• A generic with the same formulation and full LGS/Dravet labeling would face the highest infringement risk.
• CBD is a small molecule; biosimilar rules do not apply.
• The patent is part of a broader GW Pharmaceuticals/Jazz cannabidiol patent and Orange Book estate.
• The patent term extends into the mid-2030s, subject to the official USPTO term calculation and any applicable adjustment.

FAQs

Can a CBD product for focal seizures infringe Patent 10,709,674?

Not literally, because the claims require treatment of seizures in a patient with LGS or Dravet syndrome. Other patent claims or regulatory theories could still be relevant.

Does using a CBD concentration above 110 mg/mL avoid infringement?

It may avoid literal infringement of the stated concentration range, but the result depends on the precise formulation, claim construction, “about” language and any doctrine-of-equivalents analysis.

Can a generic omit strawberry flavor and avoid Patent 10,709,674?

Omitting strawberry flavor may avoid claims that expressly require strawberry flavoring. It would not necessarily avoid claim 1, which does not identify a specific flavor, or other patents in the Epidiolex estate.

Is a 505(b)(2) CBD product automatically outside the patent?

No. The regulatory pathway does not determine infringement. A 505(b)(2) product can still practice a patented method or formulation.

Does Patent 10,709,674 protect CBD purity below 95%?

No. The asserted claims require at least 95% w/w CBD, with certain dependent claims requiring at least 98% w/w. A lower-purity product may avoid those limitations but could raise separate regulatory and patent issues.

References

1. U.S. Food and Drug Administration. (2024). Epidiolex prescribing information, NDA 210365.
2. U.S. Food and Drug Administration. (2018, June 25). FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy.
3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book.
4. United States Patent and Trademark Office. (2024). Patent term adjustment and patent term extension information.
5. United States Patent and Trademark Office. (2020). U.S. Patent No. 10,709,674.
6. Jazz Pharmaceuticals plc. (2024). Annual report for the year ended December 31, 2023.

Drugs Protected by US Patent 10,709,674

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	10,709,674					USE FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH DRAVET SYNDROME
Jazz Pharms Res	EPIDIOLEX	cannabidiol	SOLUTION;ORAL	210365-001	Sep 28, 2018		RX	Yes	Yes	10,709,674					USE FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH LENNOX-GASTAUT SYNDROME

Foreign Priority and PCT Information for Patent: 10,709,674

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	1418171.3	Oct 14, 2014

International Family Members for US Patent 10,709,674

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2015332212
Australia	2021204353
Australia	2023258400