Details for Patent: 9,949,937

Which drugs does patent 9,949,937 protect, and when does it expire?

Patent 9,949,937 protects EPIDIOLEX and is included in one NDA.

This patent has forty-three patent family members in ten countries.

Summary for Patent: 9,949,937

Title:	Use of cannabinoids in the treatment of epilepsy
Abstract:	The present disclosure relates to the use of cannabidiol (CBD) for the reduction of total convulsive seizure frequency in the treatment of “treatment-resistant epilepsy” (TRE). In particular, the disclosure relates to the use of CBD of treating TRE when the TRE is Dravet syndrome; myoclonic absence seizures or febrile infection related epilepsy syndrome (FIRES). 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, Alice Mead, Orrin Devinsky
Assignee:	Jazz Pharmaceuticals Research UK Ltd
Application Number:	US15/449,185
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,949,937
Patent Claim Types: see list of patent claims	Use;

US Patent 9,949,937: Scope, Claims, Expiration, Orange Book Status, and Epidiolex Patent Landscape

US Patent 9,949,937 protects a narrow method of using highly purified cannabidiol with clobazam to reduce seizures in patients with Dravet syndrome. The core combination is: Dravet syndrome, clobazam, CBD purity of at least 98% by weight, THC content of no more than 0.15% by weight, and CBD dosing of at least 10 mg/kg/day. The patent is directed to treatment conduct, not to CBD as a molecule, a general CBD formulation, or every use of cannabidiol in epilepsy.

The patent is associated with GW Pharmaceuticals’ Epidiolex program, now commercialized by Jazz Pharmaceuticals. Its principal commercial value is an Orange Book-listed method-of-use position against generic cannabidiol products that retain a Dravet syndrome indication involving concomitant clobazam.

What drug and technology does US Patent 9,949,937 cover?

US Patent 9,949,937 covers cannabidiol treatment for treatment-resistant Dravet syndrome when CBD is administered with clobazam. The patent does not require a particular brand, dosage form, excipient system, route of administration, or manufacturing process.

Element	Requirement in independent claims
Disease	Treatment-resistant epilepsy that is Dravet syndrome
Active treatment	CBD administered with clobazam
CBD purity	At least 98% w/w CBD
THC limit	No more than 0.15% w/w Δ9-THC
CBD dose	At least 10 mg/kg/day
Claim 1 outcome	Reduction in seizure frequency
Claim 14 outcome	Treatment of seizures
Dosage form	Not expressly limited
Route	Not expressly limited
Manufacturer	Not expressly limited
CBD source	Not expressly limited

The claims are method-of-treatment claims. A party generally faces infringement risk only when the claimed treatment is performed, induced, or intentionally supported. Possession or sale of CBD, standing alone, does not satisfy every limitation of the claims.

Who owns US Patent 9,949,937?

The patent is assigned to GW Pharma Limited, the company that developed Epidiolex. Jazz Pharmaceuticals acquired GW Pharmaceuticals in 2021 and became the relevant commercial successor for Epidiolex-related rights. The patent title is generally identified as “Use of cannabidiol in the treatment of epilepsy.” [1]

How broad are the independent claims?

Claims 1 and 14 are the principal scope-defining claims.

Claim 1: seizure-frequency reduction

Claim 1 requires a method of reducing seizure frequency in a patient with treatment-resistant epilepsy characterized as Dravet syndrome. It also requires:

1. Administration of clobazam and cannabidiol.
2. CBD purity of at least 98% w/w.
3. THC content of no more than 0.15% w/w.
4. CBD administration at a dose of at least 10 mg/kg/day.

Claim 1 is cumulative. Omitting any required element may avoid literal infringement, although induced-infringement theories can depend on labeling, prescribing instructions, promotional conduct, and the overall circumstances.

Claim 14: seizure treatment

Claim 14 repeats the same technical limitations but uses “treating seizures” rather than “reducing seizure frequency.” It is an independent claim and therefore does not depend on the narrower result language in claim 1.

The practical difference is limited but material. Claim 1 expressly requires a reduction in seizure frequency. Claim 14 is framed around treatment of seizures. A generic label that instructs use of CBD with clobazam for Dravet syndrome may implicate both claims even if the label does not describe a specific seizure-frequency endpoint.

What do the dependent claims add?

The dependent claims narrow the method through outcome, treatment sequence, THC content, dosing, or dose escalation.

Claim	Added limitation	Commercial significance
2	Reduction in total convulsive seizure frequency	Targets the principal clinical endpoint in Dravet studies
3	Clobazam administered before the CBD/clobazam combination	Covers patients already receiving clobazam
4	CBD contains THC impurity	Confirms that the claim does not require THC-free CBD
5	CBD dose of at least 15 mg/kg/day	Covers higher-dose treatment
6	CBD dose of 10 mg/kg/day	Exact low-end dose
7	CBD dose of 12 mg/kg/day	Specific intermediate dose
8	CBD dose of 14 mg/kg/day	Specific intermediate dose
9	CBD dose of 15 mg/kg/day	Exact higher dose
10	CBD dose of 16 mg/kg/day	Specific higher dose
11	CBD dose of 18 mg/kg/day	Specific higher dose
12	CBD dose of 20 mg/kg/day	Upper dose expressly recited
13	Start at 5 mg/kg/day and increase by 2 to 5 mg/kg increments to at least 10 mg/kg/day	Covers titration protocols

Claims 6 through 12 create dosage-specific fallback positions. Claim 13 is commercially important because Epidiolex labeling uses dose escalation rather than immediate administration of the full maintenance dose. [2]

What is the infringement scope of the 98% CBD and 0.15% THC limitations?

The purity limitations are central claim filters.

The CBD must contain at least 98% CBD by weight. The THC impurity must not exceed 0.15% by weight. A product containing 97.9% CBD would fall outside the literal CBD-purity limitation, assuming the percentage is measured under the legally applicable analytical method. A product containing 0.16% THC would exceed the express THC ceiling.

Claim 4 does not remove the THC ceiling. It states that CBD may contain THC impurity, while claim 1 still requires no more than 0.15% w/w THC.

The claims do not expressly require:

• Pharmaceutical-grade CBD.
• A particular CBD crystalline form.
• A specific solvent or extraction process.
• A particular impurity profile other than the recited CBD and THC limits.
• A specific oral solution concentration.
• A specific excipient.
• A specific container or delivery device.

A generic manufacturer may therefore need to evaluate both formulation design and labeling. Altering excipients will not avoid the claims if the resulting product still meets the treatment, purity, THC, clobazam, disease, and dose limitations.

What doses are protected by US Patent 9,949,937?

The broadest dose limitation is at least 10 mg/kg/day. This captures 10 mg/kg/day and all higher doses, including the specifically recited 12, 14, 15, 16, 18, and 20 mg/kg/day doses.

The dose structure is:

Dose category	Coverage
Below 10 mg/kg/day	Outside the express dose limitation of claims 1 and 14
10 mg/kg/day	Expressly covered
10 to 15 mg/kg/day	Covered by the broad “at least 10” limitation
At least 15 mg/kg/day	Expressly covered by claim 5
20 mg/kg/day	Expressly covered by claim 12
Titration from 5 mg/kg/day	Covered if increased by 2 to 5 mg/kg increments to at least 10 mg/kg/day under claim 13

The dose limitation creates a potential design-around theory based on a maintenance dose below 10 mg/kg/day. That approach would face clinical and regulatory constraints if the approved label recommends titration to 10 or 20 mg/kg/day for Dravet syndrome.

Does Epidiolex labeling fall within the claims?

Yes. Epidiolex is an oral solution containing 100 mg/mL cannabidiol. The FDA-approved labeling covers seizures associated with Dravet syndrome, Lennox-Gastaut syndrome, and tuberous sclerosis complex in appropriate age groups. For Dravet syndrome, the label provides a starting dose of 2.5 mg/kg twice daily, or 5 mg/kg/day, followed by an increase to 5 mg/kg twice daily, or 10 mg/kg/day. Depending on clinical response and tolerability, the dose may be increased to 10 mg/kg twice daily, or 20 mg/kg/day. [2]

The label also addresses clobazam coadministration and the increased exposure to the active clobazam metabolite norclobazam. That labeling relationship is commercially relevant because it supports the factual treatment pattern recited in the patent.

The patent does not cover every Epidiolex use equally. Its claims are concentrated on:

• Dravet syndrome;
• concomitant clobazam;
• CBD purity of at least 98%;
• THC content no higher than 0.15%; and
• CBD doses of at least 10 mg/kg/day.

Epidiolex treatment of Lennox-Gastaut syndrome or tuberous sclerosis complex is outside the literal disease limitation of these claims, unless another patent provides relevant coverage.

When does US Patent 9,949,937 expire?

The patent’s earliest priority is in 2013. Its nominal US patent term runs approximately to 2033, subject to the official patent-term-adjustment calculation recorded by the USPTO.

Milestone	Date or period
Earliest priority	2013
US grant	March 20, 2018
Nominal 20-year term endpoint	Approximately 2033
Expected commercial relevance	Through the early 2030s, subject to official term adjustment and other statutory events

The precise expiration date should be taken from the USPTO Patent Center record and the current FDA Orange Book listing. Patent-term adjustment can move the expiration date beyond the ordinary 20-year calculation. [1, 3]

FDA regulatory exclusivity is separate from patent protection. Epidiolex received orphan-drug approvals for Dravet syndrome and Lennox-Gastaut syndrome. The seven-year orphan exclusivity periods do not extend to the patent expiration date and do not block all generic activity outside the protected orphan indication. [2, 4]

What is the Orange Book status of US Patent 9,949,937?

US Patent 9,949,937 has been associated with Epidiolex as a listed method-of-use patent in the FDA Orange Book. Orange Book listing gives an ANDA applicant a statutory patent-certification issue under Section 505(j) of the Federal Food, Drug, and Cosmetic Act. [3, 5]

An ANDA applicant generally must submit one of the following 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; or
• A section viii statement, where the applicant proposes to omit a patented method of use from its labeling.

For a method-of-use patent, the most important generic strategies are usually Paragraph IV litigation or a label carve-out. The feasibility of a carve-out depends on whether the non-patented indication can be promoted and used without encouraging the patented Dravet/clobazam regimen.

How would a Paragraph IV challenge affect generic cannabidiol entry?

A Paragraph IV certification against US Patent 9,949,937 would expose the ANDA applicant to patent litigation if the patent holder brings suit within the statutory period. A timely infringement action can trigger a 30-month stay of FDA approval, subject to statutory exceptions and court action. [5]

The likely dispute areas would include:

1. Whether the proposed product contains at least 98% CBD.
2. Whether THC is at or below 0.15% w/w.
3. Whether the generic label instructs use with clobazam.
4. Whether the label covers Dravet syndrome.
5. Whether the labeled dose reaches at least 10 mg/kg/day.
6. Whether the claims are anticipated or obvious based on prior CBD epilepsy studies.
7. Whether the claims adequately describe and enable the claimed treatment.
8. Whether the patent is enforceable.

A generic company could argue that its label omits the patented use. The patent holder could respond that the remaining label, dosing instructions, warnings, or prescribing information still encourages the claimed combination.

Which patent issues are most vulnerable to invalidity challenges?

The main validity pressure points are obviousness, written description, enablement, anticipation, and claim construction.

Obviousness

A challenger could combine prior art showing:

• CBD activity in seizure disorders;
• Dravet syndrome treatment;
• clobazam use in refractory epilepsy;
• CBD and clobazam coadministration; and
• dose escalation to 10 mg/kg/day or higher.

The patent holder would likely rely on the clinical results, the specific patient population, the high-purity CBD profile, and the clinical relationship between CBD and clobazam.

Written description and enablement

The claims cover a defined patient population and dosing range. A challenge could examine whether the specification supports the full scope of “at least 10 mg/kg/day,” including the expressly listed doses and titration scheme.

Anticipation

A single prior-art reference would need to disclose every required element, including the Dravet syndrome population, clobazam combination, CBD purity, THC threshold, and dose. The numerical purity and impurity limitations may narrow anticipation arguments, although they may also support obviousness arguments if the analytical profile was routine.

Functional treatment language

“Reducing seizure frequency” and “treating seizures” are functional limitations. The relevance of clinical evidence, statistical results, and the required degree of treatment effect may become important in claim construction and infringement disputes.

What manufacturing and formulation barriers remain?

US Patent 9,949,937 does not provide the primary manufacturing barrier for Epidiolex. It does not claim a particular process for producing CBD, a specific oral solution, or a proprietary excipient system.

The principal manufacturing issues are regulatory and analytical:

• achieving at least 98% CBD;
• maintaining THC below 0.15%;
• controlling minor cannabinoids and degradation products;
• demonstrating batch-to-batch uniformity;
• validating assay methods;
• establishing stability;
• producing a pediatric-compatible oral solution; and
• matching FDA requirements for a pharmaceutical-grade CBD product.

Separate patents or regulatory protections may cover formulation, crystalline material, processes, analytical controls, or commercial packaging. They must be reviewed independently from US Patent 9,949,937.

How does this patent compare with a CBD composition patent?

Issue	US 9,949,937	CBD composition patent
Claim type	Method of treatment	Composition or product
Required disease	Dravet syndrome	May be none
Required co-medication	Clobazam	Usually none
Required dose	At least 10 mg/kg/day	Usually none or formulation-specific
CBD purity	At least 98%	May specify a different range
THC limitation	No more than 0.15%	May specify THC or other cannabinoids
Infringement trigger	Performing or inducing the claimed treatment	Making, using, selling, or importing the product
Design-around potential	Label and indication changes	Chemical or formulation changes
Relevance to Epidiolex	High for Dravet/clobazam use	Depends on the particular product claim

The patent is narrower than a composition patent but can be commercially effective when the approved label directly maps onto the claimed regimen.

Does biosimilar risk apply to Epidiolex?

No. Epidiolex contains cannabidiol, a chemically defined small-molecule active ingredient. It is regulated through the small-molecule drug pathway, not the biologics license application and biosimilar pathway.

The relevant competitive threat is an ANDA-approved generic cannabidiol oral solution. FDA approval, therapeutic-equivalence determinations, patent certifications, and labeling carve-outs are more important than biosimilar interchangeability rules.

What litigation and settlement issues should investors monitor?

The key litigation indicators are:

• Orange Book patent certifications submitted by ANDA applicants;
• Paragraph IV notices;
• complaints filed in the US District Court for the District of Delaware or other relevant venues;
• 30-month stay dates;
• claim-construction rulings;
• preliminary-injunction requests;
• settlements permitting an agreed generic launch date;
• covenant-not-to-sue provisions;
• authorized-generic arrangements; and
• FDA approval with a section viii indication carve-out.

A settlement may preserve branded revenue even when FDA approval is granted before patent expiry. Conversely, a successful Paragraph IV judgment can enable an earlier launch and materially reduce Epidiolex revenue.

What is the commercial exposure of the patent?

The patent’s revenue exposure is concentrated in Dravet syndrome patients who receive clobazam and CBD at or above 10 mg/kg/day. It does not cover all Epidiolex revenue because the product is also approved for Lennox-Gastaut syndrome and tuberous sclerosis complex.

The highest-risk generic scenario is a full-label or substantially overlapping label that includes:

• Dravet syndrome;
• concomitant clobazam use;
• CBD titration to at least 10 mg/kg/day; and
• a high-purity CBD product with THC at or below the claimed threshold.

A lower-risk scenario is a label limited to an unclaimed indication or a regimen below the claimed dose, provided the labeling and commercial conduct do not induce use of the patented method.

Key Takeaways

• US Patent 9,949,937 is a narrow but commercially relevant method-of-use patent.
• Its core scope is high-purity CBD plus clobazam for Dravet syndrome.
• The CBD must be at least 98% w/w, with THC no higher than 0.15% w/w.
• The broad dose threshold is at least 10 mg/kg/day.
• Claims 2 through 13 add seizure outcomes, prior clobazam treatment, exact doses, and titration.
• The patent does not claim CBD itself, a specific oral solution, or a manufacturing process.
• Epidiolex labeling substantially overlaps the claimed Dravet/clobazam treatment pattern.
• The expected patent term extends into 2033, subject to the official USPTO adjustment.
• Generic exposure will center on Paragraph IV challenges, section viii carve-outs, and label-induced-infringement arguments.
• Biosimilar risk does not apply because cannabidiol is a small-molecule drug.
• The patent does not cover all Epidiolex indications, so its revenue protection is narrower than the product’s total commercial franchise.

FAQs About US Patent 9,949,937

Can a CBD product with no THC avoid US Patent 9,949,937?

Not necessarily. Claim 1 requires no more than 0.15% THC, which includes a product containing zero THC. A THC-free product may still satisfy the purity, disease, clobazam, and dose limitations.

Does prior clobazam use matter for infringement?

It matters only for dependent claim 3. Claims 1 and 14 do not require that clobazam was administered before CBD treatment began.

Does the patent cover CBD treatment for Lennox-Gastaut syndrome?

The issued claims supplied here require Dravet syndrome. They do not expressly cover Lennox-Gastaut syndrome.

Can a generic use a CBD dose below 10 mg/kg/day?

A regimen below 10 mg/kg/day would not satisfy the express dose limitation in claims 1 and 14. The generic must still assess other Epidiolex patents, FDA labeling requirements, and induced-infringement risk.

Is US Patent 9,949,937 a formulation patent?

No. It is a method-of-treatment patent. It does not require the Epidiolex 100 mg/mL oral-solution formulation or a particular excipient system.

References

1. United States Patent and Trademark Office. (2018). US Patent No. 9,949,937, Use of cannabidiol in the treatment of epilepsy.
2. U.S. Food and Drug Administration. (2023). Epidiolex (cannabidiol) oral solution: Prescribing information.
3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations, Orange Book.
4. U.S. Food and Drug Administration. (2024). Orphan drug designations and approvals database.
5. U.S. Food and Drug Administration. (2023). Approved drug products with therapeutic equivalence evaluations: Patent and exclusivity information.

Drugs Protected by US Patent 9,949,937

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						USE IN COMBINATION WITH CLOBAZAM FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH DRAVET SYNDROME

Foreign Priority and PCT Information for Patent: 9,949,937

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	1410771.8	Jun 17, 2014
United Kingdom	1506550.1	Apr 17, 2015

International Family Members for US Patent 9,949,937

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2015275886
Australia	2015275887
Australia	2020217417