Details for Patent: 9,956,185

Which drugs does patent 9,956,185 protect, and when does it expire?

Patent 9,956,185 protects EPIDIOLEX and is included in one NDA.

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

Summary for Patent: 9,956,185

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:	US15/449,177
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,956,185
Patent Claim Types: see list of patent claims	Use;

US Patent 9,956,185: Scope, Claims, Expiration, Orange Book Status and CBD Patent Landscape

US Patent 9,956,185 protects the use of high-purity cannabidiol for reducing or treating convulsive seizures in patients with treatment-resistant Dravet syndrome at doses of at least 10 mg/kg/day, subject to a maximum THC content of 0.15% by weight. The patent was assigned to GW Pharma Limited, now part of Jazz Pharmaceuticals, and is directed to a method of treatment rather than to cannabidiol as a chemical compound or to a specific branded formulation.

The patent issued on May 1, 2018. Its standard patent-term expiration is December 23, 2031, based on the relevant nonprovisional filing date, subject to any applicable patent-term adjustment or extension reflected in official records. The claims overlap materially at doses of 15 mg/kg/day and above, creating several alternative infringement routes.

What does US Patent 9,956,185 protect?

The patent protects a specific clinical use of cannabidiol, or CBD, when all of the following conditions are met:

Limitation	Requirement
Active ingredient	Cannabidiol
CBD purity	At least 98% w/w CBD
THC content	No more than 0.15% w/w delta-9-THC
Patient population	Patient with treatment-resistant epilepsy
Disease	Dravet syndrome
Seizure type	Convulsive seizures
Dose	At least 10 mg/kg/day for the broader claims; at least 15 mg/kg/day for claims 1 and 10
Therapeutic objective	Reducing convulsive seizure frequency or treating convulsive seizures

The claims use the transitional term “comprising.” That generally means the presence of additional ingredients, excipients, active agents, or treatment steps does not avoid the claim, provided the accused regimen satisfies every required limitation.

The patent does not claim all CBD products, all epilepsy treatments, or all cannabis-derived products. It covers a narrow combination of:

1. A defined CBD purity;
2. A defined THC ceiling;
3. Dravet syndrome;
4. Treatment-resistant epilepsy;
5. Convulsive seizures; and
6. A minimum daily dose.

What are the independent claims in US Patent 9,956,185?

The patent contains four principal independent claims: claims 1, 2, 10, and 11.

Claims 1 and 10: minimum dose of 15 mg/kg/day

Claims 1 and 10 require administration of CBD at a dose of at least 15 mg/kg/day.

Claim 1 is directed to reducing convulsive seizure frequency. Claim 10 is directed to treating convulsive seizures.

The principal distinction is the therapeutic language:

• Claim 1 requires reducing seizure frequency.
• Claim 10 requires treating convulsive seizures.

Both claims require the same patient, disease, CBD purity, THC content, and minimum dose.

Claims 2 and 11: minimum dose of 10 mg/kg/day

Claims 2 and 11 cover administration of CBD at a dose of at least 10 mg/kg/day.

Claim 2 concerns reducing convulsive seizure frequency. Claim 11 concerns treating convulsive seizures.

These claims are broader than claims 1 and 10 in dosage terms because they reach the 10 mg/kg/day to less-than-15 mg/kg/day range.

Dependent claims 3 through 9

Claims 3 through 9 depend from claim 2 and specify the following daily doses:

Claim	Dose
3	10 mg/kg/day
4	12 mg/kg/day
5	14 mg/kg/day
6	15 mg/kg/day
7	16 mg/kg/day
8	18 mg/kg/day
9	20 mg/kg/day

These claims create dose-specific fallback positions. A product or regimen that is disputed under the broader “at least 10 mg/kg/day” language may still be evaluated against the expressly recited dose claims.

How do the claims overlap?

The claims overlap substantially.

A patient receiving 15 mg/kg/day or more would fall within:

• Claim 1, if the treatment reduces convulsive seizure frequency;
• Claim 2, if the treatment reduces convulsive seizure frequency;
• Claim 6, if the dose is exactly 15 mg/kg/day;
• Claim 7, if the dose is exactly 16 mg/kg/day;
• Claim 8, if the dose is exactly 18 mg/kg/day;
• Claim 9, if the dose is exactly 20 mg/kg/day;
• Claim 10, if the treatment is characterized as treating convulsive seizures; and
• Claim 11, because the dose is at least 10 mg/kg/day.

The overlapping structure increases the number of claim theories available to the patent holder. It does not, however, eliminate the requirement to prove each limitation for each asserted claim.

What are the key claim-construction issues?

What does “treatment-resistant epilepsy” require?

The claims do not define treatment-resistant epilepsy solely by a numerical failure threshold. In litigation, the term could require evidence that the patient failed to obtain adequate seizure control from prior antiepileptic therapies. The relevant clinical history may include prior drugs, dose adequacy, treatment duration, tolerability, and persistent seizures.

A generic manufacturer may argue that its label does not require treatment of treatment-resistant patients. The patent holder may respond that the labeled indication, dosing instructions, clinical evidence, or physician use makes the patented method foreseeable or directed.

What does “Dravet syndrome” require?

Dravet syndrome is a specific developmental and epileptic encephalopathy, commonly associated with pathogenic SCN1A variants but diagnosed clinically in some cases without a confirmed genetic finding. The claim does not cover other epileptic encephalopathies merely because they are treatment-resistant.

Lennox-Gastaut syndrome and tuberous sclerosis complex are separate disease indications. A product used solely for those conditions would not inherently satisfy the Dravet syndrome limitation.

What does “convulsive seizures” require?

The claim is directed to convulsive seizures, not every seizure type. The relevant seizure classifications may include generalized tonic-clonic and focal-to-bilateral tonic-clonic seizures, depending on the clinical record and the applicable claim interpretation.

A regimen that reduces absence seizures but does not reduce convulsive seizures would present a weaker literal-infringement case.

Does CBD purity refer to the administered product?

The natural reading is that the administered CBD preparation must contain at least 98% w/w CBD and no more than 0.15% w/w THC. A product certificate of analysis, batch records, specifications, and testing methodology would be central to assessing compliance.

The claim does not expressly require a particular carrier oil, oral solution, capsule, tablet, route, manufacturing process, or branded product.

Is a specific dose required?

The claims recite a daily dose in mg/kg/day. A product label that recommends 10 mg/kg/day, 15 mg/kg/day, or a higher dose presents a direct method-of-use risk if the other claim elements are present.

The claim language does not specify whether the dose must be delivered once daily or in divided doses. A twice-daily regimen could satisfy the daily-dose limitation if the total administered amount reaches the claimed threshold.

What is the patent’s expiration date?

Event	Date
Earliest relevant priority or filing basis	December 23, 2010 or December 23, 2011, depending on the applicable family record
US patent issue date	May 1, 2018
Standard patent-term expiration commonly associated with the patent	December 23, 2031
Patent status	Issued patent; expiration and adjustment should be confirmed against USPTO records

Patent 9,956,185 was filed relatively late in prosecution but retains a term tied to the relevant earlier nonprovisional filing under the US patent-term rules. The issue date does not establish the expiration date.

Any patent-term adjustment, terminal disclaimer, or patent-term extension should be checked in the USPTO Patent Center record and the Orange Book entry before making a launch or litigation decision. The patent should not be treated as expiring in 2018 merely because it issued that year.

What is the Orange Book status of US Patent 9,956,185?

US Patent 9,956,185 has been associated with GW Pharma’s cannabidiol product Epidiolex, also known as Epidyolex outside the United States. Epidiolex is an FDA-approved oral cannabidiol solution.

FDA approved Epidiolex on June 25, 2018, for seizures associated with Lennox-Gastaut syndrome and Dravet syndrome in patients two years of age and older. FDA later expanded the product’s indication to seizures associated with tuberous sclerosis complex.[1]

The patent’s relevance to the Orange Book is its method-of-use coverage for CBD treatment in Dravet syndrome. An Orange Book listing can support a patent certification requirement for an ANDA applicant. It does not mean that every use of a generic CBD product infringes the patent.

How Orange Book listing affects generic applicants

An ANDA applicant generally must address listed patents through one of the statutory 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: the applicant is carving out a patented method of use.

For a CBD oral solution, the commercial risk depends heavily on the proposed label. A label directed to Dravet syndrome at 10 mg/kg/day or higher would be more exposed than a label limited to an unpatented condition or dosage regimen.

When does Epidiolex lose regulatory exclusivity?

Epidiolex received FDA approval for Dravet syndrome and Lennox-Gastaut syndrome in 2018. Orphan-drug exclusivity generally lasts seven years from approval for the orphan indication, subject to statutory exceptions. The seven-year period therefore began on June 25, 2018, and would ordinarily run through June 25, 2025, for the original orphan indications.[2]

Orphan exclusivity is separate from patent protection. The end of orphan exclusivity does not eliminate the 9,956,185 patent, and patent expiration does not necessarily eliminate other FDA exclusivities or later patent listings.

The TSC indication received FDA approval later and may have a separate regulatory and patent analysis. It does not fall within the Dravet-specific claims quoted in the request.

Which products and regimens create the highest infringement risk?

The highest-risk scenario is a pharmaceutical-grade CBD oral solution that:

• Is at least 98% CBD by weight;
• Contains no more than 0.15% THC by weight;
• Is labeled for Dravet syndrome;
• Is directed to treatment-resistant epilepsy;
• Is used for convulsive seizures; and
• Recommends at least 10 mg/kg/day.

The risk increases when the label recommends 15 mg/kg/day or more because the regimen may fall within both the 10 mg/kg/day and 15 mg/kg/day independent-claim groups.

Product or use scenario	Risk under 9,956,185
High-purity CBD for Dravet syndrome at 10 mg/kg/day	High, if treatment-resistant epilepsy and convulsive seizures are present
High-purity CBD for Dravet syndrome at 15 mg/kg/day	High
High-purity CBD for Dravet syndrome at 20 mg/kg/day	High
CBD for Lennox-Gastaut syndrome only	Lower under these specific claims
CBD for tuberous sclerosis complex only	Lower under these specific claims
CBD with more than 0.15% THC	Potentially outside the literal claim, subject to testing and claim construction
CBD with less than 98% CBD purity	Potentially outside the literal claim
CBD used for nonconvulsive seizures only	Potentially outside the literal claim
Research use without patient treatment	Usually a different infringement analysis

A label carve-out may reduce risk but cannot guarantee that physicians will not prescribe the product for the patented use. Induced-infringement exposure depends on the totality of the label, promotional materials, clinical evidence, distribution practices, and actual use.

What patent litigation and Paragraph IV issues affect CBD products?

CBD generic entry can trigger Hatch-Waxman litigation if an ANDA applicant submits a Paragraph IV certification against an Orange Book-listed patent. The patent holder generally has 45 days after receiving notice to file suit. A timely suit can trigger a 30-month stay of FDA approval under 21 U.S.C. § 355(j)(5)(B)(iii), subject to statutory exceptions and court developments.[3]

For patent 9,956,185, the core litigation issues would likely include:

1. Infringement: Whether the proposed product and label satisfy the Dravet syndrome, treatment-resistant epilepsy, convulsive seizure, purity, THC, and dose limitations.
2. Validity: Whether the claimed combination was obvious in view of earlier CBD epilepsy studies and known cannabinoid preparations.
3. Written description and enablement: Whether the specification adequately supports the full claimed range of patients and doses.
4. Indefiniteness: Whether terms such as “treatment-resistant,” “reducing,” and “convulsive seizures” provide sufficiently objective boundaries.
5. Induced infringement: Whether the ANDA label encourages physicians to perform the patented method.
6. Section viii carve-out: Whether an applicant can remove the patented Dravet use while retaining approval for other approved uses.

A Paragraph IV challenge does not itself invalidate the patent. The patent remains enforceable unless a court finds it invalid, unenforceable, or not infringed, or the parties resolve the dispute through settlement.

How strong is the patent estate around Epidiolex?

Patent 9,956,185 is one component of a broader Epidiolex patent estate. The surrounding portfolio has included patents directed to:

• CBD treatment of epilepsy;
• Particular epilepsy syndromes;
• Dosage regimens;
• Pharmaceutical compositions;
• Oral formulations;
• Manufacturing and purification processes; and
• Additional method-of-use claims.

The practical strength of the estate comes from claim layering. A generic product may avoid one claim by altering its label or dosage, yet remain exposed to another patent covering formulation, use, or dosing.

Strengths of US Patent 9,956,185

• It targets the principal clinical population for which Epidiolex was initially approved.
• It recites objective chemical thresholds for CBD and THC.
• It covers both 10 mg/kg/day and 15 mg/kg/day dose bands.
• It includes both seizure-reduction and seizure-treatment claim categories.
• It does not require a specific brand or formulation.

Potential vulnerabilities

• Prior-art references may disclose CBD for epilepsy, including pediatric refractory epilepsy.
• The combination of high CBD purity, low THC, Dravet syndrome, and the claimed dose may be challenged as an obvious clinical optimization.
• “Treatment-resistant epilepsy” may create factual disputes.
• The patent does not claim a unique molecular structure, because CBD itself was known.
• A properly drafted generic label may attempt to omit the patented Dravet use.

The claim’s enforceability depends on the full prosecution history, prior-art record, specification, and any claim-construction rulings. The issued claims alone do not establish litigation strength.

How does this patent compare with formulation and manufacturing patents?

Patent 9,956,185 is primarily a patient-treatment patent. It does not require the Epidiolex excipient system or a particular manufacturing process.

Formulation patents usually present a different risk profile. They may require specific concentrations, solvent systems, excipients, containers, or stability characteristics. Manufacturing patents may cover extraction, purification, crystallization, or control of cannabinoid impurities.

A generic manufacturer can potentially avoid a formulation patent by using a different excipient system while still facing a method-of-use patent. Conversely, a label carve-out may reduce method-of-use risk while the product remains exposed to composition or process patents.

Are biosimilar rules relevant to cannabidiol?

No. Cannabidiol is a small-molecule active ingredient, not a biologic. A competing CBD product would generally use the ANDA pathway for a pharmaceutically equivalent generic product, not the biosimilar pathway under the Public Health Service Act.

The relevant competitive questions are therefore:

• Whether the product qualifies for ANDA approval;
• Whether the applicant can use a section viii carve-out;
• Whether Orange Book patents require Paragraph IV certifications;
• Whether litigation triggers a 30-month stay; and
• Whether the applicant can obtain a first-filer or other market advantage.

What generic launch scenarios exist?

Three practical launch scenarios are most relevant.

Launch after patent expiration

A generic applicant may file a Paragraph III certification and launch after the relevant patent expires. This is the lowest litigation-risk route but delays commercial entry.

Launch after successful Paragraph IV litigation

If a court holds the patent invalid, not infringed, or unenforceable, FDA approval may proceed subject to other patents, exclusivities, and regulatory requirements.

Launch under a settlement agreement

A settlement may establish an agreed entry date, license terms, authorized-generic arrangements, or other commercial restrictions. The settlement must be analyzed across the complete patent estate because resolution of 9,956,185 alone may not clear other Orange Book-listed patents.

Does patent 9,956,185 block all nonprescription CBD products?

No. The patent is a method-of-treatment patent with multiple clinical limitations. It does not cover every CBD product sold for wellness, nutrition, cosmetics, or non-Dravet indications.

A nonprescription CBD product could still raise separate regulatory issues. FDA has stated that CBD products marketed as foods or dietary supplements face restrictions under the Federal Food, Drug, and Cosmetic Act because CBD is an active ingredient in an approved drug product.[4] That regulatory issue is distinct from infringement of patent 9,956,185.

Key Takeaways

• US Patent 9,956,185 covers high-purity CBD treatment for treatment-resistant Dravet syndrome.
• The claimed CBD must be at least 98% pure and contain no more than 0.15% THC by weight.
• Claims 2 and 11 reach doses of at least 10 mg/kg/day.
• Claims 1 and 10 reach doses of at least 15 mg/kg/day.
• Claims 3 through 9 specify doses from 10 to 20 mg/kg/day.
• The patent is directed to methods of reducing or treating convulsive seizures, not to CBD as a compound.
• The commonly reported expiration date is December 23, 2031, subject to official term adjustments or extensions.
• Epidiolex’s original orphan-drug exclusivity began June 25, 2018 and ordinarily ran for seven years.
• A generic CBD product labeled for Dravet syndrome at the claimed doses presents the highest Paragraph IV and induced-infringement risk.
• Biosimilar rules do not apply because cannabidiol is a small molecule.
• Clearance requires review of the full Epidiolex patent estate, not patent 9,956,185 alone.

FAQs

What dose of CBD falls within US Patent 9,956,185?

The broad dose claims cover at least 10 mg/kg/day. Separate independent claims cover at least 15 mg/kg/day. Dependent claims expressly recite 10, 12, 14, 15, 16, 18, and 20 mg/kg/day.

Does Epidiolex practice US Patent 9,956,185?

Epidiolex is a high-purity oral CBD product approved for Dravet syndrome and other seizure disorders. Its product characteristics and labeled dosing make it closely aligned with the subject matter of the patent, although infringement is determined claim by claim.

Can a generic CBD company avoid the patent by using a different formulation?

A different formulation may avoid a separate formulation patent, but it may not avoid 9,956,185 if the product still satisfies the CBD purity, THC, Dravet syndrome, treatment-resistant epilepsy, convulsive seizure, and dose limitations.

Does treatment of Lennox-Gastaut syndrome infringe these claims?

Not necessarily. The quoted claims specifically require Dravet syndrome. Treatment limited to Lennox-Gastaut syndrome does not satisfy that disease limitation, although other patents or claims may apply.

What is the most important document for confirming the patent expiration date?

The USPTO Patent Center record, including the patent-term adjustment calculation, is the controlling source for the US patent term. The FDA Orange Book provides the regulatory listing and expiration information used for ANDA patent certification analysis.

References

1. 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. https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-comprised-active-ingredient-derived-marijuana-treat-rare-severe-forms

2. U.S. Food and Drug Administration. (n.d.). Orphan drug designation and exclusivity. https://www.fda.gov/industry/developing-products-rare-diseases-conditions/orphan-drug-designation-and-exclusivity

3. 21 U.S.C. § 355(j)(5)(B)(iii) (2024).

4. U.S. Food and Drug Administration. (n.d.). FDA regulation of cannabis and cannabis-derived products, including cannabidiol (CBD). https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd

5. U.S. Patent No. 9,956,185. (2018). Use of cannabidiol in the treatment of epilepsy. U.S. Patent and Trademark Office.

Drugs Protected by US Patent 9,956,185

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 FOR THE TREATMENT OF CONVULSIVE SEIZURES IN PATIENTS WITH DRAVET SYNDROME

Foreign Priority and PCT Information for Patent: 9,956,185

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 9,956,185

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2015275886
Australia	2015275887
Australia	2020217417
Australia	2020220135
Australia	2022202119