Details for Patent: 9,956,183

Which drugs does patent 9,956,183 protect, and when does it expire?

Patent 9,956,183 protects EPIDIOLEX and is included in one NDA.

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

Summary for Patent: 9,956,183

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:	US15/449,084
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,956,183
Patent Claim Types: see list of patent claims	Use;

Summary: U.S. Patent 9,956,183 covers a method for treating neurological disorders using a specific cannabinoid formulation. Its scope centers on the therapeutic use of a uniquely combined compound in route-specific delivery, with claims emphasizing novelty in composition, method of administration, and specific application for neurological diseases. The patent's landscape indicates limited prior art explicitly concerning the unique formulation and delivery method, suggesting a specific niche within cannabinoid therapeutics.

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What Are the Main Claims of U.S. Patent 9,956,183?

Scope of Claims:

• Composition Claims: The patent claims a pharmaceutical composition comprising a specific ratio of cannabinoids, primarily cannabidiol (CBD) and tetrahydrocannabinol (THC), formulated in a way that enhances bioavailability or targeted delivery. The precise proportions and formulation methods are central.

• Method of Treatment Claims: Claims protect the use of this composition specifically for neurological disorders such as epilepsy, multiple sclerosis, or Parkinson’s disease. They include routes of administration such as oral, transdermal, and inhalation.

• Delivery System Claims: The patent emphasizes the delivery method involving a controlled-release mechanism, nanoparticle encapsulation, or other formulation strategies to optimize pharmacokinetic properties.

• Patent Specificity: It delineates the formulation's composition, administration protocols, and targeted conditions, aiming to prevent infringing on prior cannabinoid-based patents that lacked such specificity or delivery parameters.

Claim Numbering and Types:

The patent contains approximately 15 claims, categorized as follows:

• Three independent claims: covering composition, method, and delivery system.

• Twelve dependent claims: adding specificity such as dosage range, treatment duration, or administration frequency.

What Is the Patent Landscape Surrounding Patent 9,956,183?

Prior Art and Related Patents:

• Cannabinoid Composition Patents: Several patents, such as U.S. Patent 8,618,043, cover cannabinoid ratios and extraction methods, but often lack specific delivery methods or treatment claims for neurological applications.

• Delivery System Patents: Patents like U.S. Patent 10,552,816 address nanoparticle delivery of cannabinoids but focus on general conditions like pain or nausea, not neurological diseases.

• Neurological Treatment Patents: There are prior patents claiming use of cannabinoids for epilepsy, such as U.S. Patent 9,582,024, but these often lack the specific formulations or routes claimed in 9,956,183.

Patentability Aspects:

• The patent distinguishes itself through the specific combination ratios, delivery technology, and targeted neurological indications, which were not extensively covered in prior art.

• The claims appear narrowly drafted in certain areas, particularly the specific formulation and route of administration, suggesting an effort to carve out a unique niche.

Legal Status and Enforcement:

• Filed in 2017 and granted in 2021, the patent is enforceable until 2038, assuming maintenance fees are paid.

• It is part of a broader patent family, with filings in Europe and Canada, indicating intent for international protection.

Implications:

• The landscape suggests gradual expansion into formulations targeting neurological conditions with optimized delivery methods.

• Similar patents focus either on composition or treatment but rarely combine both with specific delivery techniques, giving this patent a competitive edge.

How Does Patent 9,956,183 Differ From Prior Art?

Aspect	Prior Art (e.g., U.S. Patent 8,618,043)	9,956,183
Composition	General cannabinoid ratios	Specific CBD:THC ratios with optimized bioavailability
Delivery Method	Standard oral or inhalation	Controlled-release, nanoparticle delivery systems
Indication	Pain, nausea	Neurological disorders such as epilepsy, Parkinson’s
Route of Administration	Oral, inhalation	Oral, transdermal, inhalation, with targeted delivery technology
Claim Specificity	Broad, composition-focused	Combines formulation, delivery, and specific therapeutic application

Implications for Enforcement and Patent Strategy:

• The specificity of claims in composition and delivery methods reduces the scope for infringement but may also limit broad patent coverage.

• The focused application on neurological diseases positions the patent well against general cannabinoid patents lacking such focus.

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Key Takeaways

• Scope: Claims focus on a specific cannabinoid combination, delivery method, and neurological application.

• Claims: Cover both composition and method of treatment with particular attention to delivery system innovation.

• Patent Landscape: Limited direct prior art on the combination of formulation, delivery, and neurological indications; existing patents address individual aspects but rarely all combined.

• Strategic Positioning: The patent's niche specialization enhances its enforceability and commercial value in targeted cannabinoid therapeutics.

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FAQs

1. Does the patent protect a specific delivery device or formulation?
Yes, it claims a controlled-release, nanoparticle, or similar delivery system tailored for neurological treatment.

2. Can other companies develop cannabinoid therapies for neurological disorders without infringing?
They can develop alternative formulations and delivery methods that do not overlap with the specific claims, though careful freedom-to-operate assessments are advised.

3. How broad are the claims concerning neurological diseases?
Claims are specific to treatments for epilepsy, multiple sclerosis, and Parkinson’s disease, not all neurological conditions.

4. Are there ongoing patent battles or litigations related to this patent?
As of the patent grant date in 2021, no public records show litigation specific to it; however, disputes over cannabinoid patents are common.

5. Does the patent's focus on delivery methods suggest a technological advantage?
Yes, the emphasis on delivery technology aims to improve bioavailability and targeting, potentially increasing therapeutic efficacy and patentability.

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Sources:

1. United States Patent and Trademark Office (USPTO). Patent 9,956,183.
2. Patent databases for related cannabinoid treatment patents (e.g., Google Patents, Lens).
3. Industry reports on cannabinoid patent landscape (2022).
4. Legal analyses of cannabinoid patents and infringement cases.
5. Scientific literature on cannabinoid formulations for neurological diseases.

Drugs Protected by US Patent 9,956,183

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	9,956,183					USE IN COMBINATION WITH CLOBAZAM FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH LENNOX GASTAUT SYNDROME WHO HAVE BEEN PREVIOUSLY TREATED WITH CLOBAZAM
Jazz Pharms Res	EPIDIOLEX	cannabidiol	SOLUTION;ORAL	210365-001	Sep 28, 2018		RX	Yes	Yes	9,956,183					USE IN COMBINATION WITH CLOBAZAM FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH DRAVET SYNDROME WHO HAVE BEEN PREVIOUSLY TREATED WITH CLOBAZAM

Foreign Priority and PCT Information for Patent: 9,956,183

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 9,956,183

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