Details for Patent: 11,207,292

Which drugs does patent 11,207,292 protect, and when does it expire?

Patent 11,207,292 protects EPIDIOLEX and is included in one NDA.

This patent has seventeen patent family members in fourteen countries.

Summary for Patent: 11,207,292

Title:	Cannabidiol preparations and its uses
Abstract:	Cannabidiol (CBD) is a cannabinoid designated chemically as 2-[(1R,6R)-3-Methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl]-5-pentyl-1,3-b- enzenediol. Its empirical formula is C.sub.21H.sub.30O.sub.2 and its molecular weight is 314.46. CBD is a cannabinoid that naturally occurs in the Cannabis sativa L. plant. CBD is a white to pale yellow crystalline solid which is insoluble in water and soluble in organic solvents. The present invention encompasses the surprising recognition that certain CBD preparations which are prepared from a botanical origin are more effective in treating diseases or disorders than preparations of CBD which are synthetic or purified to the extent no other impurities in the form of other cannabinoids are present. Prior CBD compositions have been prepared such that no psychoactive components, e.g., tetrahydrocannabinol (THC), remain in the final CBD preparation. Surprisingly, the absence of such minor impurities reduces the efficacy of CBD treatment. Such CBD preparations are characterized by chemical components and/or funtional properties that distinguish them from prior CBD compositions. One or more components of the preparations described herein provide an unexpectedly synergistic effect when utilized in combination.
Inventor(s):	Guy; Geoffrey (Cambridge, GB), Knappertz; Volker (Cambridge, GB), Whalley; Benjamin (Cambridge, GB), Woolley-Roberts; Marie (Cambridge, GB), Brodie; James (Cambridge, GB), Lach-Falcone; Katarzyna (Cambridge, GB), Sutton; Alan (Cambridge, GB), Gray; Royston (Cambridge, GB), Rana; Rohini Rajyalaxmi (Cambridge, GB)
Assignee:	GW Research Limited (Cambridge, GB)
Application Number:	17/011,715
Patent Claim Types: see list of patent claims	Use; Compound;

United States Patent 11,207,292: A Detailed Analysis of Scope and Claims

Introduction

The United States Patent 11,207,292, owned by GW Pharmaceuticals, is part of a broader patent portfolio related to cannabidiol (CBD) preparations and their uses. This patent is crucial in the context of CBD-based pharmaceuticals, particularly for the treatment of specific medical conditions.

Patent Overview

Patent Number and Ownership

The patent in question is numbered 11,207,292 and is owned by GW Pharmaceuticals, a biopharmaceutical company specializing in cannabinoid-based therapeutics[5].

Patent Family and Related Patents

This patent is part of a larger family of patents related to CBD preparations and their pharmaceutical applications. Other patents in this family include 9,949,937, 9,956,183, 9,956,184, 9,956,185, 9,956,186, and several others, all of which are integral to the protection of GW Pharmaceuticals' proprietary cannabinoid product platform[5].

Scope of the Patent

Claims and Inventions

The patent 11,207,292 encompasses various claims related to the preparation, formulation, and use of cannabidiol. Here are some key aspects:

• Preparation Methods: The patent includes methods for preparing substantially pure cannabidiol from plant material, ensuring high chromatographic purity and minimal presence of psychoactive contaminants like THC and CBN[4][5].
• Formulations: It covers specific formulations of CBD, including oral solutions, which are critical for the treatment of seizures associated with Lennox-Gastaut Syndrome (LGS), Dravet Syndrome (DS), and Tuberous Sclerosis Complex (TSC)[5].
• Pharmaceutical Uses: The patent claims extend to the pharmaceutical uses of CBD, highlighting its therapeutic potential in a broad range of disease areas.

Independent and Dependent Claims

The patent includes both independent and dependent claims. Independent claims define the core inventions, such as the methods of preparing pure CBD and its formulations. Dependent claims further specify these inventions, often detailing specific conditions, purity levels, or application methods[3].

Patent Claims Analysis

Independent Claim Length and Count

Research suggests that the scope of a patent can be measured by the length and count of its independent claims. Narrower claims, as seen in this patent, are often associated with a higher probability of grant and a shorter examination process[3].

Claim Specificity

The claims in this patent are highly specific, detailing the purification process, the desired purity levels (e.g., 95% or greater), and the absence of detectable THC and CBN. This specificity helps in defining a clear scope and reducing the likelihood of infringement disputes[4].

Patent Landscape

Competitive Environment

The patent landscape for CBD-based pharmaceuticals is highly competitive, with multiple companies seeking to develop and market similar products. GW Pharmaceuticals' extensive patent portfolio, including 11,207,292, plays a crucial role in protecting its market position and preventing generic competition until the patents expire[5].

Litigation and Settlements

There have been several litigation cases involving GW Pharmaceuticals and generic drug manufacturers, such as InvaGen, over the infringement of these patents. These cases highlight the importance of these patents in maintaining market exclusivity for Epidiolex, GW's CBD oral solution[5].

Regulatory Environment

The FDA approval process for generic versions of Epidiolex is closely tied to the patent landscape. Generic manufacturers must navigate these patents to avoid infringement, often leading to settlements or litigation. The regulatory environment emphasizes the need for clear and valid patent claims to ensure compliance and avoid legal disputes[5].

Impact on the Pharmaceutical Industry

Innovation and Research

The patent 11,207,292 and its related patents encourage innovation by protecting the intellectual property of GW Pharmaceuticals. This protection allows for continued research and development in the field of cannabinoid therapeutics, driving advancements in the treatment of various medical conditions[5].

Market Exclusivity

By securing market exclusivity through a robust patent portfolio, GW Pharmaceuticals can recoup its investment in research and development. This exclusivity also ensures that patients have access to high-quality, FDA-approved CBD products for specific therapeutic uses[5].

Key Takeaways

• Patent Scope and Claims: The patent 11,207,292 has specific claims related to the preparation and formulation of CBD, ensuring high purity and therapeutic efficacy.
• Competitive Landscape: The patent is part of a competitive landscape where GW Pharmaceuticals protects its market position through an extensive patent portfolio.
• Regulatory Compliance: The patent's validity and scope are crucial for regulatory compliance and avoiding infringement disputes.
• Innovation: The patent encourages innovation in cannabinoid therapeutics by protecting intellectual property.

FAQs

Q: What is the primary focus of United States Patent 11,207,292?

A: The primary focus is on the preparation, formulation, and pharmaceutical uses of cannabidiol (CBD), particularly for treating seizures associated with specific syndromes.

Q: How does the patent protect GW Pharmaceuticals' market position?

A: The patent protects GW Pharmaceuticals' market position by preventing generic competition until the patent expires, ensuring market exclusivity for its CBD-based products like Epidiolex.

Q: What are the key claims in the patent?

A: The key claims include methods for preparing substantially pure CBD, specific formulations like oral solutions, and the therapeutic uses of CBD in treating various medical conditions.

Q: How does the patent impact innovation in the pharmaceutical industry?

A: The patent encourages innovation by protecting GW Pharmaceuticals' intellectual property, allowing for continued research and development in cannabinoid therapeutics.

Q: What is the significance of the patent's specificity in claims?

A: The specificity in claims helps in defining a clear scope, reducing the likelihood of infringement disputes, and ensuring regulatory compliance.

Sources

1. US11207292B2 - Cannabidiol preparations and its uses - Google Patents
2. ANDA Litigation Settlements | Hatch-Waxman | Robins Kaplan LLP
3. Patent Claims and Patent Scope - Hoover Institution
4. US20060167283A1 - Method of preparing cannabidiol from plant material - Google Patents
5. IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF TEXAS - Insight.RPXCorp.com

Drugs Protected by US Patent 11,207,292

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				Y		USE FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME
Jazz Pharms Res	EPIDIOLEX	cannabidiol	SOLUTION;ORAL	210365-001	Sep 28, 2018		RX	Yes	Yes				Y		USE FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH TUBEROUS SCLEROSIS COMPLEX
Jazz Pharms Res	EPIDIOLEX	cannabidiol	SOLUTION;ORAL	210365-001	Sep 28, 2018		RX	Yes	Yes				Y		USE FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME

Foreign Priority and PCT Information for Patent: 11,207,292

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	1806953	Apr 27, 2018

International Family Members for US Patent 11,207,292

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2019259230
Brazil	112020021884
Canada	3097665
China	112512585
Denmark	3784283
Eurasian Patent Organization	202092582