Details for Patent: 10,709,673

Which drugs does patent 10,709,673 protect, and when does it expire?

Patent 10,709,673 protects EPIDIOLEX and is included in one NDA.

This patent has thirty-three patent family members in twenty countries.

Summary for Patent: 10,709,673

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):	Guy; Geoffrey (London, GB)
Assignee:	GW Research Limited (Cambridge, GB)
Application Number:	16/570,220
Patent Claim Types: see list of patent claims	Composition;

Understanding the Scope and Claims of United States Patent 10,709,673

Introduction

United States Patent 10,709,673, titled "Use of Cannabinoids in the Treatment of Epilepsy," is a significant patent in the field of pharmaceuticals, particularly in the treatment of epilepsy using cannabinoids. This patent, assigned to GW Research Limited, has been a cornerstone in the development of cannabinoid-based therapies.

Patent Overview

• Patent Number: 10,709,673 B2
• Date of Patent: July 14, 2020
• Inventors: Geoffrey Guy, among others
• Assignee: GW Research Limited, Cambridge (GB)[1][2][4].

Background and Context

The patent is part of a broader series of patents and research endeavors focused on the therapeutic use of cannabinoids, particularly cannabidiol (CBD), in treating epilepsy. This area of research has gained significant attention due to the potential of cannabinoids to provide relief for patients with severe forms of epilepsy.

Claims and Scope

Independent Claims

The patent includes several independent claims that define the scope of the invention. These claims are broad and cover various aspects of using cannabinoids in the treatment of epilepsy:

• Claim 1: This claim typically defines the broadest scope of the invention, often including the use of a specific cannabinoid, such as cannabidiol, for treating epilepsy.
• Dependent Claims: These claims are narrower and build upon the independent claims, specifying particular dosages, formulations, and methods of administration[3].

Scope of Protection

The scope of the patent is determined by its broadest independent claims. A broader claim offers more protection against infringers because it is harder to design around. For example, a claim that covers the use of cannabidiol in treating epilepsy would be broader than a claim that specifies a particular dosage or formulation[3].

Patent Landscape

Related Patents

The patent 10,709,673 is part of a larger family of patents related to the use of cannabinoids in medical treatments. Other patents in this family include:

• Patent 11,311,498: Issued on April 26, 2022, with similar claims related to the use of cannabinoids in epilepsy treatment[2].
• Patent 11,446,258: Issued on September 20, 2022, also covering the use of cannabinoids for epilepsy[4].

Patent Expiration Dates

The patent 10,709,673, along with other related patents, has specific expiration dates:

• April 26, 2039: This is the expiration date for several patents in this family, including 10,709,673[2].

Inventors and Assignees

• Geoffrey Guy: A key inventor in many of the patents related to cannabinoid therapies, particularly those assigned to GW Research Limited.
• GW Research Limited: The assignee of the patent, a company based in Cambridge, UK, known for its research and development in cannabinoid-based pharmaceuticals[1][2][4].

International Aspects

The patent has international implications, with related applications and patents filed in various jurisdictions. For example:

• International Preliminary Reports: These reports, such as those for PCT/GB2010/051066 and PCT/GB2015/053030, indicate the international scope and validation of the patent claims[1].

Legal and Regulatory Considerations

Patent Term Adjustments

The patent term can be adjusted or extended under certain conditions, such as delays in the patent office or litigation. However, for this patent, there are no term adjustments mentioned[1].

Exclusivity Periods

In addition to patent protection, the FDA grants exclusivity periods for approved drugs. These periods can run concurrently with the patent term and provide additional market protection[2].

Impact on the Pharmaceutical Industry

The patent has significant implications for the pharmaceutical industry, particularly in the development of treatments for epilepsy:

• Epidiolex: A drug developed by GW Pharmaceuticals (now part of Jazz Pharmaceuticals) that is based on the research covered by this patent. Epidiolex is the first FDA-approved drug containing a purified drug substance derived from marijuana[2].

Future Developments and Challenges

As the patent landscape evolves, there are several challenges and opportunities:

• Generic Availability: The expiration of these patents will eventually lead to the availability of generic versions of these drugs, potentially increasing access but also reducing the market share of the original patent holders[2].
• Continued Research: The ongoing research in cannabinoid therapies is likely to lead to new patents and innovations, further expanding the treatment options for epilepsy and other conditions.

Key Takeaways

• Broad Claims: The patent includes broad claims that offer significant protection against infringement.
• International Scope: The patent has international implications with related applications and patents filed globally.
• Regulatory Protection: The patent is complemented by FDA exclusivity periods, enhancing market protection.
• Impact on Industry: The patent has been instrumental in the development of cannabinoid-based treatments for epilepsy.

FAQs

1. What is the main focus of United States Patent 10,709,673?

   • The main focus is the use of cannabinoids, particularly cannabidiol, in the treatment of epilepsy.

2. Who are the inventors and assignees of this patent?

   • The inventors include Geoffrey Guy, and the assignee is GW Research Limited.

3. When does the patent expire?

   • The patent expires on April 26, 2039.

4. How does this patent impact the pharmaceutical industry?

   • It has led to the development of FDA-approved drugs like Epidiolex and has expanded treatment options for epilepsy.

5. What are the implications of the patent's expiration?

   • The expiration will lead to the potential availability of generic versions of the drug, increasing access but reducing the market share of the original patent holders.

Cited Sources

1. United States Patent and Trademark Office. Use of Cannabinoids in the Treatment of Epilepsy, US 10,709,673 B2, July 14, 2020.
2. Drugs.com. Generic Epidiolex Availability, November 6, 2024.
3. Boston University Law Review. The Ways We've Been Measuring Patent Scope Are Wrong: How to Measure and Draw Causal Inferences with Patent Scope, 2017.
4. United States Patent and Trademark Office. Use of Cannabinoids in the Treatment of Epilepsy, US 11,446,258 B2, September 20, 2022.

Drugs Protected by US Patent 10,709,673

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

Foreign Priority and PCT Information for Patent: 10,709,673

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 10,709,673

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2015332212
Australia	2021204353
Australia	2023258400
Brazil	112017007777
Canada	2963208
Canada	3232241