United States Patent 11,318,191: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 11,318,191, titled "GLP-1 Compositions and Uses Thereof," is a significant patent held by Novo Nordisk A/S, a leading pharmaceutical company. This patent is crucial for understanding the intellectual property landscape surrounding GLP-1 (Glucagon-Like Peptide-1) peptides, particularly the compound semaglutide, which is marketed under the brand name Wegovy.
Inventors and Assignee
The patent was invented by Dorthe Kot Engelund, Soeren Snitker, and Andrew Mark Louw, and assigned to Novo Nordisk A/S, based in Bagsvaerd, Denmark[2][4].
Patent Issue Date and Status
The patent was issued on May 3, 2022, and is currently active[2][4].
Scope of the Patent
Pharmaceutical Compositions
The patent pertains to pharmaceutical compositions of the GLP-1 peptide semaglutide. These compositions are characterized by containing no more than 0.1% (w/w) phenol and above 6.4 mg/ml sodium chloride. This specific formulation is designed to enhance the stability and efficacy of semaglutide[4].
Preparation and Kits
The patent also covers the methods for preparing these compositions and kits that include such compositions. The preparation methods are detailed to ensure the consistent quality of the final product[4].
Uses Thereof
The patent claims various therapeutic uses of these GLP-1 compositions, including the treatment of conditions such as type 2 diabetes and obesity. Semaglutide is known for its role in glucose control and weight management[2][4].
Claims of the Patent
The patent includes 26 claims that define the scope of the invention. These claims are divided into several categories:
Composition Claims
These claims specify the exact formulation of the GLP-1 peptide semaglutide, including the concentration of phenol and sodium chloride[4].
Method Claims
These claims describe the methods for preparing the pharmaceutical compositions and the kits that contain these compositions[4].
Use Claims
These claims outline the therapeutic uses of the GLP-1 compositions, including their application in treating various medical conditions[4].
Patent Landscape
Related Patents
Novo Nordisk A/S holds several patents related to GLP-1 peptides, including:
- Patent 8,129,343: Issued on March 6, 2012, this patent covers acylated GLP-1 compounds and their therapeutic uses. It is set to expire on December 5, 2031[5].
- Patent 8,536,122: Issued on September 17, 2013, this patent also pertains to protracted GLP-1 compounds and their therapeutic uses, with an expiration date of March 20, 2026[5].
- Patent 9,764,003: Issued on September 19, 2017, this patent focuses on the use of long-acting GLP-1 peptides[5].
Generic Availability
As of now, there is no generic version of Wegovy (semaglutide) available in the United States. The patent protection ensures that Novo Nordisk maintains exclusivity over the market for these specific formulations until the patents expire[5].
Litigation and Enforcement
Novo Nordisk is actively enforcing its patents, as evidenced by recent litigation. For example, the company has filed lawsuits against generic manufacturers who have sought FDA approval for their versions of semaglutide, alleging patent infringement[2].
Impact on the Pharmaceutical Industry
The patent landscape surrounding GLP-1 peptides, particularly semaglutide, significantly influences the pharmaceutical industry. Here are a few key points:
Market Exclusivity
Novo Nordisk's patent portfolio ensures that the company maintains market exclusivity for Wegovy until the patents expire. This exclusivity allows Novo Nordisk to control the market and pricing for these medications[5].
Research and Development
The protection offered by these patents incentivizes continued research and development in the field of GLP-1 peptides. Companies are motivated to invest in new formulations and therapeutic uses, knowing that their innovations can be protected[4].
Competition
The absence of generic versions due to patent protection limits competition in the market. This can affect the availability and affordability of these medications for patients[5].
Key Takeaways
- Patent Scope: The patent covers specific formulations of semaglutide with defined concentrations of phenol and sodium chloride.
- Therapeutic Uses: The compositions are used for treating conditions like type 2 diabetes and obesity.
- Patent Landscape: Novo Nordisk holds multiple related patents, ensuring market exclusivity until their expiration.
- Litigation: Novo Nordisk is actively enforcing its patents against potential infringers.
- Impact: The patents influence market dynamics, research, and the availability of generic alternatives.
FAQs
What is the main subject of United States Patent 11,318,191?
The main subject is pharmaceutical compositions of the GLP-1 peptide semaglutide, specifically those containing no more than 0.1% (w/w) phenol and above 6.4 mg/ml sodium chloride.
Who are the inventors of this patent?
The inventors are Dorthe Kot Engelund, Soeren Snitker, and Andrew Mark Louw.
When was the patent issued?
The patent was issued on May 3, 2022.
What are the therapeutic uses of the compositions claimed in this patent?
The compositions are used for treating conditions such as type 2 diabetes and obesity.
Are there any generic versions of Wegovy available?
No, there are currently no generic versions of Wegovy available in the United States.
Citations
- United States Patent and Trademark Office, "GLP-1 Compositions and Uses Thereof," US11318191B2.
- Case 1:23-cv-01459-UNA Document 1 Filed 12/21/23, "Complaint for Patent Infringement."
- Pharsight - GreyB, "Wegovy patent expiration."
- Google Patents, "GLP-1 compositions and uses thereof," US11318191B2.
- Drugs.com, "Generic Wegovy Availability."
