United States Patent 11,382,957: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 11,382,957, owned by Novo Nordisk A/S, is a significant patent in the field of pharmaceuticals, particularly focusing on solid compositions comprising a GLP-1 agonist. This patent is part of a broader landscape of intellectual property protecting Novo Nordisk's innovative products, such as RYBELSUS® (semaglutide) tablets.
Patent Overview
Issuance and Inventors
The patent 11,382,957 was issued on July 12, 2022, and names Per Sauerberg, Simon Bjerredgaard, and Flemming Seier Nielsen as inventors. All inventors have assigned their rights to Novo Nordisk A/S, granting the company the authority to enforce and sue for infringement of this patent[2][4].
Claims and Scope
Solid Compositions
The patent claims solid compositions for oral administration that include a GLP-1 agonist, specifically semaglutide, and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid. These compositions also include at least one excipient selected from the group consisting of a lubricant, binder, and filler[2][4].
Specific Components
- GLP-1 Agonist: The patent specifies the use of semaglutide, a well-known GLP-1 agonist used in the treatment of diabetes and weight management.
- Salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid: This component is crucial for the stability and bioavailability of the GLP-1 agonist in the solid composition.
- Excipients: The inclusion of lubricants, binders, and fillers is essential for the formulation of the solid dosage form, ensuring proper tablet characteristics and drug delivery[2].
Therapeutic Use
Medical Applications
The solid compositions claimed in this patent are designed for the treatment of various medical conditions, primarily type 2 diabetes and obesity. Semaglutide, as a GLP-1 agonist, works by mimicking the action of the natural hormone glucagon-like peptide-1, enhancing insulin secretion, and suppressing glucagon release[5].
Patent Landscape
Related Patents
The patent 11,382,957 is part of a larger portfolio of patents held by Novo Nordisk A/S, which includes several other patents related to semaglutide and its formulations. Some notable patents in this landscape include:
- U.S. Patent 8,129,343: Claims acylated GLP-1 compounds and their therapeutic uses, issued on March 6, 2012[5].
- U.S. Patent 10,960,052: Also claims solid compositions comprising a GLP-1 agonist and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid, issued on March 30, 2021[5].
- U.S. Patents 11,759,501, 11,759,502, and 11,759,503: These patents cover various aspects of semaglutide formulations and their use, all expiring on March 15, 2033[5].
Patent Expiration Dates
The patent 11,382,957 is set to expire on December 16, 2031. This expiration date is crucial for generic manufacturers and competitors, as it marks the time when they can legally produce and market generic versions of the drug without infringing on Novo Nordisk's patent rights[5].
Litigation and Challenges
Generic Approval and Infringement
The patent is currently involved in litigation related to the approval of generic versions of RYBELSUS®. Companies like Apotex are seeking FDA approval for their ANDA (Abbreviated New Drug Application) before the expiration of the asserted patents, including the 11,382,957 patent. Novo Nordisk is actively defending its patents against these generic challenges, asserting that the generic versions would infringe on their valid patent claims[2][4].
Expert Insights and Industry Impact
Market Dominance
Novo Nordisk's robust patent portfolio, including the 11,382,957 patent, has allowed the company to maintain market dominance in the GLP-1 agonist market. This portfolio ensures that competitors face significant barriers to entry, protecting Novo Nordisk's revenue streams from its innovative products.
Regulatory Environment
The patent landscape is influenced by the regulatory environment, with the FDA and USPTO playing critical roles in approving and issuing patents, respectively. The harmonization of U.S. patent laws with international standards, as well as the increased scrutiny by the Supreme Court, further shapes the patent landscape and the strategies of pharmaceutical companies like Novo Nordisk[3].
Key Takeaways
- Patent Claims: The patent 11,382,957 specifically claims solid compositions for oral administration containing a GLP-1 agonist and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid.
- Therapeutic Use: These compositions are primarily used for treating type 2 diabetes and obesity.
- Patent Landscape: Part of a broader portfolio of patents protecting semaglutide formulations.
- Expiration Date: Set to expire on December 16, 2031.
- Litigation: Currently involved in litigation related to generic approvals.
FAQs
What is the main claim of U.S. Patent 11,382,957?
The main claim of U.S. Patent 11,382,957 is for solid compositions for oral administration comprising a GLP-1 agonist, specifically semaglutide, and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid.
Who are the inventors of this patent?
The inventors of U.S. Patent 11,382,957 are Per Sauerberg, Simon Bjerredgaard, and Flemming Seier Nielsen.
What is the therapeutic use of the compositions claimed in this patent?
The compositions are used primarily for the treatment of type 2 diabetes and obesity.
When is the patent set to expire?
The patent 11,382,957 is set to expire on December 16, 2031.
Why is this patent important for Novo Nordisk?
This patent is crucial for Novo Nordisk as it protects their innovative product RYBELSUS® (semaglutide) tablets, allowing the company to maintain market dominance and protect its revenue streams.
Sources
- USPTO Document: Trials@uspto.gov Paper No. 10 571-272-7822 Entered 2023-10-04.
- Litigation Document: Case 1:24-cv-09729-RMB-AMD Document 17 Filed 12/11/24.
- Touro Law Review: Mastering Patent Claim Construction.
- Litigation Document: Case 1:24-cv-09729-RMB Document 1 Filed 10/10/24.
- Drugs.com: Generic Rybelsus Availability.
