Detailed Analysis of the Scope and Claims of United States Patent 11,759,503
Introduction
The United States Patent 11,759,503, owned by Novo Nordisk A/S, is a crucial component of the patent landscape surrounding the pharmaceutical product RYBELSUS® (semaglutide) tablets. This patent is part of a broader suite of patents that protect various aspects of semaglutide and its formulations.
Patent Overview
Issuance and Assignee
The U.S. Patent 11,759,503 was issued on September 19, 2023, and is assigned to Novo Nordisk A/S. This patent is one of the several recent patents granted to Novo Nordisk, reflecting the company's ongoing efforts to protect its intellectual property related to semaglutide[4][5].
Claims and Scope
Composition Claims
The patent 11,759,503 specifically claims solid dosage pharmaceutical compositions. These compositions include:
- A first type of granules comprising at least 75% (w/w) of sodium N-(8-(2-hydroxybenzoyl)amino)caprylic acid (SNAC) and less than 10% (w/w) of a lubricant.
- A second type of granules comprising semaglutide, at least 15% (w/w) of a filler, and less than 40% (w/w) of a binder[1][2].
Use in Medicine
The patent covers the use of these solid compositions in medicine, particularly for the treatment of conditions where GLP-1 agonists are beneficial, such as type 2 diabetes and weight management.
Patent Landscape
Related Patents
The patent 11,759,503 is part of a comprehensive patent portfolio that includes several other patents related to semaglutide and its formulations. Some of the key related patents include:
- U.S. Patent 8,129,343: Covers acylated GLP-1 compounds and their therapeutic uses.
- U.S. Patent 9,278,123: Relates to solid compositions comprising a GLP-1 agonist and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid.
- U.S. Patent 11,382,957: Covers solid compositions comprising a GLP-1 agonist and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid[1][2][5].
Expiration Dates
The patent 11,759,503 is set to expire on March 15, 2033, which aligns with the expiration dates of several other related patents, including U.S. Patents 11,759,501 and 11,759,502[5].
Litigation and Generic Challenges
Apotex's ANDA
Apotex has submitted an Abbreviated New Drug Application (ANDA) to the FDA seeking approval for a generic version of RYBELSUS® before the expiration of the Asserted Patents, including the 11,759,503 patent. This submission includes a Paragraph IV Certification, which asserts that the commercial manufacture, use, or sale of Apotex’s ANDA product will not infringe any valid claim of the Asserted Patents or that the claims of the Asserted Patents are invalid and/or unenforceable[1][2].
Novo Nordisk's Response
Novo Nordisk has responded to Apotex's ANDA by filing a lawsuit, alleging infringement of the Asserted Patents. The complaint includes detailed statements regarding the factual and legal bases for Novo Nordisk's contention that Apotex’s ANDA product infringes the patents[1][2].
Impact on Innovation and Market
Patent Scope and Quality
The breadth and clarity of patent claims, such as those in the 11,759,503 patent, are critical in the debate over patent quality. Narrower claims, as seen in this patent, are often associated with a higher probability of grant and a shorter examination process, which can encourage innovation by reducing licensing and litigation costs[3].
Market Protection
The comprehensive patent protection afforded by patents like 11,759,503 ensures that Novo Nordisk maintains its exclusive right to sell, distribute, and market RYBELSUS® in the United States until the patents expire. This protection is crucial for the company's market dominance and revenue generation from this product[2][5].
Key Takeaways
- Patent Claims: The 11,759,503 patent specifically claims solid dosage pharmaceutical compositions containing semaglutide and SNAC.
- Patent Landscape: This patent is part of a broader suite of patents protecting semaglutide and its formulations.
- Expiration Dates: The patent is set to expire on March 15, 2033.
- Litigation: Apotex’s ANDA and Novo Nordisk’s subsequent lawsuit highlight the ongoing legal battles over generic versions of RYBELSUS®.
- Impact on Innovation: The patent's scope and clarity are important for encouraging innovation and reducing litigation costs.
FAQs
What is the main subject of U.S. Patent 11,759,503?
The main subject of U.S. Patent 11,759,503 is solid dosage pharmaceutical compositions comprising semaglutide and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid.
Who is the assignee of U.S. Patent 11,759,503?
The assignee of U.S. Patent 11,759,503 is Novo Nordisk A/S.
What is the expiration date of U.S. Patent 11,759,503?
The expiration date of U.S. Patent 11,759,503 is March 15, 2033.
Why is Apotex involved in litigation related to this patent?
Apotex is involved in litigation because it submitted an Abbreviated New Drug Application (ANDA) to the FDA seeking approval for a generic version of RYBELSUS® before the expiration of the Asserted Patents, including the 11,759,503 patent.
How does this patent fit into the broader patent landscape for RYBELSUS®?
This patent is part of a comprehensive patent portfolio that includes several other patents related to semaglutide and its formulations, ensuring broad protection for Novo Nordisk's product.
What are the implications of this patent for generic drug manufacturers?
The patent prevents generic drug manufacturers from producing and selling a generic version of RYBELSUS® until the patent expires, protecting Novo Nordisk's market exclusivity.
Sources
- Case 1:24-cv-09729-RMB Document 1 Filed 10/10/24
- Case 1:24-cv-09729-RMB-AMD Document 17 Filed 12/11/24
- Patent Claims and Patent Scope - SSRN
- Rybelsus patent expiration - Pharsight
- Generic Rybelsus Availability - Drugs.com
