Understanding the Scope and Claims of United States Patent 11,759,501
Introduction
United States Patent 11,759,501, owned by Novo Nordisk A/S, is a significant patent in the pharmaceutical sector, particularly related to the GLP-1 agonist semaglutide. This patent is part of a broader portfolio of patents that protect Novo Nordisk’s product RYBELSUS® (semaglutide) tablets. Here, we will delve into the details of the patent's scope, claims, and the broader patent landscape.
Patent Overview
The patent in question, U.S. Patent No. 11,759,501, was issued on September 19, 2023. It is titled "Compositions of GLP-1 Peptides and Preparation Thereof" and names Thomas Vilhelmsen, Helle Eliasen, and Tue Hansen as inventors. This patent is one of several that Novo Nordisk has secured to protect its intellectual property related to semaglutide formulations[1].
Claim Scope
The claim scope of U.S. Patent 11,759,501 is crucial for understanding the protection it offers. Here are some key aspects of the claims:
Solid Dosage Pharmaceutical Composition
The patent claims a solid dosage pharmaceutical composition that includes:
- A salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid (salt of NAC).
- A granule, wherein the granule comprises semaglutide, a binder, and other excipients such as lubricants, fillers, or both[1].
Specific Composition Requirements
The composition must include at least 60% (w/w) of the salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid. This specific requirement ensures that the formulation meets certain standards for stability and efficacy[1].
Use of Semaglutide
Semaglutide, a GLP-1 agonist, is a key component of the composition. The patent protects the specific way semaglutide is formulated and combined with other ingredients to enhance its delivery and effectiveness[1].
Importance of Claim Scope
The scope of the claims in a patent is critical for several reasons:
Protection and Enforcement
A well-defined claim scope ensures that Novo Nordisk can enforce its patent rights effectively. Overly broad claims can be easier to invalidate, while too narrow claims may not provide sufficient protection[5].
Innovation and Licensing
The claim scope influences the incentives for innovation. Narrower claims that are more specific can encourage further innovation by allowing other companies to work around the patented technology. Broader claims, however, can stifle innovation by granting a monopoly over a wide range of ideas[3].
Litigation and Validation
The claim scope is also crucial in litigation. Broader claims are more likely to be challenged and invalidated due to issues such as the abstract idea exception or failure to meet the written description requirement. Recent court decisions, such as Yu v. Apple Inc. and Minerva Surgical, Inc. v. Hologic, Inc., highlight the importance of balancing claim breadth with specificity[5].
Patent Landscape
The patent landscape surrounding U.S. Patent 11,759,501 is complex and involves multiple related patents.
Related Patents
Novo Nordisk holds a series of patents related to semaglutide, including U.S. Patent Nos. 8,129,343, 9,278,123, 10,086,047, 10,278,923, 10,933,120, 10,960,052, 11,382,957, 11,759,502, and 11,759,503. These patents collectively protect various aspects of semaglutide formulations, including composition, use, and preparation methods[1].
Global Dossier and International Protection
The Global Dossier service provided by the USPTO allows users to access file histories of related applications from participating IP Offices, which includes the IP5 Offices. This service helps in understanding the global patent family and the protection afforded to Novo Nordisk’s inventions across different jurisdictions[4].
Challenges and Considerations
When dealing with patents like U.S. Patent 11,759,501, several challenges and considerations arise:
Prior Art and Examination Process
The examination process tends to narrow the scope of patent claims to ensure they are novel and non-obvious. Broader claims are often subject to more scrutiny and may require longer examination periods[3].
Litigation Risks
Overly broad claims can increase the risk of litigation and invalidation. Patent drafters must carefully balance the breadth of claims with the need for specificity to avoid such risks[5].
Economic and Social Implications
The scope of patent claims has economic and social implications. It can influence the cost of obtaining a patent, the likelihood of grant, and the overall innovation landscape in the industry[3].
Key Takeaways
- Specific Claim Scope: U.S. Patent 11,759,501 has a specific claim scope that includes a solid dosage pharmaceutical composition with semaglutide and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid.
- Importance of Balance: The claim scope must balance breadth with specificity to ensure effective protection and avoid litigation risks.
- Related Patents: The patent is part of a broader portfolio of patents protecting semaglutide formulations.
- Global Protection: The Global Dossier service helps in understanding the global patent family and protection across different jurisdictions.
- Economic and Social Implications: The claim scope has significant economic and social implications for innovation and licensing.
FAQs
Q: What is the main subject of U.S. Patent 11,759,501?
A: The main subject is a solid dosage pharmaceutical composition comprising semaglutide and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid.
Q: Who are the inventors listed on the patent?
A: The inventors listed are Thomas Vilhelmsen, Helle Eliasen, and Tue Hansen.
Q: Why is the claim scope important in a patent?
A: The claim scope is crucial for ensuring effective protection, avoiding litigation risks, and balancing the breadth of protection with specificity.
Q: How does the Global Dossier service relate to this patent?
A: The Global Dossier service allows users to access file histories of related applications from participating IP Offices, helping to understand the global patent family and protection.
Q: What are the risks associated with overly broad patent claims?
A: Overly broad claims can increase the risk of litigation and invalidation due to issues such as the abstract idea exception or failure to meet the written description requirement.
Sources
- Case 1:24-cv-09729-RMB Document 1 Filed 10/10/24 Page 1 of 48: This action arises under the patent laws of the United States, Title 35, United States Patent.
- PubChem - Tablet formulation comprising semaglutide and a delivery agent: This web page summarizes information in PubChem about patent US-9993430-B2.
- SSRN - Patent Claims and Patent Scope: This paper explores metrics for measuring patent scope based on claim language.
- USPTO - Search for patents: Information on searching for patents and the Global Dossier service.
- Rimon Law - The Importance of Getting the Claim Scope Right in a US Patent Application: Importance of claim scope in US patent applications.
