Detailed Analysis of the Scope and Claims of United States Patent 10,933,120
Introduction
United States Patent 10,933,120, assigned to Novo Nordisk A/S, is a crucial patent in the pharmaceutical industry, particularly in the realm of GLP-1 (Glucagon-Like Peptide-1) agonists. This patent protects the formulation and composition of RYBELSUS, a significant drug for the treatment of type 2 diabetes and other metabolic conditions.
Patent Overview
Title: Compositions of GLP-1 peptides and preparation thereof
Inventors: Thomas Vilhelmsen, Helle Eliasen, and Tue Hansen
Assignee: Novo Nordisk A/S
Patent Date: Issued on various dates, with the PCT application filed on March 15, 2013, and the PCT publication on September 26, 2013[1].
Scope of the Patent
The patent covers pharmaceutical compositions that include two types of granules:
- First Type of Granules: These granules contain a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid but do not contain any GLP-1 peptide.
- Second Type of Granules: These granules contain a GLP-1 peptide but do not contain the salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid.
- Intermediate Granules: The patent also includes processes for the preparation of these granules and compositions, as well as their use in medicine[1].
Claims of the Patent
The patent claims are extensive and cover several key aspects:
- Composition Claims: The patent claims the specific composition of the granules, including the presence of the GLP-1 peptide and the salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid in separate granules.
- Process Claims: It includes claims for the processes involved in preparing these granules and the final pharmaceutical composition.
- Use Claims: The patent also claims the use of these compositions in medical treatments, particularly for conditions such as type 2 diabetes[1][2].
Patent Landscape
Related Patents
The patent 10,933,120 is part of a broader portfolio of patents held by Novo Nordisk A/S related to GLP-1 agonists and their formulations. Other relevant patents include:
- U.S. Patent No. 8,129,343: Covers acylated GLP-1 compounds.
- U.S. Patent No. 8,536,122: Also covers acylated GLP-1 compounds.
- U.S. Patent No. 9,278,123: Relates to solid compositions comprising a GLP-1 agonist.
- U.S. Patent No. 10,960,052: Covers solid compositions comprising a GLP-1 agonist and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid[2][5].
International Protection
The patent has a significant international footprint, with thirty-nine patent family members in twenty-four countries. This extensive protection ensures that Novo Nordisk maintains its intellectual property rights globally[1].
Litigation and Enforcement
Novo Nordisk has been actively enforcing these patents against potential infringers. For example, Apotex's attempt to file an Abbreviated New Drug Application (ANDA) for a generic version of RYBELSUS has been met with litigation from Novo Nordisk, citing infringement of multiple patents, including the 10,933,120 patent[2][5].
Valuation and Strategic Importance
The value of a patent like 10,933,120 can be substantial, given its role in protecting a major pharmaceutical product. The valuation methods for patents include cost, income, and market approaches. For instance, the income approach considers the future benefits provided by the patent, such as revenue from drug sales and cost savings. Given the significant market share and revenue generated by RYBELSUS, this patent is highly valuable to Novo Nordisk[4].
Impact on Innovation and Competition
The breadth and scope of this patent, along with related patents, can influence innovation and competition in the pharmaceutical industry. While these patents protect Novo Nordisk's intellectual property, they can also create barriers for other companies seeking to develop similar products. This highlights the ongoing debate about patent scope and its impact on innovation, with some arguing that overly broad patents can stifle competition and innovation[3].
Key Takeaways
- Comprehensive Protection: The patent 10,933,120 provides comprehensive protection for the formulation and composition of RYBELSUS.
- International Coverage: It has extensive international protection, ensuring global intellectual property rights.
- Litigation and Enforcement: Novo Nordisk actively enforces this patent against potential infringers.
- Strategic Value: The patent is highly valuable due to its role in protecting a major pharmaceutical product.
- Impact on Innovation: The patent's scope can influence innovation and competition in the pharmaceutical industry.
FAQs
Q: What is the main subject of United States Patent 10,933,120?
A: The patent covers pharmaceutical compositions comprising two types of granules, one containing a GLP-1 peptide and the other containing a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid.
Q: Who is the assignee of this patent?
A: The assignee is Novo Nordisk A/S.
Q: What is the significance of this patent in the pharmaceutical industry?
A: This patent protects the formulation of RYBELSUS, a significant drug for treating type 2 diabetes and other metabolic conditions.
Q: How does this patent impact competition in the pharmaceutical industry?
A: The patent can create barriers for other companies seeking to develop similar products, potentially stifling competition and innovation.
Q: What are the key claims of this patent?
A: The patent claims cover the composition, process of preparation, and medical use of the granules and final pharmaceutical composition.
