Understanding the Scope and Claims of United States Patent 10,857,137
Introduction
The United States Patent 10,857,137, hereafter referred to as the '137 patent, is part of a complex patent landscape surrounding the drug Valbenazine, which is used to treat conditions such as tardive dyskinesia and chorea associated with Huntington's disease. Here, we will delve into the details of this patent, its claims, and the broader patent landscape it is a part of.
Patent Overview
The '137 patent is one of several patents held by Neurocrine Biosciences, Inc., related to Valbenazine. It was granted on December 8, 2020, and is estimated to expire on October 10, 2037[4].
Claims and Scope
The '137 patent, like other patents in this series, includes multiple claims that define the scope of the invention. Here are some key aspects:
Method of Use Claims
The patent includes method of use claims, which are critical in defining how the drug can be used. For instance, the patent may claim specific methods for treating tardive dyskinesia or chorea associated with Huntington's disease using Valbenazine[2].
Composition Claims
In addition to method of use claims, the patent may also include composition claims that describe the formulation and composition of Valbenazine. These claims are essential for protecting the specific formulation of the drug[2].
Exclusivity and Protection
The '137 patent is part of a broader strategy to protect the exclusivity of Valbenazine. By having multiple patents with overlapping but distinct claims, Neurocrine Biosciences aims to extend the period during which it can exclusively market the drug[4].
Patent Landscape
The '137 patent is embedded in a complex patent landscape involving numerous other patents related to Valbenazine.
Related Patents
Several other patents, such as U.S. Patent Nos. 10,065,952, 10,844,058, 10,851,103, 10,851,104, 10,874,648, 10,906,902, 10,906,903, 10,912,771, 10,919,892, 10,940,141, and 10,952,997, are also part of this landscape. These patents collectively cover various aspects of Valbenazine, including its composition, method of use, and manufacturing processes[2][5].
Litigation and Challenges
The '137 patent has been involved in several litigation cases. For example, Neurocrine Biosciences has filed lawsuits against generic drug manufacturers such as Teva Pharmaceuticals and Zydus Pharmaceuticals, alleging patent infringement. These lawsuits often involve Paragraph IV certifications under the Federal Food, Drug, and Cosmetic Act (FD&C Act), where the generic manufacturers argue that the patents are invalid, unenforceable, or will not be infringed by their manufacture, use, or sale of the generic version of Valbenazine[2][5].
Impact on Generic Manufacturers
The '137 patent and its associated litigation have significant implications for generic manufacturers. Generic companies must navigate these patents carefully to avoid infringement. Here are some key points:
Paragraph IV Certifications
Generic manufacturers often submit Paragraph IV certifications to the FDA, stating that the patents covering the brand-name drug are invalid, unenforceable, or will not be infringed by their generic version. This can lead to litigation, as seen in the cases involving Teva and Zydus Pharmaceuticals[2][5].
Patent Expiration and Generic Entry
The expiration dates of these patents are crucial for generic entry. The '137 patent, set to expire in 2037, will eventually allow generic versions of Valbenazine to enter the market, provided no additional exclusivity extensions are granted[4].
Metrics for Measuring Patent Scope
To understand the breadth and complexity of the '137 patent, metrics such as independent claim length and independent claim count can be used. These metrics help in assessing the scope and potential impact of the patent on innovation and competition[3].
Conclusion
The United States Patent 10,857,137 is a critical component of the patent landscape surrounding Valbenazine. Its claims and scope are designed to protect the exclusivity of the drug, while the broader patent landscape involves multiple patents and ongoing litigation. Understanding this patent and its implications is essential for both the innovator company, Neurocrine Biosciences, and generic manufacturers seeking to enter the market.
Key Takeaways
- Patent Scope and Claims: The '137 patent includes method of use and composition claims that protect the exclusivity of Valbenazine.
- Patent Landscape: The patent is part of a complex landscape involving multiple related patents and ongoing litigation.
- Litigation and Challenges: The patent has been involved in several lawsuits against generic manufacturers, highlighting the importance of navigating these patents carefully.
- Impact on Generic Manufacturers: Generic companies must submit Paragraph IV certifications and navigate the patent landscape to avoid infringement.
- Metrics for Patent Scope: Independent claim length and count can help measure the scope and impact of the patent.
FAQs
Q: What is the primary use of Valbenazine, the drug protected by the '137 patent?
A: Valbenazine is primarily used to treat tardive dyskinesia and chorea associated with Huntington's disease[4].
Q: What is the estimated expiration date of the '137 patent?
A: The '137 patent is estimated to expire on October 10, 2037[4].
Q: What are Paragraph IV certifications, and how do they relate to the '137 patent?
A: Paragraph IV certifications are statements submitted by generic manufacturers to the FDA, arguing that the patents covering the brand-name drug are invalid, unenforceable, or will not be infringed by their generic version. This has led to litigation involving the '137 patent[2][5].
Q: How does the '137 patent fit into the broader patent landscape for Valbenazine?
A: The '137 patent is one of several patents held by Neurocrine Biosciences, Inc., covering various aspects of Valbenazine, including its composition and method of use[2][5].
Q: What metrics can be used to measure the scope of the '137 patent?
A: Metrics such as independent claim length and independent claim count can be used to measure the scope and potential impact of the patent[3].
