United States Patent 10,065,952: A Detailed Analysis of Scope and Claims
Introduction
The United States Patent 10,065,952, hereafter referred to as the '952 patent, is a significant patent in the pharmaceutical sector, particularly related to the formulation and composition of valbenazine, a drug used for treating tardive dyskinesia. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background of the Patent
The '952 patent is associated with Neurocrine Biosciences, Inc. and is part of a series of patents related to valbenazine formulations. Valbenazine is a vesicular monoamine transporter 2 (VMAT2) inhibitor used to treat tardive dyskinesia, a side effect of long-term use of antipsychotic drugs[5].
Scope of the Patent
The scope of the '952 patent is defined by its claims, which outline the specific aspects of the invention that are protected. Here are some key points:
Claims Overview
The patent includes multiple claims that describe the composition, formulation, and methods related to valbenazine. These claims are divided into independent and dependent claims.
-
Independent Claims: These claims stand alone and define the broadest scope of the invention. For example, Claim 1 might describe a solid drug formulation comprising valbenazine or its ditosylate salt, along with specific excipients such as binders, disintegrants, and lubricants[4].
-
Dependent Claims: These claims build upon the independent claims and provide more specific details. For instance, a dependent claim might specify the weight percentage of each component in the formulation.
Claim Language and Clarity
The clarity and specificity of claim language are crucial for determining patent scope. The '952 patent follows the standard practice of using precise language to describe the invention, ensuring that the claims are clear and unambiguous. This clarity helps in avoiding potential disputes over the scope of the patent[3].
Patent Claims Analysis
Independent Claim Length and Count
Research has shown that the length and count of independent claims can be metrics for measuring patent scope. The '952 patent, like many others, has multiple independent claims, each detailing a different aspect of the invention. The length of these claims can vary, but they are generally concise and focused on the core elements of the invention[3].
Claim Scope Narrowing
During the patent examination process, the scope of claims can be narrowed to ensure that the patent is granted with clear and valid claims. The '952 patent would have undergone this process, resulting in claims that are both specific and enforceable[3].
Patent Landscape
The '952 patent is part of a larger landscape of patents related to valbenazine and its formulations.
Related Patents
Several other patents are associated with Neurocrine Biosciences, Inc., including U.S. Patent Nos. 10,844,058, 10,851,103, 10,851,104, and others. These patents collectively cover various aspects of valbenazine formulations, methods of use, and compositions[2][5].
Litigation and Enforcement
The '952 patent has been involved in litigation, particularly in cases related to generic drug approvals. For example, Neurocrine Biosciences, Inc. has filed suits against Teva Pharmaceuticals, Inc. alleging infringement of this and other related patents. These legal actions highlight the importance of this patent in protecting the intellectual property related to valbenazine[2].
Expiration and Exclusivity
The '952 patent has an expiration date of October 28, 2036. This date is critical as it marks the end of the exclusive rights granted to the patent holder. After this date, the technology described in the patent will enter the public domain, allowing other companies to manufacture and market similar products without infringing on the patent[5].
Regulatory Aspects
The '952 patent is listed in the FDA's Orange Book, which is a publication that identifies drug products approved on the basis of safety and effectiveness by the FDA. The listing in the Orange Book indicates that any generic version of valbenazine would need to address the patents listed, including the '952 patent, to gain approval[5].
Impact on Innovation and Competition
The '952 patent, along with other related patents, plays a significant role in the pharmaceutical industry by protecting innovative formulations and compositions. While these patents can create barriers to entry for generic manufacturers, they also incentivize further innovation by providing a period of exclusivity for the patent holder to recoup investment in research and development[3].
Key Takeaways
- Scope and Claims: The '952 patent has specific claims that define the composition and formulation of valbenazine, including the use of binders, disintegrants, and lubricants.
- Patent Landscape: The patent is part of a broader landscape of patents related to valbenazine, with multiple related patents covering various aspects of the drug.
- Litigation: The patent has been involved in litigation to protect the intellectual property rights of Neurocrine Biosciences, Inc.
- Expiration: The patent expires on October 28, 2036, marking the end of exclusive rights.
- Regulatory: Listed in the FDA's Orange Book, indicating its importance in regulatory approvals.
FAQs
Q: What is the main subject of the '952 patent?
A: The '952 patent is related to the formulation and composition of valbenazine, a drug used to treat tardive dyskinesia.
Q: Who is the patent holder of the '952 patent?
A: The patent holder is Neurocrine Biosciences, Inc.
Q: What are the key components of the valbenazine formulation described in the '952 patent?
A: The formulation includes valbenazine or its ditosylate salt, along with binders, disintegrants, and lubricants.
Q: Has the '952 patent been involved in any litigation?
A: Yes, it has been involved in litigation against Teva Pharmaceuticals, Inc. to protect the intellectual property rights.
Q: When does the '952 patent expire?
A: The patent expires on October 28, 2036.
Cited Sources
- United States Patent and Trademark Office - High dosage valbenazine formulation and compositions, methods [4].
- Insight.RPXCorp - Civil Action No. COMPLAINT FOR PATENT INFRINGEMENT [2].
- Hoover Institution - Patent Claims and Patent Scope [3].
- FDA - ANDA 216064 [5].
