United States Patent 10,695,329: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 10,695,329, titled "Amlodipine formulations," is a significant patent in the pharmaceutical industry, particularly in the development and manufacture of amlodipine oral liquid formulations. This patent, assigned to Silvergate Pharmaceuticals, Inc., plays a crucial role in the treatment of hypertension and coronary artery disease.
Patent Overview
Issuance and Expiration
The patent was issued on June 30, 2020, and is set to expire on October 16, 2037[5].
Inventors and Assignees
The inventors listed on the patent are Scott Brauer and Gerold L. Mosher, with Silvergate Pharmaceuticals, Inc. as the assignee[5].
Scope of the Patent
Subject Matter
The patent is directed to stable amlodipine oral liquid formulations. Amlodipine is a calcium channel blocker that affects the movement of calcium into the cells of the heart and blood vessels, thereby relaxing blood vessels and increasing the supply of blood and oxygen to the heart while reducing its workload[1].
Claims
The patent includes claims related to the composition and method of preparation of these oral liquid formulations. The claims are structured to define the scope of the patented invention, including the specific components and steps involved in preparing the formulations. For instance, the claims may specify the types and amounts of surfactants, solvents, and other additives used in the formulation[4].
Claim Construction
Claim construction is a critical aspect of patent law, as it determines the scope of protection afforded by the patent. The court looks to the words of the claims themselves, as well as the specification and prosecution history, to define the scope of the patented invention.
- Claim Language: The claims themselves provide substantial guidance as to the meaning of particular claim terms. The context in which a term is used in the asserted claim and other claims of the patent are considered[1].
- Specification: The specification is highly relevant and often dispositive in claim construction analysis. It serves as the single best guide to the meaning of a disputed term[1].
- Prosecution History: The prosecution history, including any amendments made during the application process, can provide additional guidance on the scope of the claims. For example, in the case of Azurity Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC, the prosecution history was used to argue the sequential nature of the process steps in the patent claims[1].
Patent Landscape
Related Patents
The patent landscape surrounding U.S. Patent 10,695,329 includes several other patents related to amlodipine formulations. These include:
- U.S. Patent 10,799,453: Also assigned to Silvergate Pharmaceuticals, Inc., this patent is directed to the formulation of a liquid form of amlodipine and is part of the same litigation involving Azurity Pharmaceuticals, Inc. and Amneal Pharmaceuticals, LLC[1][5].
- U.S. Patent 10,894,039: This patent, along with others such as 10,952,998, 10,959,991, 11,364,230, 11,471,409, and 11,484,498, are also related to amlodipine formulations and have similar expiration dates in 2037[2][5].
Litigation and Regulatory Status
Litigation involving these patents is ongoing. For instance, Azurity Pharmaceuticals, Inc. initiated litigation against Amneal Pharmaceuticals, LLC for infringement of the '329 and '453 patents within the statutory 45-day period. This litigation affects the approval of Amneal's ANDA (Abbreviated New Drug Application) for Amlodipine Benzoate Oral Suspension, as final approval cannot be granted until the court decides on the validity or infringement of these patents[2].
Impact on Generic Drug Approval
The presence of these patents and ongoing litigation significantly impacts the approval process for generic versions of amlodipine oral liquid formulations. Generic drug manufacturers must navigate the complex landscape of patent claims and litigation to avoid infringement. The FDA cannot grant final approval for a generic drug until the patent issues are resolved, either through the expiration of the 30-month stay period or a court decision declaring the patents invalid or not infringed[2].
Metrics for Patent Scope
The scope of a patent can be measured using various metrics, such as independent claim length and independent claim count. These metrics can provide insights into the breadth and clarity of the patent claims. For example, narrower claims are associated with a higher probability of grant and a shorter examination process, while broader claims may lead to longer and more complex prosecutions[3].
Industry Implications
The patent landscape surrounding amlodipine formulations has significant implications for the pharmaceutical industry. It highlights the importance of patent strategy and litigation in protecting intellectual property and delaying generic competition. Companies must carefully navigate this landscape to ensure compliance with patent laws and to protect their market position.
Key Takeaways
- Patent Scope: The patent defines stable amlodipine oral liquid formulations and includes specific claims related to composition and preparation.
- Claim Construction: The scope of the patent is determined by claim language, specification, and prosecution history.
- Related Patents: Several other patents related to amlodipine formulations are part of the same patent family and litigation.
- Litigation and Regulatory Status: Ongoing litigation affects the approval of generic versions of amlodipine oral liquid formulations.
- Industry Implications: The patent landscape is crucial for pharmaceutical companies to protect their intellectual property and market position.
Frequently Asked Questions (FAQs)
What is the main subject matter of U.S. Patent 10,695,329?
The main subject matter of U.S. Patent 10,695,329 is stable amlodipine oral liquid formulations used for treating hypertension and coronary artery disease.
Who are the inventors and assignees of this patent?
The inventors are Scott Brauer and Gerold L. Mosher, and the assignee is Silvergate Pharmaceuticals, Inc.
How does the prosecution history impact claim construction?
The prosecution history, including any amendments made during the application process, can provide additional guidance on the scope of the claims and may clarify the intent of the patentee and the examiner.
What is the impact of this patent on generic drug approval?
The patent and related litigation delay the approval of generic versions of amlodipine oral liquid formulations until the patent issues are resolved through court decisions or the expiration of the 30-month stay period.
How can the scope of a patent be measured?
The scope of a patent can be measured using metrics such as independent claim length and independent claim count, which provide insights into the breadth and clarity of the patent claims.
Cited Sources:
- Azurity Pharm. v. Amneal Pharm., Civ. 21-08717 (GC)
- Amlodipine Benzoate Oral Suspension - accessdata.fda.gov
- Patent Claims and Patent Scope - Hoover Institution
- US10695329B2 - Amlodipine formulations - Google Patents
- Generic Katerzia Availability - Drugs.com
