Analyzing the Scope and Claims of United States Patent 10,894,039: Amlodipine Formulations
Introduction
United States Patent 10,894,039, titled "Amlodipine Formulations," is a significant patent in the pharmaceutical industry, particularly in the treatment of hypertension and coronary artery disease (CAD). This patent, assigned to Silvergate Pharmaceuticals, Inc., is part of a series of patents related to amlodipine formulations. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background of Amlodipine
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, increasing blood and oxygen supply to the heart, and reducing the heart's workload[1].
Patent Overview
Issuance and Expiration
The patent was issued on January 19, 2021, and is set to expire on October 6, 2037[2].
Inventors and Assignee
The inventors listed are Brauer Scott and Mosher Gerold L., with Silvergate Pharmaceuticals, Inc. as the assignee[2].
Scope of the Patent
Claims
The patent provides claims related to stable amlodipine oral liquid formulations. Here are some key aspects of the claims:
- Formulations: The patent describes methods for preparing stable amlodipine oral liquid formulations. These formulations are designed to treat diseases such as hypertension and CAD[2][4].
- Components: The formulations include amlodipine besylate, sodium benzoate, and other additives. The patent specifies that amlodipine benzoate can be produced in situ by mixing these components[1][2].
- Stability: The formulations are stable at 25 °C for at least 12 months, which is crucial for maintaining the efficacy of the medication[1].
Claim Construction
The claim construction is a critical aspect of patent analysis. For U.S. Patent 10,894,039, the claims themselves provide substantial guidance on the meaning of particular claim terms. Here are some key points from the claim construction analysis:
- Order of Actions: The patent does not mandate a specific order of actions. The use of roman numerals in the claims does not imply a sequence, but rather allows for easy reference to specific steps or actions in dependent claims[1].
- Comprising: The use of the word "comprising" in the claims supports alternative sequences, allowing for additional actions to be included without disrupting the claimed sequence[1].
Patent Landscape
Related Patents
Several patents are related to U.S. Patent 10,894,039, all focusing on amlodipine formulations:
- U.S. Patent 10,695,329: Issued on June 30, 2020, this patent also covers stable amlodipine oral liquid formulations and methods for treating hypertension and CAD[2].
- U.S. Patent 10,799,453: Issued on October 13, 2020, this patent is similar in scope, covering stable amlodipine liquid formulations[2].
- U.S. Patent 10,952,998: Issued on March 23, 2021, this patent further expands on the stable amlodipine oral liquid formulations[2].
Patent Expiration Dates
All these related patents have similar expiration dates, primarily around October 6, 2037, which indicates a coordinated strategy in protecting the intellectual property related to amlodipine formulations[2].
Impact on the Pharmaceutical Industry
Treatment of Hypertension and CAD
The formulations described in U.S. Patent 10,894,039 are crucial for the treatment of hypertension and CAD. Amlodipine is widely used for these conditions, and the stable liquid formulations provide a convenient and effective delivery method[4].
Market Exclusivity
The patent and any associated exclusivity periods granted by the FDA provide Silvergate Pharmaceuticals, Inc. with a competitive advantage in the market. This exclusivity can run simultaneously with the patent and can last from 180 days to seven years, depending on the circumstances[2].
Legal and Regulatory Considerations
Patent Scope and Quality
The scope of the patent is an important aspect in debates over patent quality. Metrics such as independent claim length and independent claim count can be used to measure patent scope. Narrower claims are often associated with a higher probability of grant and a shorter examination process[3].
Litigation and Licensing
The clarity and validity of the patent claims are crucial in avoiding litigation and licensing issues. The prosecution history and claim construction analysis play significant roles in determining the patent's scope and validity[1].
Key Takeaways
- Stable Formulations: U.S. Patent 10,894,039 covers stable amlodipine oral liquid formulations, which are essential for treating hypertension and CAD.
- Claim Construction: The patent does not mandate a specific order of actions, and the use of "comprising" allows for flexibility in the formulation process.
- Related Patents: Several related patents exist, all focusing on amlodipine formulations and expiring around the same date.
- Market Impact: The patent provides a competitive advantage to Silvergate Pharmaceuticals, Inc., and is crucial for the effective treatment of hypertension and CAD.
- Legal Considerations: The patent's scope and quality are important in avoiding litigation and ensuring the validity of the claims.
FAQs
What is the primary use of the formulations described in U.S. Patent 10,894,039?
The primary use is for the treatment of hypertension and coronary artery disease (CAD).
Who are the inventors and assignee of U.S. Patent 10,894,039?
The inventors are Brauer Scott and Mosher Gerold L., and the assignee is Silvergate Pharmaceuticals, Inc.
What is the significance of the word "comprising" in the patent claims?
The word "comprising" allows for flexibility in the formulation process, enabling additional actions or components without disrupting the claimed sequence.
When does U.S. Patent 10,894,039 expire?
The patent is set to expire on October 6, 2037.
How does the patent impact the pharmaceutical industry?
The patent provides a competitive advantage to Silvergate Pharmaceuticals, Inc., and ensures the availability of stable amlodipine oral liquid formulations for treating hypertension and CAD.
Sources
- Azurity Pharm. v. Amneal Pharm., Civ. 21-08717 (GC) - Casetext
- Generic Katerzia Availability - Drugs.com
- Patent Claims and Patent Scope - Search eLibrary :: SSRN
- US10894039B2 - Amlodipine formulations - Google Patents
