United States Patent 10,952,998: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 10,952,998, titled "Amlodipine formulations," is a significant patent in the pharmaceutical sector, particularly in the treatment of hypertension and coronary artery disease. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Publication Number and Authority
The patent, numbered US10,952,998B2, was granted by the United States Patent and Trademark Office (USPTO)[4].
Prior Art and Background
Amlodipine is a well-known calcium channel blocker used primarily for the treatment of hypertension and coronary artery disease. The patent builds upon existing formulations by introducing stable oral liquid formulations of amlodipine.
Claims
The patent includes several key claims that define the scope of the invention:
- Claim 1: This claim describes a stable oral liquid formulation of amlodipine, which includes amlodipine or a salt thereof, and at least one stabilizing agent.
- Claim 2: This claim specifies the concentration of amlodipine in the formulation and the stability conditions, such as storage at about 25°C ± 5°C for at least 12 months.
- Claim 3: This claim details the method of treating hypertension using the oral liquid formulation, including the administration of the formulation in a fasted state[4].
Scope of the Patent
Independent Claim Length and Count
The scope of the patent can be measured using metrics such as independent claim length and count. Research suggests that narrower claims at publication are associated with a higher probability of grant and a shorter examination process[3].
Specific Embodiments
The patent describes various embodiments of the oral liquid formulation, including different stability conditions and methods of treatment. For instance, some embodiments specify the formulation's stability at about 25°C ± 5°C for at least 24 months, while others detail the treatment of primary (essential) hypertension and secondary hypertension[4].
Classification and Categorization
International Patent Classification (IPC)
The patent is classified under several IPC categories, including:
- A61K47/00: Medicinal preparations characterized by the non-active ingredients used.
- A61K47/06: Organic compounds, e.g., natural or synthetic hydrocarbons.
- A61K47/08: Organic compounds containing oxygen, e.g., ethers, acetals, ketones.
- A61K9/00: Medicinal preparations characterized by special physical form[4].
Therapeutic Activity
The patent falls under the therapeutic category of antihypertensives (A61P9/12), highlighting its application in treating disorders of the cardiovascular system[4].
Patent Landscape
Global Dossier and International Search
To understand the global patent landscape, tools like the Global Dossier and international patent databases are crucial. The Global Dossier provides access to the file histories of related applications from participating IP Offices, allowing users to see the patent family for a specific application and related citation data[1].
Searchable Databases
Other international databases such as the European Patent Office's esp@cenet, the Japan Patent Office's database, and the World Intellectual Property Organization's PATENTSCOPE ® Search Service provide comprehensive access to patent collections worldwide. These resources help in identifying similar or overlapping patents in different jurisdictions[1].
Prior Art and Citation Analysis
Common Citation Document (CCD)
The Common Citation Document (CCD) application consolidates prior art cited by all participating offices for the family members of a patent application. This tool is essential for visualizing the search results for the same invention produced by several offices on a single page[1].
Forward Citations
The number of forward citations a patent receives can indicate its impact and relevance. Research has shown that patents with narrower claims at publication tend to receive more forward citations, suggesting higher quality and broader applicability[3].
Practical Applications and Market Impact
Treatment of Hypertension and CAD
The stable oral liquid formulations of amlodipine described in the patent offer a significant improvement in the treatment of hypertension and coronary artery disease. These formulations can be particularly beneficial for patients who have difficulty swallowing tablets or require precise dosing[4].
Market Competition
The pharmaceutical market for antihypertensive medications is highly competitive. Patents like US10,952,998B2 play a crucial role in protecting intellectual property and providing a competitive edge to the patent holder. This protection can influence market dynamics, licensing agreements, and innovation strategies within the industry.
Key Takeaways
- Stable Oral Liquid Formulations: The patent introduces stable oral liquid formulations of amlodipine, enhancing the treatment options for hypertension and coronary artery disease.
- Narrow Claims: The patent's claims are specific and narrow, which is associated with a higher probability of grant and shorter examination process.
- Global Patent Landscape: Tools like the Global Dossier and international patent databases are essential for understanding the broader patent landscape.
- Therapeutic Classification: The patent is classified under antihypertensives, highlighting its therapeutic application.
- Market Impact: The patent has significant implications for the pharmaceutical market, particularly in the treatment of cardiovascular diseases.
FAQs
Q: What is the primary focus of United States Patent 10,952,998?
A: The primary focus is on stable oral liquid formulations of amlodipine for the treatment of hypertension and coronary artery disease.
Q: How can one search for similar patents internationally?
A: Using databases like the Global Dossier, esp@cenet, Japan Patent Office's database, and PATENTSCOPE ® Search Service.
Q: What are the key claims of the patent?
A: The key claims include the description of the stable oral liquid formulation, its stability conditions, and the method of treating hypertension.
Q: How does the patent's scope affect its market impact?
A: The narrow and specific claims of the patent protect the intellectual property and provide a competitive edge, influencing market dynamics and innovation strategies.
Q: What tools can be used to analyze prior art and citations for this patent?
A: Tools such as the Common Citation Document (CCD) and forward citation analysis can be used to understand the prior art and the patent's impact.
Sources
- USPTO: Search for patents - USPTO
- Unified Patents: CA-3038989-A1 - Amlodipine Formulations
- SSRN: Patent Claims and Patent Scope
- Google Patents: US10952998B2 - Amlodipine formulations
- Unified Patents: US-6451826-B2 - Unified Patents Portal
