Analyzing the Scope and Claims of United States Patent 11,162,500: A Detailed Examination
Introduction
United States Patent 11,162,500 is a significant patent that falls within the pharmaceutical sector, specifically related to the formulation and use of etelcalcetide, a calcium-sensing receptor agonist. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background on Etelcalcetide
Etelcalcetide, also known as AMG 416, is a peptide agonist used to treat secondary hyperparathyroidism in patients with chronic kidney disease who require hemodialysis[1][4].
Patent Overview
The patent in question, US 11,162,500, is part of a series of patents related to etelcalcetide and its formulations. Here is a brief overview:
- Publication Number: US 11,162,500
- Title: This patent is likely related to a stable liquid formulation of etelcalcetide, given the context of other patents in the series[4].
Scope of the Patent
The scope of US 11,162,500 can be understood through several key aspects:
Claims
The patent claims are crucial in defining the scope of the invention. For etelcalcetide formulations, these claims typically include:
- The composition of the liquid formulation, including the concentration of etelcalcetide and other components such as succinate.
- The method of preparing the formulation to ensure stability.
- The method of using the formulation for treating secondary hyperparathyroidism[4].
Independent Claim Length and Count
Research on patent scope suggests that independent claim length and count can be metrics for measuring the breadth and clarity of a patent. Longer and more numerous independent claims may indicate a broader scope but could also suggest complexity and potential ambiguity[3].
Claims Analysis
To understand the specific claims of US 11,162,500, we need to look at the detailed description provided in the patent document.
Composition Claims
These claims would specify the exact formulation of etelcalcetide, including the peptide itself, any stabilizers, and the concentration of each component.
Method Claims
These claims would outline the process of preparing the liquid formulation and the method of administering it to patients.
Use Claims
These claims would define the therapeutic use of the formulation, specifically its application in treating secondary hyperparathyroidism.
Patent Landscape
The patent landscape surrounding US 11,162,500 is complex and involves several key players and considerations:
Related Patents
There are multiple patents related to etelcalcetide, including US 10344765B2, which also deals with stable liquid formulations of the drug. These patents collectively protect various aspects of the drug's formulation, preparation, and use[1][4].
Litigation and Enforcement
Patents in the pharmaceutical sector are often subject to litigation, particularly when generic manufacturers seek to enter the market. The validity and enforceability of these patents are frequently challenged in court. For example, settlements and dismissals in ANDA (Abbreviated New Drug Application) litigation highlight the ongoing legal battles in this space[5].
Expiry Dates and Extensions
The patent expiry dates are crucial for understanding the market exclusivity period. For etelcalcetide-related patents, the estimated expiry dates range from 2030 to 2034, depending on the specific patent and any extensions or pediatric exclusivity granted[1].
Industry Impact
The scope and claims of US 11,162,500 have significant implications for the pharmaceutical industry:
Innovation and Competition
Broad and clear claims can protect the innovation while discouraging generic competition. However, overly broad or unclear claims can lead to litigation and diminish innovation incentives[3].
Market Exclusivity
The patent's scope determines the period of market exclusivity for the drug, affecting the timing of generic entry and the overall market dynamics.
Key Takeaways
- Specific Claims: The patent's claims define the exact formulation, preparation method, and therapeutic use of etelcalcetide.
- Scope Metrics: Independent claim length and count can indicate the breadth and clarity of the patent.
- Related Patents: Multiple patents protect different aspects of etelcalcetide, ensuring comprehensive protection.
- Litigation: The patent's validity and enforceability are subject to legal challenges, particularly from generic manufacturers.
- Market Impact: The patent's scope influences market exclusivity and competition in the pharmaceutical sector.
FAQs
Q: What is the primary use of etelcalcetide?
A: Etelcalcetide is used to treat secondary hyperparathyroidism in patients with chronic kidney disease who require hemodialysis.
Q: What are the key components of the patent claims for US 11,162,500?
A: The claims include the composition of the liquid formulation, the method of preparing it, and the method of using it for therapeutic purposes.
Q: How do independent claim length and count affect the patent scope?
A: Longer and more numerous independent claims can indicate a broader scope but may also suggest complexity and potential ambiguity.
Q: What is the estimated expiry date for patents related to etelcalcetide?
A: The estimated expiry dates range from 2030 to 2034, depending on the specific patent and any extensions.
Q: How does the patent landscape impact the pharmaceutical industry?
A: The patent scope influences market exclusivity, innovation incentives, and competition, particularly affecting the timing of generic entry.
Sources
- DrugBank: Etelcalcetide: Uses, Interactions, Mechanism of Action.
- IP Watchdog: Patent Filings Roundup: Intel Cancels Qualcomm Claims on Remand.
- Hoover Institution: Patent Claims and Patent Scope.
- Google Patents: Stable liquid formulation of AMG 416 (etelcalcetide).
- Robins Kaplan LLP: ANDA Litigation Settlements | Hatch-Waxman.
