Understanding the Scope and Claims of United States Patent 10,159,657: Norepinephrine Compositions and Methods
Introduction
United States Patent 10,159,657, titled "Norepinephrine compositions and methods therefor," is a significant patent in the pharmaceutical industry, particularly in the field of critical care medications. This patent, along with several related patents, addresses the need for stable, ready-to-inject norepinephrine formulations. Here, we will delve into the details of the patent's scope, claims, and the broader patent landscape.
Background
Norepinephrine is a sympathomimetic agent used to control blood pressure in various hypotensive states, such as septic shock and neurogenic shock, and as an adjunct treatment during cardiac arrest[4].
Patent Overview
The patent in question, U.S. Patent 10,159,657, is part of a series of patents directed to compositions and methods for ready-to-inject norepinephrine compositions with improved stability. These patents share a common specification and aim to address the need for stable, low-concentration, ready-to-inject, and antioxidant-free norepinephrine formulations[1].
Claims and Scope
Key Components
The patented compositions typically include:
- Norepinephrine or a salt thereof: In an aqueous acidic solution.
- A chelating agent: Part of the aqueous solution.
- A tonicity agent: Also included in the solution[1].
Stability Requirements
The compositions must be substantially free of antioxidants and maintain at least about 90% of the R-isomer of norepinephrine after storage at specific conditions (25±2° C. and 60±5% relative humidity) for at least three months, as determined by High-Performance Liquid Chromatography (HPLC)[1].
Claim Construction
The claim construction is crucial for understanding the scope of the patent. The court has emphasized that where a claim lists elements separately, the clear implication is that those elements are distinct components of the patented invention. This was highlighted in the case of Baxter Healthcare Corp. v. Nevakar Injectables Inc., where the court adopted specific constructions for the claim terms to ensure clarity and distinctness of the components[1].
Related Patents
The patent landscape includes several related patents that share a common specification:
- U.S. Patent 10,420,735: Addresses similar compositions and methods.
- U.S. Patent 10,471,026: Part of the same family of patents.
- U.S. Patent 10,568,850: Another patent in the series.
- U.S. Patent 10,646,458: Also related to the norepinephrine compositions.
- U.S. Patent 11,602,508: The latest in the series, with similar claims and scope[1].
Litigation and Claim Disputes
The patents have been involved in litigation, notably in the case of Baxter Healthcare Corp. v. Nevakar Injectables Inc.. Here, Baxter sought a declaratory judgment that its norepinephrine products did not infringe the patents-in-suit, while Nevakar alleged infringement. The court's decision on claim construction is critical in resolving these disputes[1].
Patent Scope Metrics
The scope of these patents can be analyzed using metrics such as independent claim length and independent claim count. These metrics help in understanding the breadth and clarity of the patent claims. Research has shown that narrower claims are associated with a higher probability of grant and a shorter examination process, indicating better patent quality[3].
Practical Implications
The stability and ready-to-inject nature of these norepinephrine compositions are crucial for clinical use. The patents ensure that the formulations meet specific standards, which is vital for patient safety and treatment efficacy. For manufacturers, understanding the scope and claims of these patents is essential to avoid infringement and to develop compliant products.
Industry Impact
The development and protection of these norepinephrine compositions reflect the ongoing efforts in the pharmaceutical industry to improve critical care medications. These patents contribute to the advancement of medical treatments by ensuring the availability of stable and effective norepinephrine formulations.
Key Takeaways
- Stability and Composition: The patents focus on stable, ready-to-inject norepinephrine compositions free of antioxidants.
- Claim Construction: Clear and distinct components are essential for understanding the patent scope.
- Related Patents: Several patents share a common specification, addressing similar compositions and methods.
- Litigation: Claim disputes are resolved through detailed claim construction and litigation.
- Patent Scope Metrics: Independent claim length and count help in assessing patent breadth and clarity.
- Industry Impact: These patents are crucial for advancing critical care medications and ensuring patient safety.
FAQs
What is the primary focus of U.S. Patent 10,159,657?
The primary focus is on compositions and methods for ready-to-inject norepinephrine with improved stability.
What are the key components of the patented norepinephrine compositions?
The compositions include norepinephrine or a salt thereof in an aqueous acidic solution, a chelating agent, and a tonicity agent.
Why is stability important in these norepinephrine compositions?
Stability is crucial to ensure that the norepinephrine maintains its efficacy and safety over time, particularly under specific storage conditions.
How are claim disputes resolved in relation to these patents?
Claim disputes are resolved through detailed claim construction and litigation, as seen in the case of Baxter Healthcare Corp. v. Nevakar Injectables Inc.
What metrics can be used to analyze the scope of these patents?
Independent claim length and independent claim count are metrics used to analyze the breadth and clarity of the patent claims.
Sources
- Baxter Healthcare Corp. v. Nevakar Injectables Inc. - Casetext
- US11413259B2 - Norepinephrine compositions and methods therefor - Google Patents
- Patent Claims and Patent Scope - Hoover Institution
- Norepinephrine: Uses, Interactions, Mechanism of Action - DrugBank
- US Patent 10159657 Norepinephrine compositions and methods therefor - Golden Wiki
