Detailed Analysis of the Scope and Claims of United States Patent 11,241,400
Introduction
United States Patent 11,241,400, titled "Compositions comprising ephedrine or an ephedrine salt and methods of making and using same," is a significant patent held by Nexus Pharmaceuticals, Inc. This patent is crucial for the production and use of ephedrine sulfate injections, particularly the EMERPHED® product. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Patent Overview
Issuance and Assignee
The patent was issued on February 8, 2022, to Nexus Pharmaceuticals, Inc., with Ahmed Shahid listed as the inventor[4][5].
Scope of the Patent
Compositions and Methods
The patent covers compositions comprising ephedrine or an ephedrine salt, specifically ephedrine sulfate, that are ready for immediate use in a clinical setting. It includes detailed methods of making and using these compositions. The focus is on providing a stable and ready-to-use formulation of ephedrine sulfate, which is essential for medical applications, particularly in managing hypotension[1][5].
Claims of the Patent
Composition Claims
The patent claims encompass various aspects of the composition, including:
- The formulation of ephedrine sulfate in a solution that is stable and ready for immediate clinical use.
- Specific concentrations and formulations to ensure efficacy and safety.
- The inclusion of preservative agents and other stabilizers to maintain the integrity of the solution[1].
Method Claims
The method claims cover the processes involved in manufacturing these compositions, including:
- Steps for preparing the ephedrine sulfate solution.
- Methods for ensuring the sterility and stability of the final product.
- Procedures for packaging and storing the solution to maintain its effectiveness[1].
Patent Landscape
Related Patents
Nexus Pharmaceuticals holds a series of patents related to EMERPHED®, including:
- U.S. Patent No. 11,090,278
- U.S. Patent No. 11,426,369
- U.S. Patent No. 11,464,752
- U.S. Patent No. 11,478,436
- U.S. Patent No. 11,571,398
These patents collectively protect various aspects of the EMERPHED® product, including its composition, methods of manufacture, and use[4][5].
Patent Expiration Dates
All the related patents, including U.S. Patent 11,241,400, have expiration dates set for May 16, 2040. This extended protection period ensures that Nexus Pharmaceuticals maintains exclusive rights to the EMERPHED® product and its manufacturing processes for nearly two decades[5].
Litigation and Enforcement
Patent Infringement
The patent is currently involved in a litigation case where Nexus Pharmaceuticals is alleging patent infringement against Gland Pharma Limited. Gland Pharma submitted an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of EMERPHED®, which Nexus claims infringes on their patents, including U.S. Patent 11,241,400[2].
Impact on the Pharmaceutical Industry
Innovation and Patient Safety
The patent reflects Nexus Pharmaceuticals' commitment to innovation and patient safety. The ready-to-use ephedrine sulfate injection addresses critical needs in clinical settings, particularly in managing hypotension during surgical procedures. This innovation enhances the efficiency and safety of medical treatments[4].
Competitive Landscape
The robust patent protection around EMERPHED® creates a significant barrier to entry for generic manufacturers. This allows Nexus Pharmaceuticals to maintain market dominance and protect its investment in research and development. However, it also raises concerns about the potential for higher costs and reduced access to essential medications due to the lack of generic alternatives[2][5].
Metrics for Patent Scope
Claim Length and Count
Research on patent scope suggests that metrics such as independent claim length and independent claim count can be used to measure the breadth of a patent. Narrower claims, as seen in U.S. Patent 11,241,400, are often associated with a higher probability of grant and a shorter examination process. This indicates that the patent is well-defined and specific, reducing the likelihood of disputes over its scope[3].
Key Takeaways
- Composition and Methods: The patent covers specific compositions of ephedrine sulfate and detailed methods for their manufacture and use.
- Patent Protection: The patent is part of a series of patents protecting the EMERPHED® product, with all related patents expiring on May 16, 2040.
- Litigation: The patent is involved in a patent infringement case against Gland Pharma Limited.
- Industry Impact: The patent enhances innovation and patient safety but also influences the competitive landscape by protecting Nexus Pharmaceuticals' market position.
FAQs
What is the main subject of U.S. Patent 11,241,400?
The main subject of U.S. Patent 11,241,400 is compositions comprising ephedrine or an ephedrine salt, specifically ephedrine sulfate, and methods for making and using these compositions in a clinical setting.
Who is the assignee of U.S. Patent 11,241,400?
The assignee of U.S. Patent 11,241,400 is Nexus Pharmaceuticals, Inc.
What is the expiration date of U.S. Patent 11,241,400?
The expiration date of U.S. Patent 11,241,400 is May 16, 2040.
Is U.S. Patent 11,241,400 involved in any litigation?
Yes, U.S. Patent 11,241,400 is involved in a patent infringement case against Gland Pharma Limited.
How does U.S. Patent 11,241,400 impact the pharmaceutical industry?
The patent enhances innovation and patient safety by providing a stable and ready-to-use formulation of ephedrine sulfate. However, it also maintains a competitive barrier, potentially affecting the availability and cost of generic alternatives.
Sources
- US11241400B2 - Compositions comprising ephedrine or an ephedrine salt and methods of making and using same - Google Patents
- Case 1:23-cv-02032-CPO-EAP Document 1 Filed 04/10/23 - Insight.RPXCorp
- Patent Claims and Patent Scope - SSRN
- Patent - EMERPHED® - EMERPHED
- Generic Emerphed Availability - Drugs.com
