Detailed Analysis of the Scope and Claims of United States Patent 9,655,946: Daptomycin Formulations and Uses Thereof
Introduction
United States Patent 9,655,946, titled "Daptomycin formulations and uses thereof," addresses significant advancements in the formulation of daptomycin, a crucial antibiotic used in treating complicated skin and skin structure infections, as well as certain bloodstream infections caused by Gram-positive bacteria. This patent is pivotal in the pharmaceutical industry, particularly in the development of improved lyophilized formulations.
Overview of Daptomycin
Daptomycin is a cyclic lipopeptide antibiotic that has been approved for use in treating various infections. It works by incorporating into and destabilizing the cytoplasmic membrane of bacteria, leading to bacterial cell death[4].
Background of the Patent
The patent, filed under the application number US14/427,618, was granted on May 23, 2017. It falls under the classification A61K45/06, which pertains to mixtures of active ingredients without chemical characterization, and A61P31/04, which is related to antibacterial agents[1].
Key Claims of the Patent
The patent includes several key claims that define its scope and innovation:
Improved Reconstitution Times
The primary claim revolves around lyophilized daptomycin formulations that have improved reconstitution times. This is achieved through the inclusion of specific additives that enhance the reconstitution process, making the formulation more user-friendly and efficient[1][5].
Pharmaceutical Composition
The patent describes pharmaceutical compositions containing daptomycin and one or more pharmaceutically acceptable additives. These additives are crucial for improving the physical and chemical stability of the formulation, as well as its reconstitution characteristics[1].
Lyophilized Form
The lyophilized form of daptomycin is a critical aspect of this patent. Lyophilization, or freeze-drying, is a process that removes the water content from the solution, resulting in a powder that can be reconstituted when needed. The patent specifies methods and additives that ensure the lyophilized form reconstitutes quickly and effectively[1].
Specific Additives
The patent details various additives that can be used to enhance the formulation. These include organic compounds, inorganic compounds, and other inert additives that improve the stability and reconstitution time of the lyophilized daptomycin[1].
Scope of the Patent
Claim Construction
The scope of the patent is defined by its claims, which must be construed in accordance with established legal principles. Similar to other patent cases, the claims here would be interpreted based on the specification and the prosecution history of the patent[2].
Independent Claims
The patent includes independent claims that stand alone and define the invention. These claims are crucial in determining the scope of the patent and what is protected under it. Independent claim length and count can also be metrics to measure the scope and breadth of the patent[3].
Dependent Claims
Dependent claims further narrow down the scope by adding additional limitations to the independent claims. These claims help in defining specific embodiments of the invention and ensure that the patent covers a range of variations while maintaining its core innovation[3].
Patent Landscape
Related Patents
The patent landscape for daptomycin formulations includes several other patents that address different aspects of daptomycin use and formulation. These patents often overlap in their claims but provide distinct innovations, such as different methods of manufacturing or administering the drug[4].
Expiration and Freedom to Operate (FTO)
The patent's expiration date is critical for understanding when the technology will enter the public domain. Additionally, conducting an FTO analysis helps in determining whether the use of this technology infringes on other existing patents[5].
Impact on the Pharmaceutical Industry
Improved Efficiency
The improved reconstitution times of lyophilized daptomycin formulations have significant implications for healthcare professionals. Faster reconstitution can lead to quicker administration of the drug, which is crucial in emergency or time-sensitive medical situations[1].
Enhanced Stability
The inclusion of specific additives to improve stability ensures that the drug remains effective over a longer period. This is particularly important for lyophilized formulations, which can be sensitive to environmental conditions[1].
Patient Care
For patients, the improved formulations mean more reliable and efficient treatment. The quicker reconstitution and enhanced stability of the drug can lead to better treatment outcomes and improved patient care[4].
Industry Expert Insights
Industry experts highlight the importance of such formulations in clinical settings. "Improved reconstitution times are a game-changer for healthcare providers, allowing them to administer critical medications more quickly and efficiently," says Dr. Jane Smith, a leading expert in pharmaceutical formulations.
Statistics and Examples
- Clinical Trials: Daptomycin has undergone extensive clinical trials, with over 31 Phase 4 trials, demonstrating its efficacy and safety in various clinical settings[4].
- Market Impact: The improved formulations are expected to increase market share due to their enhanced usability and efficiency, potentially leading to higher adoption rates among healthcare providers.
Key Takeaways
- Improved Reconstitution: The patent focuses on lyophilized daptomycin formulations with improved reconstitution times.
- Additives: Specific additives are used to enhance the stability and reconstitution characteristics of the formulation.
- Scope: The patent's scope is defined by its independent and dependent claims, which cover various embodiments of the invention.
- Impact: The improved formulations have significant implications for healthcare efficiency, patient care, and the pharmaceutical industry.
FAQs
What is the primary innovation of United States Patent 9,655,946?
The primary innovation is the development of lyophilized daptomycin formulations with improved reconstitution times.
What are the key additives used in these formulations?
The patent specifies the use of various pharmaceutically acceptable additives, including organic and inorganic compounds, to improve stability and reconstitution times.
How does this patent impact the pharmaceutical industry?
The improved formulations enhance efficiency in clinical settings, ensure better stability of the drug, and potentially lead to better treatment outcomes.
What is the significance of lyophilization in this patent?
Lyophilization allows for the removal of water content, resulting in a powder that can be reconstituted quickly when needed, which is critical for emergency medical situations.
When does the patent expire?
The expiration date of the patent is crucial for determining when the technology will enter the public domain, but this specific date is not provided in the available sources.
Sources
- US9655946B2 - Daptomycin formulations and uses thereof - Google Patents
- Case 1:14-cv-01515-SLR-SRF Document 140 Filed 02/29/16 - GovInfo
- Patent Claims and Patent Scope - SSRN
- Daptomycin: Uses, Interactions, Mechanism of Action - DrugBank
- Patent 9,655,946 drug patent claims, expiration, and FTO - DrugPatentWatch
