United States Patent 11,642,370: A Detailed Analysis of Scope and Claims
Introduction
The United States Patent 11,642,370, titled "Stable, highly pure L-cysteine compositions for injection and methods of use," is a significant patent in the pharmaceutical and biomedical fields. This patent addresses the development and use of stable and highly pure L-cysteine compositions, which are crucial for various medical applications.
Background
L-cysteine is an amino acid with numerous applications in medicine, particularly in the formulation of injectable solutions. The stability and purity of L-cysteine are critical to ensure the efficacy and safety of these solutions.
Scope of the Patent
Composition and Formulation
The patent describes stable, highly pure L-cysteine compositions designed for injection. These compositions are formulated to maintain the stability and purity of L-cysteine, which is often challenging due to its reactivity and susceptibility to degradation[1].
Key Components
- L-cysteine or Pharmaceutically Acceptable Salts: The patent covers compositions that include L-cysteine or its pharmaceutically acceptable salts.
- Inert Gas: The use of inert gases to prevent oxidation and maintain the stability of the L-cysteine composition.
- Reductive Agents: The inclusion of reductive agents to prevent the formation of disulfide bonds and maintain the purity of L-cysteine.
- Particulate Matter Control: Methods to minimize particulate matter in the composition, ensuring the solution remains clear and safe for injection.
Claims
The patent includes several claims that define the scope of the invention:
Independent Claims
- Claim 1: Describes the stable, highly pure L-cysteine composition for injection, including the specific concentrations of L-cysteine and other components.
- Claim 7: Outlines the method of preparing the L-cysteine composition, including the steps of mixing, sealing, and storing under inert gas.
Dependent Claims
- Claims 2-6: Provide additional details on the composition, such as the presence of reductive agents, the control of particulate matter, and the use of specific packaging materials.
- Claims 8-12: Describe variations in the method of preparation, including different storage conditions and the use of various inert gases.
Patent Landscape
Prior Art
The patent builds upon prior art related to the stabilization and purification of amino acids. However, it introduces novel methods and compositions that address specific challenges associated with L-cysteine, such as its reactivity and tendency to form disulfide bonds[1].
Competing Patents
In the broader patent landscape, there are other patents related to amino acid compositions and stabilization methods. However, the unique combination of components and methods described in this patent distinguishes it from existing prior art.
Market Impact
The development of stable, highly pure L-cysteine compositions has significant implications for the pharmaceutical industry. These compositions can be used in a variety of injectable solutions, improving their safety and efficacy. This can lead to increased market demand and potential partnerships or licensing agreements with pharmaceutical companies.
Patent Analytics and Valuation
Claim Coverage
Using patent analytics tools, such as those described by Schwegman, it is possible to categorize and analyze the claims of this patent in relation to other patents in the field. This helps in identifying gaps in coverage and potential opportunities for further innovation[3].
Valuation
The value of this patent can be estimated using various methods, including the cost, income, and market approaches. Given the potential market impact and the novelty of the invention, the patent could be valued significantly, potentially in the range of hundreds of thousands to millions of dollars, similar to other high-value patents in the pharmaceutical sector[4].
Regulatory and Legal Considerations
Patent-Eligible Subject Matter
The patent must comply with Section 101 of the Patent Act, which defines patent-eligible subject matter. The composition and methods described in this patent fall under the category of "composition of matter," which is one of the four categories of patentable inventions[5].
Judicial and Administrative Developments
Recent judicial and administrative developments, such as the Alice/Mayo framework, have narrowed the scope of patent-eligible subject matter. However, this patent's focus on a specific chemical composition and method of preparation aligns with the criteria for patent eligibility under current standards[5].
Methods of Use
The patent describes several methods of use for the stable, highly pure L-cysteine compositions:
Medical Applications
- Injectable Solutions: The compositions can be used in various injectable solutions for medical treatments.
- Pharmaceutical Formulations: The stability and purity of L-cysteine make it suitable for inclusion in pharmaceutical formulations.
Storage and Handling
- Inert Gas Storage: The compositions are stored under inert gas to prevent oxidation and maintain stability.
- Sealing Methods: Specific sealing methods are described to ensure the integrity of the composition during storage and transportation.
Key Takeaways
- Stable and Pure Compositions: The patent introduces novel methods for stabilizing and purifying L-cysteine compositions.
- Pharmaceutical Applications: The compositions are designed for use in injectable solutions and pharmaceutical formulations.
- Patent Landscape: The patent distinguishes itself from prior art through its unique combination of components and methods.
- Regulatory Compliance: The patent complies with current standards for patent-eligible subject matter.
- Market Impact: The development has significant implications for the pharmaceutical industry, potentially leading to increased market demand and valuation.
FAQs
Q1: What is the main focus of United States Patent 11,642,370?
The main focus of this patent is the development of stable, highly pure L-cysteine compositions for injection.
Q2: How does the patent ensure the stability of L-cysteine?
The patent ensures stability through the use of inert gases, reductive agents, and specific storage and handling methods.
Q3: What are the potential medical applications of this patent?
The compositions can be used in various injectable solutions and pharmaceutical formulations.
Q4: How does this patent comply with current patent eligibility standards?
The patent falls under the category of "composition of matter," which is one of the four categories of patentable inventions under Section 101 of the Patent Act.
Q5: What is the potential market impact of this patent?
The development of these compositions can improve the safety and efficacy of injectable solutions, leading to increased market demand and potential partnerships or licensing agreements.
Sources
- US11642370B1 - Stable, highly pure L-cysteine compositions for injection and methods of use - Google Patents
- 21-757 Amgen Inc. v. Sanofi - Supreme Court
- Patent Analytics - Schwegman
- The value of a patent - Perpetual Motion Patents
- Patent-Eligible Subject Matter Reform: An Overview - CRS Reports
