United States Patent 11,071,742: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 11,071,742, titled "Compositions for improving cell viability and methods of use thereof," is a significant patent in the field of pharmaceuticals, particularly focusing on neural cell viability. This patent, held by Amylyx Pharmaceuticals Inc., has garnered attention due to its implications in treating diseases such as amyotrophic lateral sclerosis (ALS). Here, we delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Invention Overview
The patent pertains to methods and compositions designed to improve cell viability, with a particular emphasis on neural cells. The compositions include specific compounds like sodium phenylbutyrate and taurursodiol, which are combined to form the drug product known by the tradename RELYVRIO®[2][5].
Scope of the Patent
The scope of the patent is defined by its claims, which outline the specific inventions and methods that are protected. Here are some key aspects:
Independent Claims
The patent includes several independent claims that define the core of the invention. These claims typically describe the compositions, methods of preparation, and methods of use for improving cell viability. For instance, Claim 1 might describe a composition comprising sodium phenylbutyrate and taurursodiol, while subsequent claims might detail specific methods for administering these compositions[1][4].
Dependent Claims
Dependent claims build upon the independent claims, providing additional details or limitations. These claims help to narrow down the scope and ensure that the patent covers specific embodiments of the invention without overly broad claims that could be challenged[3].
Claim Language and Metrics
The clarity and breadth of patent claims are crucial for determining patent scope. Metrics such as independent claim length (ICL) and independent claim count (ICC) are used to measure patent scope. Narrower claims, as indicated by shorter ICL and lower ICC, are often associated with a higher probability of grant and a shorter examination process[3].
Independent Claim Length (ICL)
The ICL metric measures the number of words in the shortest independent claim. This metric helps in assessing the complexity and specificity of the claim. For Patent 11,071,742, the ICL would reflect the detailed description of the compositions and methods, ensuring that the claims are clear and specific.
Independent Claim Count (ICC)
The ICC metric counts the total number of independent claims. A lower ICC suggests a more focused and narrower scope, which is generally preferred for patent quality and to avoid litigation issues. The ICC for this patent would indicate how many distinct aspects of the invention are being protected.
Patent Term Extension
The approval of RELYVRIO by the FDA has led to applications for patent term extension under 35 U.S.C. 156. This provision allows for the extension of the patent term to compensate for the time spent in the regulatory review process. The USPTO has received applications for patent term extension for several related patents, including U.S. Patent Nos. 9,872,865; 10,251,896; 10,857,162; and 11,071,742[2][5].
Regulatory Review Period
The determination of the regulatory review period is critical for calculating the patent term extension. This period includes all testing and approval phases specified in 35 U.S.C. 156(g)(1)(B). For RELYVRIO, the FDA's approval and the subsequent patent term extension applications highlight the complex process of ensuring that the patent term reflects the time spent in regulatory review[5].
Litigation and Patent Quality
The quality of patent claims, including those in Patent 11,071,742, is a subject of ongoing debate. Broad or unclear claims can lead to increased litigation costs and diminish innovation incentives. The examination process tends to narrow the scope of patent claims, ensuring that they are more specific and less prone to challenges[3].
Industry Impact
The approval and patent protection of RELYVRIO have significant implications for the treatment of ALS and other neurodegenerative diseases. The patent landscape around this invention influences the development of similar treatments and the competitive environment in the pharmaceutical industry.
Competitive Landscape
The patent landscape is dynamic, with multiple players and ongoing research in neurodegenerative diseases. Patents like 11,071,742 set a benchmark for innovation and protection in this field, influencing how other companies and researchers approach similar inventions.
Future Developments
As research continues, the scope of this patent may be expanded or narrowed based on new discoveries. The ongoing applications for patent term extension and the regulatory oversight ensure that the patent remains relevant and protected for the duration of its extended term.
Key Takeaways
- Specific Claims: The patent includes detailed claims that define the compositions and methods for improving cell viability.
- Patent Term Extension: The approval of RELYVRIO has led to applications for patent term extension to compensate for the regulatory review period.
- Regulatory Oversight: The FDA and USPTO play crucial roles in ensuring the patent term reflects the time spent in regulatory review.
- Industry Impact: The patent influences the development of treatments for neurodegenerative diseases and sets a competitive benchmark.
- Litigation and Quality: The patent claims are subject to scrutiny to ensure they are specific and clear, reducing the risk of litigation.
FAQs
Q: What is the main focus of United States Patent 11,071,742?
A: The main focus is on compositions and methods for improving cell viability, particularly neural cell viability, using compounds like sodium phenylbutyrate and taurursodiol.
Q: What is the significance of the FDA approval for RELYVRIO?
A: The FDA approval of RELYVRIO is significant because it led to applications for patent term extension, ensuring the patent term is extended to compensate for the time spent in regulatory review.
Q: How are patent claims measured for scope and clarity?
A: Metrics such as independent claim length (ICL) and independent claim count (ICC) are used to measure patent scope and clarity.
Q: What are the implications of this patent for the pharmaceutical industry?
A: The patent sets a benchmark for innovation and protection in treating neurodegenerative diseases, influencing the competitive landscape and future research.
Q: Can the scope of the patent be changed or expanded?
A: Yes, the scope of the patent can be adjusted based on new discoveries or through the patent examination and litigation processes.
Sources
- US11071742B2 - Compositions for improving cell viability and methods of use thereof - Google Patents
- United States Patent and Trademark Office - Regulations.gov
- Patent Claims and Patent Scope - Hoover Institution
- US9872865B2 - Compositions for improving cell viability and methods of use thereof - Google Patents
- Federal Register, Volume 89 Issue 43 (Monday, March 4, 2024)
