United States Patent 10,857,162: A Detailed Analysis of Scope, Claims, and Patent Landscape
Overview of the Patent
United States Patent 10,857,162, issued on December 8, 2020, is a significant patent in the pharmaceutical sector, particularly related to the treatment of conditions associated with oxidative stress and cellular viability. Here is a detailed breakdown of its scope, claims, and the surrounding patent landscape.
Patent Holders and Assignees
This patent is assigned to Amylyx Pharmaceuticals Inc., a company known for its innovative approaches to treating neurodegenerative diseases. The inventors listed are Joshua Cohen and Justin Klee, who have been instrumental in developing the compositions and methods described in the patent[2][4].
Scope of the Patent
Therapeutic Categories and Mechanisms
The patent focuses on methods and compositions for improving cell viability, particularly neural cell viability. It involves the administration of phenylbutyric acid (PBA) in combination with the bile acid tauroursodeoxycholic acid (TUDCA). These compounds work synergistically to reduce reactive oxygen metabolite-mediated oxidative damage, regulate redox homeostasis, and mitigate mitochondrial dysfunction in cells. This approach is aimed at treating or preventing diseases related to oxidative stress, such as neurodegenerative disorders[2][4].
Indicated Conditions
The patent indicates that the compositions and methods can be used to treat a variety of conditions, including those associated with oxidative stress and cellular damage. This includes neurodegenerative diseases, where the protection of neural cells is crucial[2].
Claims of the Patent
Key Claims
The patent includes several key claims that define its scope:
- Composition Claims: The patent claims compositions comprising PBA and TUDCA, which are designed to improve cell viability by reducing oxidative damage and regulating redox homeostasis.
- Method Claims: It claims methods of use for these compositions, including administering them to treat or prevent diseases related to oxidative stress.
- Synergistic Effects: The patent highlights the synergistic effects of combining PBA and TUDCA, which enhance the therapeutic efficacy compared to using either compound alone[2][4].
Patent Family Members
This patent has forty-two patent family members in nineteen countries, indicating a broad international protection for the inventions described[5].
Patent Expiration Dates
The patent is set to expire on December 24, 2033. This expiration date is consistent with other related patents held by Amylyx Pharmaceuticals Inc., which also expire around the same time[2][4].
Patent Landscape
Related Patents
Amylyx Pharmaceuticals Inc. holds several related patents that cover similar compositions and methods for improving cell viability. These include patents such as US10251896, US9872865, and US11071742, all of which expire around December 24, 2033. Another patent, US11583542, has a later expiration date of July 27, 2040[2].
Drug Exclusivity
In addition to patent protection, the FDA may grant exclusivity periods that run concurrently with the patent. This exclusivity can provide additional market protection, ranging from 180 days to seven years, depending on the circumstances[2].
Impact on Innovation and Litigation
Patent Scope and Quality
The scope and clarity of patent claims are critical in determining patent quality. Narrower claims, as seen in this patent, are often associated with a higher probability of grant and a shorter examination process. This suggests that the U.S. Patent and Trademark Office (USPTO) has been diligent in evaluating the claims to ensure they are specific and valid[3].
Litigation and Licensing
The clarity and specificity of the claims in this patent can reduce the likelihood of litigation and licensing issues. Clear claims help in avoiding disputes over patent infringement and ensure that the patent holder's rights are well-defined[3].
Conclusion
United States Patent 10,857,162 is a significant milestone in the development of treatments for conditions associated with oxidative stress and cellular damage. The patent's focus on the synergistic effects of PBA and TUDCA, its broad international protection, and its well-defined claims make it a robust asset for Amylyx Pharmaceuticals Inc. As the patent landscape continues to evolve, this patent will remain a crucial component in the company's intellectual property portfolio until its expiration in 2033.
Key Takeaways
- Therapeutic Focus: The patent focuses on improving cell viability, particularly neural cell viability, using PBA and TUDCA.
- Synergistic Effects: The combination of PBA and TUDCA enhances therapeutic efficacy.
- International Protection: The patent has forty-two family members in nineteen countries.
- Expiration Date: The patent expires on December 24, 2033.
- Related Patents: Several related patents cover similar compositions and methods.
- Impact on Innovation: Clear and specific claims reduce litigation and licensing issues.
FAQs
What is the primary use of the compositions described in Patent 10,857,162?
The primary use is to improve cell viability, particularly neural cell viability, by reducing oxidative damage and regulating redox homeostasis.
Who are the inventors of this patent?
The inventors are Joshua Cohen and Justin Klee.
What companies are associated with this patent?
The patent is assigned to Amylyx Pharmaceuticals Inc.
What is the expiration date of this patent?
The patent is set to expire on December 24, 2033.
How many patent family members does this patent have internationally?
It has forty-two patent family members in nineteen countries.
What other compounds are used in combination with phenylbutyric acid (PBA) in this patent?
Tauroursodeoxycholic acid (TUDCA) is used in combination with PBA.
