United States Patent 10,251,896: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 10,251,896, titled "Compositions for improving cell viability and methods of use thereof," is a significant patent in the field of biomedical research, particularly focusing on neurodegenerative diseases. This patent, assigned to Amylyx Pharmaceuticals Inc., introduces novel compositions and methods aimed at improving cell viability, especially neuronal viability.
Background and Technical Field
The patent is rooted in the discovery that certain compositions, specifically those combining bile acids (e.g., tauroursodeoxycholic acid or TUDCA) with phenylbutyric acid (PBA), can significantly reduce reactive oxygen metabolite-mediated oxidative damage in cells. This is crucial for treating neurodegenerative diseases such as Multiple Sclerosis (MS), Parkinson's disease, Alzheimer's disease, Huntington's disease, amyotrophic lateral sclerosis (ALS), and stroke[4].
Claims and Scope
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims are centered around the compositions and methods for improving cell viability. Key claims include:
- Compositions comprising a bile acid (e.g., TUDCA) and a phenylbutyric acid (e.g., 4-PBA) for reducing oxidative damage and improving cell viability[4].
- Methods of administering these compositions to reduce mitochondrial dysfunction and regulate redox homeostasis in cells[4].
Dependent Claims
Dependent claims further specify the conditions and applications of the independent claims. These include:
- Specific dosages and administration routes of the compositions.
- The use of these compositions in treating various neurodegenerative diseases.
- The combination of these compositions with other therapeutic agents[4].
Patent Landscape
Related Patents and Applications
The patent 10,251,896 is part of a broader patent family that includes other related patents such as US 9,872,865, US 10,857,162, and US 11,071,742. These patents collectively cover various aspects of the compositions and their applications, ensuring a comprehensive protection of the intellectual property[5].
Regulatory Approval and Extensions
The FDA has approved the new drug application (NDA) for RELYVRIO, which is based on the compositions described in this patent. The FDA verified the approval date of September 29, 2022, and has considered the regulatory review period for patent term extensions under 35 U.S.C. 156 et seq.[5].
Innovation and Impact
Scientific Breakthroughs
The invention represents a significant scientific breakthrough by identifying specific combinations of bile acids and phenylbutyric acids that can mitigate oxidative damage and improve neuronal viability. This has potential implications for the treatment of neurodegenerative diseases, which are currently poorly understood and have limited effective treatments[4].
Clinical Applications
The compositions and methods described in the patent have been evaluated in clinical settings, showing promise in improving the viability of neuronal cells. This could lead to new therapeutic strategies for diseases like Alzheimer's and ALS, which are devastating for patients and their families[4].
Legal and Regulatory Aspects
Patent Term Extensions
The patent has been subject to applications for patent term extensions under the Hatch-Waxman Act. The FDA's verification of the regulatory review period is crucial for determining the effective patent term, which can impact the exclusivity period for the drug[5].
Intellectual Property Protection
The patent's claims and scope are carefully crafted to ensure robust intellectual property protection. This is essential for Amylyx Pharmaceuticals Inc. to maintain exclusivity over the invention and prevent infringement by other companies[4].
Industry Impact and Market Potential
Market Dominance
The approval of RELYVRIO and the associated patents position Amylyx Pharmaceuticals Inc. as a leader in the treatment of neurodegenerative diseases. This can lead to significant market share and revenue, given the high demand for effective treatments in this area[5].
Collaborations and Licensing
The patent's scope and the regulatory approvals may also facilitate collaborations and licensing agreements with other pharmaceutical companies. This can accelerate the development and distribution of these treatments globally[4].
Challenges and Future Directions
Regulatory Hurdles
Despite the FDA approval, the patent and its associated products may face regulatory hurdles in other jurisdictions. Navigating these challenges will be crucial for global market access[5].
Continued Research and Development
The patent's focus on reducing oxidative damage and improving cell viability opens avenues for further research. Continued innovation in this area could lead to even more effective treatments and broader applications[4].
Key Takeaways
- Compositions and Methods: The patent introduces specific compositions combining bile acids and phenylbutyric acids to improve cell viability.
- Neurodegenerative Diseases: The invention targets neurodegenerative diseases such as Alzheimer's, Parkinson's, and ALS.
- Regulatory Approval: The FDA has approved the associated drug RELYVRIO, with verified regulatory review periods for patent term extensions.
- Market Potential: The patent positions Amylyx Pharmaceuticals Inc. as a leader in neurodegenerative disease treatments, with significant market potential.
- Future Directions: Continued research and regulatory navigation are essential for expanding the impact of this invention.
Frequently Asked Questions (FAQs)
What is the primary focus of United States Patent 10,251,896?
The primary focus is on compositions and methods for improving cell viability, particularly neuronal viability, using combinations of bile acids and phenylbutyric acids.
Which diseases are targeted by the compositions described in the patent?
The compositions are aimed at treating neurodegenerative diseases such as Multiple Sclerosis (MS), Parkinson's disease, Alzheimer's disease, Huntington's disease, amyotrophic lateral sclerosis (ALS), and stroke.
What is the regulatory status of the drug associated with this patent?
The FDA has approved the new drug application (NDA) for RELYVRIO, which is based on the compositions described in the patent, with an approval date of September 29, 2022.
How does the patent protect the intellectual property of Amylyx Pharmaceuticals Inc.?
The patent's claims and scope are designed to provide robust intellectual property protection, ensuring exclusivity over the invention and preventing infringement by other companies.
What are the potential market implications of this patent?
The patent positions Amylyx Pharmaceuticals Inc. as a leader in the treatment of neurodegenerative diseases, with significant market potential due to the high demand for effective treatments in this area.
Cited Sources:
- US10251896B2 - Compositions for improving cell viability and methods of use thereof - Google Patents
- E. I. Du Pont De Nemours & Company, Appellant, v. Berkley and ... - Justia
- Patent Claims and Patent Scope - SSRN
- United States Patent - googleapis.com
- FDA U.S. FOOD & DRUG The Honorable Katherine K. Vidal Under ... - Regulations.gov
