Detailed Analysis of the Scope and Claims of United States Patent 9,872,865
Introduction
United States Patent 9,872,865, filed by Amylyx Pharmaceuticals Inc., is a significant patent in the pharmaceutical industry, particularly for the treatment of amyotrophic lateral sclerosis (ALS). This patent is part of a series of patents related to the drug product known as RELYVRIO (sodium phenylbutyrate and taurursodiol).
Background of RELYVRIO
RELYVRIO is a drug approved by the FDA for the treatment of ALS in adults. The approval process involved extensive testing and regulatory review, which is crucial for determining the patent term extension[4].
Patent Overview
Patent Number and Title
The patent in question is U.S. Patent No. 9,872,865. The title of the patent is "Compositions for improving cell viability and methods of use thereof," which indicates its focus on improving cell viability, particularly neural cell viability[5].
Scope of the Patent
Claim Language and Scope
The scope of the patent is defined by its claims, which are the legally binding descriptions of the invention. For U.S. Patent No. 9,872,865, the claims include methods and compositions for improving cell viability. The patent scope is critical in determining the breadth and specificity of the invention.
- Independent Claim Length and Count: Research suggests that the length and count of independent claims can be metrics for measuring patent scope. Narrower claims, as seen in this patent, are often associated with a higher probability of grant and a shorter examination process[3].
Specific Claims
The patent includes claims related to the composition of sodium phenylbutyrate and taurursodiol, as well as methods for their use in improving cell viability. These claims are specific to the treatment of ALS and other neurodegenerative diseases.
- Composition Claims: The patent describes specific compositions that include sodium phenylbutyrate and taurursodiol, which are the active ingredients in RELYVRIO.
- Method Claims: The patent also includes method claims that outline the procedures for administering these compositions to improve cell viability.
Regulatory Review and Patent Term Extension
Regulatory Review Period
The FDA's approval of RELYVRIO involved a regulatory review period that is crucial for determining the potential patent term extension. The regulatory review period for RELYVRIO was determined to be 3,359 days, with 3,023 days during the testing phase and 336 days during the approval phase[4].
Patent Term Extension Applications
Amylyx Pharmaceuticals Inc. has filed applications for patent term extension for U.S. Patent No. 9,872,865, along with other related patents (U.S. Patent Nos. 10,251,896; 10,857,162; and 11,071,742). The applications seek various lengths of patent term extension, ranging from 383 days to 1,010 days, based on the regulatory review period[1][4].
Due Diligence and Petitions
Due Diligence During Regulatory Review
The FDA may receive petitions regarding whether the applicant for the patent term extension acted with due diligence during the regulatory review period. These petitions must comply with specific requirements, including being timely, containing sufficient facts, and certifying that a true and complete copy has been served upon the patent applicant[1][4].
Petition Process
Any interested person can submit electronic or written comments and petitions to the FDA. These petitions are reviewed to determine if the dates published are incorrect or if there are other issues with the patent term extension application[1][4].
Patent Landscape
Related Patents
U.S. Patent No. 9,872,865 is part of a series of patents related to RELYVRIO. Other patents, such as U.S. Patent Nos. 10,251,896, 10,857,162, and 11,071,742, also cover aspects of the drug product and its use. These patents collectively protect the intellectual property related to the composition, method of use, and other aspects of RELYVRIO[1][2].
Industry Impact
The approval and patent protection of RELYVRIO have significant implications for the treatment of ALS. The drug represents a new therapeutic option for patients, and the patent landscape ensures that Amylyx Pharmaceuticals Inc. has exclusive rights to market and distribute the drug for a specified period.
Key Takeaways
- Patent Scope: U.S. Patent No. 9,872,865 has a specific scope focused on compositions and methods for improving cell viability, particularly for ALS treatment.
- Regulatory Review: The regulatory review period for RELYVRIO was 3,359 days, which is crucial for determining the patent term extension.
- Patent Term Extension: Applications for patent term extension have been filed, seeking various lengths of extension based on the regulatory review period.
- Due Diligence: Petitions can be submitted to the FDA to determine if the applicant acted with due diligence during the regulatory review period.
- Patent Landscape: The patent is part of a series of patents related to RELYVRIO, collectively protecting the intellectual property of the drug product.
FAQs
What is the main focus of U.S. Patent No. 9,872,865?
The main focus of U.S. Patent No. 9,872,865 is on compositions and methods for improving cell viability, particularly for the treatment of amyotrophic lateral sclerosis (ALS).
What is RELYVRIO, and how is it related to U.S. Patent No. 9,872,865?
RELYVRIO is a drug product approved by the FDA for the treatment of ALS, composed of sodium phenylbutyrate and taurursodiol. U.S. Patent No. 9,872,865 is one of the patents that cover aspects of this drug product.
How is the regulatory review period determined for patent term extension?
The regulatory review period is determined by the FDA and includes all the testing and approval phases. For RELYVRIO, this period was 3,359 days[4].
Can anyone petition the FDA regarding the patent term extension?
Yes, any interested person can submit petitions to the FDA regarding the patent term extension, specifically to determine if the applicant acted with due diligence during the regulatory review period[1][4].
What are the implications of the patent landscape for RELYVRIO?
The patent landscape ensures that Amylyx Pharmaceuticals Inc. has exclusive rights to market and distribute RELYVRIO, protecting their intellectual property and providing a new therapeutic option for ALS patients.
Sources
- Federal Register, Volume 89 Issue 43 - "Determination of Regulatory Review Period for Purposes of Patent Extension; RELYVRIO"[1].
- Regulations.gov - "Application for Patent Term Extension of U.S. Patent No. 11,071,742"[2].
- Hoover Institution - "Patent Claims and Patent Scope"[3].
- Federal Register, Volume 89 Issue 43 - "Determination of Regulatory Review Period for Purposes of Patent Extension; RELYVRIO"[4].
- Google Patents - "Compositions for improving cell viability and methods of use thereof"[5].
