Detailed Analysis of the Scope and Claims of United States Patent 8,765,150
Introduction
United States Patent 8,765,150, titled "Riluzole aqueous suspensions," is a significant patent in the pharmaceutical industry, particularly for the treatment of amyotrophic lateral sclerosis (ALS). Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of Riluzole
Riluzole, a member of the benzothiazole class, is the only FDA-approved drug for the treatment of ALS. It is known for its ability to prolong the survival of patients with this debilitating disease[4].
Patent Overview
Publication and Grant Details
The patent was granted on July 1, 2014, with the application number US13/138,047. It is currently active, with maintenance fees paid up to 2022[2].
Inventive Subject Matter
The patent describes physically and chemically stable oral aqueous suspensions of riluzole. These suspensions are designed for oral administration and have minimal or no anesthetic effect, which is a significant improvement over previous formulations[1].
Scope of the Patent
Claims
The patent includes multiple claims that define the scope of the invention. Here are some key aspects:
- Composition: The patent claims cover aqueous suspensions of riluzole that include a mixture of riluzole and various excipients such as surface-active agents, wetting agents, and stabilizers. These components ensure the stability and bioavailability of the drug[1].
- Formulation: The claims specify the amounts and types of ingredients used in the suspension, including anionic surfactants, polyethylene glycol, and other additives that enhance the stability and palatability of the formulation[1].
- Manufacturing Process: The patent also covers the methods of preparing these suspensions, which involve mixing the ingredients in a specific order and under controlled conditions to ensure uniformity and stability[1].
Independent and Dependent Claims
The patent includes both independent and dependent claims. Independent claims define the broad scope of the invention, while dependent claims narrow down the scope by adding specific details or limitations. For example, one independent claim might cover the general composition of the aqueous suspension, while a dependent claim might specify the exact ratio of riluzole to a particular excipient[1].
Patent Landscape
Related Patents
Riluzole is protected by several patents, each covering different aspects of its formulation, use, and manufacturing process. Here are some notable patents related to riluzole:
- US8603514: This patent, which expired on April 3, 2024, covered other formulations and methods related to riluzole[4].
- US8765167: This patent, which expired on February 20, 2024, also pertains to riluzole formulations and is part of the same patent family as US8765150[4].
Patent Expiration and Extensions
The patent US8765150 is estimated to expire on March 12, 2029. This expiration date is crucial for generic manufacturers, as it marks the time when they can legally produce and market their own versions of riluzole aqueous suspensions[4].
Litigation and Disputes
Patents related to riluzole have been involved in various litigation cases, particularly between the original patent holders and generic drug manufacturers. These disputes often revolve around the interpretation of patent claims and the potential infringement by generic products[5].
Impact on the Pharmaceutical Industry
Innovation and Competition
The patent landscape surrounding riluzole influences innovation and competition in the pharmaceutical industry. The expiration of key patents allows generic manufacturers to enter the market, which can lead to lower drug prices and increased accessibility for patients. However, it also reduces the incentive for original patent holders to invest in further research and development[3].
Regulatory Considerations
Regulatory bodies play a crucial role in managing the patent landscape. The U.S. Patent and Trademark Office (USPTO) and the FDA work together to ensure that patents are valid and that generic products meet the necessary standards for safety and efficacy.
Key Takeaways
- Stable Formulations: US8765150 covers stable oral aqueous suspensions of riluzole, enhancing the drug's bioavailability and patient compliance.
- Patent Scope: The patent includes detailed claims about the composition, formulation, and manufacturing process of riluzole suspensions.
- Patent Expiration: The patent is set to expire on March 12, 2029, which will impact the market entry of generic versions.
- Litigation: Patents related to riluzole have been involved in various legal disputes, affecting the pharmaceutical industry's competitive landscape.
- Regulatory Impact: The patent landscape is closely monitored by regulatory bodies to ensure innovation, competition, and patient access to essential medications.
FAQs
What is the primary use of riluzole?
Riluzole is primarily used for the treatment of patients with amyotrophic lateral sclerosis (ALS)[4].
What is unique about the aqueous suspensions covered by US8765150?
The aqueous suspensions covered by this patent are physically and chemically stable and have minimal or no anesthetic effect, making them more palatable and effective for oral administration[1].
When is the patent US8765150 set to expire?
The patent US8765150 is estimated to expire on March 12, 2029[4].
How does the patent landscape affect generic drug manufacturers?
The expiration of patents like US8765150 allows generic drug manufacturers to produce and market their own versions of riluzole, increasing competition and potentially reducing drug prices[4].
What role do regulatory bodies play in managing the patent landscape?
Regulatory bodies such as the USPTO and FDA ensure that patents are valid and that generic products meet the necessary standards for safety and efficacy, balancing innovation and competition[3].
Sources
- US8765150B2 - Riluzole aqueous suspensions - Google Patents
- Drug Patents containing Riluzole - Pharsight
- Patent Claims and Patent Scope - Hoover Institution
- Riluzole: Uses, Interactions, Mechanism of Action | DrugBank Online
- Patent Litigation : No. 20-md-2930-LPS Stringham ... - GovInfo
