Understanding the Scope and Claims of United States Patent 11,241,416
Introduction
United States Patent 11,241,416, issued on February 8, 2022, is a significant patent held by Mitsubishi Tanabe Pharma Corporation (MTPC) for an edaravone suspension for oral administration. This patent is crucial in the context of treating amyotrophic lateral sclerosis (ALS) with the drug Radicava ORS.
Inventors and Assignees
The patent was invented by Hayama Tetsuo, Takahashi Tomohiro, Omura Tomoyuki, Hayashi Kouji, Matsuda Munetomo, and Miyazawa Tadashi, and is assigned to MTPC[1].
Patent Claims
The patent claims are centered around the formulation and composition of an edaravone suspension for oral administration. Here are the key aspects:
Composition
- The edaravone suspension includes edaravone particles, a dispersant, and water. This specific formulation is designed to enhance the stability and bioavailability of edaravone when administered orally[1].
Formulation Process
- The patent details the process of preparing the edaravone suspension, which involves dispersing edaravone particles in water and adding a dispersant to ensure uniform distribution and stability of the suspension[1].
Patent Scope
The scope of the patent is defined by the claims that describe the specific components and the method of preparation of the edaravone suspension.
Independent Claims
- The independent claims are those that stand alone and define the invention without reference to other claims. In this patent, these claims focus on the unique combination of edaravone particles, dispersant, and water, and the process of preparing this suspension[1].
Dependent Claims
- Dependent claims build upon the independent claims and provide additional details or limitations. These claims may include specific ratios of components, methods of mixing, or other process details that further define the invention[1].
Patent Landscape
Related Patents
The patent 11,241,416 is part of a series of patents related to edaravone formulations and their use in treating ALS. Other patents, such as 10,987,341, 11,478,450, and 11,826,352, also cover various aspects of edaravone formulations and have the same expiration date of November 1, 2039[1].
Patent Expiration
All the related patents, including 11,241,416, have an expiration date of November 1, 2039. This means that until this date, MTPC holds exclusive rights to manufacture, use, offer for sale, or sell the edaravone suspension for oral administration in the United States[1].
Litigation and Infringement
MTPC has been involved in litigation to protect its patent rights. For instance, MTPC has sued Apotex Inc. and Apotex Corp. for patent infringement related to their submission of an Abbreviated New Drug Application (ANDA) for a generic version of Radicava ORS before the expiration of the patents-in-suit[2].
Legal Action
The complaint filed by MTPC alleges that Apotex's proposed generic version of Radicava ORS infringes one or more claims of the patents, including the '416 patent. MTPC seeks a declaration that Apotex's activities would infringe the patents and an injunction to prevent Apotex from commercially manufacturing, using, offering for sale, or selling the generic version before the patent expiration[2].
Impact on Generic Competition
The litigation and the strong patent protection around Radicava ORS delay the entry of generic competitors into the market. This is significant because generic drugs can significantly reduce the cost of treatment for patients, but the patent landscape ensures that MTPC maintains its market exclusivity until the patents expire.
Conclusion on Patent Scope and Claims
The United States Patent 11,241,416 is a critical component of MTPC's intellectual property portfolio related to Radicava ORS. The patent's scope and claims are narrowly defined to protect the specific formulation and preparation process of the edaravone suspension. The ongoing litigation and the patent's expiration date highlight the importance of this patent in maintaining MTPC's market position and the potential impact on generic competition.
Key Takeaways
- Patent Claims: The patent claims cover the composition and preparation process of an edaravone suspension for oral administration.
- Patent Scope: The scope is defined by independent and dependent claims that specify the components and process details.
- Related Patents: Other patents related to edaravone formulations have the same expiration date of November 1, 2039.
- Litigation: MTPC is involved in litigation to protect its patent rights against generic competitors.
- Impact on Generic Competition: The patent protection delays the entry of generic competitors into the market.
FAQs
Q: Who are the inventors of United States Patent 11,241,416?
A: The inventors are Hayama Tetsuo, Takahashi Tomohiro, Omura Tomoyuki, Hayashi Kouji, Matsuda Munetomo, and Miyazawa Tadashi.
Q: What is the composition of the edaravone suspension described in the patent?
A: The composition includes edaravone particles, a dispersant, and water.
Q: What is the expiration date of the patent?
A: The patent expires on November 1, 2039.
Q: Why is MTPC involved in litigation related to this patent?
A: MTPC is involved in litigation to protect its patent rights against generic competitors who are seeking to market a generic version of Radicava ORS before the patent expires.
Q: How does the patent protection impact generic competition?
A: The patent protection delays the entry of generic competitors into the market, maintaining MTPC's market exclusivity until the patent expires.
Sources
- Generic Radicava ORS Availability - Drugs.com
- Complaint for Patent Infringement - United States District Court for the District of Delaware
- Patent Claims and Patent Scope - SSRN
- Civil Action No. 20-755-RGA - District of Delaware
- Patent Gazette - USPTO
