United States Patent 10,987,341: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 10,987,341, titled "Edaravone suspension for oral administration," is a significant patent in the pharmaceutical industry, particularly for the treatment of amyotrophic lateral sclerosis (ALS). This patent, held by Mitsubishi Tanabe Pharma Corporation (MTPC), protects the formulation and composition of RADICAVA ORS®, an oral suspension of edaravone. Here, we delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of Edaravone and RADICAVA ORS®
Edaravone is a free radical scavenger used in the treatment of ALS, a progressive neurodegenerative disease. RADICAVA ORS® is the oral suspension formulation of edaravone, designed to improve patient compliance and ease of administration compared to intravenous formulations.
Scope of the Patent
The scope of the patent is defined by its claims, which outline the specific aspects of the invention that are protected. Here are the key elements:
Composition
The patent describes an edaravone suspension for oral administration, which includes edaravone particles, a dispersant, and water. The formulation may also include additional components such as thickening agents (e.g., xanthan gum, methyl cellulose), stabilizers, and sweetening agents (e.g., sucrose)[1][4].
Formulation
The patent specifies the preparation method, including the mixing of edaravone particles with a dispersant and water to create a stable suspension. The formulation ensures that the edaravone remains in a suspended state, enhancing its bioavailability and stability[1][4].
Claims
The patent includes multiple claims that protect various aspects of the invention:
- Independent Claims: These are the broadest claims that define the core of the invention. For example, Claim 1 might describe the edaravone suspension composition and its method of preparation.
- Dependent Claims: These are narrower claims that build upon the independent claims. They might specify particular types of dispersants, thickening agents, or other additives used in the formulation[1][4].
Patent Claims Analysis
Independent Claims
Independent claims are crucial as they define the broadest scope of protection. For instance, an independent claim might state:
"An edaravone suspension for oral administration, comprising edaravone particles, a dispersant, and water."
This claim sets the foundation for the patent's protection, ensuring that any similar formulation would infringe on this claim unless it significantly differs[1].
Dependent Claims
Dependent claims provide additional specificity and protection. For example:
"The edaravone suspension of claim 1, wherein the dispersant is xanthan gum or methyl cellulose."
These claims ensure that specific variations of the formulation are also protected, making it harder for competitors to design around the patent[1][4].
Patent Landscape
Related Patents
The patent landscape surrounding US 10,987,341 includes other related patents held by MTPC, such as US 11,241,416, US 11,478,450, and US 11,826,352. These patents collectively protect various aspects of RADICAVA ORS®, including different formulations, methods of preparation, and uses[2].
Patent Infringement Litigation
MTPC has been involved in litigation to protect its patents against generic manufacturers. For instance, the lawsuit against Apotex Inc. and Apotex Corp. aims to prevent the commercial manufacture and sale of a generic version of RADICAVA ORS® before the expiration of the patents-in-suit[2].
Expiration Dates
The patent is set to expire on November 1, 2039, which means that until then, MTPC retains exclusive rights to manufacture, use, offer for sale, and sell RADICAVA ORS® in the United States[5].
Measuring Patent Scope
The scope of a patent can be measured in various ways, including the length of the claims and the number of patent classes. However, research suggests that the length of the first claim is a more predictive measure of patent scope. Longer claims typically imply more conditions that must be met for a patent to be infringed, making the patent narrower in scope[3].
Broad vs. Narrow Patents
Broad patents, like those with shorter, more general claims, offer more protection against infringers because they are harder to design around. In contrast, narrow patents with longer, more specific claims provide less protection but are still valuable for protecting specific innovations[3].
Impact on Generic Manufacturers
Generic manufacturers seeking to produce a version of RADICAVA ORS® must navigate the complex landscape of MTPC's patents. They must ensure that their formulation does not infringe on any of the claims in the patents-in-suit. This often involves significant research and development to create a non-infringing alternative, which can be challenging given the broad and detailed claims of the patents[2].
Conclusion
The United States Patent 10,987,341 is a critical component of MTPC's intellectual property portfolio, protecting the innovative formulation of RADICAVA ORS®. The patent's scope, defined by its claims, ensures robust protection against infringement, making it a significant barrier for generic manufacturers. Understanding the patent landscape and the specific claims of this patent is essential for any entity involved in the development or commercialization of edaravone suspensions.
Key Takeaways
- Patent Scope: Defined by independent and dependent claims that protect the composition and formulation of RADICAVA ORS®.
- Claims Analysis: Independent claims set the broadest scope, while dependent claims provide additional specificity.
- Patent Landscape: Includes related patents and ongoing litigation to protect against generic infringement.
- Expiration Date: November 1, 2039, marking the end of MTPC's exclusive rights.
- Impact on Generics: Generic manufacturers must develop non-infringing formulations, which can be challenging due to the patent's broad and detailed claims.
FAQs
What is the main subject of the United States Patent 10,987,341?
The main subject is an edaravone suspension for oral administration, specifically the formulation and composition of RADICAVA ORS®.
What are the key components of the edaravone suspension?
The key components include edaravone particles, a dispersant (such as xanthan gum or methyl cellulose), and water, with optional additives like thickening agents and sweetening agents.
Why is the patent significant for MTPC?
The patent is significant because it protects MTPC's exclusive rights to manufacture, use, offer for sale, and sell RADICAVA ORS® in the United States until its expiration date.
How does the patent impact generic manufacturers?
Generic manufacturers must ensure their formulations do not infringe on the claims of the patent, which can be challenging due to the detailed and broad protection provided by the patent.
When does the patent expire?
The patent is set to expire on November 1, 2039.
Sources
- US10987341B2 - Edaravone suspension for oral administration - Google Patents
- United States District Court Complaint for Patent Infringement - Insight.RPXCorp
- The Ways We've been Measuring Patent Scope are Wrong - Boston University Law
- US10987341B2 - Edaravone suspension for oral administration - Google Patents (Japanese)
- Generic Radicava ORS Availability - Drugs.com
