United States Patent 10,947,183: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 10,947,183, titled "Fenfluramine Compositions and Methods of Preparing the Same," is a significant patent in the pharmaceutical sector, particularly for the treatment of certain neurological conditions. This patent, assigned to Zogenix International Limited, protects the drug FINTEPLA, which is used to treat Dravet Syndrome. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background of the Patent
Patent Overview
The patent, granted on March 16, 2021, covers compositions and methods related to fenfluramine, a compound used in the treatment of Dravet Syndrome, a severe form of epilepsy[4][5].
Inventors and Assignees
The inventors listed are Derek J. Londesbrough and Marc W. Andersen, with Zogenix International Limited as the assignee[4].
Scope of the Patent
Claim Structure
The patent includes 33 claims, which are divided into independent and dependent claims. Independent claims define the broadest scope of the invention, while dependent claims narrow down the scope by adding specific limitations.
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Independent Claims: These claims outline the core aspects of the fenfluramine compositions and methods of preparation. For example, Claim 1 describes a method of preparing fenfluramine involving specific chemical reactions and conditions[4].
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Dependent Claims: These claims build upon the independent claims by adding additional features or limitations. For instance, dependent claims might specify particular solvents, reaction temperatures, or purification steps.
Claim Language and Scope
The scope of the patent is defined by the language used in the claims. The claims are written to be as broad as possible while still being specific enough to distinguish the invention from prior art. The use of terms like "comprising" and "consisting of" helps to define the scope of what is covered by the patent[3].
Claims Analysis
Key Claims
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Claim 1: This claim describes a method for preparing fenfluramine, involving the hydrolysis of a 2-(3-(trifluoromethyl)phenyl)acetonitrile composition to produce 2-(3-(trifluoromethyl)phenyl)acetic acid, followed by further chemical transformations[4].
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Claim 10: This claim covers a specific composition of fenfluramine, including the presence of certain impurities and their acceptable limits[4].
Claim Validity and Clarity
The validity and clarity of the claims are crucial for the patent's enforceability. The patent office ensures that the claims are clear, concise, and distinguishable from prior art during the examination process. The claims in this patent have been scrutinized to ensure they meet these criteria, which is reflected in the patent's grant[3].
Patent Landscape
Prior Art and References
The patent cites numerous prior art documents, including earlier patents and scientific publications. These references help to establish the novelty and non-obviousness of the invention. For example, the patent references earlier work by Williams et al. and Elsayed et al., which are relevant to the field of fenfluramine compositions[4].
Related Patents
There are several related patents that cover different aspects of fenfluramine and its applications. For instance, US Patent 10,351,509 also deals with fenfluramine compositions and methods of preparation, highlighting the ongoing research and development in this area[4].
International Filings
The patent landscape is not limited to the United States. Zogenix International Limited has likely filed corresponding patent applications in other countries to secure global protection for their invention. This is common practice to ensure comprehensive intellectual property protection[1].
Impact on Innovation and Industry
Licensing and Litigation
The breadth and clarity of patent claims can significantly impact licensing and litigation costs. Narrower, clearer claims, as seen in this patent, can reduce the likelihood of disputes and make licensing agreements more straightforward. This can foster innovation by providing clear guidelines for what is protected and what is not[3].
Market Protection
The patent protects FINTEPLA, a critical drug for treating Dravet Syndrome, until its expiration date. This protection allows Zogenix International Limited to recoup their investment in research and development, which is essential for continued innovation in the pharmaceutical industry[5].
Expiration and Maintenance
Patent Expiration
The patent's term is subject to the standard 20-year period from the filing date, adjusted for any delays during the prosecution process. Maintenance fees must be paid periodically to keep the patent in force[1].
Maintenance Fees
To maintain the patent, Zogenix International Limited must pay the required maintenance fees at the specified intervals. Failure to pay these fees can result in the patent lapsing into the public domain[1].
Conclusion
United States Patent 10,947,183 is a significant intellectual property asset for Zogenix International Limited, protecting their innovative work on fenfluramine compositions and methods. The patent's scope and claims are carefully crafted to ensure clarity and validity, which are essential for its enforceability and the protection of FINTEPLA in the market.
Key Takeaways
- Scope and Claims: The patent covers specific compositions and methods related to fenfluramine, with 33 claims that define the invention's scope.
- Patent Landscape: The patent is part of a broader landscape that includes prior art, related patents, and international filings.
- Impact on Innovation: Clear and narrow claims can reduce licensing and litigation costs, fostering innovation.
- Market Protection: The patent protects FINTEPLA until its expiration, allowing Zogenix to recoup their investment.
- Maintenance: Regular maintenance fees are necessary to keep the patent in force.
FAQs
What is the main subject of United States Patent 10,947,183?
The main subject of this patent is fenfluramine compositions and methods of preparing the same, specifically for the treatment of Dravet Syndrome.
Who are the inventors and assignees of the patent?
The inventors are Derek J. Londesbrough and Marc W. Andersen, with Zogenix International Limited as the assignee.
What is the significance of the claims in this patent?
The claims define the scope of the invention, ensuring clarity and validity. They are crucial for the patent's enforceability and market protection.
How does the patent impact the pharmaceutical industry?
The patent protects FINTEPLA, allowing Zogenix to recoup their investment in research and development. Clear claims reduce licensing and litigation costs, fostering innovation.
When does the patent expire?
The patent's term is 20 years from the filing date, adjusted for any prosecution delays, and is subject to maintenance fees.
Sources
- USPTO: Patents - USPTO. Retrieved from https://www.uspto.gov/patents
- Google Patents: Fenfluramine compositions and methods of preparing the same. Retrieved from https://patents.google.com/patent/US10351509B2/ja
- Hoover Institution: Patent Claims and Patent Scope. Retrieved from https://www.hoover.org/sites/default/files/ip2-wp16001-paper.pdf
- Google APIs: United States Patent - googleapis.com. Retrieved from https://patentimages.storage.googleapis.com/7c/45/d4/23a327cc68c527/US10947183.pdf
- Drug Patent Watch: Pharmaceutical drugs covered by patent 10,947,183. Retrieved from https://www.drugpatentwatch.com/p/patent/10947183
