United States Patent 11,542,239: A Detailed Analysis of Scope and Claims
Introduction
The United States Patent 11,542,239, titled "Elagolix sodium compositions and processes," is a significant patent in the pharmaceutical industry, particularly in the context of gonadotropin-releasing hormone (GnRH) receptor antagonists. This patent is held by AbbVie Inc. and is crucial for the production and use of elagolix sodium, a drug indicated for managing moderate to severe pain associated with endometriosis.
Background of Elagolix Sodium
Elagolix sodium is a GnRH receptor antagonist that works by blocking the action of gonadotropin-releasing hormone, thereby reducing the production of gonadotropins and subsequently lowering estrogen levels. This mechanism is effective in alleviating symptoms of endometriosis[4].
Patent Scope and Claims
Composition Claims
The patent 11,542,239 encompasses various claims related to the composition of elagolix sodium. These include specific formulations, purity levels, and methods for preparing the active pharmaceutical ingredient (API). The patent details the weight percent of the active compound, acceptable impurities, and the chemical structure of elagolix sodium (HEAUOKZIVMZVQL-VWLOTQADSA-N)[1].
Process Claims
The patent also covers the processes involved in the synthesis and purification of elagolix sodium. This includes methods for reducing impurities and ensuring the stability and efficacy of the final product. The process claims are critical as they protect the proprietary methods developed by AbbVie for producing high-quality elagolix sodium[1].
Impurity Control
A significant aspect of the patent is the control of impurities. The patent specifies acceptable levels of impurities and methods for their reduction, which is essential for maintaining the safety and efficacy of the drug. This includes the management of specific chemical groups and compounds that could affect the drug's performance[1].
Patent Landscape
Litigation and Infringement
The patent 11,542,239 is part of an ongoing patent landscape marked by litigation. AbbVie Inc. has filed several lawsuits against generic drug manufacturers, including Hetero Labs Limited, alleging patent infringement related to the production of generic versions of elagolix sodium. These lawsuits involve multiple patents, including the '239 patent, and highlight the importance of this patent in protecting AbbVie's intellectual property[2][5].
Expiration Dates and Extensions
The patent is set to expire in 2039, but it is part of a broader patent portfolio that includes other patents with varying expiration dates. This complex patent landscape allows AbbVie to maintain market exclusivity for elagolix sodium for an extended period. Other related patents, such as the '845 and '854 patents, also play a crucial role in this exclusivity[4].
Impact on Generic Manufacturers
Generic manufacturers seeking to produce versions of elagolix sodium must navigate this complex patent landscape. The filing of Abbreviated New Drug Applications (ANDAs) by companies like Hetero Labs Limited and Sun Pharmaceutical Industries Limited has led to legal battles. These manufacturers must either wait for the patents to expire, obtain a license from AbbVie, or challenge the validity of the patents in court[2][5].
Metrics for Measuring Patent Scope
The scope of the '239 patent can be analyzed using metrics such as independent claim length and independent claim count. These metrics help in understanding the breadth and complexity of the patent claims. A higher number of independent claims and longer claim lengths often indicate a broader patent scope, which can impact the ability of generic manufacturers to develop non-infringing alternatives[3].
Industry Implications
The '239 patent has significant implications for the pharmaceutical industry, particularly in the area of women's health. It protects a valuable drug that provides relief to patients with endometriosis, ensuring that AbbVie maintains a competitive edge in the market. However, it also creates barriers for generic competition, which can affect drug prices and accessibility.
Key Takeaways
- Composition and Process Claims: The patent covers specific formulations, purity levels, and synthesis methods for elagolix sodium.
- Impurity Control: The patent specifies acceptable impurity levels and methods for their reduction.
- Litigation and Infringement: AbbVie has filed lawsuits against generic manufacturers to protect this patent.
- Patent Expiration: The patent is set to expire in 2039, but it is part of a broader patent portfolio.
- Impact on Generic Manufacturers: Generic manufacturers face significant legal and regulatory hurdles in producing versions of elagolix sodium.
FAQs
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What is the primary use of elagolix sodium?
- Elagolix sodium is primarily used for the management of moderate to severe pain associated with endometriosis.
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Who holds the United States Patent 11,542,239?
- The patent is held by AbbVie Inc.
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What are the key claims of the '239 patent?
- The patent includes claims related to the composition, purity, and synthesis processes of elagolix sodium.
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Why is the '239 patent significant in the pharmaceutical industry?
- It protects a valuable drug and maintains AbbVie's market exclusivity, impacting the availability and pricing of generic alternatives.
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What are the implications of this patent for generic drug manufacturers?
- Generic manufacturers must navigate complex legal and regulatory issues, including potential litigation and the need to obtain licenses or challenge the patent's validity.
Sources
- US11542239B2 - Elagolix sodium compositions and processes - Google Patents
- AbbVie Inc. v. Hetero Labs Limited et al. - United States District Court
- Patent Claims and Patent Scope - Hoover Institution
- Elagolix: Uses, Interactions, Mechanism of Action - DrugBank Online
- ANDA Litigation Settlements - Robins Kaplan LLP
