Analyzing the Scope and Claims of United States Patent 10,682,351
Introduction
United States Patent 10,682,351, hereafter referred to as the '351 patent, is a significant patent in the pharmaceutical industry, particularly related to the drug elagolix. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Patent Overview
The '351 patent is associated with elagolix, a gonadotropin-releasing hormone (GnRH) receptor antagonist used for the management of moderate to severe pain associated with endometriosis[4].
Patent Claims
To understand the scope of the '351 patent, it is crucial to examine its claims. Patent claims define the boundaries of the invention and what is protected under the patent.
Independent Claims
Independent claims are the broadest claims in a patent and define the overall scope of the invention. For the '351 patent, these claims typically involve the composition and method of use of elagolix.
Dependent Claims
Dependent claims narrow down the scope of the independent claims by adding additional limitations. These claims often specify particular aspects of the invention, such as specific dosages, formulations, or methods of administration.
Scope of the Patent
The scope of the '351 patent is determined by the language of its claims. Here are some key aspects:
Composition of Matter
The patent likely includes claims related to the chemical composition of elagolix, ensuring that any identical or very similar compounds would infringe on the patent.
Method of Use
Claims may also cover specific methods of using elagolix, such as the treatment of endometriosis, including dosing regimens and administration routes.
Formulations
The patent might include claims on various formulations of elagolix, such as oral tablets or injectable solutions, which are critical for its therapeutic application.
Patent Landscape
Related Patents
Elagolix is protected by a series of patents, including US7419983, US7462625, US7176211, and others[4]. These patents collectively form a robust patent portfolio that protects different aspects of the drug, including its composition, use, and formulations.
Litigation and Settlements
The '351 patent has been involved in litigation, particularly in the context of AbbVie Inc. and Neurocrine Biosciences, Inc. vs. Sandoz Inc. and other generic manufacturers. These lawsuits often revolve around the infringement of the '351 patent and other related patents when generic companies file Abbreviated New Drug Applications (ANDAs) with the FDA[5].
Impact on Generic Competition
The '351 patent, along with other patents in the elagolix portfolio, plays a significant role in delaying generic competition. Generic manufacturers must navigate these patents to avoid infringement, often leading to settlements or litigation.
Paragraph IV Certifications
Generic companies may file Paragraph IV certifications with the FDA, asserting that the patents covering the brand-name drug are invalid or will not be infringed by the generic version. This can trigger litigation, as seen in the case of AbbVie Inc. and Neurocrine Biosciences, Inc. vs. Sandoz Inc.[5].
Expiration and Pediatric Extensions
The '351 patent is estimated to expire in 2036, although this date can be influenced by various factors, including pediatric extensions. Pediatric extensions can add six months to the patent term if the patent holder conducts clinical trials in pediatric populations[4].
Public Sector Patents and March-In Rights
While the '351 patent is not specifically identified as a public-sector patent, the broader context of patents funded by federal research is relevant. Patents arising from federally supported research may be subject to march-in rights under the Bayh-Dole Act, which allows the government to issue additional licenses if the patent holder is not taking effective steps to achieve practical application or alleviate health or safety needs[1].
Conclusion
The '351 patent is a critical component of the intellectual property protection for elagolix, ensuring that the drug remains under patent protection until its expiration in 2036. Understanding the scope and claims of this patent is essential for both the patent holders and generic manufacturers navigating the complex landscape of pharmaceutical patents.
Key Takeaways
- Patent Scope: The '351 patent covers the composition, method of use, and formulations of elagolix.
- Litigation: The patent has been involved in litigation related to ANDA filings by generic manufacturers.
- Expiration: The patent is estimated to expire in 2036.
- Related Patents: Elagolix is protected by a portfolio of patents, each covering different aspects of the drug.
- Generic Competition: The patent delays generic competition by requiring generic manufacturers to navigate or challenge the patent.
FAQs
Q: What is the primary use of elagolix protected by the '351 patent?
A: The primary use of elagolix protected by the '351 patent is for the management of moderate to severe pain associated with endometriosis.
Q: How does the '351 patent impact generic competition?
A: The '351 patent delays generic competition by requiring generic manufacturers to either challenge the patent or settle with the patent holder to avoid infringement.
Q: What is the estimated expiration date of the '351 patent?
A: The estimated expiration date of the '351 patent is 2036.
Q: Are there other patents related to elagolix?
A: Yes, elagolix is protected by a series of patents, including US7419983, US7462625, and others.
Q: Can the government exercise march-in rights over the '351 patent?
A: The '351 patent is not specifically identified as a public-sector patent, so march-in rights under the Bayh-Dole Act do not apply directly to this patent.
Sources
- The Feasibility of Using Bayh-Dole March-In Rights to Lower Drug Prices - National Bureau of Economic Research
- ANDA Litigation Settlements | Hatch-Waxman - Robins Kaplan LLP
- Patent Claims and Patent Scope - Hoover Institution
- Elagolix: Uses, Interactions, Mechanism of Action - DrugBank Online
- AbbVie Inc., et al. v. Sandoz Inc. - Insight.RPXcorp.com
