United States Patent 7,056,927: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 7,056,927, titled "Gonadotropin-releasing hormone receptor antagonists and methods relating thereto," is a significant patent in the pharmaceutical industry, particularly in the field of endocrinology and reproductive health. This patent, assigned to Neurocrine Biosciences, Inc., covers a class of compounds and methods for treating disorders related to gonadotropin-releasing hormone (GnRH) activity.
Background and Inventors
The patent was filed on July 6, 2004, and granted on June 6, 2006. The inventors include Zhiqiang Guo, Yongsheng Chen, Dongpei Wu, Chen Chen, Warren Wade, Wesley J. Dwight, Charles Q. Huang, and Fabio C. Tucci, all affiliated with Neurocrine Biosciences, Inc. in San Diego, CA[1][4].
Scope of the Patent
GnRH Receptor Antagonists
The patent focuses on GnRH receptor antagonists, which are compounds designed to block the action of GnRH. GnRH is a hormone that regulates the reproductive system by stimulating the release of other hormones such as luteinizing hormone (LH) and follicle-stimulating hormone (FSH). The antagonists covered by this patent are intended to treat various disorders, including those related to hormonal imbalances, fertility issues, and certain types of cancer[1][4].
Chemical Compounds
The patent describes a range of chemical compounds that act as GnRH receptor antagonists. These compounds are characterized by specific structural features, including the presence of fluoro, dione, and trifluoromethyl groups. The detailed chemical structures and synthesis methods are provided in the patent documentation[1][4].
Claims of the Patent
Independent and Dependent Claims
The patent includes both independent and dependent claims. Independent claims define the broad scope of the invention, while dependent claims narrow down the scope by adding additional limitations. The claims cover the GnRH receptor antagonists themselves, as well as methods for their use in treating various medical conditions[1][4].
Method Claims
Method claims are an essential part of this patent, outlining the procedures for administering the GnRH receptor antagonists to treat specific disorders. These methods include dosing regimens, routes of administration, and combinations with other therapeutic agents[1][4].
Patent Landscape and Litigation
Patent Infringement Litigation
The patent has been involved in several litigation cases, particularly regarding generic drug applications. For instance, AbbVie Inc. and Neurocrine Biosciences, Inc. have filed lawsuits against companies like Lupin Limited for alleged infringement related to the filing of Abbreviated New Drug Applications (ANDAs) for generic versions of elagolix sodium, a product covered by this and other related patents[2].
Generic Entry and Expiration
The patent has expired, which allows for the entry of generic versions of the covered drugs into the market. However, the litigation history indicates that the original patent holders have been vigilant in protecting their intellectual property rights until the patent's expiration[5].
Impact on Pharmaceutical and Biotechnology Industries
Genus Claims and Patent Scope
The scope of patent claims, particularly genus claims, has been a subject of significant debate and legal scrutiny. Genus claims aim to cover a broad class of compounds rather than specific embodiments. However, recent jurisprudence, such as that from the Court of Appeals for the Federal Circuit, has made it challenging to obtain and maintain broad patent protection for pharmaceuticals and biologics. This has resulted in a delicate balance between claiming too broadly and risking invalidation, or claiming too narrowly and allowing competitors to design around the claims[3].
Enablement and Written Description Requirements
The patent's validity and scope are also influenced by the enablement and written description requirements under 35 U.S.C. ยง 112. These requirements ensure that the patent specification provides enough detail to enable a person skilled in the art to make and use the invention. The current rigid approach to these requirements has made it difficult for innovators in the pharmaceutical and biotechnology industries to secure meaningful patent protection[3].
Examples and Statistics
Clinical Applications
GnRH receptor antagonists covered by this patent have been used in clinical settings for conditions such as endometriosis, uterine fibroids, and prostate cancer. For example, elagolix sodium, a drug developed based on this technology, has been approved by the FDA for the treatment of moderate to severe pain associated with endometriosis[2].
Market Impact
The expiration of this patent and the subsequent entry of generic versions can significantly impact the market. Generic drugs can reduce healthcare costs and increase accessibility to treatments. However, the litigation history surrounding this patent highlights the complexities and challenges faced by both innovator companies and generic manufacturers in navigating the patent landscape[5].
Key Takeaways
- GnRH Receptor Antagonists: The patent covers a class of compounds designed to block GnRH activity, used in treating various hormonal and reproductive disorders.
- Chemical Compounds: Detailed chemical structures and synthesis methods are provided for the antagonists.
- Method Claims: The patent includes methods for administering these compounds to treat specific medical conditions.
- Litigation and Generic Entry: The patent has been involved in several litigation cases and has expired, allowing for generic entry.
- Impact on Industries: The patent landscape, particularly genus claims and enablement requirements, poses challenges for pharmaceutical and biotechnology innovators.
FAQs
Q: What is the main subject of United States Patent 7,056,927?
A: The main subject is GnRH receptor antagonists and methods for their use in treating various medical conditions.
Q: Who are the inventors of this patent?
A: The inventors include Zhiqiang Guo, Yongsheng Chen, Dongpei Wu, Chen Chen, Warren Wade, Wesley J. Dwight, Charles Q. Huang, and Fabio C. Tucci.
Q: What are the key claims of this patent?
A: The patent includes claims for the GnRH receptor antagonists themselves and methods for their use in treating medical conditions.
Q: Has this patent been involved in any litigation?
A: Yes, it has been involved in several litigation cases related to generic drug applications and patent infringement.
Q: What is the current status of this patent?
A: The patent has expired, allowing for the entry of generic versions of the covered drugs into the market.
Sources
- Guo et al. United States Patent 7,056,927 B2, July 6, 2004.
- United States District Court AbbVie Inc., et al. v. Lupin Limited, et al., July 10, 2023.
- Falati, Shahrokh Eviscerating Patent Scope, DigitalCommons@NYLS, 2022.
- Google Patents US7056927B2 - Gonadotropin-releasing hormone receptor antagonists and methods relating thereto, June 6, 2006.
- Drug Patent Watch Patent 7,056,927, Accessed December 20, 2024.
