United States Patent 7,951,797: A Comprehensive Analysis
Introduction
United States Patent 7,951,797, titled "Substituted diazepan orexin receptor antagonists," is a significant patent in the pharmaceutical industry, particularly in the treatment of insomnia and other sleep disorders. This patent, held by Merck Sharp & Dohme Corp., covers a class of compounds that act as antagonists to orexin receptors, which are crucial in regulating sleep-wake cycles.
Background and Inventors
The patent was issued on May 31, 2011, to inventors Michael J. Breslin, Paul J. Coleman, and Christopher D. Cox, and is assigned to Merck & Co., Inc.[1][4].
Patent Claims
Overview of Claims
The patent includes several claims that define the scope of the invention. These claims can be broadly categorized into three main types:
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Claims to the Approved Product: Claims 1 to 4 specifically describe the substituted diazepan compounds that are antagonists of orexin receptors. These compounds are designed to treat insomnia and other sleep disorders by inhibiting the activity of orexin receptors[1][4].
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Claims to the Method of Using the Approved Product: Claims 5 and 6 detail the methods of using these compounds for therapeutic purposes, including the administration of these compounds to patients in need of treatment for insomnia or other sleep-related conditions[1][4].
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Claims to the Method of Manufacturing the Approved Product: While not explicitly detailed in the provided sources, the patent likely includes claims related to the synthesis and manufacturing processes of these compounds, which are essential for their production and quality control.
Specific Claims
The patent claims are precise and detailed, ensuring that the invention is well-defined and distinguishable from prior art. For example, Claim 1 describes a specific substituted diazepan compound with particular structural features that make it an effective orexin receptor antagonist[4].
Patent Term and Expiration
The patent term for U.S. Patent 7,951,797 is set to expire on November 20, 2029. This date is calculated based on the filing date of the patent application (November 30, 2007) plus a 20-year term, adjusted by a patent term extension of 721 days due to regulatory review periods[1][2].
Regulatory Review and Patent Term Restoration
The approval of the drug BELSOMRA, which is covered by this patent, involved a significant regulatory review period. The FDA determined that the regulatory review period for BELSOMRA was 2,291 days, with 1,577 days occurring during the testing phase. This led to a patent term restoration application, seeking an extension of 792 days, which was part of the overall patent term adjustment[2].
Patent Landscape
Competitors and Generic Entry
The expiration of U.S. Patent 7,951,797 in 2029 will open the door for generic versions of the drug to enter the market. This is a critical consideration for Merck Sharp & Dohme Corp. and other pharmaceutical companies that may be developing similar compounds. The patent landscape will shift significantly as generic manufacturers prepare to launch their versions of the drug, potentially altering market dynamics and pricing strategies[5].
International Patents
In addition to the U.S. patent, the invention is likely protected by international patents in various jurisdictions. These international patents would follow similar expiration dates or be adjusted based on local regulatory and patent laws.
Economic and Market Impact
The expiration of this patent will have significant economic and market implications. Generic competition can lead to reduced prices for the drug, making it more accessible to a wider population. However, it also means that Merck Sharp & Dohme Corp. will lose its exclusive rights to market the drug, potentially impacting its revenue streams.
Technical Aspects
Orexin Receptor Antagonists
The compounds described in the patent are designed to antagonize orexin receptors, which play a crucial role in regulating sleep-wake cycles. By inhibiting these receptors, the compounds help in inducing sleep and are particularly useful in treating insomnia and other sleep disorders[4].
Synthesis and Manufacturing
The patent details the synthesis and manufacturing processes of these compounds, which are critical for ensuring the quality and efficacy of the drug. These processes involve specific chemical reactions and purification steps to produce the desired compounds.
Legal and Regulatory Considerations
FDA Approval and Regulatory Review
The approval of BELSOMRA, the drug covered by this patent, involved extensive regulatory review by the FDA. The FDA's determination of the regulatory review period was essential for calculating the patent term extension[2].
Petitions and Redetermination
The Federal Register notice outlines the process for petitions and redetermination regarding the patent term extension. Interested parties can submit comments or petitions to challenge the dates or the diligence of the applicant during the regulatory review period[2].
Conclusion
United States Patent 7,951,797 is a pivotal patent in the pharmaceutical industry, particularly in the treatment of sleep disorders. The patent's claims, term, and regulatory aspects are well-defined, and its expiration will have significant implications for the market and generic competition.
Key Takeaways
- Patent Scope: Covers substituted diazepan compounds as orexin receptor antagonists.
- Claims: Include claims to the product, method of use, and potentially method of manufacture.
- Patent Term: Expires on November 20, 2029, with a patent term extension due to regulatory review.
- Regulatory Review: Involved a significant regulatory review period leading to a patent term restoration application.
- Market Impact: Expiration will allow generic entry, affecting market dynamics and pricing.
- Technical Aspects: Involves specific synthesis and manufacturing processes for the compounds.
FAQs
Q: What is the main subject of U.S. Patent 7,951,797?
A: The main subject is substituted diazepan compounds that act as antagonists to orexin receptors, used in treating insomnia and other sleep disorders.
Q: Who are the inventors of this patent?
A: The inventors are Michael J. Breslin, Paul J. Coleman, and Christopher D. Cox.
Q: What is the expiration date of U.S. Patent 7,951,797?
A: The patent expires on November 20, 2029.
Q: What is the significance of the regulatory review period for this patent?
A: The regulatory review period led to a patent term extension of 792 days, adjusting the expiration date.
Q: How will the expiration of this patent affect the market?
A: The expiration will allow generic versions of the drug to enter the market, potentially reducing prices and altering market dynamics.
Sources
- U.S. Patent and Trademark Office, "U.S. Patent No. 7,951,797," October 9, 2014.
- Federal Register, "Federal Register/Vol. 83, No. 29/Monday, February 12, 2018/Notices," February 12, 2018.
- USPTO, "Patent Claims Research Dataset," August 28, 2017.
- Google Patents, "US7951797B2 - Substituted diazepan orexin receptor antagonists," May 31, 2011.
- DrugPatentWatch, "Pharmaceutical drugs covered by patent 7,951,797," accessed December 22, 2024.
