United States Patent 8,268,848: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,268,848, titled "Cyclopropane compound," is a crucial patent held by Eisai R&D Management Co., Ltd., protecting the active ingredient of the drug Dayvigo. This patent is significant in the pharmaceutical industry, particularly in the treatment of insomnia and other sleep disorders. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Patent Overview
Issuance and Assignee
The patent was issued on September 18, 2012, and is assigned to Eisai R&D Management Co., Ltd.[4][5].
Inventors
The inventors listed on this patent include Terauchi Taro, Takemura Ayumi, Doko Takashi, Yoshida Yu, Tanaka Toshiaki, Sorimachi Keiichi, Naoe Yoshimitsu, Beuckmann Carsten, and Kazuta Yuji[4].
Scope of the Patent
Active Ingredient
The patent protects a cyclopropane compound, specifically (1R,2S)-2-(((2,4-dimethylpyrimidin-5-yl)oxy)methyl)-2-(3-fluorophenyl)-N-(5-fluoropyridin-2-yl) cyclopropanecarboxamide, which acts as a potent orexin receptor antagonist. This compound is useful in treating sleep disorders such as insomnia[4].
Therapeutic Uses
The compound is not only limited to treating insomnia but also has potential therapeutic uses for other sleep disorders. The orexin receptor antagonism is key to its mechanism of action, making it a valuable asset in the treatment of sleep-related conditions[4].
Claims of the Patent
Chemical Formulation
The patent includes claims that cover the specific chemical formulation of the cyclopropane compound and its pharmaceutically acceptable salts. These claims are detailed and specify the structural elements of the compound, including the presence of methyl, oxy, and dimethylpyrimidin groups[4].
Methods and Processes
In addition to the chemical formulation, the patent claims also encompass methods for preparing the compound and its use in treating sleep disorders. This includes various synthetic routes and pharmaceutical compositions that contain the active ingredient[4].
Patent Expiration and Status
Expiration Date
The patent is set to expire on September 18, 2031, which is approximately 6 years from the current date. However, patent expiration dates can be influenced by various legal activities such as term extensions, amendments to claims, or abandonment of the patent[1][2].
Current Status
As of the latest updates, the patent remains active. There have been recent legal activities such as the payment of maintenance fees, which indicate that the patent holder is maintaining the patent's validity[1].
Exclusivities and Market Protection
FDA Exclusivities
In addition to patent protection, Dayvigo, the drug associated with this patent, holds FDA-granted exclusivities. These include New Chemical Entity (NCE) exclusivity and another exclusivity code (M-293), which are set to expire in April 2025 and April 2026, respectively. These exclusivities prevent other companies from marketing generic or bioequivalent versions of Dayvigo, regardless of the patent status[1].
Broader Patent Landscape
Family Patents
The patent landscape for Dayvigo includes multiple patents filed in various countries, not just the United States. Understanding this broader landscape is crucial for strategizing market entry, as it helps identify markets with weaker patent protection that could be ideal for generic entry[1].
Other Related Patents
There are other patents related to Dayvigo, such as US10702529, US10188652, and US11026944, which also expire on October 21, 2035. These patents cover compositions and methods for treating insomnia, further solidifying Eisai's intellectual property position in this therapeutic area[1][2].
Impact on Generic Launch
Generic Availability
Currently, there is no therapeutically equivalent generic version of Dayvigo available in the United States. The estimated generic launch date, based on the patent and exclusivity landscape, is October 21, 2035[2].
Legal Activities and Challenges
The patents protecting Dayvigo have been open to challenges since April 7, 2024. Tracking these legal activities is essential to understanding any potential changes in the patent expiration dates or the generic launch timeline[1].
Conclusion on Patent Scope and Claims
United States Patent 8,268,848 is a critical component of the intellectual property portfolio for Dayvigo, protecting a potent orexin receptor antagonist used in treating insomnia. The patent's scope includes specific chemical formulations and methods for preparation and use, ensuring strong market protection for Eisai until its expiration.
"Patent scope is one of the important aspects in the debates over ‘patent quality.’ The purported decrease in patent quality over the past decade or two has supposedly led to granting patents of increased breadth (or ‘overly broad’ patents), decreased clarity, and questionable validity."[3]
Key Takeaways
- Patent Protection: The patent protects the active ingredient of Dayvigo, a cyclopropane compound, until its expiration in September 2031.
- Exclusivities: FDA-granted exclusivities extend market protection until April 2026.
- Broader Landscape: Multiple patents in various countries protect Dayvigo, influencing global market entry strategies.
- Generic Launch: The estimated generic launch date is October 21, 2035, based on current patent and exclusivity timelines.
- Legal Activities: Ongoing legal activities can affect the patent expiration dates and generic launch timeline.
FAQs
What is the main compound protected by US Patent 8,268,848?
The main compound protected is a cyclopropane compound, specifically (1R,2S)-2-(((2,4-dimethylpyrimidin-5-yl)oxy)methyl)-2-(3-fluorophenyl)-N-(5-fluoropyridin-2-yl) cyclopropanecarboxamide.
Who is the assignee of US Patent 8,268,848?
The assignee is Eisai R&D Management Co., Ltd.
What is the therapeutic use of the compound protected by this patent?
The compound is used as an orexin receptor antagonist for treating sleep disorders such as insomnia.
When is the patent set to expire?
The patent is set to expire on September 18, 2031.
Are there any FDA exclusivities protecting Dayvigo?
Yes, Dayvigo holds FDA-granted exclusivities, including New Chemical Entity (NCE) exclusivity and another exclusivity code (M-293), which expire in April 2025 and April 2026, respectively.
Sources
- Pharsight - GreyB: Dayvigo patent expiration.
- Drugs.com: Generic Dayvigo Availability.
- Hoover Institution: Patent Claims and Patent Scope.
- Google Patents: US8268848B2 - Cyclopropane compound.
- Unified Patents: US-8268848-B2 - Cyclopropane Compound.
