United States Patent 8,772,497: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,772,497, issued on July 8, 2014, is a significant patent in the pharmaceutical industry, particularly related to the production of a 1,2-dihydropyridine-2-one compound. This compound is crucial in the formulation of the drug FYCOMPA® (perampanel), used in the treatment of epilepsy. Here, we delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Inventors and Assignee
The patent was invented by Arimoto Itaru, Nagato Satoshi, Sugaya Yukiko, Urawa Yoshio, Ito Koichi, Naka Hiroyuki, Omae Takao, Kayano Akio, and Nishiura Katsutoshi. It is assigned to Eisai R&D Management Co., Ltd., a subsidiary of the Japanese pharmaceutical company Eisai Co., Ltd.[2][4].
Scope of the Patent
Method for Producing 1,2-Dihydropyridine-2-one Compound
The patent describes a method for commercially producing a 1,2-dihydropyridine-2-one compound, specifically the active ingredient in FYCOMPA®. This method involves several steps, including the reaction of compounds represented by specific formulas to produce the desired compound. The patent covers various production methods, crystal forms, and compositions related to this compound[2][4].
Claims of the Patent
Production Methods and Crystal Forms
The patent includes multiple claims that cover different aspects of the production process:
- Production Methods: The patent outlines several methods (1 to 13) for producing the 1,2-dihydropyridine-2-one compound, including reactions involving specific compounds and conditions[4].
- Crystal Forms: It also describes various crystal forms (14 to 19) of the compound and methods for their production (20 to 28)[4].
- Medicament and Composition: The claims extend to the medicament and composition involving the produced compound, including agents (41 to 50)[4].
Patent Expiration and Legal Status
Expiration Date
The patent is set to expire on July 1, 2026. This expiration date is critical as it marks the end of the exclusive rights granted to the patent holder, allowing generic manufacturers to potentially enter the market[2].
Legal Actions and Stay
In anticipation of the patent expiration, Eisai has taken legal actions against generic drug manufacturers who have filed Abbreviated New Drug Applications (ANDAs). These lawsuits have triggered a stay, preventing the FDA from approving any ANDA until May 2026 or until a judgment is made on the validity and infringement of the patents[1].
Patent Landscape
Related Patents
The patent landscape for FYCOMPA® includes multiple patents that protect different aspects of the drug:
- Patent 6,949,571: This patent, set to expire on May 23, 2025, covers another method for producing the 1,2-dihydropyridine-2-one compound[2].
- Other Patents: There may be additional patents related to the formulation, dosage form, or manufacturing process of FYCOMPA®, which collectively contribute to the comprehensive protection of the drug.
Patent Scope and Breadth
The breadth of a patent’s scope is crucial in determining its protective strength. A broader patent, such as one with fewer conditions in its claims, is generally harder to design around and thus offers more protection against infringers. The number of claims and the specificity of these claims in Patent 8,772,497 suggest a significant scope that protects the production method and related compositions effectively[3].
Impact on Generic Manufacturers
Generic Drug Manufacturers
Generic manufacturers seeking to produce a generic version of FYCOMPA® must navigate the patent landscape carefully. The expiration of Patent 8,772,497 in 2026 will be a critical milestone, but any ongoing litigation and the presence of other related patents could delay their market entry[1][2].
Conclusion
United States Patent 8,772,497 is a pivotal patent in the protection of FYCOMPA®, a significant drug in the treatment of epilepsy. The patent's scope and claims cover a wide range of production methods and compositions, ensuring robust protection for the inventor and assignee. As the patent approaches its expiration date, the legal landscape and potential generic competition will be closely watched.
Key Takeaways
- Patent Scope: The patent covers multiple production methods, crystal forms, and compositions related to the 1,2-dihydropyridine-2-one compound.
- Expiration Date: The patent is set to expire on July 1, 2026.
- Legal Actions: Eisai has filed lawsuits against generic manufacturers to protect the patent.
- Related Patents: Other patents, such as Patent 6,949,571, also protect aspects of FYCOMPA®.
- Impact on Generic Manufacturers: Generic entry is delayed due to ongoing litigation and the patent landscape.
FAQs
What is the main subject of United States Patent 8,772,497?
The main subject of United States Patent 8,772,497 is the method for commercially producing a 1,2-dihydropyridine-2-one compound, which is the active ingredient in the drug FYCOMPA®.
Who are the inventors and assignee of the patent?
The inventors include Arimoto Itaru, Nagato Satoshi, Sugaya Yukiko, Urawa Yoshio, Ito Koichi, Naka Hiroyuki, Omae Takao, Kayano Akio, and Nishiura Katsutoshi. The patent is assigned to Eisai R&D Management Co., Ltd.
What is the expiration date of the patent?
The patent is set to expire on July 1, 2026.
How does the patent protect against generic competition?
The patent protects against generic competition through its broad claims covering various production methods and compositions. Eisai has also filed lawsuits against generic manufacturers to trigger a stay preventing FDA approval of generic versions until the patent expires or a judgment is made.
What other patents are related to FYCOMPA®?
Another related patent is Patent 6,949,571, which covers another method for producing the 1,2-dihydropyridine-2-one compound and is set to expire on May 23, 2025.
How does the breadth of the patent affect its protective strength?
A broader patent with fewer conditions in its claims is generally harder to design around and thus offers more protection against infringers. The number of claims and specificity in Patent 8,772,497 suggest a significant scope that protects the production method and related compositions effectively.
Sources
- Catalyst Pharmaceuticals INC: Common Stock, IPO Supplement, January 4, 2024.
- Drugs.com: Generic Fycompa Availability.
- Boston University Law: The Ways We've Been Measuring Patent Scope Are Wrong.
- Google Patents: US8772497B2 - Method for producing 1, 2-dihydropyridine-2-one compound.
