Understanding the Scope and Claims of United States Patent 9,790,208: A Detailed Analysis
Introduction to Quviviq and Its Patent Protection
Quviviq, a drug developed by Idorsia Pharmaceuticals Ltd., is an orexin receptor antagonist used primarily for the treatment of sleep disorders, among other conditions. The patent landscape surrounding Quviviq is complex and crucial for understanding its market exclusivity and the potential for generic versions.
United States Patent 9,790,208 Overview
United States Patent 9,790,208, titled "Crystalline salt form of (S)-(2-(6-chloro-7-methyl-1H-benzo[d]imidazol-2-yl)-2-methylpyrrolidin-1-yl)(5-methoxy-2-(2H-1,2,3-triazol-2-yl)phenyl)methanone as orexin receptor antagonist," is a key patent protecting Quviviq.
Inventors and Assignees
This patent was invented by a team including Christoph Boss, Christine Brotschi, Markus Gude, Bibia Heidmann, Thierry Sifferlen, Markus Von Raumer, and Jodi T. Williams. It is assigned to Idorsia Pharmaceuticals Ltd.[1][2][4].
Patent Claims and Scope
Crystalline Salt Form
The patent specifically covers a crystalline salt form of the compound (S)-(2-(6-chloro-7-methyl-1H-benzo[d]imidazol-2-yl)-2-methylpyrrolidin-1-yl)(5-methoxy-2-(2H-1,2,3-triazol-2-yl)phenyl)methanone hydrochloride. This crystalline form is critical for the drug's stability and efficacy as an orexin receptor antagonist[1][2][4].
Processes and Pharmaceutical Compositions
The patent includes processes for the preparation of this crystalline form and pharmaceutical compositions that contain it. These processes and compositions are essential for the manufacturing and formulation of Quviviq[1][4].
Therapeutic Uses
The patent highlights the use of this compound in treating various disorders, including sleep disorders, anxiety disorders, addiction disorders, cognitive dysfunctions, mood disorders, and appetite disorders. The compound has also shown efficacy in animal models related to emotional states of fear and anxiety, such as phobias and post-traumatic stress disorders (PTSDs)[4].
Patent Expiration and Exclusivity
Patent Expiration Date
The patent is set to expire on December 2, 2034. This expiration date is crucial for determining when generic versions of Quviviq could potentially enter the market[1][2].
Exclusivity Periods
In addition to patent protection, Quviviq holds exclusivity periods granted by the FDA. The New Chemical Entity (NCE) exclusivity is set to expire on April 7, 2027, and another exclusivity period (M-310) expires on September 30, 2027. These exclusivity periods further extend the market exclusivity of Quviviq beyond the patent expiration dates[2].
Legal and Regulatory Activities
Recent legal activities on this patent include various communications and corrections with the regulating agency. These activities are part of the ongoing process to ensure the patent remains valid and enforceable until its expiration[2].
Impact on Generic Launch
The expiration of this patent and the associated exclusivity periods will be pivotal in determining the generic launch date of Quviviq. Currently, the estimated generic launch date is December 2, 2034, aligning with the patent expiration date[2].
Broader Patent Landscape
Quviviq is protected by multiple patents, including US Patent 9,732,075 (Benzimidazole-proline derivatives) and US Patent 10,023,560 (another crystalline salt form of the same compound). These patents collectively ensure comprehensive protection for the drug's active ingredient and its various formulations[1][2].
Challenges and Considerations
Genus Claims and Enablement
The scope of patent claims, especially genus claims, has been a subject of scrutiny in recent jurisprudence. The Federal Circuit's rigid stance on enablement and written description requirements can make it challenging for pharmaceutical companies to secure broad patent protection. This can lead to a situation where innovators are caught between claiming too broadly and risking invalidation or claiming too narrowly and allowing competitors to design around the claims[3].
Global Patent Protection
Understanding the full scope of patent protection globally is crucial. While US patents provide insights into exclusivity within the United States, Quviviq's protection extends to multiple countries. Identifying markets with weaker patent protection could be strategic for generic entry points[2].
Key Takeaways
- Patent Protection: Quviviq is protected by US Patent 9,790,208, which covers a specific crystalline salt form of the active ingredient.
- Expiration Date: The patent expires on December 2, 2034.
- Exclusivity: Additional exclusivity periods extend market exclusivity until 2027.
- Therapeutic Uses: The compound is used for treating sleep and other disorders.
- Legal Activities: Ongoing legal activities ensure the patent's validity.
- Generic Launch: The estimated generic launch date is December 2, 2034.
FAQs
1. What is the main subject of US Patent 9,790,208?
The main subject is the crystalline salt form of (S)-(2-(6-chloro-7-methyl-1H-benzo[d]imidazol-2-yl)-2-methylpyrrolidin-1-yl)(5-methoxy-2-(2H-1,2,3-triazol-2-yl)phenyl)methanone as an orexin receptor antagonist.
2. Who are the inventors and assignees of this patent?
The inventors include Christoph Boss, Christine Brotschi, Markus Gude, Bibia Heidmann, Thierry Sifferlen, Markus Von Raumer, and Jodi T. Williams. The patent is assigned to Idorsia Pharmaceuticals Ltd.
3. What are the therapeutic uses of the compound covered by this patent?
The compound is used in treating sleep disorders, anxiety disorders, addiction disorders, cognitive dysfunctions, mood disorders, and appetite disorders.
4. When does the patent expire?
The patent expires on December 2, 2034.
5. Are there any exclusivity periods beyond the patent expiration?
Yes, Quviviq holds exclusivity periods that extend until 2027, including New Chemical Entity (NCE) exclusivity and another exclusivity period (M-310).
Cited Sources
- Generic Quviviq Availability - Drugs.com
- Quviviq patent expiration - Pharsight
- Eviscerating Patent Scope - DigitalCommons@NYLS
- US9790208B2 - Crystalline salt form of (S)-(2-(6-chloro-7-methyl-1H-benzo[d]imidazol-2-yl)-2-methylpyrrolidin-1-yl)(5-methoxy-2-(2H-1,2,3-triazol-2-yl)phenyl)methanone as orexin receptor antagonist - Google Patents
