United States Patent 9,592,207: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,592,207, titled "Intranasal administration of ketamine to treat depression," is a significant patent in the field of psychiatric treatment, particularly for treatment-resistant depression. This patent is part of a series of patents known as the "Krystal Patents," which have been at the center of legal and administrative discussions.
Background and Inventors
The patent was invented by Dr. John Krystal and other co-inventors, and it is associated with Yale University and the U.S. Department of Veterans Affairs (VA). The patent's history involves complex agreements and disputes over royalty payments and ownership rights[2].
Scope of the Patent
Intranasal Administration of Ketamine
The patent describes methods and compositions for the intranasal administration of ketamine to treat depression, particularly treatment-resistant depression. This method involves delivering ketamine directly through the nasal route, which has been shown to be effective in rapidly alleviating depressive symptoms[4].
Dosage and Formulation
The patent outlines specific dosages and formulations for the intranasal administration of ketamine. It includes details on the concentration of ketamine, the use of pharmaceutically acceptable diluents such as sterile water or saline, and the inclusion of other ingredients like surfactants and bulking agents to enhance delivery and stability[1][4].
Claims of the Patent
Method Claims
The patent includes method claims that describe the process of administering ketamine intranasally to treat depression. These claims specify the dosage, frequency, and mode of administration, ensuring that the method is precise and reproducible[4].
Composition Claims
Composition claims cover the specific formulations of ketamine that are used in the intranasal administration. This includes the type of ketamine, the concentration, and any additional ingredients that are included to enhance the efficacy and stability of the formulation[4].
Device Claims
While the primary focus is on the method and composition, the patent also contemplates devices for the intranasal administration of ketamine, such as metered dose inhalers, which ensure a precise and consistent dosage[1].
Patent Landscape
Related Patents
The patent 9,592,207 is part of a series of patents filed by Dr. Krystal and his co-inventors. Other related patents include U.S. Patent Numbers 9,539,220 and 8,785,500, which also pertain to the intranasal administration of ketamine for various medical conditions[2].
Licensing and Royalties
The patent has been licensed exclusively to Janssen Pharmaceuticals, Inc. through an agreement with The Mount Sinai School of Medicine, which acted as an agent for Yale University. This licensing agreement has generated significant royalty payments, which were the subject of a dispute between Yale University, Dr. Krystal, and the VA[2].
Legal Disputes
The patent has been involved in legal disputes regarding the failure to disclose inventions and share royalties with the VA. The VA contended that Yale and Dr. Krystal knowingly avoided their obligations to disclose the patents and pay the VA its share of the royalties, leading to a settlement agreement[2].
Impact on the Medical Field
Treatment of Depression
The intranasal administration of ketamine as described in this patent has revolutionized the treatment of treatment-resistant depression. It offers a rapid and effective alternative to traditional antidepressants, which can take weeks or months to show efficacy[4].
Research and Development
The patent has spurred further research into the use of ketamine and other NMDA receptor antagonists for psychiatric disorders. It highlights the importance of innovative drug delivery methods in improving patient outcomes.
Patent Scope Metrics
Claim Length and Count
Studies on patent scope metrics suggest that the length and count of independent claims can be indicative of the patent's breadth and complexity. For the Krystal Patents, including 9,592,207, the claim structure is detailed and specific, reflecting a well-defined scope[3].
Forward Citations and Patent Maintenance
The patent's impact is also reflected in its forward citations and patent maintenance payments. Patents with narrower claims at publication, like 9,592,207, tend to have a higher probability of grant and shorter examination processes, indicating their significance and validity[3].
Key Takeaways
- Innovative Drug Delivery: The patent introduces an innovative method for the intranasal administration of ketamine to treat depression.
- Specific Dosages and Formulations: The patent details specific dosages and formulations to ensure efficacy and safety.
- Legal and Administrative Complexities: The patent is part of a complex legal landscape involving licensing agreements and royalty disputes.
- Impact on Medical Field: The patent has significantly impacted the treatment of depression and spurred further research in psychiatric disorders.
- Patent Metrics: The patent's scope and claims are well-defined, reflecting its importance and validity.
Frequently Asked Questions (FAQs)
What is the primary use of the patent 9,592,207?
The primary use of the patent 9,592,207 is for the intranasal administration of ketamine to treat treatment-resistant depression.
Who are the inventors of the patent?
The inventors of the patent include Dr. John Krystal and other co-inventors associated with Yale University and the VA.
What is the significance of the patent in the medical field?
The patent is significant because it introduces a rapid and effective method for treating depression, which has revolutionized psychiatric treatment.
What legal disputes are associated with this patent?
The patent is associated with legal disputes over the failure to disclose inventions and share royalties with the VA, leading to a settlement agreement.
How does the patent impact research and development?
The patent has spurred further research into the use of ketamine and other NMDA receptor antagonists for psychiatric disorders, highlighting the importance of innovative drug delivery methods.
Cited Sources:
- US5543434A - Nasal administration of ketamine to manage pain
- SETTLEMENT AGREEMENT - Department of Justice
- Patent Claims and Patent Scope - SSRN
- US9592207B2 - Intranasal administration of ketamine to treat depression - Google Patents
