Detailed Analysis of the Scope and Claims of United States Patent 8,895,546
Introduction
United States Patent 8,895,546, titled "Administration of benzodiazepine compositions," is a significant patent in the pharmaceutical industry, particularly in the field of nasal administration of benzodiazepine drugs. This patent, issued on November 25, 2014, is assigned to Hale Biopharma Ventures, LLC, and later associated with Neurelis, Inc.
Inventors and Assignees
The patent was invented by a team of researchers including Steve Cartt, David Medeiros, Garry Thomas Gwozdz, Andrew Loxley, Mark Mitchnick, David Hale, and Edward T. Maggio. Initially, the patent was assigned to Hale Biopharma Ventures, LLC, but it is now associated with Neurelis, Inc.[4][5].
Patent Scope and Claims
Pharmaceutical Compositions
The patent covers pharmaceutical compositions that include one or more benzodiazepine drugs, specifically designed for nasal administration. This is a critical innovation as it addresses the need for rapid and effective administration of benzodiazepines, particularly in emergency situations such as seizures[4].
Methods of Production and Use
The patent includes methods for producing these pharmaceutical compositions as well as methods for their use. The compositions are formulated to ensure rapid absorption through the nasal mucosa, providing quick relief from conditions such as acute repetitive seizures[4].
Key Claims
- The patent claims cover the specific formulations of benzodiazepine drugs suitable for nasal administration.
- It includes claims related to the methods of preparing these formulations.
- The patent also claims the use of these compositions for treating conditions such as seizures, particularly in emergency settings[4].
Patent Landscape
Related Patents
The patent is part of a broader portfolio related to the administration of benzodiazepine compositions. Other relevant patents include US Patent Nos. 11,241,414 and 11,793,786, which are also associated with Neurelis, Inc. and cover similar aspects of benzodiazepine administration[2][5].
Litigation and Enforcement
The patent has been involved in litigation, with Neurelis, Inc. filing a complaint against Padagis LLC, Padagis US LLC, and Padagis Israel Pharmaceuticals Ltd. for infringement. This litigation highlights the importance of this patent in protecting the intellectual property related to nasal benzodiazepine administration[2].
Expiration Dates
The patent is listed in the FDA's "Orange Book" and has an expiration date of March 27, 2029. This expiration date is crucial for generic drug manufacturers, as they must wait until this date to commercialize their generic versions without infringing on the patent[2][5].
Impact on the Pharmaceutical Industry
Innovation and Competition
The patent has significant implications for innovation in the pharmaceutical industry. By protecting the specific formulations and methods of nasal benzodiazepine administration, it encourages further research and development in this area while preventing unauthorized use by competitors[3].
Patient Benefits
The nasal administration of benzodiazepines, as covered by this patent, provides a rapid and effective treatment option for patients suffering from acute repetitive seizures. This method is particularly beneficial in emergency situations where traditional oral or intravenous administration may not be feasible[4].
Patent Scope Metrics
Claim Length and Count
Research on patent scope metrics suggests that the length and count of independent claims can be indicative of the patent's breadth and complexity. For US Patent 8,895,546, the claims are specific and focused on the nasal administration of benzodiazepines, indicating a well-defined scope[3].
Examination Process
The examination process for this patent likely involved a thorough review to ensure the claims were clear and not overly broad. This process is crucial in maintaining patent quality and preventing the granting of patents with ambiguous or overly broad claims[3].
Conclusion
United States Patent 8,895,546 is a pivotal patent in the field of pharmaceuticals, particularly for the nasal administration of benzodiazepine drugs. Its scope and claims are well-defined, covering specific formulations and methods that address critical medical needs. The patent's involvement in litigation and its listing in the FDA's "Orange Book" underscore its importance in the pharmaceutical industry.
Key Takeaways
- Specific Formulations: The patent covers specific formulations of benzodiazepine drugs for nasal administration.
- Methods of Production and Use: It includes methods for producing and using these compositions.
- Litigation and Enforcement: The patent is involved in litigation to protect its claims against infringement.
- Expiration Date: The patent expires on March 27, 2029.
- Impact on Industry: It encourages innovation and provides a critical treatment option for patients.
Frequently Asked Questions (FAQs)
What is the main subject of US Patent 8,895,546?
The main subject of US Patent 8,895,546 is the administration of benzodiazepine compositions, specifically for nasal administration.
Who are the inventors of this patent?
The inventors include Steve Cartt, David Medeiros, Garry Thomas Gwozdz, Andrew Loxley, Mark Mitchnick, David Hale, and Edward T. Maggio.
What is the significance of this patent in the pharmaceutical industry?
This patent is significant because it provides a rapid and effective method for administering benzodiazepines, particularly in emergency situations such as seizures.
When does the patent expire?
The patent expires on March 27, 2029.
Is this patent involved in any litigation?
Yes, Neurelis, Inc. has filed a complaint against Padagis LLC and related entities for infringement of this patent.
Cited Sources:
- United States Patent and Trademark Office - US8895546B2.
- Insight.RPXCorp - Complaint - Neurelis v Padagis.
- Hoover Institution - Patent Claims and Patent Scope.
- Google Patents - Administration of benzodiazepine compositions.
- Drugs.com - Generic Valtoco Availability.
