United States Patent 9,642,913: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 9,642,913, assigned to Neurelis, Inc., is a significant patent in the pharmaceutical sector, particularly in the field of benzodiazepine drugs administered nasally. This patent is part of a broader portfolio related to the drug Valtoco, which is used for the acute treatment of seizure clusters.
Patent Overview
Invention Description
The patent 9,642,913 describes pharmaceutical compositions that include one or more benzodiazepine drugs, specifically designed for nasal administration. This method of delivery is crucial for the rapid treatment of acute seizure clusters, where traditional oral or intravenous routes may not be feasible or effective[2][5].
Inventors and Assignees
The inventors listed on this patent include Steve Cartt, David Medeiros, Garry Thomas Gwozdz, Andrew Loxley, Mark Mitchnick, David F. Hale, and Edward T. Maggio. The assignee is Neurelis, Inc., a company specializing in the development of innovative pharmaceutical products[2][5].
Claims and Scope
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims typically cover the composition of the pharmaceutical product, the method of administration, and the specific benzodiazepine drugs used. For instance, the claims might specify the formulation of the nasal spray, the concentration of the active ingredient, and the process for preparing the composition[2].
Dependent Claims
Dependent claims further narrow down the scope by adding additional limitations to the independent claims. These could include specific dosages, administration protocols, and other detailed aspects of the pharmaceutical composition and its use[3].
Patent Landscape
Related Patents
The patent 9,642,913 is part of a larger family of patents related to Valtoco. Other relevant patents include U.S. Patent Nos. 8,895,546, 11,241,414, and 11,793,786, all of which are listed in the FDA's "Orange Book" as covering Valtoco. These patents collectively protect various aspects of the drug, including its composition, method of administration, and use[2][5].
Expiration Dates
The patent 9,642,913 is set to expire on May 11, 2025. Other related patents have different expiration dates, with some expiring as late as March 27, 2029. This staggered expiration timeline provides Neurelis, Inc. with extended market exclusivity for Valtoco[2][5].
Litigation and Enforcement
Infringement Actions
Neurelis, Inc. has been involved in several patent infringement actions to protect its intellectual property. For example, the company has sued Padagis LLC and its affiliates for infringement of the Asserted Patents, including the '546, '414, and '786 patents, in connection with Padagis's submission of an Abbreviated New Drug Application (ANDA) for a generic version of Valtoco[2].
Hatch-Waxman Act
The litigation involving Neurelis and Padagis is governed by the Hatch-Waxman Act, which provides a framework for generic drug manufacturers to challenge branded pharmaceutical companies' patents. This process often involves complex legal battles over patent validity and infringement[2].
Patent Scope and Quality
Metrics for Patent Scope
Research on patent scope suggests that metrics such as independent claim length and independent claim count can be used to measure the breadth of a patent. Narrower claims are often associated with a higher probability of grant and a shorter examination process, indicating better patent quality[3].
Critiques and Debates
There are ongoing debates about patent quality, with some arguing that overly broad or unclear claims can impede innovation. The examination process at the USPTO tends to narrow the scope of patent claims, which can affect the validity and enforceability of patents like 9,642,913[3].
Market Impact
Generic Competition
The absence of a generic version of Valtoco in the U.S. market, despite the expiration of some related patents, highlights the effective protection provided by Neurelis's patent portfolio. Generic manufacturers like Padagis are waiting for the expiration of key patents before commercializing their generic versions[5].
Innovation Incentives
The patent landscape around Valtoco demonstrates how strong intellectual property protection can incentivize innovation in the pharmaceutical sector. Neurelis's investments in research and development are protected, allowing the company to recoup its investments and continue innovating[3].
Conclusion
The United States Patent 9,642,913 is a critical component of Neurelis, Inc.'s intellectual property strategy for Valtoco. Understanding the scope, claims, and patent landscape of this patent is essential for navigating the complex world of pharmaceutical patents and ensuring market exclusivity.
Key Takeaways
- Patent Scope: The patent covers specific pharmaceutical compositions and methods for nasal administration of benzodiazepine drugs.
- Related Patents: Part of a larger family of patents protecting Valtoco, including U.S. Patent Nos. 8,895,546, 11,241,414, and 11,793,786.
- Expiration Dates: Set to expire on May 11, 2025, with other related patents expiring as late as March 27, 2029.
- Litigation: Neurelis, Inc. has engaged in patent infringement actions to protect its intellectual property.
- Market Impact: Effective protection against generic competition, incentivizing innovation in the pharmaceutical sector.
FAQs
What is the main subject of United States Patent 9,642,913?
The main subject of this patent is pharmaceutical compositions comprising one or more benzodiazepine drugs for nasal administration, specifically for the treatment of acute seizure clusters.
Who are the inventors and assignees of this patent?
The inventors include Steve Cartt, David Medeiros, Garry Thomas Gwozdz, Andrew Loxley, Mark Mitchnick, David F. Hale, and Edward T. Maggio. The assignee is Neurelis, Inc.
What is the expiration date of this patent?
The patent 9,642,913 is set to expire on May 11, 2025.
How does this patent fit into the broader patent landscape for Valtoco?
This patent is part of a larger family of patents protecting Valtoco, including U.S. Patent Nos. 8,895,546, 11,241,414, and 11,793,786, all listed in the FDA's "Orange Book."
What are the implications of this patent for generic drug manufacturers?
Generic manufacturers must wait for the expiration of key patents, including this one, before they can commercialize their generic versions of Valtoco.
Cited Sources
- United States Patent and Trademark Office. U.S. Patent No. 11,241,414 B2.
- Neurelis, Inc. v. Padagis LLC et al. Complaint, U.S. District Court for the District of Delaware.
- Marco, A. C., Sarnoff, J. D., & deGrazia, C. A. Patent Claims and Patent Scope. Hoover Institution, 2016.
- Google Patents. U.S. Patent No. 9,642,913 B2.
- Drugs.com. Generic Valtoco Availability.
