United States Patent 9,937,132: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 9,937,132, titled "Formulation of doxylamine and pyridoxine and/or metabolites or salts thereof," is a significant patent in the pharmaceutical industry, particularly for the treatment of nausea and vomiting. This patent, held by Duchesnay Inc., pertains to a dual release oral dosage system that combines doxylamine and pyridoxine, key ingredients in medications like Bonjesta.
Patent Overview
Inventors and Assignees
The patent was assigned to Duchesnay Inc., a company known for its focus on women's health and gastrointestinal disorders.
Publication and Priority Dates
The patent was published on May 8, 2018, with a priority date of June 30, 2015[1].
Scope of the Patent
Dual Release Oral Dosage System
The patent describes a dual release oral dosage system that includes both an immediate release component and a delayed release component. This system is designed to optimize the delivery of doxylamine and pyridoxine, ensuring effective and sustained relief from symptoms such as nausea and vomiting[1].
Components of the Dosage System
- Immediate Release Component: This component contains one or more of doxylamine, its analogs, derivatives, prodrugs, metabolites, or salts. Similarly, it may include pyridoxine or its analogs, derivatives, prodrugs, metabolites, or salts[1].
- Delayed Release Component: This component also contains one or more of the aforementioned forms of doxylamine and pyridoxine. The delayed release ensures a prolonged therapeutic effect[1].
Layered and Coated Formulations
The patent details various formulations where the immediate and delayed release components are arranged in a layered or coated configuration. For example, the delayed release composition can be in the core, surrounded by one or more coats of the immediate release composition[1].
Claims of the Patent
Key Claims
The patent includes multiple claims that define the scope of the invention:
- Claims related to the dual release oral dosage form with specific compositions of doxylamine and pyridoxine.
- Claims regarding the layered or coated arrangement of the immediate and delayed release components.
- Claims about the identifying characteristics of the different dual release oral dosage forms, such as shape, color, or identifying marks[1].
Dependent Claims
Dependent claims further specify the details of the composition, such as the types of polymers used for coating and the specific ratios of doxylamine to pyridoxine[1].
Patent Landscape
Related Patents and Litigation
The patent is part of a broader landscape involving similar formulations and litigation related to generic versions. For instance, Duchesnay Inc. has been involved in litigation with Alkem Labs. Ltd. regarding the Bonjesta formulation, which is protected by this and other related patents[2].
Patent Expiration and Maintenance
The patent is set to expire in the future, with maintenance fees having been paid to extend its validity. For example, the 4th-year maintenance fee for this patent was paid in 2021[5].
Impact on Pharmaceutical Industry
Treatment of Nausea and Vomiting
This patent is crucial for the treatment of nausea and vomiting, particularly in pregnant women. The dual release system ensures a rapid onset of action and sustained relief, making it a valuable asset for Duchesnay Inc.[4].
Generic Challenges
The patent's protection period affects the timing of generic versions of Bonjesta. Generic manufacturers must wait until the patent expires or negotiate settlement agreements to enter the market earlier[2].
Patent Analytics and Claim Coverage
Claim Coverage Matrix
To understand the full scope of protection, a Claim Coverage Matrix can be used to categorize patents by claims and scope concepts. This helps in identifying gaps or opportunities in the patent landscape and ensures that all aspects of the technology are protected[3].
Claim Charts and Scope Concepts
Interactive claim charts generated by tools like ClaimScape® can help in reviewing patent coverage and determining the applicability of scope concepts to target products or methods. This is particularly useful for engineers, scientists, and management to evaluate the value and coverage of their patent claims[3].
Legal and Regulatory Aspects
ANDA Litigation
The patent has been involved in ANDA (Abbreviated New Drug Application) litigation, where generic manufacturers have sought to challenge the patent's validity or negotiate settlements to enter the market. These settlements often involve complex agreements that allow generic entry under specific conditions[2].
Settlement Agreements
Settlements, such as the one between Duchesnay Inc. and Alkem Labs. Ltd., typically involve the dismissal of all claims and counterclaims without prejudice, with each party bearing its own costs and attorneys’ fees. These agreements can also include provisions for future generic entry[2].
Key Takeaways
- The patent covers a dual release oral dosage system for doxylamine and pyridoxine.
- The system includes immediate and delayed release components, which can be arranged in layered or coated configurations.
- The patent is crucial for the treatment of nausea and vomiting, particularly in pregnant women.
- It is part of a broader patent landscape involving litigation and settlement agreements with generic manufacturers.
- Patent analytics tools are essential for understanding the full scope of protection and identifying gaps or opportunities.
Frequently Asked Questions (FAQs)
What is the primary purpose of the United States Patent 9,937,132?
The primary purpose of this patent is to protect a dual release oral dosage system that combines doxylamine and pyridoxine for the treatment of nausea and vomiting.
How does the dual release system work?
The dual release system includes an immediate release component for rapid onset of action and a delayed release component for sustained therapeutic effect.
What are the key components of the dosage system?
The key components include doxylamine and pyridoxine, or their analogs, derivatives, prodrugs, metabolites, or salts, arranged in immediate and delayed release configurations.
Why is this patent important in the pharmaceutical industry?
This patent is important because it protects a formulation that provides effective and sustained relief from nausea and vomiting, particularly in pregnant women, and affects the timing of generic versions of Bonjesta.
How does patent analytics help in managing this patent?
Patent analytics helps in categorizing patents by claims and scope concepts, identifying gaps or opportunities in the patent landscape, and ensuring that all aspects of the technology are protected.
Cited Sources:
- US9937132B2 - Formulation of doxylamine and pyridoxine and/or metabolites or salts thereof - Google Patents
- ANDA Litigation Settlements | Hatch-Waxman - Robins Kaplan
- Patent Analytics | Intellectual Property Law - Schwegman
- US20160058709A1 - Plurimodal release formulation of doxylamine and pyridoxine and/or metabolites or salts thereof - Google Patents
- Bonjesta patent expiration - Pharsight
