United States Patent 9,375,404: A Detailed Analysis of Scope and Claims
Introduction
United States Patent 9,375,404, titled "Formulation of doxylamine and pyridoxine and/or metabolites or salts thereof," is a patent that has significant implications in the pharmaceutical industry, particularly in the development and manufacture of medications for pregnancy-related nausea and vomiting. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Patent Overview
Publication and Authority
The patent, US9375404B2, was published by the United States Patent and Trademark Office (USPTO) and is currently active. It was filed under the application number US14/746,635 and granted on June 7, 2016[4].
Inventors and Assignees
The patent is assigned to Duchesnay Inc., a pharmaceutical company known for its innovative formulations, particularly in the area of women's health.
Prior Art and Classification
The patent is classified under the International Patent Classification (IPC) system, specifically under A61K9/20, which pertains to medicinal preparations characterized by special physical forms such as pills, tablets, discs, and rods. The prior art keywords include metabolite, salt, doxylamine, prodrug, and pyridoxine[4].
Scope of the Patent
Technical Description
The patent describes a dual release oral dosage system comprising an immediate release component and a delayed release component. This formulation is designed to provide both rapid and sustained release of the active ingredients, doxylamine and pyridoxine, which are commonly used to treat nausea and vomiting during pregnancy. The dosage form can be in various configurations, including layered arrangements or core-coat structures, with identifying characteristics such as shape, color, or marks to distinguish different formulations[4].
Claims
The patent includes several claims that define the scope of the invention. Key claims include:
- Claim 1: A dual release oral dosage form comprising an immediate release composition and a delayed release composition.
- Claim 2: The dosage form where the immediate and delayed release compositions are in a layered arrangement.
- Claim 3: The dosage form where the immediate release composition is in one or more coats substantially surrounding a core comprising the delayed release composition[4].
Patent Claims Analysis
Independent Claim Length and Count
Research on patent scope often uses metrics such as independent claim length and count to measure the breadth of a patent. For US9375404B2, the claims are structured to ensure clarity and specificity, which is crucial for maintaining the validity and enforceability of the patent. Narrower claims, as seen in this patent, are associated with a higher probability of grant and a shorter examination process[3].
Claim Construction
The claims are constructed to cover various embodiments of the dual release formulation, ensuring that the patent protects the core innovation while allowing for some flexibility in the manufacturing process. This approach helps in preventing infringement by generic manufacturers who might attempt to create similar formulations with minor variations.
Patent Landscape
Competitors and Generics
The patent landscape around US9375404B2 is highly competitive, especially with the emergence of generic drug manufacturers. For instance, Alkem Laboratories Ltd. filed an Abbreviated New Drug Application (ANDA) with the FDA to market a generic version of Duchesnay’s Bonjesta®, which led to a patent infringement lawsuit. Duchesnay alleged that Alkem’s submission constituted an act of infringement under 35 U.S.C. § 271(e)(2)(A)[5].
Litigation
The litigation surrounding this patent highlights the importance of robust claim construction and the need for continuous monitoring of the patent landscape. Duchesnay’s legal actions against Alkem demonstrate the company’s commitment to protecting its intellectual property and maintaining market exclusivity for its innovative formulation.
Global Patent System
Global Dossier
The Global Dossier system, which includes the IP5 Offices, provides a platform for accessing file histories and related applications of patents like US9375404B2. This system helps in identifying office actions and citations across different jurisdictions, facilitating a more integrated global patent system[1].
Common Citation Document (CCD)
The Common Citation Document (CCD) application consolidates prior art citations from participating IP offices, enabling a comprehensive view of the patent family and its citations. This tool is crucial for assessing the validity and scope of patents like US9375404B2 on an international scale[1].
Practical Implications
Pharmaceutical Industry
For pharmaceutical companies, patents like US9375404B2 are vital for protecting innovative formulations and ensuring market exclusivity. The dual release formulation described in this patent offers significant clinical benefits, and the patent's scope ensures that Duchesnay can recoup its investment in research and development.
Regulatory Compliance
The patent's claims and scope must comply with regulatory requirements, such as those set by the FDA. The FDA's approval process for ANDAs, as seen in the case of Alkem Laboratories, involves careful scrutiny of patent claims to ensure that generic versions do not infringe on existing patents[5].
Key Takeaways
- Patent Scope: The patent covers a dual release oral dosage system with immediate and delayed release components, ensuring both rapid and sustained release of doxylamine and pyridoxine.
- Claims Construction: The claims are structured to be specific and narrow, enhancing the patent's validity and enforceability.
- Competitive Landscape: The patent is highly contested, with generic manufacturers attempting to enter the market, highlighting the need for robust legal protection.
- Global Implications: The patent is part of a global dossier system, facilitating international patent harmonization and citation tracking.
- Regulatory Compliance: The patent must comply with FDA regulations, particularly in the context of ANDA submissions.
FAQs
What is the main innovation protected by US9375404B2?
The main innovation is a dual release oral dosage system comprising an immediate release component and a delayed release component for the active ingredients doxylamine and pyridoxine.
Why is the claim construction important for this patent?
The claim construction is crucial because it defines the scope of the invention, ensuring clarity and specificity, which are essential for maintaining the patent's validity and enforceability.
What is the significance of the Global Dossier system for this patent?
The Global Dossier system allows for the access of file histories and related applications across participating IP offices, facilitating a more integrated global patent system and helping in identifying office actions and citations.
How does the FDA's approval process for ANDAs relate to this patent?
The FDA's approval process for ANDAs involves scrutinizing patent claims to ensure that generic versions do not infringe on existing patents like US9375404B2.
What are the practical implications of this patent for pharmaceutical companies?
For pharmaceutical companies, this patent is vital for protecting innovative formulations and ensuring market exclusivity, allowing them to recoup their investment in research and development.
Sources
- USPTO: Search for patents - USPTO. (2018, October 18).
- ACUS: U.S. Patent Small Claims Court. (2022).
- SSRN: Patent Claims and Patent Scope. (2016, September 29).
- Google Patents: US9375404B2 - Formulation of doxylamine and pyridoxine and/or metabolites or salts thereof.
- United States District Court: IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE DUCHESNAY INC. Plaintiff, v. ALKEM LABORATORIES LTD. Defendant. (2022, July 11).
