United States Patent 10,973,795: A Detailed Analysis of Scope and Claims
Overview of the Patent
United States Patent 10,973,795, titled "Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics," is a patent that focuses on the development of new formulations of gamma-hydroxybutyrate (GHB) with enhanced dissolution and pharmacokinetic properties. Here is a detailed analysis of the scope, claims, and the broader patent landscape surrounding this invention.
Background and Motivation
Gamma-hydroxybutyrate (GHB) is a compound with various therapeutic uses, including the treatment of narcolepsy and cataplexy. However, existing formulations of GHB often suffer from limitations such as poor dissolution rates and variable pharmacokinetics, which can affect the efficacy and safety of the treatment. The patent aims to address these issues by developing modified release formulations of GHB.
Scope of the Patent
Invention Description
The patent describes modified release formulations of GHB designed to improve the dissolution and pharmacokinetic properties of the compound. These formulations include various components such as polymers, solvents, and other excipients that enhance the release profile of GHB. The improved formulations are intended to provide more consistent and predictable therapeutic effects, particularly for nighttime administration to treat sleep disorders[4].
Key Components
- Polymers and Excipients: The patent details the use of water-soluble polymers, hydroxypropyl methyl cellulose, and other polymers to control the release rate of GHB.
- Solvents and Mediums: The formulations may include solvents and mediums such as deionized water and hydrogenated cottonseed oil to facilitate the processing and stability of the GHB formulations.
- Therapeutic Uses: The modified release formulations are intended for therapeutic uses, including the treatment of disorders of excessive somnolence, cataplexy, and other sleep-related disorders[4].
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention:
- Claim 1: This claim describes a modified release formulation of GHB comprising a specific combination of polymers, solvents, and other excipients designed to improve the dissolution and pharmacokinetic properties of GHB.
- Claim 10: This claim outlines a method for preparing the modified release formulation, including the steps of mixing GHB with the specified polymers and solvents, followed by processing into a suitable dosage form[4].
Dependent Claims
The dependent claims further specify various aspects of the independent claims, such as the types of polymers used, the ratios of components, and the specific therapeutic applications.
Patent Landscape
Prior Art and Related Patents
The patent landscape for GHB formulations is complex, with several prior art references and related patents. For instance, other patents and applications have also focused on improving the release profiles and pharmacokinetics of GHB, often using different approaches such as different polymers or coating compositions[5].
Global Dossier and International Filings
To understand the broader patent landscape, it is essential to review the global dossier for this patent family. The Global Dossier service provided by the USPTO allows users to access the file histories of related applications from participating IP Offices, which can include the IP5 Offices (USPTO, EPO, JPO, KIPO, and CNIPA). This helps in identifying any office actions, citations, and other relevant information that may impact the validity or scope of the patent[1].
Searchable Databases
Searching international patent offices such as the European Patent Office (EPO), Japan Patent Office (JPO), and the World Intellectual Property Organization (WIPO) through databases like esp@cenet, PATENTSCOPE, and others can provide insights into similar inventions and prior art in different jurisdictions[1].
Economic and Practical Implications
Market Impact
The development of modified release GHB formulations with improved pharmacokinetics can significantly impact the market for sleep disorder treatments. These formulations could offer better therapeutic outcomes, improved patient compliance, and potentially lower costs due to more efficient drug delivery.
Competitive Landscape
The competitive landscape in the pharmaceutical industry, particularly for sleep disorder treatments, is highly competitive. Companies and researchers continually seek to improve existing formulations and develop new ones to gain a competitive edge. This patent could provide its holders with a significant advantage in the market by offering a superior GHB formulation.
Legal and Regulatory Considerations
Patent Validity and Enforcement
The validity and enforceability of the patent depend on various factors, including the novelty and non-obviousness of the invention, the adequacy of the disclosure, and the scope of the claims. The patent holder must ensure that the patent is properly maintained and enforced to protect their intellectual property rights.
Regulatory Approvals
For the modified release GHB formulations to be marketed, they must undergo regulatory approvals from bodies such as the FDA. The patent holder must comply with all regulatory requirements, including clinical trials and safety evaluations, to obtain approval for the new formulations.
Key Takeaways
- Improved Formulations: The patent introduces modified release formulations of GHB with enhanced dissolution and pharmacokinetic properties.
- Therapeutic Uses: These formulations are designed for the treatment of sleep disorders, including narcolepsy and cataplexy.
- Patent Scope: The patent includes independent and dependent claims that define the specific components and methods for preparing the formulations.
- Global Landscape: Understanding the global dossier and searching international patent databases is crucial for assessing the broader patent landscape.
- Economic Impact: The new formulations could have significant market impact by offering better therapeutic outcomes and improved patient compliance.
FAQs
1. What is the main focus of United States Patent 10,973,795?
The main focus of this patent is the development of modified release formulations of gamma-hydroxybutyrate (GHB) with improved dissolution and pharmacokinetic properties.
2. What are the key components of the modified release formulations described in the patent?
The key components include water-soluble polymers, solvents such as deionized water, and other excipients that control the release rate of GHB.
3. What are the therapeutic uses of the modified release GHB formulations?
The formulations are intended for the treatment of disorders of excessive somnolence, cataplexy, and other sleep-related disorders.
4. How can one access the global dossier for this patent family?
The global dossier can be accessed through the Global Dossier service provided by the USPTO, which allows users to view the file histories of related applications from participating IP Offices.
5. What regulatory approvals are required for the modified release GHB formulations to be marketed?
The formulations must undergo regulatory approvals from bodies such as the FDA, including clinical trials and safety evaluations.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- ACUS - U.S. Patent Small Claims Court: https://www.acus.gov/research-projects/us-patent-small-claims-court
- USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- Google Patents - US10973795B2: https://patents.google.com/patent/US10973795B2/en
- Unified Patents Portal - CN-109789096-B: https://portal.unifiedpatents.com/patents/patent/CN-109789096-B
