United States Patent 10,864,181: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 10,864,181, titled "Method of administration of gamma hydroxybutyrate with monocarboxylate transporters," is a significant patent in the field of pharmaceuticals, particularly in the treatment of disorders using gamma-hydroxybutyrate (GHB). This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background
Gamma-hydroxybutyrate (GHB) is a drug used for various medical conditions, including narcolepsy and cataplexy. The patent in question focuses on a specific method of administering GHB, enhancing its safety and efficacy through the use of monocarboxylate transporters.
Scope of the Patent
Overview
The patent describes a method for administering GHB or its salts to a patient, emphasizing the role of monocarboxylate transporters in this process. Monocarboxylate transporters are proteins that facilitate the transport of monocarboxylates, such as GHB, across cell membranes. This method aims to improve the pharmacodynamic effects of GHB by optimizing its delivery and absorption[4].
Key Aspects
- Method of Administration: The patent outlines a specific method of administering GHB, which involves the use of monocarboxylate transporters to enhance the drug's absorption and efficacy.
- Pharmacodynamic Effects: The method is designed to optimize the pharmacodynamic effects of GHB, ensuring better treatment outcomes for patients.
- Safety and Efficacy: The patent highlights the importance of safety and efficacy in the administration of GHB, addressing potential issues such as QTc prolongation and other adverse effects associated with GHB use[4].
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims typically cover the method of administration, the use of monocarboxylate transporters, and the specific conditions under which the method is applied.
- Claim 1: This claim typically sets out the broadest definition of the method, including the administration of GHB or its salts and the involvement of monocarboxylate transporters.
- Subsequent Claims: These claims may narrow down the scope by specifying particular conditions, such as the dosage, timing, and patient population[4].
Dependent Claims
Dependent claims further refine the independent claims by adding additional limitations or specifications. These claims help to protect the invention by covering various aspects of the method, such as different formulations of GHB or specific patient groups.
Patent Landscape
Related Patents
The patent landscape for GHB-related patents is complex and includes several other patents owned by the same or different entities. For example:
- Jazz Pharmaceuticals: This company holds a series of patents related to GHB compositions and their use in treating disorders, including patents such as US 8,591,922 and US 11,554,102. These patents cover various aspects of GHB administration and treatment[2].
- Other Entities: Other pharmaceutical companies and research institutions may also hold patents related to GHB or similar compounds, which could impact the scope and enforcement of the patent in question.
Global Dossier and International Filings
The Global Dossier system, which provides access to the file histories of related applications from participating IP Offices, is crucial for understanding the international patent landscape. This system allows users to see the patent family for a specific application, including all related applications filed at participating IP Offices, along with dossier, classification, and citation data[1].
Litigation and Enforcement
Patents in the pharmaceutical sector are often subject to litigation, particularly when generic versions of drugs are sought to be approved. For instance, the litigation between Jazz Pharmaceuticals and Teva regarding the ANDA for a generic version of Xywav® highlights the importance of patent enforcement in this field[2].
Subject Matter Eligibility
The subject matter eligibility of patents, especially those involving methods of treatment, is a critical issue. The Federal Circuit's decision in Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals sets a precedent that "method of treatment" claims can be patent eligible if they practically apply natural relationships and are not directed to judicial exceptions. This decision is relevant to the patent in question, as it involves a specific method of administering GHB based on the natural relationship between GHB and monocarboxylate transporters[5].
Metrics for Measuring Patent Scope
Research has shown that metrics such as independent claim length and independent claim count can be used to measure patent scope. Narrower claims at publication are associated with a higher probability of grant and a shorter examination process. This is relevant when evaluating the scope and strength of the patent in question[3].
Public Search and Examination Data
Tools like the Patent Public Search and the Patent Examination Data System (PEDS) are essential for conducting thorough searches and analyzing the examination history of patents. These resources help in understanding the prior art and the examination process, which can influence the validity and scope of the patent[1].
Conclusion
The United States Patent 10,864,181 is a significant contribution to the field of pharmaceuticals, particularly in the administration of GHB. Understanding its scope, claims, and the broader patent landscape is crucial for both the patent holder and other stakeholders. The patent's focus on safety and efficacy, combined with its specific method of using monocarboxylate transporters, positions it as a valuable asset in the treatment of disorders.
Key Takeaways
- Specific Method of Administration: The patent describes a method of administering GHB using monocarboxylate transporters to enhance safety and efficacy.
- Pharmacodynamic Effects: The method is designed to optimize the pharmacodynamic effects of GHB.
- Patent Landscape: The patent is part of a complex landscape involving multiple related patents and international filings.
- Subject Matter Eligibility: The patent's claims are likely eligible under the Vanda decision, as they practically apply natural relationships.
- Metrics and Tools: Metrics like independent claim length and tools like the Patent Public Search and PEDS are important for evaluating the patent's scope and strength.
FAQs
What is the primary focus of United States Patent 10,864,181?
The primary focus of the patent is a method of administering gamma-hydroxybutyrate (GHB) using monocarboxylate transporters to enhance its safety and efficacy.
How does the patent improve the administration of GHB?
The patent improves the administration of GHB by utilizing monocarboxylate transporters to optimize the drug's absorption and pharmacodynamic effects.
What is the significance of the Vanda decision in relation to this patent?
The Vanda decision sets a precedent that "method of treatment" claims, like those in this patent, can be patent eligible if they practically apply natural relationships and are not directed to judicial exceptions.
How can one search for related patents and examination data?
Tools such as the Patent Public Search and the Patent Examination Data System (PEDS) can be used to search for related patents and examination data.
What metrics can be used to measure the scope of this patent?
Metrics such as independent claim length and independent claim count can be used to measure the scope of the patent, indicating its breadth and potential strength.
