United States Patent 11,253,494: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 11,253,494, titled "Method of administration of gamma hydroxybutyrate with monocarboxylate transporters," is a significant patent in the pharmaceutical industry, particularly in the treatment of narcolepsy and other related disorders. This patent is owned by Jazz Pharmaceuticals and plays a crucial role in the protection of their drugs XYREM and XYWAV.
Patent Overview
Issuance and Ownership
The patent was issued on February 22, 2022, by the United States Patent and Trademark Office (USPTO) to Jazz Pharmaceuticals, an Irish corporation with its principal place of business in Dublin, Ireland[2][4].
Patent Title and Description
The patent is focused on methods of administering gamma-hydroxybutyrate (GHB) to patients, particularly those with narcolepsy, while considering the interaction with monocarboxylate transporters (MCTs). This includes specific dosages and precautions to avoid adverse reactions when GHB is administered with other drugs like valproate[4].
Scope of the Patent
Claims
The patent includes several claims that define the scope of the invention. Here are some key aspects:
- Method of Administration: The patent claims methods for administering GHB to patients with narcolepsy, specifying daily dosages between 6 g and 10 g per day. It also includes advice on avoiding concomitant administration with valproate and other MCT inhibitors to prevent adverse reactions[4].
- Therapeutic Considerations: The claims detail the therapeutic effects and potential adverse reactions of GHB when administered with other drugs. This includes advising patients on the contraindication of using GHB with valproate and the potential increase in GHB exposure when these drugs are used together[4].
Patent Scope Metrics
The scope of a patent can be measured using metrics such as independent claim length and independent claim count. These metrics can indicate the breadth and clarity of the patent claims. For instance, narrower claims at publication are associated with a higher probability of grant and a shorter examination process, which could be relevant in evaluating the quality and validity of this patent[3].
Claims Analysis
Independent Claims
The patent includes multiple independent claims that describe the method of administration and the precautions associated with it. Here is a breakdown:
- Claim 1: Describes the method of administering GHB to a patient with narcolepsy, specifying the dosage range and advising against concomitant administration with valproate[4].
- Subsequent Claims: These claims elaborate on the method, including additional steps and considerations for patient safety, such as advising on the avoidance of MCT inhibitors and the potential therapeutic effects and adverse reactions[4].
Claim Construction
The construction of claims in this patent is crucial for determining its scope and potential infringement. The claims are constructed to cover specific methods of administration, ensuring that the patented invention is clearly defined and distinguishable from other methods[1].
Patent Landscape
Related Patents
Jazz Pharmaceuticals holds a portfolio of patents related to GHB compositions and their use in treating disorders. These include patents such as US 8,591,922, US 8,772,306, and others, which collectively protect the intellectual property surrounding XYREM and XYWAV[2].
Litigation and Infringement
The patent landscape is also influenced by litigation. For example, Jazz Pharmaceuticals has filed lawsuits against generic drug manufacturers like Teva, alleging infringement of their patents, including the '494 patent, when these manufacturers submit Abbreviated New Drug Applications (ANDAs) to the FDA[2].
FDA Approval and Listing
The patent is included in the New Drug Applications (NDAs) for XYREM and XYWAV, which are approved by the FDA. The listing of this patent in the FDA's Orange Book is critical for preventing generic competition until the patent expires[2][5].
Expiration and Protection
Patent Expiration
The patent is set to expire on a date determined by the USPTO, typically 20 years from the filing date. This expiration date is crucial for generic manufacturers planning to enter the market with their own versions of GHB-based drugs[5].
Protection of Intellectual Property
Jazz Pharmaceuticals actively protects its intellectual property through litigation and regulatory measures. The company ensures that any potential generic versions of their drugs do not infringe on their patented methods and compositions[2].
Key Takeaways
- Patent Scope: The patent covers specific methods of administering GHB to patients with narcolepsy, with a focus on safety and efficacy.
- Claims Analysis: The claims are detailed and include precautions against concomitant administration with certain drugs.
- Patent Landscape: The patent is part of a broader portfolio protecting XYREM and XYWAV, with ongoing litigation to prevent infringement.
- Expiration and Protection: The patent's expiration date is critical for future market competition, and Jazz Pharmaceuticals actively protects its intellectual property.
FAQs
What is the main focus of United States Patent 11,253,494?
The main focus of this patent is on the method of administration of gamma-hydroxybutyrate (GHB) to patients with narcolepsy, particularly considering the interaction with monocarboxylate transporters.
Which drugs are protected by this patent?
This patent protects the drugs XYREM and XYWAV, which are used in the treatment of narcolepsy and other related disorders.
What are the key claims of this patent?
The key claims include the method of administering GHB in a specified dosage range and advising against concomitant administration with valproate and other MCT inhibitors.
How does this patent fit into the broader patent landscape?
This patent is part of a portfolio held by Jazz Pharmaceuticals that protects their intellectual property related to GHB compositions and methods of use.
When does this patent expire?
The expiration date of this patent is determined by the USPTO and is typically 20 years from the filing date.
Sources
- Jazz Pharms., Inc., v. Avadel CNS - U.S. Court of Appeals for the Federal Circuit, February 24, 2023.
- Complaint in Jazz Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc. - U.S. District Court, March 21, 2023.
- Patent Claims and Patent Scope - SSRN, September 29, 2016.
- US11253494B2 - Method of administration of gamma hydroxybutyrate with monocarboxylate transporters - Google Patents.
- Patent 11,253,494 - DrugPatentWatch.
