United States Patent 10,272,062: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 10,272,062, titled "Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics," is a significant patent in the pharmaceutical field, particularly for the treatment of narcolepsy and other sleep disorders. This patent, issued on April 30, 2019, is part of a series of patents related to gamma-hydroxybutyrate (GHB) formulations.
Background and Context
Gamma-hydroxybutyrate, commonly known as GHB, is a medication used primarily for the treatment of narcolepsy, a neurological disorder characterized by excessive daytime sleepiness, cataplexy, hypnagogic hallucinations, sleep paralysis, and disturbed nocturnal sleep[1].
Scope of the Patent
The patent focuses on modified release formulations of GHB that improve the drug's dissolution and pharmacokinetic properties. Here are the key aspects of the patent's scope:
Improved Pharmacokinetics
The patent aims to provide formulations that release GHB in a manner that mimics the pharmacokinetic profile of immediate release liquid solutions of sodium oxybate, but with the potential for reduced dosing. This is achieved through a combination of immediate release and modified release portions[1][4].
Dissolution Requirements
The formulations must meet specific dissolution criteria:
- Release at least 80% of GHB within 3 hours in a dissolution apparatus using 900 mL of 0.05M monobasic potassium phosphate buffer pH 6.8 at 37°C.
- Release between 10% to 65% of GHB at 1 hour and 3 hours in 900 mL of 0.1N hydrochloric acid at 37°C and a paddle speed of 75 rpm.
- Release greater than 60% of GHB at 10 hours under similar conditions[4].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Formulation Composition
The claims specify that the modified release formulations comprise both immediate release and modified release portions of GHB. These portions are designed to release the drug at different rates to achieve the desired pharmacokinetic profile[1][4].
Therapeutic Uses
The patent claims therapeutic uses for these formulations, particularly for the treatment of narcolepsy and other sleep disorders. The improved pharmacokinetics aim to enhance the therapeutic effectiveness and safety profile of GHB[1].
Specific Release Profiles
The claims detail the specific release profiles required for the formulations, including the percentage of GHB released at various time points under different conditions[4].
Patent Landscape
The patent landscape surrounding US Patent 10,272,062 is complex and involves multiple related patents and ongoing legal disputes.
Related Patents
This patent is part of a series of continuations and continuations-in-part, starting from U.S. Provisional Application No. 62/365,812 filed on July 22, 2016. It is connected to several other patents, including U.S. Pat. No. 11,065,224, U.S. Pat. No. 10,736,866, and others, which collectively cover various aspects of GHB formulations[1][2].
Patent Expiration Dates
The patent is set to expire on July 21, 2037, along with several other related patents, marking a significant period of exclusivity for the patent holders[2].
Litigation and Infringement
There are ongoing legal disputes related to the infringement of these patents. For example, Jazz Pharmaceuticals has filed a complaint against Avadel CNS Pharmaceuticals, LLC, alleging infringement of several patents, including those related to GHB formulations. This highlights the competitive and legally complex environment surrounding these patents[5].
Impact on Pharmaceutical Industry
The patent has significant implications for the pharmaceutical industry, particularly in the development and marketing of GHB formulations.
Innovation and Competition
The improved pharmacokinetic properties and dissolution profiles provided by this patent can lead to more effective and safer treatments for narcolepsy patients. However, the patent also creates a barrier to entry for other companies seeking to develop similar formulations, potentially limiting competition and innovation in this area[1][4].
Regulatory Approval
The FDA approval process for new drug applications (NDAs) involving GHB formulations must navigate the complex patent landscape. Companies like Avadel CNS Pharmaceuticals, LLC, must ensure their products do not infringe on existing patents, as seen in the ongoing litigation with Jazz Pharmaceuticals[5].
Key Takeaways
- Improved Pharmacokinetics: The patent focuses on modified release GHB formulations with enhanced dissolution and pharmacokinetic properties.
- Specific Release Profiles: The formulations must meet specific release criteria to ensure therapeutic effectiveness.
- Therapeutic Uses: Primarily for the treatment of narcolepsy and other sleep disorders.
- Patent Landscape: Part of a series of related patents with ongoing legal disputes over infringement.
- Impact on Industry: Significant implications for innovation, competition, and regulatory approval in the pharmaceutical industry.
FAQs
What is the primary focus of US Patent 10,272,062?
The primary focus is on modified release formulations of gamma-hydroxybutyrate with improved dissolution and pharmacokinetic properties.
What are the key dissolution requirements for the formulations?
The formulations must release at least 80% of GHB within 3 hours in a specific buffer solution and between 10% to 65% in hydrochloric acid at 1 and 3 hours.
What are the therapeutic uses of these formulations?
The formulations are primarily used for the treatment of narcolepsy and other sleep disorders.
When does the patent expire?
The patent is set to expire on July 21, 2037.
Are there any ongoing legal disputes related to this patent?
Yes, there are ongoing legal disputes, such as the litigation between Jazz Pharmaceuticals and Avadel CNS Pharmaceuticals, LLC, over patent infringement.
Cited Sources
- US Patent for Modified release gamma-hydroxybutyrate formulations - Justia Patents.
- Generic Lumryz Availability - Drugs.com.
- Patent Claims and Patent Scope - SSRN.
- US10272062B2 - Modified release gamma-hydroxybutyrate formulations - Google Patents.
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE - Insight.RPXCorp.
