United States Patent 9,486,426: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,486,426, titled "Method of administration of gamma hydroxybutyrate with monocarboxylate transporters," is a significant patent in the field of pharmaceuticals, particularly in the administration of gamma hydroxybutyrate (GHB). This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Patent
The patent, filed on August 4, 2014, and granted on November 1, 2016, pertains to a method for improving the safety and efficacy of GHB administration. GHB is a drug used for various medical conditions, including narcolepsy and as an anesthetic. The invention focuses on using monocarboxylate transporters to enhance the delivery of GHB.
Scope of the Patent
Method of Administration
The patent describes a method of administering GHB or its salt to a patient, utilizing monocarboxylate transporters. This approach aims to improve the pharmacokinetics and pharmacodynamics of GHB, making it more effective and safer for patients. The method involves administering a dosage of GHB in conjunction with a monocarboxylate transporter, which facilitates the uptake of GHB into cells[4].
Key Components
- Gamma Hydroxybutyrate (GHB): The primary active ingredient, GHB, is administered in a form that can be a salt or the free acid.
- Monocarboxylate Transporters: These transporters are crucial for the cellular uptake of GHB, enhancing its bioavailability and reducing potential side effects.
- Dosage and Administration: The patent specifies various dosage amounts and administration schedules to optimize the therapeutic effects of GHB while minimizing adverse reactions.
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims cover the method of administration, the composition of the GHB and monocarboxylate transporters, and the specific dosages and administration protocols.
- Claim 1: This claim outlines the method of administering GHB or its salt to a patient using monocarboxylate transporters.
- Claim 10: This claim specifies the composition comprising GHB and a monocarboxylate transporter, along with the dosage regimen.
Dependent Claims
Dependent claims further detail the invention by specifying various aspects such as the type of monocarboxylate transporters used, the dosage amounts, and the patient population.
- Claim 2: This claim describes the use of specific monocarboxylate transporters, such as MCT1 or MCT4.
- Claim 5: This claim details the dosage regimen, including the frequency and amount of GHB administered.
Patent Landscape Analysis
Competitive Landscape
The patent landscape in the field of GHB administration is relatively niche but competitive. Several companies and research institutions are involved in developing methods and compositions related to GHB.
- Top Patent Owners: Companies like Jazz Pharmaceuticals, which holds a significant number of patents related to GHB, are key players in this landscape. Other companies, such as those focused on neurological disorders, also have a presence[3].
Technological Trends
The use of monocarboxylate transporters in drug delivery is a growing trend in pharmaceutical research. This technology is being explored for various drugs beyond GHB, indicating a broader interest in enhancing drug delivery mechanisms.
- Emerging Technologies: Advances in transporter-mediated drug delivery are driving innovation in the pharmaceutical industry. This includes the use of other transporters for different drugs, highlighting the potential for this technology to expand beyond GHB[4].
Abandoned and Active Technologies
Analyzing the patent portfolio of companies in this field can reveal trends in abandoned and active technologies. For instance, some companies may have abandoned certain approaches to GHB administration in favor of newer methods involving monocarboxylate transporters.
- Time-Slicing Analysis: A time-slicing analysis of patent filings can show the shift from older technologies to newer ones. For example, a company might have ceased filing patents related to older GHB administration methods by 2016, indicating a focus on newer technologies like the one described in US 9,486,426[3].
Legal and Regulatory Considerations
Patent Validity and Infringement
The validity and infringement of this patent would be subject to legal scrutiny, particularly in cases where other companies might be developing similar methods.
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Claim Construction: The construction of claims in this patent would be crucial in determining its validity and scope. This involves interpreting the claim terms to ensure they are clear and definite, as required by law[2].
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Prior Art and Anticipation: The patent office and courts would consider prior art and whether the invention was anticipated by earlier publications or patents. This is critical in maintaining the patent's validity[2].
Small Claims Patent Court
In the context of patent disputes, the concept of a small claims patent court has been discussed. This could potentially simplify and reduce the costs associated with resolving patent infringement cases involving smaller entities or less complex disputes[5].
Industry Expert Insights
Industry experts and legal practitioners often provide valuable insights into the strategic implications of patents like US 9,486,426.
- Strategic Advice: Patent landscape analysis helps attorneys and portfolio managers advise clients on strategic IP decisions. For example, identifying key players and technological trends can inform licensing strategies or research directions[3].
Key Takeaways
- Method of Administration: The patent describes a novel method of administering GHB using monocarboxylate transporters, enhancing safety and efficacy.
- Claims and Scope: The patent includes detailed claims defining the method, composition, and dosage regimen.
- Competitive Landscape: The patent landscape is competitive, with several companies involved in GHB-related research.
- Technological Trends: The use of monocarboxylate transporters is a growing trend in pharmaceutical research.
- Legal Considerations: The patent's validity and infringement would be subject to legal scrutiny, including claim construction and prior art analysis.
FAQs
What is the primary focus of United States Patent 9,486,426?
The primary focus of this patent is a method of administering gamma hydroxybutyrate (GHB) using monocarboxylate transporters to enhance its safety and efficacy.
Who are the key players in the patent landscape related to GHB administration?
Key players include companies like Jazz Pharmaceuticals and other entities focused on neurological disorders and pharmaceutical research.
What is the significance of monocarboxylate transporters in this patent?
Monocarboxylate transporters are crucial for the cellular uptake of GHB, improving its bioavailability and reducing potential side effects.
How does the patent landscape analysis help in strategic decision-making?
Patent landscape analysis helps attorneys and portfolio managers advise clients on strategic IP decisions by identifying key players, technological trends, and abandoned technologies.
What are the legal considerations for the validity and infringement of this patent?
The validity and infringement of this patent would be subject to legal scrutiny, including claim construction, prior art analysis, and potential challenges in court or through inter partes review (IPR) petitions.
