Understanding the Scope and Claims of United States Patent 9,132,089
Introduction
United States Patent 9,132,089, titled "Pharmaceutical Composition and Method for Treating Hypogonadism," is a significant patent in the pharmaceutical industry, particularly in the treatment of hypogonadism. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Patent Overview
The patent, issued on September 15, 2015, to Unimed Pharmaceuticals, LLC, and Besins Healthcare Inc., covers a pharmaceutical composition and method for treating hypogonadism, a condition characterized by low levels of sex hormones. The inventors, Robert E. Dudley and Dominique Drouin, developed a testosterone gel formulation that is administered transdermally to treat this condition[4].
Claims Analysis
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims typically describe the composition and the method of use.
- Claim 1: This claim describes the pharmaceutical composition, which includes a specific concentration of testosterone in a gel formulation. It outlines the components and their proportions, ensuring the stability and efficacy of the product.
- Claim 10: This claim details the method of treating hypogonadism using the described pharmaceutical composition. It specifies the dosage, administration route, and expected outcomes.
Dependent Claims
Dependent claims build upon the independent claims, providing additional details and limitations.
- Claim 2: This claim specifies the concentration range of testosterone in the gel, ensuring it falls within a therapeutic window.
- Claim 11: This claim describes the method of application, including the frequency and duration of treatment.
Subject Matter Eligibility
The 2024 USPTO guidance update on AI patent eligibility, although not directly applicable to this pharmaceutical patent, provides insights into how subject matter eligibility is determined. For pharmaceutical patents like 9,132,089, the focus is on whether the claims integrate judicial exceptions into practical applications. Here, the claims specify a tangible pharmaceutical composition and a method of treatment, which are considered practical applications and thus eligible for patent protection[1].
Practical Applications
The patent highlights several practical applications that transform the abstract idea of treating hypogonadism into a concrete technological improvement.
- Improved Delivery System: The transdermal gel formulation provides a stable and efficient delivery system for testosterone, enhancing patient compliance and treatment efficacy.
- Therapeutic Benefits: The specified concentration and method of application ensure therapeutic benefits, such as improved hormone levels and reduced symptoms of hypogonadism.
Patent Landscape
Related Patents
The patent landscape for hypogonadism treatments includes several related patents, such as U.S. Patent No. 8,741,881, U.S. Patent No. 8,754,070, and U.S. Patent No. 8,759,329, all of which are also related to testosterone gel formulations and methods of use. These patents collectively form a robust intellectual property portfolio for the treatment of hypogonadism[4].
Expiration and Exclusivity
The patent 9,132,089 has an expiration date listed in the Orange Book as August 30, 2020, with an additional six months of pediatric exclusivity. This extended exclusivity period ensures that the patent holders maintain market exclusivity for a longer period[4].
Patent Analytics and Claim Coverage
To fully understand the protection offered by this patent, patent analytics tools can be employed. These tools help in tracking patents by claims and scope concepts, identifying gaps or opportunities in the patent landscape.
- Claim Coverage Matrix: This tool categorizes patents by claims and overarching scope concepts, making it easier to filter, search, and analyze large numbers of patent claims. For 9,132,089, this would involve mapping the claims to specific technological aspects of the pharmaceutical composition and method of treatment[5].
- Claim Charts: Interactive claim charts generated by tools like ClaimScape® can help technical experts review patent coverage. These charts can highlight areas where claim coverage is strong or weak, aiding in future design and development strategies[5].
Litigation and Enforcement
The patent has been involved in litigation, particularly in the context of Abbreviated New Drug Applications (ANDAs) submitted by generic manufacturers. The patent holders have taken legal action to protect their intellectual property rights, ensuring that generic versions do not infringe on the patented composition and method[4].
Key Takeaways
- Patent Scope: The patent covers a specific pharmaceutical composition and method for treating hypogonadism, with detailed claims that ensure practical applications.
- Practical Applications: The claims integrate judicial exceptions into practical applications, ensuring patent eligibility.
- Related Patents: The patent is part of a broader portfolio of related patents, enhancing the intellectual property protection for hypogonadism treatments.
- Expiration and Exclusivity: The patent expired in 2020 with additional pediatric exclusivity, extending market exclusivity.
- Patent Analytics: Tools like Claim Coverage Matrix and Claim Charts are essential for understanding and managing the patent landscape.
FAQs
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What is the main subject matter of United States Patent 9,132,089?
- The patent covers a pharmaceutical composition and method for treating hypogonadism using a testosterone gel formulation.
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Who are the inventors of this patent?
- The inventors are Robert E. Dudley and Dominique Drouin.
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What is the significance of the transdermal gel formulation in this patent?
- The transdermal gel formulation provides a stable and efficient delivery system for testosterone, enhancing patient compliance and treatment efficacy.
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How does the patent landscape look for hypogonadism treatments?
- The patent is part of a robust intellectual property portfolio that includes several related patents, ensuring comprehensive protection for hypogonadism treatments.
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What tools can be used to analyze and manage the claims of this patent?
- Tools like Claim Coverage Matrix and Claim Charts, generated by patent analytics software, can help in analyzing and managing the claims and scope concepts of the patent.
Sources
- Understanding the 2024 USPTO Guidance Update on AI Patent - Mintz
- AndroGel 1.62% Patent Definition - Law Insider
- Patent Claims Research Dataset - USPTO
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT - Insight.RPXCorp
- Patent Analytics - SLWIP
