United States Patent 9,744,181: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 9,744,181 is a significant patent in the pharmaceutical industry, particularly related to the combination therapy of emtricitabine, rilpivirine, and tenofovir disoproxil fumarate. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Patent Overview
Patent Number and Expiration Date
The patent number 9,744,181 is associated with a combination drug product that includes emtricitabine, rilpivirine, and tenofovir disoproxil fumarate. This patent is set to expire on January 13, 2024, including pediatric exclusivity[1][4].
Scope of the Patent
Drug Composition
The patent covers a specific formulation of emtricitabine, rilpivirine, and tenofovir disoproxil fumarate, which is used in the treatment of HIV-1 infection. The combination of these active ingredients is crucial for the therapeutic efficacy of the drug product[1][4].
Therapeutic Use
The drug is indicated for the treatment of HIV-1 infection in adults and pediatric patients who are at least 12 years of age and weigh at least 35 kg. The combination therapy is designed to inhibit the replication of HIV-1, thereby managing the disease[1].
Claims of the Patent
Independent and Dependent Claims
The patent includes both independent and dependent claims. Independent claims define the broad scope of the invention, while dependent claims further limit the scope by adding additional features or requirements. For patent 9,744,181, the claims likely include specific formulations, dosages, and methods of administration of the combination therapy[3].
Claim Language and Scope
The claim language is critical in defining the patent's scope. For pharmaceutical patents, claims often include the chemical structure of the active ingredients, the formulation, and the method of use. The clarity and breadth of these claims can significantly impact the patent's enforceability and the potential for litigation[3].
Patent Landscape
Related Patents
The patent landscape surrounding 9,744,181 includes several other patents related to the same or similar drug combinations. These patents, such as 6,642,245, 6,703,396, 8,592,397, 8,716,264, and 9,457,036, are also associated with emtricitabine, rilpivirine, and tenofovir disoproxil fumarate formulations. These patents collectively form a complex web of intellectual property rights that generic manufacturers must navigate[1][4].
Litigation and Settlements
The patent has been involved in several litigation cases, particularly with generic drug manufacturers. For example, Mylan Pharmaceuticals Inc. filed an Abbreviated New Drug Application (ANDA) with paragraph IV certifications, challenging the validity, enforceability, or infringement of the patents, including 9,744,181. Litigation was initiated in the United States District Court for the Northern District of West Virginia[1].
Generic Drug Applications
Generic drug manufacturers often file ANDAs, which include certifications regarding the patents listed in the Orange Book. For patent 9,744,181, these certifications typically assert that the patent is invalid, unenforceable, or will not be infringed by the generic product. This process can lead to litigation and settlements that define the terms under which generic versions can enter the market[1][5].
Impact on Generic Manufacturers
Regulatory Compliance
Generic manufacturers must comply with FDA regulations and navigate the patent landscape to avoid infringement. This involves careful analysis of the patent claims and expiration dates to determine when a generic version can be launched without infringing the existing patents[1][4].
Litigation Risks
The risk of litigation is high when generic manufacturers challenge the validity or enforceability of patents like 9,744,181. These cases can result in significant legal costs and delays in market entry. Settlements may allow generic manufacturers to enter the market earlier but often come with conditions and restrictions[2][5].
Conclusion on Patent Scope and Claims
The United States Patent 9,744,181 is a critical component of the intellectual property protecting the combination therapy of emtricitabine, rilpivirine, and tenofovir disoproxil fumarate. Understanding the scope and claims of this patent, as well as the broader patent landscape, is essential for both innovator and generic drug manufacturers.
Key Takeaways
- Patent Expiration: The patent expires on January 13, 2024, including pediatric exclusivity.
- Drug Composition: The patent covers a specific formulation of emtricitabine, rilpivirine, and tenofovir disoproxil fumarate.
- Therapeutic Use: The drug is used for the treatment of HIV-1 infection.
- Claims: The patent includes independent and dependent claims defining the formulation, dosage, and method of administration.
- Litigation: The patent has been involved in several litigation cases with generic manufacturers.
- Regulatory Compliance: Generic manufacturers must carefully navigate the patent landscape to avoid infringement.
FAQs
What is the expiration date of the United States Patent 9,744,181?
The patent is set to expire on January 13, 2024, including pediatric exclusivity.
What is the therapeutic use of the drug covered by patent 9,744,181?
The drug is indicated for the treatment of HIV-1 infection in adults and pediatric patients.
What are the key components of the drug formulation covered by this patent?
The formulation includes emtricitabine, rilpivirine, and tenofovir disoproxil fumarate.
How do generic manufacturers navigate the patent landscape for this drug?
Generic manufacturers must file ANDAs with paragraph IV certifications and may face litigation if they challenge the validity or enforceability of the patents.
What are the potential risks for generic manufacturers challenging this patent?
Generic manufacturers face significant legal costs and potential delays in market entry due to litigation risks.
Sources
- FDA: ANDA 208452 - accessdata.fda.gov
- Robins Kaplan LLP: ANDA Litigation Settlements | Robins Kaplan LLP Law Firm
- Hoover Institution: Patent Claims and Patent Scope - hoover.org
- FDA: ANDA 209721 - accessdata.fda.gov
- Robins Kaplan LLP: ANDA Litigation Settlements | Resources - Robins Kaplan
