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Last Updated: December 22, 2024

Details for Patent: 8,592,397

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Which drugs does patent 8,592,397 protect, and when does it expire?

Patent 8,592,397 protects ATRIPLA, COMPLERA, STRIBILD, and TRUVADA, and is included in four NDAs.

This patent has sixty-two patent family members in twenty-nine countries.

Summary for Patent: 8,592,397

Title:	Compositions and methods for combination antiviral therapy
Abstract:	The present invention relates to therapeutic combinations of [2-(6-amino-purin-9-yl)-1-methyl-ethoxymethyl]-phosphonic acid diisopropoxycarbonyloxymethyl ester (tenofovir disoproxil fumarate, Viread.RTM.) and (2R, 5S, cis)-4-amino-5-fluoro-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimi- din-2-one(emtricitabine, Emtriva.TM., (-)-cis FTC) and their physiologically functional derivatives. The combinations may be useful in the treatment of HIV infections, including infections with HIV mutants bearing resistance to nucleoside and/or non-nucleoside inhibitors. The present invention is also concerned with pharmaceutical compositions and formulations of said combinations of tenofovir disoproxil fumarate and emtricitabine, and their physiologically functional derivatives, as well as therapeutic methods of use of those compositions and formulations.
Inventor(s):	Dahl; Terrence C. (Sunnyvale, CA), Menning; Mark M. (San Francisco, CA), Oliyai; Reza (San Carlos, CA)
Assignee:	Gilead Sciences, Inc. (Foster City, CA)
Application Number:	12/195,161
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,592,397
Patent Claim Types: see list of patent claims	Composition; Compound; Dosage form; Use;
Patent landscape, scope, and claims:	Detailed Analysis of the Scope and Claims of United States Patent 8,592,397 Introduction United States Patent 8,592,397, titled "Compositions and methods for combination antiviral therapy," was issued on November 26, 2013, to Gilead Sciences, Inc. This patent is significant in the field of antiviral treatments, particularly for HIV and other viral infections. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention. Inventors and Assignees The patent was invented by Terrence C. Dahl, Mark M. Menning, and Reza Oliyai, and assigned to Gilead Sciences, Inc., a leading pharmaceutical company known for its innovative treatments in the field of antiviral therapies[5]. Patent Claims Overview of Claims The patent includes a series of claims that define the scope of the invention. These claims can be broadly categorized into two main types: composition claims and method claims. Composition Claims Composition claims pertain to the specific formulations and combinations of antiviral compounds. For example, the patent describes compositions that include a combination of emtricitabine, tenofovir disoproxil fumarate, and other antiviral agents. These compositions are designed to provide effective antiviral therapy with reduced side effects and improved patient compliance[5]. Method Claims Method claims outline the procedures for using these compositions in antiviral therapy. This includes the administration routes, dosages, and treatment regimens. The methods described are aimed at treating various viral infections, with a primary focus on HIV. Scope of the Patent Antiviral Therapy The patent's scope is centered around combination antiviral therapy, which involves using multiple antiviral agents to target different aspects of the viral life cycle. This approach is known for its efficacy in treating HIV and other viral infections by reducing the likelihood of drug resistance and improving treatment outcomes[5]. Specific Compounds The patent specifically mentions the use of emtricitabine and tenofovir disoproxil fumarate, among other compounds. These are key components of several antiviral drugs, including Atripla, a well-known HIV treatment developed by Gilead Sciences[5]. Patent Landscape Related Patents The patent landscape surrounding U.S. Patent 8,592,397 includes several related patents that cover various aspects of antiviral therapy. For instance, Patent 8,716,264, also assigned to Gilead Sciences, Inc., covers similar compositions and methods for combination antiviral therapy. These patents collectively form a robust intellectual property portfolio that protects Gilead's innovations in this field[5]. Government Interest and Funding Some patents in the antiviral therapy space may have government-interest statements due to federal funding for research and development. However, U.S. Patent 8,592,397 does not appear to have such statements, indicating that it may not be subject to the march-in rights provisions under the Bayh-Dole Act[1]. Patent Claim Metrics Claim Length and Count The scope of a patent can be analyzed using metrics such as independent claim length and independent claim count. While the specific metrics for U.S. Patent 8,592,397 are not provided here, these metrics can indicate the breadth and clarity of the patent claims. Generally, narrower claims with fewer words and fewer independent claims are associated with higher patent quality and a shorter examination process[3]. Litigation and Enforcement Patents in the pharmaceutical industry are often subject to litigation, particularly when generic manufacturers seek to enter the market. The detailed statement requirements for Paragraph IV Notice Letters, as seen in other patent litigation cases, highlight the importance of clear and detailed explanations for allegations of non-infringement or invalidity. For U.S. Patent 8,592,397, any potential litigation would need to adhere to these stringent requirements to challenge the patent's validity or infringement claims[2]. Impact on Innovation The patent's impact on innovation in antiviral therapy is significant. By protecting Gilead's specific compositions and methods, the patent incentivizes further research and development in this area. However, broad or unclear claims can sometimes impede innovation by increasing licensing and litigation costs, as noted in discussions on patent quality[3]. Key Takeaways Inventors and Assignees: The patent was invented by Terrence C. Dahl, Mark M. Menning, and Reza Oliyai, and assigned to Gilead Sciences, Inc. Claims: The patent includes composition and method claims related to combination antiviral therapy. Scope: The patent focuses on antiviral therapy, particularly for HIV, using specific compounds like emtricitabine and tenofovir disoproxil fumarate. Patent Landscape: The patent is part of a broader intellectual property portfolio related to antiviral therapies. Claim Metrics: The clarity and breadth of claims can be analyzed using metrics like independent claim length and count. Litigation: Any challenges to the patent would need to follow detailed statement requirements. FAQs What is the main focus of U.S. Patent 8,592,397? The main focus of U.S. Patent 8,592,397 is on compositions and methods for combination antiviral therapy, particularly for treating HIV. Who are the inventors of this patent? The inventors are Terrence C. Dahl, Mark M. Menning, and Reza Oliyai. What company is assigned this patent? The patent is assigned to Gilead Sciences, Inc. What are the key compounds mentioned in this patent? The key compounds mentioned include emtricitabine and tenofovir disoproxil fumarate. How does this patent impact innovation in antiviral therapy? The patent protects Gilead's innovations, incentivizing further research and development in antiviral therapy, but broad or unclear claims could potentially impede innovation. Are there any related patents to U.S. Patent 8,592,397? Yes, there are related patents, such as Patent 8,716,264, which also cover compositions and methods for combination antiviral therapy. More… ↓ ⤷ Subscribe

Drugs Protected by US Patent 8,592,397

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006		DISCN	Yes	No	8,592,397	⤷ Subscribe	Y			TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER	⤷ Subscribe
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006		DISCN	Yes	No	8,592,397	⤷ Subscribe	Y			TREATMENT OF HIV-1 INFECTION IN ADULTS	⤷ Subscribe
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011		RX	Yes	Yes	8,592,397	⤷ Subscribe	Y			TREATMENT OF HIV INFECTION	⤷ Subscribe
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012		RX	Yes	Yes	8,592,397	⤷ Subscribe	Y			TREATMENT OF HIV INFECTION	⤷ Subscribe
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-001	Aug 2, 2004	AB	RX	Yes	Yes	8,592,397	⤷ Subscribe	Y			TREATMENT OF HIV	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Patented / Exclusive Use	>Submissiondate

International Family Members for US Patent 8,592,397

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Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
African Regional IP Organization (ARIPO)	2089	⤷ Subscribe
Argentina	040805	⤷ Subscribe
Argentina	043332	⤷ Subscribe
Argentina	101679	⤷ Subscribe
Austria	398455	⤷ Subscribe
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

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