Details for Patent: 8,716,264

Which drugs does patent 8,716,264 protect, and when does it expire?

Patent 8,716,264 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: 8,716,264

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)- -pyrimidin-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:	12/204,174
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,716,264
Patent Claim Types: see list of patent claims	Dosage form; Use;

United States Patent 8,716,264: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

United States Patent 8,716,264, titled "Compositions and Methods for Combination Antiviral Therapy," is a significant patent held by Gilead Sciences, Inc. This patent is crucial in the context of antiviral therapies, particularly for the treatment of HIV. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.

Background and History

The patent 8,716,264 is part of a series of patents filed by Gilead Sciences, Inc., with its roots tracing back to provisional U.S. patent applications 60/440,246 and 60/440,308 filed on January 14, 2003. This patent is a continuation of several earlier applications, including application No. 12/204,174 filed on September 4, 2008, which ultimately led to the issuance of this patent on September 30, 2014[2].

Scope of the Patent

The patent 8,716,264 covers compositions and methods for combination antiviral therapy, specifically focusing on the treatment of HIV infection. The patent describes various combinations of antiviral compounds, including emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), which are key components of the drug Truvada®. These combinations are designed to enhance the efficacy and reduce the side effects of antiviral treatments[2][4].

Claims of the Patent

The patent includes several claims that define the scope of the invention. Key claims include:

• Claims 1-3, which describe specific combinations of FTC and TDF.
• Claims 9, 16, 17, 33, and 34, which outline methods for treating HIV infection using these combinations.
• These claims are critical as they define the patented invention and determine what constitutes infringement[2][5].

Claim Construction

In patent infringement cases, the construction of claims is a pivotal issue. The court must determine the meaning of the claim terms based on their "ordinary and customary" meaning to a person of ordinary skill in the art at the time of the invention. This involves analyzing the claims in the context of the entire patent, including the specification, but without importing limitations from the specification that are not present in the claims themselves[2].

Patent Infringement Litigation

Gilead Sciences, Inc. has been involved in several patent infringement cases related to this patent. For example, in the case against Mylan Inc., Gilead alleged that Mylan's generic combination tablet of FTC and TDF infringed claims of the '264 patent, among others. Mylan countered by alleging that certain claims of the patent were invalid, unenforceable, or not infringed by their product[2][5].

Patent Landscape Analysis

A patent landscape analysis provides valuable insights into the technological domain of antiviral therapies. This analysis includes:

• Application and Filing Dates: Tracking the history of patent applications and filings helps in understanding the development timeline of the technology.
• Legal Status: Knowing the status of patents (alive, pending, lapsed, revoked, or expired) is crucial for strategic decision-making.
• Expected Expiry Dates: Identifying when patents are expected to expire can influence business strategies, such as planning for generic drug launches[3].

Market Impact and Competitors

The patent landscape in the antiviral therapy domain is highly competitive. Gilead Sciences, Inc. holds a significant position with patents like 8,716,264, which protect key drugs like Truvada®. However, generic manufacturers like Mylan Inc. are continually challenging these patents to enter the market. The validity and enforceability of these patents are critical in determining market access and pricing strategies[2][4].

International Patent Landscape

The validity of Gilead's patents is not uniform across all jurisdictions. For instance, equivalent patents in Europe have been successfully invalidated, highlighting the complexity of international patent landscapes. This disparity can affect global market strategies and the availability of generic versions of drugs like Truvada®[4].

Public Health and Access to Medication

The debate around patents like 8,716,264 also involves public health considerations. Critics argue that these patents restrict access to life-saving medications by preventing generic competition. Gilead, however, emphasizes the importance of these patents in funding research and development of new treatments[4].

Key Takeaways

• Patent Scope and Claims: The patent 8,716,264 covers specific combinations of antiviral compounds and methods for treating HIV.
• Litigation and Claim Construction: The patent has been subject to several infringement cases, with claim construction being a critical aspect.
• Patent Landscape: Understanding the legal status, filing dates, and expected expiry dates of related patents is essential for strategic planning.
• Market and Public Health Impact: The patent significantly influences market competition and access to antiviral medications.

FAQs

Q: What is the primary focus of United States Patent 8,716,264?

A: The primary focus is on compositions and methods for combination antiviral therapy, specifically for treating HIV infection.

Q: Which drug is protected under this patent?

A: The patent protects the drug Truvada®, which is a combination of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF).

Q: What is the significance of claim construction in patent infringement cases?

A: Claim construction determines the meaning of the claim terms, which is crucial in deciding whether a product infringes the patent.

Q: How does the international patent landscape affect Gilead's patents?

A: The validity of Gilead's patents can vary by jurisdiction, with some patents being invalidated in certain countries, which affects global market strategies.

Q: Why are patents like 8,716,264 important for public health?

A: These patents influence access to life-saving medications by either protecting proprietary treatments or allowing for generic competition, which can impact drug pricing and availability.

Cited Sources:

1. United States Patent and Trademark Office, "US9457036.pdf"
2. Casetext, "Gilead Scis., Inc. v. Mylan Inc., 107 F. Supp. 3d 541"
3. Sagacious Research, "Navigating Technological Domains with Patent Landscape Analysis"
4. IPWatchdog, "Examining the Truvada #BreakThePatent Debate: Gilead Responds"
5. RPX Corporation, "Case 1:14-cv-00099-IMK Document 94 Filed 01/22/15 Page 1 of 21"

Drugs Protected by US Patent 8,716,264

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	8,716,264		Y			TREATMENT OF HIV INFECTION
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011		RX	Yes	Yes	8,716,264		Y			TREATMENT OF HIV INFECTION
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012		RX	Yes	Yes	8,716,264		Y			TREATMENT OF HIV INFECTION
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-001	Aug 2, 2004	AB	RX	Yes	Yes	8,716,264		Y			TREATMENT OF HIV INFECTION

International Family Members for US Patent 8,716,264

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