Details for Patent: 9,296,769

Which drugs does patent 9,296,769 protect, and when does it expire?

Patent 9,296,769 protects SYMTUZA, BIKTARVY, DESCOVY, GENVOYA, ODEFSEY, and VEMLIDY, and is included in six NDAs.

Protection for BIKTARVY has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has fifty-seven patent family members in forty-one countries.

Summary for Patent: 9,296,769

Title:	Tenofovir alafenamide hemifumarate
Abstract:	A hemifumarate form of 9-[(R)-2-[[(S)-[[(S)-1-(isopropoxycarbonyl)ethyl]amino]phenoxyphosphinyl]- methoxy]propyl]adenine (tenofovir alafenamide), and antiviral therapy using tenofovir alafenamide hemifumarate (e.g., anti-HIV and anti-HBV therapies).
Inventor(s):	Liu; Dazhan (Edmonton, CA), Shi; Bing (Foster City, CA), Wang; Fang (Foster City, CA), Yu; Richard Hung Chiu (San Francisco, CA)
Assignee:	Gilead Sciences, Inc. (Foster City, CA)
Application Number:	14/197,873
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,296,769
Patent Claim Types: see list of patent claims	Composition; Compound; Use; Process;

United States Patent 9,296,769: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

United States Patent 9,296,769, hereafter referred to as the '769 patent, is a significant patent held by Gilead Sciences, Inc. This patent protects several key pharmaceutical products, including SYMTUZA, BIKTARVY, DESCOVY, GENVOYA, ODEFSEY, and VEMLIDY. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.

Patent Overview

The '769 patent is part of a series of patents related to tenofovir alafenamide (TAF), a prodrug of tenofovir, which is used in the treatment of HIV and hepatitis B. This patent specifically covers the monofumarate form of tenofovir alafenamide and its compositions[2].

Claim Construction

The claims of the '769 patent have been subject to judicial interpretation, particularly in the context of patent litigation. Key terms such as "tenofovir alafenamide monofumarate" and "tenofovir alafenamide hemifumarate" have been defined to clarify their scope.

• Tenofovir Alafenamide Monofumarate: This term refers to a monofumarate form of tenofovir alafenamide, which is a specific chemical structure including its ionized and associated forms[1].
• Tenofovir Alafenamide Hemifumarate: Although not directly claimed in the '769 patent, this term is relevant in related patents and refers to a hemifumarate form of tenofovir alafenamide[1].

Protected Drugs

The '769 patent protects a range of antiretroviral and antiviral drugs, including:

• SYMTUZA: A combination therapy for HIV-1 treatment.
• BIKTARVY: Another combination therapy for HIV-1 treatment.
• DESCOVY: Used for the treatment of HIV-1 and also as pre-exposure prophylaxis (PrEP).
• GENVOYA: A combination therapy for HIV-1 treatment.
• ODEFSEY: Used for the treatment of HIV-1.
• VEMLIDY: Used for the treatment of chronic hepatitis B[2].

Patent Expiration

The '769 patent is set to expire on August 15, 2032. This expiration date is crucial as it marks the period after which generic versions of the protected drugs could potentially enter the market, assuming no patent term extensions or other exclusivities are granted[4].

Patent Landscape

The '769 patent is part of a complex patent landscape that includes multiple patents and exclusivities.

Multiple Patents and Exclusivities

Drugs like those protected by the '769 patent are often covered by multiple patents, each with its own expiration date. For example, DESCOVY is also protected by other patents that have already expired, such as U.S. patent 5,814,639, but the '769 patent extends the exclusivity period until 2032[4].

Orange Book Listings

The '769 patent is listed in the FDA's Orange Book, which is a critical resource for understanding the patent landscape of approved drug products. The Orange Book includes information on patent numbers, expiration dates, and exclusivity periods, which are essential for generic drug manufacturers and regulatory bodies[3].

Litigation and Disputes

Patent disputes and litigation are common in the pharmaceutical industry. The '769 patent has been involved in litigation, particularly in cases where generic manufacturers have sought to challenge the patent's validity or scope. For instance, the District of Delaware has issued rulings on the construction of key claim terms in related patents[1].

Impact on Generic Competition

The expiration of the '769 patent will have significant implications for generic competition. Generic drug manufacturers can file Abbreviated New Drug Applications (ANDAs) once the patent expires, provided they do not infringe on any remaining patents or exclusivities. However, the presence of multiple patents and exclusivities can delay the entry of generic drugs into the market[3].

Market Exclusivity

The market exclusivity period for drugs protected by the '769 patent can range from several years to over a decade after the initial approval. For example, some drugs studied by the USPTO had market exclusivity periods ranging from about 3 to 16 years before generic competition emerged[3].

Conclusion

The '769 patent is a critical component of Gilead Sciences' intellectual property portfolio, protecting key pharmaceutical products. Understanding the scope, claims, and patent landscape of this patent is essential for both the pharmaceutical industry and regulatory bodies.

Key Takeaways

• Scope and Claims: The '769 patent covers the monofumarate form of tenofovir alafenamide and its compositions.
• Protected Drugs: Includes SYMTUZA, BIKTARVY, DESCOVY, GENVOYA, ODEFSEY, and VEMLIDY.
• Patent Expiration: Set to expire on August 15, 2032.
• Patent Landscape: Part of a complex landscape with multiple patents and exclusivities.
• Impact on Generic Competition: Expiration will allow generic competition, but multiple patents can delay generic entry.

FAQs

Q1: What is the primary compound protected by the '769 patent?

The primary compound protected by the '769 patent is tenofovir alafenamide monofumarate.

Q2: Which drugs are protected by the '769 patent?

The '769 patent protects SYMTUZA, BIKTARVY, DESCOVY, GENVOYA, ODEFSEY, and VEMLIDY.

Q3: When is the '769 patent set to expire?

The '769 patent is set to expire on August 15, 2032.

Q4: How does the '769 patent fit into the broader patent landscape?

The '769 patent is part of a complex patent landscape that includes multiple patents and exclusivities, which can affect the timing of generic drug entry into the market.

Q5: What is the significance of the Orange Book in relation to the '769 patent?

The Orange Book lists the '769 patent and provides critical information on patent numbers, expiration dates, and exclusivity periods, which is essential for understanding the patent landscape and for generic drug manufacturers.

Sources

1. District of Delaware: Memorandum Order, Gilead Sciences, Inc. v. Apotex, Inc., et al., C.A. No. 20-189-MN[1].
2. Drug Patent Watch: Pharmaceutical drugs covered by patent 9,296,769[2].
3. USPTO: Drug patent and exclusivity study[3].
4. KEI: Comments on the FDA Orange Book[4].

Drugs Protected by US Patent 9,296,769

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018		RX	Yes	Yes			Y	Y		TREATMENT OF HIV-1 INFECTION IN ADULTS WHO HAVE NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018		RX	Yes	Yes			Y	Y		TREATMENT OF HIV-1 INFECTION IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 40 KG WHO HAVE NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS
Gilead Sciences Inc	BIKTARVY	bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210251-002	Oct 7, 2021		RX	Yes	No					Y
Gilead Sciences Inc	BIKTARVY	bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210251-001	Feb 7, 2018		RX	Yes	Yes					Y
Gilead Sciences Inc	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215-002	Jan 7, 2022		RX	Yes	No					Y

International Family Members for US Patent 9,296,769

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
African Regional IP Organization (ARIPO)	3639
Argentina	087546
Australia	2012296622
Australia	2014271320
Brazil	112014003420