Details for Patent: 9,708,342

Which drugs does patent 9,708,342 protect, and when does it expire?

Patent 9,708,342 protects BIKTARVY and is included in one NDA.

This patent has sixty-two patent family members in forty-two countries.

Summary for Patent: 9,708,342

Title:	Sodium (2R,5S,13aR)-7,9-dioxo-10-((2,4,6-trifluorobenzyl)carbamoyl)-2,3,4,- 5,7,9,13,13a-octahydro-2,5-methanopyrido[1',2':4,5]pyrazino[2, 1-b][1, 3]oxazepin-8-olate
Abstract:	The present invention relates to sodium (2R,5S,13aR)-7,9-dioxo-10-((2,4,6-trifluorobenzyl) carbamoyl)-2,3,4,5,7,9,13,13a-octahydro-2,5-methanopyrido[1',2':4,5]pyraz- ino[2,1-b][1,3] oxazepin-8-olate Form I and the therapeutic uses thereof.
Inventor(s):	Carra; Ernest A. (Foster City, CA), Chen; Irene (San Mateo, CA), Zia; Vahid (Palo Alto, CA)
Assignee:	Gilead Sciences, Inc. (Foster City, CA)
Application Number:	14/744,915
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,708,342
Patent Claim Types: see list of patent claims	Use; Composition; Compound; Dosage form;

Understanding the Scope and Claims of United States Patent 9,708,342

Introduction

United States Patent 9,708,342, assigned to Gilead Sciences, Inc., is a significant patent in the field of antiviral therapy, particularly for the treatment and prevention of HIV. This patent focuses on a specific compound and its pharmaceutical formulations, which are crucial in modern HIV treatment regimens.

Patent Overview

Issuance and Inventors

• The patent was issued on July 18, 2017, to inventors Ernest A. Carra, Irene Chen, and Vahid Zia[1].

Compound and Formulations

• The patent pertains to sodium (2R,5S,13aR)-7,9-dioxo-10-((2,4,6-trifluorobenzyl)carbamoyl)-2,3,4,5,7,9,13,13a-octahydro-2,5-methanopyrido[1′,2′:4,5]pyrazino[2,1-b][1,3]oxazepin-8-olate Form I. This compound is a key component of the antiviral drug Biktarvy, which is a combination therapy of bictegravir, emtricitabine, and tenofovir alafenamide[1].

Scope of the Patent

Therapeutic Uses

• The patent covers the therapeutic uses of the specified compound for treating or prophylactically preventing HIV infection. This includes various pharmaceutical formulations that incorporate the compound, which are designed to enhance its efficacy and bioavailability[1].

Pharmaceutical Formulations

• The patent details various pharmaceutical formulations of the compound, including but not limited to tablets, capsules, and other oral dosage forms. These formulations are optimized to ensure stable and effective delivery of the active ingredient[1].

Claims of the Patent

Independent and Dependent Claims

• The patent includes a set of independent and dependent claims that define the scope of the invention. Independent claims typically outline the broadest aspects of the invention, while dependent claims narrow down the scope by adding specific details or limitations[3][5].

Claim Language and Scope

• The claims are written in a manner that ensures clarity and specificity. For instance, the independent claims might describe the chemical structure of the compound and its pharmaceutical formulations, while dependent claims could specify particular methods of preparation, dosages, or administration routes. The use of clear and concise language is crucial to avoid ambiguity and ensure the patent's validity[3][5].

Patent Landscape

Related Patents

• The patent landscape surrounding U.S. Patent 9,708,342 includes several related patents held by Gilead Sciences, Inc. These patents cover various aspects of the antiviral therapy, including different forms of tenofovir alafenamide and other components of Biktarvy. For example, patents such as 10,385,067 and 10,548,846 also relate to the therapeutic compositions and formulations of tenofovir alafenamide[1].

Patent Expiration Dates

• The patent is set to expire on June 19, 2035. This expiration date is critical for understanding the timeline during which Gilead Sciences, Inc. holds exclusive rights to the compound and its formulations. After this date, the patent will enter the public domain, potentially allowing generic versions of the drug to be developed[1].

Impact on Antiviral Therapy

Clinical Significance

• The compound and formulations described in this patent are clinically significant because they form part of Biktarvy, a highly effective antiviral therapy for HIV. Biktarvy has been praised for its high efficacy, tolerability, and convenience, as it is administered as a single tablet once daily[1].

Market and Competition

• The exclusivity provided by this patent gives Gilead Sciences, Inc. a competitive edge in the antiviral therapy market. However, as the patent approaches its expiration date, other pharmaceutical companies may begin to develop generic versions, which could impact the market dynamics and pricing of the drug[1].

Legal and Regulatory Aspects

Government-Interest Statements

• While this patent does not specifically mention government-interest statements, it is important to note that many patents, especially those related to pharmaceuticals, may involve government funding. The Bayh-Dole Act requires patent holders who received government funding to include government-interest statements in their patents, which can affect the patent's scope and potential march-in rights[2].

Metrics for Measuring Patent Scope

Independent Claim Length and Count

• To assess the scope of this patent, metrics such as independent claim length and independent claim count can be used. These metrics help in evaluating the breadth and clarity of the patent claims. Narrower claims with fewer words and fewer independent claims are generally associated with a higher probability of grant and a shorter examination process[3][5].

Conclusion

United States Patent 9,708,342 is a pivotal patent in the field of HIV treatment, covering a critical component of the antiviral drug Biktarvy. Understanding its scope, claims, and the broader patent landscape is essential for both pharmaceutical companies and regulatory bodies. The patent's expiration date and the potential for generic competition highlight the dynamic nature of the pharmaceutical industry.

Key Takeaways

• Compound and Formulations: The patent covers sodium (2R,5S,13aR)-7,9-dioxo-10-((2,4,6-trifluorobenzyl)carbamoyl)-2,3,4,5,7,9,13,13a-octahydro-2,5-methanopyrido[1′,2′:4,5]pyrazino[2,1-b][1,3]oxazepin-8-olate Form I and its pharmaceutical formulations.
• Therapeutic Uses: The patent is for the treatment and prevention of HIV.
• Patent Expiration: The patent expires on June 19, 2035.
• Related Patents: Other patents held by Gilead Sciences, Inc. cover related aspects of antiviral therapy.
• Clinical Significance: The compound is part of the highly effective antiviral therapy Biktarvy.
• Metrics for Scope: Independent claim length and count are useful metrics for evaluating the patent's scope.

FAQs

1. What is the main compound covered by U.S. Patent 9,708,342?

   • The main compound is sodium (2R,5S,13aR)-7,9-dioxo-10-((2,4,6-trifluorobenzyl)carbamoyl)-2,3,4,5,7,9,13,13a-octahydro-2,5-methanopyrido[1′,2′:4,5]pyrazino[2,1-b][1,3]oxazepin-8-olate Form I.

2. What is the therapeutic use of the compound described in the patent?

   • The compound is used for the treatment and prevention of HIV infection.

3. Who are the inventors of U.S. Patent 9,708,342?

   • The inventors are Ernest A. Carra, Irene Chen, and Vahid Zia.

4. When does the patent expire?

   • The patent expires on June 19, 2035.

5. What is the significance of this patent in the pharmaceutical industry?

   • This patent is significant because it covers a key component of the antiviral drug Biktarvy, which is a highly effective treatment for HIV.

Sources

1. Drugs.com - Generic Biktarvy Availability.
2. National Bureau of Economic Research - The Feasibility of Using Bayh-Dole March-In Rights to Lower Drug Prices.
3. Hoover Institution - Patent Claims and Patent Scope.
4. Perpetual Motion Patents - The Value of a Patent.
5. SSRN - Patent Claims and Patent Scope.

Drugs Protected by US Patent 9,708,342

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 Inc	BIKTARVY	bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210251-002	Oct 7, 2021		RX	Yes	No	9,708,342		Y	Y
Gilead Sciences Inc	BIKTARVY	bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210251-001	Feb 7, 2018		RX	Yes	Yes	9,708,342		Y	Y

International Family Members for US Patent 9,708,342

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	100903
Australia	2015276860
Australia	2018203175
Brazil	112016029605