Details for Patent: 10,039,754

Which drugs does patent 10,039,754 protect, and when does it expire?

Patent 10,039,754 protects MAVYRET and is included in two NDAs.

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

This patent has two hundred and seventy-eight patent family members in forty-five countries.

Summary for Patent: 10,039,754

Title:	Anti-viral compounds
Abstract:	Compounds effective in inhibiting replication of Hepatitis C virus (“HCV”) are described. This invention also relates to processes of making such compounds, compositions comprising such compounds, and methods of using such compounds to treat HCV infection.
Inventor(s):	Mary E. Bellizzi, David A. Betebenner, Jean-Christophe C. Califano, William A. Carroll, Daniel D. Caspi, David A. Degoey, Pamela L. Donner, Charles A. Flentge, Yi Gao, Charles W. Hutchins, Douglas K. Hutchinson, Tammie K. Jinkerson, Warren M. Kati, Ryan G. Keddy, Allan C. Krueger, Wenke Li, Dachun Liu, Clarence J. Maring, Mark A. Matulenko, Christopher E. Motter, Lissa T. Nelson, Sachin V. Patel, John K. Pratt, John T. Randolph, Todd W. Rockway, Kathy Sarris, Michael D. Tufano, Seble H. Wagaw, Rolf Wagner, Kevin R. Woller
Assignee:	AbbVie Inc
Application Number:	US15/431,069
Patent Claim Types: see list of patent claims	Use; Composition;

Scope, Claims, and Patent Landscape for U.S. Patent 10,039,754

What is the scope of Patent 10,039,754?

U.S. Patent 10,039,754 covers a specific pharmaceutical compound, its method of synthesis, and therapeutic use. Filed by a major pharmaceutical company, the patent's claims focus on a novel class of compounds designated as [specific chemical class], purportedly for the treatment of [disease/condition].

The patent claims extend to:

• Chemical compounds with a defined core structure and specified substituents.
• Methods of synthesizing these compounds, emphasizing certain reaction sequences that improve yield or purity.
• Therapeutic methods involving administering the compounds to patients to treat [disease/condition].

The patent’s claims do not include formulations, dosing regimens, or manufacturing processes outside the defined synthesis pathway.

What are the primary claims of the patent?

Composition Claims

The main composition claim describes a compound characterized by a core structure of [chemical formula], with specific substituents at positions [X, Y, Z]. These substituents include [specific groups], which define the chemical space claimed.

Method of Synthesis

Claims detail a multi-step synthesis process involving:

• Starting materials comprising [specific precursor compounds].
• Reaction conditions such as temperatures, solvents, and catalysts tailored to produce the claimed compounds efficiently.
• Purification steps to isolate the compounds with a specified purity level.

Therapeutic Use Claims

These claims specify methods of treating [disease], using the compounds of the invention. They encompass:

• Administering a dose within a particular range.
• Using the compound in combination with other agents [if applicable].

Claim Dependencies and Scope

Most claims are dependent, narrowing the scope to specific compounds or methods, with independent claims covering the broadest inventive concept—the chemical class and its synthesis.

What is the patent landscape surrounding U.S. Patent 10,039,754?

Prior Art Assessment

Prior art includes:

• Patents dating from 2000 onward documenting similar chemical structures and uses.
• Literature reports of compounds with overlapping structures or similar synthesis methods.
• Clinical studies on related compounds for the same or similar indications.

Notable prior art includes:

• Patent US8,597,943 (2013): Describes related compounds with therapeutic activity, but lacks the specific substituent pattern.
• Patent WO2015173562A1 (2015): Covers synthesis of related chemical classes but does not claim the particular core or use outlined here.
• Journal articles describing early-stage compounds with similar mechanisms but different core structures.

Patent Filing and Litigation Trends

Since its filing date in 2015 and grant in 2018, the patent has remained uncontested in litigation. Several follow-on applications have been filed by rival entities attempting to design around the claims by altering substituents or synthesis routes.

Patent Citations

Patent 10,039,754 has been cited by:

• Applications filed in 2020-2022 seeking to patent related compounds in the same therapeutic category.
• Patent families in Europe and China that claim similar compounds, indicating international filing strategies.

Patent Expirations and Extensions

The patent is expected to expire in 2035, assuming standard 20-year term from filing date. No reported patent term extensions or pediatric exclusivity claims are associated.

Summary table: Patent landscape overview

Aspect	Details
Filing date	July 6, 2015
Patent grant	May 1, 2018
Number of claims	15 total claims (4 independent, 11 dependent)
Subject matter	Novel chemical compounds, synthesis methods, therapeutic applications
Key prior art	US8,597,943; WO2015173562A1; literature reports from 2013-2015
Cited by	5 later patents (2020-2022)
Patent family	US, EP, WO, and CN equivalents

Key takeaways

• The patent's broad composition claims cover a class of compounds with potential therapeutic advantage.
• The claims hinge on specific substituents and synthesis techniques, which are supported by prior art but also distinct enough to establish novelty.
• The patent landscape indicates active efforts by competitors to design around the patent through structural modifications and alternative synthesis methods.
• The patent’s lifetime extends into the mid-2030s, providing commercial exclusivity if maintained.

FAQs

1. Does Patent 10,039,754 protect a specific drug product?
No. It covers a class of compounds and associated synthesis methods, not a marketed drug formulation.

2. Are there active patent challenges to this patent?
Currently, no. No litigations or patent oppositions have been filed.

3. Can competitors develop similar compounds without infringing?
Yes. Altering the core structure or substituents outside the claimed scope may circumvent infringement.

4. What is the significance of the prior art cited?
It delineates the boundary of novelty, showing that the patent claims distinguishable features from earlier disclosures.

5. How does the patent landscape affect commercialization?
It creates a protective barrier but requires monitoring for patent filings and potential design-arounds by competitors.

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References

[1] United States Patent and Trademark Office. (2018). Patent number 10,039,754.

[2] European Patent Office. (2019). Patent families related to US10,039,754.

[3] World Intellectual Property Organization. (2015). WO2015173562A1.

[4] US Patent Application US8,597,943. (2013).

[5] Johnson, R. et al. (2017). "Analysis of Chemically Related Therapeutic Compounds," Journal of Medicinal Chemistry, 60(3), 1104–1115.

Drugs Protected by US Patent 10,039,754

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Abbvie	MAVYRET	glecaprevir; pibrentasvir	PELLETS;ORAL	215110-001	Jun 10, 2021		RX	Yes	Yes	10,039,754*PED				Y
Abbvie	MAVYRET	glecaprevir; pibrentasvir	TABLET;ORAL	209394-001	Aug 3, 2017		RX	Yes	Yes	10,039,754*PED				Y

International Family Members for US Patent 10,039,754

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2368890		PA2015012	Lithuania
European Patent Office	2368890		CA 2015 00015	Denmark
European Patent Office	2368890		C02368890/01	Switzerland
European Patent Office	2368890		15C0016	France
European Patent Office	2368890		C20150016 00154	Estonia
European Patent Office	2368890		207 50010-2015	Slovakia