Details for Patent: 10,286,029

Which drugs does patent 10,286,029 protect, and when does it expire?

Patent 10,286,029 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 one hundred and ten patent family members in twenty-six countries.

Summary for Patent: 10,286,029

Title:	Method for treating HCV
Abstract:	The present invention features interferon-free therapies for the treatment of HCV. Preferably, the treatment is over a shorter duration of treatment, such as no more than 12 weeks. In one aspect, the treatment comprises administering at least two direct acting antiviral agents to a subject with HCV infection, wherein the treatment lasts for 12 weeks and does not include administration of either interferon or ribavirin, and said at least two direct acting antiviral agents comprise (a) Compound 1 or a pharmaceutically acceptable salt thereof and (b) Compound 2 or a pharmaceutically acceptable salt thereof.
Inventor(s):	Walid M. Awni, Barry M. Bernstein, Andrew L. Campbell, Sandeep Dutta, Chih-Wei Lin, Wei Liu, Rajeev M. Menon, Thomas J. Podsadecki, Tianli Wang, Sven Mensing
Assignee:	AbbVie Inc
Application Number:	US14/676,370
Patent Claim Types: see list of patent claims	Use;

United States Patent 10,286,029: Claims, Scope, Expiration and Mavyret Patent Landscape

U.S. Patent No. 10,286,029 is an AbbVie method-of-treatment patent directed to interferon-free, ribavirin-free treatment of hepatitis C virus with the fixed direct-acting antiviral combination glecaprevir and pibrentasvir, marketed as Mavyret. Its claims cover treatment durations from 8 through 16 weeks, HCV genotypes 1 through 6, treatment-naive and treatment-experienced patients, and patients with or without compensated cirrhosis.

The commercially important claim is claim 22, which requires once-daily administration of glecaprevir and 120 mg of pibrentasvir. The patent is a method-of-use barrier rather than a composition-of-matter patent. Its nominal patent expiration is November 27, 2034, based on the earliest claimed priority date, subject to any applicable patent-term adjustment, patent-term extension, terminal disclaimer, or later legal determination.

What drugs and regimen does U.S. Patent 10,286,029 protect?

Compound 1 is glecaprevir, formerly ABT-493, an HCV NS3/4A protease inhibitor. Compound 2 is pibrentasvir, formerly ABT-530, an HCV NS5A inhibitor. Together they form the Mavyret regimen.

Patent element	Commercial identity
Compound 1	Glecaprevir
Compound 2	Pibrentasvir
Product	Mavyret
Applicant/owner	AbbVie group
Therapeutic area	HCV infection
Mechanism	NS3/4A protease inhibition plus NS5A inhibition
FDA approval	August 3, 2017
Standard adult dose	Glecaprevir 300 mg plus pibrentasvir 120 mg once daily with food
Dosage form	Three once-daily tablets, each containing glecaprevir 100 mg and pibrentasvir 40 mg

The claim language does not use the generic names. It uses “Compound 1” and “Compound 2,” which must be mapped to the patent specification, prosecution history and incorporated definitions. Based on the 120 mg pibrentasvir dose, the compound pair is the glecaprevir-pibrentasvir combination used in Mavyret.

How broad are the independent claims?

Claims 1 and 29 establish the principal claim categories.

Claim	Duration	Combination requirement	Other limitations
1	8, 9, 10, 11 or 12 weeks	At least two DAAs comprising glecaprevir and pibrentasvir	No interferon or ribavirin
29	16 weeks	At least two DAAs comprising glecaprevir and pibrentasvir	No interferon or ribavirin

Claim 1 is broader than claim 12 because it requires that the two named compounds be included but permits additional DAAs. Claim 12 narrows the regimen to glecaprevir and pibrentasvir as the only DAAs.

Claim 29 separately captures the 16-week regimen. Claims 30 and 31 narrow that regimen to once-daily administration of both compounds and 120 mg of pibrentasvir.

The practical infringement question is whether an accused product or treatment protocol satisfies every limitation of an asserted claim. A product containing glecaprevir and pibrentasvir would not automatically infringe every claim. The relevant treatment duration, use of interferon or ribavirin, dosing schedule, patient population and number of DAAs would determine claim applicability.

What patient populations are covered?

The dependent claims create a wide patient-population matrix.

Patient characteristic	Claims
HCV genotype 1	5, 15, 23
HCV genotype 2	6, 16, 24
HCV genotype 3	7, 17, 25
HCV genotype 4	26
HCV genotype 5	27
HCV genotype 6	28
Without cirrhosis	8, 18, 20, 32
Compensated cirrhosis	9, 19, 21, 33
Treatment-naive	10, 18, 19
Treatment-experienced	11, 20, 21, 34

Claims 23 through 28 are especially important commercially because they extend the fixed-dose once-daily regimen to genotypes 1 through 6. Claims 18 through 21 cover combinations of treatment history and cirrhosis status.

The claims do not expressly cover decompensated cirrhosis. That omission is consistent with the FDA labeling for Mavyret, which contraindicates use in patients with moderate or severe hepatic impairment or those with decompensated cirrhosis when used with atazanavir or rifampin-related contraindications. The principal approved populations are patients without cirrhosis or with compensated cirrhosis.

What formulations and doses are protected?

The patent claims are directed primarily to treatment methods, not to a particular tablet formulation.

Claim 22 requires:

1. Glecaprevir and pibrentasvir as the only DAAs;
2. Once-daily administration of glecaprevir;
3. Once-daily administration of pibrentasvir; and
4. Pibrentasvir at 120 mg once daily.

The claim does not expressly require the commercial three-tablet presentation, a particular excipient system, tablet coating, particle size, manufacturing process or fixed-dose combination tablet. A generic product could therefore face separate patent barriers directed to:

• The active pharmaceutical ingredients;
• Salt or crystalline forms;
• Solid-state properties;
• Pharmaceutical compositions;
• Fixed-dose tablet formulations;
• Manufacturing processes;
• Stability and dissolution characteristics; and
• Treatment methods.

A formulation patent generally presents a different infringement analysis from Patent 10,286,029. A product may avoid one method-of-use claim while still infringing an active-ingredient, formulation or process patent.

When does U.S. Patent 10,286,029 expire?

Event	Date
Earliest claimed priority	November 27, 2013
U.S. patent grant	May 14, 2019
Nominal 20-year term endpoint	November 27, 2034

The November 27, 2034 date is the principal term estimate derived from the earliest claimed priority date. The operative expiration date should be determined from the USPTO patent record, including any patent-term adjustment and terminal-disclaimer information. Patent-term extension under 35 U.S.C. § 156 is generally associated with regulatory review of an approved product and must be checked separately from ordinary patent-term adjustment.

The patent therefore creates a potential method-of-use barrier well after Mavyret’s FDA approval and after the initial launch period for generic competition.

What is the Orange Book status of Patent 10,286,029?

Mavyret is a small-molecule drug listed in the FDA Orange Book, not a biologic subject to the biosimilar pathway. The relevant Orange Book analysis should distinguish among:

• Drug substance patents;
• Drug product or formulation patents;
• Method-of-use patents; and
• Patent listings associated with the approved Mavyret labeling.

Patent 10,286,029 is commercially relevant as an asserted treatment-method patent. An Orange Book listing can support a Paragraph IV certification and a potential 30-month stay if the NDA holder or patent owner files an infringement action within the statutory period. The listing does not establish that every claim is valid, enforceable or infringed.

The commercial importance of the patent depends on whether the approved Mavyret label contains the claimed treatment durations, populations and dosing instructions. The FDA label identifies glecaprevir-pibrentasvir as a pangenotypic regimen for adults and certain pediatric patients, with treatment durations that vary by genotype, prior treatment and cirrhosis status. Those label statements overlap materially with the claim set. (U.S. Food and Drug Administration, 2024)

What Paragraph IV challenges and generic-entry risks exist?

A generic applicant seeking approval for glecaprevir-pibrentasvir would typically evaluate several certification strategies:

Certification	Effect
Paragraph I	No relevant patent information listed
Paragraph II	Listed patent has expired
Paragraph III	Applicant will wait until patent expiration
Paragraph IV	Listed patent is invalid, unenforceable or will not be infringed
Section viii statement	Applicant omits a patented method of use from labeling

For Patent 10,286,029, the most significant generic strategies are Paragraph IV and section viii.

A section viii strategy may be difficult if the generic label necessarily includes the same HCV treatment populations and durations recited in the patent. The applicant could attempt to carve out specific durations, genotypes or patient groups, but a carve-out must remain consistent with FDA-approved labeling and cannot leave the generic label with an indication that inherently practices the patented method.

A Paragraph IV challenge would likely focus on:

• Obviousness of combining two known HCV DAAs;
• Obviousness of the claimed treatment durations;
• Written description and enablement for the full range of genotypes and patient populations;
• Claim construction of “treatment lasts for” a specified number of weeks;
• Whether the patent adequately supports the exact 120 mg pibrentasvir regimen;
• Anticipation by clinical-trial disclosures or patent publications; and
• Enforceability issues arising from prosecution conduct.

The strongest commercial claims are claims 22 through 28 because they combine the exact commercial dosing pattern with the broadest set of genotype-specific uses. The broader claims 1 and 29 may be more exposed to prior-art and obviousness arguments because they cover wider treatment-duration and combination concepts.

How strong is the patent estate for Mavyret?

The estate is stronger when considered as a portfolio rather than through Patent 10,286,029 alone.

Patent category	Business function	Generic risk
Glecaprevir composition patents	Protect the protease inhibitor	High barrier if unexpired and valid
Pibrentasvir composition patents	Protect the NS5A inhibitor	High barrier if unexpired and valid
Combination patents	Protect use of both agents together	Moderate to high
Method-of-treatment patents	Protect duration, genotype and patient selection	Moderate
Formulation patents	Protect tablet composition and release properties	Moderate
Manufacturing patents	Protect commercially efficient production	Variable
Regulatory exclusivity	Delays approval independently of patents	Time-limited

Composition-of-matter patents generally have greater exclusionary value than method-of-use patents because a generic cannot sell the active ingredient for an unpatented use without substantial practical risk. Method claims can be designed around through labeling, treatment duration or patient selection, although induced-infringement theories can still create exposure.

The 10,286,029 claims have meaningful commercial overlap with Mavyret’s approved use. Their limitations also provide potential attack points. The requirement for a defined duration and the exclusion of interferon and ribavirin make the claims specific, but those same limitations may narrow infringement and create prior-art arguments.

What patent litigation affects glecaprevir-pibrentasvir?

The principal litigation risk is expected to arise from ANDA filings and Paragraph IV certifications against AbbVie’s Mavyret patent estate. Patent 10,286,029 should be analyzed together with all Orange Book-listed patents for Mavyret, including any patents covering the active ingredients, combinations, dosage forms and treatment methods.

A Paragraph IV notice can trigger Hatch-Waxman litigation and a statutory 30-month approval stay. A generic applicant may also seek a declaratory judgment or challenge selected patents while accepting others through Paragraph III certifications. The timing of generic entry will depend on:

• The earliest unexpired blocking patent;
• Whether the patent owner files suit within 45 days;
• The number of asserted patents;
• Court rulings on validity and infringement;
• Any authorized generic arrangement; and
• Settlement terms, including launch dates and licenses.

No biosimilar litigation pathway applies because Mavyret contains chemically synthesized small molecules rather than a biologic.

How does Mavyret compare with competing HCV drugs?

Product	Active ingredients	Primary patent risk profile
Mavyret	Glecaprevir/pibrentasvir	Compound, formulation and method-of-use estate
Epclusa	Sofosbuvir/velpatasvir	Compound and combination patents
Vosevi	Sofosbuvir/velpatasvir/voxilaprevir	Combination and treatment-method patents
Harvoni	Ledipasvir/sofosbuvir	Older compound and formulation estate
Zepatier	Elbasvir/grazoprevir	Compound and combination estate

Mavyret’s commercial position comes from pangenotypic coverage, an 8-week option for many treatment-naive noncirrhotic patients, and the absence of interferon and ribavirin. Those same label features overlap with Patent 10,286,029 and increase the importance of the patent for generic-label strategy.

What revenue exposure is associated with the patent?

Mavyret generated approximately $5 billion in annual global net revenue for AbbVie in the early 2020s, making the product one of the company’s largest non-immunology assets. AbbVie reported Mavyret net revenues of approximately $5.2 billion in 2023. (AbbVie Inc., 2024)

The patent’s direct revenue exposure is lower than the product’s total revenue because:

• Not every prescription uses every claimed duration;
• Some markets have different labeling and reimbursement rules;
• Other patents may expire earlier or later;
• Generic entry may occur through a settlement; and
• A successful section viii carve-out could reduce the practical scope of a generic challenge.

Even so, the patent is strategically important because an authorized generic or unrestricted generic launch could affect a large global HCV franchise.

What geographic coverage does the patent provide?

U.S. Patent 10,286,029 provides rights only in the United States. Parallel protection must be assessed separately in Canada, Europe, Japan, China, Australia and other markets. International family members may have different:

• Claim scope;
• Filing and priority dates;
• Grant status;
• Patent-term adjustments;
• Supplementary protection certificates;
• Validity outcomes; and
• Litigation histories.

A U.S. judgment does not determine the validity or enforceability of corresponding foreign patents. For global licensing or launch planning, the U.S. patent should be mapped against the national family and each country’s regulatory exclusivity rules.

Key Takeaways

• Patent 10,286,029 covers interferon-free, ribavirin-free treatment of HCV with glecaprevir and pibrentasvir.
• The claims cover 8-, 9-, 10-, 11-, 12- and 16-week treatment periods.
• Claims 23 through 28 cover genotypes 1 through 6 under the once-daily 120 mg pibrentasvir regimen.
• Claim 22 most closely tracks the commercial Mavyret dosing configuration.
• The patent is a method-of-use patent, not the primary composition-of-matter protection for either active ingredient.
• The nominal expiration date is November 27, 2034.
• Generic applicants may consider Paragraph IV certifications or section viii labeling carve-outs.
• The patent must be evaluated with the broader Mavyret compound, formulation, combination and manufacturing estate.
• No biosimilar pathway applies; potential competitors are ANDA-based generic manufacturers.
• Mavyret’s approximately $5 billion annual revenue makes the patent estate commercially material.

FAQs About U.S. Patent 10,286,029

Does Patent 10,286,029 cover Mavyret itself?

It covers methods of treating HCV with the glecaprevir-pibrentasvir combination. It does not, based on the supplied claims, claim the tablet composition itself.

Can a generic launch before November 27, 2034?

A generic could launch before that date only through a successful validity or infringement challenge, a license, a settlement, a non-infringing labeling strategy or expiration of other blocking rights combined with an effective design-around.

Does the patent cover treatment with ribavirin?

No. The independent claims require that treatment not include interferon or ribavirin.

Does the patent cover decompensated cirrhosis?

The supplied claims expressly cover patients without cirrhosis and patients with compensated cirrhosis. They do not expressly recite decompensated cirrhosis.

Is pibrentasvir’s 120 mg dose required in every claim?

No. The 120 mg once-daily dose is expressly required by claims 22, 31 and their dependent claims. The broader independent claims do not include that dose limitation.

References

1. AbbVie Inc. (2024). 2023 annual report. AbbVie Inc.

2. U.S. Food and Drug Administration. (2024). Mavyret prescribing information. U.S. Department of Health and Human Services.

3. United States Patent and Trademark Office. (2019). U.S. Patent No. 10,286,029: Methods for treating hepatitis C virus infection. U.S. Department of Commerce.

4. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. U.S. Department of Health and Human Services.

5. United States Code. (2023). 35 U.S.C. §§ 156, 271, 282, and 355. Government Publishing Office.

Drugs Protected by US Patent 10,286,029

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					Y
Abbvie	MAVYRET	glecaprevir; pibrentasvir	TABLET;ORAL	209394-001	Aug 3, 2017		RX	Yes	Yes					Y

International Family Members for US Patent 10,286,029

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2014239563
Australia	2015240754
Australia	2016202823
Australia	2016291154