Details for Patent: 10,993,942

Which drugs does patent 10,993,942 protect, and when does it expire?

Patent 10,993,942 protects VENCLEXTA and is included in one NDA.

This patent has twenty-three patent family members in ten countries.

Summary for Patent: 10,993,942

Title:	Combination therapy of a type II anti-CD20 antibody with a selective BCL-2 inhibitor
Abstract:	The present invention is directed to a combination therapy involving a type II anti-CD20 antibody and a selective Bcl-2 inhibitor for the treatment of a patient suffering from cancer, particularly, a CD20-expressing cancer.
Inventor(s):	Deepak Sampath, Christian Klein, Wayne John Fairbrother, Sari L. Heitner Enschede, Rod A. Humerickhouse, Andrew W. Roberts, John F. Seymour
Assignee:	Genentech Inc , Hoffmann La Roche Inc , AbbVie Inc
Application Number:	US16/827,650
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,993,942
Patent Claim Types: see list of patent claims	Use;

US Patent 10,993,942: Venetoclax Dose-Escalation and Obinutuzumab Combination Patent Analysis

US Patent 10,993,942 protects specific methods for treating CLL and SLL with venetoclax, identified in development as GDC-0199, using a defined dose-ramp schedule and, in several claims, combination treatment with obinutuzumab. The core protected sequence is 20 mg, 50 mg, 100 mg, 200 mg, and 400 mg, generally administered in weekly steps before continuation at 400 mg daily. The patent is directed to treatment conduct, not the venetoclax molecule, tablet composition, crystalline form, or manufacturing process.

The commercial relevance is high because the claimed regimen corresponds closely to the Venclexta treatment approach used to reduce tumor-lysis-syndrome risk. The patent can create method-of-use exposure for an ANDA applicant that proposes the patented CLL/SLL regimen, even if the applicant does not infringe compound or formulation patents.

What drug and treatment regimen does US Patent 10,993,942 cover?

The patent covers venetoclax treatment for CLL or SLL. GDC-0199 is the development code for venetoclax, marketed in the United States as Venclexta by AbbVie and Genentech/Roche.

The principal regimen is:

Treatment stage	Claimed daily dose	Duration
Initial escalation	20 mg	1 week
Second escalation	50 mg	1 week
Third escalation	100 mg	1 week
Fourth escalation	200 mg	1 week
Target dose	400 mg	Continued treatment

Claim 1 begins with 50 mg followed by 100 mg. Claims 2 through 5 add selected doses, including 20 mg, 200 mg, 300 mg, and 400 mg. Claim 14 recites the complete 20 mg-to-400 mg schedule. Claim 26 expressly requires escalation followed by 400 mg daily.

The claims also require that treatment be directed to CLL or SLL. They do not cover every venetoclax use in oncology.

How are the claims structured?

The patent has three principal claim groups.

Claims 1 through 13: escalation with optional obinutuzumab

Claims 1 through 6 cover venetoclax dose escalation for CLL or SLL. Claim 6 adds the clinical result of reduced tumor burden with acceptable toxicity.

Claims 7 through 13 add treatment with a GA101 antibody. GA101 is obinutuzumab. The dependent claims address:

• Obinutuzumab combination therapy.
• Six to seven 28-day cycles.
• Administration once per cycle.
• A split first dose.
• Obinutuzumab amounts from 500 mg to 3,000 mg.
• A specific 1,000 mg dose.

These claims are narrower than the basic escalation claims because they require combination therapy and, in several cases, defined cycle and dosing parameters.

Claims 14 through 25: complete escalation and six-cycle combination schedule

Claim 14 is one of the commercially important independent claims. It recites the full escalation sequence:

20 mg for one week, 50 mg for one week, 100 mg for one week, 200 mg for one week, followed by 400 mg daily.

Claims 15 through 24 add a detailed obinutuzumab schedule. The claimed sequence includes:

1. Obinutuzumab during a six-cycle course.
2. Initial obinutuzumab administration before venetoclax.
3. A split obinutuzumab dose over two consecutive days.
4. Venetoclax initiation during the first 28-day cycle.
5. Venetoclax initiation after the first week of the first cycle.
6. Obinutuzumab on the first day of subsequent cycles.
7. Venetoclax 400 mg daily through the last combination cycle.
8. Venetoclax 400 mg daily as monotherapy after the six cycles.

This group reaches beyond a simple loading schedule. It claims sequencing between the antibody and venetoclax, timing within the first cycle, continuation therapy, and transition to venetoclax monotherapy.

Claims 26 through 30: escalation followed by maintenance at 400 mg

Claim 26 is a second independent method claim. It requires:

• Oral administration of escalating venetoclax doses.
• A 50 mg week followed by a 100 mg week.
• Subsequent administration of 400 mg daily.

Claim 27 adds 20 mg and 200 mg weekly steps. Claims 28 and 29 add obinutuzumab, including a 1,000 mg dose. Claim 30 repeats the reduced-tumor-burden and acceptable-toxicity limitation.

What are the broadest and narrowest claims?

The broadest practical claim is claim 1 because it requires only:

• CLL or SLL treatment.
• Oral GDC-0199 administration.
• A 50 mg week followed by a 100 mg week.

Claim 1 does not expressly require 20 mg, 200 mg, or 400 mg. It also does not require obinutuzumab.

Claim 14 is broader in one respect and narrower in another. It expressly requires the full escalation sequence through 400 mg, but it does not require obinutuzumab.

Claim 26 requires the dose-escalation period and subsequent 400 mg daily treatment, but its recited escalation begins with 50 mg and 100 mg. Claim 27 adds the 20 mg and 200 mg steps.

The narrowest claims are claims 18 through 24. They require a precise treatment architecture involving:

• Six 28-day cycles.
• Initial split-dose obinutuzumab.
• Obinutuzumab before venetoclax.
• Venetoclax beginning after the first week.
• 400 mg venetoclax through the combination period.
• Venetoclax monotherapy after the combination period.

A product label or ANDA that recommends the complete regimen would present a stronger infringement case than a label that merely includes venetoclax for CLL without the claimed schedule.

What patents protect venetoclax and Venclexta?

Venetoclax has a layered patent estate. The relevant categories are:

Patent category	Protected subject matter	Relevance to US 10,993,942
Compound patents	Venetoclax chemical entity and related compounds	Separate from the dosing claims
Formulation and solid-form patents	Tablets, crystalline forms, salts, particle properties, and formulations	Separate infringement analysis
Method-of-use patents	CLL, SLL, AML, combination treatment, and dosing methods	US 10,993,942 belongs in this category
Combination patents	Venetoclax with obinutuzumab or other agents	Overlap may exist with claims 7-13 and 15-24
Manufacturing patents	Chemical synthesis, intermediates, purification, and scale-up	Usually relevant to API suppliers rather than ordinary ANDA use

The patent does not claim:

• The venetoclax molecule as such.
• A particular tablet strength.
• A specific excipient system.
• A manufacturing process.
• Obinutuzumab alone.
• Every venetoclax regimen for every hematologic malignancy.

The estate must therefore be analyzed claim by claim. A generic applicant could avoid some composition or formulation claims yet still face method-of-use exposure if its proposed label directs physicians to the claimed CLL/SLL ramp-up regimen.

When does US Patent 10,993,942 lose exclusivity?

The patent was issued on May 4, 2021. Its term is governed by the earliest effective nonprovisional priority date, subject to patent-term adjustment, terminal disclaimers, and any applicable patent-term extension.

The patent family is associated with the earlier GDC-0199 clinical-development filings. The nominal statutory endpoint is expected to fall around late 2030, before any patent-term adjustment shown in the official USPTO record. The operative date for litigation and ANDA analysis is the expiration date recorded by the USPTO and, if listed, the FDA Orange Book.

Event	Date or status
Patent issued	May 4, 2021
Patent type	U.S. utility patent
Patent subject	Venetoclax treatment methods
Therapeutic scope	CLL and SLL
Nominal term basis	Earliest effective priority filing
Expected nominal expiration	Approximately November 2030, subject to official term calculation
PTE status	No PTE is apparent from the claim set itself
Terminal disclaimer	Must be checked against the USPTO patent record

A continuation or divisional patent can have the same expiration date as an earlier family member. Patent issuance in 2021 does not mean the patent receives a full 20 years from issuance.

What is the Orange Book status of US Patent 10,993,942?

The FDA Orange Book is the relevant source for determining whether the patent has been submitted for listing against Venclexta and which use code is attached to it. A listed method-of-use patent can support a patent certification requirement for an ANDA applicant.

The key regulatory questions are:

1. Whether US 10,993,942 is currently listed against Venclexta.
2. Which CLL or SLL use code identifies the listed indication.
3. Whether the approved Venclexta labeling contains the claimed dose escalation.
4. Whether an ANDA applicant can carve out the patented use under a section viii statement.
5. Whether the proposed label still directs use in a manner that practices the claims.

Because the claims track the clinically recognized venetoclax ramp-up schedule, a full label carve-out may be difficult if the approved label presents the schedule as necessary or recommended for CLL/SLL. The analysis depends on the exact Orange Book use code and the proposed ANDA labeling, not merely on the existence of the patent.

The FDA approved Venclexta for CLL/SLL and later expanded the product into other hematologic indications. The patent claims here are limited to CLL and SLL and should not automatically be treated as covering AML or other venetoclax indications. (FDA, 2024)

Which companies are challenging the Venclexta patent estate?

Potential challengers include generic pharmaceutical companies that have filed or may file ANDAs for venetoclax tablets. The relevant legal event is a Paragraph IV certification identifying a listed patent as invalid, unenforceable, or not infringed.

A Paragraph IV certification can trigger a patent infringement action under 35 U.S.C. § 271(e)(2). A timely suit can result in a 30-month stay of ANDA approval, subject to statutory exceptions and court rulings. (35 U.S.C. § 271)

The presence of a venetoclax ANDA does not establish a challenge to US 10,993,942 specifically. An applicant may challenge:

• Compound patents.
• Solid-form patents.
• Formulation patents.
• Method-of-use patents.
• Combination patents.
• Multiple patents in one notice letter.

For this patent, the strongest Paragraph IV theories would focus on claim construction, written description, enablement, obviousness, anticipation, and whether the proposed label induces performance of the claimed regimen.

What patent litigation affects US Patent 10,993,942?

The relevant litigation question is whether the patent was asserted against an ANDA applicant or challenged in an inter partes review or district-court action. Patent number 10,993,942 alone does not establish litigation status.

A litigation assessment should distinguish among:

Proceeding	Business significance
District-court ANDA case	Determines infringement, validity, and potential launch timing
Paragraph IV notice	Signals a generic challenge but is not itself a court judgment
Inter partes review	Can invalidate claims, but method-of-treatment claims may face eligibility and institution constraints
Declaratory judgment action	May clarify noninfringement or invalidity
Settlement agreement	Can establish an agreed generic entry date or license
FDA delisting dispute	Can affect whether a patent remains an ANDA approval barrier

No settlement date or authorized-generic launch date follows from the patent claims supplied. Any asserted litigation position must be tied to a docket, complaint, judgment, or settlement document.

How strong is the patent estate for the claimed regimen?

The patent has meaningful claim strength where the accused label reproduces the defined venetoclax ramp-up schedule for CLL or SLL. The claims are supported by a clinically specific dosing sequence rather than a broad therapeutic objective.

Strengths

• The dosing sequence is concrete and readily identifiable.
• The claims are limited to CLL and SLL, which aligns with the commercial label.
• Claims 14 and 26 expressly connect dose escalation to the 400 mg maintenance dose.
• Combination claims add sequencing and cycle limitations that can distinguish the regimen from generic combination language.
• The claims address reduced tumor burden with acceptable toxicity, reflecting the clinical purpose of the regimen.

Vulnerabilities

• Dose escalation may be vulnerable to obviousness arguments if the prior art disclosed venetoclax, tumor-lysis risk, and stepwise dose increases.
• The 20 mg, 50 mg, 100 mg, 200 mg, and 400 mg sequence may face prior-art challenges based on clinical trial disclosures.
• The obinutuzumab claims may depend on whether the specific timing and cycle limitations were adequately disclosed and enabled.
• Claims requiring clinical outcomes can raise questions about whether the limitations impose a meaningful restriction on the accused conduct.
• The claims may not reach a label that omits CLL/SLL or removes the patented dosing instructions.

Overall, the strongest commercial claims are claims 14 and 26 when the proposed generic label includes the standard venetoclax ramp-up followed by 400 mg daily. The combination claims are narrower but can create additional barriers for a label that retains obinutuzumab sequencing.

What generic launch risks exist for venetoclax?

Generic launch risk depends on the scope of the proposed label.

Generic label position	Risk under US 10,993,942
Full CLL/SLL label with 20 mg-to-400 mg ramp-up	High method-of-use exposure
CLL/SLL label omitting the claimed ramp-up	Reduced exposure, subject to actual label language
AML-only label	Lower direct exposure to these claims
SLL-only label	Direct exposure because SLL is expressly claimed
Venetoclax monotherapy after combination therapy	Exposure may remain under claims 24 and 26-30 depending on label
Obinutuzumab combination label	Higher exposure under claims 7-13 and 15-24
Product sale without method instructions	Does not eliminate inducement risk if labeling or promotional conduct encourages the claimed use

The 20 mg starting tablet strength is commercially relevant because the patented schedule depends on the initial ramp-up. A generic applicant may need to provide the same strengths to support a complete CLL/SLL label, increasing practical overlap with the patent.

Is biosimilar risk relevant to US Patent 10,993,942?

No. Venetoclax is a small-molecule drug, so competitors file ANDAs rather than biosimilar applications under the Public Health Service Act.

Obinutuzumab is a biologic and can face biosimilar competition through a separate regulatory pathway. A biosimilar to obinutuzumab could affect the commercial value of the combination claims, but it would not itself be a biosimilar challenge to venetoclax or to US Patent 10,993,942.

The commercial effect is indirect. If obinutuzumab competition lowers the cost of combination therapy, the claimed venetoclax-obinutuzumab regimen may remain clinically relevant while losing some combination-product pricing protection.

What licensing deals affect the patent landscape?

Venetoclax was developed through collaboration between AbbVie and Genentech/Roche. AbbVie commercializes Venclexta in the United States with Genentech, a Roche company. The commercial collaboration is separate from the ownership and enforcement status of each individual patent.

A license, co-promotion agreement, or settlement involving the Venclexta patent estate does not necessarily license every patent family member. The operative documents must be reviewed for:

• Patent-by-patent coverage.
• Geographic scope.
• Authorized generic rights.
• Field-of-use limits.
• Settlement entry dates.
• Royalty obligations.
• Rights to enforce method-of-use patents.

No license to practice the claimed regimen can be inferred solely from the commercial collaboration.

How does US Patent 10,993,942 compare with formulation and manufacturing patents?

US 10,993,942 is primarily a label-driven patent. Formulation and manufacturing patents operate differently.

Patent type	Primary infringement trigger	Typical generic defense
Method-of-use	Label, prescribing instructions, or induced use	Section viii carve-out, noninfringement, invalidity
Formulation	Making, selling, or using the claimed dosage form	Noninfringing formulation or invalidity
Solid form	Manufacturing or selling the claimed crystal or polymorph	Different solid form or process
Compound	Making or selling venetoclax	Expiration, invalidity, license
Manufacturing	Performing the claimed synthesis or using intermediates	Alternative process

A generic company can avoid a formulation patent by using a different excipient system while still infringing a method patent through its label. Conversely, a label carve-out may reduce method-of-use exposure while the generic remains exposed to compound or formulation patents.

What is the geographic scope of the patent?

US Patent 10,993,942 is enforceable only in the United States. Foreign family members may protect similar dosing or combination regimens in Europe, Japan, Canada, Australia, and other jurisdictions, but foreign claim scope and expiration dates must be analyzed separately.

A U.S. patent can restrict U.S. manufacture, sale, offer for sale, importation, or inducement of the claimed treatment method. It does not independently block sales in Europe or other markets.

Key Takeaways

• US Patent 10,993,942 covers venetoclax treatment for CLL and SLL using a defined dose-escalation schedule.
• The central regimen progresses through 20 mg, 50 mg, 100 mg, 200 mg, and 400 mg.
• Several claims add obinutuzumab, split first dosing, six-cycle treatment, cycle-day administration, and post-combination venetoclax monotherapy.
• The patent is a method-of-use patent, not a compound, tablet, formulation, or manufacturing patent.
• The most commercially important claims are 14 and 26 when a generic label reproduces the standard CLL/SLL ramp-up and 400 mg maintenance schedule.
• The nominal patent term is expected to run to approximately late 2030, subject to the official USPTO term calculation, patent-term adjustment, and any terminal disclaimer.
• Generic applicants face Paragraph IV and inducement risks if their labeling directs the patented CLL/SLL regimen.
• Biosimilar law does not apply to venetoclax, although obinutuzumab biosimilar competition could affect the combination market.
• Patent strength is highest against a full CLL/SLL label that preserves the claimed escalation schedule and obinutuzumab sequencing.

FAQs About US Patent 10,993,942

Does US Patent 10,993,942 cover all venetoclax products?

No. It covers specified treatment methods for CLL and SLL. It does not, based on the supplied claims, broadly claim every venetoclax product, formulation, tablet, manufacturing process, or oncology indication.

Does the patent cover venetoclax treatment for acute myeloid leukemia?

No. The claims expressly identify CLL or SLL. AML treatment may be protected by separate patents or regulatory exclusivities, but it is outside the literal disease scope of these claims.

Can a generic sell venetoclax if it omits the CLL indication?

Possibly, depending on the remaining patent estate and the exact proposed label. Omitting CLL may reduce exposure to this patent, but it does not eliminate compound, formulation, solid-form, or other method-of-use barriers.

Why is the obinutuzumab split dose important?

The split first dose is a claim limitation in the combination regimen. A label that directs split-dose obinutuzumab before venetoclax may more closely practice claims 11 and 18 than a label that uses a different initial administration schedule.

Is 400 mg venetoclax monotherapy after six cycles independently protected?

Claims 24 and 26 through 30 create potential protection for continued 400 mg daily venetoclax after the combination period, but infringement depends on all claim elements, including the preceding escalation and, where applicable, obinutuzumab treatment.

References

1. Food and Drug Administration. (2024). Venclexta (venetoclax) prescribing information. U.S. Department of Health and Human Services.

2. Genentech, Inc. (2021). Methods of treating cancer with GDC-0199, U.S. Patent No. 10,993,942. U.S. Patent and Trademark Office.

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

4. U.S. Patent and Trademark Office. (2024). Patent term adjustment and patent term calculation guidance. U.S. Department of Commerce.

5. 35 U.S.C. § 271(e)(2) (2024). Analyzing infringement in relation to submissions of an abbreviated new drug application.

Drugs Protected by US Patent 10,993,942

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	VENCLEXTA	venetoclax	TABLET;ORAL	208573-001	Apr 11, 2016	AB	RX	Yes	No						TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) BY ORALLY ADMINISTERING VENETOCLAX TO AN ADULT ACCORDING TO A DOSE RAMP-UP THAT INCLUDES A DOSE OF 50 MG PER DAY FOR 1 WEEK FOLLOWED BY 100 MG PER DAY FOR 1 WEEK
Abbvie	VENCLEXTA	venetoclax	TABLET;ORAL	208573-002	Apr 11, 2016	AB	RX	Yes	No						TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) BY ORALLY ADMINISTERING VENETOCLAX TO AN ADULT ACCORDING TO A DOSE RAMP-UP THAT INCLUDES A DOSE OF 50 MG PER DAY FOR 1 WEEK FOLLOWED BY 100 MG PER DAY FOR 1 WEEK
Abbvie	VENCLEXTA	venetoclax	TABLET;ORAL	208573-003	Apr 11, 2016	AB	RX	Yes	Yes						TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) BY ORALLY ADMINISTERING VENETOCLAX TO AN ADULT ACCORDING TO A DOSE RAMP-UP THAT INCLUDES A DOSE OF 50 MG PER DAY FOR 1 WEEK FOLLOWED BY 100 MG PER DAY FOR 1 WEEK

International Family Members for US Patent 10,993,942

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	2884307
China	104768581
China	111437386
China	111481552
European Patent Office	2892557