United States Patent 11,166,951: Claim Scope and US Landscape for BCL-2 + BTK Combination in CLL/SLL
US Patent 11,166,951 covers a method of treating chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL) using a two-agent combination: a BCL-2 inhibitor plus a Bruton’s tyrosine kinase (BTK) inhibitor, with additional dependent claim limits around sequence, dose, anti-CD20 co-therapy, salt vs free base, and genetic subsets (notably 17p deletion and 11q deletion).
The core claim set is drafted to read on any BCL-2 inhibitor and any BTK inhibitor that fit the recited generic formula/definition (the formulas themselves are not text-visible in the prompt), and to capture administration timing options (before, concurrent, after). The claim language also uses CLL/SLL as the disease nucleus, which narrows enforceable scope to that indication set while leaving room for payer- and investigator-relevant clinical populations such as relapsed/refractory (R/R) and cytogenetic high-risk subsets.
What is the independent claim actually covering? (Claim 1)
Claim 1 is the operative independent claim. It recites a treatment method for:
- Hematological malignancy: CLL or SLL
- Administered to a human subject in need thereof
- “Therapeutically effective amounts of” two drug classes:
- (1) a BCL-2 inhibitor of a specified formula (or a pharmaceutically acceptable salt)
- (2) a BTK inhibitor of a specified formula (or a pharmaceutically acceptable salt)
Combination structure. Claim 1 is an “administering” method. It does not require a defined dosing regimen in Claim 1 itself; it only requires “therapeutically effective amounts.”
Key enforceability consequence. Because the independent claim is class/generic-formula-based (rather than limited to one named compound), the infringement analysis turns on whether the accused products fall within the “BCL-2 inhibitor of the formula” and “BTK inhibitor of the formula” definitions.
How do the dependent claims expand or narrow scope? (Claims 2-18)
Sequence controls
- Claim 2: BCL-2 inhibitor administered before BTK inhibitor
- Claim 3: BCL-2 inhibitor administered concurrently with BTK inhibitor
- Claim 4: BCL-2 inhibitor administered after BTK inhibitor
Impact. Together, these dependent claims cover three sequencing patterns. In practice, they reduce design-around leverage based on administration order.
Anti-CD20 co-therapy add-on
- Claim 5: method further includes anti-CD20 antibody selected from:
- rituximab, obinutuzumab, ofatumumab, veltuzumab, tositumomab, ibritumomab
- plus “fragments, derivatives, conjugates, variants, radioisotope-labeled complexes, and biosimilars”
Impact. Claim 5 creates a pathway for enforceability over triple-therapy regimens (BCL-2 inhibitor + BTK inhibitor + anti-CD20), while still keeping Claim 1 as the baseline for dual therapy.
Hard dose caps (BTK inhibitor)
- Claim 6: BTK inhibitor is 100 mg
- Claim 7: BTK inhibitor is 100 mg administered twice per day
Impact. These dependent claims narrow to a regimen matching dosing schedules like 100 mg BID. If an accused BTK dosing differs, Claim 6 or 7 may not read.
Hard dose caps (BCL-2 inhibitor)
- Claim 8: BCL-2 inhibitor is 400 mg
Impact. This is a regimen-specific limitation that can matter for infringement if the relevant BCL-2 inhibitor dosing differs materially.
Disease narrowing
- Claim 9: hematological malignancy is CLL
- Claim 10: CLL is relapsed or refractory
Cytogenetic subset narrowing
- Claims 11-14:
- Claim 11: human has 17p chromosomal deletion
- Claim 12: human has 11q chromosomal deletion
- Claim 13: R/R CLL due to 17p deletion
- Claim 14: R/R CLL due to 11q deletion
Impact. These dependent claims target high-risk cohorts where outcomes and treatment choices are often differentiated. They also narrow the patient population in clinical trial design and labeling arguments.
Salt vs free base scope
- Claims 15-18:
- BCL-2 inhibitor can be free form or salt
- BTK inhibitor can be free form or salt
Impact. These dependent claims are typically aimed at blocking form-factor or salt-form workarounds.
What is the effective claim “coverage map” for combinations?
Claim 1 establishes the broadest coverage (dual therapy). Claims 2-4 define sequencing permutations. Claim 5 defines a triple-therapy pathway. Claims 6-8 define specific regimen dosing. Claims 9-14 define specific disease subpopulations.
Coverage matrix (practical infringement framing)
| Feature |
Claim coverage |
| Disease |
CLL or SLL (Claim 1); CLL only (Claim 9); R/R (Claim 10); plus 17p or 11q deletions (Claims 11-14) |
| Therapy components |
Any recited BCL-2 inhibitor formula (or salt) + any recited BTK inhibitor formula (or salt) (Claim 1) |
| Timing |
BCL-2 before BTK (Claim 2), concurrent (Claim 3), after (Claim 4) |
| Triple therapy |
Adds anti-CD20 antibodies (Claim 5) |
| Dose |
BTK 100 mg (Claim 6), BTK 100 mg BID (Claim 7), BCL-2 400 mg (Claim 8) |
| Form |
Free form or salt for each component (Claims 15-18) |
Which product combinations are most likely to land inside Claim 1?
The prompt does not show the BCL-2 and BTK inhibitor structures in text, only “formula:” placeholders. As a result, the precise mapping must remain at the claim-logic level: any BCL-2 inhibitor that matches the recited formula and any BTK inhibitor that matches the recited formula.
That said, the claim concept (BCL-2 + BTK for CLL/SLL) aligns tightly with the best-known real-world development space where:
- BCL-2 inhibition targets apoptosis resistance in CLL/SLL.
- BTK inhibition modulates B-cell receptor signaling and improves disease control.
- Anti-CD20 antibodies are commonly layered in for deeper responses.
From a landscape standpoint, the highest probability of claim overlap is with commercial or late-stage agents that are well recognized as belonging to these two classes and that are used for CLL/SLL in combinations.
How does the dosing language affect design-around? (Claims 6-8)
Claims 6-8 introduce regimen-specific limits that can materially affect infringement in at least two ways:
- If an accused regimen does not match the numerical dosing limits, it may evade the dependent claims while still risking exposure under Claim 1 (which does not specify numerical doses).
- If an accused regimen matches the dose but uses different timing or disease cohort inclusion, dependent claims 2-4 and 9-14 can still create overlapping infringement vectors.
Given Claim 1’s breadth, the numerical dose dependent claims are best seen as adding fallback position(s) rather than the only enforcement hook.
What is the “patient population” narrowing strategy? (Claims 10-14)
Claims 10-14 concentrate on:
- R/R CLL
- CLL with 17p deletion (often associated with TP53 dysfunction)
- CLL with 11q deletion (often associated with ATM loss)
Landscape implication. Even when a broader CLL label exists, cytogenetic subset framing often drives clinical trial eligibility. This creates multiple pathways where a combination used in high-risk cohorts can land within dependent claim scope even if standard-risk cohorts are treated differently.
What does the anti-CD20 list do for the patent landscape? (Claim 5)
Claim 5’s anti-CD20 portion is structured to cover:
- Named antibodies: rituximab, obinutuzumab, ofatumumab, veltuzumab, tositumomab, ibritumomab
- Broad extensions: fragments, derivatives, conjugates, variants, radioisotope-labeled complexes, biosimilars
Key practical effect. If the BCL-2 + BTK backbone is used with an anti-CD20 antibody in any of these forms, the “third agent” does not need to be one of the newest biosimilars; the claim anticipates broad variants.
How should this patent be positioned within the US enforcement landscape?
1) Claim 1 drives dual-therapy coverage
The broadest independent claim is the primary enforcement target in any invalidity or infringement dispute because it does not require:
- numerical dose (depends on effective amount language)
- specific sequence (covered by dependent claims, but Claim 1 itself already reads broadly)
- specific anti-CD20 co-therapy (dependent)
2) Dependent claims add multiple “narrowing fallbacks”
Dependent claims create layered positions:
- sequencing (Claims 2-4)
- addition of anti-CD20 (Claim 5)
- regimen dosing (Claims 6-8)
- high-risk cytogenetics (Claims 10-14)
- form factors (salt/free base) (Claims 15-18)
This architecture is typical of combination therapy patents where the applicant expects some uncertainty about exact regimen design.
Potential overlap patterns with competitor portfolios (high-level, claim-driven)
Because the claim language is class/generic-formula based, overlap patterns will be determined by whether the competitor’s BCL-2 inhibitor and BTK inhibitor fall within the recited formula definitions. In US patent landscapes, this often produces three categories of risk:
-
Direct class overlap
Competitors using class-defining BCL-2 and BTK inhibitors in CLL/SLL combination regimens face the highest risk of falling within Claim 1.
-
Regimen-structure overlap
Even if dose differs, triple therapy with an anti-CD20 antibody and/or specific sequencing can push designs into dependent claims.
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Population-specific overlap
If clinical use targets R/R or 17p/11q deletion subpopulations, dependent claims 10-14 can increase risk even for otherwise similar regimens.
Key Takeaways
- US Patent 11,166,951 is structured around a dual combination for CLL/SLL: a BCL-2 inhibitor + a BTK inhibitor, both defined by formula scope (with salt coverage).
- Sequence is covered across dependent claims (BCL-2 before, concurrent, or after BTK), reducing order-based design-around options.
- Regimen specificity exists in dependent claims through BTK 100 mg and BTK 100 mg BID plus BCL-2 400 mg, but Claim 1 remains dose-agnostic via “therapeutically effective amounts.”
- Triple therapy is explicitly pulled in via anti-CD20 antibodies (broad list plus variants and biosimilars).
- Patient stratification is a major narrowing lever: R/R CLL and 17p deletion / 11q deletion are specifically claimed.
- Form changes (free base vs salt) are anticipated through dependent claims.
FAQs
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What does Claim 1 cover in one sentence?
A method treating CLL or SLL by administering a BCL-2 inhibitor plus a BTK inhibitor to a human subject in need thereof, using therapeutically effective amounts.
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Does the patent require a specific dosing schedule in the independent claim?
No. Claim 1 requires “therapeutically effective amounts.” Specific numerical dosing appears in dependent claims (Claims 6-8).
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Can infringement occur if the BCL-2 inhibitor is given after the BTK inhibitor?
Yes. Dependent Claim 4 covers BCL-2 inhibitor given after BTK inhibitor.
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Does the patent cover adding anti-CD20 antibodies?
Yes. Dependent Claim 5 adds anti-CD20 antibody co-therapy with a broad antibody/variant list.
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Are high-risk cytogenetic subsets included?
Yes. Dependent Claims 11-14 cover subjects with 17p deletion and/or 11q deletion, including R/R CLL.
References
[1] United States Patent No. 11,166,951 (claims provided in prompt).
