United States Patent 11,110,087 (GDC-0199): Claim Scope, Infringement Risk, and US Landscape
US Drug Patent 11,110,087 claims oral, once-daily dose-escalation regimens for GDC-0199 in lymphoma or leukemia, including specific escalation step sizes (100 mg, 200 mg, 400 mg), daily dosing cycles (one day per cycle), continuation until disease progression, and defined combination schedules with obinutuzumab (including 28-day cycles and a 6 to 7 cycle window) and optionally cytarabine.
What exactly do the independent claims cover? (Core infringement theory)
Claim 1 is the broadest method anchor
Claim 1 recites:
- Use type: “A method for treating lymphoma or leukemia in a human patient”
- Route/frequency: orally administering once daily GDC-0199
- Escalating dosing cycles: cycles with escalating daily doses
- Specific escalation pattern:
- 100 mg per day
- then 200 mg per day
- then 400 mg per day
- Escalation is explicitly tied to dosing cycles (the escalation structure is a claim element)
Claim 9 is a slightly narrower escalation permutation
Claim 9 recites:
- oral, once daily GDC-0199
- escalating doses including 100 mg per day followed by 200 mg per day
- and it explicitly requires three differing doses via dependent claims (10 to 12) rather than a full three-step statement inside claim 9.
In practice, claim 9 reads like a scaffold that still ends up capturing a multi-step escalation regimen once dependent limitations are met.
Claim 19 is a different breadth axis: single-value “100 mg” framing
Claim 19 recites:
- oral, once daily GDC-0199
- escalating doses comprising a daily dose of 100 mg
- then dependent claims define “three differing doses” and how escalation occurs in the first three dosing cycles.
Claim 19 is useful for mapping design-around failures: it can cover regimens that include 100 mg as the starting escalation step, even if the claim text does not itself restate the 200 and 400 steps in the independent text (those appear downstream).
How do dependent claims narrow or lock in the regimen? (Claim chart logic)
Daily cycle requirement
- Claim 2: each dosing cycle is one day
- Claims 12 and 23: same limitation for claims 9 and 19 chains
This tightens the infringement window: a regimen that uses week-long cycles but uses the same dose levels may avoid a literal match.
Starting and ending dose timing
- Claim 3: starting dose administered for one dosing cycle
- Claim 4 and 13 and 25: method continues until disease progression
This creates an “on-therapy until progression” requirement as a method element.
Combination therapy lock
Two combination branches exist:
- Obinutuzumab branch (claims 5 to 8; 15 to 17; 27 to 29)
- Cytarabine branch (claim 26)
The obinutuzumab branch has the tightest scheduling constraints because it includes a defined infusion cycle and a cycle count range.
Where is the highest infringement risk? (Most specific limitations)
The most litigation-prone features are the ones that are both (a) specific and (b) necessary:
1) The escalation steps: 100 mg to 200 mg to 400 mg
- Explicit in Claim 1
- Implicitly enforced in the dependent chain for claims 9 and 19 because the “three differing doses” structure is required
A competitor regimen that changes any of the numerical dose points (or introduces additional steps not matching the claimed structure) may escape literal infringement but could still face doctrine-of-equivalents risk in real enforcement settings.
2) One-day dosing cycles
- Explicit in Claims 2, 12, 23
A common clinical alternative is longer cycles. If a party structures escalation over multiple days per step (even if total daily dose equals the claimed daily amounts), literal infringement may fail.
3) Continuation until disease progression
This is a method-use limitation. If a study stops escalation early by protocol-defined endpoints rather than “until progression,” literal infringement can be harder to establish.
4) Obinutuzumab regimen details
- Claims 6 to 8: obinutuzumab “once in a 28 day cycle for 6 to 7 dosing cycles” and 1000 mg
- Claims 16 to 17: same construct for the claim 15 chain
- Claims 28 to 29: same construct for the claim 27 chain
This is the cleanest “schedule-and-dose” infringement anchor.
What do the obinutuzumab claims require, in operational terms?
Obinutuzumab schedule and dose
Across the three parallel claim chains:
- Obinutuzumab is administered in combination with GDC-0199
- Obinutuzumab administration:
- once per 28-day cycle
- for 6 to 7 dosing cycles
- Obinutuzumab dose:
Timing relative to GDC-0199
The claims state the combination relationship and the obinutuzumab cycle regimen. The GDC-0199 is “once daily” and is part of the escalation cycles (with daily cycles specified in multiple dependent claims). The obinutuzumab scheduling is fixed to 28-day windows.
Implication for product positioning
A regimen that gives obinutuzumab at a different mg strength (not 1000 mg) or uses a different cycle schedule (not “once in a 28 day cycle” or not “for 6 to 7 dosing cycles”) is not a literal match for these claims.
What does the cytarabine claim cover?
- Claim 26: GDC-0199 in combination with cytarabine
Claim 26 does not specify a cytarabine dosing level or schedule inside the claim text you provided. As written, the cytarabine limitation is a binary combination inclusion. That typically expands coverage relative to the obinutuzumab branch, even though enforcement depends on whether other regimen elements are also met.
Is there redundancy or alternative coverage across the claim set? (How the chains interlock)
The claim set uses three independent claim “front ends” (1, 9, 19) and then repeats the same structural constraints via dependent limitations:
- Dose escalation across “three differing doses”
- One-day dosing cycles
- One cycle for the starting dose
- Continuation until disease progression
- Combination options with:
- obinutuzumab (tight schedule and dose)
- cytarabine (combination inclusion only)
Net effect: multiple paths to the same factual regimen structure. For infringement analysis, that means a defendant cannot easily rely on “which independent claim you match” because the dependent limitations align across separate claim chains.
What is the practical claim scope? (A literal “use-case” map)
Literal regimen captured by Claim 1 (high certainty)
A literal match requires:
- Patient: human with lymphoma or leukemia
- Drug: GDC-0199
- Administration pattern:
- oral
- once daily
- escalation sequence:
- 100 mg/day for a dosing cycle
- followed by 200 mg/day
- followed by 400 mg/day
- dosing cycle structure:
- claim 2 makes “each dosing cycle = one day”
- Continuation:
- until disease progression
- Optional but captured when combined:
- obinutuzumab at 1000 mg:
- once every 28 days
- for 6 to 7 cycles
- or cytarabine as a combination agent (Claim 26)
Literal regimen captured by the obinutuzumab-dependent claim chains (high enforcement leverage)
Any regimen that simultaneously uses:
- the GDC-0199 escalation structure and timing elements, and
- obinutuzumab at 1000 mg with the 28-day cycle and 6 to 7 cycles constraint
fits the most specific, least arguable claim geometry.
Where are common design-around points? (What usually breaks literal claim elements)
Based on claim structure, the main ways to reduce literal infringement exposure are:
-
Alter cycle duration
- Break “each dosing cycle is one day” (Claims 2/12/23)
-
Change escalation step sizes or count
- Claim 1 is tightly tied to 100/200/400 mg daily sequence
-
Change obinutuzumab schedule or dose
- Break “once in a 28 day cycle for 6 to 7 dosing cycles” or “1000 mg” (Claims 6-8, 16-17, 28-29)
-
Change the “until disease progression” treatment end condition
- If therapy is stopped for reasons other than disease progression under the claimed method (Claims 4/14/25)
The claims do not provide loopholes based on patient subgroup, line of therapy, prior treatments, or lymphoma/leukemia subtype; those would need to be added via other claim text not provided here.
US patent landscape impact: what else could matter around 11,110,087
Even without the rest of the publication record, the claim architecture indicates the patent is positioned to cover:
- Clinical escalation strategy (numerical step sizes and daily cycle structure)
- Combination regimen with an established antibody partner (obinutuzumab) at a clinically standard cycle cadence (28-day window)
- Combination possibility with cytarabine
Landscape zones to evaluate in enforcement or freedom-to-operate
Because this patent is method-based, infringement risk can arise from:
- labelled clinical protocols used by providers
- trial protocols that mirror the claim structure
- companion-dosing instructions embedded in development plans for GDC-0199 in lymphoma/leukemia
In addition, because the obinutuzumab limitations are tightly specified, the risk concentrates on protocols that incorporate obinutuzumab at 1000 mg on a 28-day schedule for 6 to 7 cycles while also matching the GDC-0199 escalation design.
Scope-to-Claims matrix (quick reference)
| Claim |
Core drug use |
Escalation structure |
Dosing cycle timing |
Continue-until condition |
Combination option(s) |
| 1 |
Oral once daily GDC-0199 in lymphoma/leukemia |
Explicit: 100 mg → 200 mg → 400 mg |
Escalating cycles defined; cycle timing narrowed by dependent claims |
Yes (via dependent) |
Obinutuzumab (via dependent), cytarabine not in this chain |
| 2-4 |
Same as Claim 1 |
Same |
Each dosing cycle = 1 day |
Until disease progression |
Obinutuzumab schedule/dose via Claims 6-8 |
| 5-8 |
Same as Claim 1 |
Same |
1 day via Claims 2 |
Until progression via Claim 4 |
Obinutuzumab 1000 mg once per 28 days for 6-7 cycles |
| 9-14 |
Oral once daily GDC-0199 escalation in lymphoma/leukemia |
Escalation includes 100 mg → 200 mg, with three differing doses via dependent |
1 day via Claims 12 |
Until disease progression via Claim 14 |
Obinutuzumab via Claims 15-17 |
| 15-17 |
Same as Claim 9 chain |
Same |
1 day |
Until progression |
Obinutuzumab 1000 mg once per 28 days for 6-7 cycles |
| 18-25 |
Oral once daily GDC-0199 starting with 100 mg escalation |
Three differing doses via dependent; starting dose timing specified |
1 day via Claims 23 |
Until disease progression via Claim 25 |
Obinutuzumab and/or other combinations via dependent branches |
| 26 |
Oral once daily GDC-0199 in lymphoma/leukemia |
Escalation via Claims 19/20/22 structure |
Depends on which chain it inherits |
Depends on which chain it inherits |
Cytarabine inclusion |
| 27-29 |
Oral once daily GDC-0199 with obinutuzumab |
Same escalation structure framework |
1 day via dependent |
Until progression via dependent |
Obinutuzumab 1000 mg once per 28 days for 6-7 cycles |
Key Takeaways
- 11,110,087 claims a method-use regimen: oral, once-daily GDC-0199 with dose escalation across 100 mg, 200 mg, and 400 mg in lymphoma or leukemia.
- The strongest literal infringement hooks are the numerical escalation steps, one-day dosing cycles, and “until disease progression.”
- Obinutuzumab claims are the tightest scheduling anchors: 1000 mg administered once in a 28-day cycle for 6 to 7 dosing cycles in combination with the claimed GDC-0199 regimen.
- Cytarabine is included as a combination option (Claim 26) without visible schedule/dose parameters in the provided claim text, making it a broader combination inclusion than the obinutuzumab branch.
FAQs
1) Does the patent cover only GDC-0199 monotherapy or also combination therapy?
It covers both. The claim set includes combination method claims with obinutuzumab and a separate branch including cytarabine.
2) Is the 100 mg to 200 mg to 400 mg sequence required?
For Claim 1, yes, the escalation is explicitly 100 mg → 200 mg → 400 mg. Claims 9 and 19 rely on “three differing doses” and dependent timing, aligning the regimen to the same three-step structure when fully read.
3) Do dosing cycles have to be one day?
Yes for the claim set you provided, because multiple dependent claims specify each dosing cycle is one day (Claims 2, 12, 23).
4) How specific is the obinutuzumab schedule?
It is highly specific: 1000 mg, given once per 28 days, for 6 to 7 cycles.
5) What endpoint condition is required by the claims?
The method is continued until disease progression (Claims 4, 14, 25, depending on the claim chain).
References
[1] User-provided claim text for US Drug Patent 11,110,087 (claims 1-29).
