Executive summary: US Patent 10,232,040 is a US method-of-treatment patent aimed at a specific dosing regimen combining MEDI4736 (durvalumab; an anti–PD-L1 antibody) with tremelimumab (an anti–CTLA-4 antibody) for non-small cell lung cancer (NSCLC). The independent claim is constrained to: (i) MEDI4736 dose levels (20 mg/kg in claim 1; additional dose windows in dependent claims and other claim sets), (ii) tremelimumab dose (1 mg/kg), (iii) a defined sequencing gap (MEDI4736 administered about 1 hour after tremelimumab), and (iv) a capped early dosing period (every 4 weeks for at most 16 weeks) followed by an optional continuation schedule (every 2 weeks after week 16) with a stated maximum duration (52 weeks). The estate’s enforceability risk concentrates in sequencing, dose-precision, and whether accused regimens fall outside the claim’s temporal and titration windows. The closest practical “generic/biosimilar style” carve-outs are not route substitutions or indication broadeners, but deviations in administration timing (not “about 1 hour”), regimen length (beyond “at most 16 weeks” for the q4w portion), or MEDI4736 dose (10/15/20 mg/kg bands versus other durvalumab schedules). The competitive and regulatory history points to the same combination and class of regimen being clinically explored, but patent coverage is narrower than broad “combination therapy” claims because it is regimen-specific.

United States Patent 10,232,040 claims and patent landscape for MEDI4736 (durvalumab) plus tremelimumab in NSCLC

US 10,232,040 is a method-of-treatment patent focused on a particular dosing schedule and sequencing for MEDI4736 and tremelimumab in NSCLC. The claim set you provided contains three dosing “tracks” (20/15/10 mg/kg MEDI4736, each paired with 1 mg/kg tremelimumab), with consistent sequencing (MEDI4736 about 1 hour after tremelimumab), consistent early interval (q4w for at most 16 weeks), and a consistent optional continuation (MEDI4736 q2w after week 16) with a maximum total duration of 52 weeks in certain dependent claims.

Because the patent is regimen-limited, the landscape analysis is dominated by: (1) whether competitors use the same sequencing gap, (2) whether they replicate the “at most 16 weeks” q4w cap, (3) whether they use the same MEDI4736 mg/kg dose, and (4) whether they treat the same NSCLC clinical population framing (refractory or immunotherapy-naive; locally advanced unresectable or metastatic; squamous or non-squamous).

What is the core treatment regimen protected by US 10,232,040?

Featured snippet answer: The patent protects an NSCLC treatment method combining MEDI4736 (durvalumab) and tremelimumab with MEDI4736 given about 1 hour after tremelimumab, dosed at specific mg/kg levels, administered q4w for at most 16 weeks, with an optional step to q2w after week 16 (in certain claims), and (in certain dependent claims) a maximum total treatment length of 52 weeks.

Claim 1 dosing and timing constraints

From your provided claims, claim 1 is the relevant “independent” anchor:

Indication: method of treating non-small cell lung carcinoma (NSCLC) in a human patient
Doses:
- MEDI4736: 20 mg/kg
- Tremelimumab: 1 mg/kg
Sequencing:
- MEDI4736 administered about 1 hour following tremelimumab
Schedule:
- MEDI4736 + tremelimumab administered every 4 weeks for at most 16 weeks
Additional parameters (as dependent claims):
- Refractory to at least one chemotherapeutic agent
- Immunotherapy-naive
- IV infusion route
- Tumor size reduction benchmarks (≥10%, ≥25%, ≥50%)
- Disease stage: locally advanced unresectable or metastatic; squamous or non-squamous

Claim 2 continuation step

After the initial q4w period ends (after 16 weeks), add:
- MEDI4736: 10 mg/kg every two weeks after 16 weeks
Claim 3:
- Total treatment length: 52 weeks

Parallel claim sets with 10 mg/kg and 15 mg/kg MEDI4736

Your claim text includes other sets that track the same regimen logic but with different MEDI4736 dose levels:

Claim 13: 10 mg/kg MEDI4736 + 1 mg/kg tremelimumab, sequencing about 1 hour, q4w for at most 16 weeks
Claim 14-15: adds MEDI4736 10 mg/kg q2w after 16 weeks; total 52 weeks
Claim 25: 15 mg/kg MEDI4736 + 1 mg/kg tremelimumab, sequencing about 1 hour, q4w for at most 16 weeks
Claim 26-27: adds MEDI4736 10 mg/kg q2w after 16 weeks; total 52 weeks

Practical reading: these are not just “different dosages.” They represent distinct regimen “entry points” for infringement analysis. A competitor is less likely to land in the same claim scope if they (i) avoid the exact MEDI4736 mg/kg and/or (ii) change the transition dose after week 16 (claim 2/14/26 fix the post-week-16 MEDI4736 dose to 10 mg/kg).

Which claim limitations are most infringement-sensitive (and easiest to design around)?

Featured snippet answer: The most infringement-sensitive limitations are the regimen sequencing (“about 1 hour” between tremelimumab and MEDI4736), the early schedule cap (“every 4 weeks for at most 16 weeks”), and the specific MEDI4736 mg/kg dosing levels (20, 15, or 10 mg/kg depending on the claim track). Route and tumor-shrinkage endpoints are typically more evidentiary than definitional in method claims.

1) “About 1 hour” sequencing

Your claims require MEDI4736 is administered about 1 hour after tremelimumab.
This is a timing constraint that can be operationally altered in clinical protocols and label-driven administration workflows.
The phrase “about” matters in claim construction; still, for design-around, shifting to same-day same-time, a different fixed interval (e.g., 2–3 hours), or sequential next-day administration can reduce likelihood of meeting the “about 1 hour” window.

2) “Every 4 weeks for at most 16 weeks” cap

The q4w portion is limited to at most 16 weeks.
Many immunotherapy protocols have multi-month maintenance phases; any regimen that changes this early cap (e.g., extends q4w beyond week 16 without switching to the post-16 schedule) is a potential non-infringing alternative depending on the dependent claim strategy.

3) MEDI4736 mg/kg selection and post-16 transition

Claims define MEDI4736 at:
- 20 mg/kg (claim 1 track)
- 15 mg/kg (claim 25 track)
- 10 mg/kg (claim 13 track)
Dependent claims add post-16 MEDI4736 dosing at 10 mg/kg every two weeks.
Competitors that use a different maintenance dose (even if they use durvalumab class) may avoid dependent claim scope.

4) Population framing (refractory vs immunotherapy-naive)

The claims as written include dependent limitations for:
- NSCLC refractory to at least one chemotherapeutic agent (with a list of chemotherapeutics)
- immunotherapy-naive patients
These are “conditional” dependent claim limitations. Whether they are asserted affects enforcement probability. A regimen targeting only one population subset reduces claim coverage if the accused method does not satisfy the dependent limitation.

5) Tumor response thresholds

Claims include tumor size reduction by at least about 10%, 25%, or 50%.
These are outcome-based constraints in method claims. Proving them for an accused regimen can be evidentiary-heavy and may lead to litigation focusing on trial endpoints, imaging assessment methods, and timing of measurement.

What do claims cover regarding patient population, disease stage, and histology?

Featured snippet answer: Coverage includes NSCLC broadly, with dependent claim options specifying locally advanced unresectable or metastatic disease and squamous versus non-squamous histology, plus optional dependent limitations for refractory or immunotherapy-naive status.

Disease status

Claim 11/23/35: locally advanced unresectable or metastatic NSCLC
Claim 12/24/36: squamous or non-squamous

Prior therapy status

Claim 4/16/28: refractory to at least one chemotherapeutic agent prior to MEDI4736 + tremelimumab
Claim 6/18/30: immunotherapy-naive prior to MEDI4736 + tremelimumab

Chemotherapeutic agents listed

In your provided dependent claims, the refractory list includes:

Vemurafenib
Erlotinib
Afatinib
Cetuximab
Carboplatin
Bevacizumab
Gefitinib
Pemetrexed

Enforcement effect: If an accused regimen uses tremelimumab + durvalumab but the patient population is not refractory to at least one listed agent (as opposed to different prior therapies), that dependent coverage may not be triggered.

What patents cover MEDI4736 plus tremelimumab combinations in NSCLC beyond US 10,232,040?

Executive constraint: A complete “patent landscape” mapping requires the full US application bibliographic data and the full family set for US 10,232,040, then correlating to other relevant families (e.g., MEDI4736/durvalumab combination dosing, CTLA-4 combination schedules, and regimen sequencing patents) and to the Orange Book or relevant FDA biologics listings. The prompt provides only the claim text and not the patent’s publication/application number, assignee, priority dates, or related family identifiers. Without that, an accurate cross-patent landscape cannot be produced.

Accordingly, no landscape chart of other specific US patents can be asserted here.

How strong is the patent estate for regimen-specific protection (timing, dose, and duration)?

Featured snippet answer: Strength is tied to whether competitors replicate the exact combination dosing “recipe.” The estate is strong for enforcement against methods that use the same MEDI4736 mg/kg, the same tremelimumab dose, the same “about 1 hour” sequencing, and the same q4w-for-maximum-16-weeks structure. Its vulnerability is highest where competitors alter timing, switch dose or schedule before the claimed transition point, or avoid the dependent claim dose transition.

Strength drivers

Specific mg/kg dosing and fixed tremelimumab dose (1 mg/kg)
Sequencing requirement (about 1 hour)
Defined early schedule cap (q4w for at most 16 weeks)
Defined optional continuation schedule (q2w post-16 with MEDI4736 at 10 mg/kg) in dependent claims
Inclusion of clinical framing that may align to specific trial protocols (unresectable/metastatic NSCLC; refractory/immunotherapy-naive)

Primary weak points

Sequencing flexibility: competitors can adjust administration intervals and avoid “about 1 hour.”
Schedule flexibility: extending or altering the q4w period beyond the “at most 16 weeks” cap can exit claim scope.
Dose flexibility: using other durvalumab dosing regimens (even within the same drug class) may avoid the mg/kg constraints.
Outcome thresholds (tumor shrinkage): if asserted, they may increase evidentiary burden.

How does the MEDI4736 plus tremelimumab regimen compare to common immune-oncology dosing approaches?

From a patent scope standpoint, the differentiators are unusually tight:

“About 1 hour” sequencing is uncommon as a drafted limitation in broad combination therapy patents.
The “q4w for at most 16 weeks” plus a specific “post-16” step creates a regimen architecture that can be engineered around.
The dose transition for MEDI4736 to 10 mg/kg q2w after 16 weeks is a second engineering lever.

Key business implication: even if the competitor uses the same two molecules in NSCLC, a protocol that changes sequencing or duration windows may reduce infringement risk more than a protocol that merely changes route.

What generic entry risks exist for US 10,232,040?

Featured snippet answer: No “generic entry” risk exists in the conventional small-molecule sense because MEDI4736/durvalumab and tremelimumab are antibodies. The operative competitive risk is not generic substitution. It is the ability of biosimilar developers or competing biologic regimens to use a different dosing/sequence schedule and exit claim limitations.

Where biosimilar developers can mitigate risk

Avoid matching the “about 1 hour” sequencing
Avoid matching the q4w cap “for at most 16 weeks”
Avoid matching the specific MEDI4736 mg/kg (20/15/10) and the post-16 transition dose (10 mg/kg q2w)
Target patient subsets that do not satisfy dependent refractory or immunotherapy-naive limitations (if those dependent claims are asserted)

What FDA regulatory status is most relevant to this patent claim set?

Executive constraint: The prompt does not provide the assignee, application, or publication linkage required to map US 10,232,040 to specific FDA approvals, labeling regimens, or the biologics license application (BLA) milestones. Without that, a correct Orange Book/Biologics License Application regulatory status summary cannot be produced.

No FDA pathway mapping is provided.

What patent litigation affects US 10,232,040?

Executive constraint: The prompt does not provide the patent’s assignee, case caption, court, or any litigation identifier. Without those, listing litigation and settlement terms would risk inaccuracy.

No litigation summary is provided.

What are the key claim-by-claim takeaways for freedom-to-operate analysis?

A. Independent claim anchor (claim 1)

A method infringes most directly when it matches:

MEDI4736 20 mg/kg + tremelimumab 1 mg/kg
MEDI4736 about 1 hour after tremelimumab
Both administered every 4 weeks for at most 16 weeks

B. Dependent escalation and duration (claims 2-3)

Potentially narrower add-ons:

After week 16: MEDI4736 10 mg/kg every 2 weeks
Total length of treatment 52 weeks

C. Alternate dose tracks

MEDI4736 at 10 mg/kg (claim 13) and 15 mg/kg (claim 25) preserve the same core sequencing and q4w for at most 16 weeks architecture.

D. Conditional patient framing

Dependent claims for refractory and immunotherapy-naive status may matter only if the accused population matches the limitation.

E. Outcome thresholds

Tumor size reduction percentages are additional constraints that can make enforcement proof-dependent.

Key Takeaways

US 10,232,040 is regimen-specific: it protects a MEDI4736 + tremelimumab NSCLC administration sequence with defined dose levels, a “about 1 hour” timing gap, and a capped q4w period of “at most 16 weeks.”
The strongest enforcement target is a protocol that copies the exact dosing recipe including the post-week-16 MEDI4736 transition to 10 mg/kg q2w (in the dependent claims that recite it).
The most practical design-around levers are administration timing and schedule architecture: deviating from the “about 1 hour” sequencing and/or changing the q4w cap and transition timing can move methods outside claim coverage even if both molecules are used.
Because the claims are method-of-treatment and antibody-based, “generic entry” is not the main risk. The competitive risk is competing biologic regimens using non-matching schedules and dosing levels.

FAQs

How can a clinical protocol avoid infringing a “MEDI4736 about 1 hour after tremelimumab” sequencing limitation?
What scheduling change most effectively avoids the “every 4 weeks for at most 16 weeks” limitation?
If an accused regimen uses durvalumab and tremelimumab at different MEDI4736 mg/kg doses, which US 10,232,040 claim tracks are most at risk?
Do dependent claim limitations for refractory prior chemotherapy vs immunotherapy-naive materially affect infringement risk in practice?
How do outcome-based tumor size reduction thresholds (≥10%, ≥25%, ≥50%) impact proof strategy in enforcement of method claims?

References (APA)

(No patent bibliographic or external source data was provided in the prompt for US 10,232,040 beyond the claim text.)

Title:	Anti-B7 H1 and anti-CTLA-4 antibodies for treating non-small cell lung cancer
Abstract:	Provided herein are methods of treating non-small cell lung cancers comprising administering an effective amount of MEDI4736 or an antigen-binding fragment thereof and tremelimumab or an antigen-binding fragment thereof.
Inventor(s):	Narwal; Rajesh (Gaithersburg, MD), Robbins; Paul (Gaithersburg, MD), Karakunnel; Joyson (Gaithersburg, MD), Dar; Mohammed (Gaithersburg, MD)
Assignee:	MEDIMMUNE, LLC (Gaithersburg, MD)
Application Number:	14/710,101
Patent Claims:	see list of patent claims
Patent landscape, scope, and claims summary:	Executive summary: US Patent 10,232,040 is a US method-of-treatment patent aimed at a specific dosing regimen combining MEDI4736 (durvalumab; an anti–PD-L1 antibody) with tremelimumab (an anti–CTLA-4 antibody) for non-small cell lung cancer (NSCLC). The independent claim is constrained to: (i) MEDI4736 dose levels (20 mg/kg in claim 1; additional dose windows in dependent claims and other claim sets), (ii) tremelimumab dose (1 mg/kg), (iii) a defined sequencing gap (MEDI4736 administered about 1 hour after tremelimumab), and (iv) a capped early dosing period (every 4 weeks for at most 16 weeks) followed by an optional continuation schedule (every 2 weeks after week 16) with a stated maximum duration (52 weeks). The estate’s enforceability risk concentrates in sequencing, dose-precision, and whether accused regimens fall outside the claim’s temporal and titration windows. The closest practical “generic/biosimilar style” carve-outs are not route substitutions or indication broadeners, but deviations in administration timing (not “about 1 hour”), regimen length (beyond “at most 16 weeks” for the q4w portion), or MEDI4736 dose (10/15/20 mg/kg bands versus other durvalumab schedules). The competitive and regulatory history points to the same combination and class of regimen being clinically explored, but patent coverage is narrower than broad “combination therapy” claims because it is regimen-specific. United States Patent 10,232,040 claims and patent landscape for MEDI4736 (durvalumab) plus tremelimumab in NSCLC US 10,232,040 is a method-of-treatment patent focused on a particular dosing schedule and sequencing for MEDI4736 and tremelimumab in NSCLC. The claim set you provided contains three dosing “tracks” (20/15/10 mg/kg MEDI4736, each paired with 1 mg/kg tremelimumab), with consistent sequencing (MEDI4736 about 1 hour after tremelimumab), consistent early interval (q4w for at most 16 weeks), and a consistent optional continuation (MEDI4736 q2w after week 16) with a maximum total duration of 52 weeks in certain dependent claims. Because the patent is regimen-limited, the landscape analysis is dominated by: (1) whether competitors use the same sequencing gap, (2) whether they replicate the “at most 16 weeks” q4w cap, (3) whether they use the same MEDI4736 mg/kg dose, and (4) whether they treat the same NSCLC clinical population framing (refractory or immunotherapy-naive; locally advanced unresectable or metastatic; squamous or non-squamous). What is the core treatment regimen protected by US 10,232,040? Featured snippet answer: The patent protects an NSCLC treatment method combining MEDI4736 (durvalumab) and tremelimumab with MEDI4736 given about 1 hour after tremelimumab, dosed at specific mg/kg levels, administered q4w for at most 16 weeks, with an optional step to q2w after week 16 (in certain claims), and (in certain dependent claims) a maximum total treatment length of 52 weeks. Claim 1 dosing and timing constraints From your provided claims, claim 1 is the relevant “independent” anchor: Indication: method of treating non-small cell lung carcinoma (NSCLC) in a human patient Doses: MEDI4736: 20 mg/kg Tremelimumab: 1 mg/kg Sequencing: MEDI4736 administered about 1 hour following tremelimumab Schedule: MEDI4736 + tremelimumab administered every 4 weeks for at most 16 weeks Additional parameters (as dependent claims): Refractory to at least one chemotherapeutic agent Immunotherapy-naive IV infusion route Tumor size reduction benchmarks (≥10%, ≥25%, ≥50%) Disease stage: locally advanced unresectable or metastatic; squamous or non-squamous Claim 2 continuation step After the initial q4w period ends (after 16 weeks), add: MEDI4736: 10 mg/kg every two weeks after 16 weeks Claim 3: Total treatment length: 52 weeks Parallel claim sets with 10 mg/kg and 15 mg/kg MEDI4736 Your claim text includes other sets that track the same regimen logic but with different MEDI4736 dose levels: Claim 13: 10 mg/kg MEDI4736 + 1 mg/kg tremelimumab, sequencing about 1 hour, q4w for at most 16 weeks Claim 14-15: adds MEDI4736 10 mg/kg q2w after 16 weeks; total 52 weeks Claim 25: 15 mg/kg MEDI4736 + 1 mg/kg tremelimumab, sequencing about 1 hour, q4w for at most 16 weeks Claim 26-27: adds MEDI4736 10 mg/kg q2w after 16 weeks; total 52 weeks Practical reading: these are not just “different dosages.” They represent distinct regimen “entry points” for infringement analysis. A competitor is less likely to land in the same claim scope if they (i) avoid the exact MEDI4736 mg/kg and/or (ii) change the transition dose after week 16 (claim 2/14/26 fix the post-week-16 MEDI4736 dose to 10 mg/kg). Which claim limitations are most infringement-sensitive (and easiest to design around)? Featured snippet answer: The most infringement-sensitive limitations are the regimen sequencing (“about 1 hour” between tremelimumab and MEDI4736), the early schedule cap (“every 4 weeks for at most 16 weeks”), and the specific MEDI4736 mg/kg dosing levels (20, 15, or 10 mg/kg depending on the claim track). Route and tumor-shrinkage endpoints are typically more evidentiary than definitional in method claims. 1) “About 1 hour” sequencing Your claims require MEDI4736 is administered about 1 hour after tremelimumab. This is a timing constraint that can be operationally altered in clinical protocols and label-driven administration workflows. The phrase “about” matters in claim construction; still, for design-around, shifting to same-day same-time, a different fixed interval (e.g., 2–3 hours), or sequential next-day administration can reduce likelihood of meeting the “about 1 hour” window. 2) “Every 4 weeks for at most 16 weeks” cap The q4w portion is limited to at most 16 weeks. Many immunotherapy protocols have multi-month maintenance phases; any regimen that changes this early cap (e.g., extends q4w beyond week 16 without switching to the post-16 schedule) is a potential non-infringing alternative depending on the dependent claim strategy. 3) MEDI4736 mg/kg selection and post-16 transition Claims define MEDI4736 at: 20 mg/kg (claim 1 track) 15 mg/kg (claim 25 track) 10 mg/kg (claim 13 track) Dependent claims add post-16 MEDI4736 dosing at 10 mg/kg every two weeks. Competitors that use a different maintenance dose (even if they use durvalumab class) may avoid dependent claim scope. 4) Population framing (refractory vs immunotherapy-naive) The claims as written include dependent limitations for: NSCLC refractory to at least one chemotherapeutic agent (with a list of chemotherapeutics) immunotherapy-naive patients These are “conditional” dependent claim limitations. Whether they are asserted affects enforcement probability. A regimen targeting only one population subset reduces claim coverage if the accused method does not satisfy the dependent limitation. 5) Tumor response thresholds Claims include tumor size reduction by at least about 10%, 25%, or 50%. These are outcome-based constraints in method claims. Proving them for an accused regimen can be evidentiary-heavy and may lead to litigation focusing on trial endpoints, imaging assessment methods, and timing of measurement. What do claims cover regarding patient population, disease stage, and histology? Featured snippet answer: Coverage includes NSCLC broadly, with dependent claim options specifying locally advanced unresectable or metastatic disease and squamous versus non-squamous histology, plus optional dependent limitations for refractory or immunotherapy-naive status. Disease status Claim 11/23/35: locally advanced unresectable or metastatic NSCLC Claim 12/24/36: squamous or non-squamous Prior therapy status Claim 4/16/28: refractory to at least one chemotherapeutic agent prior to MEDI4736 + tremelimumab Claim 6/18/30: immunotherapy-naive prior to MEDI4736 + tremelimumab Chemotherapeutic agents listed In your provided dependent claims, the refractory list includes: Vemurafenib Erlotinib Afatinib Cetuximab Carboplatin Bevacizumab Gefitinib Pemetrexed Enforcement effect: If an accused regimen uses tremelimumab + durvalumab but the patient population is not refractory to at least one listed agent (as opposed to different prior therapies), that dependent coverage may not be triggered. What patents cover MEDI4736 plus tremelimumab combinations in NSCLC beyond US 10,232,040? Executive constraint: A complete “patent landscape” mapping requires the full US application bibliographic data and the full family set for US 10,232,040, then correlating to other relevant families (e.g., MEDI4736/durvalumab combination dosing, CTLA-4 combination schedules, and regimen sequencing patents) and to the Orange Book or relevant FDA biologics listings. The prompt provides only the claim text and not the patent’s publication/application number, assignee, priority dates, or related family identifiers. Without that, an accurate cross-patent landscape cannot be produced. Accordingly, no landscape chart of other specific US patents can be asserted here. How strong is the patent estate for regimen-specific protection (timing, dose, and duration)? Featured snippet answer: Strength is tied to whether competitors replicate the exact combination dosing “recipe.” The estate is strong for enforcement against methods that use the same MEDI4736 mg/kg, the same tremelimumab dose, the same “about 1 hour” sequencing, and the same q4w-for-maximum-16-weeks structure. Its vulnerability is highest where competitors alter timing, switch dose or schedule before the claimed transition point, or avoid the dependent claim dose transition. Strength drivers Specific mg/kg dosing and fixed tremelimumab dose (1 mg/kg) Sequencing requirement (about 1 hour) Defined early schedule cap (q4w for at most 16 weeks) Defined optional continuation schedule (q2w post-16 with MEDI4736 at 10 mg/kg) in dependent claims Inclusion of clinical framing that may align to specific trial protocols (unresectable/metastatic NSCLC; refractory/immunotherapy-naive) Primary weak points Sequencing flexibility: competitors can adjust administration intervals and avoid “about 1 hour.” Schedule flexibility: extending or altering the q4w period beyond the “at most 16 weeks” cap can exit claim scope. Dose flexibility: using other durvalumab dosing regimens (even within the same drug class) may avoid the mg/kg constraints. Outcome thresholds (tumor shrinkage): if asserted, they may increase evidentiary burden. How does the MEDI4736 plus tremelimumab regimen compare to common immune-oncology dosing approaches? From a patent scope standpoint, the differentiators are unusually tight: “About 1 hour” sequencing is uncommon as a drafted limitation in broad combination therapy patents. The “q4w for at most 16 weeks” plus a specific “post-16” step creates a regimen architecture that can be engineered around. The dose transition for MEDI4736 to 10 mg/kg q2w after 16 weeks is a second engineering lever. Key business implication: even if the competitor uses the same two molecules in NSCLC, a protocol that changes sequencing or duration windows may reduce infringement risk more than a protocol that merely changes route. What generic entry risks exist for US 10,232,040? Featured snippet answer: No “generic entry” risk exists in the conventional small-molecule sense because MEDI4736/durvalumab and tremelimumab are antibodies. The operative competitive risk is not generic substitution. It is the ability of biosimilar developers or competing biologic regimens to use a different dosing/sequence schedule and exit claim limitations. Where biosimilar developers can mitigate risk Avoid matching the “about 1 hour” sequencing Avoid matching the q4w cap “for at most 16 weeks” Avoid matching the specific MEDI4736 mg/kg (20/15/10) and the post-16 transition dose (10 mg/kg q2w) Target patient subsets that do not satisfy dependent refractory or immunotherapy-naive limitations (if those dependent claims are asserted) What FDA regulatory status is most relevant to this patent claim set? Executive constraint: The prompt does not provide the assignee, application, or publication linkage required to map US 10,232,040 to specific FDA approvals, labeling regimens, or the biologics license application (BLA) milestones. Without that, a correct Orange Book/Biologics License Application regulatory status summary cannot be produced. No FDA pathway mapping is provided. What patent litigation affects US 10,232,040? Executive constraint: The prompt does not provide the patent’s assignee, case caption, court, or any litigation identifier. Without those, listing litigation and settlement terms would risk inaccuracy. No litigation summary is provided. What are the key claim-by-claim takeaways for freedom-to-operate analysis? A. Independent claim anchor (claim 1) A method infringes most directly when it matches: MEDI4736 20 mg/kg + tremelimumab 1 mg/kg MEDI4736 about 1 hour after tremelimumab Both administered every 4 weeks for at most 16 weeks B. Dependent escalation and duration (claims 2-3) Potentially narrower add-ons: After week 16: MEDI4736 10 mg/kg every 2 weeks Total length of treatment 52 weeks C. Alternate dose tracks MEDI4736 at 10 mg/kg (claim 13) and 15 mg/kg (claim 25) preserve the same core sequencing and q4w for at most 16 weeks architecture. D. Conditional patient framing Dependent claims for refractory and immunotherapy-naive status may matter only if the accused population matches the limitation. E. Outcome thresholds Tumor size reduction percentages are additional constraints that can make enforcement proof-dependent. Key Takeaways US 10,232,040 is regimen-specific: it protects a MEDI4736 + tremelimumab NSCLC administration sequence with defined dose levels, a “about 1 hour” timing gap, and a capped q4w period of “at most 16 weeks.” The strongest enforcement target is a protocol that copies the exact dosing recipe including the post-week-16 MEDI4736 transition to 10 mg/kg q2w (in the dependent claims that recite it). The most practical design-around levers are administration timing and schedule architecture: deviating from the “about 1 hour” sequencing and/or changing the q4w cap and transition timing can move methods outside claim coverage even if both molecules are used. Because the claims are method-of-treatment and antibody-based, “generic entry” is not the main risk. The competitive risk is competing biologic regimens using non-matching schedules and dosing levels. FAQs How can a clinical protocol avoid infringing a “MEDI4736 about 1 hour after tremelimumab” sequencing limitation? What scheduling change most effectively avoids the “every 4 weeks for at most 16 weeks” limitation? If an accused regimen uses durvalumab and tremelimumab at different MEDI4736 mg/kg doses, which US 10,232,040 claim tracks are most at risk? Do dependent claim limitations for refractory prior chemotherapy vs immunotherapy-naive materially affect infringement risk in practice? How do outcome-based tumor size reduction thresholds (≥10%, ≥25%, ≥50%) impact proof strategy in enforcement of method claims? References (APA) (No patent bibliographic or external source data was provided in the prompt for US 10,232,040 beyond the claim text.) More… ↓ ⤷ Start Trial

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>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

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World Intellectual Property Organization (WIPO)	2016030455	⤷ Start Trial
World Intellectual Property Organization (WIPO)	2015173267	⤷ Start Trial
United States of America	2023115328	⤷ Start Trial
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>Country	>Patent Number	>Estimated Expiration

Patent: 10,232,040

Summary for Patent: 10,232,040