US Patent 11,622,991 (Voclosporin for Lupus Nephritis): Claim Scope, Degree of Coverage, and US Patent Landscape

US Patent 11,622,991 is a method-of-treatment patent for lupus nephritis (LN) using voclosporin in combination with mycophenolate mofetil (MMF) and corticosteroids, with dose initiation at 23.7 mg BID and response-guided down-titration based on % eGFR decline to a reduced voclosporin dose (15.8 mg BID or 7.9 mg BID). The core novelty is not voclosporin alone or MMF alone, but the specific renal-function monitoring trigger and the target eGFR threshold (<60 mL/min/1.73 m²) for dose reduction, plus optional branches tied to duration and corticosteroid taper to ≤2.5 mg/day by week 16.

What is US Patent 11,622,991 and what are its independent claim elements?

Executive answer: The patent claims a clinical algorithm: start voclosporin 23.7 mg BID + MMF + corticosteroids, measure eGFR at baseline and at a second time point, then reduce voclosporin to 15.8 mg BID or 7.9 mg BID only if eGFR decreases by >20% to <30% below baseline and falls to <60. Dependent claims add duration minima, steroid taper, isomer composition, UPCR thresholds, and alternate continuing-dose logic.

Independent claim structure (as provided for claim 1 and claim 14)

Claim 1: baseline renal trigger with conditional down-titration

Select an LN subject:
- Determine eGFR at first time point prior to starting therapy.
Administer combination:
- Voclosporin starting 23.7 mg PO BID
- MMF
- Corticosteroids
Assess eGFR at a second time point after initiating therapy.
Down-titrate voclosporin if criteria met:
- eGFR decrease is >20% to <30% below baseline
- and eGFR becomes to below 60 mL/min/1.73 m²
- then administer reduced dose 15.8 mg BID or 7.9 mg BID.

Claim 14: adds proteinuria performance condition (UPCR <0.5 mg/mg)

Claim 14 is a variant of claim 1 that adds an extra constraint tied to the dosing outcome:

Down-titration criteria still include the eGFR % decline and the <60 threshold
but it additionally requires that administering step d achieves:
- UPCR <0.5 mg/mg

Key claim elements that drive infringement risk

Patient selection is algorithmic and numeric: baseline eGFR must be determined, and other dependent claims specify inclusion thresholds (eg, eGFR ≥45).
The starting dose is numeric and constrained: 23.7 mg BID.
The monitoring trigger is tightly bounded:
- eGFR decline must fall within (20%, 30%) (exclusive bounds as written)
The absolute floor is hard:
- eGFR must drop to below 60
The remedy is numeric:
- voclosporin down-titrated to 15.8 mg BID or 7.9 mg BID
Dependent claim branches add performance and regimen constraints:
- duration of continued dosing
- corticosteroid taper by week 16
- isomer composition of voclosporin
- UPCR-based selection and/or outcome

How broad is the scope: what clinical actions does the claim actually cover?

Executive answer: The patent covers prescribing and administering a specific voclosporin regimen with response-guided dose reduction driven by eGFR decline between 20% and 30% to below 60, in combination with MMF and corticosteroids. It does not merely cover voclosporin dosage forms or manufacturing.

Direct method-of-use coverage

Claim scope is tied to:

selection of LN patients using measured eGFR,
dosing with voclosporin 23.7 mg BID plus MMF + corticosteroids,
and administering a reduced voclosporin dose based on a defined renal response window.

This is a classic “treating clinician” infringement model: the claim is practiced when the algorithm is followed for a treated subject.

What is not required (based on your provided claim set)

From the text you supplied, the claims do not require:

a particular LN class (I–VI) or biopsy grade,
a particular MMF dosing regimen,
a particular corticosteroid start dose other than in dependent claims restricting taper by week 16,
a specified time duration between first and second time points (other than dependent claims for minimum overall continued dosing after start).

Isomer composition limits: narrower carve-in

Dependent claim 4/19:

voclosporin is a mixture of:
- ≥90% E isomer
- ≤10% Z isomer This narrows coverage to products meeting that composition feature, assuming the formulation marketed by generic entrants differs.

What exact eGFR trigger defines infringement and how do the bound ranges change coverage?

Executive answer: The central trigger is a two-part renal condition:

Relative decline: >20% to <30% from baseline
Absolute status: to <60 mL/min/1.73 m²

If a competitor’s regimen triggers dose reduction outside that band, the claim is not literally met.

Claim 13 adds an alternate continuation condition

Claim 13: continue 23.7 mg BID if:

eGFR decreases by ≤20% below baseline

That creates a second monitored decision branch and can expand the “practice” covered even where dose is not reduced.

Claim 12 adds a third time point logic

Claim 12:

assesses eGFR at a third time point
and if between first and third points eGFR declines in the same >20% to <30% band to below 60, then dose reduction applies

This matters for design-around: a protocol that uses different timepoints could evade depending on how “second” and “third” timepoints map to practice.

Which dependent claims most affect exclusivity: dose, UPCR, steroids, and duration

Dose reduction alternatives

Claim 3: reduced dose is 15.8 mg BID
Claim 15/27: reduced dose is 7.9 mg BID

If a generic or competitor down-titration uses only one reduced dose, coverage may still occur if that dose is among claimed options.

Corticosteroid taper requirement

Claim 2/17/21: corticosteroids dose is not more than 2.5 mg/day by week 16
plus minimum continued dosing durations (see below)

This makes the claim sensitive to steroid-sparing protocols. If a treating physician tapers steroids differently, literal infringement of that dependent claim may not occur, but claim 1 could still be asserted.

Minimum duration constraints

Claim 6/21: at least 16 weeks Claim 7/22: at least 24 weeks Claim 8/23: at least 48 weeks Claim 9/24: at least 52 weeks Claim 17: explicit tie to week 16 steroid limit.

These duration-dependent claims can be used to assert infringement against protocols that keep patients on the algorithm longer.

UPCR thresholds: selection and outcome performance

Claim 10/25 (selection): select LN subject with UPCR ≥1.5 mg/mg
Claim 14 (outcome): administering step d achieves UPCR <0.5 mg/mg

These are dual-purpose constraints:

they can limit patient class and
they can be leveraged to argue that generic/competitor regimens that do not achieve this proteinuria outcome are not practicing the claim.

What formulation and composition constraints exist inside the claim set?

Executive answer: The only explicit formulation-composition constraint provided is the E/Z isomer ratio for voclosporin.

Voclosporin isomer composition (Claim 4/19)

≥90% E isomer
≤10% Z isomer

For a generic, the risk is whether the generic’s active pharmaceutical ingredient and/or drug product achieves that same isomer composition. In litigation, this becomes a technical proof issue: isomer composition can vary by synthetic process and purification.

How strong is the “patent estate” posture for this algorithmic voclosporin regimen?

Executive answer: Based solely on your provided claim text, the patent’s strength comes from tight numeric ranges and multiple decision gates that can be used as “need-to-hit-all-elements” arguments. But those same tight boundaries also provide clearer paths for clinical design-around if dosing algorithms are changed.

Strength vectors

High specificity: starting dose, down-titration doses, eGFR window, absolute threshold, and (in some dependents) UPCR and steroid taper.
Multiple dependent “layers”:
- patient selection (eGFR/UPCR),
- monitoring logic (second/third timepoints),
- dosing outcome (UPCR <0.5),
- maintenance duration,
- steroid taper,
- isomer composition.

Each layer gives litigators multiple footholds.

Weakness vectors for enforcement

Algorithmic exclusivity is narrow. If a competing regimen deviates on:
- eGFR threshold bounds,
- absolute cutoff (<60),
- timepoint scheduling,
- steroid taper,
- UPCR objectives,
- or uses a different starting dose, literal claim coverage can fail.

Which generic entry risks exist for voclosporin LN dosing protocols that differ from this eGFR algorithm?

Executive answer: Generic “risk” is tied less to capsule/tablet equivalence and more to whether prescribers follow the claimed monitoring and dose-adjustment algorithm for the same patient phenotype and outcomes.

Likely design-around paths

Modify the dosing trigger to:
- act at eGFR decline thresholds outside (20%, 30%),
- or remove the absolute <60 step,
- or adjust timing so that the relevant monitoring does not match “second” or “third” timepoints as claimed.
Change concomitant regimen such that:
- corticosteroid taper does not meet ≤2.5 mg/day by week 16 (dependent coverage).
Use different UPCR selection/outcome targets such that the claim 14 outcome condition UPCR <0.5 is not achieved as a required step.

Counterpoint: claim 1 without UPCR outcome

Even if competitors avoid claim 14, claim 1 can still be asserted if they follow the eGFR trigger and dose modifications in the same way, with MMF and corticosteroids.

What patent expiration and exclusivity timeline issues matter for 11,622,991?

Executive answer: Without the application priority data, prosecution history, and prosecution-to-grant details (none provided in your prompt), the calendar expiration cannot be computed reliably, and exclusivity tethering (for example to an NDA/BLA exclusivity block) cannot be established from claim text alone.

(Per instruction constraints, no expiration dates are produced.)

What is the Orange Book status of voclosporin for lupus nephritis under this patent?

Executive answer: Orange Book status depends on the specific FDA application (NDA) and the listing mapping for 11,622,991. Your prompt provides only the claim language and does not identify the NDA/BLA number or the Orange Book listing record.

(Per instruction constraints, no Orange Book assertions are produced.)

How does this algorithm compare with other LN patent patterns (method-of-use vs composition)?

Executive answer: US 11,622,991 is a method-of-use algorithm. Many LN intellectual property portfolios include:

compound/polymorph/process patents (earlier),
formulation patents (dose form and stability),
and clinical regimen patents (dosing, tapering, monitoring thresholds).

This patent sits in the third category, with numerically bounded clinical triggers that are well-suited to enforcement where competitors market a regimen that induces the same decision-making.

Key Takeaways

Core claim coverage: a clinician-directed algorithm using voclosporin 23.7 mg BID + MMF + corticosteroids, with eGFR monitoring and down-titration to 15.8 mg BID or 7.9 mg BID only when eGFR declines >20% to <30% and drops below 60 mL/min/1.73 m².
Additional coverage gates:
- steroid taper: ≤2.5 mg/day by week 16 (dependent claims),
- duration: ≥16, 24, 48, or 52 weeks depending on which dependent claim is invoked,
- UPCR: selection UPCR ≥1.5 mg/mg and (in claim 14) outcome UPCR <0.5 mg/mg.
Composition constraint exists via E/Z isomer ratio (≥90% E, ≤10% Z), narrowing potential coverage depending on the generic’s active ingredient composition.
Design-around is plausible because the claim is tightly bounded to specific numeric windows and monitoring logic; non-matching dosing triggers and outcome targets can avoid literal infringement.

FAQs

If a clinician follows voclosporin 23.7 mg BID but reduces dose at exactly 20% eGFR decline, does that meet the claim?
The claim’s range is >20% to <30%, so an exactly 20% threshold does not fall within the written bounds.
Does claim 14 require UPCR <0.5 mg/mg as an outcome of the reduced-dose step?
Yes. Claim 14 explicitly includes an outcome condition tied to administering step d achieving UPCR <0.5 mg/mg.
Can infringement occur without meeting the corticosteroid taper requirement?
Yes for claim 1, because the ≤2.5 mg/day by week 16 limit appears in dependent claims (eg, claim 2/17/21), not in the independent claim 1 as provided.
Does changing the voclosporin starting dose avoid infringement?
The independent claim as provided requires a starting dose of 23.7 mg BID, so changing the start dose can avoid literal coverage.
Is isomer composition relevant only to one dependent claim or the whole patent?
In the provided claim set, the E/Z isomer ratio is specified in dependent claims (eg, claim 4 and claim 19), so it is a relevant constraint when those dependents are asserted.

References

US Patent 11,622,991 (claims as provided in prompt).

Title:	Protocol for treatment of lupus nephritis
Abstract:	By employing a pharmacodynamic dosing regimen, the effectiveness of a protocol for treatment of a proteinuric kidney disease with voclosporin can be maximized while minimizing undesirable side effects.
Inventor(s):	Neil SOLOMONS, Robert B. HUIZINGA
Assignee:	Aurinia Pharmaceuticals Inc
Application Number:	US17/713,140
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,622,991
Patent Claim Types: see list of patent claims	Use; Delivery;
Patent landscape, scope, and claims:	US Patent 11,622,991 (Voclosporin for Lupus Nephritis): Claim Scope, Degree of Coverage, and US Patent Landscape US Patent 11,622,991 is a method-of-treatment patent for lupus nephritis (LN) using voclosporin in combination with mycophenolate mofetil (MMF) and corticosteroids, with dose initiation at 23.7 mg BID and response-guided down-titration based on % eGFR decline to a reduced voclosporin dose (15.8 mg BID or 7.9 mg BID). The core novelty is not voclosporin alone or MMF alone, but the specific renal-function monitoring trigger and the target eGFR threshold (<60 mL/min/1.73 m²) for dose reduction, plus optional branches tied to duration and corticosteroid taper to ≤2.5 mg/day by week 16. What is US Patent 11,622,991 and what are its independent claim elements? Executive answer: The patent claims a clinical algorithm: start voclosporin 23.7 mg BID + MMF + corticosteroids, measure eGFR at baseline and at a second time point, then reduce voclosporin to 15.8 mg BID or 7.9 mg BID only if eGFR decreases by >20% to <30% below baseline and falls to <60. Dependent claims add duration minima, steroid taper, isomer composition, UPCR thresholds, and alternate continuing-dose logic. Independent claim structure (as provided for claim 1 and claim 14) Claim 1: baseline renal trigger with conditional down-titration Select an LN subject: Determine eGFR at first time point prior to starting therapy. Administer combination: Voclosporin starting 23.7 mg PO BID MMF Corticosteroids Assess eGFR at a second time point after initiating therapy. Down-titrate voclosporin if criteria met: eGFR decrease is >20% to <30% below baseline and eGFR becomes to below 60 mL/min/1.73 m² then administer reduced dose 15.8 mg BID or 7.9 mg BID. Claim 14: adds proteinuria performance condition (UPCR <0.5 mg/mg) Claim 14 is a variant of claim 1 that adds an extra constraint tied to the dosing outcome: Down-titration criteria still include the eGFR % decline and the <60 threshold but it additionally requires that administering step d achieves: UPCR <0.5 mg/mg Key claim elements that drive infringement risk Patient selection is algorithmic and numeric: baseline eGFR must be determined, and other dependent claims specify inclusion thresholds (eg, eGFR ≥45). The starting dose is numeric and constrained: 23.7 mg BID. The monitoring trigger is tightly bounded: eGFR decline must fall within (20%, 30%) (exclusive bounds as written) The absolute floor is hard: eGFR must drop to below 60 The remedy is numeric: voclosporin down-titrated to 15.8 mg BID or 7.9 mg BID Dependent claim branches add performance and regimen constraints: duration of continued dosing corticosteroid taper by week 16 isomer composition of voclosporin UPCR-based selection and/or outcome How broad is the scope: what clinical actions does the claim actually cover? Executive answer: The patent covers prescribing and administering a specific voclosporin regimen with response-guided dose reduction driven by eGFR decline between 20% and 30% to below 60, in combination with MMF and corticosteroids. It does not merely cover voclosporin dosage forms or manufacturing. Direct method-of-use coverage Claim scope is tied to: selection of LN patients using measured eGFR, dosing with voclosporin 23.7 mg BID plus MMF + corticosteroids, and administering a reduced voclosporin dose based on a defined renal response window. This is a classic “treating clinician” infringement model: the claim is practiced when the algorithm is followed for a treated subject. What is not required (based on your provided claim set) From the text you supplied, the claims do not require: a particular LN class (I–VI) or biopsy grade, a particular MMF dosing regimen, a particular corticosteroid start dose other than in dependent claims restricting taper by week 16, a specified time duration between first and second time points (other than dependent claims for minimum overall continued dosing after start). Isomer composition limits: narrower carve-in Dependent claim 4/19: voclosporin is a mixture of: ≥90% E isomer ≤10% Z isomer This narrows coverage to products meeting that composition feature, assuming the formulation marketed by generic entrants differs. What exact eGFR trigger defines infringement and how do the bound ranges change coverage? Executive answer: The central trigger is a two-part renal condition: Relative decline: >20% to <30% from baseline Absolute status: to <60 mL/min/1.73 m² If a competitor’s regimen triggers dose reduction outside that band, the claim is not literally met. Claim 13 adds an alternate continuation condition Claim 13: continue 23.7 mg BID if: eGFR decreases by ≤20% below baseline That creates a second monitored decision branch and can expand the “practice” covered even where dose is not reduced. Claim 12 adds a third time point logic Claim 12: assesses eGFR at a third time point and if between first and third points eGFR declines in the same >20% to <30% band to below 60, then dose reduction applies This matters for design-around: a protocol that uses different timepoints could evade depending on how “second” and “third” timepoints map to practice. Which dependent claims most affect exclusivity: dose, UPCR, steroids, and duration Dose reduction alternatives Claim 3: reduced dose is 15.8 mg BID Claim 15/27: reduced dose is 7.9 mg BID If a generic or competitor down-titration uses only one reduced dose, coverage may still occur if that dose is among claimed options. Corticosteroid taper requirement Claim 2/17/21: corticosteroids dose is not more than 2.5 mg/day by week 16 plus minimum continued dosing durations (see below) This makes the claim sensitive to steroid-sparing protocols. If a treating physician tapers steroids differently, literal infringement of that dependent claim may not occur, but claim 1 could still be asserted. Minimum duration constraints Claim 6/21: at least 16 weeks Claim 7/22: at least 24 weeks Claim 8/23: at least 48 weeks Claim 9/24: at least 52 weeks Claim 17: explicit tie to week 16 steroid limit. These duration-dependent claims can be used to assert infringement against protocols that keep patients on the algorithm longer. UPCR thresholds: selection and outcome performance Claim 10/25 (selection): select LN subject with UPCR ≥1.5 mg/mg Claim 14 (outcome): administering step d achieves UPCR <0.5 mg/mg These are dual-purpose constraints: they can limit patient class and they can be leveraged to argue that generic/competitor regimens that do not achieve this proteinuria outcome are not practicing the claim. What formulation and composition constraints exist inside the claim set? Executive answer: The only explicit formulation-composition constraint provided is the E/Z isomer ratio for voclosporin. Voclosporin isomer composition (Claim 4/19) ≥90% E isomer ≤10% Z isomer For a generic, the risk is whether the generic’s active pharmaceutical ingredient and/or drug product achieves that same isomer composition. In litigation, this becomes a technical proof issue: isomer composition can vary by synthetic process and purification. How strong is the “patent estate” posture for this algorithmic voclosporin regimen? Executive answer: Based solely on your provided claim text, the patent’s strength comes from tight numeric ranges and multiple decision gates that can be used as “need-to-hit-all-elements” arguments. But those same tight boundaries also provide clearer paths for clinical design-around if dosing algorithms are changed. Strength vectors High specificity: starting dose, down-titration doses, eGFR window, absolute threshold, and (in some dependents) UPCR and steroid taper. Multiple dependent “layers”: patient selection (eGFR/UPCR), monitoring logic (second/third timepoints), dosing outcome (UPCR <0.5), maintenance duration, steroid taper, isomer composition. Each layer gives litigators multiple footholds. Weakness vectors for enforcement Algorithmic exclusivity is narrow. If a competing regimen deviates on: eGFR threshold bounds, absolute cutoff (<60), timepoint scheduling, steroid taper, UPCR objectives, or uses a different starting dose, literal claim coverage can fail. Which generic entry risks exist for voclosporin LN dosing protocols that differ from this eGFR algorithm? Executive answer: Generic “risk” is tied less to capsule/tablet equivalence and more to whether prescribers follow the claimed monitoring and dose-adjustment algorithm for the same patient phenotype and outcomes. Likely design-around paths Modify the dosing trigger to: act at eGFR decline thresholds outside (20%, 30%), or remove the absolute <60 step, or adjust timing so that the relevant monitoring does not match “second” or “third” timepoints as claimed. Change concomitant regimen such that: corticosteroid taper does not meet ≤2.5 mg/day by week 16 (dependent coverage). Use different UPCR selection/outcome targets such that the claim 14 outcome condition UPCR <0.5 is not achieved as a required step. Counterpoint: claim 1 without UPCR outcome Even if competitors avoid claim 14, claim 1 can still be asserted if they follow the eGFR trigger and dose modifications in the same way, with MMF and corticosteroids. What patent expiration and exclusivity timeline issues matter for 11,622,991? Executive answer: Without the application priority data, prosecution history, and prosecution-to-grant details (none provided in your prompt), the calendar expiration cannot be computed reliably, and exclusivity tethering (for example to an NDA/BLA exclusivity block) cannot be established from claim text alone. (Per instruction constraints, no expiration dates are produced.) What is the Orange Book status of voclosporin for lupus nephritis under this patent? Executive answer: Orange Book status depends on the specific FDA application (NDA) and the listing mapping for 11,622,991. Your prompt provides only the claim language and does not identify the NDA/BLA number or the Orange Book listing record. (Per instruction constraints, no Orange Book assertions are produced.) How does this algorithm compare with other LN patent patterns (method-of-use vs composition)? Executive answer: US 11,622,991 is a method-of-use algorithm. Many LN intellectual property portfolios include: compound/polymorph/process patents (earlier), formulation patents (dose form and stability), and clinical regimen patents (dosing, tapering, monitoring thresholds). This patent sits in the third category, with numerically bounded clinical triggers that are well-suited to enforcement where competitors market a regimen that induces the same decision-making. Key Takeaways Core claim coverage: a clinician-directed algorithm using voclosporin 23.7 mg BID + MMF + corticosteroids, with eGFR monitoring and down-titration to 15.8 mg BID or 7.9 mg BID only when eGFR declines >20% to <30% and drops below 60 mL/min/1.73 m². Additional coverage gates: steroid taper: ≤2.5 mg/day by week 16 (dependent claims), duration: ≥16, 24, 48, or 52 weeks depending on which dependent claim is invoked, UPCR: selection UPCR ≥1.5 mg/mg and (in claim 14) outcome UPCR <0.5 mg/mg. Composition constraint exists via E/Z isomer ratio (≥90% E, ≤10% Z), narrowing potential coverage depending on the generic’s active ingredient composition. Design-around is plausible because the claim is tightly bounded to specific numeric windows and monitoring logic; non-matching dosing triggers and outcome targets can avoid literal infringement. FAQs If a clinician follows voclosporin 23.7 mg BID but reduces dose at exactly 20% eGFR decline, does that meet the claim? The claim’s range is >20% to <30%, so an exactly 20% threshold does not fall within the written bounds. Does claim 14 require UPCR <0.5 mg/mg as an outcome of the reduced-dose step? Yes. Claim 14 explicitly includes an outcome condition tied to administering step d achieving UPCR <0.5 mg/mg. Can infringement occur without meeting the corticosteroid taper requirement? Yes for claim 1, because the ≤2.5 mg/day by week 16 limit appears in dependent claims (eg, claim 2/17/21), not in the independent claim 1 as provided. Does changing the voclosporin starting dose avoid infringement? The independent claim as provided requires a starting dose of 23.7 mg BID, so changing the start dose can avoid literal coverage. Is isomer composition relevant only to one dependent claim or the whole patent? In the provided claim set, the E/Z isomer ratio is specified in dependent claims (eg, claim 4 and claim 19), so it is a relevant constraint when those dependents are asserted. References US Patent 11,622,991 (claims as provided in prompt). More… ↓ ⤷ Start Trial

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Aurinia	LUPKYNIS	voclosporin	CAPSULE;ORAL	213716-001	Jan 22, 2021		RX	Yes	Yes	11,622,991	⤷ Start Trial				TREATMENT OF PATIENTS WITH ACTIVE LUPUS NEPHRITIS	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Patented / Exclusive Use	>Submissiondate

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2018266850	⤷ Start Trial
Australia	2024202977	⤷ Start Trial
Brazil	112019023766	⤷ Start Trial
Canada	3063040	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 11,622,991

Which drugs does patent 11,622,991 protect, and when does it expire?

Summary for Patent: 11,622,991