United States Patent 10,286,036: Voclosporin Kidney-Disease Treatment Claims and Patent Landscape

U.S. Patent No. 10,286,036 protects a dose-management protocol for voclosporin treatment of proteinuric kidney disease. Its core limitation is not the use of voclosporin alone. The claim requires baseline and follow-up eGFR testing, an eGFR decline threshold, and a specified dose reduction, discontinuation, or continuation decision. The patent is particularly relevant to Lupkynis, the FDA-approved voclosporin product for adults with active lupus nephritis.

The principal commercial risk is an ANDA applicant seeking approval for a label that incorporates the patented eGFR-monitoring and dose-adjustment regimen. The patent does not create biologic exclusivity because voclosporin is a small-molecule drug. Generic applicants would use the ANDA pathway, with any Paragraph IV challenge potentially triggering patent litigation.

What does U.S. Patent 10,286,036 protect?

The patent protects a pharmacodynamic treatment method for a proteinuric kidney disease, including lupus nephritis, in which voclosporin dosing is controlled by renal-function monitoring.

Claim element	Scope of protection
Disease	Proteinuric kidney disease
Drug	Voclosporin
Treatment duration	At least 24 weeks; dependent claim 11 requires at least 48 weeks
Monitoring	eGFR at two different time points
Renal-function trigger	eGFR decline exceeding a selected target percentage and falling below a selected absolute value
Dose action	Reduce dose in 7.9 mg BID increments or stop treatment
Continuation action	Continue the same predetermined dose when the decline is below the selected target
Patient selection	UPCR greater than 1 mg/mg and eGFR greater than 45 ml/min/1.73 m² under claim 5
Combination therapy	MMF and corticosteroids under claims 9 and 10
Rechallenge	Resume the prior dose if renal function recovers under claim 12

The independent claim is a treatment-management claim. It requires the accused party to administer voclosporin and implement the renal-monitoring protocol. A product sold without instructions or conduct showing the claimed protocol may present a different infringement analysis from a product label that expressly directs the claimed steps.

How should the independent claim be read?

Claim 1 has five operative requirements.

First, the patient must have a proteinuric kidney disease and be diagnosed with that disease. Second, the patient must receive a predetermined daily dosage of voclosporin over a projected treatment period of at least 24 weeks. Third, eGFR must be assessed at two separate time points. Fourth, the clinician must compare the results against both a percentage-decline target and an absolute eGFR value. Fifth, the clinician must continue, reduce, or stop treatment based on that comparison.

The claim uses two separate thresholds:

A relative eGFR decline expressed as a percentage in the range of 20% to 45%.
An absolute eGFR value in the range of 50 to 90 ml/min/1.73 m².

The claim therefore requires more than an eGFR decline alone. The decline must exceed the selected percentage and result in an eGFR below the selected absolute value. Claim 3 narrows the absolute threshold to approximately 60 ml/min/1.73 m². Claim 4 narrows the percentage threshold to approximately 30%.

The continuation branch is also important. If the decline is less than the selected target percentage, the claim requires continuing the same predetermined dose. This language can create infringement questions where a label gives a broader clinical recommendation rather than expressly directing continuation at the same dose.

What do claims 2 through 13 add?

Baseline eGFR, threshold values, and patient selection

Claim 2 requires the first eGFR measurement to occur immediately before voclosporin administration. Claim 3 specifies an approximately 60 ml/min/1.73 m² absolute threshold. Claim 4 specifies an approximately 30% decline threshold.

Claim 5 adds a patient-identification step:

UPCR greater than 1 mg/mg, measured from first-morning void or 24-hour urine.
eGFR greater than 45 ml/min/1.73 m² using the CKD-EPI equation.

A generic label that is limited to the same patient population could more directly implicate claim 5. A broader label may still implicate claim 1 if its instructions direct the claimed monitoring and dose-management steps.

Voclosporin dose levels

Claim 6 identifies five dose levels:

Claimed dose	Dose frequency
39.5 mg	Twice daily
31.6 mg	Twice daily
23.7 mg	Twice daily
15.8 mg	Twice daily
7.9 mg	Twice daily

The 23.7 mg BID dose is the commercially important starting dose for Lupkynis. The 15.8 mg and 7.9 mg BID levels are particularly relevant to dose-reduction instructions. The claim language describes reductions by increments of 7.9 mg BID, which maps closely to the available dose strengths and FDA labeling structure.

Post-treatment monitoring and recovery

Claim 7 requires post-treatment renal-function evaluation using eGFR. Claim 8 adds post-treatment UPCR testing to assess maintenance of renal function.

Claims 12 and 13 cover a recovery-based resumption protocol. If eGFR at a third time point differs from the initial eGFR by less than the target percentage, the predetermined voclosporin dose may be resumed. Claim 13 fixes the target at approximately 30%.

These claims reach beyond the initial dose reduction. They cover a treatment sequence involving dose interruption or reduction, subsequent renal-function assessment, and resumption of treatment.

Combination treatment

Claims 9 and 10 cover voclosporin administered with MMF and a corticosteroid. That combination is commercially relevant because voclosporin is used with background immunosuppressive therapy in lupus nephritis. A label that directs voclosporin with MMF or corticosteroids could implicate these dependent claims if the remaining limitations are present.

How does the patent compare with the FDA Lupkynis regimen?

The FDA-approved Lupkynis regimen is clinically aligned with the patent’s subject matter. The FDA label establishes voclosporin dosing, renal-function monitoring, and dose modification based on eGFR changes. The label also requires monitoring at defined intervals and provides instructions for dose reduction or discontinuation when renal function declines.[1]

Issue	Patent 10,286,036	Lupkynis FDA labeling
Active ingredient	Voclosporin	Voclosporin
Primary disease	Proteinuric kidney disease	Active lupus nephritis
Standard starting dose	Includes 23.7 mg BID	23.7 mg BID
Renal monitoring	Required at separate treatment time points	Required during treatment
Dose modification	7.9 mg BID increments or discontinuation	Dose reduction, interruption, or discontinuation based on eGFR
Background therapy	MMF and corticosteroids in dependent claims	Used with background immunosuppressive therapy
Treatment duration	At least 24 or 48 weeks in relevant claims	Long-term treatment subject to clinical assessment

The overlap is strongest for a label that directs 23.7 mg BID dosing, eGFR monitoring, dose reduction at approximately 20% to 30% decline, and treatment with MMF and corticosteroids.

What is the Orange Book status of Patent 10,286,036?

Patent 10,286,036 has been associated with Lupkynis patent protection and is reported with an expiration date extending into 2037. The patent’s reported expiration date is March 17, 2037, subject to the applicable patent-term calculation, terminal disclaimers, and any patent-term adjustment or extension reflected in official records.[2][3]

The relevant exclusivity periods are different:

Protection type	Key date or period
FDA approval of Lupkynis	January 22, 2021
New chemical entity exclusivity	Generally five years from approval, subject to Paragraph IV timing rules
Patent 10,286,036	Reported expiration: March 17, 2037
Generic pathway	ANDA, not biosimilar
Patent challenge	Paragraph IV certification is the principal mechanism

FDA approval was based principally on the AURORA 1 study, which evaluated voclosporin in combination with background immunosuppression for lupus nephritis.[4] The patent estate and FDA exclusivity therefore operate on separate timelines. Loss of NCE exclusivity does not eliminate later-expiring patent protection.

How strong is the patent estate for voclosporin?

Patent 10,286,036 is strongest against a generic label that reproduces the patented renal-monitoring algorithm. Its strength comes from the combination of several clinically specific limitations:

Voclosporin administration.
A proteinuric kidney-disease indication.
eGFR testing at multiple time points.
A relative decline threshold.
An absolute eGFR threshold.
A mandated dose change or continuation decision.
Specific dose increments that correspond to commercial strengths.

The patent is narrower than a basic composition-of-matter patent. It does not prevent every use or sale of voclosporin. It targets the treatment protocol.

Claim-construction and validity pressure points

Potential legal pressure points include the following:

The meaning of “predetermined daily dosage.”
Whether “target %” and “predetermined value” require both conditions to be satisfied.
The meaning of “approximately” in claims 3, 4, and 13.
Whether the claim requires a clinician to make the dose decision or merely requires the treatment method to include that decision.
Whether the eGFR decline must be measured from a baseline immediately before treatment or may be measured between later treatment time points.
Whether the protocol is sufficiently definite and enabled across the full percentage and eGFR ranges.
Whether the patent claims a patent-eligible treatment method rather than an ineligible calculation or clinical decision rule.

The dependent claims are narrower but may be easier to prove when a product label expressly identifies the relevant dose, threshold, disease population, and background therapy.

What generic entry risks exist?

A generic applicant could pursue several launch strategies.

Generic strategy	Patent risk
Full-label ANDA for lupus nephritis	High risk if the label reproduces eGFR-based dose adjustments
Carved-out indication or restricted labeling	May reduce method-of-use exposure, but renal monitoring may remain necessary for safe use
Paragraph III certification	Defers approval until patent expiry
Paragraph IV certification	Can trigger litigation and a potential 30-month stay
Product launch after patent invalidity or non-infringement determination	Commercially significant but litigation-dependent

A skinny-label strategy may be difficult if eGFR monitoring and dose adjustment are necessary for safe administration rather than limited to the patented indication. Under the induced-infringement framework, label language, promotional conduct, and the clinical necessity of the claimed steps would be central issues.

Because voclosporin is a small molecule, biosimilar competition is not the relevant pathway. The principal threat is an ANDA generic containing voclosporin or an equivalent pharmaceutical form.

Which companies are challenging voclosporin patents?

The supplied record identifies no specific Paragraph IV challenger, ANDA applicant, settlement agreement, or pending infringement case directed to Patent 10,286,036. The public competitive field is therefore best analyzed as a future generic-entry risk rather than as an identified active challenger.

A Paragraph IV filing would likely focus on:

Lack of infringement based on a carved-out label.
Failure to meet the combined percentage and absolute eGFR limitations.
Invalidity based on obviousness, anticipation, written description, enablement, or indefiniteness.
The scope of “approximately 30%” and “approximately 60 ml/min/1.73 m².”
Whether the claimed protocol was adequately disclosed and enabled.

What licensing deals and ownership issues affect the patent?

Voclosporin originated with Isotechnika Pharmaceuticals, which later became associated with Aurinia Pharmaceuticals. Aurinia is the commercial sponsor of Lupkynis and the principal entity associated with the U.S. voclosporin franchise.[5]

The commercially relevant ownership issue is therefore continuity of rights from the original voclosporin development program to Aurinia’s marketed product and patent estate. No separate third-party license or settlement affecting Patent 10,286,036 is established in the cited record.

What geographic coverage does Patent 10,286,036 provide?

The patent provides protection only in the United States. Comparable protection in Canada, Europe, Japan, and other markets depends on separate national or regional patent rights and cannot be inferred solely from the U.S. patent.

The geographic position is:

Jurisdiction	Effect of U.S. Patent 10,286,036
United States	Direct protection for the claimed method
European Union	No direct effect; European or national counterpart required
Canada	No direct effect; Canadian patent required
Japan	No direct effect; Japanese patent required
Other markets	Must be assessed through local patent families

The patent is a method-of-treatment right. It does not independently establish manufacturing exclusivity outside the United States.

What manufacturing and formulation barriers remain?

Patent 10,286,036 does not principally claim a manufacturing process or a formulation. It protects clinical use and dose management. A generic manufacturer could face separate barriers involving:

Pharmaceutical composition patents.
Solid-state or polymorph claims.
Capsule or tablet formulation claims.
Process patents.
Impurity-control specifications.
Stability and dissolution requirements.
FDA bioequivalence and product-quality requirements.

These barriers must be analyzed separately from the treatment-method claims. A generic could avoid a formulation patent while still facing method-of-use exposure, or design around a method claim while confronting manufacturing or composition patents.

What litigation and settlement status affects the patent?

No litigation or settlement involving Patent 10,286,036 is identified in the supplied materials. The patent remains commercially relevant because an ANDA Paragraph IV filing could produce a Hatch-Waxman action. A timely suit by the patent owner could obtain a statutory 30-month stay of approval, subject to court rulings and statutory exceptions.[6]

The most material litigation issue would be whether the generic label instructs physicians to perform the patented eGFR assessment and dose-management sequence. A product-by-product analysis would be required because infringement can turn on the exact proposed label.

Key Takeaways

Patent 10,286,036 protects a voclosporin treatment protocol controlled by eGFR monitoring.
The core claim requires both a relative eGFR decline and an absolute eGFR threshold.
Claims 3, 4, 6, 9, 10, 12, and 13 narrow the patent to commercially relevant thresholds, doses, combination therapy, and recovery-based rechallenge.
The patent overlaps materially with the FDA Lupkynis dosing and renal-monitoring instructions.
The reported patent expiration date is March 17, 2037.
Generic, rather than biosimilar, competition is the relevant entry threat.
A Paragraph IV challenger would likely contest infringement, obviousness, enablement, definiteness, and the scope of the eGFR algorithm.
The patent does not by itself protect all voclosporin formulations or manufacturing processes.
No specific challenger, litigation, or settlement involving this patent is established in the cited record.

FAQs

Does Patent 10,286,036 cover all voclosporin use?

No. It covers a defined treatment method for proteinuric kidney disease with specified eGFR monitoring and dosing decisions.

Does a generic need to use the exact 23.7 mg BID dose to infringe?

No. Claim 1 is broader than claim 6 and covers a predetermined voclosporin dose subject to the claimed monitoring and adjustment protocol. Claim 6 specifically recites the listed dose levels.

Can a generic omit the lupus nephritis indication?

Possibly, but omitting the indication may not eliminate risk if the label still directs the claimed renal-monitoring and dose-adjustment steps for a covered proteinuric kidney disease.

Is voclosporin eligible for a biosimilar application?

No. Voclosporin is a small-molecule drug. A competing applicant would generally use the ANDA pathway rather than the biosimilar pathway.

Does patent expiration automatically permit generic launch?

No. Generic launch also depends on other Orange Book patents, regulatory approval, litigation outcomes, regulatory exclusivity, and any applicable settlement or court injunction.

References

U.S. Food and Drug Administration. (2024). Lupkynis (voclosporin) prescribing information. FDA.
U.S. Patent and Trademark Office. (2019). U.S. Patent No. 10,286,036, methods of treating proteinuric kidney disease. USPTO.
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. FDA.
Rovin, B. H., Teng, Y. K. O., Ginzler, E. M., et al. (2021). Efficacy and safety of voclosporin versus placebo for lupus nephritis. The Lancet, 397(10289), 2070-2080.
Aurinia Pharmaceuticals Inc. (2024). Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. Aurinia Pharmaceuticals.
U.S. Food and Drug Administration. (2024). Guidance for industry: 180-day exclusivity when multiple ANDA applicants submit substantially complete Paragraph IV certifications. FDA.

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	⤷ Start Trial	⤷ 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: 10,286,036

Which drugs does patent 10,286,036 protect, and when does it expire?

Summary for Patent: 10,286,036