DCT
2:25-cv-03986
Aurinia Pharma Inc v. Sandoz Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Aurinia Pharmaceuticals Inc. (Canada)
- Defendant: Sandoz Inc. (Delaware)
- Plaintiff’s Counsel: Gibbons P.C.; Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
- Case Identification: 2:25-cv-03986, D.N.J., 05/08/2025
- Venue Allegations: Plaintiff alleges venue is proper in the District of New Jersey because Defendant Sandoz maintains a regular and established place of business in the district and has committed acts of infringement there. The complaint further notes that Sandoz has previously been sued in the district without contesting venue.
- Core Dispute: Plaintiff alleges that Defendant’s filing of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiff’s LUPKYNIS® (voclosporin) drug product constitutes an act of infringement of two patents covering treatment protocols for lupus nephritis.
- Technical Context: The patents relate to personalized dosing regimens for voclosporin, an immunosuppressant used to treat lupus nephritis, a serious autoimmune kidney disease.
- Key Procedural History: This action was initiated under the Hatch-Waxman Act following a March 24, 2025 Notice Letter from Sandoz, which included a Paragraph IV certification asserting that the patents-in-suit are invalid, unenforceable, or will not be infringed by Sandoz's proposed generic product. The complaint was filed within the 45-day statutory window, triggering a potential 30-month stay of FDA approval for the generic.
Case Timeline
| Date | Event |
|---|---|
| 2017-05-12 | '036 & '991 Patent Priority Date |
| 2019-05-14 | U.S. Patent No. 10,286,036 Issues |
| 2021-01-22 | FDA Approves Aurinia's LUPKYNIS® (voclosporin) NDA |
| 2023-04-11 | U.S. Patent No. 11,622,991 Issues |
| 2025-03-24 | Sandoz Sends Paragraph IV Notice Letter to Aurinia |
| 2025-05-08 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 10,286,036 - "Protocol for the Treatment of Lupus Nephritis," issued May 14, 2019
The Invention Explained
- Problem Addressed: The patent describes that the standard of care for lupus nephritis (LN) has had limited success, with low rates of complete remission for patients (ʼ036 Patent, col. 2:37-43).
- The Patented Solution: The invention is a "pharmacodynamic" treatment protocol that adjusts the dosage of voclosporin based on an individual patient's response, specifically by monitoring their estimated Glomerular Filtration Rate (eGFR). If a patient's eGFR decreases by a certain percentage to below a specified threshold, the protocol calls for reducing or stopping the voclosporin dose to mitigate side effects while maintaining therapeutic benefit (ʼ036 Patent, Abstract; col. 3:1-20). The patent provides a graphical representation of the overall treatment regimen, including a "forced steroid taper" alongside the administration of voclosporin and mycophenolate mofetil (MMF) (ʼ036 Patent, Fig. 1).
- Technical Importance: This response-guided dosing strategy was designed to improve the safety and efficacy profile for treating a debilitating disease by personalizing the drug administration based on a key indicator of kidney function (ʼ036 Patent, col. 2:61-66).
Key Claims at a Glance
- The complaint asserts at least one claim (Compl. ¶33). Independent claim 1 is representative:
- A pharmacodynamic method to treat a proteinuric kidney disease comprising administering a predetermined daily dosage of voclosporin for at least 24 weeks.
- The method further comprises assessing the patient's eGFR at a first and second time point.
- If the eGFR decreases by more than a "target %" to below a "predetermined value," the daily dosage of voclosporin is reduced or stopped.
- If the eGFR decreases by less than the "target %," the same dosage is continued.
- The complaint does not explicitly reserve the right to assert dependent claims.
U.S. Patent No. 11,622,991 - "Protocol for Treatment of Lupus Nephritis," issued April 11, 2023
The Invention Explained
- Problem Addressed: Similar to its parent patent, the '991 Patent addresses the need for improved treatment protocols for LN, noting that even with advanced therapies, complete remission remains elusive for many patients (ʼ991 Patent, col. 2:41-47).
- The Patented Solution: The patent claims a more specific method for treating LN. The protocol involves selecting a patient based on initial eGFR, administering a specific starting dose of voclosporin (23.7 mg BID) with MMF and corticosteroids, and then monitoring the patient's eGFR. The core of the solution is a rule-based dose reduction to specific lower doses (15.8 mg or 7.9 mg BID) if the patient's eGFR drops within a defined range (>20% to <30%) to below a 60 ml/min/1.73 m² threshold (ʼ991 Patent, Abstract; col. 4:1-14). A chart illustrates the study design, including a primary endpoint at 24 weeks and a secondary endpoint at 48 weeks, showing different voclosporin dose arms against a placebo (ʼ991 Patent, Fig. 1).
- Technical Importance: The invention provides a more refined, data-driven set of rules for managing voclosporin therapy, aiming to achieve high remission rates, as shown in clinical trial results, while actively managing potential kidney-related side effects (ʼ991 Patent, col. 2:23-37; Fig. 2).
Key Claims at a Glance
- The complaint asserts at least one claim (Compl. ¶46). Independent claim 1 is representative:
- A method of treating LN by first selecting a patient based on a pre-treatment eGFR.
- Administering a starting dose of 23.7 mg voclosporin BID, along with MMF and corticosteroids.
- Assessing the patient's eGFR at a second time point.
- Administering a reduced dose of 15.8 mg or 7.9 mg BID if the eGFR decreases by >20% to <30% to a value below 60 ml/min/1.73 m².
- The complaint does not explicitly reserve the right to assert dependent claims.
III. The Accused Instrumentality
Product Identification
- Defendant Sandoz's proposed "generic voclosporin products," for which it is seeking FDA approval via Abbreviated New Drug Application (ANDA) No. 220223 (Compl. ¶1).
Functionality and Market Context
- The complaint alleges that Sandoz's generic voclosporin products are "the same, or substantially the same, as Aurinia's LUPKYNIS®" (Compl. ¶23). The intended use is for the treatment of lupus nephritis. The complaint alleges that upon approval, Sandoz will market, sell, and distribute these products, which will be prescribed by physicians and used by patients in the United States (Compl. ¶¶10-11, 34).
IV. Analysis of Infringement Allegations
The complaint alleges that Sandoz's submission of its ANDA is a technical act of infringement under 35 U.S.C. § 271(e)(2)(A) and that the future sale of the product will induce infringement of the patented methods (Compl. ¶¶29, 35-36, 42, 48-49). The infringement theory is that the proposed label for Sandoz's generic product will instruct healthcare providers and patients to use the drug in a manner that practices the steps of the asserted method claims.
'036 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A pharmacodynamic method to treat a proteinuric kidney disease which method comprises administering to a subject diagnosed with said disease a predetermined daily dosage of effective amounts of voclosporin over a projected treatment period of at least 24 weeks... | Sandoz's proposed generic voclosporin product is for the treatment of lupus nephritis, a proteinuric kidney disease. The complaint alleges its proposed label will instruct administration for treatment periods that will include at least 24 weeks. | ¶¶33-36 | col. 3:1-7 |
| (a) assessing the estimated Glomerular Filtration Rate (eGFR) of said subject at at least a first time point and a second time point on different days of said treatment period... | The complaint alleges that Sandoz's proposed label will instruct or encourage physicians to monitor patient kidney function, including eGFR, during treatment, consistent with the standard of care and the patented method. | ¶¶35-36 | col. 3:8-11 |
| (b) (i) if the eGFR of said subject decreases by more than a target %...to below a predetermined value...reducing the daily dosage by increment(s) of 7.9 mg BID or stopping the administering of voclosporin... | The complaint alleges the proposed label will recommend dose modifications based on patient response, including eGFR changes, thereby inducing physicians to perform the claimed reduction or cessation step. | ¶¶35-36 | col. 3:12-17 |
'991 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method of treating lupus nephritis (LN) in a subject, the method comprising: a) selecting for treatment a subject having LN... | The complaint alleges Sandoz's proposed label will instruct physicians to select appropriate patients with LN for treatment with its generic voclosporin product. | ¶¶46-49 | col. 8:20-26 |
| b) administering to the subject voclosporin...at a starting dose of 23.7 mg administered orally twice daily (BID); | The complaint alleges Sandoz's proposed product is a bioequivalent of LUPKYNIS® and its label will instruct administration at the same starting dose. | ¶¶46-49 | col. 8:12-14 |
| c) assessing the subject's eGFR at a second time point after initiating the administering step b); | The complaint alleges the proposed label will instruct physicians to monitor patient eGFR after initiating therapy. | ¶¶46-49 | col. 8:49-52 |
| d) administering to the subject a reduced dose of 15.8 mg BID or 7.9 mg BID voclosporin...if...the subject's eGFR decreases in the range of >20% to <30% below the subject's eGFR at the first time point to below 60 ml/min/1.73 m². | The complaint alleges the proposed label will instruct physicians to reduce the dose in response to specific eGFR declines, thereby inducing infringement of this dose-reduction step. | ¶¶46-49 | col. 8:53-65 |
Identified Points of Contention:
- Scope Questions: Do the method claims, which require specific actions by a healthcare provider (e.g., "assessing eGFR," "administering a reduced dosage"), cover situations where a physician's clinical judgment may deviate from the patented protocol? The central question for inducement will be whether the language of Sandoz's proposed label requires or merely suggests performing the claimed steps.
- Technical Questions: What evidence will be presented that Sandoz's proposed label will instruct the highly specific dose reductions recited in the '991 patent (i.e., to 15.8 mg or 7.9 mg BID)? A mismatch between the label's instructions and the claim's specific requirements may support a non-infringement argument.
V. Key Claim Terms for Construction
Term: "pharmacodynamic method" ('036 Patent, Claim 1)
- Context and Importance: This term appears at the start of the claim and frames its scope. The definition is critical because if construed broadly, it could cover any treatment guided by patient response. If construed narrowly, it may be limited to the specific eGFR-monitoring protocol detailed in the patent. Practitioners may focus on this term to determine if the claim is limited to the precise protocol tested or covers a broader principle of response-guided dosing.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification introduces the invention as providing "a pharmacodynamic dosing schedule based on individual patient responses" (ʼ036 Patent, col. 2:22-24), suggesting the principle is key.
- Evidence for a Narrower Interpretation: The detailed description of the "specific embodiment" of the method repeatedly and exclusively ties the "pharmacodynamic" aspect to monitoring eGFR according to specific percentage-based rules (ʼ036 Patent, col. 3:21-42).
Term: "administering to the subject a reduced dose of 15.8 mg BID or 7.9 mg BID voclosporin" ('991 Patent, Claim 1)
- Context and Importance: This limitation recites highly specific dosages. The infringement analysis will hinge on whether Sandoz's proposed label instructs physicians to reduce the dosage to these exact amounts under the specified conditions. A lack of such specific instruction on the label could be a primary non-infringement defense.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A party might argue this is exemplary, though the explicit recitation in an independent claim makes this difficult. The specification discusses dose reductions in "increments of 7.9 mg" generally (ʼ991 Patent, col. 7:35-37), which could suggest flexibility.
- Evidence for a Narrower Interpretation: The claim language is precise and uses the numerical values "15.8 mg" and "7.9 mg." The patent links these specific doses to capsules containing 7.9 mg of voclosporin, reinforcing the intent to claim these exact amounts (ʼ991 Patent, col. 7:25-29).
VI. Other Allegations
- Indirect Infringement: The complaint is founded on allegations of induced infringement under 35 U.S.C. § 271(b). It alleges Sandoz knows its proposed package insert will "recommend, suggest, encourage, and/or instruct" healthcare professionals and patients to use the generic product in a way that directly infringes the patented methods (Compl. ¶¶36, 49). It also pleads contributory infringement, alleging the generic product is not a staple article of commerce and is especially adapted for an infringing use (Compl. ¶¶37-38, 50-51).
- Willful Infringement: The complaint does not use the term "willful infringement." However, it alleges that Sandoz had "actual knowledge" of the '036 and '991 patents since at least the time it filed its ANDA and sent its Notice Letter (Compl. ¶¶31, 44). These allegations may form the basis for a later claim for enhanced damages or a finding that the case is exceptional under 35 U.S.C. § 285.
VII. Analyst’s Conclusion: Key Questions for the Case
The resolution of this case will likely depend on the court's determination of the following key questions:
- A central issue will be one of induced infringement: Does the content of Sandoz's proposed product label, which must be substantially similar to the brand-name label, go beyond merely making an equivalent drug available and instead actively instruct or encourage physicians to perform every step of the patented methods, including the specific eGFR assessments and dose adjustments?
- A critical question will be one of claim scope versus label instructions: Will the claim terms, particularly the specific numerical dosages in the '991 patent (e.g., "15.8 mg BID or 7.9 mg BID"), be construed so narrowly that Sandoz can argue its label allows for plausible, non-infringing uses or fails to instruct the precise, claimed dose modifications?
- An underlying evidentiary question will be whether Aurinia can demonstrate that the standard of care for using voclosporin has become coextensive with its patented methods, such that any physician prescribing Sandoz's generic product for its intended purpose would inevitably practice the claimed invention.