DCT
2:25-cv-02613
Aurinia Pharma Inc v. Lotus Pharmaceutical Co Ltd
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Aurinia Pharmaceuticals Inc. (Canada)
- Defendant: Lotus Pharmaceutical Co., Ltd. (Taiwan)
- Plaintiff’s Counsel: Gibbons P.C.
- Case Identification: 2:25-cv-02613, D.N.J., 04/11/2025
- Venue Allegations: Plaintiff alleges venue is proper because Defendant is a foreign corporation not resident in the United States, and the court has personal jurisdiction over it through its business contacts and partnerships in New Jersey, as well as its prior litigation in the district.
- Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) for a generic version of the drug LUPKYNIS® (voclosporin) constitutes an act of infringement of two patents covering therapeutic protocols for treating lupus nephritis.
- Technical Context: The patents relate to pharmacodynamic dosing methods for voclosporin, a calcineurin inhibitor, designed to maximize therapeutic benefit while minimizing kidney-related side effects in patients with lupus nephritis.
- Key Procedural History: This action was initiated under the Hatch-Waxman Act following Plaintiff's receipt of a Paragraph IV certification notice from Defendant, which stated that Defendant's ANDA seeks FDA approval to market its generic product prior to the expiration of Plaintiff's patents. The patents-in-suit are listed in the FDA's "Orange Book" for LUPKYNIS®.
Case Timeline
| Date | Event |
|---|---|
| 2017-05-12 | Earliest Priority Date for '036 and '991 Patents |
| 2019-05-14 | U.S. Patent No. 10,286,036 Issues |
| 2021-01-22 | FDA Approves NDA for LUPKYNIS® (voclosporin) |
| 2023-04-11 | U.S. Patent No. 11,622,991 Issues |
| 2025-02-26 | Defendant Sends Paragraph IV Notice Letter to Plaintiff |
| 2025-04-11 | 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 complete remission achieved in less than 10% of subjects in some instances (’036 Patent, col. 2:38-44).
- The Patented Solution: The invention is a "pharmacodynamic" method for treating proteinuric kidney diseases like LN. It involves administering voclosporin, monitoring a patient's estimated Glomerular Filtration Rate (eGFR) over time, and then adjusting the voclosporin dosage—either by reducing it or stopping it entirely—if the eGFR drops by a specified percentage below a predetermined value, thereby minimizing a key side effect (’036 Patent, Abstract; col. 5:26-42). The patent’s Figure 1 graphically depicts a clinical trial design incorporating this type of protocol (’036 Patent, Fig. 1).
- Technical Importance: This protocol allows for a personalized approach to dosing a potent immunosuppressant, aiming to manage its known nephrotoxicity and improve the overall therapeutic window for patients (’036 Patent, col. 4:62-67).
Key Claims at a Glance
- The complaint asserts at least one claim; independent claim 1 is representative.
- Essential elements of claim 1 include:
- A pharmacodynamic method to treat a proteinuric kidney disease by administering voclosporin for at least 24 weeks.
- Assessing the subject's eGFR at a first and second time point.
- If the eGFR decreases by more than a target percentage (20-45%) to below a predetermined value (50-90 ml/min/1.73 m²), reducing or stopping the voclosporin dosage.
- If the eGFR decreases by less than the target percentage, continuing the same dosage.
- The complaint reserves the right to assert additional claims (Compl. ¶32).
U.S. Patent No. 11,622,991 - "Protocol for the Treatment of Lupus Nephritis," issued April 11, 2023
The Invention Explained
- Problem Addressed: The '991 Patent addresses the same problem of low success rates for existing LN treatments and the need for improved protocols (’991 Patent, col. 2:21-37).
- The Patented Solution: The invention provides a specific method for treating LN by co-administering voclosporin, mycophenolate mofetil (MMF), and corticosteroids. The method specifies a starting voclosporin dose (23.7 mg twice daily) and a rule for dose reduction (to 15.8 mg or 7.9 mg twice daily) if the patient's eGFR decreases by >20% to <30% to a value below 60 ml/min/1.73 m² (’991 Patent, claim 1). Figure 2 presents clinical data showing superior complete and partial remission rates for voclosporin-treated groups compared to a control group (’991 Patent, Fig. 2).
- Technical Importance: The claimed method provides a clinically-validated, specific dosing regimen that demonstrates high rates of remission while actively managing patient safety by adjusting for changes in kidney function (’991 Patent, col. 10:60-col. 11:4).
Key Claims at a Glance
- The complaint asserts at least one claim; independent claim 1 is representative.
- Essential elements of claim 1 include:
- A method of treating LN in a subject selected for treatment.
- Administering voclosporin at a starting dose of 23.7 mg twice daily (BID), along with MMF and corticosteroids.
- Assessing the subject's eGFR at first and second time points.
- Administering a reduced voclosporin 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 reserves the right to assert additional claims (Compl. ¶45).
III. The Accused Instrumentality
Product Identification
- Defendant’s generic voclosporin products, for which it seeks FDA approval in ANDA No. 220206 (Compl. ¶1).
Functionality and Market Context
- The complaint alleges that the accused generic products are "the same, or substantially the same, as Aurinia's LUPKYNIS®" and are intended for the same therapeutic use: the treatment of lupus nephritis (Compl. ¶19, ¶22). The act of infringement is the submission of the ANDA itself, which seeks approval for a product whose proposed labeling will allegedly instruct medical professionals and patients to use the generic drug in a manner that practices the patented methods (Compl. ¶¶35, 48). No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The complaint does not include a claim chart or the Defendant's proposed product label. The infringement theory is based on inducement, alleging the label for the generic product will instruct users to perform the claimed methods.
'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...a predetermined daily dosage of effective amounts of voclosporin... | Defendant's ANDA seeks approval for its generic voclosporin products for the treatment of lupus nephritis, a proteinuric kidney disease. The proposed label will allegedly instruct such administration. | ¶28; ¶33 | col. 9:55-61 |
| assessing the estimated Glomerular Filtration Rate (eGFR) of said subject at at least a first time point and a second time point... | The proposed label will allegedly instruct a course of treatment that includes monitoring for voclosporin's known effects on kidney function, which requires assessing eGFR. | ¶35 | col. 9:62-65 |
| if the eGFR of said subject decreases by more than a target %...reducing the daily dosage by increment(s)...or stopping the administering of voclosporin... | The proposed label will allegedly instruct physicians to adjust the voclosporin dosage in response to changes in eGFR, thereby directing the performance of this claimed step. | ¶34; ¶35 | col. 11:1-6 |
'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...administering to the subject voclosporin...at a starting dose of 23.7 mg administered orally twice daily (BID)... | Defendant's proposed generic product is a copy of LUPKYNIS®, which is approved at this starting dose. The proposed label will allegedly instruct administration at this specific dose for LN. | ¶19; ¶46 | col. 33:57-67 |
| assessing the subject's eGFR at a second time point after initiating the administering step... | The proposed label will allegedly direct physicians to monitor patient kidney function (eGFR) after starting treatment, in line with standard practice for this drug class. | ¶48 | col. 34:1-2 |
| 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%...to below 60 ml/min/1.73 m². | The proposed label will allegedly contain instructions that encourage or direct physicians to reduce the voclosporin dose in the specific manner claimed in response to a specified decline in eGFR. | ¶47; ¶48 | col. 34:3-12 |
- Identified Points of Contention:
- Evidentiary Question: The central dispute will depend on the specific language of Defendant's proposed product label, which is not included in the complaint. The key question is whether the label's instructions and warnings will be found to actively "encourage, recommend, or promote" the performance of every limitation of the asserted claims.
- Scope Questions: Does the language in the proposed label merely inform physicians of voclosporin's properties and potential side effects, leaving the specific patented dosing adjustments to their independent medical judgment, or does it affirmatively teach the patented method? The distinction between describing a drug's clinical profile and inducing infringement of a specific patented protocol will be a focal point.
V. Key Claim Terms for Construction
The Term: "pharmacodynamic method" (’036 Patent, claim 1)
- Context and Importance: This preamble term may be argued as limiting. Its construction is important because Defendant could argue that its proposed product label merely describes standard safety monitoring, not a specific "pharmacodynamic method" as patented. Plaintiff will likely argue the claim body itself defines the term's meaning in context.
- Intrinsic Evidence for a Broader Interpretation: The body of claim 1 provides a full definition of the method, suggesting "pharmacodynamic method" is simply a general descriptor for the steps that follow (’036 Patent, col. 9:55-col. 11:6).
- Intrinsic Evidence for a Narrower Interpretation: The specification extensively discusses a specific clinical trial (AURA study) and the dosing rules derived from it, suggesting the term could be tied to a more structured protocol than general clinical observation (’036 Patent, Fig. 1; col. 4:51-61).
The Term: "administering to the subject a reduced dose" (’991 Patent, claim 1)
- Context and Importance: This is an active step in the method claim. Practitioners may focus on this term because infringement requires that the proposed label instructs this specific action. The dispute will center on whether the label's guidance on dose modification constitutes an instruction to perform this step under the claimed conditions.
- Intrinsic Evidence for a Broader Interpretation: The specification describes dose reduction as a key feature for managing side effects, supporting a view that any label language guiding such a reduction would fall within the claim’s scope (’991 Patent, col. 7:31-39).
- Intrinsic Evidence for a Narrower Interpretation: The claim recites a specific eGFR-decline trigger for the dose reduction. Defendant may argue that unless its label recites this exact trigger-and-response algorithm, it does not instruct the claimed step, particularly if the label provides more general guidance. (’991 Patent, col. 34:6-12).
VI. Other Allegations
- Indirect Infringement: The complaint's primary theory is indirect infringement. It alleges that Defendant will induce infringement by physicians and patients because its proposed package insert will instruct them to use the generic product in a way that directly infringes the patented methods (Compl. ¶¶34-35, 47-48). It also pleads contributory infringement, alleging the generic voclosporin products are a material part of the inventions and not a staple article of commerce suitable for substantial non-infringing use (Compl. ¶¶36-37, 49-50).
- Willful Infringement: The complaint does not use the term "willful," but it alleges that Defendant has had actual knowledge of the patents since at least the date it sent the Notice Letter on February 26, 2025 (Compl. ¶30, ¶43). These allegations of pre-suit knowledge of the patents and the alleged infringement could form the basis for a later claim of willful infringement if Defendant were to launch its product commercially.
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of induced infringement: Does the specific text of Defendant's proposed product label go beyond merely describing voclosporin's clinical characteristics and instead actively instruct or encourage physicians to perform the complete, multi-step dosing and monitoring protocols recited in the asserted claims?
- A key evidentiary question will be one of factual correspondence: Since the complaint relies on general allegations, the case will turn on a direct comparison of the ANDA's proposed label against the specific limitations of the asserted claims, such as the starting dose of 23.7 mg BID and the precise eGFR-based criteria for dose reduction.
- A final question relates to claim interpretation and validity: Can the patented methods, which combine a known drug with specific monitoring and dose-adjustment steps, be distinguished from what a skilled physician would have considered to be standard, obvious, or routine patient care when prescribing a calcineurin inhibitor for lupus nephritis?