DCT
2:25-cv-02807
Aurinia Pharma Inc v. Galenicum Health Slu
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Aurinia Pharmaceuticals Inc. (Canada)
- Defendant: Galenicum Health S.L.U. (Spain)
- Plaintiff’s Counsel: Gibbons P.C.
- Case Identification: 2:25-cv-02807, D.N.J., 04/17/2025
- Venue Allegations: Plaintiff alleges venue is proper in the District of New Jersey because Defendant is a foreign corporation not resident in the United States, and the district has personal jurisdiction over it.
- 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 a treatment protocol for lupus nephritis.
- Technical Context: The patents relate to personalized dosing protocols for voclosporin, an immunosuppressant used to treat lupus nephritis, a serious autoimmune kidney disease.
- Key Procedural History: The lawsuit was initiated under the Hatch-Waxman Act following Defendant’s submission of an ANDA with a Paragraph IV certification, asserting that Plaintiff’s patents are invalid, unenforceable, or will not be infringed. Plaintiff received a Notice Letter from Defendant on March 5, 2025, and filed this complaint within the 45-day statutory window, which triggers an automatic 30-month stay on FDA approval of the generic product.
Case Timeline
| Date | Event |
|---|---|
| 2017-05-12 | Earliest Priority Date for '036 & '991 Patents |
| 2019-05-14 | '036 Patent Issued |
| 2021-01-22 | FDA Approved LUPKYNIS® NDA |
| 2023-04-11 | '991 Patent Issued |
| 2025-03-05 | Plaintiff Received Notice Letter from Defendant |
| 2025-04-17 | 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 prior standard-of-care treatments for lupus nephritis (LN), an inflammatory kidney disease, had low rates of success, with complete remission achieved in less than 10% of subjects ('036 Patent, col. 2:37-44). A key side effect of treatment with calcineurin inhibitors like voclosporin is a potential decrease in kidney function, measured by the estimated glomerular filtration rate (eGFR) ('036 Patent, col. 2:62-66).
- The Patented Solution: The patent discloses a "pharmacodynamic" treatment method that aims to improve efficacy while managing safety. The protocol involves administering voclosporin and monitoring the patient's eGFR at different time points. If a patient's eGFR decreases by more than a specified target percentage to below a predetermined value, the voclosporin dosage is reduced or stopped, thereby personalizing the therapy to the patient's physiological response ('036 Patent, Abstract; col. 3:1-25).
- Technical Importance: This protocol represents an attempt to optimize the therapeutic window of voclosporin by creating a structured, data-driven approach to dose modification, potentially allowing more patients to benefit from the drug while mitigating the risk of drug-induced kidney damage ('036 Patent, col. 2:62-col. 3:25).
Key Claims at a Glance
- The complaint asserts infringement of at least one claim of the '036 patent (Compl. ¶30). The lead independent claim is Claim 1.
- Independent Claim 1 recites a method with the following essential elements:
- Administering a predetermined daily dosage of voclosporin for at least 24 weeks to treat a proteinuric kidney disease.
- Assessing the subject's eGFR at a first and a second time point.
- Reducing or stopping the voclosporin dosage if the eGFR decreases by more than a target percentage (within a 20-45% range) to below a predetermined value (within a 50-90 ml/min/1.73 m² range).
- Continuing the same dosage if the eGFR decreases by less than the target percentage.
- 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: The '991 Patent addresses the same clinical challenge as its parent '036 Patent: the need for a more effective and safer treatment protocol for lupus nephritis than the existing standard of care ('991 Patent, col. 1:21-48).
- The Patented Solution: This patent further refines the treatment protocol. It claims a method that begins with selecting an LN patient based on a pre-treatment eGFR assessment. The method specifies a starting voclosporin dose (23.7 mg twice daily) co-administered with other drugs. It then claims a specific dose-reduction step if the patient's eGFR decreases within a narrower, defined range (>20% to <30%) ('991 Patent, col. 2:51-col. 4:11). Certain claims also add a treatment outcome—achieving a specific low level of protein in the urine—as a component of the claimed method ('991 Patent, Claim 14).
- Technical Importance: The '991 Patent claims a more structured and specific version of the treatment protocol, defining the patient selection criteria, starting dose, and a more precise eGFR-based trigger for dose reduction, aiming for a standardized yet personalized therapeutic regimen ('991 Patent, col. 33:57-col. 34:2).
Key Claims at a Glance
- The complaint asserts infringement of at least one claim of the '991 patent (Compl. ¶43). The lead independent claims appear to be Claims 1 and 14.
- Independent Claim 1 recites a method with the following essential elements:
- Selecting a subject with LN based on a pre-treatment eGFR.
- Administering a starting dose of 23.7 mg voclosporin twice daily, along with MMF and corticosteroids.
- Assessing the subject's eGFR at a second time point.
- Administering a reduced dose (15.8 mg or 7.9 mg BID) if the eGFR decreases in the range of >20% to <30% to below 60 ml/min/1.73 m².
- Independent Claim 14 includes all the elements of Claim 1 and adds a final limitation:
- Wherein the administration of the reduced dose "achieves a urine protein creatinine ratio (UPCR) of <0.5 mg/mg."
- The complaint does not explicitly reserve the right to assert dependent claims.
III. The Accused Instrumentality
Product Identification
- The accused instrumentality is Defendant Galenicum's proposed "generic voclosporin products" for which it filed Abbreviated New Drug Application (ANDA) No. 220072 with the FDA (Compl. ¶1).
Functionality and Market Context
- The complaint alleges that Galenicum's generic product is "the same, or substantially the same, as Aurinia's LUPKYNIS®" (Compl. ¶20). Infringement is predicated on the future use of this generic product. The complaint alleges that upon approval, the generic product will be prescribed by physicians and used by patients according to instructions on its proposed package insert, which will allegedly direct users to perform the patented methods of treatment (Compl. ¶31, 33, 44, 46).
- No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The complaint does not contain a detailed claim chart. The infringement theory is based on the allegation that Defendant's proposed product label for its generic voclosporin will instruct physicians and patients to use the product in a manner that directly 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...a predetermined daily dosage of an effective amounts of voclosporin... | The proposed package insert for Galenicum's generic product will instruct physicians to administer voclosporin to treat lupus nephritis. | ¶30, 33 | col. 3:1-6 |
| assessing the estimated Glomerular Filtration Rate (eGFR) of said subject at at least a first time point and a second time point... | The proposed package insert will instruct physicians to monitor patients' eGFR during treatment. | ¶33 | col. 3:7-10 |
| if the eGFR...decreases by more than a target %...reducing the daily dosage...or stopping the administering... | The proposed package insert will instruct physicians to reduce or stop the voclosporin dosage if a patient’s eGFR declines according to specified parameters. | ¶33 | col. 3:11-17 |
| if the eGFR...decreases by less than said target %...continuing administering the same predetermined daily dosage... | The proposed package insert will instruct physicians to continue the voclosporin dosage if a patient’s eGFR remains stable. | ¶33 | col. 3:18-22 |
- '991 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| selecting for treatment a subject having LN, the selecting comprising determining the subject's estimated Glomerular Filtration Rate (eGFR) at a first time point... | The proposed package insert will instruct physicians to select appropriate LN patients for treatment, which will include assessing their baseline renal function. | ¶44, 46 | col. 33:57-61 |
| administering to the subject voclosporin...at a starting dose of 23.7 mg administered orally twice daily (BID)... | The proposed package insert will instruct the administration of a 23.7 mg BID starting dose of voclosporin. | ¶44, 46 | col. 33:62-col. 34:2 |
| 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%"... | The proposed package insert will instruct physicians to reduce the voclosporin dosage to a specified level if the patient’s eGFR declines by the claimed amount. | ¶44, 46 | col. 34:3-11 |
- Identified Points of Contention:
- Scope Questions: The primary point of contention will be factual: do the instructions on Galenicum’s proposed generic label, which are not yet public, actually contain all the specific steps of the asserted claims? The patents claim highly specific, multi-step monitoring and dose-adjustment protocols (e.g., eGFR decrease of ">20% to <30%" in the '991 Patent). The infringement case depends on the proposed label mirroring these specific instructions.
- Technical Questions: A key legal and technical question for '991 Patent Claim 14 is whether a method claim reciting a specific clinical outcome ("achieves a UPCR of <0.5 mg/mg") can be directly infringed. A physician performs the administration and monitoring steps, but does not "perform" the step of the patient achieving a particular result, raising questions about whether any single actor directly infringes all limitations of the claim.
V. Key Claim Terms for Construction
Term ('036 Patent): "pharmacodynamic method"
- Context and Importance: This term appears in the preamble of Claim 1 and frames the entire invention. Its construction will determine whether the claim is limited to the specific eGFR-based dose-adjustment steps that follow, or if it has a broader meaning. Practitioners may focus on this term to dispute whether the accused method, even if it involves dose adjustment, qualifies as the specific "pharmacodynamic method" claimed.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The general description refers to the invention as a "protocol" that "takes advantage of assessments of parameters associated with the response of individual subjects" ('036 Patent, col. 2:30-34), which could suggest any responsive dosing regimen.
- Evidence for a Narrower Interpretation: The claim body itself immediately defines the method by a specific set of rules based on eGFR changes ('036 Patent, col. 4:7-25). The abstract also ties the "pharmacodynamic dosing regimen" directly to maximizing effectiveness "while minimizing undesirable side effects," which the specification identifies as decreased eGFR ('036 Patent, Abstract).
Term ('991 Patent): "achieves a urine protein creatinine ratio (UPCR) of <0.5 mg/mg"
- Context and Importance: This limitation in independent Claim 14 defines the method in terms of a successful clinical outcome. This is a critical term because infringement of a method claim typically requires the performance of affirmative steps, not the achievement of a result that is not guaranteed for every patient. The defendant will likely argue this limitation makes direct infringement by a single actor (i.e., the prescribing physician) difficult to prove.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification describes a UPCR of ≤0.5 mg/mg as the definition of "complete remission (CR)," a desired goal of the therapy ('991 Patent, col. 9:49-54). This may support the view that the method is simply a method for achieving this result.
- Evidence for a Narrower Interpretation: The plain language of Claim 14 includes "achieves" as a limitation of the method itself. This suggests that for infringement to occur, the method must actually produce this result in a given patient, a factor outside the direct control of the physician administering the drug. This could support an argument that the claim is invalid for lack of enablement or that infringement cannot be proven on a class-wide basis.
VI. Other Allegations
- Indirect Infringement: The complaint alleges that upon approval, Galenicum will induce infringement by providing a product with a package insert that will "recommend, suggest, encourage, and/or instruct" healthcare professionals and patients to perform the patented methods (Compl. ¶33, 46). It is also alleged that the generic voclosporin products are not a staple article of commerce suitable for substantial non-infringing use and are especially adapted for an infringing use, forming a basis for contributory infringement (Compl. ¶34-35, 47-48).
- Willful Infringement: The complaint does not contain a formal count for willful infringement. However, it alleges that Galenicum has had "actual knowledge" of both patents since at least the date of its Notice Letter on March 5, 2025, which could form the basis for a later willfulness claim or a request for enhanced damages (Compl. ¶28, 41).
VII. Analyst’s Conclusion: Key Questions for the Case
This case, typical of ANDA litigation for method-of-use patents, will likely center on the specific language of the defendant's proposed drug label and the scope of the patent claims.
- A central evidentiary question will be one of instructional equivalence: will the instructions for use on Galenicum’s proposed generic voclosporin label direct physicians to perform the exact, multi-step eGFR monitoring and dose-adjustment protocol required by the asserted claims, or will the label's guidance be more general, creating a potential mismatch with the specific claim limitations?
- A key legal question will concern infringement of outcome-based claims: for '991 Patent Claim 14, can Aurinia prove direct infringement of a method claim that requires the patient to "achieve" a specific clinical result? The court will need to address whether infringement occurs simply by practicing the steps intended to produce the outcome, or if the outcome itself must be achieved, raising complex questions of proof and claim validity.