DCT
2:25-cv-02580
Aurinia Pharma Inc v. Hikma Pharma USA Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Aurinia Pharmaceuticals Inc. (Canada)
- Defendant: Hikma Pharmaceuticals USA Inc. (Delaware)
- Plaintiff’s Counsel: Gibbons P.C.; Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
- Case Identification: 2:25-cv-02580, D.N.J., 04/10/2025
- Venue Allegations: Plaintiff alleges venue is proper in the District of New Jersey because Defendant maintains a regular and established place of business in the district and has committed acts of infringement there, including the preparation and filing of its Abbreviated New Drug Application (ANDA). The complaint also notes that Defendant has previously been sued in the district and has not contested venue.
- Core Dispute: Plaintiff alleges that Defendant’s filing of an ANDA to market a generic version of Plaintiff's LUPKYNIS® (voclosporin) drug constitutes an act of infringement of two patents covering methods of treating lupus nephritis.
- Technical Context: The technology concerns specific dosing protocols for the immunosuppressant drug voclosporin, used to treat lupus nephritis, a serious and life-threatening autoimmune disease that causes kidney inflammation.
- Key Procedural History: This action was initiated under the Hatch-Waxman Act following a Notice Letter dated February 24, 2025, in which Defendant notified Plaintiff that it had filed an ANDA containing a Paragraph IV certification, asserting that Plaintiff's patents are invalid, unenforceable, and/or will not be infringed by the proposed generic product.
Case Timeline
| Date | Event |
|---|---|
| 2017-05-12 | ’036 and ’991 Patents Priority Date |
| 2019-05-14 | ’036 Patent Issue Date |
| 2021-01-22 | Aurinia's LUPKYNIS® FDA Approval Date |
| 2023-04-11 | ’991 Patent Issue Date |
| 2025-02-24 | Hikma's Paragraph IV Notice Letter Date |
| 2025-04-10 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 10,286,036 - “Protocol for the Treatment of Lupus Nephritis”
The Invention Explained
- Problem Addressed: The patent describes that standard-of-care treatments for lupus nephritis (LN) have shown limited success, with low rates of complete remission and significant side effects (’036 Patent, col. 2:38-44). There is a need for a therapeutic approach that improves efficacy while managing patient safety.
- The Patented Solution: The invention is a "pharmacodynamic" method for treating proteinuric kidney diseases like LN with voclosporin. The protocol involves administering a predetermined dose of voclosporin and monitoring the patient's estimated Glomerular Filtration Rate (eGFR). If the eGFR decreases by a specified target percentage to below a predetermined value, the voclosporin dosage is reduced or stopped. This feedback loop is designed to maximize therapeutic benefit while minimizing the risk of drug-induced kidney toxicity, a known side effect (’036 Patent, Abstract; col. 3:1-19). The study design upon which the protocol is based is shown in the patent’s Figure 1 (’036 Patent, FIG. 1).
- Technical Importance: This response-guided dosing strategy aims to improve the therapeutic window for voclosporin, allowing for more effective treatment of a debilitating disease by personalizing the dose to an individual patient’s physiological response (’036 Patent, col. 4:58-66).
Key Claims at a Glance
- The complaint asserts infringement of 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 (a) assessing the patient's estimated Glomerular Filtration Rate (eGFR) at a first and second time point.
- And (b) if the eGFR decreases by more than a target percentage (in the range of 20-45%) to below a predetermined value (in the range of 50-90 ml/min/1.73 m²), reducing or stopping the voclosporin dose.
- If the eGFR decreases by less than the target percentage, continuing the same voclosporin dose.
- The complaint does not specify dependent claims but reserves the right to assert any claims.
U.S. Patent No. 11,622,991 - “Protocol for the Treatment of Lupus Nephritis”
The Invention Explained
- Problem Addressed: As a continuation of the work in the ’036 Patent, this patent also addresses the need for an improved treatment protocol for LN that balances efficacy and safety (’991 Patent, col. 2:35-48).
- The Patented Solution: The ’991 Patent claims a more specific method of treating LN. It recites administering a specific starting dose of voclosporin (23.7 mg twice daily) in combination with mycophenolate mofetil (MMF) and corticosteroids. It then details a more specific dosing-adjustment rule: if a patient's eGFR decreases by >20% to <30% to a value below 60 ml/min/1.73 m², the dose is reduced to a specific lower level (15.8 mg or 7.9 mg BID) (’991 Patent, Claim 1). The patent also introduces using early response markers, such as a reduction in urinary protein/creatinine ratio (UPCR), to predict long-term success and decide whether to terminate ineffective therapy early (’991 Patent, col. 4:30-53).
- Technical Importance: This patent provides a more refined, clinically-tested protocol that further personalizes treatment by specifying starting doses, combination therapies, and precise rules for dose modification, potentially improving patient outcomes.
Key Claims at a Glance
- The complaint asserts infringement of at least one claim (Compl. ¶46). Independent claim 1 is representative:
- A method of treating LN comprising (a) selecting a patient and determining their baseline eGFR.
- (b) Administering a combination therapy of voclosporin (at a starting dose of 23.7 mg BID), MMF, and corticosteroids.
- (c) Assessing the patient's eGFR at a second time point.
- (d) Administering a reduced dose of voclosporin (15.8 mg or 7.9 mg BID) if the eGFR decreases in the range of >20% to <30% below baseline to a value below 60 ml/min/1.73 m².
- The complaint does not specify dependent claims but reserves the right to assert any claims.
III. The Accused Instrumentality
Product Identification
Hikma's generic voclosporin products, which are the subject of Abbreviated New Drug Application (ANDA) No. 219663 (Compl. ¶1).
Functionality and Market Context
The complaint alleges that Hikma's generic products are "the same, or substantially the same, as Aurinia's LUPKYNIS®" (Compl. ¶23). In this ANDA litigation context, the infringement allegation is not based on a currently marketed product but on the future act of making, using, or selling the generic product for the treatment of LN. The key infringing functionality is the use of the drug according to the instructions that will be included in its proposed package insert. The complaint alleges these instructions will lead physicians and patients to practice the patented methods, thereby inducing infringement (Compl. ¶¶ 35-36, 48-49).
IV. Analysis of Infringement Allegations
No probative visual evidence provided in complaint.
’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... voclosporin... | Hikma seeks FDA approval to market its generic voclosporin product for the treatment of lupus nephritis, a proteinuric kidney disease. | ¶¶ 23, 29 | col. 3:1-4 |
| (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... | Hikma’s proposed product label will allegedly instruct healthcare professionals to monitor patient eGFR during treatment with its voclosporin product. | ¶¶ 35-36 | col. 3:6-10 |
| (b) (i) if the eGFR of said subject decreases by more than a target %... reducing the daily dosage... or stopping the administering of voclosporin to said subject... | Hikma’s proposed product label will allegedly instruct healthcare professionals to reduce the voclosporin dose or discontinue treatment if a patient’s eGFR declines, thereby practicing the patented dose-adjustment step. | ¶¶ 35-36 | col. 3:11-19 |
’991 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| b) administering to the subject voclosporin, mycophenolate mofetil (MMF), and corticosteroids, wherein the administering comprises administering the voclosporin at a starting dose of 23.7 mg administered orally twice daily (BID); | Hikma's proposed label will allegedly instruct for the administration of its generic voclosporin at a 23.7 mg BID starting dose in combination with MMF and corticosteroids. | ¶¶ 48-49 | col. 33:63-67 |
| c) assessing the subject's eGFR at a second time point after initiating the administering step b); | Hikma's proposed label will allegedly instruct for the monitoring of patient eGFR after initiating treatment. | ¶¶ 48-49 | col. 34:1-2 |
| 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%... to below 60 ml/min/1.73 m². | The proposed label for Hikma's product will allegedly instruct physicians to reduce the dose to a specific lower level if the patient's eGFR declines according to the specified criteria. | ¶¶ 48-49 | col. 34:4-12 |
Identified Points of Contention
- Scope Questions: A primary issue will be whether the language of Hikma's proposed label will be found to meet every limitation of the asserted method claims. This raises the question of whether the label merely provides general safety warnings about monitoring kidney function, or if it explicitly instructs physicians to perform the specific, multi-step, criteria-based dose adjustments that form the core of the patented methods.
- Technical Questions: The central evidentiary question for infringement will be the exact content of Hikma’s proposed product label. What specific text in the label will Aurinia point to as instructing the "assessing" of eGFR and the subsequent "reducing" of the dosage in direct response to the specific numerical and percentage-based criteria required by the claims?
V. Key Claim Terms for Construction
The complaint does not provide sufficient detail for a full analysis of claim construction disputes, but based on the patent language, certain terms are likely to be critical.
The Term: "pharmacodynamic method" (’036 Patent, Claim 1)
- Context and Importance: This term appears at the beginning of the broadest independent claim of the ’036 Patent and defines the invention's fundamental character. Its construction will be critical to determining whether the claim covers only the specific feedback-loop protocol described or a broader range of clinical practices involving patient monitoring.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The plain meaning of "pharmacodynamic" relates to the effect of a drug on the body. A factfinder may be persuaded that any method where a dose is adjusted based on a measured physiological effect (like eGFR) falls within this definition.
- Evidence for a Narrower Interpretation: The specification consistently uses the term in the context of a specific, structured protocol involving assessing eGFR at multiple time points and comparing the change to a baseline to make a dose-adjustment decision (’036 Patent, col. 4:46-54). Practitioners may focus on this term because a narrow definition tied to this specific protocol could make it more difficult to prove that a product label induces infringement.
The Term: "assessing" (’036 Patent, Claim 1; ’991 Patent, Claim 1)
- Context and Importance: This term defines an active step required by the claims. The dispute may center on whether routine, periodic monitoring of a patient's kidney function constitutes "assessing" under the claims, or if the term requires a more directed evaluation performed for the specific purpose of implementing the claimed dose-adjustment logic.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The term itself is general, and a party could argue it simply means to measure or determine the eGFR value.
- Evidence for a Narrower Interpretation: The structure of the claims links the "assessing" step to the conditional "if...then" logic of the dose-adjustment step (’036 Patent, Claim 1). This suggests "assessing" is not a standalone observation but part of an integrated decision-making process, a point a defendant may emphasize to narrow the claim's scope.
VI. Other Allegations
- Indirect Infringement: The complaint alleges that Hikma will induce infringement under 35 U.S.C. § 271(b). This allegation is based on the assertion that Hikma’s proposed package insert for its generic product will instruct and encourage healthcare professionals and patients to use the product in a manner that directly infringes the claims of the patents-in-suit (Compl. ¶¶ 35-36, 48-49).
- Willful Infringement: The complaint does not contain an explicit allegation of willful infringement or a request for enhanced damages under 35 U.S.C. § 284. It does allege that Hikma has had actual knowledge of the patents since at least the date of its Notice Letter (Compl. ¶¶ 31, 44).
VII. Analyst’s Conclusion: Key Questions for the Case
- A key question will be one of induced infringement: Will the specific instructions and warnings in Hikma’s proposed product label be found to actively encourage or instruct physicians to perform every step of the patented methods, including the precise eGFR monitoring and dose-adjustment logic, or will the label be viewed as providing only general guidance that does not rise to the level of inducement?
- A central issue for the litigation will be patent validity. While not detailed in the complaint, Hikma’s Paragraph IV certification asserts that the patents are invalid and/or unenforceable (Compl. ¶26). The case will likely involve significant disputes over whether the claimed dosing protocols are obvious in light of prior art knowledge regarding the treatment of lupus nephritis and the management of side effects for this class of drugs.
- The outcome may also turn on a question of claim construction: Can Aurinia successfully argue for a broad interpretation of terms like "pharmacodynamic method," or will Hikma persuade the court to adopt a narrower construction that requires the performance of the specific, multi-step feedback loop explicitly detailed in the patent specifications, potentially making infringement more difficult to prove?