Ingenus Pharmaceuticals, LLC v. Nexus Pharmaceuticals, Inc.

CourtDistrict Court, N.D. Illinois
DecidedMay 6, 2025
Docket1:22-cv-02868
StatusUnknown

This text of Ingenus Pharmaceuticals, LLC v. Nexus Pharmaceuticals, Inc. (Ingenus Pharmaceuticals, LLC v. Nexus Pharmaceuticals, Inc.) is published on Counsel Stack Legal Research, covering District Court, N.D. Illinois primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Ingenus Pharmaceuticals, LLC v. Nexus Pharmaceuticals, Inc., (N.D. Ill. 2025).

Opinion

IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF ILLINOIS EASTERN DIVISION

INGENUS PHARMACEUTICALS, LLC, and LEIUTIS PHARMACEUTICALS LLP, Case No. 22−cv−02868 Plaintiffs, Judge Mary M. Rowland v.

NEXUS PHARMACEUTICALS, INC.,

Defendant.

MEMORANDUM OPINION AND ORDER

Plaintiffs Ingenus Pharmaceuticals, LLC (“Ingenus”) and Leiutis Pharmaceuticals LLP (“Leiutis,” and collectively “Plaintiffs”) sued Defendant Nexus Pharmaceuticals, Inc. (“Nexus”), alleging that Nexus infringed U.S. Patent No. 10,993,952 (the “’952 Patent”). Before the Court now is Nexus’s motion for summary judgment for lack of standing [137]. For the reasons stated herein, Nexus’s motion is granted in part and denied in part. SUMMARY JUDGMENT STANDARD Summary judgment is proper where “the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.” Fed. R. Civ. P. 56(a); see also Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986). A genuine dispute as to any material fact exists if “the evidence is such that a reasonable jury could return a verdict for the nonmoving party.” Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). The substantive law controls which facts are material. Id. After a “properly supported motion for summary judgment is made, the adverse party ‘must set forth specific facts showing that there is a genuine issue for trial.’” Id. at 250 (quoting Fed. R. Civ. P. 56(e)).

The Court “consider[s] all of the evidence in the record in the light most favorable to the non-moving party, and [ ] draw[s] all reasonable inferences from that evidence in favor of the party opposing summary judgment.” Logan v. City of Chicago, 4 F.4th 529, 536 (7th Cir. 2021) (quotation omitted). The Court “must refrain from making credibility determinations or weighing evidence.” Viamedia, Inc. v. Comcast Corp., 951 F.3d 429, 467 (7th Cir. 2020) (citing Anderson, 477 U.S. at 255). In ruling on summary judgment, the Court gives the non-moving party “the benefit of reasonable

inferences from the evidence, but not speculative inferences in [its] favor.” White v. City of Chicago, 829 F.3d 837, 841 (7th Cir. 2016) (internal citations omitted). “The controlling question is whether a reasonable trier of fact could find in favor of the non-moving party on the evidence submitted in support of and opposition to the motion for summary judgment.” Id. BACKGROUND

On July 30, 2020, the United States Food and Drug Administration (“FDA”) approved Plaintiffs’ New Drug Application (“NDA”) No. 212501, which was for the sale and manufacture of a cyclophosphamide solution for intravenous use (the “Ingenus Product”). [164] ¶ 5. Cyclophosphamide is used for the treatment of malignant diseases such as lymphomas, myeloma, leukemia, breast carcinoma, and more. [164] ¶ 8. On December 28, 2021, Nexus submitted its Abbreviated New Drug Application No. 216783 (“ANDA”), which sought FDA approval for cyclophosphamide solution for intravenous injection. [159] ¶¶ 28. Nexus’s proposed drug product contains as formulation ingredients cyclophosphamide, ethanol, propylene glycol,

polyethylene glycol, and monothioglycerol, as does Plaintiffs’ product. [159] ¶ 28. The FDA approved Nexus’s ANDA on October 29, 2024. [154] ¶ 4. At the time Plaintiffs filed this lawsuit, they were the owners and assignees of the ‘952 Patent. [164] ¶ 13. On June 6, 2024, however, Ingenus and Leiutis executed an agreement in which Leiutis terminated its rights in the ‘952 Patent and transferred all rights to Ingenus (the “Termination Agreement”). [164] ¶¶ 16-17. Plaintiffs’ counsel subsequently confirmed in email communications that Leiutis retained no

further rights in the ‘952 Patent. [164] ¶ 21. On June 11, 2024, Ingenus and Dr. Reddy’s Laboratories (“DRL”) executed an agreement under which Ingenus transferred at least some rights in the ‘952 Patent to DRL (the “DRL Agreement”). [164] ¶¶ 22-23. The DRL Agreement states that it “grants to DRL an exclusive . . . license” to develop, manufacture, commercialize, and/or have commercialized the Ingenus Product. [164] ¶ 24; [116-1] at 3. Under the

terms of the agreement, DRL is required to pay Ingenus a portion of any profits it makes from selling the Ingenus Product. [116-1] § 5.1.1. The DRL Agreement provides various conditions on both parties’ abilities to sublicense, subcontract, or assign any of their rights or obligations under the agreement. See [164] ¶¶ 25 – 28. The DRL Agreement further provides that Ingenus and DRL will “enter into separate supply agreement for Ingenus to manufacture and supply the Ingenus Product,” though no party has produced any separate supply agreements in this litigation. [164] ¶ 28. Under the terms of the DRL Agreement, Ingenus has “the obligation and sole right

. . . to initiate, control, and settle . . . any action alleging Infringement of” the ‘952 Patent. [164] ¶ 36; [116-1] § 6.3.2. Further, DRL has no rights under the agreement other than those explicitly granted therein. [164] ¶ 44; [116-1] § 2.5. ANALYSIS I. Standing

To have standing to bring a patent infringement claim, plaintiffs “must meet both constitutional and prudential [or statutory] standing requirements.” Morrow v. Microsoft Corp., 499 F.3d 1332, 1338 (Fed. Cir. 2007).1 Nexus argues that following the Termination Agreement and the DRL Agreement, neither Ingenus nor Leiutis have either form of standing and their infringement claim must be dismissed. Constitutional standing and statutory standing stem from different areas of law and require different inquiries. “[S]tanding in a patent case is anything but straightforward,” and its confusion “has been exacerbated by inconsistent rulings.”

Uniloc USA, Inc. v. Motorola Mobility, LLC, No. CV 17-1658-CFC, 2020 WL 7771219, at *3 (D. Del. Dec. 30, 2020), aff'd, 52 F.4th 1340 (Fed. Cir. 2022). Indeed, the Federal Circuit has itself acknowledged that its caselaw has wrongly “often treated ‘statutory standing’ . . . as jurisdictional,” despite that the jurisdictional question is one of

1 The parties use the terms “statutory standing” and “prudential standing” interchangeably. The law likewise treats the terms as synonyms. See Lexmark Int'l, Inc. v. Static Control Components, Inc., 572 U.S. 118, 128 n.4 (2014). The Court uses the term “statutory standing” in this opinion. constitutional rather than statutory standing. Lone Star Silicon Innovations LLC v. Nanya Tech. Corp., 925 F.3d 1225, 1235 (Fed. Cir. 2019). In Lexmark, the Supreme Court explained that statutory standing does not

implicate subject-matter jurisdiction and requires a separate analysis from constitutional standing. Lexmark Int'l, Inc. v. Static Control Components, Inc., 572 U.S. 118, 128 n.4 (2014). Constitutional standing asks whether a plaintiff has a redressable injury in fact as contemplated by Article III of the constitution, Intell. Tech LLC v. Zebra Techs. Corp., 101 F.4th 807, 813 (Fed. Cir. 2024), cert. denied, 145 S. Ct. 568 (2024) (citing Lujan v. Defs. of Wildlife, 504 U.S. 555

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Ingenus Pharmaceuticals, LLC v. Nexus Pharmaceuticals, Inc., Counsel Stack Legal Research, https://law.counselstack.com/opinion/ingenus-pharmaceuticals-llc-v-nexus-pharmaceuticals-inc-ilnd-2025.