Biogen Inc. v. Sandoz Inc.

District Court, D. Delaware·Decided May 1, 2025·No. 1:22-cv-01190·Unknown

Opinion

IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE BIOGEN INC. and BIOGEN MA INC., Plaintiffs, v. C.A. No. 22-1190-GBW SANDOZ INC. and POLPHARMA BIOLOGICS S.A., Defendants.

MEMORANDUM ORDER Plaintiffs Biogen Inc. and Biogen MA Inc. (collectively, “Biogen” or “Plaintiffs”) filed their Second Amended Complaint (D.J. 98) against Defendants Sandoz Inc. (“Sandoz”) and Polpharma Biologics S.A. (“Polpharma”) (collectively, “Defendants”) to “halt Sandoz’s and Polpharma’s [(purported)] past, current, and future intended infringement of Biogen’s rights pursuant to the patent laws of the United States.” D.I. 98 ] 2; see Biogen Inc. v. Sandoz Inc., No. CV 22-1190-GBW, 2023 WL 7130655, at *1-2 (D. Del. June 29, 2023). Pending before the Court are the following motions in limine: 1. Plaintiffs’ Motion in Limine #1 to Exclude Evidence, Testimony, or Argument Regarding Prior Litigations Involving Tysabri® (ECF No. 630-1 at PageID 55191) (“Plaintiffs’ MIL #1”), which has been fully briefed (ECF No. 630-1 at PageID 55193-55196, 55316- 55320; ECF No. 631 at PageID 55738-55741); 2. Plaintiffs’ Motion in Limine #2 to Exclude Inadmissible Parol Evidence That Contradicts Unambiguous Contract Terms (ECF No. 630-1 at PageID 55747) (“Plaintiffs’ MIL #2”),

which has been fully briefed (ECF No. 630-1 at PageID 55749-55752, 55861-55865; ECF No. 631 at PageID 55896-55899); 3. Defendants’ Motion in Limine to Exclude Information Improperly Relied on by Biogen’s Experts (ECF No. 631 at PageID 55905) (“Defendants’ MIL #1”), which has been fully briefed (ECF No. 631 at PageID 55906-55909; ECF No. 632 at PageID 56133-56138; ECF No. 633 at PageID 57319-57321); 4. Defendants’ Motion in Limine to Exclude Information Not Disclosed During Discovery (ECF No. 633 at PageID 57325) (“Defendants’ MIL #2”), which has been fully briefed (id. at PageID 57326-57329, 57437-57442, 57594-57596); and 5. Defendants’ Motion in Limine to Exclude Information Related to Alleged Misappropriation of Biogen Confidential Information (ECF No. 634 at PageID 57602) (“Defendants’ MIL #3”), which has been fully briefed (id. at PageID 57603-57605, 57626- 57631, 57775-57777). For the following reasons, the Court does not grant any of the parties’ motions in limine. 1. BACKGROUND A. Tysabri “Biogen developed the biologic product TYSABRI® (natalizumab) (‘Tysabri’), which is ‘a humanized monoclonal antibody that targets the alpha-4 (or a4) integrin component of adhesion molecules found on many white blood cells.’”” 2023 WL 7130655, at *1 (quoting D.I. 98 { 34). “It is used to treat relapsing forms of multiple sclerosis (“MS’}—a chronic, progressive, and disabling autoimmune disease of the central nervous system (‘CNS’), i-e., the brain and spinal cord—and used to treat moderate to severe Crohn’s Disease (‘CD’}—a chronic, autoimmune disease of the gastrointestinal (‘GI’) tract.” /d. (quoting D.L. 98 [J 29-33).

“In February 2005, it was discovered that a small number of individuals who had received Tysabri during the clinical trials developed progressive multifocal leukoencephalopathy (‘PML’)—an infection of the brain.” Jd. (quoting D.I. 98 [J 38-39). “Individuals may develop PML when John Cunningham polyomavirus or John Cunningham Virus (‘JCV’) is reactivated in the body.” Jd. (quoting D.I. 98 40). “Biogen scientists worked on developing assays to address how to better predict whether a patient is at risk of developing PML while taking Tysabri.” Jd. “In January 2012, the FDA approved the ‘first and only clinically and analytically validated anti- JCV antibody assay, the Stratify™ JCV Antibody Enzyme-Linked Immunosorbent Assay (‘ELISA’) Test (‘Stratify’ or the ‘Stratify assay’).’” Jd. (quoting D.I. 98 4 56). IL. LEGAL STANDARDS “A district court is accorded a wide discretion in determining the admissibility of evidence under the Federal Rules.”! “The Court is vested with broad inherent authority to manage its cases, which carries with it the discretion and authority to rule on motions in limine prior to trial.” “A motion in limine is a vehicle to exclude inadmissible or prejudicial evidence before it is offered at trial.”? “A motion in limine is designed to ‘narrow the evidentiary issues for trial and to eliminate unnecessary trial interruptions.” “A motion in limine is appropriate for ‘evidentiary

' Toledo Mack Sales & Serv., Inc. v. Mack Trucks, Inc., 386 F. App’x 214, 218 (3d Cir. 2010) (nonprecedential) (quoting United States v. Abel, 469 U.S. 45, 54 (1984)). 2 DNOW, L.P. v. Schramm, Inc., No. CV 17-1575, 2019 WL 13229219, at *1 (D. Del. May 17, 2019) (quoting Ridolfi v. State Farm Mut. Auto. Ins. Co., No. CV 15-859, 2017 WL 3198006, at *2 (M.D. Pa. July 27, 2017)). 3 Novartis AG v. Actavis Elizabeth LLC, No. CV 14-1487-LPS, 2017 WL 1398347, at *2 (D. Del. Apr. 17, 2017); see Chervon (HK) Ltd. v. One World Techs., Inc., No. CV 19-1293-GBW, D.I. 521 at 2 (D. Del. Feb. 5, 2025). 4 Chervon, No. CV 19-1293-GBW, D.I. 521 at 2 (quoting Bradley v. Pittsburgh Bd. of Educ., 913 F.2d 1064, 1069 (3d Cir. 1990)); see Fed. Judicial Ctr., Patent Case Management Judicial Guide

submissions that clearly ought not be presented . . . because they clearly would be inadmissible for any purpose.’”° Although “[m]Jany motions in limine do require the court’s disposition pretrial,” United States v. Adams, 36 F.4th 137, 150 (3d Cir. 2022), “motions in limine often present issues for which final decision is best reserved for a specific trial situation.” Walden v. Georgia-Pac. Corp., 126 F.3d 506, 518 n.10 (3d Cir. 1997). Thus, “[a] trial court considering a motion in limine may reserve judgment until trial in order to place the motion in the appropriate factual context.” “Trial courts [are] [often] more reluctant to exclude evidence in a bench trial than a jury trial.” Wright v. Elton Corp., No. CV 17-286-JFB, 2022 WL 1091280, at *1 (D. Del. Apr. 12, 2022). “Courts have often denied motions in limine in bench trials because the rationale underlying motions in limine does not apply [equally] in bench trials.”’ “While some courts do

(3d ed. 2016) (“Motions in limine provide the court with an opportunity to establish procedures and substantive limitations that will streamline the evidence, shorten the trial, and reduce jury confusion.”). 5 Chervon, No. CV 19-1293-GBW, D.I. 521 at 2 (alterations in original) (quoting Evolved Wireless, LLC v. Apple Inc., No. CV 15-542-JFB-SRF, 2019 WL 1100471, at *1 (D. Del. Mar. 7, 2019)); see Leonard v. Stemtech Health Scis., Inc., 981 F. Supp. 2d 273, 276 (D. Del. 2013) (“Evidence should not be excluded pursuant to a motion in limine, unless it is clearly inadmissible on all potential grounds.”). 6 DNOW, 2019 WL 13229219, at *1 (quoting United States v. Tartaglione, 228 F. Supp. 3d 402, 406 (E.D. Pa. 2017)). 1 Zanghi v. Freightcar Am., Inc., No. 3:13-146, 2015 U.S. Dist. LEXIS 196744, at *3 (W.D. Pa. July 31, 2015); see, e.g., Shaw v. CitiMortgage, Inc., No. 3:13-CV-0445-LRH-VPC, 2016 U.S. Dist. LEXIS 55411, at *6-7 (D. Nev. Apr. 26, 2016) (‘As a preliminary matter, the Court notes that trial in this case will be a bench trial. Because of this, the Court will be in a better position to rule upon challenges to witnesses and evidence during the course of trial when there will be more context and a fuller understanding of the issues and evidence in the case. . . . The rationale underlying pre-trial motions in limine does not apply in a bench trial, where it is presumed the judge will disregard inadmissible evidence and rely only upon competent evidence. ... The more prudent course in a bench trial, therefore, is to resolve evidentiary doubts in favor of admissibility.”); Genosource, LLC v. SECURA Ins., No. 21-CV-86 CJW-KEM, 2023 WL

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Biogen Inc. v. Sandoz Inc., (D. Del. 2025).

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