Johnson & Johnson v. Samsung Bioepis Co Ltd

── Johnson & Johnson v. Samsung Bioepis Co Ltd ── Court: Court of Appeals for the Third Circuit Date: April 14, 2026 Category: General U.S. COURT OF APPEALS FOR THE THIRD CIRCUIT No. 25-1831 JOHNSON & JOHNSON, a New Jersey corporation; JANSSEN BIOTECH, INC., a Pennsylvania corporation, Appellants v. SAMSUNG BIOEPIS CO. LTD., a Korean corporation. ________________ Appeal from the U.S. District Court, D.N.J. Judge Georgette Castner, No. 3:25-cv-01439 Before: HARDIMAN, KRAUSE, and FREEMAN, Circuit Judges Argued Sept. 9, 2025; Decided Apr. 14, 2026 ________________ OPINION OF THE COURT KRAUSE, Circuit Judge. Rarely do courts grant injunctive relief before the plaintiff secures a judgment. And even more rarely is that relief granted in contract cases, where it is usually the case that monetary damages can later be quantified, so the plaintiff’s alleged injury does not qualify as “irreparable harm.” Nevertheless, in some contexts, we have recognized that the complexity or risk of permanent alteration of a given market can make ascertaining legal loss impossible and thus render monetary damages impractical. Such is the case here, according to Appellants Johnson & Johnson and Janssen Biotech, Inc. (together Janssen). Janssen claims that Appellee Samsung Bioepis Co., Ltd. (Samsung) issued a license to a subsidiary of the Cigna Group in violation of Samsung’s contract with Janssen, and that a preliminary injunction should issue against Samsung because the harms to Janssen would otherwise be irreparable. Because we agree with the District Court that Janssen failed to establish irreparable harm, we will affirm its denial of relief. I. BACKGROUND A. Factual Background This case concerns the marketplace for “biologics,” a “class of medications that derive from natural sources, such as living cells and entities.” App. 2 (citation modified). Because these medications are “far more costly to manufacture than traditional small molecule pharmaceuticals,” id. (citation modified), patents that cover them are closely guarded, and those that are effective and popular can generate significant profits. But patents expire, and though they are typically enforceable for a twenty-year term after the filing date, see 35 U.S.C. § 154(a)(2), the “effective patent life” of a biologic— the period of actual market exclusivity from the time a medication clears the post-filing clinical trials and regulatory approvals and reaches the marketplace until the expiration of the patent, see Proveris Sci. Corp. v. Innovasystems, Inc., 536 2 F.3d 1256, 1260-61 (Fed. Cir. 2008)—is typically far shorter, see In re Forest, 134 F.4th 1198, 1200 n.3 (Fed. Cir. 2025). At the end of a biologic’s effective patent life, manufacturers of generic versions of the medication, called “biosimilars,” can enter the biologics market. Not surprisingly then, patent holders typically seek to enforce their rights for as long as possible, often obtaining related or overlapping patents so they can still require biosimilar manufacturers to obtain a license even after the original patent expires.1 That was the strategy pursued by Janssen after it developed and patented ustekinumab, a biologic generally referred to and marketed under the brand name “Stelara.” Stelara is used to treat plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis, and over its fifteen-year effective patent life, Stelara generated sales of over $70 billion. In September 2023, however, Janssen’s patent on the composition of ustekinumab—U.S. Patent No. 6,902,734 (the ’734 Patent)— expired, opening the door for other manufacturers, like Samsung, to obtain FDA approval for their ustekinumab biosimilars—in Samsung’s case, called ustekinumab-ttwe or “SB17.” Janssen, however, claimed that SB17 would still infri