Health Law Daily Wrap Up, DRUGS AND BIOLOGICS—3d Cir.: Biologics manufacturers failed to establish irreparable harm in biosimilar controversy, (Apr 17, 2026)

By Sherri M. Schroeder, J.D.

The appeals court agreed that Janssen failed to show irreparable harm would be caused by Samsung issuing a license to its subsidiary to market a Stelara biosimilar.

Johnson & Johnson and Janssen Biotech, Inc. (Janssen) claim that Samsung Bioepis Co., Ltd. (Samsung) issued a license to a subsidiary of the Cigna Group to market a Stelera biosimilar in violation of Samsung’s contract with Janssen. Janssen also claims that the court should issue a preliminary injunction against Samsung because the harms to Janssen would be otherwise irreparable. A district court disagreed and denied the injunction, holding that Janssen had not shown irreparable harm. Upon appeal, the U.S. Court of Appeals for the Third Circuit affirmed the denial, finding that none of Janssen’s arguments—loss of market share as per se irreparable harm, the standard for when damages are unavailable, loss of negotiating leverage, and consideration of the severity of Janssen’s alleged harms—were persuasive (Johnson & Johnson v. Samsung Bioepis Co., No. 25-1831 (3d Cir. Apr. 14, 2026))

Biosimilars. Janssen developed and patented ustekinumab, a biologic generally referred to and marketed under the brand name “Stelara.” After Stelara’s patent expired, Samsung attempted to obtain FDA approval of its “SB17” biosimilar. Janssen sued, claiming infringement of various patents related to Stelar. A settlement agreement ended the litigation. Later, after Samsung entered into a private-label distributor agreement with a subsidiary of the Cigna Group, that Cigna subsidiary announced it would begin to offer a Stelera biosimilar for $0 out-of-pocket for eligible patients in early 2025. Janssen then filed suit, claiming breach of the settlement agreement. One of Janssen’s claims asserted that it would be irreparably harmed because the distribution of the private-label biosimilar would result in a potential loss of Janssen’s market share, ability to compete, and negotiation leverage. Janssen then motioned for a preliminary injunction to prevent Samsung from supplying the biosimilar to Cigna subsidiary or authorizing its distribution during the pendency of the litigation. A district court denied the motion, and Janssen appealed.

Market share. Janssen’s first argument was that the introduction of the private-label product would necessarily have a permanent negative impact on Janssen’s sales, customer relationships, and pricing. Janssen used Novartis Consumer Health v. Johnson & Johnson-Merck Consumer Pharmaceuticals (290 F.3d 578 (3d Cir. 2002)) to say that such a “permanent” loss of market share per se constitutes irreparable harm. However, the court found Novartis to be inapposite because (1) the evidence in the case supporting irreparable injury from loss of market share was “far stronger;” (2) Novartis arose in the “distinct” context of the Lanham Act during an era when showing of a likelihood of success for trademark infringement and false advertising cases meant that courts applied the presumption, but in the case at hand damages are always the default remedy for breach of contract; and (3) even if the Novartis presumption had applied more generally, the Supreme Court later disavowed the case.

Standard when damages unavailable. Janssen next argued that the district court erred by requiring the damage calculation be “impossible” or “incapable of calculation” to obtain a preliminary injunction. Relying on BP Chemicals Ltd. v. Formosa Chem & Fibre (229 F.3d 254 (3d Cir. 2000)), Janssen argued that it should have been sufficient to establish the calculation of damages was merely “difficult to calculate.” The court, however, stated that Janssen took the BP Chemicals language out of context. The court clarified that BP Chemicals held that “injuries to reputation are difficult to calculate, and thus money damages are an inadequate remedy,” and later precedent extended that to other intangible harms. In the instant case, however, Janssen did not allege intangible harms, but rather lost sales and market share. Furthermore, the district court was not requiring the damage calculation be truly “impossible,” but rather that the calculation be “impracticable.”

Loss of negotiating leverage. Janssen next argued the district court erred in completely ignoring its loss of negotiating leverage if the private-label biosimilar entered the market. The appeals court, however, pointed out that the district court did consider Jenssen’s evidence of potential loss of negotiating leverage and the cases cited, but determined as a factual matter that Janssen’s claimed loss of negotiating leverage against Cigna was “too speculative.” A movant must demonstrate an actual and imminent injury, not one that is remote or speculative. “The bald assertion of irreparable harm from a loss of negotiating leverage and the ‘domino effect’ that loss allegedly would have on a movant’s business does not clear that threshold,” the court stated. “Yet bald assertions of lost negotiating leverage are all that Janssen has presented.”

Severity threshold. Lastly, Jenssen argued the district court erred as a matter of law by subjecting Janssen’s loss of market share to a specific “severity” threshold. The court, however, explained that when the district court stated it was not persuaded that the introduction of the private-label biosimilar would “crush the market,” it was simply distinguishing Abbott Laboratories v. Sandoz, which is an out-of-circuit case where the plaintiff alleged it would “face a 90% decline in market share” if a generic drug entered the market. The district court in this case was not adopting a particular percentage threshold for lost market share, per the court. However, “at the extremes, the severity of harm does have a role to play in the irreparable harm inquiry in breach of contract cases,” stated the court. However, according to the court, Janssen did not establishe that it is so reliant on Stelara sales that it would not be able to easily absorb any short-term harm before a trial on the merits. Therefore, the district court correctly determined that the severity of financial harm in this case did not entitle Janssen to a preliminary injunction.

Conclusion. Therefore, the court found the district court had applied the correct legal standards when assessing Janssen’s purported injuries absent a preliminary injunction, considered all the parties’ evidence, and reasonable concluded that Janssen was not likely to suffer irreparable harm. Because Janssen failed to meet its evidentiary burden, the court affirmed the district court’s denial of the preliminary injunction.

The case is No. 25-1831.

Judge: Krause, C.

Attorneys: Lisa S. Glasser (Irell & Manella LLP) for Johnson & Johnson. Bram M. Alden (Hueston Hennigan LLP) for Samsung Bioepis Co. Ltd.

Companies: Samsung Bioepis Co. Ltd.; Johnson & Johnson

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