IP Law Daily, PATENT—3d Cir.: Third Circuit affirms denial of preliminary injunction in Janssen-Samsung biosimilar licensing dispute, (Apr 15, 2026)

By Steven Melendez

Janssen says it faces irreparable harm from Samsung’s unauthorized licensing of a biosimilar drug that treats plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis, to a Cigna unit.

The Third Circuit affirmed a federal district court’s decision to deny a preliminary injunction to Johnson & Johnson and Janssen Biotech, Inc. (together referred to as Janssen), in a lawsuit which claims that Samsung Bioepis Co., Ltd. issued a license to a Cigna Group unit in violation of a contract between the parties. Janssen had not shown that it would suffer irreparable harm without the injunction, the appellate panel found, noting the standard for irreparable harm is typically high in contract disputes. The case arises from a patent settlement concerning a biologic drug used to treat multiple chronic inflammatory conditions (Johnson & Johnson v. Samsung Bioepis Co. Ltd., No. 25-1831 (3d Cir. Apr. 14, 2026)).

Background. The case involves Janssen’s biologic drug called ustekinumab, marketed under the brand name Stelara and used to treat plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. In September 2023, Janssen’s patent on the composition of ustekinumab expired, letting other manufacturers seek Food and Drug Administration (FDA) approval for biosimilars, such as Samsung’s ustekinumab-ttwe, also known as SB17.

But Janssen claimed SB17 would still infringe various patents it had obtained that were still in effect. Resulting litigation ended with a settlement that acknowledged that SB17 would “infringe on one or more” Janssen patents without the agreement, delayed SB17’s entry into the market until February 2025 and gave Samsung a limited patent license. This prohibited sublicensing with a few exceptions, including for “commercialization partners to import, sell and offer to sell SB17 Product on behalf of [Samsung],” according to the ruling.

Samsung entered into a commercialization agreement and sublicense agreement with Sandoz AG, which Sandoz claimed in a press release gave it “exclusive rights to commercialize” SB17, branded as Pyzchiva. Packaging indicated that Samsung manufactured SB17 for Sandoz.

Then, Samsung entered into two other agreements. Samsung and Sandoz in November 2024 a “Private Label Distributor (PLD) Agreement” with Quallent Pharmaceuticals Health LLC, a subsidiary of Cigna Group. That designated Quallent “as a commercialization partner” and said that Samsung “shall manufacture,” Sandoz “shall supply,” and Quallent “shall distribute” SB17. The parties also entered a sublicense agreement giving the Cigna unit a “non-exclusive, non-transferable sublicense” to sell SB17 “under Quallent’s own label,” subject to the terms of Samsung’s license from Janssen. And Cigna’s healthcare provider unit announced it would offer a Stelera biosimilar for $0 out-of-pocket in early 2025.

Janssen sued, claiming Samsung’s sublicense to Quallent breached the settlement agreement since it didn’t fall under the commercialization-partner exception, or any other exception to downstream licensing. Janssen claimed it would be irreparably harmed due to “a potential loss of Janssen’s market share, ability to compete, and negotiation leverage,” according to the appellate ruling, and sought a preliminary injunction.

The parties submitted expert declarations from economists, with Janssen’s economist pointing to the potential for losing almost a quarter of the market—based on Cigna’s large role in the overall prescription market—and Samsung’s expert arguing the loss would be “relatively modest, and at the very least... measurable,” and perhaps not imminent, pointing to previous examples where it takes time to shift a formulary to new biosimilar drugs. The district court found Janssen had not shown irreparable harm, denying a preliminary injunction, and Janssen appealed.

Janssen argued on appeal that loss of market share in a complex market, like the one for biologics, is sufficient to demonstrate irreparable harm; that the calculation of damages need only be difficult, not impossible, to show irreparable harm; that the loss of negotiating leverage with Cigna is not speculative; and that the severity of its injury should have factored more in the district court analysis.

Loss of market share. Janssen argued it would suffer permanent loss of market share, and thus irreparable harm, citing Third Circuit precedent Novartis Consumer Health, Inc. v. Johnson & Johnson-Merck Consumer Pharmaceuticals Co., 290 F.3d 578 (3d Cir. 2002). But the appellate panel distinguished the cases, finding that the case for irreparable injury was stronger in the Novartis case, which involved competing nighttime heartburn medication. There, a new medication had already had a measurable effect, and due in part to brand loyalty, the court found post-trial remedies would not suffice. “Here, in contrast, the market consequences of Quallent’s private-label entering the marketplace are not yet known, and biologics patients, who are often steered to the label prescribed by their doctors, are not ‘brand-loyal,’” according to the ruling.

Additionally, that was a Lanham Act case in an era when the Third Circuit presumed irreparable harm in trademark infringement cases. And, the court found, it “subsequently disavowed” the “presumption in play” in Novartis after the Supreme Court ruling on irreparable harm in the patent context in eBay Inc. v. MercExchange, L.L.C., 547 U.S. 388 (2006).

Generally, in breach of context cases, “damages are always the default remedy,” the court noted.

Difficult calculation. Janssen also argued that the district court erred in requiring calculation of damages be “impossible” or be damages “incapable of calculation” rather than merely “difficult to calculate.”

That has been a standard used for injuries to reputation and other intangible harms, rather than market share-related harms, the court found, but the “impossible” standard comes directly from Third Circuit caselaw. And the district court, according to the appellate ruling, did not require that calculation be truly “impossible” but that it be “impracticable” or “practically impossible.”

Loss of negotiating leverage. Janssen also claimed the district court erred in “essentially ignoring an entire category of irreparable harm,” meaning its loss of negotiating leverage against Cigna and other companies if the Quallent drug came on the market. But the appeals court found the district court did review the related evidence and cited cases but found the claimed loss, as a factual matter, “too speculative.”

The appellate panel reviewed the finding “for clear error” but found none. And cases cited by Janssen didn’t hold that loss of negotiating power was enough for a preliminary injunction. “None held that loss of negotiating power alone was sufficient to support a preliminary injunction, and some did not address the irreparable harm factor at all,” according to the ruling.

Severity of harms. Jenssen also claimed the district court erred by holding it to a specific “severity” threshold. But the appeals court found the district court had not adopted a specific “percentage threshold,” and that severity of financial harm is a factor, such as in cases where financial harm might put a party out of business.

“The District Court thus correctly determined that the severity of financial harm in this case did not entitle Janssen to a preliminary injunction,” the court found.

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: Johnson & Johnson; Samsung Bioepis Co. Ltd.

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