The panel affirmed District Judge Georgette Castner's denial of J&J's bid to enjoin Samsung's sublicense arrangement with Quallent Pharmaceuticals for private-label distribution of SB17, a biosimilar of Stelara. Stelara generated over $70 billion in sales across its fifteen-year effective patent life.

Circuit Judge Krause, writing for the panel, anchored the opinion in the traditional reluctance to grant pre-judgment relief in contract disputes. "Rarely do courts grant injunctive relief before the plaintiff secures a judgment," Judge Krause wrote, adding that "even more rarely is that relief granted in contract cases, where it is usually the case that monetary damages can later be quantified."

The dispute traces to the September 2023 expiration of Janssen's ustekinumab patent and a subsequent settlement that delayed Samsung's market entry until February 2025. Samsung then struck agreements with Sandoz for exclusive commercialization and separately with Cigna's Quallent subsidiary for private-label distribution.

J&J contended that Cigna's vertically integrated model would let it steer patients to its private-label version, potentially capturing nearly 23% of the national market. The panel found that harm "too speculative," citing expert testimony that any formulary changes might not be "imminent."

Judge Krause also rejected J&J's reliance on older precedent, writing that the company's proposed categorical rule was "contrary to the 'case-by-case' analysis required by this Court." The panel emphasized that "damages are always the default remedy for breach of contract."

On J&J's claim of lost negotiating leverage with Cigna, the court said the company offered only "bald assertions of lost negotiating leverage" without making a "clear showing of immediate irreparable injury."

Judge Castner had credited Samsung's expert economist, who testified that any losses were "relatively modest" and "measurable and quantifiable," over J&J's expert, who pointed to Humira biosimilars as an analog where private-label products captured significant market share.