The Third Circuit rejected Johnson & Johnson's attempt to halt Samsung Bioepis from supplying its Stelara biosimilar to Quallent Pharmaceuticals, a subsidiary of healthcare giant Cigna, in a dispute over whether the arrangement violated their settlement agreement. The case centers on Samsung's ustekinumab biosimilar SB17 and a drug that generated over $70 billion in sales over its fifteen-year effective patent life.

Circuit Judge Krause, writing for a unanimous panel, rejected J&J's core argument that market share loss in complex pharmaceutical markets should be treated as categorically irreparable. "Rarely do courts grant injunctive relief before the plaintiff secures a judgment," Judge Krause wrote, explaining 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 arose after Janssen's patent on ustekinumab expired in September 2023, leading to a settlement agreement that delayed Samsung's market entry until February 2025. Samsung then entered agreements with both Sandoz for exclusive commercialization rights and separately with Cigna's Quallent subsidiary for private-label distribution.

J&J argued that Cigna's vertically integrated healthcare model would allow it to steer patients to its private-label version, potentially capturing nearly 23% of the national market. But the appeals court held the claimed harm "too speculative," particularly given expert testimony that any formulary changes might not be "imminent."

Judge Krause 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."

The court also rejected J&J's argument about lost negotiating leverage with Cigna, noting that J&J provided only "bald assertions of lost negotiating leverage" without demonstrating a "clear showing of immediate irreparable injury."

District Judge Georgette Castner had concluded that Samsung's expert economist was more persuasive in arguing that any losses were "relatively modest" and "measurable and quantifiable," compared to J&J's expert who pointed to similar dynamics with Humira biosimilars where private-label products captured significant market share.