Writing for a unanimous panel, Circuit Judge Krause affirmed U.S. District Judge Georgette Castner's denial of a preliminary injunction that would have halted Samsung's supply of SB17, marketed as Pyzchiva, to Quallent Pharmaceuticals Health LLC during the pendency of Janssen's breach-of-contract suit.
The underlying dispute centers on Stelara, Janssen's biologic treatment for plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis, which generated over $70 billion in sales over its fifteen-year effective patent life. After Janssen's core ustekinumab patent expired in September 2023, Samsung obtained FDA approval for SB17 and settled related patent litigation with Janssen. The settlement granted Samsung a limited patent license and permitted sublicenses only to "commercialization partners" selling SB17 "on behalf of" Samsung.
Samsung and Sandoz later entered a Private Label Distributor Agreement with Quallent, a Cigna Group subsidiary, and Samsung issued Quallent a companion sublicense to sell SB17 under Quallent's own label. Janssen argued the arrangement fell outside the commercialization-partner exception and sought to enjoin the supply during litigation.
Judge Castner credited Samsung's expert, Dr. DeForest McDuff, over Janssen's expert, Dr. Robert Popovian, and concluded Janssen had not shown its damages would be incapable of calculation. She denied the injunction despite finding Janssen likely to succeed on the merits of its breach-of-contract claims.
The Third Circuit rejected Janssen's argument that loss of market share in a complex biopharmaceutical market is categorically sufficient to establish irreparable injury. The panel held that because damages are the default remedy for breach of contract, the availability of monetary damages typically precludes a finding of irreparable harm.
The court distinguished its prior Novartis decision, noting it involved false advertising claims under the Lanham Act, where courts historically applied a presumption of irreparable harm that has been discredited by the Supreme Court's rulings in eBay and Winter. The panel also found Janssen's own Humira evidence cut against it, noting the brand manufacturer there reached a co-branding agreement allowing its healthcare-conglomerate competitor to reap a percentage of its profits in exchange for returning Humira to its formulary.
On Janssen's final argument regarding negotiating leverage against Cigna, the panel held that 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 the threshold. The court required proof of actual and imminent harm rather than remote or speculative injury, and affirmed the denial on all four of Janssen's arguments.