The settlement at issue granted Samsung a limited patent license that permitted sublicenses only to "commercialization partners" selling the biosimilar SB17 "on behalf of" Samsung. Janssen sued after Samsung and Sandoz entered a Private Label Distributor Agreement with Quallent Pharmaceuticals Health LLC, a Cigna Group subsidiary, and granted Quallent a non-exclusive sublicense to sell SB17 under Quallent's own label.
Stelara generated over $70 billion in sales during its fifteen-year effective patent life, according to the opinion. Janssen's core ustekinumab patent expired in September 2023, after which Samsung obtained FDA approval for SB17 and the parties settled related patent litigation.
U.S. District Judge Georgette Castner found Janssen likely to succeed on the merits of its breach-of-contract claims but denied the preliminary injunction after crediting Samsung's expert, Dr. DeForest McDuff, who opined that any harm to Janssen would be quantifiable and might not even be imminent. Janssen's expert, Dr. Robert Popovian, had argued that Cigna's roughly 23% share of the U.S. prescription market meant the private-label biosimilar could capture nearly a quarter of potential consumers nationally, citing Humira's 31% market-share loss to private-label biosimilars.
Writing for a unanimous panel, Circuit Judge Krause affirmed. The court held that because damages are the default remedy for breach of contract, the availability of monetary damages typically precludes a finding of irreparable harm, and rejected Janssen's argument that loss of market share in a complex biopharmaceutical market is categorically sufficient to establish irreparable injury.
The panel distinguished its prior Novartis decision, which involved false advertising claims under the Lanham Act and applied a presumption of irreparable harm that the court said had been discredited by the Supreme Court's eBay and Winter decisions. The correct standard, the panel said, requires showing that damage calculation is impracticable or practically impossible, not merely difficult.
Janssen's own Humira evidence cut against it, the court found, because that market study showed the brand manufacturer reached a co-branding agreement under which its healthcare-conglomerate competitor could reap a percentage of its profits in exchange for returning Humira to its formulary. That suggested negotiating disadvantages could be remedied through monetary arrangements, the panel said.
On Janssen's claim that it would lose negotiating leverage against Cigna, the court 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 panel said the standard requires proof of actual and imminent rather than remote or speculative harm.
The panel affirmed the denial on all four of Janssen's arguments.