Amid the global shortage of prostate cancer drug Lupron, AbbVie took its partner Takeda to court over alleged failures to live up to supply agreements. Now, a court has denied the company's plea to force Takeda to fill orders.
In an opinion (PDF) this week, Delaware Chancery Court Vice Chancellor Sam Glasscock III denied AbbVie's request to compel Takeda to fill supply orders from its plant in Hikari, Japan.
Under a deal between the companies, AbbVie sells the drug in the U.S. and Canada. Because Takeda is the sole supplier of the drug worldwide, AbbVie relies on the Japanese drugmaker for its product.
Problem is, the med has been in short supply worldwide after the FDA and Takeda in 2019 found "protocol violations" at the plant, Glasscock wrote in this week's opinion. Thanks to "remediation efforts" including a weeks-long production hold global supply hiccups and shortages have persisted to this day, Glasscock wrote.
AbbVie had asked the court to find that Takeda breached its contract plus issue damages and "injunctive relief," or an order forcing Takeda to supply the drug. In his new opinion, Glasscock said an injunction would be "unworkable" because it'd force the court to oversee Takeda's operations and would "inevitably lead to contempt hearings" over Takeda's ability to fulfill orders.
"In other words, even if I find that Takeda has breached its contract with AbbVie and that, as a result, AbbVie faces irreparable harm, the injunctive relief sought is unavailable," Glasscock wrote.
The Lupron saga started in November 2019, when FDA inspectors traveled to Japan to review production processes at the Hikari site. In a June 2020 warning letter, the FDA slapped Takeda for poor equipment maintenance, faulty documentation and quality shortfalls. The company has been working to resolve those concerns, but the Lupron problem has dragged on throughout this year.
Right now, the FDA lists most Lupron Depot dose forms as "available" in the U.S., but there's one dose that's not expected to become available until next January.
While Glasscock decided against an injunction forcing Takeda to fill orders, he hasn't made a ruling on whether the company breached its contract. He plans to issue a decision on that issue in "due course," he said, and another trial phase on damages could follow.