A U.S. District Court has lifted a temporary restraining order on Eli Lilly that was issued on May 26 in response to a lawsuit brought against the company by Amylin Pharmaceuticals. It denied Amylin’s request for a preliminary injunction on the Lilly diabetes sales force and other relief.
On May 16, Amylin said that it had filed a case against Lilly because the latter’s collaboration with Boehringer Ingelheim (BI) conflicted with Amylin’s relationship with Lilly. Amylin and Lilly have an almost 10-year partnership centered on commercializing the now FDA-approved injectable diabetes drug Byetta® (exenatide) and the long-acting exenatide formulation Bydureon™, which has yet to be approved in the U.S. but was recommended for approval in Europe in April.
One of the drugs covered under Lilly and BI’s type 2 diabetes drug deal, signed in January, is the oral dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin, which Amylin says will directly compete with exenatide products. Linagliptin is currently under regulatory review in Europe and Japan, and received FDA approval on May 3.
Amylin is seeking a preliminary and permanent injunction to stop Lilly from using the same sales force to sell both exenatide and linagliptin. Commenting on the most recent court decision, Amylin says, "Amylin continues to believe that Lilly's conduct violates our diabetes collaboration agreements, is anticompetitive, and limits patients' treatment options.
“It is important to note that the Court's decision did not make any findings on the merits of our claims but merely declines to award injunctive relief based on the conclusion that monetary damages would be sufficient,” the company pointed out. “We intend to vigorously pursue the litigation to enforce our legal and contractual rights."
Lilly of course was pleased with the decision, stating, "We have complied with our contractual obligations under our agreements with Amylin and done so in a manner fully consistent with all applicable laws,” Robert A. Armitage, svp and general counsel for Lilly, says. “We believe that Amylin's allegations against Lilly are entirely without merit, and we fully expect to prevail in this litigation."