Stay Pending IPR Does Not Justify Extension of Statutory 30-Month Stay of FDA Approval

The court denied plaintiffs' motion to extend the stay of FDA approval after the court granted defendants' renewed motion to stay pending inter partes review. "Plaintiffs argue that if the Court grants Defendants’ request for a stay, the Court should order corresponding extension of the regulatory stay. There is no law that justifies this request. The only basis that courts have relied on to extend the regulatory stay is the violation of the statutory requirement of 21 U.S.C. § 355(j)(5)(B)(iii) that a party has failed to reasonably cooperate in expediting the litigation. There is no basis to make such a finding in this case. Therefore, the Court declines Plaintiffs’ invitation to extend or toll the regulatory law stay."

Eli Lilly and Company et al v. Accord Healthcare, Inc. et al, 1-14-cv-00389 (INSD December 11, 2015, Order) (Baker, M.J.)