The provisions of U.S. regulatory law regarding FDA approval for less than all the indications for which an innovator drug was approved under 21 U.S.C. § 355(j)(2)(A)(viii) (the.
Litigation involving drug price reporting under the Medicaid Drug Rebate Program (MDRP) has been very active in 2022. Most recently, on August 3, 2022, an Illinois federal jury.
The Federal Circuit today affirmed a decision by the District Court denying defendant Thales DIS AIS Deutschland USA's motion for preliminary injunction to prevent patentee plaintiff.
One of the most basic questions under the False Claims Act—what facts a relator must plead to state a claim—is also one of the most difficult to answer.