FTC files amicus brief outlining harm caused by improper Orange Book listings

The USA’s Federal Trade Commission (FTC) says it has filed an amicus brief to address the anticompetitive harm that stems from improperly listed patents in the Food and Drug Administration’s (FDA) publication of “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the “Orange Book.”

The Commission’s filing relates to an antitrust case brought by drug manufacturer Mylan Pharmaceuticals and several other affiliated entities alleging that the US subsidiary of French pharm major Sanofi (Euronext: SAN) and other affiliated entities have engaged in anticompetitive conduct to monopolize the market for injectable insulin glargine, a drug used to treat diabetes. Mylan alleges Sanofi monopolized the injectable insulin glargine market in part by abusing the FDA’s Orange Book regulatory process. Specifically, Mylan alleges Sanofi delayed and blocked Mylan’s generic drug called Semglee from competing with Sanofi’s branded insulin glargine drug Lantus by improperly listing several drugs in the Orange Book.

Delaying consumer access to a lower-priced competing drug