The attorneys general of several states (the States) today announced their submission, for approval by the U.S. District Court for the District of New Jersey, of a settlement agreement with Akzo Nobel, N.V., and its subsidiary, Organon USA Inc. (collectively, Organon), resolving the States' allegations that Organon violated the antitrust laws by engaging in various anticompetitive acts relating to its anti-depressant drug, Remeron. The States' complaint alleges, among other things, that Organon made a "fraudulent misrepresentation" to the FDA about the claims of a patent listed on the FDA's Orange Book, so as to delay by approximately eight months the introduction of generic competition to Remeron. Under the settlement, Organon would pay tens of millions of dollars in damages and become subject to strong injunctive terms barring future anticompetitive conduct.
Federal Trade Commission staff conducted a parallel, nonpublic investigation regarding Organon's conduct. The FTC staff's investigatory record contains significant evidence indicating that Organon may have violated Section 5 of the Federal Trade Commission Act by knowingly making misleading statements to the FDA in order to delay introduction of generic competition to Remeron.
FTC staff closely coordinated their investigation with the States. Working with the States, FTC staff took the lead in developing and negotiating the injunctive terms that are encompassed in the States' proposed settlement. In consideration of the comprehensive, effective, and appropriate injunctive terms contained in the States' proposed settlement, the FTC's investigation into Organon's activities relating to Remeron has been closed.