USA's FTC files amicus brief in support of rehearing of ciprofloxacin "pay-for-delay" case

Further confirming its abhorrence of deals made by originator and generic drugmakers delaying the arrival of copy medicines, the US Federal Trade Commission has filed an amicus brief in the US Court of Appeals for the Second Circuit, recommending that it hold a rehearing before all the judges ("en banc") of the ciprofloxacin (Cipro) "pay-for-delay" case.

The case concerns payments made by German drug major Bayer, the branded manufacturer of Cipro, to potential generic competitors. In 1997, to settle patent litigation, Bayer paid its potential generic competitor a total of $398.1 million in exchange for the generic's agreement to stay off the market for six years. On April 29, 2010, the Second Circuit ruled in favor of the defendants in this case, bound by an earlier decision (The Pharma Letter April 30). The Court, however, invited the plaintiffs to seek review by the full Court of Appeals, citing the 'exceptional importance' of the antitrust implications of 'pay-for-delay' settlements.

In its brief, the FTC states that the rehearing is needed so the court can reconsider an earlier ruling regarding 'pay-for-delay' which 'effectively shields a pernicious practice, which imposes enormous costs on American consumers for pharmaceutical drugs, from antitrust scrutiny.'