Rush Bill HR 3709 would curb drug patent settlement agreements, says HP&M lawyer

The US Congress has been silent on new legislation addressing drug patent settlement agreements (aka “reverse payment agreements” or “pay-for-delay agreements”) since the US Supreme Court issued its June 2013 opinion in Federal Trade Commission versus Actavis 570 (The Pharma Letter June 18), notes Kurt Karst, writing on the Hyman, Phelps & McNamara FDA Law Blog.

The Court declined to hold that reverse payment settlement agreements are presumptively unlawful, and that “Courts reviewing such agreements should proceed by applying the ‘rule of reason,’ rather than under a ‘quick look’ approach.”

Notwithstanding the Court’s holding on the appropriate test to apply to drug patent settlement agreements, however, the Court also held that the FTC should have been given the opportunity to prove its antitrust claims and that the exclusionary potential of a patent does not immunize a drug patent settlement agreement from antitrust attack, said Mr Karst, noting that the case in now progressing as reported by Law360.