Reverse Payments by Patent Holders Likely to be Challenged

According to Diane Green-Kelly, of Mayer, Brown, Rowe & Maw LLP, recent decisions make it clear that settlement agreements between drug manufacturers to resolve patent infringement litigation triggered by a paragraph IV certification (for approval of a generic drug under the Hatch-Waxman Act) involving "reverse payments" made by a patent holder to an alleged infringer will be treated as highly suspect. Now that such agreements must be filed with the FTC and the DOJ within 10 days of their execution, drug manufacturers contemplating such agreements should be prepared to defend them on the merits against an almost certain challenge.