Cash Payments To Settle Hatch-Waxman Litigation Do Not Violate Antitrust Laws

A unanimous panel of the U.S. Court of Appeals for the Federal Circuit affirmed a district court's grant of summary judgment granted to Bayer, holding that reverse payment settlements of a bona fide patent litigation are within the exclusionary zone of the patent and not redressable by federal antitrust law. In re Ciprofloxacin Hydrochloride Antitrust Litigation, Case Nos. 08-1907 (Fed. Cir., Oct. 15, 2008) (Prost, J.).

Bayer owns a patent directed to compounds that exhibit antibacterial properties, specifically ciprofloxacin hydrochloride, the active ingredient in Cipro®. Barr Labs, a generic drug manufacturer, filed an Abbreviated New Drug Application (ANDA) for a generic version of Cipro®. Included in the ANDA was a Paragraph IV certification, which indicated that Barr was seeking to market its product prior to the expiration of the Bayer patent because the patent was invalid. As the first Paragraph IV ANDA filer, Barr was entitled to a 180-day period of market