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September 4, 2012

FTC August Actions Continue to Put a Spotlight On Pharmaceutical Patent Agreements


The Federal Trade Commission (FTC) demonstrated that it was not taking a summer break this August, but rather turning up the heat in its efforts to scrutinize the competitive effects of pharmaceutical industry agreements regarding patents. On August 13, 2012, the FTC announced that it was proposing to amend the Hart-Scott-Rodino (HSR) premerger notification rules to broaden the types of exclusive patent rights transfers—in the pharmaceutical industry only—that are reportable under the HSR Act. The FTC also announced that it moved for leave to file an amicus brief in US District Court in New Jersey in In re Effexor XR Antitrust Litigation, arguing that a branded company's commitment not to launch an authorized generic (AG) in competition with a generic company (a "no-AG commitment") as part of a patent settlement constitutes a "payment" for delayed generic entry under the Third Circuit's recent decision in In re K-Dur Antitrust Litigation adopting the FTC's position on the standard for antitrust review of pharmaceutical patent settlements.