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United States: Pharmaceutical Antitrust

Michael Gallagher et al., GCR - The Antitrust Review of the Americas 2017, August 2016

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The past year has seen an increase in US case law developments in the area of pharmaceutical antitrust. This chapter focuses on the four types of pharmaceutical antitrust cases that have been most active: • US trial court and appellate court decisions adjudicating antitrust claims under the rule of reason test announced by the US Supreme Court in Federal Trade Commission v Actavis for innovator and generic settlements of pharmaceutical patent litigation involving alleged reverse payments or pay for delay; • so-called product-hopping antitrust claims against innovator pharmaceutical companies that introduce new versions of brand-name drugs facing generic competition; • alleged barriers to competition created when innovator companies deny generic companies access to sample product under REMS safety restrictions on distribution; and • challenges to pharmaceutical manufacturers’ pricing practices...

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