The US Federal Trade Commission has filed a friend-of-the-court (amicus) brief in the US Court of Appeals for the Second Circuit, clarifying the legal standards that apply in certain antitrust cases involving the pharmaceutical sector.
The case relates to Forest Laboratories and six generic drug manufacturers’ alleged efforts to delay competition with Bystolic (nebivolol), Forest’s brand-name high blood pressure drug. In the Commission’s brief, the FTC urged the appeals court to reverse a district court’s decision to dismiss the case and recognize that large reverse payments Forest made to the generic companies may violate the antitrust laws.
Reverse-payment settlements, also known as pay-for-delay, are agreements in which a brand-name drug manufacturer pays a would-be generic competitor - whether in monetary or non-monetary form - to abandon a patent challenge and refrain from offering its generic drug product for a number of years.
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