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In 2016, in Apotex Inc. v. Acorda Therapeutics, Inc., the United States Court of Appeals for the Second Circuit held that a generic drug company could not rely solely on the timing of the Food and Drug Administration’s (“FDA’s”) disposition of a citizen suit and approval of a generic application to state a claim under the Sherman Act based on sham litigation. By contrast, in 2009, in In re DDAVP Direct Purchaser Antitrust Litigation, the Second Circuit held that precisely such evidence was sufficient to state a Sherman Act claim. This Comment argues that the Second Circuit’s revision of the burden of proof for showing a sham citizen suit incentivizes brand-name drug companies to file sham citizen suits as a means to extend their monopolies, which would harm both generic drug manufacturers and the American public. Given the competitive and public health ramifications associated with regulating prescription drugs, it is crucial that U.S. courts give sufficient weight to the underlying policies behind consumer-protection statutes such as the Hatch-Waxman Act and the Sherman Act in order to avoid unintentionally harming the public.


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5 Sep 2022
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  • Subject
    • Consumer Protection Law

    • Courts

    • Food and Drug Law

    • Health Law and Policy

    • Litigation

  • Journal title
    • Boston College Law Review

  • Volume
    • 58

  • Issue
    • 6

  • Pagination
    • E. Supp. 147

  • Date submitted

    5 September 2022