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ARTICLE · 17 JULY 2024

GENERICally Speaking: A Hatch-Waxman Litigation Bulletin

Robins Kaplan LLP
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This quarterly issue of the GENERICally Speaking campaign provides you and your company with some of the knowledge beneficial to remaining attentive to the complexity of ANDA patent litigation.

United StatesIntellectual Property
Oren D. Langer
Oren D. Langer
Christopher A. Pinahs
Christopher A. Pinahs
Emily J. Tremblay
Emily J. Tremblay
Christine May
Christine May

This quarterly issue of the GENERICally Speaking campaign provides you and your company with some of the knowledge beneficial to remaining attentive to the complexity of ANDA patent litigation.

In this issue:

  • Amarin Pharma, Inc. v. Hikma Pharms. USA Inc.
    Vascepa® (icosapent ethyl)
    Because plaintiff plausibly pled that, despite its section viii carve-out, defendant had induced infringement of the asserted patents, defendant is not entitled to dismissal at the Rule 12 motion stage.
  • Salix Pharms., Ltd. v. Norwich Pharms. Inc.
    Xifaxan® (rifaximin)
    The Federal Circuit affirmed the obviousness of two sets of patents, but also affirmed the denial of generic manufacturer's Rule 60 motion seeking to carve out an infringing indication in its ANDA after the district court entered judgment of infringement and validity as to patents covering that indication.

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