Generically Speaking: A Hatch-Waxman Litigation Bulletin

The Summer 2022 issue of the GENERICally Speaking email 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 we review Q2 cases and issue(s) presented:

• Novartis Pharms. Corp. v. Accord Healthcare, Inc.
  Gilenya® (fingolimod HCl)
  The Federal Circuit granted Defendants’ petition for panel rehearing, vacated its prior decision, and reversed the district court’s judgment that the asserted claims were not invalid for inadequate written description.
• Bausch Health Ireland, Ltd. v. Padagis Israel Pharms., Ltd.
  Duobrii® (halobetasol propionate / tazarotene)
  The court granted summary judgment of no inequitable conduct.
• Astellas US LLC v. Hospira, Inc.
  Lexiscan® (regadenoson)
  After bench trial, the Court found that the patents-in-suit were not infringed by Hospira.

Relevant ANDA updates highlighted in this issue:

• ANDA Approvals
• ANDA Litigation Settlements
• Generic Launches
• New ANDA Cases