GENERICally Speaking Hatch Waxman Bulletin

The Hatch-Waxman Litigation practice group at Robins Kaplan LLP is pleased to offer the latest edition of their quarterly publication regarding ANDA patent litigation issues and the generics business.

GENERICally Speaking: A Hatch-Waxman Litigation Bulletin

First Quarter

The First quarter 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:

  • Jazz Pharms., Inc. v. Avadel CNS Pharms., LLC
    Xyrem® (sodium oxybate)
    Appeals court affirmed finding that a patent covering a computer-implemented system to address REMS conditions is not a method patent appropriately listed in the FDA’s Orange Book as covering a drug’s use.
  • Azurity Pharms., Inc. v. Alkem Labs. Ltd.
    Epaned® (enalapril maleate)
    Relying on the disclosures of the prior art, crediting defendant’s expert testimony, and finding no example in the patent specification that practices all of the claimed limitations, the court found the patents-in-suit invalid as obvious and lacking adequate written description.
  • Vanda Pharms. Inc. v. Teva Pharms. USA, Inc.
    Hetlioz® (tasimelteon)
    District of New Jersey Court finds that, on balance of the pertinent Jumara factors, transfer to the District of Delaware is appropriate.
  • Exelixis, Inc. v. MSN Labs. Private Ltd.
    Cabometyx® (cabozantinib (S)-malate)
    Rejecting defendant’s lead compound analysis, the court found one of the patents-in-suit not invalid as obvious, and another of the patents-in-suit not infringed.
  • Azurity Pharms., Inc. v. Bionpharma Inc.
    Epaned® (enalapril maleate)
    Claim preclusion does not apply when the current claims—which do not include buffer limitations—are not “essentially the same” as prior claims, which contain buffer claim limitations.

Relevant ANDA Updates highlighted in this issue:

Oren D. Langer


Managing Partner, New York Office

New Drug Applications and 505(b)(2) Applications
Reported settlements in federal district court cases
Abbreviated New Drug Applications and 505(b)(2) Applications
Federal district court cases that are filed pursuant to the Hatch-Waxman Act
Xyrem® (sodium oxybate)
Epaned® (enalapril maleate)
Cabometyx® (cabozantinib (S)-malate)
Epaned® (enalapril maleate)

GENERICally Speaking: A Hatch-Waxman Litigation Bulletin