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:

The articles on our website include some of the publications and papers authored by our attorneys, both before and after they joined our firm. The content of these articles should not be taken as legal advice. The views and opinions expressed in this article are those of the author(s) and do not necessarily reflect the views or official position of Robins Kaplan LLP.


Oren D. Langer


Managing Partner, New York Office

Christine May


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