GENERICally Speaking Hatch Waxman Bulletin

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:

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