GENERICally Speaking

A Hatch-Waxman
Litigation Bulletin

Robins Kaplan LLP's Hatch-Waxman Litigation Practice Group publishes GENERICally Speaking quarterly to provide insights into the complexities of ANDA patent litigation and the generics industry. Designed for professionals navigating this dynamic area, the publication highlights key developments, strategic considerations, and trends shaping the generics landscape.

In this Q4 issue: 

• Purdue Pharma L.P. v. Accord Healthcare, Inc.
  OxyContin® (oxycodone HCl)
  Federal Circuit affirmed finding of obviousness when district court did not err in finding a motivation to combine with a reasonable expectation of success and also did not dismiss Plaintiffs’ secondary consideration arguments.
• Teva Branded Pharm. Products R&D, Inc. v. Amneal Pharms. of NY, LLC
  ProAir® HFA (albuterol sulfate)
  To list a patent in the Orange Book, that patent must, among other things, claim at least the active ingredient; thus, patents claiming just the device components of the product approved in an NDA do not meet the listing requirement of claiming the drug for which the applicant submitted the application.
• Galderma Labs., L.P. v. Lupin Inc.
  Oracea® (doxycycline USP)
  The Court of Appeals affirmed the district court’s finding of no infringement related to a combination immediate/delayed release pharmaceutical formulation.
• Novartis Pharms. Corp. v. MSN Pharms., Inc.
  Entresto® (valsartan/sacubitril)
  The Federal Circuit declined to reconsider and reweigh “highly factual evidence anew” and affirmed the district court’s denial of a preliminary injunction.
• Janssen Pharms., Inc. v. Teva Pharms. USA, Inc.
  Invega Sustenna® (paliperidone palmitate)
  On remand, the court found that defendant did not meet its clear and convincing burden to show that the patent-in-suit, which claimed various dosing regimens for a drug used to treat schizophrenia, was invalid as obvious.
• Melinta Therapeutics, LLC v. Nexus Pharms., Inc.
  Minocin® (minocycline)
  After a bench trial, the court found that the asserted formulation claims were infringed and not invalid.
• Novartis Pharms. Corp. v. Becerra
  Entresto® (sacubitril/valsartan)
  After finding that FDA did not act arbitrarily by excluding part of Entresto’s dosing regimen from the generic manufacturer’s drug label, the court upheld FDA approval for the generic manufacturer.
• Exelixis, Inc. v. MSN Labs. Private Ltd.
  Cabometyx® (cabozantinib (L)-malate)
  Although defendant did not infringe one of the patents-in-suit, the remaining patents-in-suit were found infringed and not invalid on the basis of obvious-type double patenting.
• Silvergate Pharms., Inc. v. Bionpharma Inc.
  Epaned® (enalapril maleate)
  Defendant’s motion for fees on the basis that Plaintiff pursued the litigation for an improper purpose, made arguments that were objectively baseless, and acted in an unreasonable manner in litigating the case, was denied.