GENERICally Speaking Hatch Waxman Bulletin

This quarterly 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:

• Amarin Pharma, Inc. v. Hikma Pharms. USA Inc.
  Vascepa® (icosapent ethyl)
  Because plaintiff plausibly pled that, despite its section viii carve-out, defendant had induced infringement of the asserted patents, defendant is not entitled to dismissal at the Rule 12 motion stage.
• Salix Pharms., Ltd. v. Norwich Pharms. Inc.
  Xifaxan® (rifaximin)
  The Federal Circuit affirmed the obviousness of two sets of patents, but also affirmed the denial of generic manufacturer’s Rule 60 motion seeking to carve out an infringing indication in its ANDA after the district court entered judgment of infringement and validity as to patents covering that indication.
• Janssen Pharms., Inc. v. Teva Pharms. USA, Inc.
  Invega Sustenna® (paliperidone palmitate)
  Because the district court applied a more rigid obviousness analysis that that prescribed by KSR, and because claim scope was to “a” patient and not a population of patients, finding of invalidity on the basis of obviousness was vacated and remanded.
• Janssen Pharms., Inc. v. Tolmar, Inc.
  Invega Sustenna® (paliperidone palmitate)
  The Federal Circuit vacating a finding of non-obviousness of an identical patent by another district court did not lead to reconsideration of this court’s finding of non-obviousness because this court applied the reasoning that the Federal Circuit laid out in its opinion while it considered the issue of obviousness at trial.
• Teva Branded Pharm. Products R&D, Inc. v. Amneal Pharms. of NY, LLC
  ProAir® HFA (albuterol sulfate)
  Defendants’ motion for judgment on the pleadings seeking patent delisting from FDA’s Orange Book was granted when the patents did not claim the drug for which the applicant submitted the application or a drug product.
• Pharmacyclics LLC v. Alvogen Pine Brook LLC
  Imbruvica® (ibrutinib)
  Because both parties were vexatious in their litigation conduct, the court denied plaintiffs’ motion for attorneys’ and experts’ fees.

Relevant ANDA Updates highlighted in this issue:

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