GENERICally Speaking Hatch Waxman Bulletin

The Fall 2021 issue of the GENERICally Speaking email 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:

• Belcher Pharms., LLC v. Hospira, Inc.
  Epinephrine
  Federal Circuit affirms finding of unenforceability on the basis of inequitable conduct where plaintiff’s employee—involved in regulatory application and patent prosecution—made inconsistent statements to FDA and PTO Examiner regarding claimed pH range.
• GlaxoSmithKline LLC v. Teva Pharms. USA, Inc.
  Coreg® (carvedilol)
  Appeals court vacated JMOL of non-infringement based on section section viii carve out, reinstated jury’s damages award, and remanded for further proceedings.
• Sun Pharma Global FZE v. Lupin Ltd.
  Bromsite® (bromfenac ophthalmic solution)
  The patent in suit is not infringed and invalid as obvious and indefinite, but not unenforceable on the basis of inequitable conduct.
• Par Pharmaceutical Inc. v. Eagle Pharmaceuticals Inc.
  Vasostrict® (vasopressin)
  Because the ANDA controlled when it came to the issue of infringement, the pH range of the ANDA product fell outside of the claimed pH range, thereby justifying the court’s non-infringement finding.
• Pharmacyclics LLC v. Alvogen Pine Brook LLC
  Imbruvica® (ibrutinib)
  Defendant did not meet its burden in proving that the four patents-in-suit were invalid on the basis of anticipation, obviousness, and lacking adequate written description.
• Amarin Pharma, Inc. v. Hikma Pharms. USA Inc.
  Vascepa® (icosapent ethyl)
  The court recommended denying a motion to dismiss for lack of causation, finding that patentee plausibly pled a novel theory of induced infringement against a health insurance provider who actively encouraged the use of a generic drug through its approval and payment process.
• Takeda Pharma Co. v. Zydus Pharma Inc.
  Prevacid® SoluTab™
  After filing competing summary judgment motions, the court granted plaintiff’s motion and denied defendant’s motion, finding that the underlying patent infringement suit was not a sham litigation.
• Almirall, LLC v. Torrent Pharms., Ltd.
  Aczone® Gel, 7.5% (Dapsone)
  Defendant’s motion pursuant to Fed. R. Civ. P. 12(c) for judgment of non-infringement on the pleadings granted.
• Auxilium Pharms., Inc. v. FCB I LLC
  Testim® (testosterone gel)
  The court denied plaintiff’s motion for a default judgment because the complaint did not include a sufficiently pled cause of action.

Relevant ANDA Updates highlighted in this issue:

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