GENERICally Speaking Hatch Waxman Bulletin

The Spring 2022 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:

• GlaxoSmithKline LLC v. Teva Pharms. USA, Inc.
  Coreg® (carvedilol)
  Defendant’s petition for rehearing en banc, seeking review of the Federal Circuit decision to vacate JMOL based on Defendant’s “skinny label” and reinstate the underlying jury verdict and damages award, was denied.
• Adapt Pharma Operations Ltd. v. Teva Pharms. USA, Inc.
  Narcan® (naloxone)
  The Federal Circuit affirmed the district court’s opinion after finding: (i) that a POSA would have been motivated to combine the prior-art references to arrive at the claimed invention; (ii) that the prior art, as a whole, did not teach away from the claimed invention; and (iii) the appropriate weight was given to the lack of secondary considerations in the record evidence.
• Novartis Pharms. Corp. v. Accord Healthcare, Inc.
  Gilenya® (fingolimod HCl)
  Finding of adequate written description of a negative limitation affirmed based on crediting expert testimony on the knowledge and perspective of a POSA.
• Genentech, Inc. v. Sandoz, Inc.
  Esbriet® (pirfenidone)
  After a three-day bench trial, the court found that Sandoz did not induce infringement of either set of patents-in-suit, that one set of patents directed to liver-function tests was invalid as obvious, and that another set of patents directed to drug-drug interactions was not invalid.
• Bausch Health Ireland Ltd. v. Mylan Labs. Ltd.
  Trulance® (plecanatide)
  Defendants’ motion to dismiss was granted in part on grounds of personal jurisdiction, and the case transferred to the Northern District of West Virginia.
• Horizon Medicines LLC v. Dr. Reddy’s Labs., Inc.
  Vimovo® (naproxen/esomeprazole magnesium)
  Because effective esomeprazole required by the claims at issue did not materially differ from the effective uncoated PPI claims in a prior litigation, Plaintiffs were barred from proceeding on the basis of issue preclusion.
• Azurity Pharms., Inc. v. Alkem Labs., Ltd.
  Firvanq® (vancomycin HCl)
  Taking all inferences in Plaintiff’s favor as the non-moving party, the court could not conclude that the undisputed facts precluded infringement and denied Defendant’s motion for judgment on the pleadings.
• Amarin Pharm., Inc. v. Hikma Pharms. USA Inc.
  Vascepa® (icosapent ethyl)
  In view of Defendant’s skinny label, which removed from the package insert of the accused product the indication that is the subject of the patents-in-suit, the court granted Defendant’s motion to dismiss.

Relevant ANDA Updates highlighted in this issue:

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