GENERICally Speaking

In this issue:

• Exelixis, Inc. v. MSN Labs. Private Ltd.
  Cabometyx® (cabozantinib (L)-malate)
  Judgment that asserted claims covering crystalline cabozantinib (L)-malate salts were adequately supported by written description affirmed; appeal concerning separate impurity patent dismissed as moot and underlying judgment vacated.
• Norwich Pharms., Inc. v. Kennedy, Jr.
  Xifaxan® (rifaximin)
  FDA correctly concluded that Actavis had not forfeited its 180-day exclusivity for failure to market, but applied the wrong causation standard in determining that Actavis had not forfeited exclusivity for failure to obtain tentative approval.
• Scilex Pharms. Inc. v. Aveva Drug Delivery Systems, Inc.
  ZTlido® (lidocaine topical patch)
  Judgment of noninfringement affirmed where the district court correctly construed the term “dissolving agent” to require that it both dissolve lidocaine and maintain it in a dissolved state, precluding infringement under the doctrine of equivalents.
• Otsuka America Pharm., Inc. v. Hetero Labs Ltd.
  Nuedexta® (dextromethorphan hydrobromide / quinidine sulfate)
  Preliminary injunction largely affirmed where the district court correctly construed claim terms governing a weight-to-weight ratio limitation, but the Federal Circuit vacated the district court’s waiver of the Rule 65(c) bond requirement.
• United Therapeutics Corp. v. Liquidia Techs., Inc.
  Tyvaso® and Tyvaso DPI® (treprostinil)
  Following a bench trial, the court found infringement of method-of-treatment claims covering inhaled treprostinil for PH-ILD and rejected Defendant’s obviousness, on-sale-bar, and inherent-anticipation defenses; and also held that certain dependent claims reciting treatment outcomes were not entitled to patentable weight.
• Vanda Pharms. Inc. v. Teva Pharms. USA, Inc.
  Hetlioz® (tasimelteon)
  Granting summary judgment of noninfringement where generic tasimelteon labels did not affirmatively encourage prescribers to discontinue beta blockers before administering tasimelteon and the generic products had substantial non-infringing uses.
• Vertex Pharms. Inc. v. Lupin Ltd.
  Kalydeco® (ivacaftor)
  Following trial, judgment of noninfringement entered where Lupin’s generic contained approximately 74.26% ivacaftor and Vertex’s asserted claims required either 80% or “about 80%” ivacaftor.
• Jazz Pharms. Ireland Ltd. v. Tris Pharma, Inc.
  Xywav® (calcium, magnesium, potassium, and sodium oxybates oral solution)
  Motion to dismiss denied where Hatch-Waxman complaint plausibly alleged infringement based on defendant’s original Paragraph IV certifications and the court declined to consider defendant’s post-filing amendments to its NDA.

Relevant ANDA Updates highlighted in this issue:

ANDA Approvals

ANDA Litigation Settlements

Generic Launches

New ANDA Cases