Generically Speaking: A Hatch-Waxman Litigation Bulletin – Trials & Appeals & Compensation

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:

• Endo Ventures Unlimited Co. v. Nexus Pharms.
  Inc.
  
  ephedrine sulfate
  
  Motion to dismiss for lack of personal jurisdiction granted when
  Defendant’s principal place of business and state of
  incorporation were not in the forum state and its intentions to
  open and use a facility in the forum state could not form a basis
  for the Court to exercise specific personal jurisdiction over
  Defendant.




• Mallinckrodt plc v. Airgas Therapeutics
  LLC
  
  INOmax® (nitric oxide)
  
  The court found that plaintiffs had not met their burden of
  pleading that French defendant purposefully directed its activities
  at the United States, and as a result, the court did not have
  personal jurisdiction.




• UCB, Inc. v. Mylan Techs. Inc.
  
  Neupro® (rotigotine)
  
  Because a genuine issue of material fact existed as to the scope
  of defendant’s amended ANDA, defendant’s summary judgment
  motion seeking a finding that plaintiff breached its covenant not
  to sue was denied.




• Genentech, Inc. v. Sandoz, Inc.
  
  Esbriet® (pirfenidone)
  
  As none of the private interest factors set forth in Jumara v.
  State Farm strongly favored transfer, and most were either
  neutral or disfavored transfer, the balance of the private interest
  factors did not weigh in favor of granting defendants’ motion
  to transfer.




• Janssen Pharms., Inc. v. Tolmar,
  Inc.
  
  Invega Sustenna® (paliperidone extended-release
  suspension)
  
  Defendant failed to prove by clear and convincing evidence that
  the patent-in-suit was obvious, lacked adequate written
  description, and was not enabled.




• Endo Par Innovation Co. v. BPI Labs,
  LLC
  
  Adrenalin® (epinephrine)
  
  Defendant’s motion to dismiss or, in the alternative, motion
  for a more definite statement was denied when plaintiff’s
  complaint adequately pled the requisite allegations under 35 U.S.C.
  § 271(e)(2).




• Novartis Pharms. Corp. v. Mylan Pharms.
  Inc.
  
  Entresto® (sacubitril/valsartan)
  
  Because Mylan’s ANDA product was substantially pure and
  comprised a hemipentahydrate, it was found to infringe the
  patents-in-suit.




• Mylan Pharms. Inc. v. Bayer Intellectual Property
  GmbH, C.A.
  
  Xarelto® (rivaroxaban)
  
  The court retained subject matter jurisdiction in ANDA
  holder’s declaratory-judgment action even when (i) patentee did
  not sue within 45 days after receipt of paragraph IV letter and
  (ii) patentee gave ANDA holder a covenant not to sue.

Relevant ANDA Updates highlighted in this
issue:

The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.