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:

• Astellas Pharma, Inc. v. Sandoz Inc.
  Myrbetriq® (mirabegron)
  The district court’s judgment of invalidity under Section 101 was vacated and remanded when that defense was never before the district court to decide in the first instance.
• Allergan USA, Inc. v. MSN Labs. Private Ltd.
  Viberzi® (eluxadoline)
  District court’s findings of invalidity on the basis of obviousness-type double patenting and lack of written description were reversed by the Federal Circuit.
• Purdue Pharma L.P v. Accord Healthcare Inc.
  OxyContin® (oxycodone HCl)
  The asserted patent was obvious because a skilled artisan would have been motivated, with a reasonable expectation of success, to adapt a prior art reference to generate a tamper-resistant matrix tablet on a commercial scale by using a conventional heating device without simultaneous exposure to pressure.
• Exeltis USA, Inc. v. Lupin Ltd.
  Slynd® (drospirenone)
  Formulation claims reciting limitations concerning particle size and dissolution properties were found valid and infringed after a bench trial.
• Teva Branded Pharm. Products R&D, Inc. v. Deva Holding A.S.
  ProAir® HFA (albuterol sulfate)
  Declaratory judgment subject matter jurisdiction exists where a plaintiff pleads sufficient facts to support the finding that there is a definite and concrete infringement dispute between parties with adverse legal interests, which is real and substantial, and which could be resolved by the issuance of a declaratory judgment.
• Novartis Pharms. Corp. v. Becerra
  Entresto® (sacubitril/valsartan)
  Economic loss, alone, does not constitute irreparable harm; thus, motion for a temporary restraining order and preliminary injunction was denied.
• Novartis Pharms. Corp. v. Hetero USA Inc.
  Entresto® (sacubitril/valsartan)
  After finding the patent-in-suit invalid, the district court denied plaintiff’s motion for a preliminary injunction pending appeal.
• Novartis Pharms. Corp. v. MSN Pharms. Inc.
  Entresto® (sacubitril/valsartan)
  Novartis’s motion for a preliminary injunction was denied because it likely could not prove infringement or show that money could not remedy any alleged harm resulting from generic market entry.
• Pacira Pharms., Inc. v. eVenus Pharms. Labs., Inc.
  Exparel® (bupivacaine)
  After trial, the court found the asserted claims invalid as obvious and inherently anticipated in view of the prior art.
• Otsuka Pharm. Co., Ltd. v. Lupin Ltd.
  Jynarque® (tolvaptan)
  Because plaintiffs failed to recreate defendant’s manufacturing method and nothing in the DMF demonstrated infringement, the court found all asserted claims not infringed, and also found that some of the claims were not invalid.
• Allergan Holdings Unlimited Co. v. MSN Labs. Private Ltd.
  Viberzi® (eluxadoline)
  Because defendant did not adequately plead facts showing prejudice and did not meet the heightened pleading standard of Rule 9(b), the court struck a counterclaim and affirmative defenses related to laches, unenforceability, and patent misuse.

Relevant ANDA Updates highlighted in this issue:

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