GENERICally Speaking Hatch Waxman Bulletin

The Hatch-Waxman Litigation practice group at Robins Kaplan LLP is pleased to offer the latest edition of their quarterly publication regarding ANDA patent litigation issues and the generics business.

GENERICally Speaking Q1

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:

Neupro® (rotigotine)
Esbriet® (pirfenidone)
Invega Sustenna® (paliperidone extended-release suspension)
Adrenalin® (epinephrine)
Entresto® (sacubitril/valsartan)
New Drug Applications and 505(b)(2) Applications
Reported settlements in federal district court cases
Abbreviated New Drug Applications and 505(b)(2) Applications
Federal district court cases that are filed pursuant to the Hatch-Waxman Act

GENERICally Speaking: A Hatch-Waxman Litigation Bulletin

Fourth Quarter