GENERICally Speaking - Vol. 8, No. 1

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: A Hatch-Waxman Litigation Bulletin.

Taking on an ANDA patent litigation requires significant corporate resources, time, and money. Staying on top of industry news and outcomes, following trends in the judiciary and the steps others are taking, and keeping informed of recently-enacted rules and legislation are critical.

This bulletin provides you and your company with some of the knowledge beneficial to remaining attentive to the complexity of ANDA patent litigation. We hope you find it helpful.

Relevant Court Decisions

  • Merck Sharp & Dohme Corp. v. Amneal Pharms. LLC
    Affirming judgment of non-infringement, the Federal Circuit found that district did not abuse its discretion in denying request for additional samples and a new trial, did not err in finding that plaintiff failed to demonstrate that ANDA product was not representative of defendants’ final commercial product, and did not err in its infringement analysis.
  • The Medicines Co. v. Hospira, Inc.
    The Federal Circuit affirmed the lower court’s finding of non-infringement, but remanded the case to determine if patents are covered by a distribution agreement, which would render them invalid based on the on-sale bar.
  • Aptalis Pharmatech, Inc. v. Apotex Inc.
    Because the district court erred in construing the claims, its infringement judgment was vacated and remanded for further findings consistent with the new claim construction.
  • GlaxoSmithKline LLC v. Teva Pharma. USA, Inc.
    After a jury found for plaintiff, the court granted defendant’s post-trial motion for judgment as a matter of law because there was neither sufficient nor substantial evidence supported the jury finding of inducement.
  • Indivior Inc. v. Mylan Techs. Inc.
    Defendants did not infringe the patents-in-suit because plaintiff failed to present statistically significant evidence to show that all of the asserted claims were infringed.
  • Shire LLC v. Abhai, LLC
    In addition to finding the patents-in-suit infringed, the court sanctioned defendant for reporting for the first time—in the middle of trial—that it performed its FDA testing incorrectly.
  • Impax Labs., Inc. v. Actavis Labs. FL, Inc.
    Granting summary judgment of no literal infringement, denying summary judgment of no infringement under the doctrine of equivalents and of no indirect infringement.
  • Celgene Corp. v. Hetero Labs Ltd.
    The court denied defendants’ motion to dismiss, pending limited venue-related discovery.
  • Alcon Research, Ltd. v. Watson Labs., Inc.
    While the prior art did teach the w/v% range, it did not do so in solution dosage forms, therefore, the patent-in-suit was not obvious.
  • Leo Pharma A/S v. Actavis Labs. UT, Inc.
    The Magistrate Judge recommended dismissing defendant’s inequitable-conduct counterclaim for failure to identify a specific individual who purportedly intentionally failed to disclose relevant prior art to the Patent Office.
  • Idenix Pharms. LLC v. Gilead Sciences, Inc.
    The court granted judgment of invalidity as a matter of law based on lack of enablement, and denied defendant’s motions for judgment as a matter of law based on lack of written description and for reduced damages.
  • iCeutica Pty v. Lupin Ltd.
    The court granted summary judgment of non-infringement based on findings of no literal infringement and that prosecution history estoppel barred application of the doctrine of equivalents.
  • Helsinn Healthcare S.A. v. Dr. Reddy’s Labs., Ltd.
    Motion for preliminary injunction denied where defendant had raised a substantial question about the central issue in the case, which Plaintiff had not shown lacked substantial merit.
  • Hospira, Inc. v. Amneal Pharms. LLC
    All but one of the patents-in-suit were invalid as obvious based on the prior art, including an earlier version of the commercial drug label, which provided a POSA with the motivation to develop the claimed invention.

The articles on our Website include some of the publications and papers authored by our attorneys, both before and after they joined our firm. The content of these articles should not be taken as legal advice.