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.

Vol. 8, No. 1

Spring 2018

Relevant court decisions highlighted in this issue:

  • 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.

Relevant ANDA updates highlighted in this issue:

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

Oren D. Langer

Partner

Managing Partner, New York Office
Member of Executive Board

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.
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.
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.
Granting summary judgment of no literal infringement, denying summary judgment of no infringement under the doctrine of equivalents and of no indirect infringement.
The court denied defendants’ motion to dismiss, pending limited venue-related discovery.
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.
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 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.
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.
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.
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.
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.
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.
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.

Vol. 8, No. 2

Summer 2018

Vol. 8, No. 3

Fall 2018