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. 9, No. 3

Fall 2019

The Fall 2019 issue of the GENERICally Speaking email campaign provides you and your company with some of the knowledge beneficial to remaining attentive to the complexity of ANDA patent litigation.

Relevant court decisions highlighted in this issue:

  • Allergan Sales, LLC v. Sandoz, Inc.
  • INO Therapeutics LLC v. Praxair Distribution Inc.
  • Nalpropion Pharms., Inc. v. Actavis Labs FL, Inc.
  • Sanofi-Aventis U.S., LLC v. Dr. Reddy’s Labs., Inc.

Relevant ANDA Updates highlighted in this issue:

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

Oren D. Langer


Managing Partner, New York Office

“Wherein” clauses in a method of treatment claim are claim limitations that should be given weight, resulting in the affirmance of a preliminary injunction.
But for a clerical error to be addressed on remand, the Federal Circuit affirms findings of ineligible subject matter and non-infringement.
The Federal Circuit affirmed the district court’s finding that one of the patents was adequately described, but reversed the district court’s finding of non-obviousness.
Plaintiff’s disclaimer of claims found invalid by the PTAB mooted any controversy before the appellate court associated with that patent, and a second patent-in-suit was not invalid because the district court did not err in rejecting the defendants’ obviousness challenge.
While the district court’s finding of literal infringement was reversed, the Federal Circuit affirmed the district court’s finding of infringement under the doctrine of equivalent because the narrowing amendment was tangential to the recited salt in the accused product.
Where the defendants sought out a claim construction in the district court, the Federal Circuit affirmed a finding of non-infringement, and where the defendant did not seek a clarifying claim construction, the Federal Circuit affirmed a finding of infringement.
The court denied defendant’s motion to enforce its settlement agreement with plaintiff after the at-risk launch and subsequent settlement of another defendant.
The asserted claims of 1% ivermectin formulation are invalid on the basis of anticipation in light of a prior art reference that teaches application of 1-5% ivermectin formulation for treatment of the same indication.
Because plaintiffs failed to show specifically how defendants committed any act of infringement in New Jersey—particularly by filing an ANDA in West Virginia with the FDA in Maryland—or that any future, intended acts were a part of the infringement analysis, venue was improper in the District of New Jersey.
The court denies defendant’s motion for judgment of non-infringement in response to ANDA holder modification of its ANDA specification after trial.
Relying on plaintiffs’ testing of defendant’s ANDA product, and finding that the prior art taught away from the claimed invention, the court held the asserted claims valid and infringed.
The court granted plaintiffs’ motion to dismiss defendant’s antitrust and patent misuse counterclaims and related affirmative defenses.

Vol. 8, No. 4

Winter 2019

Vol. 9, No. 1

Spring 2019

Vol. 9, No. 2

Summer 2019