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. 4

Winter 2019

Relevant court decisions highlighted in this issue:

  • Novartis Pharms. Corp v. Breckenridge Pharm. Inc.
    A post-URAA patent that issues after, and expires before, a pre-URAA patent does not qualify as a double-patenting reference against the pre-URAA patent.
  • Novartis AG v. Ezra Ventures LLC
    “Effectively” extending the term of a second patent was not a violation of 35 U.S.C. § 156.
  • Tris Pharma Inc. v. Actavis Labs. Fl, Inc.
    On appeal, the Federal Circuit found that the district court’s conclusions of law related to its obviousness findings were based on inadequate factual findings, and therefore vacated and remanded.

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

Patent-in-suit is invalid because certain limitations are inherent in the prior art.
The court disagreed with Plaintiff’s argument that the labeling, promotional materials, and samples related to Defendants’ product showed intent to induce infringement, and granted summary judgment in Defendants’ favor.
“Effectively” extending the term of a second patent was not a violation of 35 U.S.C. § 156.
A post-URAA patent that issues after, and expires before, a pre-URAA patent does not qualify as a double-patenting reference against the pre-URAA patent.
Judgment on the pleadings was appropriate where plaintiff’s Answer to counterclaims conceded non-infringement at the time of the counterclaim.
District court’s finding that plaintiff demonstrated a likelihood of success on the merits was reversed on the basis of (i) specification disclaimer and (ii) issue preclusion.
On appeal, the Federal Circuit found that the district court’s conclusions of law related to its obviousness findings were based on inadequate factual findings, and therefore vacated and remanded.
The word “target,” appearing twice in each of the independent asserted claims is indefinite, thereby rendering the patents-in-suit invalid on summary judgment.
Plaintiff’s testing of representative ANDA products demonstrated literal infringement.
The claims of the patent-in-suit were infringed, and though adequately described, they were found invalid as obvious.
After limited discovery on plaintiffs’ alter-ego theory, the court granted defendant’s motion to dismiss for lack of personal jurisdiction.
The Federal Circuit concluded that the district court did not err in invalidating all asserted claims of the Copaxone patents as obvious.

Vol. 9, No. 1

Spring 2019

Vol. 9, No. 2

Summer 2019

Vol. 9, No. 3

Fall 2019