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. 1

Spring 2019

Relevant court decisions highlighted in this issue:

  • Helsinn Healthcare S.A. v. Teva Pharms. USA, Inc.
    A commercial sale to a third party who is required to keep the invention confidential may place the invention “on sale” under § 102(a).
  • Endo Pharms. Inc. v. Teva Pharms. USA, Inc.
    The Federal Circuit reversed the district court’s holding that the claims of the ’737 patent were ineligible under 35 U.S.C. § 101.
  • Grünenthal GmbH v. Alkem Labs. Ltd.
    Finding no clear error on the part of the district court concerning the issues of non-obviousness and non-infringement resulting from a “section viii” carve-out, the Federal Circuit affirmed.

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

A Hatch-Waxman Act complaint complies with the requirements of Iqbal and Twombly when it alleges plaintiff’s: (i) interest in the patent, (ii) receipt of the paragraph IV certification, (iii) knowledge of the filing of the ANDA or NDA, and (iv) contention that the defendant’s proposed product will infringe.
The Federal Circuit reversed the district court’s holding that the claims of the ’737 patent were ineligible under 35 U.S.C. § 101.
Finding no clear error on the part of the district court concerning the issues of non-obviousness and non-infringement resulting from a “section viii” carve-out, the Federal Circuit affirmed.
Judgment of non-infringement vacated as a result of improper claim construction and judgment of non-obviousness remanded to make an express finding on motivation to combine references.
JMOL of non-infringement was affirmed when the data relied on for proving infringement were speculative and not within the parameters of the district court’s claim construction.
Because plaintiff did not have standing, its motion for a preliminary injunction to bar the FDA from depriving it of its 180-day marketing exclusivity was denied and defendants’ motion to dismiss was granted.
Dismissal granted when plaintiff made no allegation (or reasonable basis to infer) that defendant would be involved in the commercial manufacture, use, or sale of ANDA applicant’s product after FDA approval.
Disqualification was permitted when law firm’s representation of defendant gave rise to a concurrent conflict of interest under Model Rule 1.7.
A commercial sale to a third party who is required to keep the invention confidential may place the invention “on sale” under § 102(a).

Vol. 8, No. 4

Winter 2019

Vol. 9, No. 2

Summer 2019

Vol. 9, No. 3

Fall 2019