GENERICally Speaking - Vol. 9, 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

  • 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.
  • Forest Labs., LLC v. Sigmapharm Labs., LLC
    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.
  • Brigham & Women’s Hospital, Inc. v. Perrigo Co.
    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.
  • Salix Pharms., Inc. v. Mylan Pharms Inc.
    Disqualification was permitted when law firm’s representation of defendant gave rise to a concurrent conflict of interest under Model Rule 1.7.
  • Belcher Pharms., LLC v. Int’l Medication Systems
    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.
  • Teva Pharms. U.S.A., Inc. v. Azar
    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.
  • Adverio Pharma Gmbh v. Alembic Pharms. Ltd.
    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.

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.