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.

GENERICally Speaking: A Hatch-Waxman Litigation Bulletin

Fourth Quarter

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

In this issue:

  • H. Lundbeck A/S v. Lupin Ltd.
    Trintellix® (vortioxetine)
    Defendants’ proposed carved-out label was the basis for the court’s non-infringement opinion, which was affirmed on appeal.
  • Actelion Pharms. Ltd. v. Mylan Pharms. Inc.
    Veletri® (epoprostenol)
    Because the District Court should have addressed the extrinsic evidence to understand how a skilled artisan would understand the claim language, the Federal Circuit vacated the lower court’s construction of “a pH of 13 or higher” and its judgment of infringement.
  • Corcept Therapeutics, Inc. v. Teva Pharms. USA, Inc.
    Korlym® (mifepristone)
    Plaintiff did not meet its burden to prove induced infringement because there was no direct infringement and no intent to induce on the part of the Defendant.
  • Acadia Pharms. Inc. v. Aurobindo Pharma Ltd.
    Nuplazid® (pimavanserin tartrate)
    The patent-in-suit was not invalid for obviousness-type double patenting based on the court’s interpretation of 35 U.S.C. § 121.
  • Eisai R&D Mgmt. Co., Ltd. v. Dr Reddy’s Labs., Inc.
    Halaven® (eribulin mesylate)
    The court granted plaintiff’s motion to dismiss on the grounds that plaintiff offered defendant a covenant not to sue thereby divesting the court of subject matter jurisdiction.
  • Norwich Pharms., Inc. v. Becerra
    Xifaxan® (rifaximin)
    Because the district court’s final judgment explicitly prohibited final approval until a date certain, the FDA did not err in granting tentative—and not final—approval to an amended ANDA that included a skinny label.
  • Bausch Health Ireland Ltd. v. Padagis Israel Pharms. Ltd.
    Arazlo® (tazarotene)
    The court granted plaintiff’s Rule 12(c) motion concerning Defendant’s inequitable conduct counterclaim because Defendant raised a new argument unsupported by the factual allegations in its Amended Answer and did not plead facts that would make plausible the inference that, but for the withholding certain material prior art, Plaintiff would not have overcome the rejection for obviousness and obtained allowance.

Relevant ANDA Updates highlighted in this issue:

Oren D. Langer


Managing Partner, New York Office

Nuplazid® (pimavanserin tartrate)
Trintellix® (vortioxetine)
Xifaxan® (rifaximin)
New Drug Applications and 505(b)(2) Applications
Reported settlements in federal district court cases
Abbreviated New Drug Applications and 505(b)(2) Applications
Federal district court cases that are filed pursuant to the Hatch-Waxman Act