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 Summer 2021

Summer 2021

The Summer 2021 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.

A few of the relevant court decisions highlighted in this issue:

  • UCB, Inc. v. Catalent Pharma Solutions, Inc.
    Vimpat® (lacosamide)
    No preliminary injunction when Defendant contract manufacturer’s actions of importing, testing, and manufacturing lacosamide products were reasonably related to the submission its customer’s 505(b)(2) drug application with the FDA and protected under the Safe Harbor provision of the Hatch-Waxman Act.
  • Silvergate Pharms. Inc. v. Bionpharma Inc.
    Epaned® (enalapril maleate)
    Prosecution-history estoppel and the disclosure-dedication doctrine foreclose plaintiff’s infringement claims.
  • Vifor (Int’l) AG v. Mylan Labs. Ltd.
    Vimpat® (lacosamide)
    While the asserted patent claim may have contained an error, it was not obvious that a POSA easily could recognize it, and therefore the PTO, not the court, should consider and deal with any correction determination.
  • Mitsubishi Tanabe Pharma Co. v. Sandoz, Inc.
    Invokana® and Invokamet® (canagliflozin),
    Court rejects defendant’s lead-compound analysis and double-patenting arguments, finding the patents-in-suit not invalid.
  • UCB, Inc. v. Actavis Labs. UT, Inc.
    Neupro® (rotigotine)
    When a previous covered product, and the patents covering it, shared the same weight ratio claimed in the asserted claims, the court found that the patent-in-suit was anticipated, presumed obvious, and therefore invalid.

Relevant ANDA Updates highlighted in this issue:

Oren D. Langer


Managing Partner, New York Office
Member of Executive Board

Reported settlements in federal district court cases
Federal district court cases that are filed pursuant to the Hatch-Waxman Act
New Drug Applications and 505(b)(2) Applications
Abbreviated New Drug Applications and 505(b)(2) Applications
Epaned® (enalapril maleate)
Injectafer® (ferric carboxymaltose injection)
Invokana® and Invokamet® (canagliflozin)
Neupro® (rotigotine)

GENERICally Speaking Winter 2021

Winter 2021

GENERICally Speaking Spring 2021

Spring 2021

GENERICally Speaking Fall 2021

Fall 2021