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 Spring 2021

Spring 2021

The Spring 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:

  • Takeda Pharm. Co. Ltd. v. Torrent Pharms. Ltd.
    Nesina® (alogliptin)
    The district court did not commit clear error in its finding that a skilled artisan would not have been motivated to make defendants’ proposed scaffold and isosteric replacements with a reasonable expectation of success.
  • AstraZeneca AB v. Mylan Pharms. Inc.
    Symbicort® (budesonide and formoterol fumarate dihydrate)
    The patents-in-suit are not invalid as obvious because defendant failed to show it would have been obvious to select and combine the elements of the claimed invention, and because certain prior art actually taught away from the claimed invention.
  • Horizon Medicines LLC v. Dr. Reddy’s Labs., Inc.
    Vimovo® (naproxen and esomeprazole magnesium)
    The court denied summary judgment of invalidity on the basis of issue preclusion when the defendant could not show that the identical issue was previously adjudicated.

Relevant ANDA Updates highlighted in this issue:

Oren D. Langer


Managing Partner, New York Office
Member of Executive Board

Federal district court cases that are filed pursuant to the Hatch-Waxman Act
Symbicort® (budesonide and formoterol fumarate dihydrate)

GENERICally Speaking Winter 2021

Winter 2021

GENERICally Speaking Summer 2021

Summer 2021

GENERICally Speaking Fall 2021

Fall 2021