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 Q4


The Winter 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.

In this issue:

  • AstraZeneca AB v. Mylan Pharms., Inc.
    Symbicort® (formoterol/budesonide)
    The appellate court reversed the district court’s claim construction and vacated and remanded its finding of infringement, but affirmed the district court’s determination that the patents-in-suit were not invalid as obvious.
  • Biogen Int’l GMBH v. Mylan Pharms. Inc.
    Tecfidera® (dimethyl fumarate)
    The Federal Circuit held that the district court did not clearly err in determining that the asserted claims were invalid for lack of written description.
  • Horizon Medicines LLC v. Alkem Labs. Ltd.
    Duexis® (ibuprofen/famoditine)
    Federal Circuit affirmed district court’s findings that asserted claims of one patent-in-suit are invalid as obvious and that the asserted claims of a second patent-in-suit are not infringed by Defendant’s ANDA.
  • Celgene Corp. v. Mylan Pharms., Inc.
    Pomalyst® (pomalidomide)
    Because Mylan did not have a regular and established place of business in NJ, the Federal Circuit affirmed the district court’s dismissal of the underlying action for lack of person jurisdiction.
  • Association for Accessible Medicines v. Bonta
    Because California’s AB 824—which presumed branded-generic patent litigation settlements were anticompetitive—likely violated the dormant Commerce Clause and likely irreparably harmed Plaintiff association’s members, the court granted Plaintiff’s motion for preliminary injunction.
  • Janssen Pharms., Inc. v. Teva Pharms. USA, Inc.
    Invega Sustenna® (paliperidone palmitate)
    Defendant did not prove by clear and convincing evidence that the asserted claims were obvious, indefinite, or lacking an adequate written description.
  • Melinta Therapeutics, LLC v. Nexus Pharms., Inc.
    Minocin® (minocycline HCl)
    The court denied defendant’s Rule 12(b)(3) motion to dismiss and granting defendant’s motion to transfer venue to the Northern District of Illinois.
  • Jazz Pharms., Inc. v. Avadel Pharms. Plc
    Xyrem® (sodium oxybate)
    The court found that there were questions of fact as to whether Plaintiff was required to list the ’963 patent in the Orange Book, and that precluded entry of judgment on the pleadings.
  • AstraZeneca AB v. Zydus Pharms. (USA) Inc.
    Farxiga® (dapagliflozin)
    Because the main piece of prior art did not identify a lead compound for further development and other references taught away from the claimed invention, the asserted claims were held not invalid.
  • Bausch Health Ireland Ltd. v. Padagis Israel Pharms. Ltd.
    Bryhali® (halobetasol propionate)
    Defendant’s motion to amend to include affirmative defense and counterclaim of inequitable conduct was granted when applicants failed to disclose relevant clinical study data and prior art saying the opposite of declaration submitted during prosecution and in support of invention.
  • H. Lundbeck A/S v. Lupin Ltd.
    Trintellix® (vortioxetine hydrobromide)
    Defendants failed to invalidate all of the patents-in-suit, but Plaintiffs failed to prove that Defendants’ ANDA products, with one exception, would infringe the asserted claims.

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
Trintellix® (vortioxetine hydrobromide)