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 Q3

The Fall 2022 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 we review Q3 cases and issue(s) presented:

  • Par Pharm., Inc. v. Eagle Pharms., Inc.
    Vasostrict® (vasopressin)
    Because the ANDA specification controls and defines a non-infringing product under § 271(e)(2), and the district court did not abuse its discretion, the Federal Circuit affirmed a finding of non-infringement and a denial of plaintiff’s request for declaratory judgment.
  • In re Entresto (Sacubitril/Valsartan) Patent Litigation
    Entresto® (sacubitril and valsartan)
    Because the Hatch-Waxman Act is silent on the issue of subject matter jurisdiction for an ANDA applicant’s counterclaims, the court found that the Act bars declaratory judgment counterclaims against late-listed Orange Book patents when Defendants never submit paragraph IV notice letters for those patents.
  • Bial-Portela & Ca. S.A. v. Alkem Labs. Ltd.
    Aptiom® (eslicarbazepine acetate)
    After a three-day bench trial, the court presented its infringement and invalidity findings concerning various patents claiming methods of administration and the formulation of an anti-seizure medication.
  • United Therapeutics Corp. v. Liquidia Technologies, Inc.
    Tyvaso® (treprostinil)
    A product-by-process patent was found invalid as anticipated because an identical product was in the prior art while defendant was found to induce infringement of a method patent, which also held not invalid.
  • Vifor Fresenius Medical Care Renal Pharma Ltd. v. Teva Pharms. USA, Inc.
    Velphoro® (sucroferric oxyhydroxide)
    Given statements in its proposed label, and the fact that the prior art did not teach the claimed dosing regimen, the patent-in-suit was found infringed and not invalid.
  • Chiesi USA, Inc. v. Aurobindo Pharma USA, Inc.
    Cleviprex® (clevidipine injectable emulsions)
    After a seven-day bench trial, the court found the asserted claims infringed, not obvious, and not unenforceable on the basis of inequitable conduct.
  • Tris Pharma, Inc. v. Teva Pharms. USA, Inc.
    QuilliChew ER® (methylphenidate)
    After a bench trial, the court found all asserted claims infringed and rejected the ANDA filer’s invalidity defenses.
  • Salix Pharms., Ltd. v. Norwich Pharms., Inc.
    Xifaxan® (rifaximin)
    After a bench trial, the court found one set of asserted patents infringed and not invalid, while the remaining two sets of asserted patents were invalid as obvious.
  • AstraZeneca AB v. Mylan Pharms., Inc.
    Symbicort® (budesonide and formoterol)
    A complaint that identifies the ANDA and alleges that the ANDA will infringe has enough facts to state a claim for relief under § 271(e)(2), even when asserted patent had not issued until after ANDA was approved.
  • Sanofi-Aventis U.S. LLC v. Apotex Corp.
    Jevtana® (cabazitaxel)
    Magistrate Judge recommends that patentee’s assertion of amended claims that issued out of an IPR proceeding may be the basis for res judicata.

Relevant ANDA updates highlighted in this issue:

Oren D. Langer


Managing Partner, New York Office

Bernard B. Pound


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
Entresto® (sacubitril and valsartan)
Aptiom® (eslicarbazepine acetate)
Vasostrict® (vasopressin)
Cleviprex® (clevidipine injectable emulsions)
QuilliChew ER® (methylphenidate)
Symbicort® (budesonide and formoterol)
Jevtana® (cabazitaxel)

GENERICally Speaking: A Hatch-Waxman Litigation Bulletin - Q1

GENERICally Speaking: A Hatch-Waxman Litigation Bulletin - Q2

GENERICally Speaking: A Hatch-Waxman Litigation Bulletin - Q4