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

Third Quarter

The third 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:

  • United Therapeutics Corp. v. Liquidia Technologies, Inc.
    Tyvaso® (treprostinil)
    The district court did not clearly err in its factual findings based on the record evidence that the claims of one of the patents-in-suit were not invalid and infringed, and that the claims of the other patent-in-suit were invalid.
  • CMP Development, LLC v. Amneal Pharms. LLC
    CaroSpir® (spironolactone)
    Because tragacanth powder did not act as a suspending agent in the same way as xanthan gum, plaintiff did not meet its burden of establishing infringement under the doctrine of equivalents.
  • Novartis Pharms. Corp. v. Alembic Pharms. Ltd.
    Entresto® (sacubitril/valsartan)
    The court reiterated a more relaxed pleading standard in ANDA litigations by not requiring plaintiff to rely on ANDAs, product samples, and other confidential information from a first litigation as factual predicate in the complaint of a follow-on patent litigation.
  • Takeda Pharms. U.S.A., Inc. v. Mylan Pharms., Inc.
    Colcrys® (colchicine)
    Court grants summary judgment allowing ANDA holder to launch early given unambiguous terms of settlement agreement resolving previous litigation.
  • Allergan USA, Inc. v. MSN Labs. Private Ltd.
    Viberzi® (eluxadoline)
    The asserted claims were invalid for lack of adequate written description where (i) there was no description of a pharmaceutical formulation that did not require a glidant and (ii) the claims claimed “fillers” and “disintegrants,” but only one species of each was described throughout the specification.
  • Zogenix, Inc. v. Apotex Inc.
    Fintepla® (fenfluramine HCl)
    Magistrate Judge’s report was adopted and Defendant’s motion to dismiss was granted based on admissions in Plaintiff’s labeling concerning the administration of the accused product.
  • Purdue Pharma L.P. v. Accord Healthcare Inc.,
    OxyContin® (oxycodone HCl)
    Motion for judgment on the pleadings on the basis of collateral estoppel was denied because triable issues of fact exist that were undecided in the prior trial opinion.
  • UCB, Inc. v. Annora Pharma Priv. Ltd.
    Briviact® (brivaracetam)
    Asserted claim was not obvious when defendants could not show a reasonable expectation of success in modifying a compound to increase lipophilicity to increase antiepileptic activity.
  • Taiho Pharm. Co., Ltd. v. Eugia Pharma Specialties Ltd.
    Lonsurf® (trifluorothymidine / tipiracil)
    The asserted claim was not invalid because (i) a skilled artisan would not have been motivated to administer the claimed drug in twice-daily doses; and (ii) the patent specification adequately described clinical trials where cancer patients received the combination therapy by oral administration twice-daily.
  • Orexo AB v. Sun Pharm. Indus. Ltd.
    Zubsolv® (buprenorphine/naloxone)
    Trial court found that the ANDA product would infringe the asserted claims, and that those claims were not indefinite, non-enabled, inadequately described, or obvious.
  • In re Entresto (Sacubitril/Valsartan) Patent Litigation
    Entresto® (sacubitril/valsartan)
    Because the patented complexes were unknown as of the priority date of the patent-in-suit, the inventors did not possess the invention and therefore could not have adequately described them.
  • Novartis Pharms. Corp. v. Mylan Pharms. Inc.
    Entresto® (sacubitril / valsartan)
    Testing confirmed that Defendant’s API met the purity specification limitations in the asserted claims, and therefore infringed the patents-in-suit.

Relevant ANDA Updates highlighted in this issue:

Oren D. Langer


Managing Partner, New York Office

Christine May


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
CaroSpir® (spironolactone)
Entresto® (sacubitril/valsartan)
OxyContin® (oxycodone HCl)
Fintepla® (fenfluramine HCl)
Briviact® (brivaracetam)
Lonsurf® (trifluorothymidine / tipiracil)
Zubsolv® (buprenorphine/naloxone)
Entresto® (sacubitril/valsartan)
Entresto® (sacubitril / valsartan)

GENERICally Speaking: A Hatch-Waxman Litigation Bulletin

Fourth Quarter

GENERICally Speaking: A Hatch-Waxman Litigation Bulletin

First Quarter

GENERICally Speaking Q2

Second Quarter test