Hatch-Waxman Act/ANDA Litigation

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Protecting patents and maximizing their value are paramount to the success of brand pharmaceutical companies and university technology departments, in particular as they relate to generic competitors who file Abbreviated New Drug Applications (ANDAs) under the Hatch-Waxman Act.

Saul Ewing’s experienced patent litigation team advises brand pharmaceutical companies of all sizes in all phases of ANDA cases, including at the U.S. Court of Appeals for the Federal Circuit and the U.S. Supreme Court.

Our attorneys:

  • Currently serve as New Jersey and Delaware litigation counsel in complex, high-profile ANDA cases for more than two dozen pharmaceutical and medical device company cases where billions of dollars in sales are at stake
  • Have significant experience litigating small molecule and polymorph patents as well as large molecule (biologics) patents
  • Advocate for clients at emergent proceedings for restraining orders and injunctions
  • Enforce and defend IP rights pursuant to confidentiality agreements

Our patent litigation team has been recognized nationally as one of the top five “Go-To” law firms for patent litigation in a report by Lex Machina, and has continuously been ranked fourth, nationally, for the number of cases filed on behalf of patentees, and on behalf of ANDA plaintiffs.

Go-To New Jersey Counsel for Brand Pharmaceutical Companies

Saul Ewing’s ANDA Litigation team has represented the following brand pharmaceutical companies and related entities:

  • Abraxis Bioscience, LLC
  • AbbVie Inc.
  • Acadia Pharmaceuticals Inc.
  • Actelion Pharmaceuticals Ltd.
  • Adamas Pharma, LLC
  • Adapt Pharma, LLC
  • Alkermes Pharma Ireland Limited
  • Aquestive Therapeutics, Inc.
  • Auxilium Pharmaceuticals, Inc.
  • BioMarin Pharmaceutical Inc.
  • Boehringer Ingelheim International GmbH
  • Bristol-Myers Squibb Company
  • Celgene Corporation
  • Chiesi USA, Inc.
  • Cilag GmbH International
  • Corcept Therapeutics, Inc.
  • Daiichi Sankyo
  • Dexcel Ltd.
  • DePuy Orthopaedics, Inc. (J&J)
  • Eagle Pharmaceuticals, Inc.
  • Eisai Co., Ltd.
  • Endo Pharmaceuticals Inc.
  • Gilead Sciences, Inc.
  • GlaxoSmithKline, plc
  • Helsinn Healthcare S.A.
  • Horizon Orphan LLC
  • Indivior Inc.
  • Janssen Pharmaceuticals, Inc. (J&J)
  • Jazz Pharmaceuticals
  • King Pharmaceuticals
  • Merck Sharp & Dohme Corp.
  • Mitsubishi Tanabe Pharma Corporation
  • Opiant Pharmaceuticals, Inc.
  • Prometheus Laboratories
  • Reckitt Benckiser LLC
  • Roche Palo Alto LLC
  • R-Tech Ueno, Ltd.
  • Samsung Bioepis Co., Ltd.
  • Shire Development LLC
  • Sucampo Pharmaceuticals, Inc.
  • Sumitomo Dainippon Pharma Co., Ltd.
  • Sunovion Pharmaceuticals Inc.
  • Supernus Pharmaceuticals, Inc.
  • Takeda Pharmaceutical Company Limited
  • TherapeuticsMD, Inc.
  • United Therapeutics Corporation
  • University of California
  • University of Illinois
  • Vivus, Inc.

Experience with Judges

Saul Ewing’s ANDA Litigation team regularly appears before the following Judges:

  • Jessica S. Allen, U.S.M.J. (D.N.J.)
  • Madeline Cox Arleo, U.S.D.J. (D.N.J.)
  • Douglas E. Arpert, U.S.M.J. (D.N.J.)
  • Tonianne J. Bongiovanni, U.S.M.J. (D.N.J.)
  • Renee Marie Bumb, U.S.D.J. (D.N.J.)
  • Claire C. Cecchi, U.S.D.J. (D.N.J.)
  • Stanley R. Chesler, U.S.D.J. (D.N.J.)
  • Mark Falk , U.S.M.J. (D.N.J.)
  • Lois H. Goodman, U.S.M.J. (D.N.J.)
  • Michael A. Hammer, U.S.M.J. (D.N.J.)
  • Katharine S. Hayden, U.S.D.J. (D.N.J.)
  • Noel L. Hillman, U.S.D.J. (D.N.J.)
  • Edward S. Kiel, U.S.M.J. (D.N.J.)
  • Robert B. Kugler, U.S.D.J. (D.N.J.)
  • Brian R. Martinotti, U.S.D.J. (D.N.J.)
  • Kevin McNulty, U.S.D.J. (D.N.J.)
  • Julien X. Neals, U.S.D.J. (D.N.J.)
  • Zahid N. Quraishi, U.S.D.J. (D.N.J.)
  • Esther Salas, U.S.D.J. (D.N.J.)
  • Matthew J. Skahill, U.S.M.J. (D.N.J.)
  • Peter G. Sheridan, U.S.D.J. (D.N.J.)
  • Michael Shipp, U.S.D.J. (D.N.J.)
  • John Michael Vazquez, U.S.D.J. (D.N.J.)
  • Cathy L. Waldor, U.S.M.J. (D.N.J.)
  • Leda Dunn Wettre, U.S.M.J. (D.N.J.)
  • Susan D. Wigenton, U.S.D.J. (D.N.J.)
  • Karen M. Williams, U.S.M.J. (D.N.J.)
  • Freda L. Wolfson, Chief Judge (D.N.J.)

 

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Experience

For a selection of our current and recent Hatch-Waxman Act/ANDA litigation matters, click here.

  • Representation of Mitsubishi Tanabe Pharma Corp. (“MTPC”), Janssen (a division of Johnson & Johnson), and Cilag GmbH International in ANDA litigation against Zydus involving the compound patent covering Janssen’s blockbuster Type II diabetes Invokana® drug product.
    • Complete trial victory following a seven-day remote trial during the COVID-19 pandemic in the fall of 2020 before the Honorable Chief Judge Freda L. Wolfson, U.S.D.J.
    • The first Hatch-Waxman case to be tried remotely from start to finish in the District of New Jersey - and one of the first nationally.
    • Precedent-setting, 63-page trial opinion by Chief Judge Wolfson, holding that the patents-in-suit are not invalid as obvious and that the latest-expiring patent is not invalid for obviousness-type double patenting.
    • Trial court rejected Zydus’s “obviousness-type double patenting” argument holding that plaintiffs were not trying to improperly extend the life of one of the patents by obtaining a second patent for claims that are not patentably distinct from an earlier patent's claims.
    • Case of first impression, which has received wide media attention.
  • Representation of Takeda Pharmaceuticals Ltd. in ANDA litigation against Torrent and Indoco involving the Nesina®, Kazano®, and Oseni® drug products, which are used to treat Type II diabetes.
    • Complete trial victory for Takeda following a bench trial before the Honorable Stanley R. Chesler, U.S.D.J. in the District of New Jersey.
    • Final judgment blocked the two defendant drug makers from bringing to market generic versions of Takeda’s brand drug products.
    • Judge Chesler’s 59-page trial opinion upheld the validity of the patent-in-suit finding that “Defendants’ obviousness theories show the operation of hindsight,” and that Defendants put forth a “a theory with major defects and does not come close to meeting the clear and convincing standard for successful validity challenges.”
    • Defendants appealed the trial decision at the Federal Circuit; affirmed in favor of Takeda in February 2021.
  • Representation of Indivior Inc., Indivior UK Limited, and Aquestive Therapeutics, Inc. in ANDA litigation against Dr. Reddy's, Alvogen, Par, and Teva involving the Suboxone® sublingual film brand drug product. Suboxone® sublingual film is used to treat opioid dependency with annual worldwide sales totaling more than $1 billion.
    • Obtained an Order from U.S. District Judge Kevin McNulty to enjoin at-risk launches of generic product by obtaining a TRO against Alvogen and both a TRO and a preliminary injunction against Dr. Reddy's.
    • Defeated three post-TC Heartland transfer motions brought by Dr. Reddy's, Alvogen, and Teva.
    • Prevailed in a motion to bifurcate antitrust counterclaims filed by Alvogen and Dr. Reddy’s in 2019.
    • The Par and Teva cases were dismissed on terms favorable to Indivior and Aquestive. The cases against Alvogen and Dr. Reddy’s remain pending.
  • Representation of Helsinn Healthcare S.A. and Roche Palo Alto LLC in ANDA litigation against Teva and Dr. Reddy's involving the Aloxi® brand drug product. Both litigations resulted in trial victories for Helsinn.
    • Court issued a 167-page opinion and judgment in favor of Helsinn against Teva on infringement and validity, upholding Helsinn's patents over multiple claims of obviousness and the on-sale bar provisions of the America Invents Act (an issue of first impression due to changes in the AIA).
    • The trial decision was reversed on appeal at the Federal Circuit, and after granting a writ of certiorari, the U.S. Supreme Court affirmed the Federal Circuit in early 2019.
  • Representation of Sunovion Pharmaceuticals (formerly Sepracor Inc.) against 10 generic pharmaceutical manufacturers in ANDA litigation involving Sunovion’s Lunesta® brand drug product. Lunesta® is a highly successful sleep aid with annual sales totaling approximately $1 billion.
    • Case concluded at the Federal Circuit with a precedent-setting judgment of infringement and dismissal of all inequitable-conduct defenses in favor of Sunovion.
    • Prior to the appeal, the district court issued one of the first post-Exergen decisions dismissing a generic drug manufacturer's inequitable-conduct defense.
  • Representation of Jazz Pharmaceuticals against Roxane, Amneal, Par, Ranbaxy, Watson, Sun, Wockhardt, and Lupin in ANDA litigation involving the Xyrem® brand drug product, which is used to treat cataplexy and daytime sleepiness in narcolepsy patients. Xyrem® has annual sales totaling approximately $130 million. 
  • Representation of Celgene Corporation:
    • ANDA litigation against 12 generic defendant groups involving the Revlimid brand drug product ($11 billion annual sales worldwide).
    • ANDA litigation against 6 generic defendant groups involving the Pomalyst brand drug product ($2 billion annual sales worldwide).
    • ANDA litigation against 19 generic defendant involving the Otezla brand drug product ($1.5 billion annual sales worldwide).
    • ANDA litigation against 2 generic defendant groups involving the Thalomid brand drug product. 
  • Representation of Boehringer Ingelheim Pharma GmbH & Co. K.G., et al.:
    • ANDA litigation against 7 generic defendant groups involving the Pradaxa brand drug product.
    • ANDA litigation against 3 generic defendant groups involving the Aggrenox brand drug product.
    • ANDA litigation against 6 generic defendant groups involving the Gilotrif brand drug product.
    • ANDA litigation against Lupin Atlantis Holdings SA and Lupin Limited involving the Spiriva brand drug product.
  • Representation of Supernus Pharmaceuticals, Inc.:
    • ANDA litigation against 6 generic defendant groups involving the Trokendi brand drug product.
    • ANDA litigation against 4 generic defendant groups involving the Oxtellar XR brand drug product. Two cases were litigated through trial with U.S. District Judge Renee M. Bumb finding in favor of Supernus, and both decisions were affirmed by the Federal Circuit. The other two cases remain pending.
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