Intellectual Property

ANDA Litigation

Your Hatch-Waxman counsel need to possess deep experience in patent litigation and have exceptional technical knowledge and training to best enforce your exclusive patent rights. Mintz Levin's Hatch-Waxman litigation group includes some of the most experienced attorneys in this space. We have a proven track record of success in Hatch-Waxman litigation, having tried cases to verdict and gotten those verdicts upheld on appeal. The technical and strategic knowledge that our professionals bring to their work, leads to the levels of satisfaction clients have come to expect from Mintz Levin. 

Mintz Levin's Hatch-Waxman litigation team will guide you from portfolio development tracking and analysis through to initial ANDA filings and the entire regulatory and litigation process. We have the experience to strategically and effectively represent you in enforcing the patent rights of your most valuable assets. We recognize that each Hatch-Waxman litigation is different, and we put the time and resources into ensuring that your particular case is handled with the utmost attention to detail.  Whether a single generic has filed an Abbreviated New Drug Application or a dozen have, clients know that we will bring an efficiently staffed and experienced team to bear on their behalf.

Quick Facts

  • Focused exclusively on protecting the patent rights of innovator pharmaceuticals.
  • Practice leaders recognized as Leading Practitioners in Managing Intellectual Property, Best Lawyers, and Super Lawyers, among others.
  • Successfully represented clients from strategy through trial and appeal.
  • Multiple published decisions out of the Federal Circuit and District Courts.
  • Technically proficient professionals with backgrounds in chemistry, chemical engineering, pharmacology, and bioorganic chemistry, including more than 20 PhDs in those and related fields.

Rankings & Recognitions

  • IAM Patent 1000 (2016)
    • Patent Litigation Practice and 7 attorneys, including head of ANDA Litigation Practice, Dave Conlin, recognized among the "World's Leading Patent Practitioners"
  • Managing Intellectual Property (2016)
    • Head of ANDA Litigation practice, Dave Conlin, identified as a “Patent Star”
  • Legal 500
    • Two leaders of the ANDA Litigation practice, Dave Conlin and Kathleen Carr, recognized as leading Life Sciences attorneys
  • LMG Life Sciences
    • Leader of ANDA Litigation practice, Kathleen Carr, identified as a leading practitioner for Hatch-Waxman Litigation
  • Chambers USA (2016)
    • 3 IP attorneys, including the Division Head, identified as leaders in their respective patent fields 
  • BTI Consulting Group's 2016 Litigation Outlook
    • IP Litigation ranked in top 5% of all law firms by corporate counsel
  • Case Study: Mintz Levin Secures Full Victory for Innovators in Lengthy Hatch-Waxman Battle

    On October 10, 2017, the Southern District of New York (SDNY) entered judgment on a decision that closed the door on contentious federal district court Hatch-Waxman litigation that Mintz Levin handled on behalf of innovator pharmaceutical clients Kowa Pharmaceuticals and Nissan Chemical, handing our clients a complete victory on all asserted claims, and protecting their unique cholesterol-lowering medication, Livalo®.

    Eight generic drug manufacturers filed Abbreviated New Drug Applications (ANDAs) with the US Food & Drug Administration (FDA) in 2014 and 2015, claiming that certain of our clients’ patents are invalid and/or would not be infringed by the drugs they planned to manufacture. To protect our clients’ interests, Mintz Levin’s team sued each of the generic manufacturers in a series of cases filed in the SDNY beginning in late 2014.

    As part of their attack, defendants Mylan and Sawai petitioned for inter partes review (IPR) of one of the two patents before the Patent Trial and Appeal Board (PTAB). The Mintz Levin team successfully defeated those IPRs, resulting in the PTAB denying institution of all three petitions.

    Throughout the process, the individual defendants attacked each patent with multiple theories of invalidity and/or non-infringement. The various defendants retained 18 defense experts in an attempt to support their attacks. As a result of Mintz Levin’s efforts, several defendants settled the litigation before trial, and another settled after trial. Three defendants — Amneal, Apotex and Lupin — remained in the litigation for trial, necessitating a 10-day trial in January 2017. The court issued separate decisions on each patent, with our clients prevailing in both decisions.

    The first decision, handed down on April 11, 2017, upheld the validity of US Patent No. 5,856,336, which expires on December 25, 2020, and covers the active pharmaceutical ingredient in Livalo®, pitavastatin calcium, and its use for treating elevated cholesterol. The second decision, handed down on September 19, 2017, found that the proposed generic products of one of the remaining defendants would infringe (the other defendant had abandoned its non-infringement position), and upheld the validity of all asserted claims of US Patent No. 8,557,993, which expires on February 2, 2024, and which covers the polymorph of pitavastatin calcium contained in Livalo®.

    The Kowa Pharmaceuticals and Nissan Chemical legal team was led by David Conlin and Kathleen Carr, and included Intellectual Property Members Adam Samansky, Thomas Wintner, John Bauer, and Kevin Ainsworth, Counsel Peter Cuomo, Jennifer Dereka, and Sharon O'Brien, Associates Joseph Rutkowski, Richard Maidman, and Megan Yung, and paralegal Vicki Francis.

    Ongoing Litigation

    • Kowa Pharmaceuticals America et al v. Amneal Pharmaceuticals, LLC, and related cases
      Representing plaintiffs Kowa Company, Ltd., Kowa Pharmaceuticals America, Inc. and Nissan Chemical Industries, Ltd. in litigation which has involved compound, formulation, and polymorph patents directed toward quinoline-type mevalonolactones (or, pitavastatin calcium) relating to the drug product Livalo®. Several of the cases successfully resolved, and after a 10-day trial, plaintiffs recently prevailed on all issues in two court decisions against the remaining defendants, Amneal and Apotex. Amneal and Apotex recently appealed to the Federal Circuit. The team also defeated institution of three inter partes reviews filed by generic manufacturer defendants in these cases:
      • Kowa Company, Ltd., et al. v. Amneal Pharmaceuticals, LLC (1:14-cv-2758, SDNY)
      • Kowa Company, Ltd., et al. v. Apotex, Inc., et al. (1:14-cv-7934, SDNY)
      • Kowa Company, Ltd., et al., v. Aurobindo Pharma Limited, et al. (1:14-cv-02497, SDNY)
      • Kowa Company, Ltd., et al. v. Mylan, Inc. (1:14-cv-2647, SDNY)
      • Kowa Company, Ltd., et al. v. Orient Pharma Co., Ltd. (1:14-cv-2759, SDNY)
      • Kowa Company, Ltd., et al. v. Sawai USA, Inc. (1:14-cv-5575, SDNY)
      • Kowa Company, Ltd., et al. v. Zydus Pharmaceuticals (USA) Inc. (1:14-cv-2760, SDNY)
      • Kowa Company, Ltd., et al. v. Lupin Limited, et al. (1:15-cv-3935, SDNY)
      Another related case recently was filed, which successfully resolved.
      • Kowa Company, Ltd., et al. v. Hetero Drugs Limited, et al. (1:17-cv-04421, SDNY)

    Completed Litigations

    • Horizon Pharma AG and Jagotec AG v. Watson Laboratories, Inc. - Florida, et al. (1:13cv5124, DNJ)
      Co-counsel and represented Jagotec AG, a wholly owned subsidiary of Skyepharma, in this Hatch-Waxman/Paragraph IV litigation. The case was settled on favorable terms.
    • Takeda Chemical Industries Ltd. v. Mylan and Alphapharm; 417 F. Supp. 2d 341, (S.D.N.Y. 2006); aff'd, 492 F.3d 1350 (Fed. Cir. 2007); cert. denied. 552 U.S. 1295 (2008)
      Post-KSR case interpreting Supreme Court approach to obviousness and upholding non-obviousness of important pharmaceutical advances.
    • Takeda Chemical Industries, Ltd. v. Mylan Labs., Inc., et al., 459 F. Supp. 2d 227 (S.D.N.Y. 2006), aff'd, 549 F.3d 1381 (Fed. Cir. 2008), cert. denied, 552 U.S. 1295 (2008).
      Affirmed a finding of an exceptional case under 35 U.S.C. § 285 and a subsequent award of attorneys’ fees. (See 2007 WL 840368 (S.D.N.Y. Mar. 21, 2007)
    • Takeda Pharmaceutical Co., Ltd. et al. v. Mylan, Inc. et al. (1:12-cv-00024, S.D.N.Y.)
      Represented Takeda in asserting 10 patents against Mylan in this Hatch-Waxman/Paragraph IV litigation involving an extended release formulation of a popular antidiabetic drug. The case was settled on favorable terms.
    • Mitsubishi Chemical Corp., et al. v. Barr Laboratories, Inc., et al. (1:07-CV-11614, S.D.N.Y.)
      Successfully represented Mitsubishi Chemical and Mitsubishi Tanabe Pharma Corp. in a Hatch-Waxman/Paragraph IV litigation regarding formulation of a blood anticoagulant used to treat heparin-induced thrombocytopenia (HIT). The validity of the patent was upheld after a lengthy bench trial, in a 156-page decision. (718 F. Supp. 2d 382 (S.D.N.Y. 2010))
    • Mitsubishi Chemical Corp., et al. v. Barr Laboratories, Inc., et al. (2010-1432, Court of Appeals for the Federal Circuit)
      Represented Mitsubishi as Plaintiff-Appellee against Barr Laboratories' appeal of judgment from S.D.N.Y. Federal Circuit affirmed that claims in the '052 patent were not anticipated and would not have been obvious. (435 Fed. Appx. 927 (Fed. Cir. Aug. 2, 2011))
    • Takeda Pharmaceutical Co., Ltd., et al. v. Alphapharm, Inc., Inc., et al., and related cases
      Represented Takeda in several Hatch-Waxman/Paragraph IV litigations in which our clients asserted that multiple defendants infringed seven patents directed to compositions and methods of using a popular oral anti-diabetic. Defendants included Accord, Alphapharm, Amneal, Apotex, Aurobindo, Cadila/Zydus, Dr. Reddy's, Hetero, Macleods, Mylan, Ranbaxy, Sandoz, Synthon, Teva, Torrent, Watson, and Wockhardt. The cases were settled on favorable terms.