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Hatch-Waxman / ANDA Litigation

  • Horizon Medicines LLC v. Teva Pharmaceuticals USA, Inc., 2:20-cv-08188 (D. NJ) – Lead Counsel to Teva Pharmaceuticals USA, Inc., in ANDA litigation involving fixed-dose oral combination product.
  • Kowa Pharmaceuticals America et al v. Amneal Pharmaceuticals, LLC, and related cases - Represented plaintiffs Kowa Company, Ltd., Kowa Pharmaceuticals America, Inc. and Nissan Chemical Industries, Ltd. in litigation which 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 pre-trial, and after a 10-day trial plaintiffs prevailed on all issues in two court decisions against the remaining defendants, Amneal and Apotex. Mintz represents Kowa and Nissan in the appeal filed by Amneal and Apotex in the Federal Circuit. The team also defeated institution of three inter partes reviews filed by generic manufacturer defendants in these cases.
  • 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.
  • Mitsubishi Chemical Corp., et al. v. Barr Laboratories, Inc., et al. (SDNY, 1:07-cv-11614) – 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 (SDNY 2010))
  • Mitsubishi Chemical Corp. v. Barr Laboratories, Inc., No. 2010-1432, 2011 WL 3288394 (Fed. Cir. Aug. 2, 2011) - Obtained affirmance of district court judgment upholding client’s patent over anticipation and obviousness challenges.
Case Study
For Kowa Pharmaceuticals and Nissan Chemical, Mintz sued nine generic drug makers that had filed Abbreviated New Drug Applications (ANDA) with the FDA. The court upheld the validity and infringement of all asserted claims in two patents for the cholesterol drug Livalo®.
Case Study
Mintz protected clients’ patents related to the cholesterol drug Livalo®. Mintz defended against three IPRs filed by generic manufacturers that had filed Abbreviated New Drug Applications (ANDA) with the FDA and secured Patent Trial and Appeal Board denials of institution of the generic companies’ IPR petitions.