Noah M. Leibowitz is a Partner in the Firm’s Intellectual Property Group and Litigation Department. Noah’s diverse practice has a special focus on litigation and regulatory issues affecting the pharmaceutical, biotechnology and healthcare industries. His experience includes leading trial teams as first-chair counsel in multiple patent jury trials, as well as negotiating complex collaboration, development and license agreements and advising on merger and acquisition transactions and securities offerings.
Noah has particular familiarity with Hatch–Waxman litigation and regulation. Since 2003, Noah has represented Daiichi Sankyo (formerly Daiichi Pharmaceutical) in litigation to enforce Daiichi’s patent on its multibillion–dollar–per–year blockbuster anti–infective Levaquin®. He was a member of the trial team that successfully defended the Levaquin® patent in an eight–week trial and on appeal. Noah also successfully represented Daiichi Sankyo in Hatch-Waxman challenges to its Benicar®, Benicar® HCT and Azor® products.
Recently Noah represented Daiichi Sankyo in an ICC arbitration seated in Singapore, stemming from Daiichi Sankyo’s acquisition of a majority interest in Ranbaxy. Following an eleven-day merits hearing, in May 2016, the arbitral tribunal found that the former owners of Ranbaxy fraudulently concealed and misrepresented the nature and severity of FDA and DOJ investigations of Ranbaxy, and awarded Daiichi Sankyo the rupee-denominated equivalent of over $525 million, including fees, interest and costs.
Noah tried two patent cases to verdict in the first two months of 2017, winning both. Noah was lead trial counsel for IOENGINE in cases involving secure USB storage devices. The cases, against Interactive Media and Imation, were tried to two juries one month apart, which each found all asserted claims of IOENGINE’s patent valid and infringed, credited IOENGINE’s founder as the sole inventor of the patented technology, and collectively awarded over $12 million in damages for past infringement.
Noah has participated in well over 100 consummated or contemplated transactions and offerings, many involving companies in the healthcare and pharmaceutical industries, including Abbott Laboratories, Accellent, Aisling Capital, Alvogen, Atricure, Boston Scientific, Cardinal Health, CSL Limited, Endo Pharmaceuticals, Galen Holdings, Gland Pharma, Indevus Pharmaceuticals, Lexicon Pharmaceuticals, Link Spine Group, MedAssets-Precyse, NantPharma, PPD, Press Ganey, Q-Med, Stiefel Laboratories, Veracyte and ZS Pharma.
Noah represented Human Genome Sciences in a series of patent and antitrust cases over HGS’s Benlysta®, the first FDA approved treatment for systemic lupus in over 50 years. HGS challenged Genentech’s and City of Hope’s well-known Cabilly patents, related to antibody manufacture. Noah also represented Eli Lilly in a challenge to the Cabilly patents over Lilly’s cancer treatment Erbitux®.
In the Lipitor “pay for delay” action, Noah obtained a complete dismissal with prejudice of all allegations against both Daiichi Sankyo and its U.S. subsidiary. The case alleged a conspiracy to delay the entry of generic Lipitor and to fix the price of the generic version at just slightly less than the branded price during the exclusivity period for the first generic filer. Lipitor is the best-selling drug in the history of pharmaceuticals.
Noah represented Biosynexus, Inc., in a licensing dispute against Glaxo Group (a division of GlaxoSmithKline) and MedImmune, related to the development of a monoclonal antibody therapy for the prevention of staphylococcal infections in premature babies. Noah successfully obtained a preliminary injunction on behalf of Biosynexus and defended that decision on appeal.
In addition to his client representations, Noah has written numerous articles in legal publications. He co-authored the chapter on “Special Considerations in Hatch-Waxman Litigation” in the second and third editions of Anatomy of a Patent Case, prepared by the Complex Litigation Committee of the American College of Trial Lawyers. He also co-authored the chapter on United States law in Intellectual Property in the Life Sciences, published by Globe Law and Business.
Noah received his A.B., magna cum laude, in Biology and Psychology from Columbia University in 1996 and his J.D. from Columbia Law School (James Kent Scholar, Harlan Fiske Stone Scholar) in 1999. While in school, he conducted independent research in a biochemistry laboratory, leading to publication in a peer-reviewed journal. Noah has been consistently recognized by SuperLawyers since 2011, first as a Rising Star and since 2013 as a top Intellectual Property Litigation attorney in the New York Metro area.