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Overview

Warren MacRae is a partner in the Patent Litigation practice of Loeb & Loeb and is based in the firm’s New York office. He has extensive experience litigating high-stakes patent cases, including representing clients as counsel defending their patents covering hundred-million and billion dollar drug products. Throughout his career he has been counseled clients in all aspects of patent law, focusing his practice on chemical patent matters, with particular emphasis on Hatch-Waxman litigation and matters unique to the pharmaceutical industry.

Warren has successfully represented brand pharmaceutical companies in Hatch-Waxman cases regarding issues including infringement, validity, and enforceability of patents directed to compounds, compositions, and methods of use. He has represented clients before the Court of Appeals for the Federal Circuit and has successfully argued numerous appeals involving strategically important patent applications to the Patent Board of the United States Patent and Trademark Office (USPTO).

Representative matters that exemplify Warren’s depth of experience, include:

Diverse Litigation Experience and Federal Circuit Appeals 

  • Hoffmann-La Roche, Inc. et al. v. Apotex Inc. et al., 07-cv04417 (SRC) (D.N.J.), (concerning the prescription osteoporosis drug Boniva® (Ibandronate)). 
  • Warner Chilcott Co., LLC et al. v. Teva Pharms. USA, Inc. et al., 08-cv-627-LPS (D. Del), (concerning the prescription osteoporosis drug Actonel® (Risedronate)).
  • Hoffmann-La Roche, Inc. and Genentech, Inc. v. Airis Pharma Private Ltd., 17-cv-7912 (KBF) (S.D.N.Y.), (concerning the prescription drug Valcyte® (Valganciclovir hydrochloride), an oral antiviral medication used for the treatment and prevention of cytomegalovirus (CMV) infections).
  • Gilead Sciences, Inc., Hoffmann-La Roche, Inc., F. Hoffmann-La Roche Ltd. and Genentech, Inc. v. Lupin Pharmaceuticals, Inc. et al., 15-cv-01956-JFM and 15-cv-02793-JFM (D. Md.),( concerning the prescription drug Tamiflu® (oseltamivir phosphate), an oral anti-viral drug approved for the treatment of acute, uncomplicated influenza).
  • Genentech, Inc. and InterMune, Inc. v. Apotex Inc., et al., 19-cv-00078 (RGA) (D. Del.), (concerning the prescription drug Esbriet® (pirfenidone), an oral medication used for the treatment of idiopathic pulmonary fibrosis).
  • Zeavision, LLC v. Roche Vitamins, Inc. (4:03-cv-212) (DJS) (E.D. Mo.), (representing F. Hoffmann-La Roche AG, Roche Vitamins, Inc., and Roche Vitamins, Ltd., concerning compositions and methods for treating macular degeneration employing zeaxanthin).
  • Board of Trustees of Leland Stanford Junior University v. Roche Molecular Systems, Inc., 563 F.Supp.2d 1016 (N.D. Cal. 2008), (providing strategic counseling regarding patents concerning HIV test kits, including a PCR assay).
  • Montell North America, Inc. v. The Dow Chemical Company, Inc., 4:97-cv-87 (S.D. Tex.)(concerning pioneer inventions to production of polymers).
  • Mead Johnson & Co. v. Barr Laboratories, 97-cv-6317 (JES) (S.D.N.Y.)(concerning trazadone). 
  • Smithkline Beecham Corp. v. Synthon Pharmaceuticals, Ltd., 1:00-cv-01179 (M.D.N.C.)(concerning Paxil® (paroxetine mesylate derivative)).
  • Eli Lilly & Co. v. Barr Labs., Inc., 251 F.3d 955 (Fed. Cir. 2001)(concerning Prozac®).
  • Metso Minerals, Inc. v. Powerscreen Int'l Distrib. Ltd., 06-cv-1446,(E.D.N.Y.)(concerning conveyor machines for separating materials). 
  • In re Basell Poliolefine, Italia S.p.A., 547 F.3d 1371 (Fed. Cir. 2008)(concerning a patent issued after pending for 50 years, and covering Prof. Giulio Natta’s Nobel Prize winning invention for the production of polyethylene).

Multiparty Interferences

  • Anderson, et al., v. Morgan et al., Interference No. 104,712, (involving Anderson, et al., Gene Therapy, U.S. Patent No. 5,399,346, the first U.S. patent ever issued for gene therapy treatment). 
  • Staehelin et al. v. Secher et al., Interference No. 101,597, (involving monoclonal antibodies produced by a murine derived hybrid cell line wherein the antibody is capable of specifically binding to at least one antigenic determinant of interferon-alpha). 
  • Bryce, et al. v. Kligman, Interference No. 102,638, (involving retinoids for photodamaged skin).
  • Harris, et al. v. Dobrusin, et al., Interference No. 104,798, (involving 9 – cis retinoic acid). 
  • Evans, et al. v. Bollag, et al., Interference (involving use of retinoids for the treatment of premalignant epithelial lesions and malignant tumors of epithelial origin, particularly testicular cancer).
  • Higuchi, et al. v. Mitoma, et al., Interference No. 103,489 (involving use of PCR technology for homogenous nucleic acid amplification and detection).
  • Palackal et al. v. Resconi et al., (interference concerning metallocenes for preparing polymers).

Strategic Counseling and Due Diligence

  • Representing Big Pharma in numerous potential and completed business ventures, including acquisitions of companies and detailed analysis of intellectual property rights.
  • Counseling Big Pharma and Biotech companies regarding strategic pre-litigation and ongoing litigation analyses involving many of their branded drug products in preparation for and defense of potential litigations, including Hatch-Waxman specific suits and biotechnology-related suits in defense of their branded drug products. 

Managed and Assisted in the Management of Patent Dockets, and Prevailed in Multiple Appeals to the PTO Board 

  • Rolic Ltd. (the former Liquid Crystal Group of F. Hoffmann-La Roche)
  • Givaudan-Roure (a Swiss multinational manufacturer of flavors, fragrances, and active cosmetic ingredients)
  • Roche Vitamins, Inc. (nutraceutical and vitamin compositions) 
  • Hoffmann-La Roche, Inc. (assisted in the prosecution and provided strategic counseling regarding strategically important applications for certain pharmaceutical products)
  • Successfully prosecuted and appealed multiple strategically important patent applications for Basell Poliolefine, Italia S.p.A., (now LyondellBasell) to allowance.
  • Successfully prosecuted and appealed multiple patent applications to allowance for the Swiss giant Nestlé (Nestec S.A.).

PTAB Experience: Actelion Pharmaceuticals Ltd v. ICOS Corp., Nos. IPR2015-00561 and IPR2015-00562 (PTAB)(prevailed in two IPRs concerning sildenafil citrate).

  • “Intellectual Property Basics & Strategy,” Summit on Life Sciences, sponsored by MoBIO – Missouri Biotechnology Association – and the Missouri Chamber of Commerce
    Speaker
  • "Getting the Most out of Your Method of Use Claims and Use Codes," NJIPLA 25th Annual Pharmaceutical / Chemical Patent Practice Update
    Presenter

Education

  • St. John's University, Organic Chemistry, M.S.
  • St. John's University School of Law, J.D.
  • St. John's University, B.S., cum laude, with honors in Chemistry

Court Admissions

  • Supreme Court of the United States
  • U.S. Court of Appeals, Federal Circuit
  • U.S. District Court for the Eastern District of New York
  • U.S. District Court for the Southern District of New York
  • U.S. District Court for the Western District of New York

Bar Admissions

  • New York
  • United States Patent and Trademark Office