Warren K. MacRae

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).