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 multi-million and multi-billion dollar drug products. He has been counselling clients in all aspects of patent law for more than two decades and specializes in chemical patent matters, with particular focus 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 Board of Patent Appeals and Interferences (BPAI) of the United States Patent and Trademark Office (USPTO).
Representative cases that Warren has litigated include:
- Hoffmann-La Roche Inc. et al. v. Apotex Inc. et al. (D.N.J.);
- Warner Chilcott Co., LLC et al. v. Teva Pharms. USA, Inc. et al. (D. Del);
- Hoffmann-La Roche Inc. v. Apotex Inc. et al., 2010 U.S. Dist. LEXIS 92264 (D.N.J. Sept. 2, 2010);
- Hoffmann-La Roche Inc. v. Apotex Inc. et al., 2011 U.S. Dist. LEXIS 127922 (D.N.J. Nov. 3, 2011);
- Hoffmann-La Roche Inc. v. Cobalt Pharms. Inc. et al., 2010 U.S. Dist. LEXIS 119432 (D.N.J. Nov. 10, 2010);
- Montell North America Inc. v. The Dow Chemical Company, Inc. (S.D.TX.);
- Mead Johnson & Co. v. Barr Laboratories (S.D.N.Y.);
- Eli Lilly & Co. v. Barr Labs., Inc., 251 F.3d 955 (Fed. Cir. 2001);
- Smithkline Beecham Corp. v. Synthon Pharmaceuticals, Ltd., (M.D.N.C.);
- In re Basell Poliolifine, Italia S.p.A., 547 F.3d 1371 (Fed. Cir. 2008);
- Metso Minerals, Inc. v. Powerscreen Int'l Distrib. Ltd., 06cv1446, (E.D.N.Y.); litigated infringement action relating to mobile aggregate material processing plants; discovered key prior art references and developed obviousness defense that resulted in reversal of a jury verdict of willful patent infringement and a holding of invalidity under 35 USC §103 in Metso Minerals, Inc. v. Powerscreen Int'l Distrib., 2013 U.S. App. LEXIS 9645, 2013 WL 1969309 (Fed. Cir. May 14, 2013).
He has also successfully represented Fortune 100 companies in inter parte proceedings before the USPTO including re-examinations of US patents and has advised his clients in successfully opposing foreign patent applications resulting in freedom to operate. He has been active throughout his career in counselling clients from the point of preparing patent applications through licensing and successful resolutions of a wide range of disputes involving patents.
In addition to his extensive litigation experience, Warren has guided his clients in structuring, preparing, and negotiating agreements for a broad range of intellectual property and technology-centered transactions, including license, technology transfer, complex partnering, strategic alliance, royalty monetization, and merger and acquisition transactions. His experience includes:
- Representation of pharmaceutical and biotechnology companies in connection with numerous licensing, joint development, and world-wide commercialization transactions for drug candidates for the treatment of cancer, central nervous system diseases, and other indications with an aggregate potential value of several billions of dollars.
- Representation of medical instrumentation companies in connection with multi-million dollar projects for the design, development, and manufacturing of products and systems for the in vitro diagnostic, surgical/therapeutic, and laboratory automation markets, as well as drug delivery systems.
- Representation of major international fragrance and cosmetic company in connection with the in-licensing and subsequent development and world-wide distribution of several designer fragrances and cosmetic lines.
- 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
- 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
- New York
- United States Patent and Trademark Office