Michael P. Dougherty
In his 30-year career as a patent litigator, Michael Dougherty has made protecting his pharmaceutical and biotechnology clients' products his primary goal.
Representing brand pharmaceuticals in suits against generic drug companies under the Hatch-Waxman Act is a cornerstone of his practice. Mike represents some of the top drug makers in the world, and his record of success includes wins for companies like Merck & Co., Hoffmann-La Roche, and Schering Corporation. He regularly appears in U.S. district courts and the Court of Appeals for the Federal Circuit, as well as the International Trade Commission.
With his keen insight into the industry and his own background in biology, Mike truly understands the science behind his clients' products and guides them through the complex patent issues involved in the development of new ones. He has vast experience with Abbreviated New Drug Applications (ANDAs), conducts due diligence investigations concerning intellectual property portfolios, and handles Section 337 investigations in the U.S. International Trade Commission.
Mike has written for several pharmaceutical and biotechnology publications, such as the Food and Drug Law Journal and IAM Life Sciences. He has served on the Pharmaceutical and Biotechnology Issues committee of the Intellectual Property Owners Association, and has been a featured speaker in several national intellectual property conferences focused on the pharmaceutical industry.
He received his B.A. in biology and English from Case Western Reserve University in 1982 and his J.D. from the Marshall-Wythe School of Law at the College of William & Mary in 1985, where he was an executive editor of the William & Mary Law Review.
Areas of Focus
Merck Sharp & Dohme v. Savior Lifetec: Representing Merck in Hatch-Waxman suit concerning Invanz® antibiotic product. (Pending)
Merck Sharp & Dohme v. Hospira, Inc.: Representing Merck in Hatch-Waxman suit concerning Invanz® antibiotic product. (Pending)
Merck Frosst Canada v. Teva Pharmaceuticals USA: Represented Merck in Hatch-Waxman suit concerning Singulair® product.
Schering Corporation v. Sandoz Inc.: Lead counsel for Schering in Hatch-Waxman suit involving Schering's Noxafil® product.
Roche v. Ranbaxy: Represented Roche in Hatch-Waxman litigation involving Valcyte® product. Settled favorably for Roche with Ranbaxy stipulating to infringement of the patent.
ITC Inv. No. 337-TA-568 (2006): Co-counsel for Roche in ITC proceeding brought by Amgen against Roche's MIRCERA® product.