Dennies Varughese

Dennies Varughese, Pharm.D., is a Director in the Trial & Appellate Practice Group at Sterne, Kessler, Goldstein & Fox, where he specializes in high-stakes pharmaceutical patent and trademark litigation, particularly under the Hatch-Waxman Act. His practice encompasses a broad range of technologies within the pharmaceutical and biotechnological arts, including controlled-release polymers, hypoglycemic treatments, antilipidemic treatments, antimalarials, microfluidics, and in vivo imaging. He is also recognized for his expertise in FDA regulatory and early commercialization strategies, product targeting, patent settlement, and anti-counterfeiting enforcement.

Mr. Varughese has significant experience representing both brand and generic pharmaceutical companies in intellectual property disputes. While the tracked case shows an appearance as local counsel for the defendant in Astellas Pharma Inc. et al. v. Hikma Pharmaceuticals USA Inc., his overall practice demonstrates an ability to work on both sides of complex pharmaceutical litigation. He also previously served as lead counsel for Juul Labs, Inc. in trademark and trade dress disputes.

A prominent aspect of his practice includes extensive involvement in proceedings before the U.S. Patent Trial and Appeal Board (PTAB), where he handles inter partes review (IPR) and post-grant review (PGR) proceedings. He was involved in the first-ever IPR filed in an ANDA case (Vigamox®) and served as lead counsel in a covered business method (CBM) review in a pharmaceutical case (Xyrem®). His PTAB experience also includes representing clients in IPRs related to drugs such as Dymista® and Zytiga®. He is a contributing author to "Patent Office Litigation," a comprehensive treatise on contested proceedings before the Patent Office.

Prior to his legal career, Mr. Varughese completed a post-doctoral fellowship at Bristol-Myers Squibb Co., worked with GlaxoSmithKline's Medical Affairs division, and was a licensed pharmacist in Pennsylvania. He earned his J.D., cum laude, from Temple University Beasley School of Law, where he was a member of the Temple Law Review, and holds a Pharm.D. from the University of the Sciences. He is admitted to practice in the District of Columbia, New Jersey, Pennsylvania, and before the U.S. Patent & Trademark Office.