Dennies Varughese

Practice Areas

Dennies specializes in the full range of intellectual property disputes, having handled numerous high-stakes patent and trademark litigation in district courts, as well as many contested proceedings before the U.S. Patent Trial and Appeal Board (“PTAB”) at the Patent Office. In addition to patent disputes, Dennies has extensive experience in anti-counterfeiting and trademark enforcement.

Career

Dennies Varughese, Pharm.D., a director in Sterne Kessler’s Trial & Appellate Practice Group, is a trial attorney and globally recognized strategic advisor for pharmaceutical clients. Ranked as a leading life sciences litigator by various national accrediting agencies, Dennies has been lead trial counsel on dozens of high-stakes district court cases and PTAB matters involving blockbuster pharmaceuticals, on both the brand and generic side, including: Abilify® (aripiprazole), Zytiga® (abiraterone), Dymista® (azelastine/fluticasone), Cialis® (tadalafil), Gilenya® (fingolimod), Nexium 24® (esomeprazole OTC), Revlimid® (lenalidomide), and many others. Notably, he successfully defeated injunction motions clearing the way for first-wave generics into the lucrative market for Abilify®, at that time the largest pharmaceutical litigation ever. Dennies has also handled many cases for market leaders in other industries, including biopharmaceuticals, chemicals, medical devices, diagnostics, telecommunications, and electronics.

Dennies, a frequent lecturer and author, is often quoted in legal publications and is a thought leader on Paragraph IV disputes. He is sought after by generic and brand companies alike for strategic advice on FDA regulatory and early commercialization strategies, product targeting, 505(b)(2) product design, at-risk launch, 180-Day marketing exclusivity and forfeiture, labeling carve-outs, patent settlement and licensing, supply and distribution agreements, drug products liability, and antitrust issues bearing on patent settlements.

Prior to his legal career, Dennies completed a post-doctoral fellowship at Bristol-Myers Squibb Co., worked within GlaxoSmithKline’s Medical Affairs division, and served as an adjunct professor of pharmacy at Rutgers University. He was also a licensed pharmacist in Pennsylvania.

Education