Dennies Varughese, Pharm.D.

Overview

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. 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.

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.

In addition to patent disputes, Dennies has extensive experience in anti-counterfeiting and trademark enforcement. He served as lead counsel for Juul Labs, Inc. in various trademark and trade dress disputes against unauthorized copyists of Juul’s highly successful Electronic Nicotine Delivery Systems.

Dennies also has an active practice before the PTAB involving inter partes review (“IPR”) and post-grant review (“PGR”) proceedings. He was involved in the first ever IPR filed in an ANDA case (Vigamox®) in 2012, and served as lead counsel in the only to-date CBM in a pharmaceutical case (Xyrem®). A full listing of Dennies’ representative matters before the PTAB can be found below. Dennies is a contributing author of Patent Office Litigation, a comprehensive treatise exploring all aspects of contested proceedings before the Patent Office.

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.

Dennies received his J.D. from Temple University Beasley School of Law. In law school, he was a member of the Temple Law Review, was awarded the Barrister Award for excellence in trial advocacy, the Podwil Memorial Prize for excellence in intellectual property, and the Matkoff Scholarship award. He graduated with honors, cum laude. He earned his Pharm.D. from the University of the Sciences, Philadelphia.

Dennies grew up in Philadelphia and he loves the Philadelphia Eagles.

Representative Matters

Hatch-Waxman Litigation Engagements

• AstraZeneca Pharmaceuticals LP v. Intas Pharmaceutical Ltd. (currently representing Intas in Hatch Waxman litigation over SEROQUEL® XR) (D.N.J.) (08-cv-04804)
• AstraZeneca Pharmaceuticals LP v. Glenmark Generics, Inc. (currently representing Glenmark in multiple Hatch Waxman patent litigations over CRESTOR®) (D. Del.) (10-cv-00341; 10-cv-00543
• Takeda Pharmaceuticals Co. v. Torrent Pharmaceuticals Ltd. (represented Torrent in Hatch Waxman patent litigation over ACTOS®) (S.D.N.Y.) (09-cv-6051)
• GlaxoSmithKline v. Glenmark Generics, Inc. (represented Glenmark in Hatch Waxman patent litigation over MALARONE®) (D. Del) (09-cv-00608)

Patent Litigation Engagements

• Teva v. Glenmark Pharmaceuticals, Inc. (represented Glenmark in patent litigation over carvedilol) (D.N.J.) (08-cv-4355)
• Typhoon Touch Technologies v. Motion Computing et al.(represented Typhoon Touch in patent litigation over portable touch screen computers) (E.D. Tex) (07-cv-00546)
• Nexans, Inc. v. General Cable Corporation (represented General Cable in patent litigation over high-speed data communication cables) (E.D. Pa.) (07-cv-02296)
• Nutrition 21, Inc. v. General Nutrition Company (assisted in representation of Nutrition 21 in patent litigation over chromium picolinate) (E.D. Tex) (05-cv-00291)

PTAB Engagements

• Amneal Pharmaceuticals LLC et al. v. Allergan, Inc. et al. (representing Amneal in IPR proceedings concerning an acne drug) (IPR2018-00608, IPR2019-00207)
• Argentum Pharmaceuticals LLC et al. v. Cipla Limited et al. (represented Cipla in an IPR of a patent covering DYMISTA®) (IPR2017-00807)
• Wockhardt Bio AG et al. v. Janssen Oncology, Inc. et al. (represented Wockhardt in an IPR of a patent covering ZYTIGA®) (IPR2016-01582)
• Wockhardt Bio AG v. Jazz Pharmaceuticals, Inc. (represented Wockhardt in an IPR of a patent claiming microbe-resistant formulations) (IPR2016-00370)
• Amneal Pharmaceuticals LLC v. Jazz Pharmaceuticals, Inc. (IPR2015-00547, -00546, -00545) (CMB2014-00150, -00149)
• Amneal Pharmaceuticals LLC v. Endo Pharmaceuticals, Inc. (IPR2014-01365, -00361, -00360, 00160)
• Ricoh Americas Corporation v. MPHJ Technology Investments, Inc. (IPR 2013-00302)

Education

• J.D., Temple University Beasley School of Law, cum laude
• Pharm.D., University of the Sciences