Mind + Muscle

technical minds + legal muscle

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Sterne Kessler Goldstein Fox
Dennies Varughese, Pharm.D.

Mind + Muscle

Dennies Varughese, Pharm.D.

Director

 

Dennies Varughese, Pharm.D., a director in Sterne Kessler’s Litigation Group, is a proven trial advocate and globally-recognized strategic advisor to pharmaceutical clients. Dennies specializes in patent litigation under the Hatch-Waxman Act, but he has also handled many cases involving a wide range of other industries, including biopharmaceuticals, chemicals, medical devices, diagnostics, telecommunications, and electronics.  

Dennies has been lead counsel on numerous high-stakes patent disputes in district and appellate courts, as well as before the Patent Trial and Appeal Board (PTAB) involving various blockbuster pharmaceuticals, including Abilify® (aripiprazole), Zytiga® (abiraterone), Dymista® (azelastine/fluticasone), Cialis® (tadalafil), Gilenya® (fingolimod), Nexium 24® (esomeprazole OTC), Revlimid® (lenalidomide), Myrbetriq® (mirabegron), Xyrem® (sodium oxybate), and many others. Notably, he was lead counsel on the Inter Partes Review (IPR) Petitions that lead to nullification of six patents covering Jazz’s blockbuster Xyrem®. Also, as co-lead counsel, 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, a frequent lecturer and author, is a highly-respected thought leader on Paragraph IV disputes, and is sought after by generic and brand companies alike for strategic advice on FDA regulatory and early commercialization strategies, including 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.   

Dennies is a contributing author of Patent Office Litigation, Second Edition, published in 2017 by Thomson Reuters Westlaw. The book provides a fresh and comprehensive exploration of patent office litigation proceedings, including how the proceedings interact with other aspects of patent procurement and enforcement. He also authored multiple early, ground-breaking papers discussing the strategic use of the America Invents Act’s post-grant proceedings in Hatch-Waxman cases, and was involved in the first ever IPR filed in an ANDA case (Vigamox®), and the only to-date CBM in a pharmaceutical case (Xyrem®).

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.

In law school, Dennies 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.

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

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)
  • 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)
  • Admissions
      • New Jersey

      • Pennsylvania

      • United States Patent and Trademark Office

      • District of Columbia

  • Education
    • J.D., Temple University cum laude

    • Pharm.D., University of the Sciences, Philadelphia

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