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Andrew Berdon is a Partner in the New York office.  Mr. Berdon is a litigator and trial lawyer with extensive experience in the area of ANDA litigation under the Hatch-Waxman Amendments to the Federal Food, Drug and Cosmetic Act.  Mr. Berdon also represents clients in complex litigation matters, including: business disputes, antitrust, regulatory enforcement and white collar criminal investigations, internal corporate investigations, and corporate governance matters.

Lead trial counsel for EKR Therapeutics in Hatch Waxman patent litigation against Sun Pharmaceuticals arising out of Sun’s submission of an ANDA referencing EKR’s branded product CARDENE® I.V.  On March 31, 2009, the court granted EKR’s cross motion for summary judgment of infringement.  See EKR Therapeutics v. Sun Pharmaceutical Industries, Limited, Civ. Action No. 07-1788 (KSH) (D.N.J.).

Lead trial counsel for Stiefel Laboratories, a GSK Company, in Hatch Waxman patent litigation against Perrigo Israel Pharmaceuticals Ltd. and Perrigo Company arising out of Perrigo’s submission of an ANDA referencing Stiefel’s branded product OLUX-E® Foam.  This matter is currently pending.  Stiefel Laboratories, Inc. and Stiefel Research Australia Pty. Ltd. v. Perrigo Israel Pharmaceuticals Ltd. and Perrigo Company, (C.A. No. 10-592) (D. Del.).

Lead trial counsel for Shionogi Pharma, Inc. and LifeCycle Pharma in Hatch Waxman patent litigation against IMPAX Laboratories, Inc. arising out of IMPAX’s submission of an ANDA referencing Shionogi’s branded product Fenoglide® .  This matter is currently pending.  Shionogi Pharma, Inc. and LifeCycle Pharma v. IMPAX Laboratories, Inc. (C.A. No. 10-358) (D. Del).

Lead trial counsel for Medicis Pharmaceutical Corp. in Hatch Waxman patent litigation against Nycomed US, Inc. and Nycomed GMBH arising out of Nycomed’s submission of an ANDA referencing Medicis’ Vanos® Cream.  This matter is currently pending.  Medicis Pharmaceuticals Corp. v. Nycomed US, Inc. et al. (SDNY and D. Del.).

Lead trial counsel for Medicis Pharmaceutical Corp. in Hatch Waxman patent litigation against Taro Pharmaceutical USA, Inc. and Taro Pharmaceutical Industries, Ltd. arising out of Taro’s submission of an ANDA referencing Medicis’ Vanos®  Cream.  This matter recently settled with Taro admitting infringement and validity of the patent in suit.  Medicis Pharmaceuticals Corp. v. Taro Pharmaceutical Industries, Ltd. et al. (SDNY and D. Del. )

Trial counsel for Pharmaceutical Product Development, Inc. in an action alleging intentional breach of contract and fraud related to PPD’s acquisition of Magen Biosciences, Inc.  This matter is currently pending in Delaware Chancery Court.  Pharmaceutical Product Development, Inc. v. TVM Life Sciences Ventures VI, L.P. et al., C.A. No. 5688 (Del. Ch. 2010). 

Lead trial counsel for Stiefel Laboratories/Connetics Corp. in Hatch Waxman patent litigation against Cobrek Pharmaceuticals arising out of Cobrek’s submission of an ANDA referencing Connetics’ branded product EVOCLIN® Foam.  Settled with Cobrek taking a royalty bearing license.  Stiefel Labs, Inc. v. Cobrek Pharm., Inc., C.A. No. 09-167 (SLR) (D. Del.).

Lead trial counsel for Stiefel Laboratories/Connetics Corp. in Hatch Waxman patent litigation against Pentech Pharmaceuticals arising out of Pentech’s submission of an ANDA referencing Connetics’ branded product LUXIQ® Foam.  Settled on terms that prevent a generic launch until 2013. Connetics Corp. v. Pentech Pharm., Inc., 07-C-6297 (N.D. Ill.)

Lead trial counsel for Stiefel Laboratories/Connetics Corp. in Hatch Waxman patent litigation against Perrigo Corp. arising out of Perrigo’s submission of an ANDA referencing Connetics’ branded product OLUX® Foam.  Connetics Corp. v. AGIS Indus.(1983), LTD., 05 Civ 05-5038 (HAA) (D.N.J. 2005).  That matter was settled on terms that included the defendants taking a royalty-bearing license under the patent in suit after Stiefel obtained a favorable claim construction ruling and the court denied Agis’ motion for summary judgment of non-infringement.  Quinn Emanuel was then hired as trial counsel for Stiefel in a similar case against Cobrek Pharmaceuticals and Cipla, Ltd. arising out of Cobrek’s submission of a subsequently-filed ANDA referencing OLUX®.   Connetics Corp. v. Pentech Pharm., No. 08-CV-2230 (N.D. Ill.).

Represented Reliant Pharmaceuticals as lead counsel in FDA regulatory proceedings and related patent litigation regarding competing branded cholesterol lowering agents.  Successfully opposed a Citizen’s Petition asking FDA to block approval of Reliant’s product and then served as lead counsel in a declaratory judgment action brought under the patent laws seeking to hold four of its competitors’ patents not infringed, invalid and unenforceable.  Prior to trial, the matter was settled on terms that permitted the Reliant product to remain on the market without the payment of past royalties.

Mr. Berdon has also conducted numerous internal corporate investigations and provided confidential advice to the boards of publicly traded corporations regarding internal compliance and corporate integrity matters.