Source: https://www.greengriffith.com/team/detail/emer-simic
Timestamp: 2019-04-22 19:11:27+00:00

Document:
Emer is a partner of Green, Griffith & Borg-Breen LLP. Emer focuses her practice on pharmaceutical patent litigation, post-grant review and client counseling. Emer has extensive experience representing both plaintiffs and defendants in patent litigation arising under the Hatch-Waxman Act and has served as trial counsel in patent infringement litigation arising in U.S. Federal District Courts. Emer’s expertise extends to managing all facets of patent litigation, including pre-suit investigation, fact and expert discovery, dispositive motions, pre-trial preparation and trial. Emer has also successfully represented clients in inter partes review proceedings before the Patent Trial and Appeal Board. Originally from Ireland, Emer is a qualified Barrister and holds undergraduate and master degrees from the University of Cambridge.
Chicago‐Kent College of Law, J.D.
University of Cambridge, M. Phil.
Par Pharmaceutical v. QuVa Pharma et al. – Emer is counsel for QuVa in a trade secret action regarding vasopressin for injection.
Dexcel v. Takeda – Emer was counsel in successfully defending Dexcel against alleged infringement of Takeda’s Orange Book-listed patents for lansoprazole delayed-released orally disintegrating tablets (“ODT”). As a result of this ruling, Dexcel launched the first lansoprazole ODT product sold Over-The-Counter (“OTC”) in the US market.
Par v. Horizon (PTAB) – Emer was counsel in successfully defending one of Horizon’s Orange Book-listed patent for its RAVICTI® oral liquid product in an IPR proceeding against Par, IPR2015-01117. Par appealed PTAB’s decision to the Federal Circuit. The Federal Circuit affirmed per curiam PTAB’s decision upholding the patentability of Horizon’s ’012 patent.
Par v. Horizon (PTAB) – Emer was counsel for Horizon in defending multiple IPR proceedings (IPR2017-0167, -01768, -01769, and -01550) filed by Par against Horizon’s patents relating to Horizon’s RAVICTI® product used for the treatment of Urea Cycle Disorders (UCD) in patients two months of age and older. Pursuant to a settlement agreement reached between the parties, the IPRs were terminated.
Horizon v. Par (E.D. Tex.) – Emer was counsel for Horizon in Hatch-Waxman litigation against Par related to Par’s Abbreviated New Drug Application that seeks approval to market a generic equivalent to Horizon’s RAVICTI® oral formulation for the treatment of Urea Cycle Disorders (UCD) in patients two months of age and older. Subsequent to the Federal Circuit per curiam affirmation of PTAB’s decision upholding the patentability of Horizon’s ’012 patent, this litigation in E.D. Tex. was voluntarily dismissed and a new suit was filed in Delaware.
Horizon v. Par (D. Del. and D.N.J.) – Emer was counsel for Horizon in Hatch-Waxman litigations against Par related to Par’s Abbreviated New Drug Application that seeks approval to market a generic equivalent to Horizon’s RAVICTI® oral formulation for the treatment of Urea Cycle Disorders (UCD) in patients two months of age and older. Those litigations were successfully settled.
Horizon v. Lupin – Emer was counsel for Horizon in Hatch-Waxman litigations against Lupin related to Lupin’s Abbreviated New Drug Application that seeks approval to market a generic equivalent to Horizon’s RAVICTI® oral formulation for the treatment of Urea Cycle Disorders (UCD) in patients two months of age and older. Those matters settled.
Lupin v. Horizon (PTAB) – Emer was counsel for Horizon in defending IPR proceedings (IPR2017-01159 and IPR2017-01160) filed by Lupin against Horizon’s patents relating to Horizon’s RAVICTI® product used for the treatment of Urea Cycle Disorders (UCD) in patients two months of age and older. Pursuant to a settlement agreement reached between the parties, the IPRs were terminated.
Lupin v. Horizon (PTAB) – Emer was counsel for Horizon in defending IPR proceedings (IPR2016-00829) filed by Lupin against Horizon patents relating to Horizon’s RAVICTI® product used for the treatment of Urea Cycle Disorders (UCD) in patients two months of age and older. Horizon appealed PTAB’s final written decision to the Federal Circuit. Pursuant to a settlement agreement reached between the parties, Lupin withdrew as Appellees from the Federal Circuit Appeal.
Horizon v. Watson – Emer was counsel for Horizon in litigation against Watson related to Watson’s Abbreviated New Drug Application that was seeking approval to market a generic equivalent to Horizon’s Rayos® tablet product. That litigation was successfully settled.
Pfizer v. Lupin – Emer was counsel for Lupin in litigation related to Lupin’s Abbreviated New Drug Application that was seeking approval to market a generic equivalent of Pristiq® desvenlafaxine. That litigation was successfully settled.
Apotex v. Lupin – Emer was counsel for Lupin in litigation related to Lupin’s generic Accupril® (quinapril) products. That litigation was successfully settled.
Purdue v. Sandoz – Emer was counsel for Sandoz in litigation related to Sandoz’s Abbreviated New Drug Application that was seeking approval to market a generic equivalent to Purdue’s OxyContin®oxycodone extended release products.
Schering v. Sandoz – Emer was counsel for Sandoz in litigation related to Sandoz’s Abbreviated New Drug Application that was seeking approval to market a generic equivalent to Schering’s Noxafil® posaconazole product.
Abbott v. Lupin – Emer was counsel for Lupin in litigation related to Lupin’s Abbreviated New Drug Application that was seeking approval to market a generic equivalent to Abbott’s Trilipix® choline fenofibrate product. That litigation was successfully settled.
Eli Lilly v. APP Pharmaceuticals – Emer was counsel for APP at trial in litigation related to APP Pharmaceutical’s Abbreviated New Drug Application that was seeking approval to market a generic equivalent to Eli Lilly’s Alimta® pemetrexed product.

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