EducationChicago-Kent College of Law (J.D., 2008) Honorable Society of King’s Inns (Barrister-At-Law, 2006) University of Cambridge (M.Phil., 2002) University of Cambridge (B.A., 2001), Natural Sciences
Emer Simic is a partner in the Intellectual Property Practice Group and focuses her practice on patent litigation and counseling in the pharmaceutical and biotech space. Emer has substantial experience successfully representing pharmaceutical and biotech companies in Hatch-Waxman and patent infringement disputes before the U.S. District Court and before the Patent Trial and Appeal Board (PTAB). A strategic advisor and compelling advocate, Emer partners with her clients to achieve their goals at all phases of litigation, from pre-litigation counseling and opinions through FDA filings, discovery, trial and appeal.
Emer's ability to harmonize scientific knowledge with her legal acumen outside the courtroom enables her to effectively counsel her clients on complex IP matters throughout the product lifecycle, from advising on patent prosecution strategy and portfolio management to providing opinions on validity and FTO. Emer also assists with due diligence investigations for pharmaceutical mergers and acquisitions. Building and maintaining robust client relationships is a cornerstone of her practice, aiding businesses through informed decision-making that aligns with her client’s strategic objectives.
Originally from Ireland, Emer also holds the distinction of being a qualified barrister. Within the legal community, she is highly lauded for her accomplishments: listed in Intellectual Asset Management's (IAM) Patent 1000 for Litigation, named among the top "40 Under 40 Illinois Attorneys to Watch" by the Chicago Daily Law Bulletin, honored as one of "Chicago's Notable Women Lawyers" by Crain's Custom Media, and designated an "IP Star" by Managing IP.
Representative Matters
- Pfizer Inc. et al. v. Zenara Pharma Private Limited – counsel for Defendant, Zenara Pharma Private Limited in Hatch-Waxman litigation involving Zenara’s Abbreviated New Drug Application for tafamadis (61 mg) capsules.
- Actelion Pharmaceuticals Ltd. v. Gland Pharma Limited – counsel for Defendant, Gland Pharma Limited in Hatch-Waxman litigation involving Gland’s Abbreviated New Drug Application for epoprostenol sodium for injection (1.5 mg/vial and 0.5 mg/vial)
- InfoRLife SA and WG Critical Care, LLC v. Hikma Pharmaceuticals USA, Inc. – Counsel for Hikma in Hatch-Waxman litigation concerning Hikma’s Abbreviated New Drug Application for midazolam 0.9% sodium chloride (50 mg/50 ml and 100mg/100 ml) solution, for intravenous use. The case was successfully settled, and Hikma launched its product.
- Represented NDA holder and patent owner in Hatch-Waxman litigation concerning Cambia® (diclofenac potassium powder for oral solution). Obtained favorable settlement.
- Represented 503B outsourced compounding manufacturer in a trade secret action brought in federal district court regarding vasopressin for injection. That litigation was successfully settled.
- Successfully defended private pharmaceutical company at trial against alleged infringement of Orange Book-listed patents for lansoprazole delayed-released orally disintegrating tablets (ODT). As a result of this ruling, the first lansoprazole ODT product was sold Over-The-Counter (“OTC”) in the U.S. market.
- Counsel for innovator company in multiple Hatch-Waxman litigations filed against generic drug companies concerning RAVICTI® for the treatment of UCD in patients two months of age and older. Those litigations were successfully settled.
- Counsel for innovator company in Hatch-Waxman litigation filed against generic drug companies concerning Rayos®. That litigation was successfully settled.
- Represented multinational pharmaceutical company in litigation arising from its Abbreviated New Drug Application seeking approval to market a generic desvenlafaxine product. That litigation was successfully settled.
- Represented multinational pharmaceutical company in litigation related to its generic quinapril product. That litigation was successfully settled.
- Represented pharmaceutical company in litigation arising from its Abbreviated New Drug Application seeking approval to market generic oxycodone extended release products.
- Represented pharmaceutical company in litigation arising from its Abbreviated New Drug Application seeking approval to market a generic posaconazole product.
- Represented multinational pharmaceutical company in litigation arising from its Abbreviated New Drug Application seeking approval to market a generic choline fenofibrate product. That litigation was successfully settled.
- Represented pharmaceutical company at trial in litigation arising from its Abbreviated New Drug Application seeking approval to market a generic pemetrexed product.
PTAB
- Lead counsel for Fonterra Cooperative Group Limited and Fonterra (USA) Inc. in IPRs challenging U.S. Patent Nos. 10,709,146 and 10,729,150 assigned to Arla Foods AMBA concerning whey protein products.
- Successfully defended a pharmaceutical company’s Orange Book-listed patent for its RAVICTI® product in an IPR proceeding against competitor. Competitor appealed PTAB’s decision to the Federal Circuit. The Federal Circuit affirmed per curiam PTAB’s decision upholding the patentability of client’s ’012 patent.
- Successfully defended a pharmaceutical company in multiple IPR proceedings filed by competitor against client’s patents relating to its RAVICTI® . Pursuant to a settlement agreement reached between the parties, the IPRs were terminated.
- Represented pharmaceutical company in defending IPR proceedings filed by multinational pharmaceutical competitor against client’s patents relating to its RAVICTI® product. Pursuant to a settlement agreement reached between the parties, the IPRs were terminated.
- Represented pharmaceutical company in defending IPR proceedings filed by competitor against client’s patents relating to its RAVICTI® product. Client appealed PTAB’s final written decision to the Federal Circuit. Pursuant to a settlement agreement reached between the parties, competitor withdrew as Appellees from the Federal Circuit Appeal.
- Selected as one of the top “40 Under 40 Illinois Attorneys to Watch” by the Chicago Daily Law Bulletin in 2020
- Honored in “Chicago’s Notable Women Lawyers” by Crain’s Custom Media, 2020
- Listed in Intellectual Asset Management’s (IAM) Patent 1000 in Litigation, 2020-2023: Silver - Illinois.
- Named an “IP Star - Patent,” Managing Intellectual Property, 2020, 2022-2023
- Named in the Illinois Rising Stars list, as published in Illinois Super Lawyers, 2012‐2021
- Selected by peers as a Leading Lawyer in Intellectual Property Law and Patent Law–Leading Lawyers Network, 2016–2022
- The Best Lawyers in America, recommended in “Litigation - Patent” since 2023
Bar Admissions
Court Admissions
- State of Illinois Supreme Court
- U.S. Court of Appeals for the Federal Circuit
- U.S. District Court for the Northern District of Illinois
- American Bar Association
- The Coalition of Women’s Initiatives in Law: President (2024), Vice President (2023), Secretary (2021-2022); Chicago Chapter Board Member (2020 – Present), National Board Member (2023 – Present)
- Chicago Women in IP
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