Karin A. Hessler

Karin’s practice spans patent litigation, U.S. Food and Drug Administration (FDA) regulatory counseling, and public policy advocacy for the pharmaceutical industry. She advises pharmaceutical manufacturers and trade associations on the full spectrum of legal, regulatory, and policy issues affecting their businesses, combining sophisticated litigation experience with firsthand engagement before Congress, federal agencies, and senior Administration officials. Before rejoining Wiley, Karin served as Chief Legal and Intellectual Property Officer of the Association for Accessible Medicines (AAM), where she led significant legislative, regulatory, and litigation initiatives on behalf of the generic and biosimilar industries.

Representative Matters

• Recognized subject matter expert on the full spectrum of legal and policy issues affecting the generic and biosimilar industries, including patent reform, Hatch-Waxman and BPCIA frameworks, FDA regulatory pathways, antitrust enforcement, drug pricing policy, and international trade and tariff issues.
• Extensive Hatch-Waxman patent litigation experience in all phases of litigation, including Faslodex^®, Antara^®, Amrix^®, Treanda^®, Abilify^®, Ofirmev^®, and Detrol^® Deep experience with inter partes review on pharmaceutical patents.
• Deep, practical expertise in complex FDA regulatory issues, including 180-day exclusivity, interchangeability, citizen petitions, Orange Book listings, and exclusivity frameworks.
• Substantial trade experience, including leading industry engagement on tariff and trade policies, ultimately culminating in a Section 232 tariff exemption for generic and biosimilar manufacturers.
• Led industry advocacy on a broad range of patent, trade, antitrust, and FDA issues, working extensively with Congress, federal agencies, and senior Administration officials to advance industry priorities.
• Substantial experience in constitutional and regulatory litigation, including an Eighth Circuit victory invalidating state drug pricing legislation on dormant Commerce Clause grounds.
• Led the generic and biosimilar industry’s advocacy efforts in a significant pharmaceutical patent matter that culminated in a unanimous 9-0 U.S. Supreme Court victory.
• Extensive patent litigation experience in other industries, including a successful jury trial team that obtained invalidity and non-infringement rulings on behalf of a large telecommunications company in a patent infringement case pertaining to data cards. Member of a team that secured a victory for ARM, Ltd. in defense of claims of patent infringement pertaining to the design of microprocessors.

Professional Experience

• Association for Accessible Medicines
  • Chief Legal and Intellectual Property Officer (2025-2026)
  • General Counsel (2022-2025)
  • Vice President and Deputy General Counsel (2020-2022)
  • Assistant General Counsel (2019-2020)
• Wiley Rein LLP
  • Partner (2017-2019)
  • Associate (2008-2016)
• Graduate Research Assistant, Duke University Department of Biochemistry (2003-2004)
• Research Assistant, Lafayette College Department of Chemistry (2001-2002)

Recognitions

• Received 2011 Burton Award for Distinguished Legal Writing