Washington, DC – Wiley is pleased to announce that Karin A. Hessler has rejoined the firm as a partner in its Intellectual Property Practice. A pharmaceutical industry legal and policy leader, Hessler brings nearly two decades of experience in patent litigation, U.S. Food and Drug Administration (FDA) regulatory counseling, and public policy advocacy. Drawing on experience spanning private practice, trade association leadership, and advocacy before Congress and senior Administration officials, she advises clients on complex legal, regulatory, and policy issues affecting the pharmaceutical industry.
Hessler returns to Wiley after seven years at the Association for Accessible Medicines (AAM), the leading trade association representing generic and biosimilar manufacturers, where she most recently served as Chief Legal and IP Officer. There, she led significant legal, regulatory, legislative, and litigation initiatives on behalf of the generic and biosimilar industries, working extensively with Congress, federal agencies, and senior Administration officials on issues including patent reform, FDA regulation, antitrust enforcement, trade policy, and drug pricing.
“We are happy to welcome Karin back to Wiley,” said Wiley Managing Partner Peter D. Shields. “She returns with significant industry experience that builds on her strong foundation as a patent litigator. Her addition strengthens our IP capabilities and brings clients a valuable perspective through years of working at the forefront of issues affecting the pharmaceutical industry.”
Before joining AAM, Hessler spent more than a decade at Wiley, representing clients in complex patent disputes involving pharmaceuticals and other technologies, including Hatch-Waxman litigation. She handled matters through all stages of litigation, from claim construction and summary judgment through trial and appeal, and counseled pharmaceutical and medical device companies on patent prosecution and IP strategy.
“Karin brings a distinctive perspective to the pharmaceutical industry,” said Ralph J. Caccia, chair of Wiley’s litigation and investigations practices. “She combines extensive patent litigation experience with deep knowledge of FDA regulatory issues, legislative developments, trade and tariff issues, and industry policy. That breadth of experience allows her to help clients navigate challenges that often extend beyond any single legal discipline.”
At Wiley, Hessler will advise clients across the broad range of legal, regulatory, and policy issues affecting the pharmaceutical industry. Her experience spans intellectual property (IP), FDA regulation, legislative and agency advocacy, antitrust and competition matters, trade policy, and strategic industry initiatives, giving clients a distinctive perspective on the forces shaping the life sciences sector. She will continue to maintain an active patent litigation practice, representing clients in complex IP disputes while helping them navigate the broader regulatory and policy considerations that increasingly influence litigation strategy and business objectives.
“Wiley is where I began my legal career and built the foundation for the work I do today, so it is especially meaningful to return to the firm,” Hessler said. “I know firsthand the strength of Wiley’s lawyers and the depth of its capabilities across litigation, regulatory, and policy matters. I look forward to rejoining the team and helping clients navigate the evolving challenges and opportunities facing the life sciences industry.”
Wiley’s Intellectual Property Practice represents clients in high-stakes IP litigation and provides strategic counseling on the protection, enforcement, and management of intellectual property. The team advises clients across patent litigation and prosecution, trademarks, copyrights, and trade secrets, drawing on the firm’s deep experience before the U.S. Patent and Trademark Office (USPTO), U.S. Copyright Office, FDA, and other federal agencies involved in IP matters.