Associate Professor of Law, Center for Intellectual Property and Entrepreneurship, University of Missouri School of Law
Professor Lietzan researches, writes, and teaches primarily in the areas of food and drug regulation, intellectual property, and administrative law. Some of her recent scholarship has focused on the nature and purpose of the new drug approval system, federal regulation of fecal microbiota transplantation, federal regulation of products derived from cannabis, the political economy of the Hatch-Waxman (generic drug) statute, and incentives to study already approved drugs for new uses. She is an award-winning teacher, and she has been an elected member of the American Law Institute since 2006.
Professor Lietzan brings to her scholarship and teaching eighteen years of private practice experience, eight of them as a partner in the food and drug group at Covington & Burling in Washington, DC. In practice, she handled a wide range of complex legal problems and broader legislative and regulatory policy questions affecting FDA-regulated companies. This work included lifecycle management and strategy issues, regulatory strategy and advocacy, white collar defense, congressional investigations, briefing in products liability cases, and international regulatory policy work. She was involved in every major amendment to the Federal Food, Drug, and Cosmetic Act (FDCA) between 1997 and 2014 and was deeply immersed for more than a decade in the development of the Biologics Price Competition and Innovation Act of 2010. She has been consistently identified by her peers in private practice as a “Best Lawyer in America” in the categories of FDA law (since 2013) and Biotechnology Law (since 2007).
Professor Lietzan has held one leadership position or another at the Food and Drug Law Institute (FDLI) since 2004, including a stint on its Board of Directors from 2008 to 2012. She also held leadership positions in the American Bar Association’s Section of Science and Technology Law for fourteen years.
Professor Lietzan received a bachelor’s degree from the University of North Carolina, where she graduated with honors in history. She holds a master’s degree in history from UCLA and a law degree with high honors from Duke Law School.
Professor of Law, University of Baltimore School of Law (on leave); Senior Counsel, U.S. Department of Justice
Professor Dolin’s scholarship centers on patent law with a specific focus on how the patent regime affects innovation, especially in bio-pharmaceutical areas. His work in these areas includes a number of scholarly articles, presentations, amicus briefs, and congressional testimony.
Dr. Dolin is currently on leave from his academic duties while he serves as Senior Counsel in the Civil Rights Division of the United States Department of Justice.
From January 2020 to January 2022, Professor Dolin served as a resident Associate Justice of the Supreme Court of the Republic of Palau. In this role, he (together with other members of the Court) heard appeals in civil, criminal, administrative, and constitutional law matters.
Prior to joining the University of Baltimore School of Law, Professor Dolin held visiting appointments in other law schools. He also served as a law clerk to the Hon. Pauline Newman, of the U.S. Court of Appeals for the Federal Circuit and the late Hon. H. Emory Widener Jr., of the U.S. Court of Appeals for the Fourth Circuit.
Rumors that he has a real Russian bear in his office are entirely true.
Associate Professor of Law, Center for Intellectual Property and Entrepreneurship, University of Missouri School of Law
Professor Lietzan researches, writes, and teaches primarily in the areas of food and drug regulation, intellectual property, and administrative law. Some of her recent scholarship has focused on the nature and purpose of the new drug approval system, federal regulation of fecal microbiota transplantation, federal regulation of products derived from cannabis, the political economy of the Hatch-Waxman (generic drug) statute, and incentives to study already approved drugs for new uses. She is an award-winning teacher, and she has been an elected member of the American Law Institute since 2006.
Professor Lietzan brings to her scholarship and teaching eighteen years of private practice experience, eight of them as a partner in the food and drug group at Covington & Burling in Washington, DC. In practice, she handled a wide range of complex legal problems and broader legislative and regulatory policy questions affecting FDA-regulated companies. This work included lifecycle management and strategy issues, regulatory strategy and advocacy, white collar defense, congressional investigations, briefing in products liability cases, and international regulatory policy work. She was involved in every major amendment to the Federal Food, Drug, and Cosmetic Act (FDCA) between 1997 and 2014 and was deeply immersed for more than a decade in the development of the Biologics Price Competition and Innovation Act of 2010. She has been consistently identified by her peers in private practice as a “Best Lawyer in America” in the categories of FDA law (since 2013) and Biotechnology Law (since 2007).
Professor Lietzan has held one leadership position or another at the Food and Drug Law Institute (FDLI) since 2004, including a stint on its Board of Directors from 2008 to 2012. She also held leadership positions in the American Bar Association’s Section of Science and Technology Law for fourteen years.
Professor Lietzan received a bachelor’s degree from the University of North Carolina, where she graduated with honors in history. She holds a master’s degree in history from UCLA and a law degree with high honors from Duke Law School.
Andrew A. Hufford is an Intellectual Property attorney with Brinks Gilson & Lione. His practice emphasizes US and global patent prosecution in biopharma, chemistry, and plant genetics. He also has significant experience in patent and trade secret litigation, inter-partes review, and patent due diligence. Mr. Hufford is the Vice Chair of the Utah State Bar Intellectual Property Section; a founding member of the David K. Winder IP Inns of Court; and an active member of the American Bar Association’s IP Law Section.
Mr. Hufford was a Professor of Biology before practicing law. He holds a Bachelor of Science (Cum Laude, Phi Beta Kappa) and Master of Science in Biochemistry, and spent several years conducting clinical pharmacology research. He earned his J.D. from the University of Houston, where he was an Articles Editor with the Houston Journal of Health Law and Policy and a member of the Moot Court and Mock Trial teams.
Professor of Law, University of Baltimore School of Law (on leave); Senior Counsel, U.S. Department of Justice
Professor Dolin’s scholarship centers on patent law with a specific focus on how the patent regime affects innovation, especially in bio-pharmaceutical areas. His work in these areas includes a number of scholarly articles, presentations, amicus briefs, and congressional testimony.
Dr. Dolin is currently on leave from his academic duties while he serves as Senior Counsel in the Civil Rights Division of the United States Department of Justice.
From January 2020 to January 2022, Professor Dolin served as a resident Associate Justice of the Supreme Court of the Republic of Palau. In this role, he (together with other members of the Court) heard appeals in civil, criminal, administrative, and constitutional law matters.
Prior to joining the University of Baltimore School of Law, Professor Dolin held visiting appointments in other law schools. He also served as a law clerk to the Hon. Pauline Newman, of the U.S. Court of Appeals for the Federal Circuit and the late Hon. H. Emory Widener Jr., of the U.S. Court of Appeals for the Fourth Circuit.
Rumors that he has a real Russian bear in his office are entirely true.
Associate Professor of Law, Center for Intellectual Property and Entrepreneurship, University of Missouri School of Law
Professor Lietzan researches, writes, and teaches primarily in the areas of food and drug regulation, intellectual property, and administrative law. Some of her recent scholarship has focused on the nature and purpose of the new drug approval system, federal regulation of fecal microbiota transplantation, federal regulation of products derived from cannabis, the political economy of the Hatch-Waxman (generic drug) statute, and incentives to study already approved drugs for new uses. She is an award-winning teacher, and she has been an elected member of the American Law Institute since 2006.
Professor Lietzan brings to her scholarship and teaching eighteen years of private practice experience, eight of them as a partner in the food and drug group at Covington & Burling in Washington, DC. In practice, she handled a wide range of complex legal problems and broader legislative and regulatory policy questions affecting FDA-regulated companies. This work included lifecycle management and strategy issues, regulatory strategy and advocacy, white collar defense, congressional investigations, briefing in products liability cases, and international regulatory policy work. She was involved in every major amendment to the Federal Food, Drug, and Cosmetic Act (FDCA) between 1997 and 2014 and was deeply immersed for more than a decade in the development of the Biologics Price Competition and Innovation Act of 2010. She has been consistently identified by her peers in private practice as a “Best Lawyer in America” in the categories of FDA law (since 2013) and Biotechnology Law (since 2007).
Professor Lietzan has held one leadership position or another at the Food and Drug Law Institute (FDLI) since 2004, including a stint on its Board of Directors from 2008 to 2012. She also held leadership positions in the American Bar Association’s Section of Science and Technology Law for fourteen years.
Professor Lietzan received a bachelor’s degree from the University of North Carolina, where she graduated with honors in history. She holds a master’s degree in history from UCLA and a law degree with high honors from Duke Law School.
Andrew A. Hufford is an Intellectual Property attorney with Brinks Gilson & Lione. His practice emphasizes US and global patent prosecution in biopharma, chemistry, and plant genetics. He also has significant experience in patent and trade secret litigation, inter-partes review, and patent due diligence. Mr. Hufford is the Vice Chair of the Utah State Bar Intellectual Property Section; a founding member of the David K. Winder IP Inns of Court; and an active member of the American Bar Association’s IP Law Section.
Mr. Hufford was a Professor of Biology before practicing law. He holds a Bachelor of Science (Cum Laude, Phi Beta Kappa) and Master of Science in Biochemistry, and spent several years conducting clinical pharmacology research. He earned his J.D. from the University of Houston, where he was an Articles Editor with the Houston Journal of Health Law and Policy and a member of the Moot Court and Mock Trial teams.
Topics
The Bayh-Dole Act and the Debate Over “Reasonable Price” March-In Rights
In 1980, Congress passed the bipartisan Patent and Trademark Law Amendments Act—better known as the...
Sandoz, Inc. v. Amgen, Inc. Post-Decision SCOTUScast
Erika Lietzan
On June 12, 2017, the Supreme Court decided Sandoz, Inc. v. Amgen, Inc. consolidated with...
Courthouse Steps: Sandoz Inc. v. Amgen Inc. - Podcast
Gregory Dolin, Erika Lietzan
In a decision likely to shape not only future biosimilar litigation but the biosimilar industry...
Courthouse Steps: Sandoz Inc. v. Amgen Inc.
TeleforumCourthouse Steps: Amgen, Inc. v. Sandoz, Inc. - Podcast
Andrew A. Hufford
The Biologics Price Competition and Innovation Act of 2010 (42 U.S.C. § 262) created an...
Courthouse Steps: Amgen, Inc. v. Sandoz, Inc.
Teleforum