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.
Partner, Kirkland & Ellis LLP
Mr. Jay Lefkowitz is a leading partner in Kirkland’s litigation practice and a member of the Firm’s Global Executive Management Committee. He is also an adjunct professor at Columbia Law School, where he teaches a seminar on Supreme Court advocacy. Mr. Lefkowitz has served as lead trial and appellate counsel in a wide variety of substantive areas, including shareholder disputes, antitrust, product liability, litigation against the FDA and False Claims Act matters. He has also conducted numerous internal investigations for public companies and audit committees.
In its 2013 release of “The 100 Most Influential Lawyers in America,” The National Law Journal describes Mr. Lefkowitz as “a leading voice on school choice issues” and “a no-nonsense appellate and antitrust lawyer for an array of blue-chip clients.” The Legal 500 U.S. noted that Mr. Lefkowitz “provides a depth of understanding and influence in some of the highest courts of our country,” and in Chambers USA, America’s Leading Lawyers for Business, clients say, “‘Jay is brilliant; there is no other way to put it.’” Mr. Lefkowitzwas also named a Law360 “MVP of the Year” in 2011 for his Appellate practice, and in 2012, 2013, 2014 and 2015 for his Life Sciences work. Mr. Lefkowitz is one of only three of the 189 MVPs named to the list five years in a row. The American Lawyer named him its “Lawyer of the Week” in December 2012 for his role in winning an antitrust lawsuit in the pharmaceutical industry.
Mr. Lefkowitz takes on groundbreaking work for high-profile clients, representing more than a dozen major pharmaceutical, medical device and health care companies in important and frequently precedent-setting matters. Mr. Lefkowitz has won two landmark 5-4 decisions at the U.S. Supreme Court in favor of the pharmaceutical industry overturning the decision of three Circuit Courts of Appeal. In Pliva v. Mensing in 2011, on behalf of Teva and Actavis, Mr. Lefkowitz convinced the Court to reject the views of the FDA and the Solicitor General and establish that generic drug companies may no longer be sued for “failure to warn claims,” finding that federal law preempts state law under the Constitution’s supremacy clause. His victory in Mutual v. Bartlett in 2013, overturned a $21 million verdict on behalf of Sun Pharmaceuticals, and extended the Mensing ruling to cover design defect claims.
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.
President and Senior Counsel, Casey Law Office, P.C.
Stephen Casey is President and Senior Counsel at Casey Law Office, P.C. After high school, Stephen entered the United States Navy, and while there supervised operation of nuclear reactors in the United States Navy for eight years, holding several leadership and supervisory positions in what is regularly acknowledged as one of the most academically rigorous program in the United States military. In 1999, Stephen finished his naval service and attended LeTourneau University in Longview, Texas, where he double-majored in Biblical Studies and History-Political Science, graduating with a 4.0 GPA. He continued his education at Regent University School of Divinity, earning a pre-doctoral Master of Arts in Biblical Interpretation. Subsequently, Stephen attended Regent University School of Law, where he was selected based on his writing skills to serve as an editor for Regent's Law Review. Stephen also was active with the Federalist Society, and participated in moot courts.
Both during and after law school Stephen clerked with several firms and was selected in 2008 to clerk with the Texas Supreme Court in the chambers of former Justice Scott Brister. Following his time on the Court, Stephen decided to open his own law practice so he could tailor cases to client's individual needs. Stephen is also an Allied Attorney with the Alliance Defending Freedom, a Blackstone Fellow, and serves as Co-Founder and Chief Counsel for the Texas Center for Defense of Life. Stephen also continues to serve in the Federalist Society.
Stephen lives in Round Rock with his wife and five children, where they are active in the community. He and his family attend Austin Vineyard Church, and he remains activing in local, state, and national political issues.
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.
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.
Partner, Barr & Klein PLLC
Steve Klein, a partner at Barr & Klein PLLC, is an experienced free speech attorney who has successfully fought for the First Amendment rights of his clients against local, state and federal regulators. As a lobbyist, Steve’s advocacy has led to the successful amendment of state laws to respect political engagement and prevented the enactment of laws that burden it. Steve has published articles in several legal journals, and his commentary has appeared in The Wall Street Journal, The Washington Times, The Detroit News, and other outlets. Steve earned a bachelors degree in politics at Hillsdale College and a law degree from Ave Maria School of Law, where he served as Managing Editor of the Ave Maria Law Review. He is licensed to practice law in the District of Columbia, Illinois and Michigan.
Vice President of Domestic and Economic Policy, The Heritage Foundation
Roger Severino is Vice President of Economic and Domestic Policy, and the Joseph C. and Elizabeth A. Anderlik Fellow at The Heritage Foundation.
Severino is a national authority on civil rights, conscience and religious freedom, the administrative state, and information privacy, particularly as applied to health care law and policy. Find his tweets at @RogerSeverino_.
Severino spearheaded the HHS Accountability Project while a Senior Fellow at EPPC from 2021 to 2023. Previously, Severino was Director of HHS’ Office for Civil Rights, where he led a team of over 250 staff enforcing our nation’s civil rights, conscience and religious freedom, and health information privacy laws. He served from 2017 to 2021 and was the longest-serving OCR director of the past three decades.
Prior to joining HHS, Severino served for two years as Director of the DeVos Center for Religion and Civil Society at Heritage, advocating for life, family, and religious-freedom policies. Before that, he was a trial attorney for seven years at the U.S. Department of Justice’s Civil Rights Division where he enforced the Fair Housing Act and the Civil Rights Act of 1964. Severino started his legal career at the Becket Fund for Religious Liberty, where he was Legal Counsel and Chief Operations Officer and defended the rights of people of all faiths under federal and international law.
Severino has been profiled in The New York Times, The Atlantic, The Wall Street Journal, and The Hill and has appeared on Fox News, CNN, MSNBC, NPR, and PBS, among others. In 2020, The New York Times dubbed him and his wife Carrie, “a conservative power couple” to be reckoned with.
Severino holds a JD from Harvard Law School, a master’s degree in public policy, with highest distinction, from Carnegie Mellon University, and a bachelor’s degree in business from the University of Southern California. He was appointed by President Trump to the Administrative Conference of the United States and is a member of the District of Columbia and the Commonwealth of Virginia bars.
As OCR director, Severino founded the federal government’s first division dedicated exclusively to conscience and religious freedom compliance and enforcement. He enforced the Weldon Amendment for the first time against a state (California) after it coerced families and religious organizations into paying for abortion insurance coverage, leading to a $200 million federal funding disallowance. He also enforced laws protecting pro-life pregnancy resource centers from discrimination by states hostile to their message and enforced laws prohibiting forced participation in abortions by medical professionals.
With respect to civil rights, Severino protected older persons and people with disabilities from being denied life-saving care due to discriminatory “quality of life” judgments, especially during the COVID-19 pandemic. He also achieved a landmark sexual harassment resolution with Michigan State University in the wake of the Larry Nassar sexual assault scandal and protected the rights of non-English speakers to have equal access to health and human services.
In the area of health privacy, he secured the largest HIPAA monetary settlement in history and achieved the largest number of enforcement resolutions both in a single year and across four years. He also facilitated the transformational use of Skype, Zoom, and Facetime for delivery of telehealth during the COVID-19 pandemic and beyond.
His regulatory reform activities resulted in a comprehensive conscience protection regulation and proposed a life-affirming disability rights regulation. He achieved regulatory savings of $3.6 billion in health care industry costs over five years and identified and proposed an additional $3.2 billion in cost savings from the repeal of ineffective and unnecessary regulatory burdens.
Severino is a Spanish speaker who teaches salsa and west coast swing in his spare time.
Courthouse Steps: Sandoz Inc. v. Amgen Inc.
TeleforumUpdate: In re Fosamax (Alendronate Sodium) Products Liability Litigation
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.
TeleforumA Second Look at the CREATES Act: What’s Not Being Said
Erika Lietzan
Note from the Editor: This article critically discusses the CREATES Act, which is currently pending...
Litigation Update: Crisis Pregnancy Centers and the First Amendment
TeleforumTopics
The United Nations' Misguided Approach to Healthcare Access
Intellectual property (IP) protections promote innovation and spur research and development into life-saving drugs and...
Book Review: The Intimidation Game
Stephen R. Klein
Note from the Editor: This article favorably reviews Kimberley Strassel’s new book about efforts by...
Zubik v. Burwell - Post-Decision SCOTUScast
Roger Severino
On May 16, 2016, the Supreme Court decided Zubik v. Burwell, the lead case in...
Topics
SCOTUS Opinion: Zubik v. Burwell
Zubik v. Burwell: By a vote of 8-0, judgments of the Courts of Appeals are...