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The Biden Administration recently proposed new regulatory guidelines that would permit agencies to impose price controls on products based on inventions derived from upstream federally funded research. The new regulations would affect such price controls by expanding the “march-in” power of the Bayh-Dole Act.
In addition to its core function allowing universities and other contractors to retain ownership of inventions created with federal funds, this law authorizes, under very specific circumstances, the funding agency (e.g., the National Institutes of Health (NIH) or the Department of Energy) to grant licenses, without authorization of the patent owner, to any inventions made with funding provided by the agency. The proposed new guidelines would add the price of the end-product derived from those early-stage inventions to the list of specific circumstances.
Since its enactment in 1980, the march-in power of the Bayh-Dole Act has never been used. When asked about using the price of the end product as one of the circumstances, the law’s namesake Senators, Birch Bayh and Bob Dole, stated the text of their law did not authorize price-based march-in. Importantly, the NIH has rejected numerous petitions over the past several decades to use the march-in power to lower the prices of patented drugs or medical devices. Proponents of the new regulatory guidelines, however, argue that the statute does authorize an agency to consider price as a march-in trigger and the Biden Administration argues that march-in is a key tool to lower drug prices.
This panel discussed the regulatory proposal for price controls under the Bayh-Dole Act and other vehicles (e.g., the IRA and reasonable/reference pricing clauses in licenses or collaborative research agreements), whether they represent regulatory overreach by the Executive Branch, and whether it is wise policy to implement price controls on drugs and other products or services in the U.S. innovation economy. -
For several weeks, much media attention has focused on reports of flags flown outside the primary residence and vacation home of Supreme Court Justice Samuel Alito. Several publications assert that the flags are associated with support for the “Stop the Steal” movement, Christian nationalism, and/or the January 6 attack on the U.S. Capitol.
These reports have led some reporters and lawmakers to question the impartiality of Justice Alito in cases involving former President Trump, and/or January 6 defendants. Justice Alito has issued statements directly addressing these reports and has not recused himself from any cases. On this topic, the Chief Justice declined a request for a meeting from two Democratic U.S. Senators, stating, in part, that "the format proposed - a meeting with leaders of only one party who have expressed an interest in matters currently pending before the Court - simply underscores that participating in such a meeting would be inadvisable."
Is this latest media coverage and Congressional interest part of a growing trend to target certain members of the Court? Is the legitimacy of the Court itself being called into question? This program will address the contentions made against Justice Alito and the broader implications for journalism, professional ethics, separation of powers, and future respect for the Supreme Court as an essential American institution.
Featuring: Dan Mclaughlin, Senior Writer, National Review Online Allyson Newton Ho, Partner & Co-Chair, Constitutional and Apellate Law Practice Group, Gibson, Dunn & Crutcher LLP -
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On October 30, 2023, President Biden signed the most far-reaching presidential action in AI, Executive Order 14,110, Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence. The EO directs dozens of federal agencies to take over 100 discrete actions to implement it over eight distinct policy areas. The EO received significant attention and a broad range of responses from the regulated public and congressional policymakers. Moreover, the States have grown highly active in regulating AI. This panel will discuss the consequences of the EO on the federal executive branch, the federal legislative process, States, and the tech industry as well as independent federal agency AI regulatory action with an eye toward the opportunities and challenges to come.
Featuring:
Johnathan Smith, Vice President and Legal Director, MacArthur Justice Center
Hon. Keith Sonderling, Commissioner, Equal Employment Opportunity Commissioner
Adam Thierer, Senior Fellow, R Street Institute
(Moderator) Prof. Aram A. Gavoor, Associate Dean for Academic Affairs and Professorial Lecturer in Law, The George Washington University Law School -
Since Dobbs v. Jackson Women’s Health Organization, state courts and legislatures have grappled with its legal and policy implications, especially as they pertain to abortion and IVF. In LePage v. Center for Reproductive Medicine, for example, the Alabama Supreme Court held that frozen embryos should be regarded as “children” for the purposes of Alabama’s Wrongful Death of a Minor Act. And in Planned Parenthood v. Mayes, the Arizona Supreme Court upheld an 1864 law that bans all abortions in the state except those deemed necessary to save the life of the mother.
These recent rulings have been highly criticized by commentators on both sides of the aisle, and they raise important questions about the legal status of IVF and abortion in the wake of Dobbs v. Jackson Women’s Health Organization. For example, in both cases, the courts interpreted the law in accordance with textualist principles, and the state legislatures swiftly enacted measures to address the state supreme court decisions afterward. Are these cases therefore examples of the proper allocation of powers, where the judiciary says what the law is, and the legislature is tasked with implementing policy? With the question of abortion being returned to the legislative process post-Dobbs, do these cases invite more thoughtful dialogue about abortion and IVF policy, or do they sow further acrimony? Were these cases rightly decided? Can we articulate a legal standard vis-à-vis abortion and IVF that is both thoughtful and conceptually consistent? In what ways do abortion and IVF interact, both philosophically and legally? Please join us as we discuss these issues and others with some of the leading scholars in this space.
Featuring:
Prof. I. Glenn Cohen, James A. Attwood and Leslie Williams Professor of Law & Deputy Dean; Faculty Director, Petrie-Flom Center for Health Law Policy, Biotechnology & Bioethics; Harvard University Law School
Prof. O. Carter Snead, Director, de Nicola Center for Ethics and Culture and Professor of Law, University of Notre Dame Law School
(Moderator) Jennie Bradley Lichter, Deputy General Counsel, The Catholic University of America -
A New York City jury recently convicted former President Donald Trump of 34 criminal counts of falsifying business documents. In New York, it is a misdemeanor to falsify business records with “the intent to defraud,” a crime with a two year statute of limitations. If the falsification is carried out for the purpose of concealing another crime, it is a felony, with an extended statute of limitations.
Following the verdict, Bragg pointed to the prosecution’s methodical presentation of “extensive hard evidence” in support of the outcome. Some legal experts agree. Others, however, have criticized the DA’s case and predict it will be overturned on appeal for any of several reasons. These include questions about Judge Merchan's impartiality, the prosecution’s legal theory, the evidence allowed and not allowed at trial, and the jury instructions. One much-discussed question, for example, is that Manhattan District Attorney Bragg’s case charged Trump with a felony records violation, but he did not specify until his closing argument what other crime(s) the records violations were designed to conceal. Moreover Judge Merchan's jury instructions told the jury that they need not agree on that question, but instead that they only had to agree that the violations were designed to conceal a crime. Was this correct as a matter of statutory and constitutional law? In addition, there are questions about whether some of the conduct alleged actually constituted a crime, for either statutory or constitutional reasons. There are also important questions about the propriety and prudence of bringing charges of this type against a former President of the opposite party from that of the other actors in the system. Finally, there are many important questions about what happens next.
Join us for an expert discussion of this historic case and its wide-ranging legal and prudential implications.
Featuring:
Sarah Isgur, Senior Editor, The Dispatch
Prof. William G. Otis, Adjunct Professor of Law, Georgetown Law -
On May 30, 2024, the Supreme Court issued its decision in National Rifle Association of America v. Vullo. In a 9-0 decision, the Court sided with the NRA, affirming the actions taken by New York Department of Financial Services Maria Vullo violated the First Amendment. The case, known as one of the two "jawboning" cases heard this term (along with Murthy v. Missouri) raised the question of whether the First Amendment allows a government regulator to threaten regulated entities with adverse regulatory actions if they do business with a controversial speaker, as a consequence of (a) the government’s own hostility to the speaker’s viewpoint or (b) a perceived “general backlash” against the speaker’s advocacy.
Join us for a panel discussion breaking down and analyzing this case and what can be expected, especially in light of the fact Murthy has yet to be decided.
Featuring:
Thomas Berry, Research Fellow, Robert A. Levy Center for Constitutional Studies, Cato Institute
Robert Corn-Revere, Chief Counsel, FIRE
Vera Eidelman, Staff Attorney, Speech, Technology, and Privacy Project, ACLU
John J. Vecchione, Senior Litigation Counsel, New Civil Liberties Alliance
(Moderator) Casey Mattox, Vice President for Legal and Judicial Strategy, Americans for Prosperity -
Ranked choice voting, also known as instant runoff voting, is a voting method where voters select several candidates in the order of preference on a single ballot. Ranked choice voting has been used by certain states, cities, and political party primaries. Recently, a series of jurisdictions have implemented bans on ranked choice voting. A panel of experts, which includes an attorney, economist, and political scientist, will analyze ranked choice voting and present a diversity of perspectives on whether ranked choice voting should be implemented in American elections.
Featuring:
Lisa L. Dixon, Executive Director, Center for Election Confidence
Dr. Martha Kropf, Professor, Political Science and Public Administration, University of North Carolina at Charlotte
Walter K. Olson, Senior Fellow, Cato Institute
(Moderator) Maya Noronha, Civil Rights Attorney -
Balancing safety and justice is especially challenging in the pretrial context where difficult decisions must be made quickly while evidence is still being gathered. In September 2023, an overhaul of Illinois’ pretrial system went into effect, eliminating the use of cash bail while also expanding the authority of judges to detain defendants without bail. As states and local jurisdictions across the country weigh pretrial policies, what can we learn from the Illinois experience to date? This panel of experts will review preliminary data and specific cases that shed light on this question. The conversation will also consider to what degree experiences have differed in rural and urban areas and examine what adjustments are needed.
Featuring:
Robert Berlin, State’s Attorney, DuPage County, Illinois
Hon. Eugene Doherty, Appellate Court Justice, Illinois Appellate Court for the Fourth District
Dr. David Olson, Professor, Department of Criminal Justice and Criminology & Co-Director, Center for Criminal Justice, Loyola University Chicago
(Moderator) Marc Levin, Chief Policy Counsel, Council on Criminal Justice and Senior Advisor, Right on Crime -
Between 2010-2014, the Supreme Court handed down four decisions resulting in the Mayo-Alice two-step test for what counts as an invention or discovery eligible for patent protection. In the ensuing decade, the issue of whether this test is indeterminate, too restrictive, or both, has been vigorously debated by lawyers, judges, and scholars. Recently, Senators Thom Tillis (R-NC) and Christopher Coons (D-DE) introduced the Patent Eligibility Restoration Act (PERA), which would abrogate the Mayo-Alice test among other substantive and procedural reforms to patent eligibility doctrine. This webinar discussed PERA and its implications for the U.S. innovation economy as leader in innovation in the 21st century facing new challenges from global competitors like China.
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On April 25th, the Environmental Protection Agency announced a suite of final rules meant to reduce pollution from fossil fuel-fired power plants.
The rule was among four measures targeting coal and natural gas plants that the EPA said would provide “regulatory certainty” to the power industry and encourage them to make investments to transition “to a clean energy economy.” The measures include requirements to reduce toxic wastewater pollutants from coal-fired plants and to safely manage coal ash in unlined storage ponds.Supporters of the new rule argue that it aligns well with the EPA's statutory authority, the current state of electric markets, and available emissions-reduction technologies. However, opponents contend that it is legally flawed and could jeopardize grid reliability.
What legal and policy issues does this rule potentially raise? Does it trigger "major questions" issues? Is the agency relying on unproven technology, potentially violating the statutory requirement that emission standards be based on proven systems? Moreover, does the rule infringe on state prerogatives for regulating existing sources? Join us as we delve into these questions and analyze the legal complexities surrounding this new rule.Featuring:
Kevin Poloncarz, Partner, Covington & Burling LLPJustin Schwab, Founder, CGCN Law, PLLC -
Throughout Arizona’s history as a state, the criminal code authorized penalties against any person who performed or procured an abortion for a pregnant woman. In 1971, Planned Parenthood Center of Tucson challenged that law on state and federal constitutional grounds. In early 1973, the state intermediate appellate court upheld the criminal law as constitutional. Shortly thereafter, SCOTUS issued Roe v. Wade recognizing a federal constitutional right to abortion. And the Arizona appellate court then enjoined enforcement of the state’s criminal abortion law.
The Arizona legislature codified numerous abortion-related laws in the ensuing years. One such law, enacted in 2022, adopted a “15-week ban.” Later that same year, SCOTUS issued its opinion in Dobbs v. Jackson Women’s Health Organization, which overturned Roe and concluded that the federal constitution does not support a right to abortion.
Dobbs thus set a collision course for two Arizona laws: the previously enjoined but still on-the-books criminal law from 1973 and the 2022 15-week ban. On April 9, 2024, the Arizona Supreme Court issued its opinion in Planned Parenthood v. Mayes / Hazelrigg, resolving the question of which law currently governs.
Hon. James D. Smith will join us to break down the majority and dissenting opinions. -
Congress passed the Antiquities Act in 1906 to protect Native American archaeological sites from looters and vandalism, empowering the President to designate historic landmarks, structures, or objects of scientific interest as national monuments on federal land. However, it also imposed limitations, requiring such designations to cover only "the smallest area compatible with the proper care and management of the objects to be protected." Initially, Presidents designated monuments focused on safeguarding specific landmarks or structures.
Over time, modern Presidents have expanded their authority under the Antiquities Act, interpreting "objects" broadly to include ecosystems. President Obama notably expanded the Act's use, establishing 29 new national monuments. However, this expansion faced pushback, with President Trump reducing the size of certain monuments and lifting usage restrictions. President Biden's subsequent actions, such as expanding the Grand Staircase monument and reinstating fishing bans, further illustrate the contentious nature of presidential monument designations.
All these challenges present interesting questions of statutory interpretation, limits on presidential power, the authority of the judiciary to review Presidential action, and the scope and content of both the major questions doctrine and the nondelegation doctrine.
Please join Adam Griffin, Separation of Powers Attorney at Pacific Legal Foundation, for a litigation update on these exciting cases and the future of presidential power under the Antiquities Act. -
On April 23, 2024, the FTC voted 3-2 to adopt a final rule banning the use of non-compete agreements nationwide, impacting 30 million workers by the FTC’s own estimates. This near categorical ban on the non-compete agreements is a contrast from a regime in which these agreements had been recognized to have potential procompetitive value and therefore were reviewed for reasonableness. It also marks a departure from the state law in many jurisdictions. Less than 24 hours after the vote, two lawsuits have challenged the rule based on statutory and Constitutional grounds. This breaking news panel discussed the final rule, grounds for statutory and Constitutional challenges, and state AG reactions.
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FTC Chair Khan has sought to implement aggressive and profound changes at the agency from novel approaches on antitrust to groundbreaking rulemakings. But will these efforts have lasting effects?
Former FTC Chairs Tim Muris and Maureen Ohlhausen were joined by Howard Beales, former Director of the Bureau of Consumer Protection at the FTC, to compare these efforts with previous Chair-initiated policy shifts at the agency. Professors Muris and Beales also unveiled their extensive research, published by the Competitive Enterprise Institute, analyzing key differences compared to earlier FTC efforts at promoting change.
This panel discussed: How should a change agent manage the existing career staff? How should relations with Congress and other key stakeholders be managed? How can change best be implemented in the face of a potentially hostile judiciary and other formidable obstacles? What role should institutional norms play in answering these questions? -
Starbucks Corp. v. McKinney sits at an interesting intersection of Labor and Administrative law. The facts of the case concern Starbucks Corp.'s alleged retaliation against seven Memphis workers for unionization efforts. The employees received disciplinary action and ultimately lost their jobs in the wake of their involvement in a unionization effort. In the following investigation, the NLRB found that there was reasonable cause to believe Starbucks had acted in retaliation against protected unionization efforts. A district court issued a temporary injunction and required the 7 former employees to be reinstated. The Sixth Circuit affirmed on appeal, concluding the NLRB had satisfied its burden in showing there was "reasonable cause" that Starbucks had violated the National Labor Relations Act and thus the NLRB could use its remedial power. Starbucks appealed again and the case was heard by the Supreme Court on April 23, 2023.
The question before the Supreme Court, however, is not the Labor Law question of whether Starbucks violated the NLRA, but an Administrative law one as the case asks what standard the NLRB needed to meet to obtain an injunction under Section 10(j) of the NLRA from a court. Is "reasonable cause" enough or is there a more stringent test a court should use?
Join us as we break down and analyze this interesting case and the Oral Argument in the days following the argument before the Court.
Featuring:
Sheng Li, Litigation Counsel, New Civil Liberties Alliance -
In 2021, in Arkansas State Conference NAACP v. Arkansas Board of Apportionment, private litigants sued to challenge the Arkansas state House redistricting map as violating Section 2 of the Voting Rights Act by illegally diluting the vote of racial minorities. In 2022, the U.S. District Court for the Eastern District of Arkansas ruled that Section 2 of the Voting Rights Act does not grant a private right of action. In 2023, the U.S. Court of Appeals for the Eighth Circuit affirmed the district court holding, and in 2024, the Eighth Circuit denied rehearing of the case en banc. In this panel, three voting rights practitioners will provide their analysis of the Voting Rights Act, the Eighth Circuit's decision, and the implications of this decision on redistricting and voting rights cases.
Featuring:
J. Christian Adams, President and General Counsel, Public Interest Legal Foundation
Nicholas Bronni, Solicitor General, The State of Arkansas
Jeffrey Wice, Adjunct Professor of Law, New York Law School & Senior Fellow, New York Census and Redistricting Institute
(Moderator) Maya Noronha, Civil Rights Attorney -
On March 5, 2024, U.S. District Court Judge Mark Pittman of the Northern District of Texas entered a declaratory judgment and nationwide injunction against the Minority Business Development Agency, preventing the agency from extending a federally-sponsored racial preference to groups seeking to access capital and government contracts. This case, Nuziard v. MBDA, expands upon last summer's Supreme Court ruling in SFFA v. Harvard, which struck down affirmative action in college admissions. Daniel Lennington of the Wisconsin Institute for Law & Liberty, who litigated the case, discussed the case and its impact on the future of equality.
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In 2002, under Chairman Michael Powell, the FCC passed the Cable Modem Order which classified cable modem internet service providers (ISPs) as not subject to common carrier non-discrimination requirements. The order’s critics said the FCC had created a non-neutral internet where dominant firms could use their market power to harm consumers and diminish competition. After several attempts, which the D.C. Circuit rejected, the FCC under Chairman Wheeler imposed network neutrality requirements on ISPs in the Protecting and Promoting the Open Internet order in 2015. Then, the FCC under Chairman Pai largely revoked the network neutrality rules in the Restoring Internet Freedom order in 2017. Now, under Chair Rosenworcel the FCC has just reimposed network neutrality.
This panel discussed the legal future on appeal of this most recent iteration in what appears to be an unending partisan regulatory saga—especially in light of the Supreme Court’s changing views on administrative review. The panel also investigated whether this over two decade old policy dispute is fighting yesterday’s war as many believe that there have been few competitive abuses by ISPs during the last two decades—and arguably competitive abuses by dominant firms has moved elsewhere in the web. -
In the consolidated Students for Fair Admissions cases, the Supreme Court held unlawful the use of race in undergraduate admissions at Harvard University and the University of North Carolina. Many colleges and universities have nonetheless indicated that they plan to circumvent the decision by using proxies for race instead. A 1978 Supreme Court case, Village of Arlington Heights v. Metropolitan Housing, held that using proxies for race to discriminate is generally as unlawful as using race itself. Arlington Heights also sets forth a test for identifying when a challenged policy is prohibited proxy discrimination. But the lower courts have applied Arlington Heights in different ways to challenged admissions policies, with some lower courts engaging in tough scrutiny of challenged policies and with others being much more deferential to assertions of benign intent.
This panel addressed: is proxy discrimination unlawful under the Fourteenth Amendment? If yes, what is the right legal test -- Arlington Heights or something else? What challenged policies, if any, are prohibited proxy discrimination? -
John Ream, an engineer and owner of Trek Brewing Company which creates craft beers in Newark, Ohio, is suing the U.S. Department of Treasury over the regulations that prohibit distilling spirits and hard alcohols at home. Mr. Ream asserts that he would like to pursue the hobby of distilling spirits at home for his personal use but cannot because of federal legislation. The federal law, passed under the Commerce Clause of the Constitution, makes it a felony punishable by $10,000 in fines and five years in prison, to distill hard alcohol, even for personal use. Mr. Ream, represented by The Buckeye Institute, alleges that this prohibition is unconstitutional and exceeds the powers granted Congress by the Commerce Clause, since it seeks to regulate non-commercial activity.
The case was filed in the United States District Court for the Southern District of Ohio, early in 2024, and is currently making its way through the litigation process.
Join us for a litigation update on Ream v. U.S. Department of Treasury featuring Robert Alt, lead attorney at The Buckeye Institute representing Mr. Ream.
Featuring:
Robert Alt, President and CEO, The Buckeye Institute
(Moderator) Andrew Grossman, Partner, BakerHostetler LLP - Se mer
