Volume 54, Issue 4

3 posts

Lenity Before Kisor: Due Process, Agency Deference, and the Interpretation of Ambiguous Penal Regulations

By Thomas Z. Horton

When interpreting ambiguous punitive regulations, lower courts face a choice: either follow the Supreme Court’s instruction in Kisor v. Wilkie and defer to the enforcing agency’s typically more severe interpretation, or rely on the venerable rule of lenity — also endorsed by the Supreme Court — and adopt a less severe interpretation. This choice need not be made. Kisor deference and lenity do not clash when properly applied because these two doctrines operate at different levels of ambiguity. Lenity tips in favor of a defendant when a regulation’s meaning is subject to “reasonable doubt,” whereas agency deference applies only when a regulation is “genuinely ambiguous” — a more searching standard. Lenity, therefore, must apply before agency deference. This order of operations makes sense of both the doctrines and their justifications. Lenity’s constitutional underpinnings — in particular, the due process requirements of “fair notice” and conviction “beyond a reasonable doubt” — take precedence over the lower-order policy rationales behind agency deference.

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The Patent Trap: The Struggle for Competition and Affordability in the Field of Biologic Drugs

By Charlotte Geaghan-Breiner

The biologic drug market in the U.S. suffers from a dearth of competition. Ten years after the passage of the Biologics Price Competition and Innovation Act (BPCIA), competition from biosimilars remains weak, and prices of branded biologics continue to increase at rates that outstrip inflation. This crisis of non-competition has resulted in billions of dollars in lost savings and reduced access to treatment, especially for vulnerable groups. Patent thickets — dense webs of overlapping patents — are one of the main barriers to biosimilar competition. By protecting their products with patent thickets, branded biologic manufacturers are able to deter competition from biosimilars and maintain periods of market exclusivity that far exceed statutory limits. This Note analyzes regulatory gaps in the BPCIA that allow patent thickets to thrive, and recommends both legislative and administrative solutions. Part II assesses the market landscape for biologic drugs in the U.S. and concludes that, of all barriers to biosimilar competition, patent thickets are the most significant. Part III evaluates the BPCIA framework in light of patent thickets and identifies aspects of the statute that allow patent thickets to block biosimilar market entry. Part IV analyzes recent legislative proposals to address the problem of patent thickets, and recommends administrative changes to strike a better balance between innovation and competition in the field of biologics.

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Immigration Court is Out of Sessions: Restoring Nonregulatory Termination to Immigration Judges Post–Matter of S-O-G- & F-D-B-

By Susanna Booth

In 2018, Attorney General Jeff Sessions promulgated three Board of Immigration Appeals (BIA) decisions that sharply curtailed the power of immigration judges (IJs) to manage their own dockets and safeguard the due process rights of immigrant respondents. One such decision, Matter of S-O-G- & F-D-B-, eliminated IJs’ ability to terminate proceedings outside of specific circumstances, removing a traditional tool IJs used to dispense with unnecessary or unconstitutional proceedings.

Yet recent circuit court decisions undergird the conclusion that Matter of S-O-G- & F-D-B-’s reasoning is incorrect. This Note first traces the long history of expanding IJ authority, highlighting IJs’ gradual recognition of a discretionary termination power. After examining the reasoning of S-O-G- & F-D-B-, this Note then argues that, contrary to the Attorney General’s interpretation, IJs do possess the inherent authority to terminate removal proceedings, even outside of circumstances specifically identified by statute. Finally, this Note considers the viability of eventual challenges to S-O-G- & F-D-B- and argues that either executive, legislative, or judicial action is necessary to restore IJs’ power to discretionarily terminate proceedings and protect the rights of immigrant respondents.

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