Faculty Notes

Elvin R. Latty Professor of Law Arti Rai is the lead investigator on a one-year grant from the Laura and John Arnold Foundation to examine whether the administrative system for patent review established by the America Invents Act of 2011 is impacting patent terms for small-molecule drugs and large-molecule biologics and thereby affecting the availability of less expensive generic or biosimilar equivalents.

The study is the first rigorous empirical investigation of the role that the administrative review system, known as the Patent Trial and Appeal Board (PTAB), is playing relative to federal district courts, previously the sole venue for patent challenges. It focuses on how the introduction of the PTAB has impacted effective patent terms for small-molecule drugs — those generally administered as pills — and large molecule biologics, which are generally delivered as infusions and injections. In order to evaluate impact, the study is examining both patents on the key compounds as well as secondary patents that cover such ancillary features as formulations and are sometimes considered to be of lower quality than compound patents. Rai, the faculty co-director of the Duke Center for Innovation Policy and an internationally recognized expert in innovation policy and intellectual property, administrative, and health law, is the former administrator of policy and external affairs at the U.S. Patent and Trademark Office (USPTO). She is undertaking the study with three colleagues.

Bills pending before both the U.S. House of Representatives and the Senate would require challengers to choose between contesting small molecule and biologic patents in federal court or at the PTAB. But in their grant application, Rai and her colleagues point to key research that shows the industry “often manages to extend monopoly protection over patents of even dubious validity simply because it’s so hard to challenge them in federal court.” They contend that the PTAB, with administrative judges who are technical experts, facilitates “faster and cheaper challenges” and, possibly, greater accuracy. The current study, Rai said, will provide essential empirical context for the current policy debate. They are building novel and highly detailed datasets to facilitate three main areas of inquiry: the factors that drive case selection in the district courts and at the PTAB, to discern the incremental role the PTAB is playing over and above district court litigation for different classes of patents; the effect of the PTAB on the timing and prevalence of generic and biosimilar entry; and what the data suggest about settlements in PTAB challenges and how they may be influencing generic and biosimilar availability.

On Nov. 19, Rai testified before the U.S. House Committee on the Judiciary’s Subcommittee on Courts, Intellectual Property, and the Internet in a hearing titled “The Patent Trial and Appeal Board and the Appointments Clause: Implications of Recent Court Decisions.”

The hearing considered implications of an Oct. 31 ruling of the U.S. Court of Appeals for the Federal Circuit in Arthrex, Inc., v. Smith & Nephew, Inc., Arthrocare Corp., in which the court held the appointment of the administrative patent judges (APJs) to the PTAB by the U.S. Secretary of Commerce to be in violation of the Constitution’s Appointments Clause. The court severed the portion of the Patent Act that restricts removal of APJs from office, thereby making them “inferior officers” that can be appointed by “heads of departments” like cabinet secretaries, as opposed to “principal officers” that must be nominated by the president and confirmed by the U.S. Senate.

After exploring different implications of the Federal Circuit’s ruling, Rai testified that the “cleanest path forward” would involve “surgical” congressional intervention that gives the USPTO director a unilateral right of review over APJ decisions including, potentially, a right that applies retroactively.

“This approach would cure any perceived constitutional infirmity without subjecting APJs to political pressure that isn’t transparent,” she wrote in her prepared testimony submitted in advance of the hearing. “In order to accommodate the director’s workload, the right of review should be discretionary.”

Brandon Garrett

L. Neil Williams, Jr. Professor of Law Brandon Garrett is serving as independent monitor for a landmark settlement in Texas that could become a national model for cash bail reform.

Garrett, the faculty director of the Duke Center for Science and Justice, is monitoring implementation of the O’Donnell Consent Decree in Harris County, Texas. Harris County encompasses Houston and, with nearly 5 million people, is the nation’s third-most populous county. Chief Judge Lee Rosenthal of the U.S. District Court of the Southern District of Texas signed the motion to appoint on March 3.

Working closely with deputy monitor Sandra Guerra Thompson, professor of law and director of the Criminal Justice Institute at the University of Houston Law Center, and with Dr. Dottie Carmichael of the Public Policy Research Institute at Texas A&M University, Garrett is directing a seven-year monitoring project that includes ongoing analysis of Harris County data and intensive engagement with stakeholders in Texas.

The O’Donnell Consent Decree settles three years of litigation in O’Donnell v. Harris Cty., a class action lawsuit brought in federal court after the titular plaintiff was arrested for driving on a suspended license and jailed when she could not afford bail set at $2,500. In the complaint, the plaintiffs alleged that the county’s bail practices contributed to an average of 500 people per night being detained in the Harris County Jail for misdemeanors.

In January 2019, after an initial preliminary injunction order that took effect June 6, 2017, and an appeal, Harris County, the misdemeanor judges, and the sheriff promulgated new bail rules that required the prompt post-arrest release on unsecured bonds of the vast majority of people arrested for misdemeanor offenses. Pursuant to the rules, everyone else is afforded a bail hearing with counsel, and most are then also ordered released. These rules provided the foundation for the global consent decree, which the parties agreed to in July 2019 and which Chief Judge Rosenthal approved on Nov. 21.

Garrett’s proposal was selected from four finalists in a competitive bid process and was approved by the plaintiffs, judges, county, and sheriff as the proposal “most likely to lead to successful and timely implementation of the consent decree and, ultimately, a self-sustaining, self-monitoring system that promotes liberty, court appearance, and community safety.” The monitorship is being guided by nine principles derived from the consent decree: transparency; accountability; permanency; the protection of constitutional rights; racial, ethnic, and socioeconomic fairness; public safety and effective law enforcement; maximizing liberty; cost and process efficiency; and demonstrated effectiveness. A leading scholar of criminal justice outcomes, evidence, and constitutional rights, Garrett is focusing on research and policy aspects of the decree, overseeing teams at Duke’s Center for Science and Justice and the Public Policy Research Institute at Texas A&M University. Philip J. Cook, the ITT/Terry Sanford Distinguished Professor Emeritus at the Sanford School of Public Policy, whose current research focuses on the economics of crime, will advise Garrett on cost analysis.

Thomas Maher

Senior Lecturing Fellow Thomas Maher, who has taught criminal trial practice to Duke Law students for nearly 30 years, has joined the Duke Center for Science and Justice as executive director.

Maher practiced criminal defense law in state and federal court for more than 20 years before becoming, in 2006, executive director of the Durham-based Center for Death Penalty Litigation, where he represented capital defendants in trial, appellate, and post-conviction proceedings. In 2009 he became executive director of the North Carolina Office of Indigent Defense Services (IDS), where he advocated for more funding for public defense statewide and pushed forward initiatives to improve the quality of representation.

In February, North Carolina Supreme Court Chief Justice Cheri Beasley MJS ’18 presented Maher with the court’s highest honor, the Friend of the Court award, for his dedication to the Judicial Branch and his 11 years of service at IDS.

With Brandon Garrett, the faculty director, and collaborators across the university, Maher is helping to translate the work of the Duke Center for Science and Justice into policy solutions based on empirical evidence for problems and inequities throughout the criminal justice system in North Carolina and beyond.

Said Garrett: “Tom has a deep knowledge of criminal practice, tremendous leadership experience, and a lifelong commitment to public service. He has, in a short time, brought his insight and energies to all of our center projects. We on the faculty are thrilled to collaborate with him — and our Duke Law students, who have been inspired by him for years now, are fortunate to have new opportunities to learn from him.”

Maher’s extensive career in criminal defense includes serving as co-counsel in the high-profile 2003 murder trial of Durham author Michael Peterson, who was convicted and later released after evidence emerged of misconduct by a State Bureau of Investigation agent. He has worked on numerous capital cases, including that of Leon Brown, an intellectually disabled man who was sentenced to death as a 15-year-old after giving a false confession to rape and murder and exonerated by DNA evidence 30 years later.

James Cox

James Cox, the Brainerd Currie Professor of Law, has co-authored new editions of two casebooks: Business Organizations: Cases and Materials, Unabridged 12th ed. (West Academic, 2019) (with Melvin Aron Eisenberg); and Securities Regulation: Cases and Materials, 9th ed. (Wolters Kluwer, 2019) (with others). The new edition of Business Organizations offers detailed information on corporate law and covers new principal cases, text, and explanatory materials designed to illustrate the development of corporate law. As it has since its first edition, Securities Regulation: Cases and Materials contains a teachable mix of problems, cases, and textual material, encouraging students to build their knowledge base by being active problem solvers.

Rebecca Rich

Clinical Professor Rebecca Rich ’06 received the Duke Bar Association’s 2020 Distinguished Teaching Award on April 9.

Rich, the assistant director of legal writing who teaches first-year Legal Analysis, Research and Writing and the Scholarly Writing Workshop and Writing for E-Discovery for upper-level students, was praised by student nominators for her accessibility and warmth towards students. “Quite simply, there is nobody in the building who offers the blend of humility, availability, authenticity, and positivity that she brings into her classroom and office every day,” wrote one. Another noted her “communicative and open messages” after the Covid-19 pandemic moved classes online: “In the sea of anxiety and chaos, her simultaneous sense of calm, encouragement, and faith in our abilities served as a buoy that helped me get through the first week of remote learning. The Duke Law community is so fortunate to have her on its faculty.”

Rich co-chaired Duke Law’s Teaching Initiative from 2014 to 2017 and has taught in the Law School’s D.C. Summer Institute on Law & Policy and Pre-Law Undergraduate Scholars Program. Prior to joining the faculty in 2009, she practiced civil litigation with Ellis & Winters in Raleigh and clerked for Justice Patricia Timmons-Goodson MJS ’14 on the North Carolina Supreme Court.

Steven Schwarcz

Steven Schwarcz, the Stanley A. Star Professor of Law & Business, is the co-editor of Systemic Risk in the Financial Sector: Ten Years After the Great Crash (Centre for International Governance Innovation, 2019). The book draws on some of the world’s leading experts on financial stability and regulation to examine and critique the progress made since 2008 in addressing systemic risk, covering such topics as central banks and macroprudential policies; fintech; regulators’ perspectives from the United States and the European Union; the logistical and incentive challenges that impede standardization and collection; clearing houses and systemic risk; optimal resolution and bail-in tools; and bank leverage, welfare, and regulation. Schwarcz, a senior fellow of the Centre for International Governance Innovation, contributes the book’s closing chapter, in which he argues that although regulators have accomplished much in the past decade to help stabilize the financial system, much remains to be done, and that a more systematic regulatory framework is required to correct market failures that could trigger and transmit systemic risk.

George Christie

George Christie, James B. Duke Professor Emeritus of Law, is the co-author of Cases and Materials on the Law of Torts, 6th ed. (West Academic, 2019) (with others). The sixth edition continues the use of minimally edited cases, serves as a vehicle for teaching first-year students the essential techniques of case analysis and legal method, and is modified throughout to include developments in tort law since the fifth edition was published in 2012.