Sovereign Immunity for Rent: How the Commodification of Tribal Sovereign Immunity Reflects the Failures of the U.S. Patent System

Last year, a Fortune 500 pharmaceutical company attempted to rent the sovereign immunity of an American Indian tribe in order to shield its patents on a dry-eye drug from invalidation by generic competitors in inter partes review. Pharmaceutical firms are notorious for pursuing unconventional methods to extend the duration of their patents and, in this sense, the maneuver is unsurprising. The exploitation, however, of an historically disenfranchised community with limited economic opportunities is particularly unsettling. This Article will provide, firstly, a factual summary of the legal background of this case; secondly, a review of the February 2018 decision of the Patent Trial and Appeal Board (“PTAB”) to deny the application of tribal sovereign immunity in this case; thirdly, a review of the July 2018 decision of the U.S. Court of Appeals for the Federal Circuit, affirming the PTAB’s decision; fourthly, a discussion of the ways in which the precedent set by Allergan’s maneuver may adversely affect consumer welfare by undermining the process of inter partes review; fifthly, an analysis of the history of tribal sovereign immunity and how its exploitation in this case reflects the historic oppression of American Indians; and finally, strategies to deter such transactions from recurring in the future

The Death of the Legal Subject

The law is often engaged in prediction. In the calculation of tort damages, for example, a judge will consider what the tort victim’s likely future earnings would have been, but for their particular injury. Similarly, when considering injunctive relief, a judge will assess whether the plaintiff is likely to suffer irreparable harm if a preliminary injunction is not granted. And for the purposes of a child custody evaluation, a judge will consider which parent will provide an environment that is in the best interests of the child. Relative to other areas of law, criminal law is oversaturated with prediction. Almost every decision node in the criminal justice system demands a prediction of individual behavior: does the accused present a flight risk, or a danger to the public (pre-trial detention); is the defendant likely to recidivate (sentencing); and will the defendant successfully reenter society (parole)? Increasingly, these predictions are made by algorithms, many of which display racial bias, and are hidden from public view. Existing scholarship has focused on de-biasing and disclosing algorithmic models, but this Article argues that even a transparent and unbiased algorithm may undermine the epistemic legitimacy of a judicial decision. Law has historically generated truth claims through discursive and dialogic practices, using shared linguistic tools, in an environment characterized by proximity and reciprocity. In contrast, the truth claims of data science are generated from data processing of such scale and complexity that it is not commensurable with, or reversible to, human reasoning. Data science excludes the individual from the production of knowledge about themselves on the basis that “unmediated” behavioral data (not self-reported or otherwise subject to conscious manipulation by the data subject) offers unrivaled predictive accuracy. Accordingly, data science discounts the first-person view of reality that has traditionally underwritten legal processes of truth-making, such as individual testimony. As judges turn to algorithms to guide their decision making, knowledge about the legal subject is increasingly algorithmically produced. Statistical predictions about the legal subject displace qualitative knowledge about their intentions, motivations, and moral capabilities. The reasons why a particular defendant might refrain from recidivism, for example, become less important than the statistical features they share with historical recidivists. This displacement of individual knowledge with algorithmic predictions diminishes the participation of the legal subject in the epistemic processes that determine their fundamental liberties. This produces the death of the legal subject, or the emergence of new, algorithmic practices of signification that no longer require the input of the underlying individual

Ocularcentrism and Deepfakes: Should Seeing Be Believing?

The pernicious effects of misinformation were starkly exposed on January 6, 2021, when a violent mob of protestors stormed the nation’s capital, fueled by false claims of election fraud. As policymakers wrestle with various proposals to curb misinformation online, this Article highlights one of the root causes of our vulnerability to misinformation, specifically, the epistemological prioritization of sight above all other senses (“ocularcentrism”). The increasing ubiquity of so-called “deepfakes”—hyperrealistic, digitally altered videos of events that never occurred—has further exposed the vulnerabilities of an ocularcentric society, in which technology-mediated sight is synonymous with knowledge. This Article traces the evolution of visual manipulation technologies that have exploited ocularcentrism and evaluates different means of addressing the issues raised by deepfakes, including the use of copyright law

The Incredible Shrinking Victory: Eli Lilly v. Canada, Success, Judicial Reversal, and Continuing Threats from Pharmaceutical ISDS

This Article examines the Eli Lilly v. Canada arbitration award and its potential impact on intellectual property-based investor-state dispute settlements affecting pharmaceuticals. It begins by providing contextual background on ISDS and the underlying Eli Lilly patent invalidations. It then critiques the award and discusses the dangers of its overly cautious grounds of decision and its explicit validation of IP-based ISDS. The Article further illustrates these dangers through a discussion of the stunning judicial reversal of the promise/utility doctrine by the Canadian Supreme Court, the withdrawal of a compulsory licensing proposal in Colombia, and the deregistration of a competing generic Hepatitis C medicine in Ukraine. Ultimately, it recommends that ISDS provisions be removed or rewritten to prevent the possibility of bringing IP-related claims

Meet Your New Overlords: How Digital Platforms Develop and Sustain Technofeudalism

Much has been written about the free speech quasi-jurisprudence being developed by social media platforms through content moderation policies unconstrained by constitutional limits. This Article focuses on a specific subset of that content moderation—namely, the takedown of user-generated content in the name of copyright enforcement. This Article argues that the unlimited power of online platforms to regulate access to user-generated content through antipiracy algorithms leads to three perverse outcomes. First, the removal of lawful content falsely flagged as “infringing” results in the suppression of legitimate speech and a reduction in the diversity of online discourse. Second, the erosion of lawful exceptions and limitations to copyright protection through algorithmic adjudication alters the fundamental social contract established by copyright legislation, displaces decades of carefully developed fair use jurisprudence, and transfers adjudicatory power from courts to corporations. Third, the monetization of user-generated content not by users, but by copyright owners (following the flagging of content as “infringing”), is symptomatic of a broader, systemic exploitation of users that is occurring on digital platforms, also known as “technofeudalism.

Access to Medicines and Human Rights

This chapter will introduce you to key issues and resources in access to medicines and human rights. In addition, this chapter will help you understand why, more now than ever, access to medicines must be understood and approached as a human rights issue. Some of these issues are also addressed in Chapter 1 on Patient Care, Chapter 2 on HIV/AIDS, Chapter 3 on Tuberculosis and Human Rights, and Chapter 5 on Palliative Care and Human Rights. The chapter is organized into ve sections that answer the following questions: 1. How is access to medicines a human rights issue? 2. What is a human rights-based approach to advocacy, litigation, and programming? 3. What are some examples of effective human rights-based work in the area of access to medicines? 4. Where can I nd additional resources on human rights-based approach to access to medicines? 5. What are key terms related to a human rights-based approach to access to medicines

Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK.

BACKGROUND: A safe and efficacious vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), if deployed with high coverage, could contribute to the control of the COVID-19 pandemic. We evaluated the safety and efficacy of the ChAdOx1 nCoV-19 vaccine in a pooled interim analysis of four trials. METHODS: This analysis includes data from four ongoing blinded, randomised, controlled trials done across the UK, Brazil, and South Africa. Participants aged 18 years and older were randomly assigned (1:1) to ChAdOx1 nCoV-19 vaccine or control (meningococcal group A, C, W, and Y conjugate vaccine or saline). Participants in the ChAdOx1 nCoV-19 group received two doses containing 5 × 1010 viral particles (standard dose; SD/SD cohort); a subset in the UK trial received a half dose as their first dose (low dose) and a standard dose as their second dose (LD/SD cohort). The primary efficacy analysis included symptomatic COVID-19 in seronegative participants with a nucleic acid amplification test-positive swab more than 14 days after a second dose of vaccine. Participants were analysed according to treatment received, with data cutoff on Nov 4, 2020. Vaccine efficacy was calculated as 1 - relative risk derived from a robust Poisson regression model adjusted for age. Studies are registered at ISRCTN89951424 and ClinicalTrials.gov, NCT04324606, NCT04400838, and NCT04444674. FINDINGS: Between April 23 and Nov 4, 2020, 23 848 participants were enrolled and 11 636 participants (7548 in the UK, 4088 in Brazil) were included in the interim primary efficacy analysis. In participants who received two standard doses, vaccine efficacy was 62·1% (95% CI 41·0-75·7; 27 [0·6%] of 4440 in the ChAdOx1 nCoV-19 group vs71 [1·6%] of 4455 in the control group) and in participants who received a low dose followed by a standard dose, efficacy was 90·0% (67·4-97·0; three [0·2%] of 1367 vs 30 [2·2%] of 1374; pinteraction=0·010). Overall vaccine efficacy across both groups was 70·4% (95·8% CI 54·8-80·6; 30 [0·5%] of 5807 vs 101 [1·7%] of 5829). From 21 days after the first dose, there were ten cases hospitalised for COVID-19, all in the control arm; two were classified as severe COVID-19, including one death. There were 74 341 person-months of safety follow-up (median 3·4 months, IQR 1·3-4·8): 175 severe adverse events occurred in 168 participants, 84 events in the ChAdOx1 nCoV-19 group and 91 in the control group. Three events were classified as possibly related to a vaccine: one in the ChAdOx1 nCoV-19 group, one in the control group, and one in a participant who remains masked to group allocation. INTERPRETATION: ChAdOx1 nCoV-19 has an acceptable safety profile and has been found to be efficacious against symptomatic COVID-19 in this interim analysis of ongoing clinical trials. FUNDING: UK Research and Innovation, National Institutes for Health Research (NIHR), Coalition for Epidemic Preparedness Innovations, Bill & Melinda Gates Foundation, Lemann Foundation, Rede D'Or, Brava and Telles Foundation, NIHR Oxford Biomedical Research Centre, Thames Valley and South Midland's NIHR Clinical Research Network, and AstraZeneca

Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK

Background A safe and efficacious vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), if deployed with high coverage, could contribute to the control of the COVID-19 pandemic. We evaluated the safety and efficacy of the ChAdOx1 nCoV-19 vaccine in a pooled interim analysis of four trials. Methods This analysis includes data from four ongoing blinded, randomised, controlled trials done across the UK, Brazil, and South Africa. Participants aged 18 years and older were randomly assigned (1:1) to ChAdOx1 nCoV-19 vaccine or control (meningococcal group A, C, W, and Y conjugate vaccine or saline). Participants in the ChAdOx1 nCoV-19 group received two doses containing 5 × 1010 viral particles (standard dose; SD/SD cohort); a subset in the UK trial received a half dose as their first dose (low dose) and a standard dose as their second dose (LD/SD cohort). The primary efficacy analysis included symptomatic COVID-19 in seronegative participants with a nucleic acid amplification test-positive swab more than 14 days after a second dose of vaccine. Participants were analysed according to treatment received, with data cutoff on Nov 4, 2020. Vaccine efficacy was calculated as 1 - relative risk derived from a robust Poisson regression model adjusted for age. Studies are registered at ISRCTN89951424 and ClinicalTrials.gov, NCT04324606, NCT04400838, and NCT04444674. Findings Between April 23 and Nov 4, 2020, 23 848 participants were enrolled and 11 636 participants (7548 in the UK, 4088 in Brazil) were included in the interim primary efficacy analysis. In participants who received two standard doses, vaccine efficacy was 62·1% (95% CI 41·0–75·7; 27 [0·6%] of 4440 in the ChAdOx1 nCoV-19 group vs71 [1·6%] of 4455 in the control group) and in participants who received a low dose followed by a standard dose, efficacy was 90·0% (67·4–97·0; three [0·2%] of 1367 vs 30 [2·2%] of 1374; pinteraction=0·010). Overall vaccine efficacy across both groups was 70·4% (95·8% CI 54·8–80·6; 30 [0·5%] of 5807 vs 101 [1·7%] of 5829). From 21 days after the first dose, there were ten cases hospitalised for COVID-19, all in the control arm; two were classified as severe COVID-19, including one death. There were 74 341 person-months of safety follow-up (median 3·4 months, IQR 1·3–4·8): 175 severe adverse events occurred in 168 participants, 84 events in the ChAdOx1 nCoV-19 group and 91 in the control group. Three events were classified as possibly related to a vaccine: one in the ChAdOx1 nCoV-19 group, one in the control group, and one in a participant who remains masked to group allocation. Interpretation ChAdOx1 nCoV-19 has an acceptable safety profile and has been found to be efficacious against symptomatic COVID-19 in this interim analysis of ongoing clinical trials