Law Commons^™

Stumbling Over Trips: The International Intellectual Property Waiver Petition And The U.S. Executive, Jordan Paradise, Christina Conroy

Faculty Publications & Other Works

This article examines the relationship among intellectual property (IP) law protections; United States (U.S.) and international law and policy; and the actualization of diagnostics, drugs, and vaccines in the time of the COVID-19 coronavirus. Two key international treaties that relate to IP law--The Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement and the Doha Declaration on the TRIPS Agreement and Public Health (Doha Declaration) - establish international norms for the protection of IP. Core aspects of each of these treaties are described along with the role of the World Trade Organization (WTO) and concepts of compulsory licensing. As a result …

Stumbling Over Trips: The International Intellectual Property Waiver Petition And The U.S. Executive, Jordan Paradise, Christina Conroy

Faculty Publications & Other Works

This article examines the relationship among intellectual property (IP) law protections; United States (U.S.) and international law and policy; and the actualization of diagnostics, drugs, and vaccines in the time of the COVID-19 coronavirus. Two key international treaties that relate to IP law--The Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement and the Doha Declaration on the TRIPS Agreement and Public Health (Doha Declaration) - establish international norms for the protection of IP. Core aspects of each of these treaties are described along with the role of the World Trade Organization (WTO) and concepts of compulsory licensing. As a result …

Confronting Intellectual Property Nationalism, Cynthia M. Ho

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Stories about nations engaging in vaccine (and medical) nationalism by hoarding limited COVID-19 vaccines and treatments are widespread, but there is a hidden phenomenon that has exacerbated vaccine nationalism and prolonged the pandemic: intellectual property nationalism or “IP nationalism.” This Article coins and explains this term and highlights its negative impacts. Essentially, some nations, primarily of the Global North, are hoarding essential knowledge protected by intellectual property (IP). This Article argues that IP nationalism has contributed to millions of unnecessary deaths and limited the growth of the global economy. Meanwhile, countries and pharmaceutical companies obscure the role of IP nationalism …

Medical Device Artificial Intelligence: The New Tort Frontier, Charlotte A. Tschider

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The medical device industry and new technology start-ups have dramatically increased investment in artificial intelligence (AI) applications, including diagnostic tools and AI-enabled devices. These technologies have been positioned to reduce climbing health costs while simultaneously improving health outcomes. Technologies like AI-enabled surgical robots, AI-enabled insulin pumps, and cancer detection applications hold tremendous promise, yet without appropriate oversight, they will likely pose major safety issues. While preventative safety measures may reduce risk to patients using these technologies, effective regulatory-tort regimes also permit recovery when preventative solutions are insufficient.

The Food and Drug Administration (FDA), the administrative agency responsible for overseeing the …

Legal Opacity: Artificial Intelligence’S Sticky Wicket, Charlotte A. Tschider

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Proponents of artificial intelligence (“AI”) transparency have carefully illustrated the many ways in which transparency may be beneficial to prevent safety and unfairness issues, to promote innovation, and to effectively provide recovery or support due process in lawsuits. However, impediments to transparency goals, described as opacity, or the “black-box” nature of AI, present significant issues for promoting these goals.

An undertheorized perspective on opacity is legal opacity, where competitive, and often discretionary legal choices, coupled with regulatory barriers create opacity. Although legal opacity does not specifically affect AI only, the combination of technical opacity in AI systems with legal opacity …

Copyright Law's Impact On Machine Intelligence In The United States And The European Union, Matthew Sag

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No abstract provided.

Reexamining Eli Lilly V. Canada: A Human Rights Approach To Investor-State Disputes?, Cynthia M. Ho

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This Article provides valuable insight to the broader discussion of reforming investor-state disputes. Many have noted that the system is in a crisis due to a lack of democratic accountability and inconsistent decisions, which create a chilling effect on legitimate domestic law and policy. Despite substantial discussion in recent years concerning how to reform investor-state disputes, there is only limited discussion concerning the extent to which such disputes challenge domestic intellectual property (IP) limits, as well as global IP norms. Moreover, even among those who recognize the challenge to IP limits, the relevance of human rights is generally not addressed. …

Defense Against The Dark Arts Of Copyright Trolling, Matthew Sag, Jake Haskell

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In this Article, we offer both a legal and a pragmatic framework for defending against copyright trolls. Lawsuits alleging online copyright infringement by John Doe defendants have accounted for roughly half of all copyright cases filed in the United States over the past three years. In the typical case, the plaintiff's claims of infringement rely on a poorly substantiated form pleading and are targeted indiscriminately at noninfringers as well as infringers. This practice is a subset of the broader problem of opportunistic litigation, but it persists due to certain unique features of copyright law and the technical complexity of Internet …

Internet Safe Harbors And The Transformation Of Copyright Law, Matthew Sag

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This Article explores the potential displacement of substantive copyright law in the increasingly important online environment. In 1998, Congress enacted a system of intermediary safe harbors as part of the Digital Millennium Copyright Act (DMCA). The internet safe harbors and the associated system of notice-and-takedown fundamentally changed the incentives of platforms, users, and rightsholders in relation to claims of copyright infringement. These different incentives interact to yield a functional balance of copyright online that diverges markedly from the experience of copyright law in traditional media environments. More recently, private agreements between rightsholders and large commercial internet platforms have been made …

Ip Litigation In United States District Courts: 1994 To 2014, Matthew Sag

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This Article undertakes a broad-based empirical review of intellectual property (“IP”) litigation in U.S. federal district courts from 1994 to 2014. Unlike the prior literature, this study analyzes federal copyright, patent, and trademark litigation trends as a unified whole. It undertakes a systematic analysis of the records of more than 190,000 cases filed in federal courts and examines the subject matter, geographical, and temporal variation within federal IP litigation over the last two decades.

This Article analyzes changes in the distribution of IP litigation over time and their regional distribution. The key findings of this Article stem from an attempt …

Strength In Intellectual Property Protection And Foreign Direct Investment Flows In Least Developed Countries, James T. Gathii

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No abstract provided.

A Collision Course Between Trips Flexibilities And Investor-State Proceedings, Cynthia M. Ho

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This Article discusses an important, yet understudied threat to patent, as well as other intellectual property sovereignty under TRIPS: pending and potential challenges by companies under international agreements protecting investments. Although such agreements have existed for decades, Philip Morris and Eli Lilly are blazing a new path for companies to sue countries they claim interfere with their intellectual property rights through so-called investor-state arbitrations. These suits seek hundreds of millions in compensation and even injunctive relief for alleged violations of internationally agreed intellectual property norms. The suits fundamentally challenge TRIPS flexibilities at the very time the Declaration on Patent Protection …

Copyright Trolling, An Empirical Study, Matthew Sag

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ABSTRACT: This detailed empirical and doctrinal study of copyright trolling presents new data showing the astonishing rate of growth of multi-defendant John Doe litigation in United States district courts over the past decade. It also presents new evidence of the association between this form of litigation and allegations of infringement concerning pornographic films. Multi-defendant

John Doe lawsuits have become the most common form of copyright litigation in several U.S. districts, and in districts such as the Northern District of Illinois, copyright litigation involving pornography accounts for more than half of new cases.

This Article highlights a fundamental oversight in the …

Sovereignty Under Siege: Corporate Challenges To Domestic Intellectual Property Decisions, Cynthia M. Ho

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Countries face a new threat that strikes at their ability to balance protection of intellectual property rights against other priorities, such as public health. They may have to pay substantial compensation to companies that dislike domestic intellectual property laws. This threat is much more significant than the Agreement on Trade-Related Aspects of Intellectual Property Rights ("TRIPS"), a landmark international agreement concluded twenty years ago, that for the first time required all countries to provide "minimum" levels of intellectual property rights; before that time, countries were not obligated to provide any such rights at all. Since the conclusion of TRIPS, policymakers …

Drugged Out: How Cognitive Bias Hurts Drug Innovation, Cynthia M. Ho

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No abstract provided.

Should All Drugs Be Patentable?: A Comparative Perspective, Cynthia M. Ho

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Although there has been substantial discussion of the proper scope of patentable subject matter in recent years, drugs have been overlooked. This Article begins to address that gap with a comparative perspective. In particular, this Article considers what is permissible under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), as well as how India and Canada have utilized TRIPS flexibilities in different ways to properly reward developers of valuable new drugs, while also considering the social harm of higher prices beyond an initial patent term on drugs.

This Article brings valuable insight into this area at a critical …

Predicting Fair Use, Matthew Sag

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No abstract provided.

An Information-Gathering Approach To Copyright Policy, Matthew Sag

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For over a century and with increasing frequency, major controversies have erupted between large distributors of copyrighted works (song publishers, movie studios, record labels, book publishers, etc.) and makers of new technologies for experiencing those works (player piano manufacturers, VCR manufacturers, the creators of file sharing software, Google Books, etc.). Usually, the copyright owners and the technology firms reach a licensing deal-but not without some form of government intervention. Various institutions within the federal government have become involved in these disputes, using a variety of different mechanisms. This Article is a theoretical investigation of government intervention in these content-technology copyright …

Orphan Works As Grist For The Data Mill, Matthew Sag

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The phenomenon of library digitization in general, and the digitization of so-called“orphan works” in particular, raises many important copyright law questions. However, as this Article explains, correctly understood, there is no orphan works problem for certain kinds of library digitization.

The distinction between expressive and non-expressive works is already well recognized in copyright law as the gatekeeper to copyright protection—novels are protected by copyright, while telephone books and other uncreative compilations of data are not. The same distinction should generally be made in relation to potential acts of infringement.

Preserving the functional force of the idea-expression distinction in the digital …

Patent Breaking Or Balancing?: Separating Strands Of Fact From Fiction Under Trips., Cynthia M. Ho

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This article provides the first comprehensive analysis of when compulsory licensing of patents is permissible as a matter of international law under the Agreement of Trade-Related Aspects of Intellectual Property TRIPS).Thailand's recent compulsory licenses of patents on a variety of medications provide a convenient vehicle to analyze the limits of compulsory licensing under TRIPS. Thailand's actions are unique; most countries hesitate to issue compulsory licenses in the wake of legal uncertainties regarding TRIPS requirements as well as political pressure. This article capitalizes on the many issues involved in Thailand's licenses to provide an authoritative interpretation of the scope of compulsory …

Ideology And Exceptionalism In Intellectual Property — An Empirical Study., Matthew Sag

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No abstract provided.

A New World Order For Addressing Patent Rights And Public Health., Cynthia M. Ho

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No abstract provided.

Do Patents Promote The Progress Of Justice?: Reflections On Varied Visions Of Justice, Cynthia M. Ho

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No abstract provided.

Inoculation Inventions: The Interplay Of Infringement And Immunity In The Development Of Biodefense Vaccines, Cynthia M. Ho

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No abstract provided.

Balancing Patent Rights And Affordability Of Prescription Drugs In Addressing Bio-Terrorism: An Analysis Of In Re Ciprofloxacin Hydrochloride Antitrust Litigation, James T. Gathii

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No abstract provided.

The Structural Power Of Strong Pharmaceutical Patent Protection In U.S. Foreign Policy, James T. Gathii

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No abstract provided.

Who Deserves The Patent Pot Of Gold?: An Inquiry Into The Proper Inventorship Of Patient Based Discoveries, Cynthia M. Ho

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No abstract provided.

Attacking The Copyright Evildoers In Cyberspace, Cynthia M. Ho

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No abstract provided.

Rights, Patents, Markets And The Global Aids Pandemic, James T. Gathii

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No abstract provided.

Splicing Morality And Patent Law: Issues Arising From Mixing Mice And Men,, Cynthia M. Ho

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No abstract provided.