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Unpatenting Product Hops, Michael S. Sinha Jan 2024

Unpatenting Product Hops, Michael S. Sinha

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On July 9, 2021, President Joseph R. Biden signed Executive Order 14036 (“Promoting Competition in the American Economy”), which directed the U.S. Food and Drug Administration (FDA) and the U.S. Patent and Trademark Office (USPTO) to collaborate on new approaches to increasing competition and lowering prices in the pharmaceutical marketplace. In response, the USPTO outlined several new initiatives, among them an intent to improve the robustness and reliability of issued patents.

A major impetus for the Executive Order was the pervasive nature of pharmaceutical product hopping, which occurs when manufacturers introduce new follow-on versions of lucrative pharmaceutical products to the …


Equitable Ecosystem: A Two-Pronged Approach To Equity In Artificial Intelligence, Rangita De Silva De Alwis, Amani Carter, Govind Nagubandi Apr 2023

Equitable Ecosystem: A Two-Pronged Approach To Equity In Artificial Intelligence, Rangita De Silva De Alwis, Amani Carter, Govind Nagubandi

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Lawmakers, technologists, and thought leaders are facing a once-in-a-generation opportunity to build equity into the digital infrastructure that will power our lives; we argue for a two-pronged approach to seize that opportunity. Artificial Intelligence (AI) is poised to radically transform our world, but we are already seeing evidence that theoretical concerns about potential bias are now being borne out in the market. To change this trajectory and ensure that development teams are focused explicitly on creating equitable AI, we argue that we need to shift the flow of investment dollars. Venture Capital (VC) firms have an outsized impact in determining …


Antitrust Interoperability Remedies, Herbert J. Hovenkamp Jan 2023

Antitrust Interoperability Remedies, Herbert J. Hovenkamp

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Compelled interoperability can be a useful remedy for dominant firms, including large digital platforms, who violate the antitrust laws. They can address competition concerns without interfering unnecessarily with the structures that make digital platforms attractive and that have contributed so much to economic growth.

Given the wide variety of structures and business models for big tech, “interoperability” must be defined broadly. It can realistically include everything from “dynamic” interoperability that requires real time sharing of data and operations, to “static” interoperability which requires portability but not necessarily real time interactions. Also included are the compelled sharing of intellectual property or …


Selling Antitrust, Herbert J. Hovenkamp Aug 2022

Selling Antitrust, Herbert J. Hovenkamp

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Antitrust enforcers and its other defenders have never done a good job of selling their field to the public. That is not entirely their fault. Antitrust is inherently technical, and a less engaging discipline to most people than, say, civil rights or criminal law. The more serious problem is that when the general press does talk about antitrust policy it naturally gravitates toward the fringes, both the far right and the far left. Extreme rhetoric makes for better press than the day-to-day operations of a technical enterprise. The extremes are often stated in overdramatized black-and-white terms that avoid the real …


Digital Cluster Markets, Herbert J. Hovenkamp Apr 2022

Digital Cluster Markets, Herbert J. Hovenkamp

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This paper considers the role of “cluster” markets in antitrust litigation, the minimum requirements for recognizing such markets, and the relevance of network effects in identifying them.

One foundational requirement of markets in antitrust cases is that they consist of products that are very close substitutes for one another. Even though markets are nearly always porous, this principle is very robust in antitrust analysis and there are few deviations.

Nevertheless, clustering noncompeting products into a single market for purposes of antitrust analysis can be valuable, provided that its limitations are understood. Clustering contributes to market power when (1) many customers …


Access To Medicines And Pharmaceutical Patents: Fulfilling The Promise Of Trips Article 31bis, Ezinne Miriam Igbokwe, Andrea Tosato Feb 2022

Access To Medicines And Pharmaceutical Patents: Fulfilling The Promise Of Trips Article 31bis, Ezinne Miriam Igbokwe, Andrea Tosato

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The Agreement on Trade-Related Aspects of Intellectual Property (TRIPS) is one of the cornerstones of the World Trade Organization (WTO). TRIPS requires all WTO member countries (Members) to adopt minimum standards for the protection of intellectual property (IP). This international treaty is highly controversial. Its critics claim that TRIPS imposes a wealth transfer from poorer Members (net IP importers) to richer ones (net IP exporters). Its supporters maintain that trade between developing and developed economies cannot thrive without an internationally-harmonized IP framework. The most contentious issue has long been the impact of the TRIPS patents regime on access to medicines. …


Monopolizing Digital Commerce, Herbert J. Hovenkamp Jan 2022

Monopolizing Digital Commerce, Herbert J. Hovenkamp

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Section 2 of the Sherman Act condemns firms who “monopolize,” “attempt to monopolize,” or “combine or conspire” to monopolize—all without explanation. Section 2 is the antitrust law’s only provision that reaches entirely unilateral conduct, although it has often been used to reach collaborative conduct as well. In general, § 2 requires greater amounts of individually held market power than do the other antitrust statutes, but it is less categorical about conduct. With one exception, however, the statute reads so broadly that criticisms of the nature that it is outdated cannot be based on faithful readings of the text.

The one …


Navigating The Identity Thicket: Trademark's Lost Theory Of Personality, The Right Of Publicity, And Preemption, Jennifer E. Rothman Jan 2022

Navigating The Identity Thicket: Trademark's Lost Theory Of Personality, The Right Of Publicity, And Preemption, Jennifer E. Rothman

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Both trademark and unfair competition laws and state right of publicity laws protect against unauthorized uses of a person’s identity. Increasingly, however, these rights are working at odds with one another, and can point in different directions with regard to who controls a person’s name, likeness, and broader indicia of identity. This creates what I call an "identity thicket" of overlapping and conflicting rights over a person’s identity. Current jurisprudence provides little to no guidance on the most basic questions surrounding this thicket, such as what right to use a person’s identity, if any, flows from the transfer of marks …


Antitrust And Platform Monopoly, Herbert J. Hovenkamp Nov 2021

Antitrust And Platform Monopoly, Herbert J. Hovenkamp

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Are large digital platforms that deal directly with consumers “winner take all,” or natural monopoly, firms? That question is surprisingly complex and does not produce the same answer for every platform. The closer one looks at digital platforms the less they seem to be winner-take-all. As a result, competition can be made to work in most of them. Further, antitrust enforcement, with its accommodation of firm variety, is generally superior to any form of statutory regulation that generalizes over large numbers.

Assuming that an antitrust violation is found, what should be the remedy? Breaking up large firms subject to extensive …


What Is The Relationship Between Language And Thought?: Linguistic Relativity And Its Implications For Copyright, Christopher S. Yoo Sep 2021

What Is The Relationship Between Language And Thought?: Linguistic Relativity And Its Implications For Copyright, Christopher S. Yoo

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To date, copyright scholarship has almost completely overlooked the linguistics and cognitive psychology literature exploring the connection between language and thought. An exploration of the two major strains of this literature, known as universal grammar (associated with Noam Chomsky) and linguistic relativity (centered around the Sapir-Whorf hypothesis), offers insights into the copyrightability of constructed languages and of the type of software packages at issue in Google v. Oracle recently decided by the Supreme Court. It turns to modularity theory as the key idea unifying the analysis of both languages and software in ways that suggest that the information filtering associated …


Intellectual Property As A Determinant Of Health, Ana Santos Rutschman Jan 2021

Intellectual Property As A Determinant Of Health, Ana Santos Rutschman

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Public health literature has long recognized the existence of determinants of health, a set of socio-economic conditions that affect health risks and health outcomes across the world. The World Health Organization defines these determinants as “forces and systems” consisting of “factors combin[ing] together to affect the health of individuals and communities.” Frameworks relying on determinants of health have been widely adopted by countries in the global South and North alike, as well as international institutional players, several of which are direct or indirect players in transnational intellectual property (IP) policymaking. Issues raised by the implementation of IP policies, however, are …


Did The America Invents Act Change University Technology Transfer?, Cynthia L. Dahl Jan 2021

Did The America Invents Act Change University Technology Transfer?, Cynthia L. Dahl

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University technology transfer offices (TTOs) are the gatekeepers to groundbreaking innovations sparked in research laboratories around the U.S. With a business model reliant on patenting and licensing out for commercialization, TTOs were positioned for upheaval when the America Invents Act (AIA) transformed U.S. patent law in 2011. Now almost ten years later, this article examines the AIA’s actual effects on this patent-centric industry. It focuses on the five key areas of most interest to TTOs: i) first to file priority; ii) broadening of the universe of prior art; iii) carve-out to the prior commercial use defense; iv) micro-entity fees; and …


Propertizing Fair Use, Abraham Bell, Gideon Parchomovsky Jan 2021

Propertizing Fair Use, Abraham Bell, Gideon Parchomovsky

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In its current form, fair use doctrine provides a personal defense that applies narrowly to the specific use by the specific user. The landmark case of Google v. Oracle, currently pending before the Supreme Court, illustrates why this is problematic. Even if the Court were to rule that Google’s use of Oracle’s Java API’s was fair, the ruling would not protect the numerous parties that developed Java applications for the Android operating system; it would only shelter Google and Google’s particular use. This is not an isolated problem; the per use/per user rule cuts across fair uses of copyrighted …


Self-Actualization And The Need To Create As A Limit On Copyright, Christopher S. Yoo Jan 2021

Self-Actualization And The Need To Create As A Limit On Copyright, Christopher S. Yoo

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Personhood theory is almost invariably cited as one of the primary theoretical bases for copyright. The conventional wisdom views creative works as the embodiment of their creator’s personality. This unique connection between authors and their works justifies giving authors property interests in the results of their creative efforts.

This Chapter argues that the conventional wisdom is too limited. It offers too narrow a vision of the ways that creativity can develop personality by focusing exclusively on the results of the creative process and ignoring the self-actualizing benefits of the creative process itself. German aesthetic theory broadens the understanding of the …


The Intellectual Property Of Covid-19, Ana Santos Rutschman Jan 2021

The Intellectual Property Of Covid-19, Ana Santos Rutschman

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The response to COVID-19 is indissolubly tied to intellectual property. In an increasingly globalized world in which infectious disease pathogens travel faster and wider than before, the development of vaccines, treatments and other forms of medical technology has become an integral part of public health preparedness and response frameworks. The development of these technologies, and to a certain extent the allocation and distribution of resulting outputs, is informed by intellectual property regimes. These regimes influence the commitment of R&D resources, shape scientific collaborations and, in some cases, may condition the widespread availability of emerging technologies. As seen throughout this chapter, …


The Law Of Employee Data: Privacy, Property, Governance, Matthew T. Bodie Jan 2021

The Law Of Employee Data: Privacy, Property, Governance, Matthew T. Bodie

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The availability of data related to the employment relationship has ballooned into an unruly mass of personal characteristics, performance metrics, biometric recordings, and creative output. The law governing this collection of information has been awkwardly split between privacy regulations and intellectual property rights, with employees generally losing on both ends. This Article rejects a binary approach that either carves out private spaces ineffectually or renders data into isolated pieces of ownership. Instead, the law should implement a hybrid system that provides workers with continuing input and control without blocking efforts at joint production. In addition, employers should have fiduciary responsibilities …


Offensive Mark Owners Have An Enforcement Problem, Yvette Joy Liebesman Jan 2021

Offensive Mark Owners Have An Enforcement Problem, Yvette Joy Liebesman

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In Iancu v. Brunetti, the Supreme Court held that the Lanham Act 2(a) bars for "immoral" or "scandalous" marks are facially unconstitutional viewpoint discrimination, and thus violate a trademark owner’s First Amendment rights. Brunetti, as well as its predecessor, Matal v. Tam, focused entirely on how the government might generate viewpoint discrimination at the point of trademark registration. The Court did not consider whether enforcement of trademarks—via courts of law, Customs and Border Protection, or the International Trade Commission—is government speech, and thus exempt from First Amendment free speech scrutiny. Yet the Court’s seminal holding of Shelley v. Kraemer illustrates …


Contracting For Algorithmic Accountability, Cary Coglianese, Erik Lampmann Jan 2021

Contracting For Algorithmic Accountability, Cary Coglianese, Erik Lampmann

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As local, state, and federal governments increase their reliance on artificial intelligence (AI) decision-making tools designed and operated by private contractors, so too do public concerns increase over the accountability and transparency of such AI tools. But current calls to respond to these concerns by banning governments from using AI will only deny society the benefits that prudent use of such technology can provide. In this Article, we argue that government agencies should pursue a more nuanced and effective approach to governing the governmental use of AI by structuring their procurement contracts for AI tools and services in ways that …


Competitive Harm From Vertical Mergers, Herbert J. Hovenkamp Oct 2020

Competitive Harm From Vertical Mergers, Herbert J. Hovenkamp

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The antitrust enforcement Agencies' 2020 Vertical Merger Guidelines introduce a nontechnical application of bargaining theory into the assessment of competitive effects from vertical acquisitions. The economics of such bargaining is complex and can produce skepticism among judges, who might regard its mathematics as overly technical, its game theory as excessively theoretical or speculative, or its assumptions as unrealistic.

However, we have been there before. The introduction of concentration indexes, particularly the HHI, in the Merger Guidelines was initially met with skepticism but gradually they were accepted as judges became more comfortable with them. The same thing very largely happened again …


The Use Of Technical Experts In Software Copyright Cases: Rectifying The Ninth Circuit’S “Nutty” Rule, Shyamkrishna Balganesh, Peter Menell Jun 2020

The Use Of Technical Experts In Software Copyright Cases: Rectifying The Ninth Circuit’S “Nutty” Rule, Shyamkrishna Balganesh, Peter Menell

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Courts have long been skeptical about the use of expert witnesses in copyright cases. More than four decades ago, and before Congress extended copyright law to protect computer software, the Ninth Circuit in Krofft Television Prods., Inc. v. McDonald’s Corp., ruled that expert testimony was inadmissible to determine whether Mayor McCheese and the merry band of McDonaldland characters infringed copyright protection for Wilhelmina W. Witchiepoo and the other imaginative H.R. Pufnstuf costumed characters. Since the emergence of software copyright infringement cases in the 1980s, substantially all software copyright cases have permitted expert witnesses to aid juries in understanding software …


Google V. Oracle Amicus Merits Stage Brief: Vindicating Ip’S Channeling Principle And Restoring Jurisdictional Balance To Software Copyright Protection, Peter Menell, David Nimmer, Shyamkrishna Balganesh Jan 2020

Google V. Oracle Amicus Merits Stage Brief: Vindicating Ip’S Channeling Principle And Restoring Jurisdictional Balance To Software Copyright Protection, Peter Menell, David Nimmer, Shyamkrishna Balganesh

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The Federal Circuit’s decisions in Oracle v. Google conflict with this Court’s seminal decision in Baker v. Selden, 101 U.S. 99 (1879), misinterpret Congress’s codification of this Court’s fundamental channeling principle and related limiting doctrines, and upend nearly three decades of sound, well-settled, and critically important decisions of multiple regional circuits on the scope of copyright protection for computer software. Based on the fundamental channeling principle enunciated in Baker v. Selden, as reflected in § 102(b) of the Copyright Act, the functional requirements of APIs for computer systems and devices, like the internal workings of other machines, are …


Justice Department's New Position On Patents, Standard Setting, And Injunctions, Herbert J. Hovenkamp Jan 2020

Justice Department's New Position On Patents, Standard Setting, And Injunctions, Herbert J. Hovenkamp

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A deep split in American innovation policy has arisen between new economy and old economy innovation. In a recent policy statement, the Antitrust Division of the Justice Department takes a position that tilts more toward the old economy. Its December, 2019, policy statement on remedies for Standard Essential Patents issued jointly with the U.S. Patent and Trademark Office and the National Institute of Standards and Technology reflects this movement.

The policy statement as a whole contains two noteworthy problems: one is a glaring omission, and the other is a mischaracterization of the scope of antitrust liability. Both positions are strongly …


The Complicated Relationship Of Patent Examination And Invalidation, Gregory Reilly Jan 2020

The Complicated Relationship Of Patent Examination And Invalidation, Gregory Reilly

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The conventional view is that the Patent Office examines patent applications before issuance to assure compliance with the statutory criteria of patentability. Ex post invalidation in district court litigation or Patent Office cancellation proceedings then reviews the Patent Office’s work to correct errors that result from the Patent Office’s shortcomings, bias, or “rational ignorance” that limits resources spent on examination because of the irrelevance of most patents. Scholars, the Federal Circuit, and the Supreme Court have all endorsed this conventional view. However, it is wrong—or at least overly simplistic. The American patent system is only partially a system of ex …


Restructuring Copyright Infringement, Gideon Parchomovsky, Abraham Bell Jan 2020

Restructuring Copyright Infringement, Gideon Parchomovsky, Abraham Bell

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Copyright law employs a one-size-fits-all strict liability regime against all unauthorized users of copyrighted works. The current regime takes no account of the blameworthiness of the unauthorized user or of the information costs she faces. Nor does it consider ways in which the rightsholders may have contributed to potential infringements, or ways in which they could have cheaply avoided them. A non-consensual use of a copyrighted work entitles copyright owners to the full panoply of remedies available under the Copyright Act, including supra-compensatory damage awards, disgorgement of profits and injunctive relief. This liability regime is unjust, as it largely fails …


Privative Copyright, Shyamkrishna Balganesh Jan 2020

Privative Copyright, Shyamkrishna Balganesh

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“Privative” copyright claims are infringement actions brought by authors for the unauthorized public dissemination of works that are private, unpublished, and revelatory of the author’s personal identity. Driven by considerations of authorial autonomy, dignity, and personality rather than monetary value, these claims are almost as old as Anglo-American copyright law itself. Yet modern thinking has attempted to undermine their place within copyright law and sought to move them into the domain of privacy law. This Article challenges the dominant view and argues that privative copyright claims form a legitimate part of the copyright landscape. It shows how privative copyright claims …


The Ai Author In Litigation, Yvette Joy Liebesman, Julie Cromer Young Jan 2020

The Ai Author In Litigation, Yvette Joy Liebesman, Julie Cromer Young

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Many scholars have posited whether a computer possessing Artificial Intelligence (AI) could be considered an author as defined per the Copyright Act of 1976. What was once a thought experiment is now becoming reality. To date, scholarship has focused primarily been on whether an AI meets the requirements of authorship from a purely objective legal framework or whether an AI could be an author based on the doctrines of incentives, independent creation, and creativity.

However, a burden inherent in the rights and liabilities of authorship is the ability to be held liable if that author’s expressive work is infringing on …


Reviewing Inter Partes Review Five Years In: The View From University Technology Transfer Offices, Cynthia L. Dahl Jan 2020

Reviewing Inter Partes Review Five Years In: The View From University Technology Transfer Offices, Cynthia L. Dahl

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With the implementation of the inter partes review (IPR) proceeding under the America Invents Act in 2012, university technology transfer offices (TTOS) were worried that the value of their patents might be irreparably harmed. With IPR proceedings making patent challenges easy, relatively inexpensive, and a threat extending over the lifetime of a patent, TTOs wondered if IPRs might do nothing short of undermining their licensing business model.

However, although IPRs have irreparably changed the patent infringement landscape outside of the university setting, the effect on university patents has not been nearly as severe. This chapter explores why that might be …


Valuing The Freedom Of Speech And The Freedom To Compete In Defenses To Trademark And Related Claims In The United States, Jennifer E. Rothman Jan 2020

Valuing The Freedom Of Speech And The Freedom To Compete In Defenses To Trademark And Related Claims In The United States, Jennifer E. Rothman

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This book chapter appears in the CAMBRIDGE HANDBOOK ON INTERNATIONAL AND COMPARATIVE TRADEMARK LAW, edited by Jane C. Ginsburg & Irene Calboli (Cambridge Univ. Press 2020). The Chapter provides an overview of the defenses to trademark infringement, dilution, and false endorsement claims that serve the goals of free expression and fair competition. In particular, the Chapter covers the defenses of genericism, functionality, descriptive and nominative fair use, the Rogers test, statutory exemptions to dilution claims, and the questions of whether and how an independent First Amendment defense applies in light of recent Supreme Court decisions.

In addition to providing a …


Frand And Antitrust, Herbert J. Hovenkamp Jan 2020

Frand And Antitrust, Herbert J. Hovenkamp

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This paper considers when a patentee’s violation of a FRAND commitment also violates the antitrust laws. It warns against two extremes. First, is thinking that any violation of a FRAND obligation is an antitrust violation as well. FRAND obligations are contractual, and most breaches of contract do not violate antitrust law. The other extreme is thinking that, because a FRAND violation is a breach of contract, it cannot also be an antitrust violation.

Every antitrust case must consider the market environment in which conduct is to be evaluated. SSOs operated by multiple firms are joint ventures. Antitrust’s role is to …


Vaccines And Ip Preparedness In The Coronavirus Outbreak, Ana Santos Rutschman Jan 2020

Vaccines And Ip Preparedness In The Coronavirus Outbreak, Ana Santos Rutschman

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The COVID-19 pandemic has shed renewed light on the importance of research and development (R&D) on biopharmaceutical products needed to prevent or lessen the burden posed by outbreaks of infectious diseases. Among these, the need for new vaccines has become of paramount importance. While a race to develop different types of vaccines unfolds at unusual speed, there are still significant shortcomings in the ecosystem that leads to the production and dissemination of vaccines targeting infectious diseases like COVID-19.