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

Intellectual Property As A Determinant Of Health, Ana Santos Rutschman

All Faculty Scholarship

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 ...


Financial Terms In License Agreements, Jorge L. Contreras Dec 2020

Financial Terms In License Agreements, Jorge L. Contreras

Utah Law Faculty Scholarship

This chapter in the forthcoming casebook Intellectual Property Licensing and Transactions: Theory and Practice (2020, forthcoming), discusses the financial terms of IP licensing agreements including fixed payments, running royalties, sublicensing income, milestone payments, equity compensation and cost reimbursement, as well as most-favored and audit clauses. Numerous areas of recent controversy are addressed including the establishment of royalty rates through the entire market value rule (EMVR) versus the smallest salable patent practicing unit (SSPPU) rule, royalties for bundled rights, rules of thumb discredited by the courts, royalty escalation clauses and more. Examples are drawn primarily from biotechnology, high-tech and copyright licensing ...


Antitrust And Competition Issues, Jorge L. Contreras Dec 2020

Antitrust And Competition Issues, Jorge L. Contreras

Utah Law Faculty Scholarship

This Chapter offers a broad overview of the impact of U.S. antitrust laws on IP licensing and transactions. A basic understanding of antitrust law is critical to the analysis of IP licensing arrangements, whether concerning patents, copyrights or trademarks. This chapter offers a summary of the antitrust doctrines that arise frequently in IP and technology-focused transactions — price fixing and market allocation, resale price maintenance, tying, monopolization, refusals to deal, standard setting and pay-for-delay settlements, with coverage of the major cases and enforcement agency guidance. Antitrust issues also play a role in the analysis of joint ventures, which are discussed ...


Pledging Intellectual Property For Covid-19, Jorge L. Contreras Dec 2020

Pledging Intellectual Property For Covid-19, Jorge L. Contreras

Utah Law Faculty Scholarship

COVID-19 differs from other recent public health crises with respect to its sudden onset, its rapid spread, the lack of any known vaccine or cure and resulting shortages of critical medical equipment. The convergence of these factors has prompted both governments and IPR holders around the world to seek ways to increase the availability of IPR necessary to combat the pandemic. Governmental compulsory licensing, IPR pools and voluntary IPR pledges have all been used in the past, though in situations that differ in important respects from the COVID-19 pandemic. Each is designed to result, to a greater or lesser degree ...


No License, No Problem – Is Qualcomm’S Ninth Circuit Antitrust Victory A Patent Exhaustion Defeat?, Jorge L. Contreras, Jorge L. Contreras Dec 2020

No License, No Problem – Is Qualcomm’S Ninth Circuit Antitrust Victory A Patent Exhaustion Defeat?, Jorge L. Contreras, Jorge L. Contreras

Utah Law Faculty Scholarship

The Ninth Circuit’s recent decision in FTC v. Qualcomm (9th Cir., Aug. 11, 2020) is generally viewed as a resounding victory for Qualcomm. But in praising Qualcomm’s egalitarian approach toward rival chip makers, the Ninth Circuit points out that instead of granting licenses to these rivals, Qualcomm merely “declines to enforce its patents” against them “even though they practice Qualcomm’s patents”. As such, the Ninth Circuit states that Qualcomm’s “policy toward rival chipmakers could be characterized as ‘no license, no problem’”. Yet, from the standpoint of patent exhaustion, this approach could actually be a very big ...


First Sale And Exhaustion, Jorge L. Contreras Dec 2020

First Sale And Exhaustion, Jorge L. Contreras

Utah Law Faculty Scholarship

This chapter in the forthcoming case book "Intellectual Property Licensing and Transactions: Theory and Practice" addresses issues of first sale and exhaustion for licensing transactions involving patents, copyrights and trademarks. Among the issues considered are licensing versus sale of software, patent exhaustion, post-sale restrictions, international exhaustion and gray market imports.


It’S Anti-Suit Injunctions All The Way Down – The Strange New Realities Of International Litigation Over Standards-Essential Patents, Jorge L. Contreras Aug 2020

It’S Anti-Suit Injunctions All The Way Down – The Strange New Realities Of International Litigation Over Standards-Essential Patents, Jorge L. Contreras

Utah Law Faculty Scholarship

Today’s markets for technology products — from smartphones to home appliances to automobiles — are inherently global. This is especially true of products that embody technical standards — protocols like 5G, Wi-Fi, Bluetooth and USB that are covered by hundreds, thousands, or tens of thousands of patents (so-called “standards-essential patents” or “SEPs”). Given the global scope and size of these markets, it is not surprising that patent litigation over standardized products is often conducted on a global scale. This article looks at an increasingly important aspect of these global standards wars: the ability of a court in one jurisdiction to prevent a ...


Patent Fakes: How Fraudulent Inventions Threaten Public Health, Innovation, And The Economy, Jorge L. Contreras Aug 2020

Patent Fakes: How Fraudulent Inventions Threaten Public Health, Innovation, And The Economy, Jorge L. Contreras

Utah Law Faculty Scholarship

Because there is no practical way for patent examiners to verify that the inventions claimed in patent applications actually work, a surprising number of patents are issued for inventions that have turned out to be imaginary, fraudulent or otherwise non-existent. What's more, as illustrated by the recent attempt by Labrador Diagnostics to assert a patent acquired from now-defunct Theranos against firms developing testing kits for COVID-19, these patents present a genuine threat to businesses operating in important sectors of the economy. While it is unrealistic to expect patent examiners to verify the functionality of every claimed invention, there are ...


Association For Molecular Pathology V. Myriad Genetics: A Critical Reassessment, Jorge L. Contreras Aug 2020

Association For Molecular Pathology V. Myriad Genetics: A Critical Reassessment, Jorge L. Contreras

Utah Law Faculty Scholarship

The Supreme Court’s 2013 decision in Association for Molecular Pathology v. Myriad Genetics is part of the Court’s recent quartet of patent eligibility decisions, which also includes Bilski v. Kappos, Mayo v. Prometheus and Alice v. CLS Bank. Each of these decisions has significantly shaped the contours of patent eligibility under Section 101 of the Patent Act in ways that have been both applauded and criticized. The Myriad case, however, was significant beyond its impact on Sec-tion 101 jurisprudence. Perhaps one of the most remarkable things about Myriad is that it meant so many different things to so ...


Kenya’S Intellectual Property Bill, 2020, And Its Shortcomings In Adopting All Lawful Trips Public Health Flexibilities, Brook K. Baker Jun 2020

Kenya’S Intellectual Property Bill, 2020, And Its Shortcomings In Adopting All Lawful Trips Public Health Flexibilities, Brook K. Baker

Joint PIJIP/TLS Research Paper Series

Given the importance of access to medicines to human rights and well-being in Kenya, it is appropriate to analyze whether Kenya has currently incorporated the allowed public health flexibilities to the greatest extent possible in its draft Intellectual Property Bill, 2020. This analysis will focus on the patent, utility model, and enforcement measures only as they are the ones directly relevant to access to medicines and other health technologies. The analysis starts with the premise that Kenya wishes to avoid granting unwarranted patents on unworthy inventions, especially with respect to medicines and other health technologies. In particular, the assumption is ...


Research And Repair: Expanding Exceptions To Patent Infringement In Response To A Pandemic, Jorge L. Contreras Apr 2020

Research And Repair: Expanding Exceptions To Patent Infringement In Response To A Pandemic, Jorge L. Contreras

Utah Law Faculty Scholarship

The doctrinal areas on which this essay focuses are two longstanding but narrow exemptions from patent infringement: one that permits scientific research, and one that permits the owner of a patented device to repair it. Though distinct at first glance, both of these doctrines act to permit activity that would otherwise be considered patent infringement. They are exceptions to the exclusivity that the law grants to patent holders – particularly the right to “make” a patented article and, to a lesser degree, to “use” it, and for this reason they are particularly salient when patents may impact critical lifesaving technologies. This ...


Is Biopharma Ready For The Standards Wars?, Jorge L. Contreras Apr 2020

Is Biopharma Ready For The Standards Wars?, Jorge L. Contreras

Utah Law Faculty Scholarship

This symposium contribution sheds new light on Momenta v. Amphastar, a recent federal case in which issues relating to standardization and patent disclosure that have previously been observed in the semiconductor, computing and telecommunications sectors found their way into a dispute between two biosimilar manufacturers. One such manufacturer, Momenta, participated in the development of a standard for testing the purity of generic enoxaparin under the auspices of the United States Pharmacopeial Convention, but failed to disclose that it had applied for a patent on the testing method. When Momenta later sued Amphastar for infringement based on its use of that ...


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

Faculty Scholarship at Penn Law

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 ...


Against Progress: Interventions About Equality In Supreme Court Cases About Copyright Law, Jessica Silbey Jan 2020

Against Progress: Interventions About Equality In Supreme Court Cases About Copyright Law, Jessica Silbey

Faculty Scholarship

This symposium essay is adapted from my forthcoming book Against Progress: Intellectual Property and Fundamental Values in the Internet Age (Stanford University Press 2021 forthcoming). The book’s primary argument is that, with the rise of digital technology and the ubiquity of the internet, intellectual property law is becoming a mainstream part of law and culture. This mainstreaming of IP has particular effects, one of which is the surfacing of on-going debates about “progress of science and the useful arts,” which is the constitutional purpose of intellectual property rights.

In brief, Against Progress describes how in the 20th century intellectual ...


The Mosaic Of Coronavirus Vaccine Development: Systemic Failures In Vaccine Innovation, Ana Santos Rutschman Jan 2020

The Mosaic Of Coronavirus Vaccine Development: Systemic Failures In Vaccine Innovation, Ana Santos Rutschman

All Faculty Scholarship

Scientists are racing to develop vaccines against the novel coronavirus. While some vaccine candidates may enter the market in record time, the current vaccine innovation ecosystem exposes governance lacunas at both the international and domestic levels.


Regulatory Malfunctions In The Drug Patent Ecosystem, Ana Santos Rutschman Jan 2020

Regulatory Malfunctions In The Drug Patent Ecosystem, Ana Santos Rutschman

All Faculty Scholarship

Patent protection for several of the world’s best-selling and most promising drugs — biologics — has begun waning. Over the next few years, many other drugs in this category will lose critical patent protection. In principle, this should open the United States market to competition, as more manufacturers are now able to produce relatively cheaper versions of these expensive drugs, known as biosimilars. That, however, has not been the case. This Article examines this problem in the context of the articulation between anticompetitive behaviors and regulatory interventions in the biopharmaceutical arena, and argues for a novel solution: a timelier response provided ...


Response To Oliar And Stern: On Duration, The Idea/Expression Dichotomy, And Time, Wendy J. Gordon Jan 2020

Response To Oliar And Stern: On Duration, The Idea/Expression Dichotomy, And Time, Wendy J. Gordon

Faculty Scholarship

Courts often use possession to determine who should own unclaimed resources. Yet, as Oliar and Stern demonstrate, the concept of possession is little more than a metaphor, capable of being applied to a broad range of phenomena. The authors helpfully deploy “time” as a metric to sort through the rules determining what should count as possession, and they survey the likely costs and benefits attached to choosing earlier versus later events as triggers for acquiring title.

With those tools in hand, Oliar and Stern employ “time” and the analogy of physical possession to address problems in copyright, patent, and trademark ...


Brief Of Amicus Curiae Professor Jorge L. Contreras In Support Of Appellee And Affirmance In Ftc V. Qualcomm, Jorge L. Contreras Jan 2020

Brief Of Amicus Curiae Professor Jorge L. Contreras In Support Of Appellee And Affirmance In Ftc V. Qualcomm, Jorge L. Contreras

Utah Law Faculty Scholarship

Qualcomm participated in the development of 3G and 4G wireless telecommunication standards under the auspices of two SDOs, the Telecommunications Industry Association (“TIA”) and the Alliance for Telecommunications Industry Solutions (“ATIS”). Each of these SDOs had adopted intellectual property rights policies (IPR Policies) that required their participants to grant licenses of SEPs to implementers of their standards on FRAND terms. Yet, over the course of several years, Qualcomm refused to license its SEPs to numerous actual and potential modem chip rivals including MediaTek, Project Dragonfly (a joint venture of NTT DoCoMo, Samsung and several Japanese manufacturers), Samsung, VIA Telecom, Intel ...


Disguised Patent Policymaking, Saurabh Vishnubhakat Oct 2019

Disguised Patent Policymaking, Saurabh Vishnubhakat

Faculty Scholarship

Patent Office power has grown immensely in this decade, and the agency is wielding its power in predictably troubling ways. Like other agencies, it injects politics into its decisions while relying on technocratic justifications. It also reads grants of authority expansively to aggrandize its power, especially to the detriment of judicial checks on agency action. However, this story of Patent Office ascendancy differs from that of other agencies in two important respects. One is that the U.S. patent system still remains primarily a means for allocating property rights, not a comprehensive regime of industrial regulation. Thus, the Patent Office ...


Renewed Efficiency In Administrative Patent Revocation, Saurabh Vishnubhakat Jul 2019

Renewed Efficiency In Administrative Patent Revocation, Saurabh Vishnubhakat

Faculty Scholarship

Administrative patent revocation in the U.S. is poised to enter a new period of efficiency, though ironically it will be an efficiency that the America Invents Act originally put in place. The Court’s recent approval of the constitutionality of Patent Trial and Appeal Board ("PTAB") proceedings was blunted by the Court’s accompanying rejection of partial institution. This Patent Office practice of accepting and denying validity review petitions piecemeal had been a key part of the agency’s procedural structure from the start. As a result, the Court’s decision in SAS Institute v. Iancu to require a ...


The Mixed Case For A Ptab Off-Ramp, Saurabh Vishnubhakat Jun 2019

The Mixed Case For A Ptab Off-Ramp, Saurabh Vishnubhakat

Faculty Scholarship

This Essay begins from the emerging agenda in the political branches for reforming various aspects of the USPTO Patent Trial and Appeal Board, and focuses on a particular reform: the creation of a PTAB off-ramp whereby a patent being challenged in an administrative revocation proceeding could be removed into a system primarily aimed at amending its claims and preserving its validity. To put the proposal into perspective, the Essay presents specific empirical trends, largely unexplored until now, that implicate patent reliance interests to which the PTAB has done injury. Ultimately, because the benefits and costs from a PTAB off-ramp are ...


The Patentability Of Genetic Therapies: Car-T And Medical Treatment Exclusions Around The World, Luis Gil Abinader, Jorge L. Contreras Jun 2019

The Patentability Of Genetic Therapies: Car-T And Medical Treatment Exclusions Around The World, Luis Gil Abinader, Jorge L. Contreras

Utah Law Faculty Scholarship

More than eighty countries, including the members of the European Patent Convention, the United States, Canada, New Zealand, China, Japan, and India, currently exclude or limit the patentability of methods of medical treatment. CAR-T and other recent gene and cell therapies, which operate based on the extraction of genetic or cellular material from a patient, the alteration of such material, and the reintroduction of such material to the patient’s body, should, under most or all of these legal regimes, be considered medical treatments that are thus excluded from patentability, or as to which patent enforcement is limited. Accordingly, we ...


The Patent Option, Daniel J. Gervais Mar 2019

The Patent Option, Daniel J. Gervais

Vanderbilt Law School Faculty Publications

There is a shift in the shape of intellectual property (IP) tools used to strengthen and lengthen the right of pharmaceutical companies to exclude others from making and marketing their products. Patents have traditionally been the tool of choice. Over the past two decades, however, pharmaceutical companies have increased their degree of reliance on a right known as “data exclusivity.” This right, which now exists in most major jurisdictions, is the right to prevent third parties from relying on the clinical trial data submitted by another pharmaceutical company to obtain marketing approval for a bioequivalent or biosimilar product. The right ...


The Non-Doctrine Of Redundancy, Saurabh Vishnubhakat Feb 2019

The Non-Doctrine Of Redundancy, Saurabh Vishnubhakat

Faculty Scholarship

This Article explores and evaluates a controversial practice that the Patent Office undertook beginning early in the post-AIA regime, the practice of denying otherwise meritorious requests for review because of what the Office termed "redundant" grounds. The controversy over redundancy-based rejections had several sources. One was that making such rejections required the Patent Office to decide petitions piecemeal—and, indeed, the agency claimed that power for itself—even though it was not clear that this power lay within the statute. Another source was that the Patent Office persistently declined to explain what, in the agency's view, did or did ...


Private Law, Conflict Of Laws, And A Lex Mercatoria Of Standards-Development Organizations, Jorge L. Contreras Feb 2019

Private Law, Conflict Of Laws, And A Lex Mercatoria Of Standards-Development Organizations, Jorge L. Contreras

Utah Law Faculty Scholarship

Technical standards created by industry standards-development organizations (SDOs) enable interoperability among products manufactured by different vendors. Over the years, SDOs have developed policies to reduce the risk that SDO participants holding patents covering the SDO’s standards will disrupt or hinder the development and deployment of these standards. These policies, including commitments to license standards-essential patents (SEPs) on terms that are fair, reasonable and non-discriminatory (FRAND), gain transnational application given the international character of SDO activities and are most effectively interpreted and applied on the basis of private law (contractual) principles. However, SDO policies are typically embodied in an SDO ...


Exploring The Interfaces Between Big Data And Intellectual Property Law, Daniel J. Gervais Jan 2019

Exploring The Interfaces Between Big Data And Intellectual Property Law, Daniel J. Gervais

Vanderbilt Law School Faculty Publications

This article reviews the application of several IP rights (copyright, patent, sui generis database right, data exclusivity and trade secret) to Big Data. Beyond the protection of software used to collect and process Big Data corpora, copyright’s traditional role is challenged by the relatively unstructured nature of the non-relational (noSQL) databases typical of Big Data corpora. This also impacts the application of the EU sui generis right in databases. Misappropriation (tort-based) or anti-parasitic behaviour protection might apply, where available, to data generated by AI systems that has high but short-lived value. Copyright in material contained in Big Data corpora ...


Attacking Innovation, Jeffrey A. Maine Jan 2019

Attacking Innovation, Jeffrey A. Maine

Faculty Publications

Economists generally agree that innovation is important to economic growth and that government support for innovation is necessary. Historically, the U.S. government has supported innovation in a variety of ways: (1) a strong legal system for patents; (2) direct support through research performed by government agencies, grants, loans, and loan guarantees; and (3) indirect support through various tax incentives for private firms. In recent years, however, we have seen a weakening of the U.S. patent system, a decline in direct funding of research, and a weakening of tax policy tools used to encourage new innovation. These disruptive changes ...


The Federal Circuit As An Institution, Ryan G. Vacca Jan 2019

The Federal Circuit As An Institution, Ryan G. Vacca

Law Faculty Scholarship

The Court of Appeals for the Federal Circuit is a unique institution. Unlike other circuit courts, the Federal Circuit’s jurisdiction is bound by subject area rather than geography, and it was created to address a unique set of problems specific to patent law. These characteristics have affected its institutional development and made the court one of the most frequently studied appellate courts. This chapter examines this development and describes the evolving qualities that have helped the Federal Circuit distinguish itself, for better or worse, as an institution.

This chapter begins with an overview of the concerns existing before creation ...


Institutional Design For Innovation: A Radical Proposal For Addressing § 101 Patent Eligible Subject Matter, Kristen Osenga Jan 2019

Institutional Design For Innovation: A Radical Proposal For Addressing § 101 Patent Eligible Subject Matter, Kristen Osenga

Law Faculty Publications

The doctrine of patent-eligible subject matter is a mess, and it is weakening patent rights in this country. Nearly everyone, from the bar to the bench and from academia to industry, has called for reform. Multiple proposals to amend 35 U.S.C. § 101 have been drafted, each aimed at trying to make the doctrine more workable. Although offered with the best intentions, the proposals to fix patent-eligible subject matter are doomed to fail because none of the proposals address which institution is best suited to determine patent eligibility.

This Article takes a different, and perhaps radical, tactic. Specifically, patent-eligible ...


Comparative Analysis Of Innovation Failures And Institutions In Context, Mark Mckenna Jan 2019

Comparative Analysis Of Innovation Failures And Institutions In Context, Mark Mckenna

Journal Articles

Many different legal and non-legal institutions govern and therefore shape knowledge production. It is tempting, given the various types of knowledge, knowledge producers, and systems with and within which knowledge and knowledge producers and users interact, to look for reductionist shortcuts — in general but especially in the context of comparative institutional analysis. The temptation should be resisted for it leads to either what Harold Demsetz called the Nirvana Fallacy or what Elinor Ostrom critiqued as myopic allegories.

We suggest that comparative institutional analysis must be accompanied by comparative failure analysis, by which we mean rigorous and contextual comparative analysis of ...