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Articles 31 - 60 of 76
Full-Text Articles in Law
U.S. Federal Genomic Data Release And Access Policies, Jorge L. Contreras
U.S. Federal Genomic Data Release And Access Policies, Jorge L. Contreras
Utah Law Faculty Scholarship
Researchers today have access to a vast aggregation of human and nonhuman genomic data, largely on an open access basis. According to the Joint Genome Institute’s Genomes OnLine Database (GOLD), data from more than 40,000 sequencing projects around the world, representing more than 375,000 different organisms, were publicly available to researchers as of July 2020. The availability of this tremendous public resource is due, in large part, to the data release policies developed a quarter century ago, toward the beginning of the Human Genome Project (HGP), which have been carried forward, in modified form, to the present. These policies impose …
Antitrust And Competition Issues, Jorge L. Contreras
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 …
Intellectual Property Rights And The Rule Of Law, Jorge L. Contreras
Intellectual Property Rights And The Rule Of Law, Jorge L. Contreras
Utah Law Faculty Scholarship
The subject of this conference is the “Rule of Law”, so I would like to address my opening comments to a trending narrative that casts opposition to the demands of patent holders as a form of lawlessness. This narrative specifically takes aim at a practice that has been termed “efficient infringement” – the idea that a firm may rationally decide to infringe patents either because it will be too costly for the patent holder to enforce its rights in court, or because it is happy to take its chances in court, where an asserted patent may be invalidated and where …
Sometimes Frand Does Mean License-To-All, Jorge L. Contreras
Sometimes Frand Does Mean License-To-All, Jorge L. Contreras
Utah Law Faculty Scholarship
FRAND commitments are creations of written policy documents and contract law. Accordingly, the existence of a “License to All” obligation under a FRAND commitment must arise from the relevant policy language. Numerous SDO policies expressly impose “License to All” requirements. Some SDO policies are ambiguous with respect to this requirement and such ambiguities should be resolved based on an examination of extrinsic evidence including the intentions of policy drafters, the shared understandings of SDO participants, and the historical precedents for such policies. In many cases, an examination of these factors should lead to the conclusion that “License to All” is, …
Intellectual Property Pools And Aggregation, Jorge L. Contreras
Intellectual Property Pools And Aggregation, Jorge L. Contreras
Utah Law Faculty Scholarship
This chapter in the forthcoming case book "Intellectual Property Licensing and Transactions: Theory and Practice" covers IP pooling, with an emphasis on patents. It begins with a discussion of the theoretical benefit of pooling, including efficiency gains and the avoidance of blocking positions, thickets and anti-commons. It then addresses antitrust analysis of pooling transactions from Standard Oil (Indiana) v. United States (U.S. 1931) through the 2017 DOJ-FTC Antitrust Guidelines. The chapter then turns to pools created to facilitate standard-setting, including the MPEG-2 and 3GPP Pools, and discusses the concept of complementarity and essentiality of pooled assets. It concludes with brief …
It’S Anti-Suit Injunctions All The Way Down – The Strange New Realities Of International Litigation Over Standards-Essential Patents, Jorge L. Contreras
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 …
Association For Molecular Pathology V. Myriad Genetics: A Critical Reassessment, Jorge L. Contreras
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 many different …
Chapter 20 – Technical Standards: Fair, Reasonable And Non-Discriminatory (Frand) Licensing, Jorge L. Contreras
Chapter 20 – Technical Standards: Fair, Reasonable And Non-Discriminatory (Frand) Licensing, Jorge L. Contreras
Utah Law Faculty Scholarship
This chapter in the forthcoming case book "Intellectual Property Licensing and Transactions" covers licensing transactions involving standards-essential patents (SEPs), including recent legal developments regarding the disclosure (and concealment) of SEPs, fair, reasonable and nondiscriminatory (FRAND) royalty rates, non-discriminatory licensing, the availability of injunctive relief for FRAND-encumbered patents, and transfers of FRAND commitments, as well as specific SDO policy clauses and license text addressing each of these issues.
Patent Fakes: How Fraudulent Inventions Threaten Public Health, Innovation, And The Economy, Jorge L. Contreras
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 a …
The Nci Cancer Moonshot Public Access And Data Sharing (Pads) Policy – Initial Assessment And Implications, Jorge L. Contreras, Tammy Frisby
The Nci Cancer Moonshot Public Access And Data Sharing (Pads) Policy – Initial Assessment And Implications, Jorge L. Contreras, Tammy Frisby
Utah Law Faculty Scholarship
Since 2013, federal research-funding agencies have been required to develop and implement broad data sharing policies. Yet agencies today continue to grapple with the mechanisms necessary to enable the sharing of a wide range of data types, from genomic and other -omics data to clinical and pharmacological data to survey and qualitative data. In 2016, the National Cancer Institute (NCI) launched the ambitious $1.8 billion Cancer Moonshot Program, which included a new Public Access and Data Sharing (PADS) Policy applicable to funding applications submitted on or after October 1, 2017. The PADS Policy encourages the immediate public release of published …
The Technical Standardization Ecosystem And Institutional Decision Making: The Case Of Intellectual Property Rights Policies, Justus Baron, Jorge L. Contreras, Martin Husovec, Pierre Larouche, Nikolaus Thumm
The Technical Standardization Ecosystem And Institutional Decision Making: The Case Of Intellectual Property Rights Policies, Justus Baron, Jorge L. Contreras, Martin Husovec, Pierre Larouche, Nikolaus Thumm
Utah Law Faculty Scholarship
In this paper, we analyze decision making on Intellectual Property Rights (IPR) policies in the standardization ecosystem. While a large literature has studied IPR policies of Standard Developing Organizations (SDOs), we contribute a more rigorous analysis of how these IPR policies are shaped by the interdependencies between SDOs and between SDOs and a variety of stakeholders. While SDO stakeholders often have opposing policy preferences, they are tied together by non-generic complementarities and a joint interest in the overall performance of the standardization system, which are constitutive characteristics of an ecosystem. The standardization ecosystem is characterized by widely shared institutional norms, …
Research And Repair: Expanding Exceptions To Patent Infringement In Response To A Pandemic, Jorge L. Contreras
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. …
Is Biopharma Ready For The Standards Wars?, Jorge L. Contreras
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 …
Brief Of Amicus Curiae Professor Jorge L. Contreras In Support Of Appellee And Affirmance In Ftc V. Qualcomm, Jorge L. Contreras
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, …
The Patentability Of Genetic Therapies: Car-T And Medical Treatment Exclusions Around The World, Luis Gil Abinader, Jorge L. Contreras
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 urge …
Sui-Genericide, Jorge L. Contreras
Sui-Genericide, Jorge L. Contreras
Utah Law Faculty Scholarship
Generic terms – those that describe a general class of goods or services – are not eligible for trademark protection. Firms have historically gone to great lengths to prevent their trademarks from becoming generic – a fate often referred to as genericide. But in a few rare cases, firms have voluntarily declared certain terms that they have created to be generic, a phenomenon that I refer to as “sui-genericide”. This article explores the little-discussed phenomenon of sui-genericide, both its origins in government-sponsored programs of the mid-twentieth century and its most recent incarnation in the area of technical interoperability standards. Though …
Making The Rules: The Governance Of Standard Development Organizations And Their Policies On Intellectual Property Rights, Justus Baron, Jorge L. Contreras, Martin Husovec, Pierre Larouche, Nikolaus Thumm
Making The Rules: The Governance Of Standard Development Organizations And Their Policies On Intellectual Property Rights, Justus Baron, Jorge L. Contreras, Martin Husovec, Pierre Larouche, Nikolaus Thumm
Utah Law Faculty Scholarship
This study provides a comprehensive analysis of the governance of standard development organizations (SDOs), with a particular emphasis on organizations developing standards for Information and Communication Technologies (ICT). The analysis is based on 17 SDO case studies, a survey of SDO stakeholders, an expert workshop, and a comprehensive review of the legal and economic literature. The study considers the external factors conditioning SDO decision making on rules and procedures, including binding legal requirements, government influence, the network of cooperative relationships with other SDOs and related organizations, and competitive forces. SDO decision-making is also shaped by internal factors, such as the …
Private Law, Conflict Of Laws, And A Lex Mercatoria Of Standards-Development Organizations, Jorge L. Contreras
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’s governing …
Understanding "Balance" Requirements For Standards-Development Organizations, Jorge L. Contreras
Understanding "Balance" Requirements For Standards-Development Organizations, Jorge L. Contreras
Utah Law Faculty Scholarship
Most technical standards-development organizations (SDOs) have adopted internal policies embodying “due process” criteria such openness, balance of interest, consensus decision making and appeals. Yet these criteria lack a generally-accepted definition and the manner in which they are implemented varies among SDOs. Recently, there has been a renewed interest in the principle that SDOs should ensure a balance of interests among their stakeholders. This article explores the origins and meaning of the balance requirement for SDOs. In doing so, it identifies four “tiers” of balance requirements, ranging from those required of all SDOs under applicable antitrust law, to those required of …
Frand Royalties, Anti-Suit Injunctions And The Global Race To The Bottom In Disputes Over Standards-Essential Patents, Jorge L. Contreras
Frand Royalties, Anti-Suit Injunctions And The Global Race To The Bottom In Disputes Over Standards-Essential Patents, Jorge L. Contreras
Utah Law Faculty Scholarship
While national courts have long exercised extraterritorial authority over domestic entities whose conduct abroad is prohibited in the domestic jurisdiction, national courts have recently begun to use disputes over domestic patent rights as vehicles for shaping the global business arrangements of private parties even absent any violation of national law. This phenomenon has become particularly pronounced in the context of “fair, reasonable and non-discriminatory” (FRAND) licenses of patents that are essential to the manufacture and sale of standardized products. This essay explores the increasing extraterritorial effect of national judicial decisions on licenses for standards-essential patents, including recent instances in which …
#Squadgoals: A Response To Seth Waxman, Amelia Rinehart
#Squadgoals: A Response To Seth Waxman, Amelia Rinehart
Utah Law Faculty Scholarship
Former Solicitor General Seth Waxman’s recent remarks, framing our current age of patent law in the Supreme Court as “interesting times,” unquestionably captures the exhilaration of an active Supreme Court in this area of the law. Waxman knows his way around patent cases decided by the Supreme Court — he presented arguments in four of the six patent cases in the 2016 Term — but he also has an extensive appellate practice before the Court of Appeals for the Federal Circuit (“Federal Circuit”), which has exclusive appellate jurisdiction over patent cases. Given his substantial experience in patent appellate litigation, Waxman …
The False Promise Of Health Data Ownership, Jorge L. Contreras
The False Promise Of Health Data Ownership, Jorge L. Contreras
Utah Law Faculty Scholarship
In recent years there have been increasing calls by patient advocates, health law scholars and would-be data intermediaries to recognize personal property interests in individual health information (IHI). While the propertization of IHI appeals to notions of individual autonomy, privacy and distributive justice, the implementation of a workable property system for IHI presents significant challenges. This essay addresses the issues surrounding the propertization of IHI from a property law perspective. It first observes that IHI does not fit recognized judicial criteria for recognition as personal property, as IHI defies convenient definition, is difficult to possess exclusively, and lacks justifications for …
Green Technology Diffusion: A Post-Mortem Analysis Of The Eco-Patent Commons, Jorge L. Contreras, Bronwyn H. Hall, Christian Helmers
Green Technology Diffusion: A Post-Mortem Analysis Of The Eco-Patent Commons, Jorge L. Contreras, Bronwyn H. Hall, Christian Helmers
Utah Law Faculty Scholarship
We revisit the effect of the “Eco-Patent Commons” (EcoPC) on the diffusion of patented environmentally friendly technologies following its discontinuation in 2016, using both participant survey and data analytic evidence. Established in January 2008 by several large multinational companies, the not-for-profit initiative provided royalty-free access to 248 patents covering 94 “green” inventions. Hall and Helmers (2013) suggested that the patents pledged to the commons had the potential to encourage the diffusion of valuable environmentally friendly technologies. Our updated results now show that the commons did not increase the diffusion of pledged inventions, and that the EcoPC suffered from several structural …
Liability Rules For Health Information, Jorge L. Contreras, Francisca Nordfalk
Liability Rules For Health Information, Jorge L. Contreras, Francisca Nordfalk
Utah Law Faculty Scholarship
The recent trend toward propertization of health data could pose significant challenges to biomedical research and public health. Property rule systems can result in sizable up-front costs in the acquisition of consent from individual data subjects, as well as the ongoing risk that data subjects will retract consent or object to unanticipated data uses, thus compromising existing data resources and analyses. We argue that property-based approaches to health data should be rejected in favor of liability rule frameworks for the protection of individual privacy interests. We demonstrate that liability rule frameworks for data governance are not only desirable from a …
The Effect Of Frand Commitments On Patent Remedies, Jorge L. Contreras, Thomas F. Cotter, Sang Jo Jong, Brian J. Love, Nicolas Petit, Peter George Picht, Norman Siebrasse, Rafał Sikorski, Masabumi Suzuki, Jacques De Werra
The Effect Of Frand Commitments On Patent Remedies, Jorge L. Contreras, Thomas F. Cotter, Sang Jo Jong, Brian J. Love, Nicolas Petit, Peter George Picht, Norman Siebrasse, Rafał Sikorski, Masabumi Suzuki, Jacques De Werra
Utah Law Faculty Scholarship
This chapter addresses a special category of cases in which an asserted patent is, or has been declared to be, essential to the implementation of a collaboratively-developed voluntary consensus standard, and the holder of that patent has agreed to license it to implementers of the standard on terms that are fair, reasonable and non-discriminatory (FRAND). In this chapter, we explore how the existence of such a FRAND commitment may affect a patent holder’s entitlement to monetary damages and injunctive relief. In addition to issues of patent law, remedies law and contract law, we consider the effect of competition law on …
Global Rate Setting: A Solution For Standard-Essential Patents?, Jorge L. Contreras
Global Rate Setting: A Solution For Standard-Essential Patents?, Jorge L. Contreras
Utah Law Faculty Scholarship
The commitment to license patents that are essential to technical interoperability standards on terms that are fair, reasonable and non-discriminatory (FRAND) is a fundamental mechanism that enables standards to be developed collaboratively by groups of competitors. Yet disagreements over FRAND royalty rates continue to bedevil participants in global technology markets. Allegations of opportunistic hold-up and hold-out continue to arise, spurring competition authorities to investigate and intervene in private standard-setting. And litigation regarding compliance with FRAND commitments has led an increasing number of courts around the world to adjudicate FRAND royalty rates, often on a global basis, but using very different …
Taking It To The Limit: Shifting U.S. Antitrust Policy Toward Standards Development, Jorge L. Contreras
Taking It To The Limit: Shifting U.S. Antitrust Policy Toward Standards Development, Jorge L. Contreras
Utah Law Faculty Scholarship
In November 2017, U.S. Assistant Attorney General Makan Delrahim, chief of the Department of Justice (DOJ) Antitrust Division, gave a speech at University of Southern California provocatively entitled “Take it to the Limit: Respecting Innovation Incentives in the Application of Antitrust Law”. In this speech, Mr. Delrahim announced a new DOJ policy approach to the antitrust analysis of collaborative standard setting and standards-development organizations (SDOs) -- the trade associations and other groups in which industry participants cooperate to develop interoperability standards such as Wi-Fi, Bluetooth, 4G and 5G, USB and the like. He explained that the DOJ had “strayed too …
The Anticommons At Twenty: Concerns For Research Continue, Jorge L. Contreras
The Anticommons At Twenty: Concerns For Research Continue, Jorge L. Contreras
Center for Law and Biomedical Sciences (LABS)
Twenty years after Heller and Eisenberg predicted the emergence of an anticommons in biomedical research, this article assesses the currency of the anticommons theory. While a patent-fueled research anticommons does not appear to have emerged in the ways that Heller and Eisenberg envisioned, there are new ways in which the fragmentation of rights -- whether through trade secrecy, narrow licensing or data propertization -- continues to threaten research and commercial development. The anticommons theory thus remains as relevant today as it was when it was first proposed.
Much Ado About Holdup, Jorge L. Contreras
Much Ado About Holdup, Jorge L. Contreras
Utah Law Faculty Scholarship
The policy debate surrounding patent hold-up in markets for standardized products is now well into its second decade with no end in sight. Fundamental questions including the definition of hold-up, whether it exists in the marketplace, and what impact it has on innovation, continue to bedevil scholars, policy makers and industry. Yet it is not clear that this debate needs to continue. Patent hold-up is a pattern of market behavior, not a legally-cognizable wrong. Whether it is commonplace or rare is largely irrelevant to liability in any given case. To the extent that hold-up behavior constitutes an abuse of market …
Rambus Redux? – Standards, Patents And Non-Disclosure In The Pharmaceutical Sector (Momenta V. Amphastar), Jorge L. Contreras
Rambus Redux? – Standards, Patents And Non-Disclosure In The Pharmaceutical Sector (Momenta V. Amphastar), Jorge L. Contreras
Utah Law Faculty Scholarship
Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc. (D.Mass 2) involves the alleged deception of a standards-development organization (SDO) by the holder of a patent essential to a standard relating to the manufacture of the drug enoxaparin. The SDO's rules regarding disclosure of standards-essential patents (SEPs) were found to be ambiguous, yet, as in Qualcomm v. Broadcom (Fed. Cir. 2008), the district court held that participant expectations created an affirmative obligation to disclose SEPs. Following the SEP holder's assertion of the undisclosed patent against a competing generic manufacturer of enoxaparin, the alleged infringer successfully raised defenses of waiver and estoppel against …