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Articles 1 - 30 of 114
Full-Text Articles in Law
The Not-So-Standard Model: Reconsidering Agency-Head Review Of Administrative Adjudication Decisions, Rebecca S. Eisenberg, Nina A. Mendelson
The Not-So-Standard Model: Reconsidering Agency-Head Review Of Administrative Adjudication Decisions, Rebecca S. Eisenberg, Nina A. Mendelson
Articles
The Supreme Court has invalidated multiple legislative design choices for independent agency structures in recent years, citing Article II and the need for political accountability through presidential control of agencies. In United States v. Arthrex, Inc., the Court turned to administrative adjudication, finding an Appointments Clause violation in the assignment of certain final patent adjudication decisions to appellate panels of unconfirmed administrative patent judges. As a remedy, a different majority declared unenforceable a statutory provision that had insulated Patent and Trademark Office (PTO) administrative adjudication decisions from political review for almost a century. The Court thereby enabled the politically appointed …
New Innovation Models In Medical Ai, W Nicholson Price Ii, Rachel E. Sachs, Rebecca S. Eisenberg
New Innovation Models In Medical Ai, W Nicholson Price Ii, Rachel E. Sachs, Rebecca S. Eisenberg
Articles
In recent years, scientists and researchers have devoted considerable resources to developing medical artificial intelligence (AI) technologies. Many of these technologies—particularly those that resemble traditional medical devices in their functions—have received substantial attention in the legal and policy literature. But other types of novel AI technologies, such as those related to quality improvement and optimizing use of scarce facilities, have been largely absent from the discussion thus far. These AI innovations have the potential to shed light on important aspects of health innovation policy. First, these AI innovations interact less with the legal regimes that scholars traditionally conceive of as …
Edward S. Rogers, The Lanham Act, And The Common Law, Jessica Litman
Edward S. Rogers, The Lanham Act, And The Common Law, Jessica Litman
Book Chapters
This book chapter is a deep dive into the story of Edward Sidney Rogers's authorship of the legislation that became the Lanham Act. Because Rogers believed that Congress lacked the power to alter the substantive law of trademark and unfair competition, he crafted draft legislation that focused on registration and other procedural details rather than substantive rights and defenses. He sought to advance two incompatible goals: he hoped to preserve the robust common law of unfair competition while requiring, or at least encouraging, all trademark owners to register their marks. Both the supporters and the opponents of the bills that …
Symposium: Diamond Anniversary: 75 Years Of The Lanham Act, Jessica Litman
Symposium: Diamond Anniversary: 75 Years Of The Lanham Act, Jessica Litman
Articles
Thank you so much for inviting me. I think this is my fifth or sixth event with the Arts and Entertainment Law Journal. It’s always lots of fun, and I learn a lot. I’ve been spending the last couple of months doing a deep dive into everything Edward Sidney Rogers with no real agenda. I’m exploring what’s there, to see if there are any interesting stories I might tell. I found a few, so this afternoon I’ll tell one of them. I want to start with the mundane observation that intellectual prop-erty and intellectual property law are global. We’ve seen …
New Innovation Models In Medical Ai, Nicholson Price Ii, Rachel Sachs, Rebecca S. Eisenberg
New Innovation Models In Medical Ai, Nicholson Price Ii, Rachel Sachs, Rebecca S. Eisenberg
Law & Economics Working Papers
In recent years, scientists and researchers have devoted considerable resources to developing medical artificial intelligence (AI) technologies. Many of these technologies—particularly those which resemble traditional medical devices in their functions—have received substantial attention in the legal and policy literature. But other types of novel AI technologies, such as those that relate to quality improvement and optimizing use of scarce facilities, have been largely absent from the discussion thus far. These AI innovations have the potential to shed light on important aspects of health innovation policy. First, these AI innovations interact less with the legal regimes that scholars traditionally conceive of …
Clearing Opacity Through Machine Learning, W. Nicholson Price Ii, Arti K. Rai
Clearing Opacity Through Machine Learning, W. Nicholson Price Ii, Arti K. Rai
Articles
Artificial intelligence and machine learning represent powerful tools in many fields, ranging from criminal justice to human biology to climate change. Part of the power of these tools arises from their ability to make predictions and glean useful information about complex real-world systems without the need to understand the workings of those systems.
The Cost Of Novelty, Will Nicholson Price Ii
The Cost Of Novelty, Will Nicholson Price Ii
Articles
Patent law tries to spur the development of new and better innovative technology. But it focuses much more on “new” than “better”—and it turns out that “new” carries real social costs. I argue that patent law promotes innovation that diverges from existing technology, either a little (what I call “differentiating innovation”) or a lot (“exploring innovation”), at the expense of innovation that tells us more about existing technology (“deepening innovation”). Patent law’s focus on newness is unsurprising, and fits within a well-told narrative of innovative diversity accompanied by market selection of the best technologies. Unfortunately, innovative diversity brings not only …
Potential Liability For Physicians Using Artificial Intelligence, W. Nicholson Price Ii, Sara Gerke, I Glenn Cohen
Potential Liability For Physicians Using Artificial Intelligence, W. Nicholson Price Ii, Sara Gerke, I Glenn Cohen
Articles
Artificial intelligence (AI) is quickly making inroads into medical practice, especially in forms that rely on machine learning, with a mix of hope and hype. Multiple AI-based products have now been approved or cleared by the US Food and Drug Administration (FDA), and health systems and hospitals are increasingly deploying AI-based systems. For example, medical AI can support clinical decisions, such as recommending drugs or dosages or interpreting radiological images.2 One key difference from most traditional clinical decision support software is that some medical AI may communicate results or recommendations to the care team without being able to communicate the …
Imaginary Bottles, Jessica Litman
Imaginary Bottles, Jessica Litman
Articles
This essay, written for a symposium commemorating John Perry Barlow, who died on February 7, 2018, revisits Barlow's 1994 essay for WIRED magazine, "The Economy of Ideas: A Framework for patents and copyrights in the Digital Age (everything you know about intellectual property is wrong)." Barlow observed that networked digital technology posed massive and fundamental challenges for the markets for what Barlow termed “the work we do with our minds” and for the intellectual property laws designed to shape those markets. He predicted that those challenges would melt extant intellectual property systems into a smoking heap within a decade, and …
A Functional Approach To Judicial Review Of Ptab Rulings On Mixed Questions Of Law And Fact, Rebecca S. Eisenberg
A Functional Approach To Judicial Review Of Ptab Rulings On Mixed Questions Of Law And Fact, Rebecca S. Eisenberg
Articles
The Court of Appeals for the Federal Circuit (“Federal Circuit”) has long relied on active appellate review to bring uniformity and clarity to patent law. It initially treated the PTO the same as the federal district courts, reviewing its factual findings for clear error and its legal conclusions de novo. Following reversal by the Supreme Court in Dickinson v. Zurko, the Federal Circuit began giving greater deference to PTO factual findings. But it continued to review the PTO’s legal conclusions de novo, while coding an expansive list of disputed issues in patent cases as legal conclusions, even when they …
Opting Into Device Regulation In The Face Of Uncertain Patentability, Rebecca S. Eisenberg
Opting Into Device Regulation In The Face Of Uncertain Patentability, Rebecca S. Eisenberg
Articles
This article examines the intersection of patent law, FDA regulation, and Medicare coverage in a particularly promising field of biomedical innovation: genetic diagnostic testing. First, I will discuss current clinical uses of genetic testing and directions for further research, with a focus on cancer, the field in which genetic testing has had the greatest impact to date. Second, I will turn to patent law and address two recent Supreme Court decisions that called into question the patentability of many of the most important advances in genetic testing. Third, I will step outside patent law to take a broader view of …
Biobanks As Innovation Infrastructure For Translational Medicine, W. Nicholson Price Ii
Biobanks As Innovation Infrastructure For Translational Medicine, W. Nicholson Price Ii
Book Chapters
Biobanks represent an opportunity for the use of big data to drive translational medicine. Precision medicine demands data to shape treatments to individual patient characteristics; large datasets can also suggest new uses for old drugs or relationships between previously unlinked conditions. But these tasks can be stymied when data are siloed in different datasets, smaller biobanks, or completely proprietary private resources. This hampers not only analysis of the data themselves, but also efforts to translate data-based insights into actionable recommendations and to transfer the discovered technology into a commercialization pipeline. Cross-project technological innovation, development, and validation are all more difficult …
The Cost Of Novelty, W. Nicholson Price Ii
The Cost Of Novelty, W. Nicholson Price Ii
Law & Economics Working Papers
Patent law tries to spur the development of new, better, innovative technology. But it focuses much more on “new” than “better” — and it turns out that “new” carries real social costs. I argue that patent law promotes innovation that diverges from existing technology, either a little (what I call “differentiating innovation”) or a lot (“exploring innovation”), at the expense of innovation that tells us more about existing technology (“deepening innovation”). Patent law’s focus on newness is unsurprising, and fits within a well-told narrative of innovative diversity accompanied by market selection of the best technologies. Unfortunately, innovative diversity brings not …
Clown Eggs, Dave Fagundes, Aaron Perzanowski
Clown Eggs, Dave Fagundes, Aaron Perzanowski
Articles
Since 1946, many clowns have recorded their makeup by having it painted on eggs that are kept in a central registry in Wookey Hole, England. This tradition, which continues today, has been referred to alternately as a form of informal copyright registration and a means of protecting clowns’ property in their personae. This Article explores the Clown Egg Register and its surrounding practices from the perspective of law and social norms. In so doing, it makes several contributions. First, it contributes another chapter to the growing literature on the norms-based governance of intellectual property, showing how clowns—like comedians, roller derby …
What We Don't See When We See Copyright As Property, Jessica Litman
What We Don't See When We See Copyright As Property, Jessica Litman
Articles
For all of the rhetoric about the central place of authors in the copyright scheme, our copyright laws in fact give them little power and less money. Intermediaries own the copyrights, and are able to structure licenses so as to maximise their own revenue while shrinking their pay-outs to authors. Copyright scholars have tended to treat this point superficially, because – as lawyers – we take for granted that copyrights are property; property rights are freely alienable; and the grantee of a property right stands in the shoes of the original holder. I compare the 1710 Statute of Anne, which …
Universities: The Fallen Angels Of Bayh-Dole?, Rebecca S. Eisenberg, Robert Cook-Deegan
Universities: The Fallen Angels Of Bayh-Dole?, Rebecca S. Eisenberg, Robert Cook-Deegan
Articles
The Bayh-Dole Act of 1980 established a new default rule that allowed nonprofit organizations and small businesses to own, as a routine matter, patents on inventions resulting from research sponsored by the federal government. Although universities helped get the Bayh-Dole Act through Congress, the primary goal, as reflected in the recitals at the beginning of the new statute, was not to benefit universities but to promote the commercial development and utilization of federally funded inventions. In the years since the passage of the Bayh-Dole Act, universities seem to have lost sight of this distinction. Their behavior as patent seekers, patent …
What We Don't See When We See Copyright As Property, Jessica Litman
What We Don't See When We See Copyright As Property, Jessica Litman
Law & Economics Working Papers
It is becoming increasingly clear that the supposed copyright wars that copyright scholars believed we were fighting – nominally pitting the interests of authors and creators against the interests of readers and other members of the audience – were never really about that at all. Instead the real conflict has been between the publishers, record labels, movie studios, and other intermediaries who rose to market dominance in the 20th century, and the digital services and platforms that have become increasingly powerful copyright players in the 21st. In this essay, adapted from the 13th annual University of Cambridge Center for Intellectual …
Creative Commons: An Explainer, Kincaid C. Brown
Creative Commons: An Explainer, Kincaid C. Brown
Law Librarian Scholarship
Copyright protection attaches automatically to original works you create, whether a poem, photograph, painting, song, video, or essay. Copyright limits what others can do with your creative work and protects your original work from, for example, being compiled or reused and sold for profit. If you hold the copyright—and didn’t, say, create the original work in an employment context where it may be subject to being a work for hire—you may want to allow others to use your work for particular purposes. You could individually negotiate a license granting rights to each person, which would undoubtedly take more and more …
Creative Commons: An Explainer, Kincaid C. Brown
Creative Commons: An Explainer, Kincaid C. Brown
Law Librarian Scholarship
Copyright protection attaches automatically to original works you create, whether a poem, photograph, painting, song, video, or essay. Copyright limits what others can do with your creative work and protects your original work from, for example, being compiled or reused and sold for profit. If you hold the copyright—and didn’t, say, create the original work in an employment context where it may be subject to being a work for hire—you may want to allow others to use your work for particular purposes. You could individually negotiate a license granting rights to each person, which would undoubtedly take more and more …
Expired Patients, Trade Secrets, And Stymied Competition, W. Nicholson Price Ii
Expired Patients, Trade Secrets, And Stymied Competition, W. Nicholson Price Ii
Articles
Patents and trade secrecy have long been considered substitute incentives for innovation. When inventors create a new invention, they traditionally must choose between the two. And if inventors choose to patent their invention, society provides strong legal protection in exchange for disclosure, with the understanding that the protection has a limit: it expires twenty years from the date of filing. At that time, the invention is opened to the public and exposed to competition. This story is incomplete. Patent disclosure is weak and focuses on one technical piece of an invention—but that piece is often only a part of the …
Fetishizing Copies, Jessica Litman
Fetishizing Copies, Jessica Litman
Book Chapters
Our copyright laws encourage authors to create new works and communicate them to the public, because we hope that people will read the books, listen to the music, see the art, watch the films, run the software, and build and inhabit the buildings. That is the way that copyright promotes the Progress of Science. Recently, that not-very-controversial principle has collided with copyright owners’ conviction that they should be able to control, or at least collect royalties from, all uses of their works. A particularly ill-considered manifestation of this conviction is what I have decided to call copy-fetish. This is the …
Regulating Secrecy, W. Nicholson Price Ii
Regulating Secrecy, W. Nicholson Price Ii
Articles
Inventors face a stark choice between two intellectual property systems of protecting innovative ideas: patents and trade secrecy. But accounts of this choice underexplore the role of the regulators that dominate some areas of innovation. Regulation interacts with intellectual property exclusivity in socially problematic ways by encouraging secrecy at the expense of innovation, efficiency, and competition. This Article theorizes how regulation empowers intellectual property generally, explains why this strengthening is problematic for trade secrecy but not for patents, and offers the solution of regulator-enforced disclosure. When a regulator defines a product or a process, it becomes much harder to successfully …
Promoting Healthcare Innovation On The Demand Side, Rebecca S. Eisenberg, W. Nicholson Price
Promoting Healthcare Innovation On The Demand Side, Rebecca S. Eisenberg, W. Nicholson Price
Law & Economics Working Papers
Innovation policy often focuses on the incentives of firms that sell new products. But optimal use of healthcare products also requires good information about the likely effects of products in different patients, and it is hard to provide the right incentives for producers to develop and disclose information that could limit future sales. Regulation partially fills this gap by requiring sellers to conduct clinical trials and report adverse events. But it is inherently problematic to rely on producers to supply negative information about their own products. Healthcare payers, however, can profit from avoiding inappropriate use of costly technologies. Recent technological …
Big Data, Patents, And The Future Of Medicine, W. Nicholson Price Ii
Big Data, Patents, And The Future Of Medicine, W. Nicholson Price Ii
Articles
Big data has tremendous potential to improve health care. Unfortunately, intellectual property law isn’t ready to support that leap. In the next wave of data- driven medicine, black-box medicine, researchers use sophisticated algorithms to examine huge troves of health data, finding complex, implicit relationships and making individualized assessments for patients. Black-box medicine offers potentially immense benefits, but also requires substantial high investment. Firms must develop new datasets, models, and validations, which are all nonrivalrous information goods with significant spillovers, requiring incentives for welfare-optimizing investment. Current intellectual property law fails to provide adequate incentives for black- box medicine. The Supreme Court …
Manufacturing Barriers To Biologics Competition And Innovation, W. Nicholson Price Ii., Arti K. Rai
Manufacturing Barriers To Biologics Competition And Innovation, W. Nicholson Price Ii., Arti K. Rai
Articles
As finding breakthrough small-molecule drugs becomes more difficult, drug companies are increasingly turning to "large molecule" biologics. Although biologics represent many of the most promising new therapies for previously intractable diseases, they are extremely expensive. Moreover, the pathway for generic-type competition set up by Congress in 2010 is unlikely to yield significant cost savings. This Article provides a fresh diagnosis of and prescription for this major public policy problem. It argues that the key cause is pervasive trade secrecy in the complex area of biologics manufacturing. Under the current regime, this trade secrecy, combined with certain features of Food and …
What Notice Did, Jessica D. Litman
What Notice Did, Jessica D. Litman
Articles
In the twenty-first century, copyright protection is automatic. It vests in eligible works the instant that those works are first embodied in a tangible format. Many Americans are unaware of that, believing instead that registration and copyright notice are required to secure a copyright. That impression is understandable. For its first 199 years, United States copyright law required authors to take affirmative steps to obtain copyright protection. The first U.S. copyright statute, enacted by Congress in 1790, required the eligible author of an eligible work to record the title of the work with the clerk of the court in the …
What Notice Did, Jessica D. Litman
What Notice Did, Jessica D. Litman
Law & Economics Working Papers
In the 21st century, copyright protection is automatic. It vests in eligible works the instant that those works are first embodied in a tangible format. Many Americans are unaware of that, believing instead that registration and copyright notice are required to secure a copyright. That impression is understandable. For its first 199 years, United States copyright law required authors to take affirmative steps to obtain copyright protection. The first U.S. copyright statute, enacted by Congress in 1790, required the eligible author of an eligible work to record the title of the work with the clerk of the court in the …
Contemporary Practice Of The United States Relating To International Law., Kristina Daugirdas, Julian Davis Mortenson
Contemporary Practice Of The United States Relating To International Law., Kristina Daugirdas, Julian Davis Mortenson
Articles
In this section: • Agreement on Iran Nuclear Program Goes into Effect • United States and China Reach Agreement Regarding Economic Espionage and International Cybersecurity Norms • United States Ratifies the International Convention for the Suppression of Acts of Nuclear Terrorism • United States Reaches Agreement with Turkey on Use of Incirlik Air Base for Strikes on ISIL; “Safe Zone” Not Part of the Deal
Diagnostics Need Not Apply, Rebecca S. Eisenberg
Diagnostics Need Not Apply, Rebecca S. Eisenberg
Articles
Diagnostic testing helps caregivers and patients understand a patient's condition, predict future outcomes, select appropriate treatments, and determine whether treatment is working. Improvements in diagnostic testing are essential to bringing about the long-heralded promise of personalized medicine. Yet it seems increasingly clear that most important advances in this type of medical technology lie outside the boundaries of patent-eligible subject matter. The clarity of this conclusion has been obscured by ambiguity in the recent decisions of the Supreme Court concerning patent eligibility. Since its 2010 decision in Bilski v. Kappos, the Court has followed a discipline of limiting judicial exclusions from …
Silent Similarity, Jessica D. Litman
Silent Similarity, Jessica D. Litman
Articles
From 1909 to 1930, U.S. courts grappled with claims by authors of prose works claiming that works in a new art form—silent movies—had infringed their copyrights. These cases laid the groundwork for much of modern copyright law, from their broad expansion of the reproduction right, to their puzzled grappling with the question how to compare works in dissimilar media, to their confusion over what sort of evidence should be relevant to show copyrightability, copying and infringement. Some of those cases—in particular, Nichols v. Universal Pictures—are canonical today. They are not, however, well-understood. In particular, the problem at the heart of …