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Articles 1 - 30 of 78
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 …
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 …
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 …
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 …
Expired Patents, Trade Secrets, And Stymied Competition, W. Nicholson Price Ii
Expired Patents, 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 …
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 …
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 …
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 …
Reconciling Intellectual And Personal Property, Aaron Perzanowski, Jason Schultz
Reconciling Intellectual And Personal Property, Aaron Perzanowski, Jason Schultz
Articles
This Article examines both the forces undermining copy ownership and the important functions it serves within the copyright system in order to construct a workable notion of consumer property rights in digital media.
Part I begins by examining the relationship between intellectual and personal property. Sometimes courts have treated those rights as inseparable, as if transfer of a copy entails transfer of the intangible right, or retention of the copyright entails ongoing control over particular copies. But Congress and most courts have recognized personal and intellectual property as interests that can be transferred separately. Although the better view, this approach …
Campbell At 21/Sony At 31, Jessica D. Litman
Campbell At 21/Sony At 31, Jessica D. Litman
Articles
When copyright lawyers gather to discuss fair use, the most common refrain is its alarming expansion. Their distress about fair use’s enlarged footprint seems completely untethered from any appreciation of the remarkable increase in exclusive copyright rights. In the nearly forty years since Congress enacted the 1976 copyright act, the rights of copyright owners have expanded markedly. Copyright owners’ demands for further expansion continue unabated. Meanwhile, they raise strident objections to proposals to add new privileges and exceptions to the statute to shelter non-infringing uses that might be implicated by their expanded rights. Copyright owners have used the resulting uncertainty …
Actavis, The Reverse Payment Fallacy, And The Continuing Need For Regulatory Solutions, Daniel A. Crane
Actavis, The Reverse Payment Fallacy, And The Continuing Need For Regulatory Solutions, Daniel A. Crane
Articles
The Actavis decision punted more than it decided. Although narrowing the range of possible outcomes by rejecting the legal rules at the extremes and opting for a rule of reason middle ground, the opinion failed to grapple with the most challenging issues of regulatory policy raised by pharmaceutical patent settlements. In particular, it failed to clearly delineate the social costs of permitting and disallowing patent settlements, avoided grappling with the crucial issues of patent validity and infringement, and erroneously focused on “reverse payments” as a distinctive antitrust problem when equally or more anticompetitive settlements can be crafted without reverse payments. …
Prometheus Rebound: Diagnostics, Nature, And Mathematical Algorithms, Rebecca S. Eisenberg
Prometheus Rebound: Diagnostics, Nature, And Mathematical Algorithms, Rebecca S. Eisenberg
Articles
The Supreme Court’s decision last Term in Mayo v. Prometheus left considerable uncertainty as to the boundaries of patentable subject matter for molecular diagnostic inventions. First, the Court took an expansive approach to what counts as an unpatentable natural law by applying that term to the relationship set forth in the challenged patent between a patient’s levels of a drug metabolite and the indication of a need to adjust the patient’s drug dosage. And second, in evaluating whether the patent claims add enough to this unpatentable natural law to be patent eligible, the Court did not consult precedents concerning the …
Antibiotic Resistance, Jessica D. Litman
Antibiotic Resistance, Jessica D. Litman
Articles
Ten years ago, when I wrote War Stories,' copyright lawyers were fighting over the question whether unlicensed personal, noncommercial copying, performance or display would be deemed copyright infringement. I described three strategies that lawyers for book publishers, record labels, and movie studios had deployed to try to assure that the question was answered the way they wanted it to be. First, copyright owners were labeling all unlicensed uses as "piracy" on the ground that any unlicensed use might undermine copyright owners' control. That epithet helped to obscure the difference between unlicensed uses that invaded defined statutory exclusive rights and other …
Wisdom Of The Ages Or Dead-Hand Control? Patentable Subject Matter For Diagnostic Methods After In Re Bilski, Rebecca S. Eisenberg
Wisdom Of The Ages Or Dead-Hand Control? Patentable Subject Matter For Diagnostic Methods After In Re Bilski, Rebecca S. Eisenberg
Articles
In 1980, the Supreme Court gave a reassuring signal to the then-nascent biotechnology industry about the availability of patent protection for the fruits of its research when it upheld the patentability of a genetically modified living organism in Diamond v. Chakrabarty. Twenty-five years later, the Court seemed poised to reexamine the limits of patentable subject matter for advances in the life sciences when it granted certiorari in Laboratory Corporation v. Metabolite. But the Federal Circuit had not addressed the patentable subject matter issue in Laboratory Corporation, and the Court ultimately dismissed the certiorari p etition as improvidently granted. Five years …
Patent Costs And Unlicensed Use Of Patented Inventions, Rebecca S. Eisenberg
Patent Costs And Unlicensed Use Of Patented Inventions, Rebecca S. Eisenberg
Articles
Recent commentators have observed, and sometimes lamented, significant gaps between the formal reach of the patent system and the practical exclusionary effect of patent law. It is costly for technology developers to obtain and assert patents, for technology users to identify the patents they might be infringing and to clear rights, and for the Patent and Trademark Office (PTO) to find patent-defeating prior art. The costs of the patent system provide shelter for infringing behavior that might otherwise lead to either licensing or liability, perhaps mitigating excesses in the patent system while retaining strong rights that motivated owners may enforce. …
Readers' Copyright, Jessica D. Litman
Readers' Copyright, Jessica D. Litman
Articles
My goal in this project is to reclaim copyright for readers (and listeners, viewers, and other members of the audience). I think, and will try to persuade you, that the gradual and relatively recent disappearance of readers’ interests from the core of copyright’s perceived goals has unbalanced the copyright system. It may have prompted, at least in part, the scholarly critique of copyright that has fueled copyright lawyers’ impression that “so many in academia side with the pirates.” It may also be responsible for much of the deterioration in public support for copyright. I argue here that copyright seems out …
Fixing Ram Copies, Aaron Perzanowski
Fixing Ram Copies, Aaron Perzanowski
Articles
Scholars, litigants, and courts have debated the status of so-called “RAM copies” - instantiations of copyrighted works in the random access memory of computing devices - for decades. The Second Circuit’s decision in Cartoon Network v. CSC Holdings has recently reignited the controversy over these putative copies. There the court held that CSC did not create copies within the meaning of the Copyright Act when it buffered fleeting segments of television programs. In many respects, the Second Circuit’s holding is a straightforward application of the Act’s nested definitions of “copies” and “fixed.” But because the court declined to apply the …
Real Copyright Reform, Jessica D. Litman
Real Copyright Reform, Jessica D. Litman
Articles
A copyright system is designed to produce an ecology that nurtures the creation, dissemination, and enjoyment of works of authorship. When it works well, it encourages creators to generate new works, assists intermediaries in disseminating them widely, and supports readers, listeners, and viewers in enjoying them. If the system poses difficult entry barriers to creators, imposes demanding impediments on intermediaries, or inflicts burdensome conditions and hurdles on readers, then the system fails to achieve at least some of its purposes. The current U.S. copyright statute is flawed in all three respects. In this Article, I explore how the current copyright …