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Articles 1 - 26 of 26
Full-Text Articles in Law
Volume Introduction, I. Glenn Cohen, Timo Minssen, W. Nicholson Price Ii, Christopher Robertson, Carmel Shachar
Volume Introduction, I. Glenn Cohen, Timo Minssen, W. Nicholson Price Ii, Christopher Robertson, Carmel Shachar
Other Publications
Medical devices have historically been less regulated than their drug and biologic counterparts. A benefit of this less demanding regulatory regime is facilitating innovation by making new devices available to consumers in a timely fashion. Nevertheless, there is increasing concern that this approach raises serious public health and safety concerns. The Institute of Medicine in 2011 published a critique of the American pathway allowing moderate-risk devices to be brought to the market through the less-rigorous 501(k) pathway,1 flagging a need for increased postmarket review and surveillance. High-profile recalls of medical devices, such as vaginal mesh products, along with reports globally …
Part I - Ai And Data As Medical Devices, W. Nicholson Price Ii
Part I - Ai And Data As Medical Devices, W. Nicholson Price Ii
Other Publications
It may seem counterintuitive to open a book on medical devices with chapters on software and data, but these are the frontiers of new medical device regulation and law. Physical devices are still crucial to medicine, but they – and medical practice as a whole – are embedded in and permeated by networks of software and caches of data. Those software systems are often mindbogglingly complex and largely inscrutable, involving artificial intelligence and machine learning. Ensuring that such software works effectively and safely remains a substantial challenge for regulators and policymakers. Each of the three chapters in this part examines …
Willard Hurst's Unpublished Manuscript On Law, Technology, And Regulation, Bj Ard, William J. Novak
Willard Hurst's Unpublished Manuscript On Law, Technology, And Regulation, Bj Ard, William J. Novak
Other Publications
It is with a great deal of excitement ( and with thanks to so many contributing colleagues and collaborators over the years ) that we are able to present to the public for the first time a newly published work by one of the great originators of modem legal history and law and society scholarship-James Willard Hurst. Hurst published his last two books, Law and Markets in United States History and Dealing with Statutes, in 1982. And, fittingly, he published his last substantive article--.-a very short comment on "The Use of Case Histories"-in the Wisconsin Law Review in 1992. In …
Risks And Remedies For Artificial Intelligence In Healthcare, W. Nicholson Price Ii
Risks And Remedies For Artificial Intelligence In Healthcare, W. Nicholson Price Ii
Other Publications
Artificial intelligence (AI) is rapidly entering health care and serving major roles, from automating drudgery and routine tasks in medical practice to managing patients and medical resources. As developers create AI systems to take on these tasks, several risks and challenges emerge, including the risk of injuries to patients from AI system errors, the risk to patient privacy of data acquisition and AI inference, and more. Potential solutions are complex but involve investment in infrastructure for high-quality, representative data; collaborative oversight by both the Food and Drug Administration and other health-care actors; and changes to medical education that will prepare …
The Life Of The Law Cannot Be Coded, Rebecca Roiphe
The Life Of The Law Cannot Be Coded, Rebecca Roiphe
Other Publications
No abstract provided.
The Crispr Patent Decision Didn’T Get The Science Right. That Doesn’T Mean It Was Wrong, Jacob S. Sherkow
The Crispr Patent Decision Didn’T Get The Science Right. That Doesn’T Mean It Was Wrong, Jacob S. Sherkow
Other Publications
No abstract provided.
The Rise Of Ethical License, Christi Guerrini, Margaret Curnette, Jacob S. Sherkow, Christopher Scott
The Rise Of Ethical License, Christi Guerrini, Margaret Curnette, Jacob S. Sherkow, Christopher Scott
Other Publications
The Broad Institute's recent licensing of its gene editing patent portfolio demonstrates how licenses can be used to restrict controversial applications of emerging technologies while society deliberates their implications.
Inventive Steps: The Crispr Patent Dispute And Scientific Progress, Jacob S. Sherkow
Inventive Steps: The Crispr Patent Dispute And Scientific Progress, Jacob S. Sherkow
Other Publications
Recent decisions by patent offices in the USA and Europe concerning the revolutionary gene-editing technology, CRISPR/Cas9, have shed light on the importance — and puzzles — of one particular area of patent law: “nonobviousness”, as it known in the USA, or, in Europe, the “inventive step”. Patent law does not always neatly align itself with the realities of biological research. But these competing decisions from the U.S. Patent and Trademark Office and the European Patent Office have put those differences on parade. Unpacking these standards for CRISPR tell us a lot about how advances in biology are actually made — …
Crispr, Surrogate Licensing, And Scientific Discovery, Jorge Contreras, Jacob S. Sherkow
Crispr, Surrogate Licensing, And Scientific Discovery, Jorge Contreras, Jacob S. Sherkow
Other Publications
Several research institutions are embroiled in a legal dispute over the foundational patent rights to CRISPR-Cas9 gene-editing technology, and it may take years for their competing claims to be resolved. But even before ownership of the patents is finalized, the institutions behind CRISPR have wasted no time capitalizing on the huge market for this groundbreaking technology by entering into a series of licensing agreements with commercial enterprises. With respect to the potentially lucrative market for human therapeutics and treatments, each of the key CRISPR patent holders has granted exclusive rights to a spinoff or "surrogate" company formed by the institution …
Key Challenges In Bringing Crispr-Mediated Somatic Cell Therapy Into The Clinic, Jacob S. Sherkow
Key Challenges In Bringing Crispr-Mediated Somatic Cell Therapy Into The Clinic, Jacob S. Sherkow
Other Publications
Genome editing using clustered regularly interspersed short palindromic repeats (CRISPR) and CRISPR-associated proteins offers the potential to facilitate safe and effective treatment of genetic diseases refractory to other types of intervention. Here, we identify some of the major challenges for clinicians, regulators, and human research ethics committees in the clinical translation of CRISPR-mediated somatic cell therapy.
Pursuit Of Profit Poisons Collaboration, Jacob S. Sherkow
Pursuit Of Profit Poisons Collaboration, Jacob S. Sherkow
Other Publications
The CRISPR–Cas9 patent battle demonstrates how overzealous efforts to commercialize technology can damage science.
Pursuit Of Profit Poisons Collaboration, Jacob S. Sherkow
Pursuit Of Profit Poisons Collaboration, Jacob S. Sherkow
Other Publications
The CRISPR–Cas9 patent battle demonstrates how overzealous efforts to commercialize technology can damage science.
23andme, The Food And Drug Administration, And The Future Of Genetic Testing, Patricia Zettler, Jacob S. Sherkow, Henry Greely
23andme, The Food And Drug Administration, And The Future Of Genetic Testing, Patricia Zettler, Jacob S. Sherkow, Henry Greely
Other Publications
On November 22, 2013, the US Food and Drug Administration (FDA) effectively halted health-related direct-to-consumer genetic testing in the United States by sending a warning letter to 23andMe, the leading company in the field, directing it to stop providing such testing. The FDA acted as the era of widespread, clinical use of DNA sequencing rapidly approaches. The agency’s action will contribute to changes in which genetic tests are offered to patients and how testing is provided.
What If Extinction Is Not Forever?, Jacob S. Sherkow
What If Extinction Is Not Forever?, Jacob S. Sherkow
Other Publications
No abstract provided.
The Future Of Gene Patents And The Implications For Medicine, Jacob S. Sherkow, Henry Greely
The Future Of Gene Patents And The Implications For Medicine, Jacob S. Sherkow, Henry Greely
Other Publications
The Supreme Court decision in Myriad Genetics struck down the patenting of human genomic DNA. What will this mean for genetic testing and medicine, more broadly?
Panel Iii: Politics And The Public In Ip & Info Law Policy Making, Michael J. Burstein, Derek Khanna, Jessica D. Litman, Sherwin Siy, Richard S. Whitt
Panel Iii: Politics And The Public In Ip & Info Law Policy Making, Michael J. Burstein, Derek Khanna, Jessica D. Litman, Sherwin Siy, Richard S. Whitt
Other Publications
We have been moving gradually from the theoretical to the practical. Having examined the impact of critical legal studies ("CLS") in the academy and having discussed the intersection between scholarship and activism, we now turn to the nitty-gritty questions of how to actually enact change in intellectual property and information law and policy.
The Meningitis Outbreak: Don't Expect Miracles From The Fda, Joanne Doroshow
The Meningitis Outbreak: Don't Expect Miracles From The Fda, Joanne Doroshow
Other Publications
The good news for states is drug industry immunity only kicks in if the drugs in question are FDA-approved. And thanks to the first-rate influence-peddling and lobbying prowess of compounding pharmacists, the tainted steroid shots at issue today are free and clear of FDA regulation.
Human Identity: The Question Presented By Human-Animal Hybridization, Jospeh Vining
Human Identity: The Question Presented By Human-Animal Hybridization, Jospeh Vining
Other Publications
What makes each of us, as individuals, human to one another, or, more generally, what makes an individual creature human? We have not often had to ask the question because of the species line based on reproductive capacity and incapacity, although "degrees of humanness" were explored in the various eugenic programs of the last century. Now the biotechnological possibility of fusing human and other forms of life is presenting the question in a new and serious way. If the traditional biological means of defining species are no longer reliable, what other criteria might determine what is "human" and what is …
Global-Change Scenarios: Their Development And Use, Edward A. Parson, Virginia Burkett, Karen Fisher-Vanden, David Keith, Linda Mearns, Hugh Pitcher, Cynthia Rosenzweig, Mort Webster
Global-Change Scenarios: Their Development And Use, Edward A. Parson, Virginia Burkett, Karen Fisher-Vanden, David Keith, Linda Mearns, Hugh Pitcher, Cynthia Rosenzweig, Mort Webster
Other Publications
This report examines the development and use of scenarios in global climate change applications. It considers scenarios of various types – including but not limited to emissions scenarios – and reviews how they have been developed, what uses they have served, what consistent challenges they have faced, what controversies they have raised, and how their development and use might be made more effective. The report is Synthesis & Assessment Product 2.1b of the US Climate Change Science Program. By synthesizing available literature and critically reviewing past experience, the report seeks to assist those who may be conducting, using, or commissioning …
War And Peace: The 34th Annual Donald C. Brace Lecture, Jessica D. Litman
War And Peace: The 34th Annual Donald C. Brace Lecture, Jessica D. Litman
Other Publications
I'd like to thank the Copyright Society and the Brace committee for inviting me to speak to you this evening. I am honored that you invited me to give this lecture. I want to talk a little bit about war - copyright war - and then I want to talk a little bit about peace. It's become conventional that we're in the middle of a copyright war.' I tried to track down who started calling it that, and what I can tell you is that about ten years ago, about the time that copyright lawyers everywhere were arguing about the …
Foreword To Berkeley Law And Technology Law Journal 21, No. 1, Aaron Perzanowski, Tara Wheatland
Foreword To Berkeley Law And Technology Law Journal 21, No. 1, Aaron Perzanowski, Tara Wheatland
Other Publications
Through the scholarship it publishes, the Berkeley Technology Law Journal - formerly the High Technology Law Journal - has tracked the evolution of technology and intellectual property law for more than two decades. In keeping with this tradition, the Annual Review of Law & Technology, now in its ninth volume, catalogs the year's most significant developments in a wide range of topic areas, which this year include intellectual property, cyberlaw, constitutional law, and telecommunications. The summaries and analyses presented here aim to provide practitioners, judges, policymakers, scholars, and students a concise and thorough encapsulation of the year in technology and …
The Least Of The Sentient Beings' And The Question Of Reduction, Refinement, And Replacement, Joseph Vining
The Least Of The Sentient Beings' And The Question Of Reduction, Refinement, And Replacement, Joseph Vining
Other Publications
The subject I was asked to think about with you today is raised by a very large change in the focus of biomedical research. In raw percentage terms, the animals involved in experimentation are now overwhelmingly rats and mice, and, perhaps because they are rats and mice, they are used in large numbers, numbers in thousands and tens of thousands at some institutions. Legal, ethical, and practical accommodation to this fact on the ground presents a host of questions. There are questions of the cost of care. There are questions of the training of veterinarians, principal investigators, and laboratory personnel. …
Patents, Product Exclusivity, And Information Dissemination: How Law Directs Biopharmaceutical Research And Development, Rebecca S. Eisenberg
Patents, Product Exclusivity, And Information Dissemination: How Law Directs Biopharmaceutical Research And Development, Rebecca S. Eisenberg
Other Publications
It's a great honor for me to be invited to deliver the Levine Distinguished Lecture at Fordham, and a great opportunity to try out some new ideas before this audience. As some of you know, I've been studying the role of patents in biomedical research and product development ("R&D") for close to twenty years now, with a particular focus on how patents work in "upstream" research in universities and biotechnology companies that are working on research problems that arise prior to "downstream" product development. But, of course, the patent strategies of these institutions are designed around the profits that everyone …
Ownership, Commercial Development, Transfer And Use Of Publicly Funded Research Results: The United States Legal Regime, Rebecca S. Eisenberg
Ownership, Commercial Development, Transfer And Use Of Publicly Funded Research Results: The United States Legal Regime, Rebecca S. Eisenberg
Other Publications
This report summarizes key provisions of the United States. legal regime concerning ownership, dissemination and commercialization of the results of publicly funded research as background for a study on the feasibility of improving access by developing countries and economies in transition to environmentally sound technologies (ESTs) developed in other parts of the world.
Limiting The Role Of Patents In Technology Transfer, Rebecca S. Eisenberg
Limiting The Role Of Patents In Technology Transfer, Rebecca S. Eisenberg
Other Publications
Federal policy since 1980 has reflected an increasingly confident presumption that patenting discoveries made in the course of government-sponsored research is the most effective way to promote technology transfer and commercial development of those discoveries in the private sector. Policymakers in the past may have thought that the best way to achieve widespread use of government-sponsored research was to make the results freely available to the public; the new pro-patent policy stresses the need for exclusive rights as an incentive for industry to invest in bringing new products to market.
The Future Of Evidence Law: Or, Some Prophecies About Proof, John W. Reed
The Future Of Evidence Law: Or, Some Prophecies About Proof, John W. Reed
Other Publications
I am honored to participate in this seminar that is part of the celebration surrounding the dedication of Colorado's new State Judicial Building. But that feeling of honor is tempered by an awareness of the responsibility and perils of the role I have been asked to play. With the assignment, "The Future of Evidence Law," I have been asked to play the prophet, to be a seer of sorts, and to suggest what rules and principles will govern proof at trials at some date in the future. Exactly what date was not specified in the invitation-a decade, perhaps? A generation? …