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Full-Text Articles in Law
The Normative Molecule: Patent Rights And Dna, Saurabh Vishnubhakat
The Normative Molecule: Patent Rights And Dna, Saurabh Vishnubhakat
Faculty Scholarship
Throughout the biotechnology age, fears about the distortionary effects of property and other legal institutions upon the health and self-determination of individuals and societies have accompanied more popularly sensational fears about unscrupulous choices within the scientific community itself. Still, for most of that time the prevailing legal regime both in the United States and in Europe remained generally permissive of ownership of, and exclusionary power over, the fruits of much biomedical research, though this leniency took different forms and came about in different ways. In particular, the policy of the United States Patent and Trademark Office to grant patents on …
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 …
Patent Protection For Crispr: An Elsi Review, Jacob S. Sherkow
Patent Protection For Crispr: An Elsi Review, Jacob S. Sherkow
Articles & Chapters
The revolutionary gene-editing technology, CRISPR, has raised numerous ethical, legal, and social concerns over its use. The technology is also subject to an increasing patent thicket that raises similar issues concerning patent licensing and research development. This essay reviews several of these challenges that have come to the fore since CRISPR’s development in 2012. In particular, the lucre and complications that have followed the CRISPR patent dispute may affect scientific collaboration among academic research institutions. Relatedly, universities’ adoption of “surrogate licensors” may also hinder downstream research. At the same time, research scientists and their institutions have also used CRISPR patents …
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 …
Who Owns Gene Editing? Patents In The Time Of Crispr, Jacob S. Sherkow
Who Owns Gene Editing? Patents In The Time Of Crispr, Jacob S. Sherkow
Other Publications
New gene-editing technologies, like CRISPR, promise revolutionary advances in biology and medicine. However, several patent disputes in the USA and UK may have complicated who can use CRISPR. What does this mean for the future of gene editing?
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 …
Law, History And Lessons In The Crispr Patent Conflict, Jacob S. Sherkow
Law, History And Lessons In The Crispr Patent Conflict, Jacob S. Sherkow
Articles & Chapters
Predicting the outcome of the ongoing patent disputes surrounding genome-editing technology is equal parts patent analysis and history.
Genome-editing technology based on clustered, regularly interspaced, short palindromic repeats (CRISPR) and CRISPR associated protein 9 (Cas9) has generated great excitement in both academia and industry. But a potential patent dispute between two sets of inventors has left the biotech community pondering its fate. Understanding several facets of patent law and history may provide some lessons about the probable — and best — outcome for the dispute.
The Critical Role Of Patents In The Development, Commercialization And Utilization Of Innovative Genetic Diagnostic Test And Personalized Medicine, Christopher M. Holman
The Critical Role Of Patents In The Development, Commercialization And Utilization Of Innovative Genetic Diagnostic Test And Personalized Medicine, Christopher M. Holman
Faculty Works
Arguments in favor of reining in the availability of effective patent protection in the area of genetic diagnostic testing are based largely on two fundamental misconceptions regarding the role of patents in this important area of technological innovation. The first is the mistaken assumption that patents negatively impact patient access to genetic diagnostic testing by preventing research that might lead to new or improved versions of a genetic test and by increasing the cost of testing services. The second is the failure to appreciate the substantial positive role patents play in in the development and utilization of genetic diagnostic tests. …
The History Of Patenting Genetic Material, Jacob S. Sherkow, Henry T. Greely
The History Of Patenting Genetic Material, Jacob S. Sherkow, Henry T. Greely
Articles & Chapters
The US Supreme Court’s recent decision in Association for Molecular Pathology v. Myriad Genetics, Inc. declared, for the first time, that isolated human genes cannot be patented. Many have wondered how genes were ever the subjects of patents. The answer lies in a nuanced understanding of both legal and scientific history. Since the early twentieth century, “products of nature” were not eligible to be patented unless they were “isolated and purified” from their surrounding environment. As molecular biology advanced, and the capability to isolate genes both physically and by sequence came to fruition, researchers (and patent offices) began to apply …
Myriad Stands Alone, Jacob S. Sherkow, Christopher T. Scott
Myriad Stands Alone, Jacob S. Sherkow, Christopher T. Scott
Articles & Chapters
Myriad took no prisoners on its way to the top of the molecular diagnostics field. That strategy is unlikely to endure.
Myriad Genetics began in 1991 as a small University of Utah startup interested in the then-novel arena of diagnostic genetic testing. After winning a highly publicized race to sequence the BRCA1 and BRCA2 breast cancer genes, the company obtained patents on the gene sequences and methods of using them to determine cancer risk. The patents were broad and interlocking, covering BRCA genomic DNA, cDNA, methods of diagnosis and systems detecting mutations. Myriad also filed for diagnostic 'toolbox' patents, including …
Exclusivity Without Patents: The New Frontier Of Fda Regulation For Genetic Materials, Gregory Dolin
Exclusivity Without Patents: The New Frontier Of Fda Regulation For Genetic Materials, Gregory Dolin
All Faculty Scholarship
Over the last twenty years, the legal and scientific academic communities have been embroiled in a debate about the patent eligibility of genetic materials. The stakes for both sides could not be higher. On one hand are the potential multi-billion dollar profits on the fruits of research (from newly discovered genes), and on the other is scientists' ability to continue and expand research into the human genome to improve patients' access to affordable diagnostic and therapeutic modalities. This debate is currently pending before the Supreme Court, which is considering a petition for certiorari in Ass'n for Molecular Pathology v. U.S. …
Stifling Or Stimulating - The Role Of Gene Patents In Research And Genetic Testing, Lawrence M. Sung
Stifling Or Stimulating - The Role Of Gene Patents In Research And Genetic Testing, Lawrence M. Sung
Congressional Testimony
No abstract provided.
Navigating Uncharted Waters: Intellectual Property Rights Surrounding Genomics Research & Development Information, Lawrence M. Sung
Navigating Uncharted Waters: Intellectual Property Rights Surrounding Genomics Research & Development Information, Lawrence M. Sung
Faculty Scholarship
No abstract provided.
Reaching Through The Genome, Rebecca S. Eisenberg
Reaching Through The Genome, Rebecca S. Eisenberg
Book Chapters
The past two decades have been a period of rapid evolution in the science of biotechnology and therefore in patent strategies, if not in patent law itself. Patent law takes a long time to catch up with science, and commentators take a long time to catch up with the law, but patent lawyers don’t have that luxury. They have to keep ahead of the game, figuring out claiming strategies that allow their clients to capture the value of future discoveries. I want to discuss some of these strategies today.
The Unblazed Trail: Bioinformatics And The Protection Of Genetic Knowledge, Lawrence M. Sung
The Unblazed Trail: Bioinformatics And The Protection Of Genetic Knowledge, Lawrence M. Sung
Faculty Scholarship
No abstract provided.
The Role Of Patents In Exploiting The Genome, Rebecca S. Eisenberg
The Role Of Patents In Exploiting The Genome, Rebecca S. Eisenberg
Book Chapters
The sequencing of the human genome is a great scientific accomplishment that opens the door to further scientific inquiry of a sort that would otherwise be impossible. In addition to being passionately interested in the patent issues this research presents, as a legal scholar I have a long-standing interest in the role of intellectual property in interactions between the public and private senators and between universities and private firms in research science, with a focus on biomedial research. However, although the Human Genome Project has provided a rich terrain for exploring these issues, I am puzzled that intellectual property issues …
Brief Amicus Curiae Of The Taxpayers Asset Project Of The Center For Study Of Responsive Law In Support Of Petitioners, Genetics Institute, Inc., Et. Al. V. Amgen Inc., 502 U.S. 856 (1991), Michael H. Davis
Law Faculty Briefs and Court Documents
Although a patent appears to be a private right, that private right is only "secondary," as this Court has stated, to the public bargain of which it is but a part. The focus must always be whether the public has received full information about the nature of the invention so that future inventors may reuse and improve it. The decision below reflects a failure to recognize the patent's monopoly nature and as a result abandons the "best mode" rule forbidding the inventor form concealing the best way of replicating the invention. By turning the subjective test of "best mode" into …