Law Commons^™

The Code Of Life And Death, Braden R. Leach

Notre Dame Journal on Emerging Technologies

Biotechnology is advancing at an astonishing clip, but our safeguards are decades behind. Given new technologies and economies of scale, it is possible for nefarious actors to assemble deadly viruses from scratch using synthetic DNA ordered off the internet. The Select Agents statute helps to prevent malicious actors from acquiring dangerous pathogens, but the Department of Health and Human Services has interpreted it to not cover synthetic DNA. Recognizing the gap, HHS issued guidance recommending that gene synthesis companies verify their customers to ensure their legitimacy and screen genetic sequences for matches to pathogen sequences. Unsurprisingly, voluntary guidance has not …

Caveat Venditor: Products Liability And Genetically Modified Foods, Kristopher A. Isham

Journal of Food Law & Policy

Genetically modified organisms (GMOs) have become a lightning rod for conflict between farmers, corporations, shareholders, government agencies, and other concerned groups. Supporters tout GMOs as a solution to the problems of diminishing returns from traditional crop plants and the rising demand for greater quantities of food. Opponents critcize GMOs for potential toxic and allergic reactions in humans, loss of biodiversity, and pesticide and antibiotic resistance in other plants and insects. As the understanding of potential applications of biotechnology broadens, the risks and benefits of such products are being scrutinized more closely.

Association For Molecular Pathology V. Myriad Genetics: A Critical Reassessment, Jorge L. Contreras

Michigan Technology Law Review

The Supreme Court’s 2013 decision in Association for Molecular Pathology v. Myriad Genetics is an essential piece 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 Section 101 jurisprudence. It was seen, and litigated, as a case impacting patient rights, access to healthcare, scientific freedom, …

Equal Protection And Ectogenesis, Brit J. Benjamin

Vanderbilt Journal of Entertainment & Technology Law

Ectogenesis is the gestation of a fetus in an artificial womb. This suite of technologies, now in use to preserve the lives of premature infants, is on the cusp of being a viable method of reproduction from conception to term. This Article argues that an equal protection challenge to a ban on utilizing ectogenetic technologies should be analyzed under intermediate or strict scrutiny. Should the US Supreme Court apply the rational basis or rational basis “with bite” standard of review to such a challenge, the petitioner should prevail.

The nature of ectogenesis is a technological alternative for a sex-specific organ. …

Emerging Governance Of Mitochondrial Replacement Therapy: Assessing Coherence Between Scientific Evidence And Policy Outcomes, Katherine Drabiak

DePaul Journal of Health Care Law

In the fall of 2016, media headlines reported news of several births of children born through “three parent IVF” or mitochondrial replacement therapy (MRT). MRT refers to an experimental procedure that entails removing the nuclear DNA from the mother’s egg or fertilized zygote and transferring it to a donor’s egg or fertilized zygote. This procedure constitutes a modification of the human germline, which has been prohibited by numerous declarations, directives, and laws promulgated by the United Nations, the Council of Europe, and other nations. In 2016, the Human Fertilisation and Embryology Authority in the United Kingdom was the first nation …

Patent Arbitration: The Underutilized Process For Resolving International Patent Disputes In The Pharmaceutical And Biotechnology Industries, Alessandra Emini

Arbitration Law Review

No abstract provided.

"Playing God?": An Examination Of The Legality Of Crispr Germline Editing Technology Under The Current International Regulatory Scheme And The Universal Declaration On The Human Genome And Human Rights, Brooke Elizabeth Hrouda

Georgia Journal of International & Comparative Law

No abstract provided.

Genome Editing And The Jurisprudence Of Scientific Empiricism, Paul Enriquez

Vanderbilt Journal of Entertainment & Technology Law

Humankind has reached, in tow by the hand of a scientific breakthrough called CRISPR, the Rubicon of precise genetic manipulation first envisioned over fifty years ago. Despite CRISPR's renown in science and its power to transform the world, it remains virtually unaddressed in legal scholarship. In the absence of on-point law, the scientific community has attempted to reach some consensus to preempt antagonistic regulation and prescribe subjective standards of use under the guise of a priori scientific empiricism. Significant and complex legal issues concerning this technology are emerging, and the void in legal scholarship is no longer tolerable.

This Article …

Use Of Facial Recognition Technology For Medical Purposes: Balancing Privacy With Innovation, Seema Mohapatra

Pepperdine Law Review

Imagine applying for a job, and as part of your application process, your prospective employer asks for a photograph. You, as an eager candidate, comply with the request and, unbeknownst to you, the employer runs your picture through a software program that scans you for any common genetic diseases and that estimates your longevity. Alas, your face indicates that you may die young. No job for you. Although this sounds like science fiction, we may not be that far off from this scenario. In June 2014, scientists from Oxford reported that they have developed a facial recognition program that uses …

Bioprospect Theory, James Ming Chen

Akron Intellectual Property Journal

Conventional wisdom treats biodiversity and biotechnology as rivalrous values. The global south is home to most of earth's vanishing species, while the global north holds the capital and technology needed to develop this natural wealth. The south argues that intellectual property laws enable pharmaceutical companies and seed breeders in the industrialized north to commit biopiracy. By contrast, the United States has characterized calls for profit-sharing as a threat to the global life sciences industry. Both sides magnify the dispute, on the apparent consensus that commercial exploitation of genetic resources holds the key to biodiversity conservation.

Both sides of this debate …

Gaps, Inexperience, Inconsistencies, And Overlaps: Crisis In The Regulation Of Genetically Modified Plants And Animals, Gregory N. Mandel

William & Mary Law Review

The regulation of genetically modified products pursuant to statutes enacted decades prior to the advent of biotechnology has created a regulatory system that is passive rather than proactive about risks, has difficulty adapting to biotechnology advances, and is highly fractured and inefficient-transgenic plants and animals are governed by at least twelve different statutes and five different agencies or services. The deficiencies resulting from this piecemeal approach to regulation unnecessarily expose society and the environment to adverse risks of biotechnology and introduce numerous inefficiencies into the regulatory system. These risks and inefficiencies include gaps in regulation, duplicative and inconsistent regulation, unnecessary …

Biotechnology Law: A Tale Of Peptides And Lasers: Is Integra Lifesciences I, Ltd. V. Kgaa The End Of The Experimental Use Defense For Biomedical Innovation, Or Does § 271(E)(1) Of The Patent Act Save The Day, Melissa J. Alcorn Ph.D.

Oklahoma Law Review

No abstract provided.

Biotechnology And Human Dignity, A Necessary And Compatible Union, Ellen Judge Hayes

Journal of Health Care Law and Policy

No abstract provided.

On The Human Body As Property: The Meaning Of Embodiment, Markets, And The Meaning Of Strangers, Thomas H. Murray

University of Michigan Journal of Law Reform

For as long as I can recall, newspapers have published brief items in which someone has calculated what the human body is "worth" on the open market. The value of the body-as reduced to its chemical components-was never more than a few dollars. A more accurate accounting, though, would include the market value of transplantable organs and tissues, as well as the potential bonanza to be had should a cell line cultured from that body prove valuable to the biotechnology industry. The bottom line could be anywhere from tens of thousands to perhaps millions of dollars.

Both moral and legal …