Law Commons^™

Mitochondrial Replacement Therapy: Let The Science Decide, Sabrina K. Glavota

Michigan Technology Law Review

Mitochondrial replacement therapy (MRT) is an in vitro fertilization technique designed to prevent women who are carriers of mitochondrial diseases from passing on these heritable genetic diseases to their children. It is an innovative assisted reproductive technology that is only legal in a small number of countries. The United States has essentially stagnated all opportunities for research and clinical trials on MRT through a rider in H.R.2029 – Consolidated Appropriations Act, 2016. The rider bans clinical trials on all therapies in which a human embryo is intentionally altered to include a heritable genetic modification. This note argues that the rider …

Lamarck Revisited: The Implications Of Epigenetics For Environmental Law, Michael P. Vandenbergh, David J. Vandenbergh, John G. Vandenbergh

Michigan Journal of Environmental & Administrative Law

For generations, a bedrock concept of biology was that genetic mutations are necessary to pass traits from one generation to the next, but new developments in genetics are challenging this fundamental assumption. A growing body of scientific evidence demonstrates that chemical alteration of the way a gene functions, whether through exposure to chemicals, foods or even traumatic experiences, may not only affect the exposed individual, but also the individual’s offspring for two generations or more. This interaction between genes and the environment, known as epigenetics, has revolutionized the understanding of how genes are expressed within an individual and how they …

Change In Regulation Is Necessary For Genetically Engineered Mosquitoes, Insung Hwang

Michigan Journal of Environmental & Administrative Law

Millions of genetically engineered (GE) mosquitoes could soon be released in Key West, Florida as an effort to eradicate wild mosquitoes that are transmitters of diseases such as malaria, dengue, and chikungunya. Both international and domestic regulations fail to provide effective regulatory schemes that can facilitate the application of this technology while ensuring all safety and environmental aspects are properly addressed. The Food and Drug Administration’s assertion of jurisdiction is based on its assessment that the GE mosquitoes are “animal drugs” under the Federal Food, Drug, and Cosmetic Act. This is especially troublesome because the end goal of using these …

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 …

After Myriad: Reconsidering The Incentives For Innovation In The Biotech Industry, Daniel K. Yarbrough

Michigan Telecommunications & Technology Law Review

35 U.S.C. § 101 allows a patent for “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.” Recently, the Supreme Court issued several key decisions affecting the doctrine of patentable subject matter under § 101. Starting with Bilski v. Kappos (2011), and continuing with Mayo Collaborative Services, Inc. v. Prometheus Laboratories (2012), Association for Molecular Pathology v. Myriad Genetics (2013) and, most recently, Alice Corporation Pty. Ltd. v. CLS Bank International (2014), every year has brought another major change to the way in which the Court assesses patentability. In Myriad, the …

Gina's Genotypes, David H. Kaye

Michigan Law Review First Impressions

In August 2009, the Board of Trustees of the University of Akron added to the university's employment policy the following proviso: "any applicant may be asked to submit fingerprints or DNA sample for purpose of a federal criminal background check." Although the federal government does not do background checks with DNA, the policy is significant because it highlights a largely unexplored feature of the Genetic Information Nondiscrimination Act of 2008 ("GINA"). Hailed by the late Senator Edward Kennedy as "the first civil rights bill of the new century of life sciences," GINA generally prohibits employers from asking for "genetic information." …

Relative Doubt: Familial Searches Of Dna Databases, Erin Murphy

Michigan Law Review

The continued growth of forensic DNA databases has brought about greater interest in a search method known as "familial" or "kinship" matching. Whereas a typical database search seeks the source of a crime-scene stain by making an exact match between a known person and the DNA sample, familial searching instead looks for partial matches in order to find potential relatives of the source. The use of a familial DNA search to identify the alleged "Grim Sleeper" killer in California brought national attention to the method, which has many proponents. In contrast, this Article argues against the practice of familial searching …

"False But Highly Persuasive": How Wrong Were The Probability Estimates In Mcdaniel V. Brown?, David H. Kaye

Michigan Law Review First Impressions

In McDaniel v. Brown, the Supreme Court will review the use of DNA evidence in a 1994 trial for sexual assault and attempted murder. The Court granted certiorari to consider two procedural issues—the standard of federal postconviction review of a state jury verdict for sufficiency of the evidence, and the district court's decision to allow the prisoner to supplement the record of trials, appeals, and state postconviction proceedings with a geneticist's letter twelve years after the trial. The letter from Laurence Mueller, a professor at the University of California at Irvine, identified two obvious mistakes in the state's expert testimony. …

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 …

Restoring The Genetic Commons: A Common Sense Approach To Biotechnology Patents In The Wake Of Ksr V. Teleflex , Anna Bartow Laakmann

Michigan Telecommunications & Technology Law Review

In this Article, I argue that a new approach to biotechnology patenting is necessary to fully realize the tremendous potential of recent advances in our understanding of the human genome. Part I places the gene patenting debate in context by highlighting the key landmarks that have shaped the biotechnology industry and outlining the products and stakeholders that comprise the industry. Part II describes the current state of the law on biotechnology patents, summarizing the Federal Circuit's application of the various doctrines that collectively define the patent landscape's parameters. In this Part, I explain how the Federal Circuit's jurisprudence is tied …

Technological Advancement And International Human Rights: Is Science Improving Human Life Or Perpetuating Human Rights Violations?, Christine A. Khalili-Borna

Michigan Journal of International Law

This Note assesses the practices of pre-implantation and prenatal genetic screening and sex-determination through an international human rights framework founded in the Universal Declaration of Human Rights (Universal Declaration), the Convention on the Rights of the Child (CRC), and the Convention on the Elimination of All Forms of Discrimination Against Women (CEDAW).

Biopiracy And Beyond: A Consideration Of Socio-Cultural Conflicts With Global Patent Policies, Cynthia M. Ho

University of Michigan Journal of Law Reform

This Article provides afresh and multi-dimensioned approach to a long-standing claim of biopiracy patents made by developing countries and communities. The basic principles of patent law and policy are first established to provide a foundation from which to evaluate the claim that genetic resources and traditional knowledge from developing countries are being misappropriated in a variety of ways that are loosely referred to as biopiracy. The Article distinguishes rhetoric from reality in examining biopiracy allegations from the perspective of national patent laws, as well as international agreements. In addition, the Article explains the underlying conflicts, misconceptions, and historical biases that …

An Examination Of Patents, Licensing, Research Tools, And The Tragedy Of The Anticommons In Biotechnology Innovation, Michael S. Mireles

University of Michigan Journal of Law Reform

The continued development of and affordable access to potentially life saving pharmaceuticals, gene therapies and diagnostics is unquestionably a socially important issue. However, crafting government policy to encourage the development of and allowing affordable access to those services and products is difficult. On one hand, the development of those services and products requires a large investment of funds because of the complexity, collaborative nature, and uncertainty of the development of those products and services. Accordingly, investors require the safety of strong and stable patent rights to ensure a return on their investment in the development of a commercial end-product or …

Life Sciences, Technology, And The Law - Symosium Transcript - March 7, 2003, Philip R. Reilly, David H. Kaye, Jonathan J. Koehler, Richard O. Lempert

Michigan Telecommunications & Technology Law Review

Life sciences, Technology, and the Law Symposium held at the University of Michigan Law School Friday, March 7, 2003

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.

Behavioral Genetics And The Best Interests Of The Child Decision Rule, David J. Herring

University of Michigan Journal of Law Reform

This Article proposes that modern child custody law should be reassessed in light of recent scientific findings. Judicial determinations of custody use the "best interests of the child" rule. The rule is justified to a large extent by the goal of maximizing child developmental outcomes. The assumption is that a child whose "best interests" are protected stands a better chance of becoming a socially well-adjusted, productive and prosperous citizen.

Recent child development studies have shown that so-called "shared environment, "or home environment factors have little effect on child development so long as the shared environment is minimally adequate. Genetics and …

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 …

Fda Approved? A Critique Of The Artificial Insemination Industry In The United States, Karen M. Ginsberg

University of Michigan Journal of Law Reform

Artificial insemination by donor is becoming an increasingly popular means to achieving parenthood. While the majority of couples use artificial insemination to overcome fertility problems, many recipients use artificial insemination to avoid passing a genetic disease to their children. However, case studies reveal the inherent dangers of artificial insemination, namely the lack of proper screening methods to avoid passing genetic diseases to children born by artificial insemination. State-by-state regulation, federal guidelines, and private adjudication have all proven to be inadequate methods of regulating the artificial insemination industry. Ginsberg proposes federal regulation as the only means of achieving a safe artificial …

Protecting Biodiversity: Recognizing International Intellectual Property Rights In Plant Genetic Resources, Rebecca L. Margulies

Michigan Journal of International Law

Accelerating deforestation in many tropical countries with the concomitant loss of plant species diversity incites increasing international concern. Until very recently, international environmental law tended to regard natural plant species as a "common heritage," a universal resource immune to private property claims. This common heritage approach to the problem of biodiversity loss has left the majority of plant species in a jurisprudential void, unprotected by property rights and subject to conflicting claims by countries with divergent goals. Unrelieved economic pressures force impoverished peoples in species-rich developing nations to resort to activities that ravage the forests, and the tragedy of biodiversity …

Federal Biotechnology Policy: The Perils Of Progress And The Risks Of Uncertainty, Al Gore

University of Michigan Journal of Law Reform

Americans have a schizophrenic view of science and technology. Some of our greatest heroes have been technological pioneers- from the Wright brothers to Lindbergh to Chuck Yeager. Until recently, we expressed unmitigated adoration for the scientists and engineers who put man in space. Yet at the same time, many Americans are generally uneasy about the triumph of technology in their own lives. One does not have to be a Luddite to rail against computers every now and then.

In deciding how to allocate precious public resources in an era of limits, legislators must take public perceptions of science very seriously. …

Sociobiology And The Law: The Biology Of Altruism In The Courtroom Of The Future, Charles F. Weiss

Michigan Law Review

A Review of Sociobiology and the Law: The Biology of Altruism in the Courtroom of the Future by John H. Beckstrom

Cloning And The Constitution: An Inquiry Into Governmental Policymaking And Genetic Experimentation, Barry J. Swanson

Michigan Law Review

A Review of Cloning And the Constitution: An Inquiry Into Governmental Policymaking and Genetic Experimentation by Ira H. Carmen

From Coitus To Commerce: Legal And Social Consequences Of Noncoital Reproduction, Joan Heifetz Hollinger

University of Michigan Journal of Law Reform

This paper argues that there is an urgent need for the creation and clarification of a legal framework within which contemporary efforts to produce or procure children can take place. State legislatures should act now in order to avoid the kind of crisis that confronts Great Britain, where an infant girl, the product of a breached surrogacy contract, has been impounded by a British court. While the court ponders how to determine the legal parentage of this particular child, Parliament considers criminal penalties for those who arrange surrogacy contracts and general regulations to constrain IVF and ET research and practice. …

Governmental Control Of Research In Positive Eugencis, I. Scott Bass

University of Michigan Journal of Law Reform

This article examines the potential societal problems that would accompany the implementation of eugenics programs and considers possible mechanisms for dealing with these problems. Governmental control of research in positive eugenics is identified as a practical means of preempting the undesirable consequences of scientific advances. Since proposed government research controls would infringe upon academic freedom of inquiry, the constitutional issues raised by this clash are framed and analyzed.