Embryos as Patients? Medical Provider Duties in the Age of CRISPR/Cas9

By: G. Edward Powell III The CRISPR/Cas9 genome engineering platform is the first method of gene editing that could potentially be used to treat genetic disorders in human embryos. No past therapies, genetic or otherwise, have been intended or used to treat disorders in existent embryos. Past procedures performed on embryos have exclusively involved creation and implantation (e.g., in-vitro fertilization) or screening and selection of already-healthy embryos (e.g., preimplantation genetic diagnosis). A CRISPR/Cas9 treatment would evade medical malpractice law due to the early stage of the intervention and the fact that it is not a treatment for the mother. In most jurisdictions, medical professionals owe no duty to pre-viable fetuses or embryos as such, but will be held liable for negligent treatment of the mother if the treatment causes injury to a born-alive child. This issue brief discusses the science of CRISPR/Cas9, the background legal status of human embryos, and the case for considering genetically engineered embryos as patients for purposes of medical malpractice law. Download Full Article (PDF) Cite: 15 Duke L. & Tech. Rev. 344

Mitochondrial Replacement Therapy and the Regulation of Reproductive Genetic Technologies in the United States

By: Bob Zhao The ability to alter the genes of future generations no longer belongs in the realm of science fiction. The genetic modification capabilities of modern science are advancing rapidly. Mitochondrial replacement therapy (MRT) represents the first crossing of the germline barrier in humans, and as of February 2015, it is the first procedure of its kind to be legalized in the Western world. How Congress decides to regulate MRT will influence future regulation of all genetic manipulation technologies. This brief argues that the current patchwork regulatory framework established in the United States is insufficient to deal with the complex issues MRT presents. As such, the creation of a new regulatory agency specifically focused on the oversight of reproductive and genetic biotechnologies may be necessary to balance the goals of ensuring the safety of research participants, promoting public debate, and stimulating continued scientific progress. Download Full Article (PDF) Cite: 15 Duke L. & Tech. Rev. 121

Born This Way: How Neuroimaging Will Impact Jury Deliberations

By: Tanneika Minott Advancements in technology have now made it possible for scientists to provide assessments of an individual’s mental state. Through neuroimaging, scientists can create visual images of the brain that depict whether an individual has a mental disorder or other brain defect. The importance of these advancements is particularly evident in the context of criminal law, where defendants are able to dispute their culpability for crimes committed where they lack the capacity to form criminal intent. Thus, in theory, a neuroimage depicting defective brain functioning could demonstrate a defendant’s inability to form the requisite criminal intent. Due to early successes in high-profile cases where advanced neuroimaging was used in this way, many researchers believe that the use of neuroimages to substantiate claims of diminished capacity and insanity is a viable option for criminal defendants. This Issue Brief argues, however, that though the use of neuroimages may have a positive effect on outcomes in theory, in actuality, the use of neuroimages will only have a negligible impact on sentencing outcomes. Download Full Article (PDF) Cite: 12 Duke L. & Tech. Rev. 219

Carbons Into Bytes: Patented Chemical Compound Protection in the Virtual World

By: B. Thomas Watson “Virtual” molecular compounds, created in molecular modeling software, are increasingly useful in the process of rational drug design. When a physical compound is patented, however, virtual use of the compound allows researchers to circumvent the protection granted to the patentee. To acquire protection from unauthorized use of compounds in their virtual form, patentees must directly claim the virtual compound. But Supreme Court decisions such as Bilski v. Kappos and Mayo Collaborative Services v. Prometheus Laboratories, Inc. call into question whether virtual compound claims are patentable subject matter under § 101. Using the guidance offered by the Supreme Court and Federal Circuit, this Issue Brief argues that virtual compound claims are not abstract ideas and therefore, consistent with patent policy, qualify as patentable subject matter. Download Full Article (PDF) Cite: 12 Duke L. & Tech. Rev. 25

After Prometheus, Are Human Genes Patentable Subject Matter?

By: Douglas L. Rogers On April 15, 2013, the U.S. Supreme Court heard oral arguments in Association for Molecular Pathology v. Myriad Genetics, Inc. on the question, “Are human genes patentable?” This article argues that human genes are not patentable and that isolating a gene from its surroundings in a human body—or creating synthetically what exists in nature as DNA—does not cause the DNA to become patentable subject matter. The isolated DNA segments of claim 1 have the identical nucleotide sequence and the same function as native DNA, and the isolated DNA of claim 1 do not reflect the marked changes required under Chakrabarty, or the inventive step required under Prometheus, to change an unpatentable product of nature into patentable subject matter. Claim 2 describes those nucleotides in the DNA sequence that code for the polypeptide identified in the Myriad Genetics patent specification and simply reflects the genetic code, an unpatentable law of nature. Since no inventive step has been added to the law of nature, claim 2 constitutes unpatentable subject matter under Prometheus. The Federal Circuit’s contrary decision in Myriad Genetics disregards 150 years of Supreme Court cases that physical phenomena found in nature and laws of nature are

Lack of Transparency in the Premarket Approval Process for Aquadvantage Salmon

By: Michael P. McEvilly After a lengthy premarket approval process, the Food and Drug Administration (FDA) is soon likely to deem AquAdvantage Salmon, a fast-growing, genetically engineered salmon, safe for human consumption. If approved, AquAdvantage Salmon will be the first genetically engineered animal designed for human consumption to go to market in the United States. Because there have been no significant changes to the statutory or regulatory framework governing agricultural biotechnology since it was established in the 1980s, the FDA reviews applications of genetically engineered animals under the New Animal Drug Application (NADA) provisions of the Federal Food, Drug, and Cosmetic Act (FDCA). The FDA’s treatment of genetically engineered food as a new animal drug has been criticized due to potential environmental and human health risks, and because of a lack of transparency throughout the regulatory process. After providing an overview of the premarket approval process, this Issue Brief argues that even under the NADA provisions, the FDA’s premarket approval risk assessment should be more transparent. In particular, the justification for trade secret status of relevant biotechnology is undermined, if not extinguished, by the need for public consideration of the biotechnology’s safety and effectiveness after a certain time in the

The Promise of Priority Review Vouchers as a Legislative Tool to Encourage Drugs for Neglected Diseases

By: Lesley Hamming Despite the intellectual property system’s success in promoting the economic well-being of the United States, this system has not achieved all socially valuable ends. Insufficient treatments are applied both to diseases endemic in developing countries, such as malaria, and rare diseases, such as rare childhood cancers. This Issue Brief reviews the existing legislative tools for promoting socially valuable drugs and biologics through market incentives. The priority review voucher (PRV) program is the latest and most unique of these legislative tools aimed at encouraging the development of drugs for neglected diseases without burdening taxpayers. The Creating Hope Act—recently signed into law as part of the Food & Drug Administration Safety & Innovation Act—extends the PRV program to rare pediatric diseases. This Issue Brief argues that some provisions in this new legislation may result in undesirable collateral effects that could prevent the legislation from fulfilling its objective of encouraging investment in treatments for rare pediatric diseases. Download Full Article (PDF) Cite: 11 Duke L. & Tech. Rev. 390

Programmers and Forensic Analyses: Accusers Under the Confrontation Clause

By: Karen Neville Recent Supreme Court cases involving the Confrontation Clause have strengthened defendants’ right to face their accusers. Bullcoming v. New Mexico explored the question of whether the testimony of the technician who performs a forensic analysis may be substituted by that of another analyst, and the Court held that producing a surrogate witness who was not sufficiently involved in the analysis violates the confrontation right. The presumption of infallible technology is fading, and courts may soon realize programmers have greater influence over the ultimate outcome of forensic tests than do the technicians who rely on such analytical tools. The confrontation right, so bolstered by recent cases, may encompass defendants’ right to demand testimony from the programmers of machines performing forensic analyses. The Bullcoming decision is certain to affect whether the right to confront the programmer will be recognized. Download Full Article (PDF) Cite: 2011 Duke L. & Tech. Rev. 010

Sherley v. Sebelius: Stem Cells and the Uneasy Interplay Between the Federal Bench and the Lab Bench

By: Ryan P. O’Quinn After Barack Obama’s election to the presidency, he promised that one of his top priorities in office would be to relieve the restrictions initiated by President George W. Bush on federal funding of embryonic stem cell research. President Obama followed through on his promise, but the celebrations in the nation’s research labs were short-lived. Anti-abortion advocates and other scientists working in the field that would allegedly be out-competed in the federal funding arena brought a legal challenge to the new government position. The struggle culminated in August 2010 with a federal district court issuing a preliminary injunction to halt the new funding initiative. Although the government successfully appealed for a stay on the injunction pending arguments in the Court of Appeals, the decision has paralyzed research in the field. This iBrief argues that the injunction was wrongly granted, predicts how higher courts might treat the case, and suggests that the proper forum for addressing this controversy lies within the scientific community, not the judiciary. Download Full Article (PDF) Cite: 2011 Duke L. & Tech. Rev. 002

Juvenile Justice, Sullivan, and Graham: How the Supreme Court’s Decision Will Change the Neuroscience Debate

By: Johanna Cooper Jennings Over the past twenty years, neuroscientists have discovered that brain maturation continues through an individual’s mid-twenties. The United States Supreme Court cited this research to support its abolition of the juvenile death penalty in Roper v. Simmons. Now the Court is faced with two cases that challenge the constitutionality of sentencing juveniles to life imprisonment without parole. Many believe these studies indicate that juveniles are both less culpable for their actions and more likely to reform; therefore, life in prison for juveniles is disproportionate, cruel, and unusual. However, others caution against the use of these studies in deciding issues of juvenile justice. This iBrief summarizes the cases currently before the Court, presents the arguments for and against the use of neuroscience in the juvenile justice debate, and analyzes the impact these cases will have on the future of neuroscience’s role in juvenile justice. Download Full Article (PDF) Cite: 2010 Duke L. & Tech. Rev. 006