Category Archives: Health & Biotechnology

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 … Continue reading

Posted in Health & Biotechnology, Patents & Technology

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 … Continue reading

Posted in Health & Biotechnology, Patents & Technology

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 … Continue reading

Posted in Health & Biotechnology

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 … Continue reading

Posted in Health & Biotechnology

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 … Continue reading

Posted in Health & Biotechnology

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 … Continue reading

Posted in Health & Biotechnology

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. … Continue reading

Posted in Health & Biotechnology

The Future of Generic Biologics: Should the United States “Follow-On” the European Pathway?

By: Ingrid Kaldre The United States is embarking on a biotechnology drug revolution. In the last few decades, biotech drugs have saved millions of lives, and the market for these miracle cures continues to grow at an astronomical rate. Unfortunately, … Continue reading

Posted in Health & Biotechnology

McKithen v. Brown: Due Process and Post-Conviction DNA Testing

By: Elizabeth A. Laughton When the Second Circuit decided McKithen v. Brown, it joined an ever-growing list of courts faced with a difficult and pressing issue of both constitutional and criminal law: is there a federal constitutional right of post-conviction … Continue reading

Posted in Health & Biotechnology

Regulating Nanotechnology: A Private–Public Insurance Solution

By: Maksim Rakhlin Nanotechnology promises to revolutionize innovation in nearly every industry. However, nanomaterials’ novel properties pose potentially significant health and environmental risks. Views in the current debate over nanotechnology regulation range from halting all research and development to allowing … Continue reading

Posted in Health & Biotechnology

Why Technology Provides Compelling Reasons to Apply a Daubert Analysis to the Legal Standard of Care in Medical Malpractice Cases

By: Nichole Hines Traditionally, courts have applied a “customary practice” standard in determining the legal standard of care in medical malpractice cases. Recently, a few courts have abandoned this dated standard and instead applied a Daubert analysis to the standard … Continue reading

Posted in Health & Biotechnology

What, if Any, Are the Ethical Obligations of the U.S. Patent Office? A Closer Look at the Biological Sampling of Indigenous Groups

By: Marina L. Whelan The patenting of biological resources collected from indigenous groups has become a controversial trend. Two U.S. patents in particular, one claiming a cell-line from a 26-year old Guayami woman and one claiming a leukemia virus from … Continue reading

Posted in Health & Biotechnology

Attack of the Clones: Legislative Approaches to Human Cloning in the United States

By: Adrienne N. Cash The legal concerns involving the application of cloning technology to humans should be of utmost concern, as the area is extremely complex. Cloning could potentially have great benefits or disastrous effects. Lawmakers have been careful to … Continue reading

Posted in Health & Biotechnology

When the Public Does Not Have a Right to Know: How the California Public Records Act Is Deterring Bioscience Research and Development

By: Nader Mousavi & Matthew J. Kleiman Many bioscience firms collaborate with public research universities to conduct innovative research through sponsored research agreements. Companies sponsoring this research usually require strict confidentiality from their academic partners in order to protect sensitive … Continue reading

Posted in Health & Biotechnology

Taking Biologics for Granted? Takings, Trade Secrets, and Off-Patent Biological Products

By: Andrew Wasson Biologics are complex medicines which are often genetically engineered, and which are sure to play an important role in curing some of humankind’s worst diseases. Not surprisingly, generic companies want a part of the biologic market. The … Continue reading

Posted in Health & Biotechnology

Disclosure of Clinical Trial Data: Why Exemption 4 of the Freedom of Information Act Should Be Restored

By: Janene Boyce Clinical trial data generated during the FDA drug approval process can be very valuable. While patients and doctors desperately need this information to make informed choices about medical treatment, drug sponsors strive to keep this resource secret … Continue reading

Posted in Health & Biotechnology

Regulating Innovative Medicine: Fitting Square Pegs in Round Holes

By: Mark Lavender Increasingly, innovative medical products are creating a quandary for the Food and Drug Administration (“FDA”) because they often transcend the FDA’s traditional categorical approach to regulating medical products. In a recent attempt to simplify this process, the … Continue reading

Posted in Health & Biotechnology

The Medicare Prescription Drug, Improvement, & Modernization Act of 2003: Are We Playing the Lottery With Healthcare Reform?

By: Melissa Ganz With millions of Americans unable to cope with the rising costs of prescription drugs, and many even forced to go without health insurance, the mounting pressure on Congress to enact major healthcare reform culminated in the Medicare … Continue reading

Posted in Health & Biotechnology

Are Biotech Crops and Conventional Crops Like Products? An Analysis Under GATT

By: Julian Wong The transatlantic debate over the use of genetically modified organisms (“GMO”s) as food products, with the US as a proponent on one side, and the European Union (“EU”) as an opponent on the other, is set to … Continue reading

Posted in Health & Biotechnology

Hatch–Waxman Reform and Accelerated Market Entry of Generic Drugs: Is Faster Necessarily Better?

By: Sarah E. Eurek Recently there has been a considerable amount of pressure to accelerate consumer access to generic drugs, which are significantly less expensive than their brand-name counterparts. One way to bring generic drugs on to the market sooner … Continue reading

Posted in Health & Biotechnology

Reviving Informed Consent: Using Risk Perception in Clinical Trials

By: Dana Ziker The current doctrine of informed consent falls far short of its potential to serve as a valuable safeguard for human research subjects. Instead of providing a channel of communication between physician and subject, informed consent is a … Continue reading

Posted in Health & Biotechnology

The Case for National DNA Identification Cards

By: Ben Quarmby Foes of the United States have demonstrated their ability to strike at the heart of this country. Fear of renewed attacks and a desire for greater national security have now prompted many to call for improvements in … Continue reading

Posted in Health & Biotechnology

Defining a New Ethical Standard for Human in Vitro Embryos in the Context of Stem Cell Research

By: Sina A. Muscati This iBrief discusses some of the social, ethical and legal considerations surrounding the use of unimplanted, in vitro embryos in stem cell research. It proposes that a new ethical standard be elucidated for these embryos. The … Continue reading

Posted in Health & Biotechnology

Regulating Functional Foods: Pre- and Post-Market Strategy

By: Dana Ziker As best we understand the government, its first argument runs along the following lines: that health claims lacking “significant scientific agreement” are inherently misleading because they have such an awesome impact on consumers as to make it … Continue reading

Posted in Health & Biotechnology

Genetic Testing in the Workplace: The Employer’s Coin Toss

By: Samantha French A toss of the coin by the modern-day employer reveals two options regarding genetic testing in the workplace. The employer may choose to take advantage of increasingly precise, available, and affordable genetic testing in order to ascertain … Continue reading

Posted in Health & Biotechnology