Law Commons^™

Pathogen Genomes As Global Public Goods (And Why They Should Not Be Patented), Jorge L. Contreras

Utah Law Faculty Scholarship

During past viral outbreaks, researchers rushed to patent genomic sequences of the viruses as they were discovered, leading to disputes and delays in research coordination. Yet similar disputes did not occur with respect to the genomic sequence of SARS-CoV-2, the virus responsible for COVID-19. With respect to COVID-19, global research collaboration occurred rapidly, leading to the identification of new variants, the ability to track the spread of the disease, and the development of vaccines and therapeutics in record time. The lack of patenting of SARSCoV-2 is likely due the U.S. Supreme Court’s 2013 ruling in Association for Molecular Pathology v. …

Direct-To-Consumer Genetic Testing: Maintenance Of Individual Privacy, Jessica L. Missel

Health Law Outlook

No abstract provided.

The Global Person: Pig-Human Embryos, Personhood, And Precision Medicine, Yvonne Cripps

Indiana Journal of Global Legal Studies

Chimeras, in the form of pig-human embryos engineered by CRISPR-Cas9 and other biotechnologies, have been created as potential sources of organs for transplantation. Against that background, and in an era of "precision medicine," this Article examines the concept of the global genetically modified person and asks whether humanness and personhood are being eroded, or finding new boundaries in intellectual property and constitutional law.

Weird Science: Frankenstein Foods And States As Laboratories Of Democracy, Jennifer Mcgee

Journal of Law and Health

The National Bioengineered Food Disclosure Standard (the 'National Standard') was signed into law July 29, 2016. This Article analyzes the National Standard and posits that Vermont’s Act 120 was a more effective labeling law because it safeguarded consumer sovereignty. The State regulatory scheme in place prior to the passage of the National Standard satisfied consumer demand for disclosure while allowing for necessary experimentation with GMO labeling. Part I provides an overview of the current federal scheme regulating GMOs. Part II analyzes of the conflict surrounding GMOs and labeling. Given that analysis, Part III compares the disclosure requirement of the National …

Regulating Human Germline Modification In Light Of Crispr, Sarah Ashley Barnett

University of Richmond Law Review

No abstract provided.

Impeding Access To Quality Patient Care And Patient Rights: How Myriad Genetics' Gene Patents Are Unknowingly Killing Cancer Patients And How To Calm The Ripple Effect, Marisa Noelle Pins

Journal of Intellectual Property Law

No abstract provided.

Can Dna Be Speech?, Jorge R. Roig

Jorge R Roig

Dna Storage Banks: The Importance Of Preserving Dna Evidence To Allow For Transparency And The Preservation Of Justice, Cristina Martin

Chicago-Kent Law Review

What is the duty to preserve information in today’s society? In order for humanity to evolve, change and flourish in the future, society needs to preserve its information from the past. In the criminal justice field, preservation of evidence has special significance. DNA evidence in particular has become a helpful aid for innocent defendants who have been improperly imprisoned. Over the past twenty years, the number of exonerations of imprisoned criminal defendants has increased dramatically. With the advancement of technology, old, previously untestable or improperly tested DNA evidence will need to be retested. However, most states do not have proper …

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. …

Genomics Unbound: The Scientific And Legal Case Against Patents Based On Naturally Occurring Dna Sequences, Fazal Khan

Scholarly Works

While there have been mixed opinions as to whether gene patents were dead in light of Prometheus,this Article argues that a proper understanding of patent law, genomics, and public policy concerns should lead to no other result. The primary focus of this piece is to rebut certain vested interests in the biotechnology industry and affirm the normative claim that gene patents improperly fetter genomics research and development. First, through the lens of the Myriad case, we will recount why there was such a strong public interest movement against recognizing such patents. Specifically, we will show how patents on naturally occurring …

Genomics Unbound: The Scientific And Legal Case Against Patents Based On Naturally Occurring Dna Sequences, Fazal Khan, Lindsay Kessler

Nevada Law Journal

No abstract provided.

The Illusion Of Interchangeability: The Benefits And Dangers Of Guidance-Plus Rulemaking In The Fda's Biosimilar Approval Process, Jonathan Stroud

Jonathan R. K. Stroud

On March 23, 2010, President Obama signed into law the ambitious Patient Protection and Affordable Care Act. While media attention focused largely on the sweeping changes the bill makes to the nation’s healthcare system, there was also a less-noticed rider to the bill, the Biologics Price Competition and Innovation Act of 2009 (Biosimilars Act). The Biosimilars Act grants the Food and Drug Administration (FDA) broad new authority to create an accelerated premarket approval pathway for generic competition to biologics in an attempt to drive biologic drug prices down and reduce the overall costs of health care. Traditionally, inventors of medical …

Beyond Abortion: Human Genetics And The New Eugenics, John R. Harding Jr.

Pepperdine Law Review

No abstract provided.

Genes 101: Are Human Genes Patentable Subject Matter?, Andrew Bowman

Richmond Journal of Law & Technology

Genes are the fundamental building blocks of all living things. They dictate hair color, eye color, even susceptibility to cancer. As such, genes inherently possess untold power. The ability of a sole company to wield this omnipotence makes a human gene patent highly sought after.

Consent To The Use Of Stored Dna For Genetics Research: A Survey Of Attitudes In The Jewish Population, Marc D. Schwartz, Karen H. Rothenberg, Linda Joseph, Judith Benkendorf, Caryn Lerman

Karen H. Rothenberg

No abstract provided.

Protecting Workers From Genetic Discrimination, Karen H. Rothenberg

Karen H. Rothenberg

No abstract provided.

The Potential For Discrimination In Health Insurance Based On Predictive Genetic Tests, Karen H. Rothenberg

Karen H. Rothenberg

No abstract provided.

Advances In Genetic Research And Technologies: Challenges For Public Policy, Karen H. Rothenberg

Karen H. Rothenberg

No abstract provided.

A Defense Of Embryonic Stem Cell Research, Gregory Dolin

All Faculty Scholarship

On November 21, 2007, sensational scientific developments were reported by major newspapers, both in the United States and abroad. The media reported a new breakthrough in the area of stem cell research. According to two articles published in Science and Cell (both highly respected scientific journals), two teams of scientists were able to “reprogram” adult stem cells into embryonic stem cells, without actually having to experiment on embryos. The discovery was immediately hailed by the White House and other opponents of embryonic stem cell research. The New York Times gushed that the “stem cell wars” may be at an end. …

Invisible Actors: Genetic Testing And Genetic Discrimination In The Workplace, Susannah Carr

University of Arkansas at Little Rock Law Review

Current federal and state law is inadequate to protect employees from employer's misuse of their genetic information. Genetic information is knowledge of a person's genome that indicates a predisposition towards an illness, disease, or medical condition, where symptoms of the condition have yet to manifest themselves. Federal law protections are insufficient, and relevant state laws vary in their scope and application. Not only are employees unevenly protected across the United States, but varying standards also make complying with the law difficult for interstate employees.

To give employees sufficient protection and to facilitate employer compliance, Congress should pass a law specifically …

Protecting Workers From Genetic Discrimination, Karen H. Rothenberg

Congressional Testimony

No abstract provided.

Patients And Biobanks, Ellen Wright Clayton

Vanderbilt Law School Faculty Publications

The question about the privacy of medical information can be stated simply: To what extent can and should patients control what the medical record contains and who has access to it and for what purposes? Patients often have apparently conflicting views on this subject. On the one hand, we, as patients, say that we prize privacy and that we fear that information will be used to harm us. On the other hand, we value the benefits that come from improved communication among providers, such as having our visits covered by third party payers and advances in medical science, which often …

Toward A More Communitarian Future? Fukuyama As The Fundamentalist Secular Humanist, June Carbone

Michigan Law Review

With The End of History and the Last Man, Francis Fukuyama established himself as the prophet of liberal democracy and free markets, heralding their triumph as the only form of governance capable of commanding legitimacy. Asked to reflect on his predictions a decade later, Fukuyama concluded that the greatest threat to liberalism comes from biotechnology because it alone has the potential to remake the human nature that liberal democracy was designed to serve. Fukuyama makes a compelling case that biotechnology may produce developments that should concern us; he is ironically less persuasive in articulating a liberal-democratic framework for governing the …

Comment: Dna As Property: Implications On The Constitutionality Of Dna Dragnets, Jonathan Will

Journal Articles

This comment will argue that when the state seeks to deprive a person of his or her DNA, greater constitutional protections than are currently afforded dragnets must be provided. Part I will discuss the unique properties of DNA, the information contained therein and why it should be constitutionally protected. Part II will briefly trace the history of DNA dragnets, including the practical and procedural uses in worldwide criminal investigations. Part III will explore current law and commentary regarding Fourth Amendment privacy interests in one’s DNA. Part IV will argue that DNA constitutes personal property, and finally, Part V will show …

Consent To The Use Of Stored Dna For Genetics Research: A Survey Of Attitudes In The Jewish Population, Marc D. Schwartz, Karen H. Rothenberg, Linda Joseph, Judith Benkendorf, Caryn Lerman

Faculty Scholarship

No abstract provided.

The Potential For Discrimination In Health Insurance Based On Predictive Genetic Tests, Karen H. Rothenberg

Congressional Testimony

No abstract provided.

Rules For Research On Human Genetic Variation: Lessons From Iceland, George J. Annas

Faculty Scholarship

Research on genetic variation aims to understand how genes function and requires the comparison of DNA samples from groups of individuals to identify variations that might have importance for health or disease. This work is easier if the samples are linked to accurate medical records and genealogic information. Iceland has medical records for all its citizens going back to World War I and detailed genealogic information going back even further. Because Iceland's small population (270,000) has long been isolated and homogeneous, it is thought by many to be an ideal place to search for disease-related genes. Journalists have cavalierly labeled …

Boling V. Romer: Federal Courts Condone Forced Withdrawal Of Blood For Dna Data Banks Despite Constitutional Concerns, C. Teddy Li

Journal of Health Care Law and Policy

No abstract provided.

Advances In Genetic Research And Technologies: Challenges For Public Policy, Karen H. Rothenberg

Congressional Testimony

No abstract provided.