Medical Jurisprudence Commons^™

Are Engineered Genetic Sequences Copyrightable?: The U.S. Copyright Office Addresses A Matter Of First Impression, Christopher M. Holman, Claes Gustafsson, Andrew W. Torrance

Faculty Works

In spite of the compelling logic that would support extending copyright to engineered DNA sequences, copyright protection for genetic code has not been legally recognized in the US, or as far as we know anywhere. The Copyright Act is silent on the point, the courts do not appear to have ever addressed the question, and the Copyright Office has taken the position that an engineered genetic sequence is not copyrightable subject matter. In an attempt to advance the conversation, we submitted an engineered DNA sequence to the Copyright Office for registration, and then appealed the Office’s decision refusing to register …

The Buying And Selling Of Human Organs From The Living: Why Not?, Timothy M. Hartman

Akron Law Review

This article will examine the propriety of establishing a system for the sale of human organs, especially the kidney. Initially, the debilitating malady of end stage renal disease will be discussed as will the marginal "cure" of the disease via hemodialysis. Next, the superior alternative to dialysis, i.e., kidney transplantation will be discussed in two ways. First, the current procedure of using living, related donors will be examined as well as harvesting kidneys from cadaver "donors". Second, the practice of transplantation will be explored for its ramifications to society and the participants in the following areas: medicine, psychology, and the …

3-D Bioprinting: Not Allowed Or Nota Allowed?, Robert Jacobson

Chicago-Kent Law Review

In 1984, Congress passed the National Organ Transplantation Act (NOTA) to improve the supply of vital human organs. A key provision of NOTA was the prohibition of acquiring, receiving, or otherwise transferring human organs. In effect, this provision bans the purchase of human organs. However, due to recent breakthroughs in 3-D bioprinting technology, scientists are on the verge of being able to create lab-grown organs suitable for transplantation. This Note will examine the applicability of NOTA to 3-D bioprinting technology and recommend amendments to NOTA that would clarify the legality of 3-D bioprinting.

The Scramble To Promote Egg Donation Through A More Protective Regulatory Regime, Jacob Radecki

Chicago-Kent Law Review

Egg “donation” is a burgeoning industry in the United States. Fertility clinics capitalize on financially needy college students by advertising substantial financial benefits; particularly gifted women may receive thousands of dollars for selling their eggs. Rosy advertisements portray a well-paying procedure that also helps bring a child to a loving parent. Yet these descriptions mask significant potential harms. With respect to known problems, hormone regimens may cause ovarian hyper-stimulation syndrome, which in the most severe cases can lead to infertility. In terms of unknown risks, anecdotal evidence suggests that the long-term side effects of egg extraction may include cancer. The …

The Role Of Agency: Compensated Surrogacy And The Institutionalization Of Assisted Reproduction Practices, Jody L. Madeira, June Cabone

Articles by Maurer Faculty

The surrogacy debate often conflates what should be seen as three distinct issues: the permissibility of the practice under any circumstances, the role of for-profit intermediaries in arranging surrogacy, and the role of compensation in influencing decision-making.

For those who see surrogacy as intrinsically objectionable, nothing short of a total ban will suffice. For those who object to the commodification of reproduction or to the role of for-profit agencies in recruiting surrogates, however, the solutions lie in regulation rather than prohibition. Commercial agencies, unlike infertile couples who enter into arrangements with their friends and relatives, are repeat players. They are …

The Art Of Informed Consent: Assessing Patient Perceptions, Behaviors, And Lived Experience Of Ivf And Embryo Disposition Informed Consent Processes, Jody L. Madeira

Articles by Maurer Faculty

No abstract provided.

Stem Cell Patents After The America Invents Act, Jacob S. Sherkow, Christopher Scott

Articles & Chapters

Under the newly passed Leahy-Smith America Invents Act (AIA), the U.S. Patent and Trademark Office may hear new challenges to stem cell patents. Here, we explore how the new law affects challenges to stem cell patents, focusing on two recent cases, and discuss the future of stem cell patent disputes.

Gene Patents In The Wake Of Association For Molecular Pathology V. Myriad Genetics, Inc.: An International Perspective On Pharmacogenomics, Stephanie S. Lim

Cardozo Journal of International and Comparative Law

Now that the Supreme Court of the United States has held that isolated DNA fragments are not patentable subject matter under 35 U.S.C. §101 in Association for Molecular Pathology v. Myriad Genetics, Inc., thousands of existing isolated gene patents can be invalidated. In the European Union, by contrast, patent protection for human genetic sequences has always been strong and the BRCA gene patents at issue in Myriad are still valid in the European Union. It remains to be seen how the differential gene patent protection regimes in these developed nations will affect the biotechnology industry.

This Note poses that question …

Generic Entry Jujitsu: Innovation And Quality In Drug Manufacturing, W. Nicholson Price Ii

IP Theory

The manufacturing side of the pharmaceutical industry has been neglected in innovation theory and policy, with the unfortunate result of stagnant manufacturing techniques driving major problems for the healthcare system. This innovation failure has roots in ineffective intellectual property incentives and high regulatory hurdles to innovative change. Changes in pure regulation or intellectual property incentives have significant potential to help the innovation deficit, but are not the only possibility for change. A relatively minor regulatory change could harness the powerful dynamics of pioneer/generic competition surrounding generic drug market entry. If pioneer firms were permitted to make label claims committing to …

Throwing Dirt On Doctor Frankenstein’S Grave: Access To Experimental Treatments At The End Of Life, Michael J. Malinowski

Journal Articles

All U.S. federal research funding triggers regulations to protect human subjects known as the Common Rule, a collaborative government effort that spans seventeen federal agencies. The Department of Health and Human Services has been in the process of re-evaluating the Common Rule comprehensively after decades of application and in response to the jolting advancement of biopharmaceutical science. The Common Rule designates specific groups as “vulnerable populations”—pregnant women, fetuses, children, prisoners, and those with serious mental comprehension challenges—and imposes heightened protections of them. This article addresses a question at the cornerstone of regulations to protect human subjects as biopharmaceutical research and …

Uncle Sam Knows What’S In Your Medicine Cabinet: The Security And Privacy Protection Of Health Records Under The Hitech Act, 30 J. Marshall J. Info. Tech. & Privacy L. 667 (2014), Ranjit Janardhanan

UIC John Marshall Journal of Information Technology & Privacy Law

No abstract provided.

Pinwheel Of Fortune, 13 J. Marshall Rev. Intell. Prop. L. 761 (2014), James Ming Chen

UIC Review of Intellectual Property Law

This paper examines public health law in the context of prospect theory, the leading behavioral account of risk aversion and risk-seeking. The paper first demonstrates how international environmental law can be mapped along prospect theory’s risk-seeking axis. It then completes this picture of prospect theory by examining National Federation of Independent Business v. Sebelius, which upheld the constitutionality of the Patient Protection and Affordable Care Act (“PPACA”). Although Sebelius upheld the PPACA as an exercise of the federal government’s taxing authority, it reasoned that a directive aimed at uninsured individuals to buy health insurance lay beyond the power of Congress …

A Scientific Approach To Intellectual Property And Health: Innovation, Access, And A Forgotten Corner Of The Universal Declaration Of Human Rights, 13 J. Marshall Rev. Intell. Prop. L. 794 (2014), Adam Houston

UIC Review of Intellectual Property Law

For years, there has been vigorous debate over the relationship between intellectual property and health, especially in the context of pharmaceutical patents. Despite numerous attempts to strike a balance between innovation and access, however, few have looked to Article 27 of the Universal Declaration of Human Rights for guidance. Article 27, and its further elaboration and codification under Article 15 of the International Covenant on Economic, Social, and Cultural Rights, explicitly address this balance by pairing the right of everyone “to share in scientific advancement and its benefits” with a similarly universal right of authors to “material interests resulting” from …

Toward A Jurisprudence Of Drug Regulation, Matthew Herder

Articles, Book Chapters, & Popular Press

Efforts to foster transparency in biopharmaceutical regulation are well underway: drug manufacturers are, for example, legally required to register clinical trials and share research results in the United States and Europe. Recently, the policy conversation has shifted toward the disclosure of clinical trial data, not just trial designs and basic results. Here, I argue that clinical trial registration and disclosure of clinical trial data are necessary but insufficient. There is also a need to ensure that regulatory decisions that flow from clinical trials — whether positive (i.e. product approvals) or negative (i.e. abandoned products, product refusals, and withdrawals) — are …

Antimony: The Use, Rights, And Regulation Of Laboratory Animals , Brenda L. Thomas

Pepperdine Law Review

No abstract provided.

Does The Constitution Protect Abortions Based On Fetal Anomaly?: Examining The Potential For Disability-Selective Abortion Bans In The Age Of Prenatal Whole Genome Sequencing, Greer Donley

Michigan Journal of Gender & Law

This Note examines whether the state or federal government has the power to enact a law that prevents women from obtaining abortions based on their fetus’s genetic abnormality. Such a ban has already been enacted in North Dakota and introduced in Indiana and Missouri. I argue below that this law presents a novel state intrusion on a woman’s right to obtain a pre-viability abortion. Moreover, these pieces of legislation contain an outdated understanding of prenatal genetic testing—-the landscape of which is quickly evolving as a result of a new technology: prenatal whole genome sequencing. This Note argues that the incorporation …

Federal Trade Commission V. Actavis, Inc. And Reverse-Payment Or Pay-For-Delay Settlements, Jacob S. Sherkow

Articles & Chapters

An imminent US Supreme Court ruling should resolve one of the thorniest legal issues facing pharmaceutical companies today.

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

Pepperdine Law Review

No abstract provided.

Medical Evidence In Cases Of Intrauterine Drug And Alcohol Exposure , Judith Larsen, Robert M. Horowitz, Ira J. Chasnoff

Pepperdine Law Review

No abstract provided.

Vaccines And The Law, Michael Sanzo Ph.D.

Pepperdine Law Review

The last twenty years have seen a sea-change in the area of proving causation in the toxic tort setting, with courts demanding stronger, scientifically tested evidence. At the same time, a closely related debate has been raging about separating cause from coincidence under the National Childhood Vaccine Injury Act compensation program for injuries that might have been the result of vaccinations. The Vaccine Act created a no-fault compensation fund financed by a tax on childhood vaccines to address harms resulting from those vaccines. Unfortunately, Congress gave little direction with regard to the level of causal certainty that would be required …

Science On Law's Terms: Implications Of Procedural Legitimacy On Scientific Evidence, Nayha Acharya

LLM Theses

Scientific evidence is relied on more and more in litigation. Discussions and debates aimed at enabling courts to make the best use scientific evidence are increasingly critical. This thesis adds the perspective of procedural legitimacy to the science and law discussion. Procedural Legitimacy is the concept that consistent adherence to legal procedure maintains the overall legitimacy of the legal system, and the validity of its outcomes. I argue that the integrity of legal procedures must be maintained where scientific evidence is presented, so that judicial decisions that rely on scientific evidence are legitimate.

Adultery By Doctor: Artificial Insemination, 1890–1945, Kara W. Swanson

Chicago-Kent Law Review

In 1945, American judges decided the first court cases involving assisted conception. The challenges posed by assisted reproductive technologies to law and society made national news then, and have continued to do so into the twenty-first century. This article considers the first technique of assisted conception, artificial insemination, from the late nineteenth century to 1945, the period in which doctors and their patients worked to transform it from a curiosity into an accepted medical technique, a transformation that also changed a largely clandestine medical practice into one of the most pressing medicolegal problems of the mid-twentieth century. Doctors and lawyers …

It’S My Body: The Biomedical Ethics Of Cell And Organ Harvest, Christina Perri

Common Reading Essay Contest Winners

First Place

Updating The Patent System's Novelty Requirement To Promote Small-Molecule Medicinal Progress, 45 J. Marshall L. Rev. 1151 (2012), Jason Brewer

UIC Law Review

No abstract provided.

The Meningitis Outbreak: Don't Expect Miracles From The Fda, Joanne Doroshow

Other Publications

The good news for states is drug industry immunity only kicks in if the drugs in question are FDA-approved. And thanks to the first-rate influence-peddling and lobbying prowess of compounding pharmacists, the tainted steroid shots at issue today are free and clear of FDA regulation.

"Introduction" (Chapter 1) Of Stories About Science In Law: Literary And Historical Images Of Acquired Expertise (Ashgate 2011), David S. Caudill

Working Paper Series

This is the introductory chapter of Stories About Science in Law: Literary and Historical Images of Acquired Expertise (Ashgate, 2011), explaining that the book presents examples of how literary accounts can provide a supplement to our understanding of science in law. Challenging the view that law and science are completely different, I focus on stories that explore the relationship between law and science, and identify cultural images of science that prevail in legal contexts. In contrast to other studies on the transfer and construction of expertise in legal settings, the book considers the intersection of three interdisciplinary projects-- law and …

The Impact Of The Biosimilars Provision Of The Health Care Reform Bill On Innovation Investments, 10 J. Marshall Rev. Intell. Prop. L. 553 (2011), Katherine N. Addison

UIC Review of Intellectual Property Law

The Biologics Price Competition and Innovation Act of 2009 provides an abbreviated FDA approval pathway for biosimilars. The passage of this biosimilar legislation is a positive step toward retaining a robust biotechnology industry in the United States while also protecting innovators. The Act’s increased FDA exclusivity is welcome, but FDA exclusivity alone is insufficient to encourage and protect innovation and investment in biosimilars. Instead, the exclusivity provided by a patent term, together with the ability to adjust this term to compensate an applicant for U.S. Patent and Trademark Office and FDA delays, is necessary to ensure development of highly specialized …

Paying Women For Their Eggs For Use In Stem Cell Research, Pamela Foohey

Scholarly Works

On June 11, 2009, the Empire State Stem Cell Board (“Board”), which administers the $600 million in New York State funds allotted to stem cell research, voted to allocate a portion of those funds to compensate women up to $10,000 for “donating” their eggs for use in stem cell research. The Board's decision makes New York the first state to affirmatively allow state funds to be used to compensate women for providing their eggs for use in stem cell research beyond mere reimbursement of associated medical and other expenses, and, similarly, distinguishes it from most international countries, which either prohibit …

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. …

A Defense Of Embryonic Stem Cell Research, Gregory Dolin, M.D.

Indiana Law Journal

No abstract provided.