Law Commons^™

The Rutabaga That Ate Pittsburgh: Federal Regulation Of Free Release Biotechnology, Michael P. Vandenbergh

Michael Vandenbergh

When the Environmental Protection Agency (EPA) first approved a field test of a bioengineered microbe,' one EPA official remarked: "We're not expecting this to be the rutabaga that eats Pittsburgh.' 2 But regulators cannot afford to be wrong. Bioengineered microbes may serve many useful purposes, but they may also cause harm to the environment and to human health.3 Although the risks of an accident stemming from the deliberate release of bioengineered microbes into the environment may be low, the resulting damage could be substantial. This note examines the possible consequences of two recent trends in biotechnology-the development of bioengineered microbes …

Halted Innovation: The Expansion Of Federal Jurisdiction Over Medicine And The Human Body, Myrisha S. Lewis

Faculty Publications

Modern medical innovations are blurring the line between medical practice and medical devices and drugs. Historically, many techniques have been developed in medicine, without any interference from the federal government, as medical practice is (and has historically been) an area of state jurisdiction. Over the past two decades, however, the U.S. Food and Drug Administration (FDA) has been exerting jurisdiction over the human body and the practice of medicine by targeting new medical techniques for oversight and subjecting the continued use of those treatments to onerous and legally questionable regulatory requirements that hinder the use of those treatments in practice. …

A Prescription For Biopharmaceutical Patents: A Cure For Inter Partes Review Ailments, Alex A. Jurisch

Seattle University Law Review

The patent system in the United States was forever changed with the introduction of the Leahy-Smith America Invents Act (AIA) in September of 2011. The AIA brought sweeping changes to American patent law in order to align the U.S. with much of the rest of the world by changing the invention priority from a “first to invent” to a “first to file” system. The first section of this note will provide a brief overview of the substance of inter partes reviews and some of the most critical negatives that have become apparent since 2013. The second section of this Note …

Emerging Governance Of Mitochondrial Replacement Therapy: Assessing Coherence Between Scientific Evidence And Policy Outcomes, Katherine Drabiak

DePaul Journal of Health Care Law

In the fall of 2016, media headlines reported news of several births of children born through “three parent IVF” or mitochondrial replacement therapy (MRT). MRT refers to an experimental procedure that entails removing the nuclear DNA from the mother’s egg or fertilized zygote and transferring it to a donor’s egg or fertilized zygote. This procedure constitutes a modification of the human germline, which has been prohibited by numerous declarations, directives, and laws promulgated by the United Nations, the Council of Europe, and other nations. In 2016, the Human Fertilisation and Embryology Authority in the United Kingdom was the first nation …

State Biotechnology Oversight: The Juncture Of Technology, Law, And Public Policy, Christine C. Vito Ph.D.

Maine Law Review

In a 1980 landmark decision, the Supreme Court of the United States ruled that genetically engineered lifeforms such as bacteria were patentable. The significance of this decision to the emerging biotechnology industry—an industry predicated on intellectual property rights—was incalculable. The characteristically research-intensive, capital-intensive biotechnology industry now had the economic incentive to push the technology of genetic engineering to previously unimagined extremes. The genetic engineering and recombinant DNA applications pursued by the biotechnology industry over the past ten years have engendered a spectrum of perplexing inquiries concerning ethical and moral values; agricultural, ecological and environmental matters; global competitiveness and economic priorities; …

Intellectual Property, Surrogate Licensing, And Precision Medicine, Jacob S. Sherkow, Jorge L. Contreras

IP Theory

The fruits of the biotechnology revolution are beginning to be harvested. Recent regulatory approvals of a variety of advanced therapies—Keytruda (pembrolizumab), Kymriah (tisagenlecleucel), and patisiran—have ushered in an age of “precision medicine” treatments that target patients’ specific genetic, physiological, and environmental profiles rather than generalized diagnoses of disease. Therapies like these may soon be supplemented by gene editing technologies such as CRISPR, which could enable the targeted eradication of deleterious genetic variants to improve human health. But the intellectual property (IP) surrounding precision therapies and their foundational technology remain controversial. Precision therapies ultimately rely—and are roughly congruent with—basic scientific information …

Vanda V. West-Ward Pharmaceuticals: Good News For The Patent Eligibility Of Diagnostics And Personalized Medicine, With Some Important Caveats, Christopher M. Holman

Faculty Works

In Mayo v. Prometheus, decided in 2011, the U.S. Supreme Court invalidated patent claims directed towards diagnostic methods useful in the optimization of drug dosage for the needs of an individual patient, i.e., an example of personalized medicine, based on the Court’s determination that the claims were directed towards a patent ineligible law of nature. Notably, the claims in Mayo did not recite a step of applying the information generated by the test, e.g., a step of administering the drug to a patient at the optimized dosage. Some, including this author, have speculated that inclusion of such a step might …

The Uneasy Case For Patent Law, Rachel E. Sachs

Michigan Law Review

A central tenet of patent law scholarship holds that if any scientific field truly needs patents to stimulate progress, it is pharmaceuticals. Patents are thought to be critical in encouraging pharmaceutical companies to develop and commercialize new therapies, due to the high costs of researching diseases, developing treatments, and bringing drugs through the complex, expensive approval process. Scholars and policymakers often point to patent law’s apparent success in the pharmaceutical industry to justify broader calls for more expansive patent rights.

This Article challenges this conventional wisdom about the centrality of patents to drug development by presenting a case study of …

Congress Considering Legislation Intended To Reverse The Recent Trend Toward Devaluation Of The Us Patent Right, Christopher M. Holman

Faculty Works

Decisions of the United States Supreme Court spanning the last quarter of a century that have, in the aggregate, substantially devalued the patent right. The Court’s four decisions reinvigorating and substantially raising the patent eligibility bar have probably resulted in the most critical commentary, but a host of other decisions have also served to erode the patent right in multiple dimensions, including the scope of potentially patent-able subject matter as well as the strength and enforce-ability of issued patents. In 2011 Congress joined in when it enacted the America Invents Act (AIA), which includes multiple provisions tending to devalue patents, …

Praxair V. Mallinckrodt: An Expanded Interpretation Of The Printed Matter Doctrine With Important Implications For Biotechnology, Christopher M. Holman

Faculty Works

Although the “printed matter doctrine” has a long history in U.S. patent law, until recently it has played a relatively minor role in policing patent-ability, so much so that an article published in 1994 essentially wrote it off as nothing more than an “archaic common law has-been.” Although the doctrine is rooted in the concept of patent eligibility, it is never mentioned in recent patent eligibility decisions of the U.S. Supreme Court such as Mayo and Alice, and patent law treatises and casebooks tend to give the doctrine little if any coverage. At its core, the printed matter doctrine has …