Law Commons^™

Mitochondrial Replacement Therapy: Let The Science Decide, Sabrina K. Glavota

Michigan Technology Law Review

Mitochondrial replacement therapy (MRT) is an in vitro fertilization technique designed to prevent women who are carriers of mitochondrial diseases from passing on these heritable genetic diseases to their children. It is an innovative assisted reproductive technology that is only legal in a small number of countries. The United States has essentially stagnated all opportunities for research and clinical trials on MRT through a rider in H.R.2029 – Consolidated Appropriations Act, 2016. The rider bans clinical trials on all therapies in which a human embryo is intentionally altered to include a heritable genetic modification. This note argues that the rider …

Association For Molecular Pathology V. Myriad Genetics: A Critical Reassessment, Jorge L. Contreras

Michigan Technology Law Review

The Supreme Court’s 2013 decision in Association for Molecular Pathology v. Myriad Genetics is an essential piece of the Court’s recent quartet of patent eligibility decisions, which also includes Bilski v. Kappos, Mayo v. Prometheus, and Alice v. CLS Bank. Each of these decisions has significantly shaped the contours of patent eligibility under Section 101 of the Patent Act in ways that have been both applauded and criticized. The Myriad case, however, was significant beyond its impact on Section 101 jurisprudence. It was seen, and litigated, as a case impacting patient rights, access to healthcare, scientific freedom, …

From Automation To Autonomy: Legal And Ethical Responsibility Gaps In Artificial Intelligence Innovation, David Nersessian, Ruben Mancha

Michigan Technology Law Review

The increasing prominence of artificial intelligence (AI) systems in daily life and the evolving capacity of these systems to process data and act without human input raise important legal and ethical concerns. This article identifies three primary AI actors in the value chain (innovators, providers, and users) and three primary types of AI (automation, augmentation, and autonomy). It then considers responsibility in AI innovation from two perspectives: (i) strict liability claims arising out of the development, commercialization, and use of products with built-in AI capabilities (designated herein as “AI artifacts”); and (ii) an original research study on the ethical practices …

The Intellectual Property Of Vaccines: Takeaways From Recent Infectious Disease Outbreaks, Ana Santos Rutschman

Michigan Law Review Online

In late 2019 and early 2020, a new strain of coronavirus, a family of pathogens causing serious respiratory illness, began infecting populations across the globe. A quick uptick in COVID-19, the disease caused by the novel pathogen, prompted the World Health Organization to declare the outbreak a Public Health Emergency of International Concern on January 30, 2020. By mid-February 2020, with 26 countries reporting cases of COVID-19 infection, the global case count had surpassed 50,000, and had resulted in over 1,500 deaths. The World Health Organization elevated the status of the outbreak to a pandemic in mid-March. As of early …

How Reporters Can Evaluate Automated Driving Announcements, Bryant Walker Smith

Journal of Law and Mobility

This article identifies a series of specific questions that reporters can ask about claims made by developers of automated motor vehicles (“AVs”). Its immediate intent is to facilitate more critical, credible, and ultimately constructive reporting on progress toward automated driving. In turn, reporting of this kind advances three additional goals. First, it encourages AV developers to qualify and support their public claims. Second, it appropriately manages public expectations about these vehicles. Third, it fosters more technical accuracy and technological circumspection in legal and policy scholarship.

Opting Into Device Regulation In The Face Of Uncertain Patentability, Rebecca S. Eisenberg

Articles

This article examines the intersection of patent law, FDA regulation, and Medicare coverage in a particularly promising field of biomedical innovation: genetic diagnostic testing. First, I will discuss current clinical uses of genetic testing and directions for further research, with a focus on cancer, the field in which genetic testing has had the greatest impact to date. Second, I will turn to patent law and address two recent Supreme Court decisions that called into question the patentability of many of the most important advances in genetic testing. Third, I will step outside patent law to take a broader view of …

Grants, Nicholson Price Ii

Articles

Innovation is a primary source of economic growth and is accordingly the target of substantial academic and government attention. Grants are a key tool in the government’s arsenal to promote innovation, but legal academic studies of that arsenal have given them short shrift. Although patents, prizes, and regulator-enforced exclusivity are each the subject of substantial literature, grants are typically addressed briefly, if at all. According to the conventional story, grants may be the only feasible tool to drive basic research, as opposed to applied research, but they are a blunt tool for that task. Three critiques of grants underlie this …

Universities: The Fallen Angels Of Bayh-Dole?, Rebecca S. Eisenberg, Robert Cook-Deegan

Articles

The Bayh-Dole Act of 1980 established a new default rule that allowed nonprofit organizations and small businesses to own, as a routine matter, patents on inventions resulting from research sponsored by the federal government. Although universities helped get the Bayh-Dole Act through Congress, the primary goal, as reflected in the recitals at the beginning of the new statute, was not to benefit universities but to promote the commercial development and utilization of federally funded inventions. In the years since the passage of the Bayh-Dole Act, universities seem to have lost sight of this distinction. Their behavior as patent seekers, patent …

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 …

An Administrative Meter Maid: Using Inter Partes Review And Post-Grant Review To Curb Exclusivity Parking Via The "Failure To Market" Provision Of The Hatch-Waxman Act, Brian T. Apel

Michigan Law Review

Congress created the unique Hatch-Waxman framework in 1984 to increase the availability of low-cost generic drugs while preserving patent incentives for new drug development. The Hatch-Waxman Act rewards generic drug companies that successfully challenge a pharmaceutical patent: 180 days of market exclusivity before any other generic firm can enter the market. When a generic firm obtains this reward, sometimes drug developers agree to pay generic firms to delay entering the market. These pay-for-delay agreements give rise to exclusivity parking and run counter to congressional intent by delaying full generic drug competition. The Medicare Prescription Drug, Improvement, and Modernization Act created …

More Than Bric-A-Brac: Testing Chinese Exceptionalism In Patenting Behavior Using Comparative Empirical Analysis, Jay P. Kesan, Alan Marco, Richard Miller

Michigan Telecommunications & Technology Law Review

Although many developing economies are increasingly influencing the global economy, China’s influence has been the greatest of these by far. Once hindered from competition by political and economic restrictions, China is now a major economic player. As China’s economic might has grown, so too has the demand for intellectual property protection for technologies originating from China. In this article, we present a detailed empirical study of Chinese patenting trends in the United States and the implications of these trends for the global economy. We compare these trends to patenting trends from earlier decades. Specifically, we compare Chinese patenting trends to …

Section 5 And The Innovation Curve, Daniel A. Crane

Book Chapters

the ftc’s authority to use Section 5 of the FTC Act to reach anticompetitive conduct that would not be illegal under the Sherman or Clayton Acts has been much discussed in recent years, particularly in conjunction with the FTC’s enforcement action against Intel. As of this writing, a Section 5 action against Google seems imminent.

Patents And Regulatory Exclusivity, Rebecca S. Eisenberg

Book Chapters

This article reexamines the sources of exclusivity for drugs, considers their limitations, and evaluates exclusivity under the new biologics legislation in light of these limitations. The current overlapping legal protections for exclusivity in the pharmaceutical marketplace reflect a series of political compromises, repeatedly renegotiated to correct for unintended consequences in the previous version of the rules. Patents and patent challenges play a central role in this system of protection, and many of the patents at stake are ultimately held invalid in litigation. It is not easy to untangle a complex legal regime that allocates billions of dollars of profits. But …

The Myth Of The Sole Inventor, Mark A. Lemley

Michigan Law Review

The theory of patent law is based on the idea that a lone genius can solve problems that stump the experts, and that the lone genius will do so only if properly incented. But the canonical story of the lone genius inventor is largely a myth. Surveys of hundreds of significant new technologies show that almost all of them are invented simultaneously or nearly simultaneously by two or more teams working independently of each other. Invention appears in significant part to be a social, not an individual, phenomenon. The result is a real problem for classic theories of patent law. …

Patent Costs And Unlicensed Use Of Patented Inventions, Rebecca S. Eisenberg

Articles

Recent commentators have observed, and sometimes lamented, significant gaps between the formal reach of the patent system and the practical exclusionary effect of patent law. It is costly for technology developers to obtain and assert patents, for technology users to identify the patents they might be infringing and to clear rights, and for the Patent and Trademark Office (PTO) to find patent-defeating prior art. The costs of the patent system provide shelter for infringing behavior that might otherwise lead to either licensing or liability, perhaps mitigating excesses in the patent system while retaining strong rights that motivated owners may enforce. …

Does Misery Love Company - Evidence From Pharmaceutical Markets Before And After The Orphan Drug Act, Frank R. Lichtenberg, Joel Waldfogel

Michigan Telecommunications & Technology Law Review

The possibility that small populations would see few medications developed for their conditions has [...] led the U.S. Congress to pass the 1983 Orphan Drug Act ("ODA"), giving firms special incentives to develop drugs for diseases afflicting fewer than 200,000 persons per year.[...][U]under the Act, drug makers receive seven years of exclusive marketing upon FDA approval of newly-developed drugs qualifying as "orphan drugs"--i.e., drugs for disorders affecting fewer than 200,000 persons.[...]Together, [the] provisions (a) increase the effective market size; and (b) reduce fixed (sunk) costs. In doing so, the Act provides a natural experiment for measuring the impact of increased …

Pdufa And Initial U.S. Drug Launches, Mary K. Olson

Michigan Telecommunications & Technology Law Review

In the 1970s and 1980s, many pharmaceutical firms launched new drugs abroad prior to gaining U.S. approval. Consequently, U.S. patients often faced delays in accessing important new medicines. High regulatory barriers to entry, such as a stringent regulation and a lengthy drug review process, contributed to this problem. This Article examines the impact of the Prescription Drug User Fee Act (PDUFA), and subsequent increases in the speed of FDA review, on the likelihood of initial U.S. drug launches. These factors are hypothesized to lower regulatory barriers to entry in the U.S. pharmaceutical market. The results show that increased drug review …

Platitudes About Product Stewardship In Torts: Continuing Drug Research And Education, Lars Noah

Michigan Telecommunications & Technology Law Review

This Article focuses on one emerging aspect of tort litigation against pharmaceutical manufacturers that, if it gained traction, portends a dramatic (and potentially counterproductive) expansion in the prescription drug industry's exposure to liability. The traditional theories of products liability--mismanufacture, defective design, and inadequate warnings--no longer exhaust the potential obligations of sellers. In addition to increasingly popular claims of misrepresentation and negligent marketing, which seem more like extensions of the three defect categories than entirely novel theories, a growing chorus of commentators would impose on pharmaceutical manufacturers a broader duty to test and educate (aspects of what they call an obligation …

Torts And Innovation, Gideon Parchomovsky, Alex Stein

Michigan Law Review

This Essay exposes and analyzes a hitherto overlooked cost of tort law: its adverse effect on innovation. Tort liability for negligence, defective products, and medical malpractice is determined by reference to custom. We demonstrate that courts' reliance on custom and conventional technologies as the benchmark of liability chills innovation and distorts its path. Specifically, recourse to custom taxes innovators and subsidizes replicators of conventional technologies. We explore the causes and consequences of this phenomenon and propose two possible ways to modify tort law in order to make it more welcoming to innovation.

Noncompliance, Nonenforcement, Nonproblem? Rethinking The Anticommons In Biomedical Research, Rebecca S. Eisenberg

Articles

A decade ago the biomedical research community was sounding alarm bells about the impact of intellectual property (IP) rights on the ability of scientists to do their work. Controversies and delays in negotiating terms of access to patented mice and genes, databases of scientific information, and tangible research materials all pointed toward the same conclusion: that IP claims were undermining traditional sharing norms to the detriment of science. Michael Heller and I highlighted one dimension of this concern: that too many IP rights in "upstream" research results could paradoxically restrict "downstream" research and product development by making it too costly …

Economics And The Design Of Patent Systems, Robert M. Hunt

Michigan Telecommunications & Technology Law Review

I use intuition derived from several of my research papers to make three points. First, in the absence of a common law balancing test, application of uniform patentability criteria favors some industries over others. Policymakers must decide the optimal tradeoff across industries. Second, if patent rights are not closely related to the underlying inventions, more patenting may reduce R&D in industries that are both R&D and patent intensive. Third, the U.S. private innovation system has become far more decentralized than it was a generation ago. It is reasonable to inquire whether a patent system that worked well in an era …

Knowledge, Competition And The Innovation: Is Stronger Ipr Protection Really Needed For More And Better Innovations, Giovanni Dosi, Luigi Marengo, Corrado Pasquali

Michigan Telecommunications & Technology Law Review

The main questions addressed in this Article are thus: given that growth is a highly desirable phenomenon and that it is primarily spurred by technological innovation, how should society solve the problem of favoring a sufficient level of investments in R&D? In particular, is it necessarily true and always desirable that, independent of any other consideration, society should protect innovators from competition and shelter them in a legally protected and enforced monopoly? Is it true that the real source of economic value of new recipes is only found in the blueprints of ideas that those recipes implement? Is it necessarily …

The Role Of The Fda In Innovation Policy, Rebecca S. Eisenberg

Michigan Telecommunications & Technology Law Review

This Article reexamines the role of FDA regulation in motivating investment in biopharmaceutical innovation. I begin by challenging the standard story that it is the patent system that makes drug development profitable, and drug regulation that makes it costly, by showing how patents add to costs and how drug regulation works in tandem with patents to protect profits. I then compare FDA-administered exclusive rights to patents as a means of fortifying drug development incentives, suggesting ways that FDA-administered rights might be preferable both from the perspective of policy makers and from the perspective of firms. In the remainder of the …

Something Must Be Done: An Argument For The Partial Deregulation Of Research On Bipolar Disorder And The Implementation Of Rolling Informed Consent, Janalee S. Kraschnewski

University of Michigan Journal of Law Reform

Bipolar disorder (BD) cripples the lives of countless individuals across the globe. The healthcare community has had difficulty securing effective, long-term treatment for this disease. This Note argues that enlarging the pool of possible research subjects through partial deregulation of BD research would facilitate the development of better treatment. This Note further proposes the implementation of a system of rolling informed consent to ensure that actual and full consent is obtained from BD research subjects.

Harnessing And Sharing The Benefits Of State-Sponsored Research: Intellectual Property Rights And Data Sharing In California's Stem Cell Initiative, Rebecca S. Eisenberg, Arti K. Rai

Articles

This Article discusses data sharing in California's stem cell initiative against the background of other data sharing efforts and in light of the competing interests that CIRM is directed to balance. We begin by considering how IP law affects data sharing. We then assess the strategic considerations that guide the IP and data policies and strategies of federal, state, and private research sponsors. With this background, we discuss four specific sets of issues that public sponsors of data-rich research, including CIRM, are likely to confront: (1) how to motivate researchers to contribute data; (2) who should have access to the …

Supporting Innovation In Targeted Treatments: Licenses Of Right To Nih-Funded Research Tools, Tanuja V. Garde

Michigan Telecommunications & Technology Law Review

Support for new drug development has taken some interesting turns in current patent law jurisprudence. Beginning with the severe curtailment of scope of the common law experimental use doctrine in Madey v. Duke University, and culminating with the recent Supreme Court decision in Merck KGaA v. Integra Lifesciences I, Ltd., broadening the scope of the statutory research exemption, the freedom to conduct experimental research using another's patented inventions becomes dependent in part on the purpose of the research. That the patent at issue in Merck was characterized by the Federal Circuit as being directed to a research tool raised the …

The Problem Of New Uses, Rebecca S. Eisenberg

Articles

Discovering new uses for drugs that are already on the market seems like it ought to be the low-lying fruit of biopharmaceutical research and development (R&D). Firms have already made significant investments in developing these drugs and bringing them to market, including testing them in clinical trials, shepherding them through the FDA regulatory approval process, building production facilities, and training sales staff to market them to physicians. By this point, the drugs have begun to enjoy goodwill among patients and physicians and casual observations in the course of clinical experience may point to potential new uses. One might expect that …

Learning The Value Of Drugs - Is Rofecoxib A Regulatory Success Story?, Rebecca S. Eisenberg

Articles

Controversy over recent revelations concerning the adverse cardiovascular effects of selective cyclooxygenase- 2 (COX-2) inhibitors has generally been framed as a story of regulatory failure, in which the Food and Drug Administration (FDA) has failed in its mission to protect the public from unsafe products. But this simplistic understanding of the mission of the FDA seems to make failure all but inevitable, if the reliable observation of the risks and benefits of a drug requires rigorous long-term studies. Perhaps in an earlier era the goal of drug regulation was simply to protect the public from poisons. Today, drug regulation guides …

The Experimental Purpose Doctrine And Biomedical Research, Tao Huang

Michigan Telecommunications & Technology Law Review

The experimental use doctrine is a common law rule in patent law that until a few years ago excused accused infringers who made and used patented products or processes on the basis of an experimental, educational, or nonprofit purpose when there was de minimis economic injury to the patent owner and de minimis economic gain to the infringer. While the application of the experimental purpose doctrine was always narrow, two recent Federal Circuit decisions indicate that there is not much left under its aegis. In Madey v. Duke University, the Federal Circuit strictly limited the application of the experimental purpose …

An Examination Of Patents, Licensing, Research Tools, And The Tragedy Of The Anticommons In Biotechnology Innovation, Michael S. Mireles

University of Michigan Journal of Law Reform

The continued development of and affordable access to potentially life saving pharmaceuticals, gene therapies and diagnostics is unquestionably a socially important issue. However, crafting government policy to encourage the development of and allowing affordable access to those services and products is difficult. On one hand, the development of those services and products requires a large investment of funds because of the complexity, collaborative nature, and uncertainty of the development of those products and services. Accordingly, investors require the safety of strong and stable patent rights to ensure a return on their investment in the development of a commercial end-product or …