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.

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 …

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. …

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.

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.

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 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 …

Lengthening The Stem: Allowing Federally Funded Researchers To Derive Human Pluripotent Stem Cells From Embryos, Jason H. Casell

University of Michigan Journal of Law Reform

Recent developments in fetal tissue research and stem cell research have led to dramatic breakthroughs in the search for cures for Parkinson's disease, Alzheimer's disease, diabetes, and a host of neurological disorders. Because this research involves fetal tissue and stem cells from human embryos, many complicated ethical and legal implications surround it. This Note explores the history of fetal tissue research and stem cell research, examines the surrounding ethical and legal issues, looks at the current state of federal law, and concludes that Congress should allow federally funded researchers to derive stem cells from discarded human embryos obtained from in …

Publish Or Perish, Gideon Parchomovsky

Michigan Law Review

The race model has been the darling of patent economists and game theorists. This model assumes that the winner, namely the first to invent, takes the patent grant with the market dominance that comes with it, whereas the second comer, in the best tradition of sports contests, obligingly accepts her loss and quietly vanishes from the scene. While the sports analogy has provided a useful framework for understanding the economics of invention, it has obfuscated an important aspect of the inventive process: the possibility of strategic publication of research findings in order to prevent the issuance of a patent to …

Antitrust Beyond Competition: Market Failures, Total Welfare, And The Challenge Of Intramarket Second-Best Tradeoffs, Peter J. Hammer

Michigan Law Review

Should antitrust law ever sanction the accumulation of market power or permit other restraints of trade if such conduct would increase social welfare? This is the challenge raised by intramarket second- best tradeoffs. The lesson of second-best analysis is that one market failure can sometimes counteract the effects of another market failure. In the presence of multiple market failures, it is conceivable that mergers or other restraints traditionally viewed as anticompetitive may be welfare-enhancing. A social planner, given the mandate of maximizing total welfare, would permit such restraints. Could an antitrust judge come to the same result under a defensible …

Federal Biotechnology Policy: The Perils Of Progress And The Risks Of Uncertainty, Al Gore

University of Michigan Journal of Law Reform

Americans have a schizophrenic view of science and technology. Some of our greatest heroes have been technological pioneers- from the Wright brothers to Lindbergh to Chuck Yeager. Until recently, we expressed unmitigated adoration for the scientists and engineers who put man in space. Yet at the same time, many Americans are generally uneasy about the triumph of technology in their own lives. One does not have to be a Luddite to rail against computers every now and then.

In deciding how to allocate precious public resources in an era of limits, legislators must take public perceptions of science very seriously. …

Scientific Responsibility And The Law, Harold P. Green

University of Michigan Journal of Law Reform

Because public policy is implicated by scientific misconduct, the legal profession should be interested in overcoming this problem. This Article studies the scientific misconduct problem and provides a personal view of the legal dilemmas that confront those who report misconduct. Part I describes how the scientific community currently deals with alleged fraud. Scientists primarily rely on the peer review system and toothless guidelines. Part II illustrates the problems in the present system through a case study of an allegation of misconduct. The author represented a man who reported scientific misconduct; the National Institutes of Health (NIH) investigation took five and …

Earmarked Appropriations: The Debate Over The Method Of Federal Funding, Donald N. Langenberg

University of Michigan Journal of Law Reform

The report that follows is the product of the Committee's deliberations.

The associations which sponsored the Committee and to which its report was addressed are at this date still considering the recommendations of the report. The Association of American Universities has adopted a resolution reaffirming its position supporting the use of scientific merit for research funding decisions and opposing earmarked funding, and agreeing to a moratorium on earmarked funding while the Association supports the creation of federally-funded research facilities programs. The American Association of State Colleges and Universities and the National Association of Independent Colleges and Universities have adopted or …

On The Human Body As Property: The Meaning Of Embodiment, Markets, And The Meaning Of Strangers, Thomas H. Murray

University of Michigan Journal of Law Reform

For as long as I can recall, newspapers have published brief items in which someone has calculated what the human body is "worth" on the open market. The value of the body-as reduced to its chemical components-was never more than a few dollars. A more accurate accounting, though, would include the market value of transplantable organs and tissues, as well as the potential bonanza to be had should a cell line cultured from that body prove valuable to the biotechnology industry. The bottom line could be anywhere from tens of thousands to perhaps millions of dollars.

Both moral and legal …

Introduction: Legislative, Administrative, And Judicial Nonscience, Samuel D. Estep

University of Michigan Journal of Law Reform

This symposium deals with the legal issues, or rather some of them, that are created by scientific research. Anyone remotely interested in scientific developments should be aware that even the existence of "new" scientific "facts," let alone the application of such discoveries to everyday activities, gives rise to a host of human value judgments that should be faced and resolved by society. Although these problems are often left in purgatory forever, it is the legal system, broadly defined, that attempts to resolve the conflict of interests (or the balancing of values) when a decision is made. Making this type of …

Federal Regulation Of Agricultural Biotechnologies, Thomas O. Mcgarity

University of Michigan Journal of Law Reform

Part I of this Article describes some of the risks and benefits of newly emerging agricultural biotechnologies. After discussing, in Part II, the role of federal agencies in regulating agricultural biotechnologies, Part III of the Article proposes elements for an adequate regulatory regime. Part IV then measures the existing legal authorities, as implemented by the USDA and the EPA, against the ideal elements. Part V examines the willingness of these agencies to regulate. Finally, Part VI suggests changes that can be made in the current regulatory regime to bring about more effective regulation and to enhance public trust in regulatory …

Cloning And The Constitution: An Inquiry Into Governmental Policymaking And Genetic Experimentation, Barry J. Swanson

Michigan Law Review

A Review of Cloning And the Constitution: An Inquiry Into Governmental Policymaking and Genetic Experimentation by Ira H. Carmen