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Association For Molecular Pathology V. Myriad Genetics: A Critical Reassessment, Jorge L. Contreras Jan 2021

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, …


The Intellectual Property Of Vaccines: Takeaways From Recent Infectious Disease Outbreaks, Ana Santos Rutschman Apr 2020

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 …


Opting Into Device Regulation In The Face Of Uncertain Patentability, Rebecca S. Eisenberg Jun 2019

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 …


Universities: The Fallen Angels Of Bayh-Dole?, Rebecca S. Eisenberg, Robert Cook-Deegan Oct 2018

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 Jan 2018

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 Oct 2015

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 Jan 2015

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 …


Patents And Regulatory Exclusivity, Rebecca S. Eisenberg Apr 2012

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 Mar 2012

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 Jan 2011

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. …


Noncompliance, Nonenforcement, Nonproblem? Rethinking The Anticommons In Biomedical Research, Rebecca S. Eisenberg Jan 2008

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 Jan 2007

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 Jan 2007

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 Jan 2007

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 …


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 Jan 2006

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 Apr 2005

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 Jan 2005

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 …


The Experimental Purpose Doctrine And Biomedical Research, Tao Huang Oct 2004

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 Oct 2004

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 …


Bayh-Dole Reform And The Progress Of Biomedicine, Arti K. Rai, Rebecca S. Eisenberg Jan 2003

Bayh-Dole Reform And The Progress Of Biomedicine, Arti K. Rai, Rebecca S. Eisenberg

Articles

Advances in fundamental biomedical research play an important and growing role in the development of new therapeutic and diagnostic products. Although the development of pharmaceutical end products has long been a proprietary enterprise, biomedical research comes from a very different tradition of open science. Within this tradition, long-standing norms call for relatively unfettered access to fundamental knowledge developed by prior researchers. The tradition of open science has eroded considerably over the past quarter century as proprietary claims have reached farther upstream from end products to cover fundamental discoveries that provide the knowledge base for future product development.


Patents, Product Exclusivity, And Information Dissemination: How Law Directs Biopharmaceutical Research And Development, Rebecca S. Eisenberg Jan 2003

Patents, Product Exclusivity, And Information Dissemination: How Law Directs Biopharmaceutical Research And Development, Rebecca S. Eisenberg

Other Publications

It's a great honor for me to be invited to deliver the Levine Distinguished Lecture at Fordham, and a great opportunity to try out some new ideas before this audience. As some of you know, I've been studying the role of patents in biomedical research and product development ("R&D") for close to twenty years now, with a particular focus on how patents work in "upstream" research in universities and biotechnology companies that are working on research problems that arise prior to "downstream" product development. But, of course, the patent strategies of these institutions are designed around the profits that everyone …


Reaching Through The Genome, Rebecca S. Eisenberg Jan 2003

Reaching Through The Genome, Rebecca S. Eisenberg

Book Chapters

The past two decades have been a period of rapid evolution in the science of biotechnology and therefore in patent strategies, if not in patent law itself. Patent law takes a long time to catch up with science, and commentators take a long time to catch up with the law, but patent lawyers don’t have that luxury. They have to keep ahead of the game, figuring out claiming strategies that allow their clients to capture the value of future discoveries. I want to discuss some of these strategies today.


Publish Or Perish, Gideon Parchomovsky Feb 2000

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 …


Ownership, Commercial Development, Transfer And Use Of Publicly Funded Research Results: The United States Legal Regime, Rebecca S. Eisenberg Jan 2000

Ownership, Commercial Development, Transfer And Use Of Publicly Funded Research Results: The United States Legal Regime, Rebecca S. Eisenberg

Other Publications

This report summarizes key provisions of the United States. legal regime concerning ownership, dissemination and commercialization of the results of publicly funded research as background for a study on the feasibility of improving access by developing countries and economies in transition to environmentally sound technologies (ESTs) developed in other parts of the world.


Upstream Patents = Downstream Bottlenecks, Rebecca S. Eisenberg, Michael A. Heller Jan 1998

Upstream Patents = Downstream Bottlenecks, Rebecca S. Eisenberg, Michael A. Heller

Articles

Thirty years ago in Science, Garrett Hardin introduced the metaphor "tragedy of the commons" to help explain overpopulation, air pollution, and species extinction. People often overuse resources they own in common because they have no incentive to conserve. Today, Hardin's metaphor is central to debates in economics, law, and science and powerful justification for privatizing commons property. While the metaphor highlights the cost of overuse when governments allow too many people to use a scarce resource, it misses the possibility of underuse when governments give too many people rights to exclude others. Privatization can solve one tragedy, but cause another.


Intellectual Property Issues In Genomics, Rebecca S. Eisenberg Aug 1996

Intellectual Property Issues In Genomics, Rebecca S. Eisenberg

Articles

Controversy over intellectual property rights in the results of large-scale cDNA sequencing raises intriguing questions about the roles of the public and private sectors in genomics research, and about who stands to benefit (and who stands to lose) from the private appropriation of genomic information. While the US Patent and Trademark Office has rejected patent applications on cDNA fragments of unknown function from the National Institutes of Health, private firms have pursued three distinct strategies for exploiting unpatented cDNA sequence information: exclusive licensing, non-exclusive licensing and dedication to the public domain.


Public Research And Private Development: Patents And Technology Transfer In Government-Sponsored Research, Rebecca S. Eisenberg Jan 1996

Public Research And Private Development: Patents And Technology Transfer In Government-Sponsored Research, Rebecca S. Eisenberg

Articles

This article revisits the logical and empirical basis for current government patent policy in order to shed light on the competing interests at stake and to begin to assess how the system is operating in practice. Such an inquiry is justified in part by the significance of federally-sponsored research and development to the overall U.S. research effort. Although the share of national expenditures for research and development borne by the federal government has declined since 1980, federal funding in 1995 still accounted for approximately thirty-six percent of total national outlays for research and development' and nearly fifty-eight percent of outlays …


Intellectual Property At The Public-Private Divide: The Case Of Large-Scale Cdna Sequencing, Rebecca S. Eisenberg Jan 1996

Intellectual Property At The Public-Private Divide: The Case Of Large-Scale Cdna Sequencing, Rebecca S. Eisenberg

Articles

The Human Genome Project provides fertile ground for studying the role of intellectual property at the wavering boundary between public and private research science. It involves a major commitment of both public and private research funds in an area that is of significant interest both to research scientists working in university and government laboratories and to commercial firms. It thus provides a wealth of new scientific discoveries that are simultaneously potential candidates for commercial development and inputs into further research. Its obvious implications for human health raise the stakes of getting the balance between private property and public access right, …


Reply To Comments On The Patentability Of Certain Inventions Associated With The Identification Of Partial Cdna Sequences, Rebecca S. Eisenberg, Robert P. Merges Jan 1995

Reply To Comments On The Patentability Of Certain Inventions Associated With The Identification Of Partial Cdna Sequences, Rebecca S. Eisenberg, Robert P. Merges

Articles

A brief reply is in order to clarify our position on the patenting of research tools. We stand by the statement that "there are reasons to be wary of patents on research tools," but that statement should not be understood as a broad condemnation of patents on research tools in all contexts. Indeed, immediately after the cited language our opinion letter acknowledges that withholding patent protection from research tools could undermine private incentives to develop research tools and to make them available to investigators or lead to greater reliance on trade secrecy. Unlike the government, which purports to pursue patent …


Limiting The Role Of Patents In Technology Transfer, Rebecca S. Eisenberg Jan 1994

Limiting The Role Of Patents In Technology Transfer, Rebecca S. Eisenberg

Other Publications

Federal policy since 1980 has reflected an increasingly confident presumption that patenting discoveries made in the course of government-sponsored research is the most effective way to promote technology transfer and commercial development of those discoveries in the private sector. Policymakers in the past may have thought that the best way to achieve widespread use of government-sponsored research was to make the results freely available to the public; the new pro-patent policy stresses the need for exclusive rights as an incentive for industry to invest in bringing new products to market.