Law Commons^™

Incentivizing Innovation, Xuan-Thao Nguyen, Jeffrey A. Maine

Articles

This Article advocates for a new approach to incentivizing innovation through the design of ex post tax incentives for research and development (R&D) investment. In contrast to many nations, the United States relies largely on ex ante tax incentives, namely a tax deduction and tax credit for qualified R&D spending. Fundamental design flaws exist with these ex ante incentives; moreover, innovation occurs continuously and yields results at the back end of the innovation cycle. An appropriate framework should take into consideration the key players in the innovation landscape. These players are often treated differently under the tax laws such that …

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 …

Chinese Innovation And Global Integration- Theoretical Framework Of Perceived Insecurities In University Technology Transfer, Clovia Hamilton

Winthrop Faculty and Staff Publications

University technology transfer is growing in China and is vital to China’s innovation and intellectual property program. This paper provides a literature review used to create a theoretical framework for explaining conflicts between university technology transfer participants. Economic development and business competitiveness relies on innovation and intellectual property generation. Given increased investments in university research and Chinese universities, it is important to be aware of conflicts between university technology transfer office staff and faculty within academic exchanges. University technology transfer is growing in China and is vital to China’s innovation and intellectual property program. Conflicts between university technology transfer participants …

Black Americans Past And Present Created Frugal Innovations And Embraced Circular Economy Principles: The Marketing Dilemma, Clovia Hamilton

Winthrop Faculty and Staff Publications

Frugal innovation is the practice whereby the rich learns from innovations developed in poor countries, and there is purportedly a current rivalry between India and China in the frugal innovation arena. This research advocates that the concept of frugal innovation did not originate in Asia or India. The practice of the rich taking the poor’s innovations is not new. In particular, Black American slaves and freed slaves developed a number of inventions in poverty conditions. It is imperative that frugal innovation research be more historically accurate so as to reduce the marginalization of contributions developed by poor innovators and to …

Trends In Private Patent Costs And Rents For Publicly-Traded United States Firms, James Bessen, Peter Neuhausler, John L. Turner, Jonathan Williams

Faculty Scholarship

We use detailed data to estimate the private costs and private rents of United States patents for publicly-traded firms. In analyzing costs, we first introduce a novel theoretical model to interpret our estimates. We then combine lawsuit data from Derwent Litalert with non-practicing entity (NPE) lawsuits collected by Patent Freedom, and use an event-study approach to estimate losses suffered by alleged infringers during 1984-2009. To estimate rents, we combine patent data from the USPTO and EPO with financial data from COMPUSTAT, and use market-value regressions to estimate the value of patent rents for publicly-traded US firms during 1979-2002. We find …

Eyes On The Prize, Head In The Sand: Filling The Due Process Vacuum In Federally Administered Contests, Steven L. Schooner, Nathaniel E. Castellano

GW Law Faculty Publications & Other Works

The article introduces readers to the recent proliferation of federal prize contests, which sovereigns have employed, albeit sporadically, since the mid-sixteenth century to incentivize breakthrough innovation. In the past decade, the federal government’s use of prize contests has skyrocketed, which makes sense in an era of constrained government resources. Prize contests offer seemingly unlimited potential to break through existing technological barriers at less expense than traditional innovation incentivizing tools such as contracts, grants, and patents. But that upside potential comes at a cost.

For every ebullient prizewinner, there are potentially innumerable “losers,” many of whom feel wronged, exploited, or, at …

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 …

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. …

Slides: Chapter 7 Of The Commission Report, David L. Bernhardt

The Past, Present, and Future of Our Public Lands: Celebrating the 40th Anniversary of the Public Land Law Review Commission’s Report, One Third of the Nation’s Land (Martz Summer Conference, June 2-4)

Presenter: David L. Bernhardt, Partner, Brownstein Hyatt Farber Schreck (Washington, DC) and former Solicitor for U.S. Department of the Interior

14 slides

Slides: Costs And Benefits Of Oil Shale Development, James T. Bartis

The Promise and Peril of Oil Shale Development (February 5)

Presenter: James T. Bartis, Senior Policy Researcher, Rand Corporation

21 slides

Slides: The Promise And Peril Of Oil Shale: Federal Law And Policy, David Bernhardt

The Promise and Peril of Oil Shale Development (February 5)

Presenter: David Bernhardt, Brownstein Hyatt Farber Schreck, Denver, CO

13 slides

Do Patents Perform Like Property?, Michael J. Meurer, James Bessen

Faculty Scholarship

Do patents provide critical incentives to encourage investment in innovation? Or, instead, do patents impose legal risks and burdens on innovators that discourage innovation, as some critics now claim? This paper reviews empirical economic evidence on how well patents perform as a property system.

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 …

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 …

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 Least Of The Sentient Beings' And The Question Of Reduction, Refinement, And Replacement, Joseph Vining

Other Publications

The subject I was asked to think about with you today is raised by a very large change in the focus of biomedical research. In raw percentage terms, the animals involved in experimentation are now overwhelmingly rats and mice, and, perhaps because they are rats and mice, they are used in large numbers, numbers in thousands and tens of thousands at some institutions. Legal, ethical, and practical accommodation to this fact on the ground presents a host of questions. There are questions of the cost of care. There are questions of the training of veterinarians, principal investigators, and laboratory personnel. …

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

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

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.

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.

Patents And Cumulative Innovation, Clarisa Long

Faculty Scholarship

Proprietary rights to the products of biomedical research have repeatedly been a source of controversy for over twenty years. Patents on biomedical innovations have allowed scientists, academics, and research institutions to raise research funds and have contributed to the growth of the biotechnology industry. But “one firm’s research tool may be another firm’s end product.” Patents have been a source of great concern for academic and basic researchers, who fear that proprietary rights to basic research results will hamper the progress of science, stifle the free flow of new knowledge and the dissemination of research results, and chill the research …

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.

Nfma Implementation Options: Managing Environmental Decisions [Outline], Susan Yonts-Shepard

The National Forest Management Act in a Changing Society, 1976-1996: How Well Has It Worked in the Past 20 Years?: Will It Work in the 21st Century? (September 16-18)

3 pages.

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

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

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, …