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Full-Text Articles in Law
Opting Into Device Regulation In The Face Of Uncertain Patentability, Rebecca S. Eisenberg
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
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 …
Patent Costs And Unlicensed Use Of Patented Inventions, Rebecca S. Eisenberg
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
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
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
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 …
Bayh-Dole Reform And The Progress Of Biomedicine, Arti K. Rai, Rebecca S. Eisenberg
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.
Upstream Patents = Downstream Bottlenecks, Rebecca S. Eisenberg, Michael A. Heller
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
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
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
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
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 …
A Technology Policy Perspective On The Nih Gene Patenting Controversy, Rebecca S. Eisenberg
A Technology Policy Perspective On The Nih Gene Patenting Controversy, Rebecca S. Eisenberg
Articles
This article will use the NIH patent controversy as a focal point for considering when the results of government-sponsored research should be patented and when they should be dedicated to the public domain. First, this article will review the recent history of federal government policy on patenting the results of government-sponsored research. Next, this article will highlight some of the complexities involved in achieving technology transfer from the public sector to the private sector that current policy may oversimplify. With this background, this article will return to a more detailed analysis of the NIH cDNA patenting controversy and consider the …
Limiting The Role Of Patents In Technology Transfer, Rebecca S. Eisenberg
Limiting The Role Of Patents In Technology Transfer, Rebecca S. Eisenberg
Articles
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. Whereas 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 propatent policy stresses the need for exclusive rights as an incentive for industry to undertake the further investment to bring new products to market. Although this propatent policy may make …
Limiting The Role Of Patents In Technology Transfer, Rebecca Sue Eisenberg
Limiting The Role Of Patents In Technology Transfer, Rebecca Sue Eisenberg
Articles
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. Whereas 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 propatent policy stresses the need for exclusive rights as an incentive for industry to undertake the further investment to bring new products to market. Although this propatent policy may make …
Patents And The Progress Of Science: Exclusive Rights And Experimental Use, Rebecca S. Eisenberg
Patents And The Progress Of Science: Exclusive Rights And Experimental Use, Rebecca S. Eisenberg
Articles
In this article I analyze the proper scope of an experimental use exemption from patent infringement liability by comparing the rationales behind promoting technological progress through granting exclusive patent rights in inventions with competing arguments for promoting scientific progress by allowing all investigators to enjoy free access to the discoveries of other scientists. I begin by reviewing key features of the patent laws and theoretical justifications for granting patent monopolies in order to clarify the implications of existing patent doctrine and theory for an experimental use exemption. I then look to the literature in the sociology, history, and philosophy of …