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Full-Text Articles in Law
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
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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 …
Artificial Intelligence In Health Care: Applications And Legal Implications, W. Nicholson Price Ii
Artificial Intelligence In Health Care: Applications And Legal Implications, W. Nicholson Price Ii
Articles
Artificial intelligence (AI) is rapidly moving to change the healthcare system. Driven by the juxtaposition of big data and powerful machine learning techniques—terms I will explain momentarily—innovators have begun to develop tools to improve the process of clinical care, to advance medical research, and to improve efficiency. These tools rely on algorithms, programs created from healthcare data that can make predictions or recommendations. However, the algorithms themselves are often too complex for their reasoning to be understood or even stated explicitly. Such algorithms may be best described as “black-box.” This article briefly describes the concept of AI in medicine, including …
Prometheus Rebound: Diagnostics, Nature, And Mathematical Algorithms, Rebecca S. Eisenberg
Prometheus Rebound: Diagnostics, Nature, And Mathematical Algorithms, Rebecca S. Eisenberg
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The Supreme Court’s decision last Term in Mayo v. Prometheus left considerable uncertainty as to the boundaries of patentable subject matter for molecular diagnostic inventions. First, the Court took an expansive approach to what counts as an unpatentable natural law by applying that term to the relationship set forth in the challenged patent between a patient’s levels of a drug metabolite and the indication of a need to adjust the patient’s drug dosage. And second, in evaluating whether the patent claims add enough to this unpatentable natural law to be patent eligible, the Court did not consult precedents concerning the …
Wisdom Of The Ages Or Dead-Hand Control? Patentable Subject Matter For Diagnostic Methods After In Re Bilski, Rebecca S. Eisenberg
Wisdom Of The Ages Or Dead-Hand Control? Patentable Subject Matter For Diagnostic Methods After In Re Bilski, Rebecca S. Eisenberg
Articles
In 1980, the Supreme Court gave a reassuring signal to the then-nascent biotechnology industry about the availability of patent protection for the fruits of its research when it upheld the patentability of a genetically modified living organism in Diamond v. Chakrabarty. Twenty-five years later, the Court seemed poised to reexamine the limits of patentable subject matter for advances in the life sciences when it granted certiorari in Laboratory Corporation v. Metabolite. But the Federal Circuit had not addressed the patentable subject matter issue in Laboratory Corporation, and the Court ultimately dismissed the certiorari p etition as improvidently granted. Five years …
Noncompliance, Nonenforcement, Nonproblem? Rethinking The Anticommons In Biomedical Research, Rebecca S. Eisenberg
Noncompliance, Nonenforcement, Nonproblem? Rethinking The Anticommons In Biomedical Research, Rebecca S. Eisenberg
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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 …
Pharma's Nonobvious Problem, Rebecca S. Eisenberg
Pharma's Nonobvious Problem, Rebecca S. Eisenberg
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This Article considers the effect of the recent decision of the U.S. Supreme Court in KSR International Co. v. Teleflex, Inc. on the nonobviousness standard for patentability as applied to pharmaceutical patents. By calling for an expansive and flexible analysis and disapproving of the use of rigid formulas in evaluating an invention for obviousness, KSR may appear to make it easier for generic competitors to challenge the validity of drug patents. But an examination of the Federal Circuit's nonobviousness jurisprudence in the context of such challenges reveals that the Federal Circuit has been employing all along the sort of flexible …
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 …
Learning The Value Of Drugs - Is Rofecoxib A Regulatory Success Story?, Rebecca S. Eisenberg
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 …
Obvious To Whom? Evaluating Inventions From The Perspective Of Phosita, Rebecca S. Eisenberg
Obvious To Whom? Evaluating Inventions From The Perspective Of Phosita, Rebecca S. Eisenberg
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In this Article, I consider the possibility of giving the USPTO input from currently active technological practitioners in evaluating the obviousness of claimed inventions. Such input could potentially serve three useful functions. First, it could improve the accuracy of USPTO decisionmaking by providing access to the perspective of actual practitioners as to the obviousness of inventions from the perspective of the hypothetical PHOSITA. Second, it could help the USPTO document the evidentiary basis for rejections that rest in part upon tacit knowledge within technological communities. Third, it could provide a quality control mechanism that would improve the credibility of USPTO …
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
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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.
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
Allowing universities to patent the results of government-sponsored research sometimes works against the public interest.
Re-Examining The Role Of Patents In Appropriating The Value Of Dna Sequences, Rebecca S. Eisenberg
Re-Examining The Role Of Patents In Appropriating The Value Of Dna Sequences, Rebecca S. Eisenberg
Articles
As public and private sector initiatives race to complete the sequence of the human genome, patent issues have played a prominent role in speculations about the significance of this achievement. How much of the genome will be subject to the control of patent holders, and what will this mean for future research and the development of products for the improvement of human health? Is a patent system developed to establish rights in mechanical inventions of an earlier era up to the task of resolving competing claims to the genome on behalf of the many sequential innovators who elucidate its sequence …
The Promise And Perils Of Strategic Publication To Create Prior Art: A Response To Professor Parchomovsky, Rebecca S. Eisenberg
The Promise And Perils Of Strategic Publication To Create Prior Art: A Response To Professor Parchomovsky, Rebecca S. Eisenberg
Articles
In a provocative recent article in the Michigan Law Review, Professor Gideon Parchomovsky observes that a firm racing with a competitor to make a patentable invention might find it strategically advantageous to publish interim research results rather than risk losing a patent race. This strategy exploits legal rules limiting patent protection to technological advances that are new and "nonobvious" in light of the "prior art" or preexisting knowledge in the field. By publishing research results, a firm adds to the prior art and thereby limits what may be patented in the future. Parchomovsky posits that, before it is able to …
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.
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
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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, …
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 …
Patenting The Human Genome, Rebecca S. Eisenberg
Patenting The Human Genome, Rebecca S. Eisenberg
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The increasing promise of federal funding for mapping and sequencing the human genome has brought with it renewed attention in the research science community to issues of intellectual property protection for products of biotechnology research. Echoing concerns raised a decade ago in the debate over commercialization of academic biomedical research, scientists have called for the free availability of all information generated through the Human Genome Project and have argued against allowing private intellectual property rights in such knowledge. Meanwhile, private parties have quietly been obtaining patents on bits and pieces of the human genome from the Patent and Trademark Office …
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
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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 …
Proprietary Rights And The Norms Of Science In Biotechnology Research, Rebecca S. Eisenberg
Proprietary Rights And The Norms Of Science In Biotechnology Research, Rebecca S. Eisenberg
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As basic research in biotechnology yields increasing commercial applications, scientists and their research sponsors have become more eager to protect the commercial value of research discoveries through intellectual property law. Some scientists fear that these commercial incentives will weaken or even undermine the norms that have traditionally governed scientific research. In this Article, Professor Eisenberg examines the interaction of proprietary rights in inventions with these traditional scientific norms. Trade secrecy, she argues, is an undesirable strategy for protection of basic research discoveries because it impedes dissemination of new knowledge to the scientific community. She finds that patent law is in …
The Patentability Of A Principle Of Nature, John B. Waite
The Patentability Of A Principle Of Nature, John B. Waite
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The extent to which courts will go in conceding patentability to a natural law, or principle of nature, is evidenced in the case of Minerals Separation Co. v. Hyde, 37 Sup. Ct. -, decided by the Supreme Court, December 11, 1916. It has always been more or less an axiom of patent law that the discovery of a principle of nature does not entitle the discoverer to a patent for it. The case usually thought of first as authority therefor, is that of Morton v. New York Eye Infirmary, 5 Blatch. 116, 2 Fisher 320. The patentees in that case …