Biotechnology Commons^™

Constitutionalizing Nature's Law: Dignity And The Regulation Of Biotechnology In Switzerland, James Toomey

Elisabeth Haub School of Law Faculty Publications

The Swiss Constitution was amended by referendum in 1992 to include two unique provisions: Article 119, which imposes strict limits on genetic and reproductive technologies in humans in order to protect ‘human dignity’, and Article 120, which commits the Swiss federal government to limiting genetic technologies in non-human species on the basis of the ‘dignity of the creature’. This article analyzes the role of ‘dignity’ as a limit on biotechnologies in the Swiss constitutional order. It concludes that the understanding of dignity the constitution embraces codifies a contestable metaphysical theory of value at the constitutional level. Specifically, the Swiss constitutional …

Advanced Biotechnology Tools For Invasive Species Management, Invasive Species Advisory Committee

National Invasive Species Council

Increasingly, genetic tools are being used to detect and solve pressing environmental, social, and health-related challenges. It is clear that investments in technology innovation can be game changing, as advances in biotechnology may provide new methods to protect the nation’s resources from the negative impacts of invasive species. The current toolbox of management options is recognizably insufficient to deal with many of the high-impact species that have been introduced. However, “surrendering” to these species is generally not a viable option from ecological, health, economic, socio-cultural, or political perspectives. Cost-efficient solutions to these “grand invasive species challenges” need to be found. …

Re-Framing Biotechnology Regulation, Alison Peck

Law Faculty Scholarship

Biotechnology is about to spill the banks of federal regulation. New genetic engineering techniques like CRISPR-Cas9 promise revolutionary breakthroughs in medicine, agriculture, and public health-but those techniques would not be regulated under the terms of the Coordinated Framework for Regulation of Biotechnology. This revolutionary moment in biotechnology offers an opportunity to correct the flaws in the framework, which was hastily patched together at the advent of the technology. The framework has never captured all relevant technologies, has never satisfied the public that risk is being effectively managed, and has never been accessible to small companies and publicly-funded labs that increasingly …

Manufacturing Barriers To Biologics Competition And Innovation, W. Nicholson Price Ii, Arti K. Rai

Faculty Scholarship

As finding breakthrough small-molecule drugs gets harder, drug companies are increasingly turning to “large molecule” biologics. Although biologics represent many of the most promising new therapies for previously intractable diseases, they are extremely expensive. Moreover, the pathway for generic-type competition set up by Congress in 2010 is unlikely to yield significant cost savings.

In this Article, we provide a fresh diagnosis of, and prescription for, this major public policy problem. We argue that the key cause is pervasive trade secrecy in the complex area of biologics manufacturing. Under the current regime, this trade secrecy, combined with certain features of FDA …

Diagnostic Patents At The Supreme Court, Arti K. Rai

Faculty Scholarship

No abstract provided.

Nudging The Fda, W. Nicholson Price Ii, I. Glenn Cohen

Law Faculty Scholarship

[Excerpt] "The FDA’s regulation of drugs is frequently the subject of policy debate, with arguments falling into two camps. On the one hand, a libertarian view of patients and the health care system holds high the value of consumer choice. Patients should get all the information and the drugs they want; the FDA should do what it can to enforce some basic standards but should otherwise get out of the way. On the other hand, a paternalist view values the FDA’s role as an expert agency standing between patients and a set of potentially dangerous drugs and potentially unscrupulous or …

The Costs Of Changing Our Minds, Nita A. Farahany

Faculty Scholarship

This isn’t quite a draft yet – it’s a concept paper. You’ll see after the first 10 pages a good bit of text in brackets, which are primarily notes for me, but it’ll give you a sense of the content of those sections. I’d like to talk through the concept – the “duty” to mitigate emotional distress damages and how courts have struggled with it, as a foray into a broader dichotomy that I see in a number of areas of law that suggest an implicit value in “cognitive liberty.” This is a smaller version of a broader book project …

Shots For Tots?, Eric A. Feldman

All Faculty Scholarship

By endorsing the use of a vaccine that makes the experience of puffing on a cigarette deeply distasteful, Lieber and Millum have taken the first few tentative steps into a future filled with medical interventions that manipulate individual preferences. It is tempting to embrace the careful arguments of “Preventing Sin” and celebrate the possibility that the profound individual and social costs of smoking will finally be tamed. Yet there is something unsettling about the possibility that parental discretion may be on the cusp of a radical expansion, one that involves a new and unexplored approach to behavior modification.

Biomedical Patents At The Supreme Court: A Path Forward, Arti K. Rai

Faculty Scholarship

Although most would argue that software patents pose a bigger challenge, the U.S. Supreme Court has recently focused on biomedical patents. Two of the Court's recent decisions scaling back such patents, Mayo v. Prometheus and AMP v. Myriad, have provoked justifiable anxiety for those concerned about biomedical innovation, particularly in the area of personalized medicine. While acknowledging significant limitations in the Court's reasoning in both cases, this Essay sketches a reading that is consistent with the results and innovation-friendly.

Intellectual Property And Opportunities For Food Security In The Philippines, Jane Payumo, Howard Grimes, Antonio Alfonso, Stanley P. Kowalski, Keith Jones, Karim Maredia, Rodolfo Estigoy

Law Faculty Scholarship

By 2050, the Philippine population is projected to increase by as much as 41 percent, from 99.9 million to nearly 153 million people. Producing enough food for such an expanding population and achieving food security remain a challenge for the Philippine government. This paper argued that intellectual property rights (IPR) can play a key role in achieving the nation’s current goal to be food-secure and provided examples to illustrate that the presence of sound intellectual property (IP) helps foster research, development, and deployment of agricultural innovations. This paper also offered key recommendations about how the IP system can be further …

The Nagoya Protocol And Synthetic Biology Research: A Look At The Potential Impacts, Margo A. Bagley, Arti K. Rai

Faculty Scholarship

This report, prepared for the Synthetic Biology Project at the Woodrow Wilson International Center for Scholars, analyzes the 2010 Nagoya Protocol to the Convention on Biological Diversity and how it may affect U.S. researchers working in the field of synthetic biology. The objective of the Protocol is to provide a transparent framework for the acquisition and sharing of genetic resources on fair and equitable terms that facilitate the conservation of biological diversity and associated traditional knowledge. The report finds significant uncertainty surrounding the temporal scope of the Agreement as well as the types of genetic material that will be covered …

A Neurological Foundation For Freedom, Nita A. Farahany

Faculty Scholarship

No abstract provided.

Leveling The Playing Field In Gmo Risk Assessment: Importers, Exporters, And The Limits Of Science, Alison Peck

Law Faculty Scholarship

The WTO system requires that trade restrictions meant to protect health and safety be based on a risk assessment supported by “sufficient scientific evidence.” Scholars and international standards organizations have pointed out, however, that science is incapable of providing answers to questions of health and safety without incorporating the risk assessors’ value judgments and assumptions. Before GMO-importing countries conduct risk assessments, GMO-producing and exporting countries have already conducted their own risk assessments, which led to their decision to produce and market the products in the first place. Both the exporting and importing countries’ risk assessments employ science informed by the …

Unstandard Standardization: The Case Of Biology, Arti K. Rai

Faculty Scholarship

How applicable are the approaches adopted by information and communication technology standards-setting organizations to biological standards? Most engineering-based industries construct products from standard, well understood components. By contrast, despite the early attachment of the moniker “genetic engineering” to biotechnology, standardization in the biological sciences has been relatively rare.

Nih Guidelines On Human Embryonic Stem Cell Research In Context: Clarity Or Confusion?, Karen H. Rothenberg, Michael R. Ulrich

Faculty Scholarship

No abstract provided.

Respecting, Rather Than Reacting To, Race In Biomedical Research: A Response To Professors Caulfield And Mwaria, Michael J. Malinowski

Journal Articles

This Commentary is part of a colloquy on race-based genetics research.

A Discourse On The Public Nature Of Research In Contemporary Life Science: A Law-Policy Proposal To Promote The Public Nature Of Science In An Era Of Academia-Industry Integration, Michael J. Malinowski

Journal Articles

This article addresses the impact of integration of academia, industry, and government on the public nature of research. The article concludes that, while the integration has benefited science immensely, regulatory measures should be taken to restore the public nature of research in an age of integration.

United States Regulation Of Stem Cell Research: Recasting Government's Role And Questions To Be Resolved, Owen C. B. Hughes, Alan L. Jakimo, Michael J. Malinowski

Journal Articles

This article directly addresses the stem cell controversy, but also the broader history and norms regarding the roles of federal and state government in U.S. science research funding.

The New Imperialism: Toward An Advocacy Strategy For Gmo Accountability, Alison Peck

Law Faculty Scholarship

No abstract provided.

Synthetic Biology: Caught Between Property Rights, The Public Domain, And The Commons, Arti K. Rai, James Boyle

Faculty Scholarship

Synthetic biologists aim to make biology a true engineering discipline. In the same way that electrical engineers rely on standard capacitors and resistors, or computer programmers rely on modular blocks of code, synthetic biologists wish to create an array of modular biological parts that can be readily synthesized and mixed together in different combinations. Synthetic biology has already produced important results, including more accurate AIDS tests and the possibility of unlimited supplies of previously scarce drugs for malaria. Proponents hope to use synthetic organisms to produce not only medically relevant chemicals but also a large variety of industrial materials, including …

Synthetic Biology: The Intellectual Property Puzzle, Arti K. Rai, Sapna Kumar

Faculty Scholarship

Synthetic biology, which operates at the intersection of biotechnology and information technology, has the potential to raise, in a particularly acute manner, the intellectual property problems that exist in both fields. A preliminary patent landscape reveals problematic foundational patents that could, if licensed and enforced inappropriately, impede the potential of the technology. The landscape also reveals a proliferation of patents on basic synthetic biology "parts" that could create transaction cost heavy patent thickets. Both foundational patents and patent thickets are likely to be particularly problematic to the extent they read on standards that synthetic biologists would like to establish. Synthetic …

Power, Privilege, And Special Interests: Rent Seeking And Subsidies In Agriculture, Matt Bogard

Agriculture Department Seminar Series

This presentation covers what Public Choice economists refer to as ‘rent seeking,’ generally seeking favor or special privilege from government through subsidies or regulatory advantages. Particularly, the biotech industry is the area of focus for this presentation. Problems with rent seeking in the biotech industry involve less innovation and industry consolidation. Policies related to biotech regulation, school lunch programs, the Clean Air Act, and ethanol subsidies are discussed. A game theoretic approach is used and it is concluded that issues related to rent seeking and special interests are not adequately addressed by recent campaign finance reform efforts. Alternatives such as …

The Gender Of Genetic Futures: The Canadian Biotechnology Strategy, Women And Health, Roxanne Mykitiuk, Fiona Miller, Lorna Weir

All Papers

No abstract provided.

Stranger In A Strange Land: Biotechnology And The Federal Circuit, Lawrence M. Sung

Faculty Scholarship

No abstract provided.

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 …