Biotechnology Commons^™

Considerations Of Potential Tort Liability With Respect To Natural Draft Cooling Towers Associated With Steam-Electric Power Plants, Thomas D. Corkran

Akron Law Review

To prevent thermal pollution and to conserve our water supply, it appears that we must learn to live with natural draft cooling towers, at least for the next several decades. Proponents of natural draft cooling towers maintain that the possibility of localized fogging and icing is negligible, but the potential hazards of artificial salt fallout are very real. Also, there appears to be a trend developing in the law which could lead to an action against the operator of a natural draft cooling tower for aesthetic annoyances. There are several theories of action which might lie in such cases, but …

Understanding The Backlog Problems Associated With Requests For Continued Examination Practice, Sean Tu

Duke Law & Technology Review

One of the greatest problems facing the current patent administration is a long patent pendency period. This study focuses on Request for Continued Examination (RCE) practice, and its effects on the current patent application backlog problem. RCEs are used to continue prosecution after a patent examiner has issued a final rejection. However, now that RCEs are placed on an examiner’s special docket, some examiners may pick up prosecution one to two years after the last action. Accordingly, there are great inefficiencies that may be created by this delay, such as relearning issues and questions from the previous action, diminished value …

The Mouse That Trolled: The Long And Tortuous History Of A Gene Mutation Patent That Became An Expensive Impediment To Alzheimer's Research, Tania M. Bubela, Saurabh Vishnubhakat, Robert Cook-Deegan

Office of the Provost

This case study presents the tale of the academic discovery of a rare mutation for early-onset Alzheimer's disease that was patented by a sole inventor and licensed to a non-practicing entity (NPE), the Alzheimer's Institute of America (AIA). Our aims are (1) to relate this story about patents, research tools, and impediments to medical progress, and (2) to inform ongoing debates about how patents affect research, disposition of university inventions, and the distribution of benefits from publicly funded research. We present an account of the hunt for Alzheimer's genes, their patenting, assignment, and enforcement based on literature, litigation records and …

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 …

Agricultural Biotechnology-An Opportunity To Feed A World Of Ten Billion, Nina V. Fedoroff, Drew L. Kershen

Faculty Articles

No abstract provided.

Diagnostic Patents At The Supreme Court, Arti K. Rai

Faculty Scholarship

No abstract provided.

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 …

Crowdfunding For Biotechs: How The Sec’S Proposed Rule May Undermine Capital Formation For Startups, Brian J. Farnkoff

Journal of Contemporary Health Law & Policy (1985-2015)

No abstract provided.

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 National Institutes Of Health, Patents, And The Public Interest: An Expanded Rationale Of Justice Breyer’S Dissent In Stanford V. Roche, Nida Shakir

Marquette Intellectual Property Law Review

In February 2010, the Alzheimer’s Institute of America (AIA) filed a patent infringement lawsuit against Jackson Laboratory, the largest repository of research mice in the world. AIA sued Jackson Laboratory for infringing on AIA’s patent covering a DNA mutation linked to Alzheimer’s disease. Jackson Lab allegedly violated that patent by distributing mice especially bred for Alzheimer’s research. READ MORE, download the article.

The Contested Vision For Agriculture's Future: Sustainable Intensive Agriculture And Agroecology, Drew L. Kershen

Faculty Articles

No abstract provided.

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.

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 Thousand Tiny Pieces: The Federal Circuit’S Fractured Myriad Ruling, Lessons To Be Learned, And The Way Forward, Jonathan R. K. Stroud

IP Theory

No abstract provided.

A Neurological Foundation For Freedom, Nita A. Farahany

Faculty Scholarship

No abstract provided.

Programmers And Forensic Analyses: Accusers Under The Confrontation Clause, Karen Neville

Duke Law & Technology Review

Recent Supreme Court cases involving the Confrontation Clause have strengthened defendants’ right to face their accusers. Bullcoming v. New Mexico explored the question of whether the testimony of the technician who performs a forensic analysis may be substituted by that of another analyst, and the Court held that producing a surrogate witness who was not sufficiently involved in the analysis violates the confrontation right.

The presumption of infallible technology is fading, and courts may soon realize programmers have greater influence over the ultimate outcome of forensic tests than do the technicians who rely on such analytical tools. The confrontation right, …

Copyright For Engineered Dna: An Idea Whose Time Has Come?, Christopher M. Holman

West Virginia Law Review

The rapidly emerging field of synthetic biology has tremendous potential to address some of the most compelling challenges facing our planet by providing clean renewable energy, nutri- tionally-enhanced and environmentally friendly agricultural products, and revolutionary new life-saving cures. However, leaders in the synthetic biology movement have voiced concern that biotechnology's current patent-centric approach to intellec- tual property is in many ways ill-suited to meet the challenge of synthetic biology, threatening to impede follow-on innovation and open access technology. For years, copyright and patent protection for computer software have existed side-by-side, the two forms of intellectual property complementing one another. Numerous …

Sherley V. Sebelius: Stem Cells And The Uneasy Interplay Between The Federal Bench And The Lab Bench, Ryan P. O'Quinn

Duke Law & Technology Review

After Barack Obama's election to the presidency, he promised that one of his top priorities in office would be to relieve the restrictions initiated by President George W. Bush on federal funding of embryonic stem cell research. President Obama followed through on his promise, but the celebrations in the nation's research labs were short-lived. Anti-abortion advocates and other scientists working in the field that would allegedly be out-competed in the federal funding arena brought a legal challenge to the new government position. The struggle culminated in August 2010 with a federal district court issuing a preliminary injunction to halt the …

Exhausted Or Unlicensed: Can Field-Of-Use Restrictions In Biotech License Agreements Still Prevent Off-Label Use Promotion After Quanta Computer?, Kristal M. Wicks

The University of New Hampshire Law Review

[Excerpt] “In the biotechnology (biotech) industry, companies must be increasingly aware of their intellectual property and how their licensing strategies can impact their rights. When licensing patented technology, it is common practice for biotech companies to include restricted field-of-use provisions in their license agreements. Such provisions permit a licensee to only use licensed technology in a defined field and restrict use or development in another field. This licensing strategy plays an important role within the biotech industry because it allows companies to more effectively control their intellectual property and to more efficiently research and develop pharmaceutical products.

A problem that …

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 …

Juvenile Justice, Sullivan, And Graham: How The Supreme Court’S Decision Will Change The Neuroscience Debate, Johanna Cooper Jennings

Duke Law & Technology Review

Over the past twenty years, neuroscientists have discovered that brain maturation continues through an individual’s mid-twenties. The United States Supreme Court cited this research to support its abolition of the juvenile death penalty in Roper v. Simmons. Now the Court is faced with two cases that challenge the constitutionality of sentencing juveniles to life imprisonment without parole. Many believe these studies indicate that juveniles are both less culpable for their actions and more likely to reform; therefore, life in prison for juveniles is disproportionate, cruel, and unusual. However, others caution against the use of these studies in deciding issues of …

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

Faculty Scholarship

No abstract provided.

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.

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.

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.

The Future Of Generic Biologics: Should The United States “Follow-On” The European Pathway?, Ingrid Kaldre

Duke Law & Technology Review

The United States is embarking on a biotechnology drug revolution. In the last few decades, biotech drugs have saved millions of lives, and the market for these miracle cures continues to grow at an astronomical rate. Unfortunately, as the market for biotech drugs is skyrocketing, drug prices are following suit. As Congress strives to make these new drugs more affordable, it must not ignore significant safety concerns unique to these revolutionary therapies. Congress should follow the lead of the European Union to create an accessible pathway for generic forms of biotech drugs that includes strict regulatory measures to ensure drug …

Mckithen V. Brown: Due Process And Post-Conviction Dna Testing, Elizabeth A. Laughton

Duke Law & Technology Review

When the Second Circuit decided McKithen v. Brown, it joined an ever-growing list of courts faced with a difficult and pressing issue of both constitutional and criminal law: is there a federal constitutional right of post-conviction access to evidence for DNA testing? This issue, which sits at the intersection of new forensic technologies and fundamental principles of constitutional due process, has divided the courts. The Second Circuit, wary of reaching a hasty conclusion, remanded McKithen’s case to the district court for consideration. The district court for the Eastern District of New York was asked to decide whether a constitutional right …

Regulating Nanotechnology: A Private–Public Insurance Solution, Maksim Rakhlin

Duke Law & Technology Review

Nanotechnology promises to revolutionize innovation in nearly every industry. However, nanomaterials’ novel properties pose potentially significant health and environmental risks. Views in the current debate over nanotechnology regulation range from halting all research and development to allowing virtually unregulated innovation. One viable regulatory solution balancing commercialization and risk is the adoption of a mandatory private-public insurance program.

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

Law Faculty Scholarship

No abstract provided.

Combining The Components Of Life: The Application Of Patent Extraterritoriality Doctrine To Biotechnology, Jennifer L. Schuster

Indiana Law Journal

No abstract provided.