Biotechnology Commons^™

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.

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 …

Assessing The Universal Declaration On Bioethics And Human Rights: Implications For Human Dignity And The Respect For Human Life, O. Carter Snead

Journal Articles

As advances in biomedical science and biotechnology continue to confer vast new powers to subdue nature for “the relief of man’s estate,” vexed moral and ethical questions inevitably arise about the use of such capacities. To what ends should they be applied? How might they be abused? Are they safe? What is the human meaning of such new powers? Might their use threaten human dignity? What does scientific freedom demand? What does justice require? Who should have access to the fruits of such scientific advances?

In democratic regimes, these questions do not long remain the subject of mere academic reflection …

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 …

Neuroimaging, Entrapment, And The Predisposition To Crime, O. Carter Snead

Journal Articles

Professor Tovino's (2007) paper is a welcome contribution to the emerging body of scholarship on the issues arising at the nexus of cognitive neuroscience (and neuroimaging in particular) and the law. It is a useful overview of the various ways in which neuroimaging might affect a wide array of legal questions. Though many of the issues that Tovino discusses are at present quite speculative (as she acknowledges), it is always wise to take advantage of the rare opportunity to reflect on the legal, ethical, and public policy implications of developments in biotechnology before they are upon us. In that spirit, …

Why Technology Provides Compelling Reasons To Apply A Daubert Analysis To The Legal Standard Of Care In Medical Malpractice Cases, Nichole Hines

Duke Law & Technology Review

Traditionally, courts have applied a "customary practice" standard in determining the legal standard of care in medical malpractice cases. Recently, a few courts have abandoned this dated standard and instead applied a Daubert analysis to the standard of care, which focuses on medical evidence that is scientifically based . In light of these recent holdings, this iBrief argues that with the increasing amounts of technologies improving evidence-based medicine, the customary practice standard is no longer a useful or appropriate test for determining the standard of care in medical malpractice cases. By applying a Daubert analysis to an expert’s testimony on …

What, If Any, Are The Ethical Obligations Of The U.S. Patent Office? A Closer Look At The Biological Sampling Of Indigenous Groups, Marina L. Whelan

Duke Law & Technology Review

The patenting of biological resources collected from indigenous groups has become a controversial trend. Two U.S. patents in particular, one claiming a cell-line from a 26-year old Guayami woman and one claiming a leukemia virus from a Hagahai man in Papua New Guinea, demonstrate just how volatile this issue has become. This iBrief examines how, in light of such "ethically questionable" patents, the U.S. Patent Office has failed to implement any procedures to identify or curb patent applications involving indigenous peoples.

Merck V. Integra And Its Aftermath: A Safe Harbor For The Commercial Use Of Biotechnology Research Tools?, Brendan M. O'Malley

Cardozo Arts & Entertainment Law Journal

No abstract provided.

The New Challenges To The International Patentability Of Biotechnology: Legal Relations Between The Wto Treaty On Trade-Related Aspects Of Intellectual Property Rights And The Convention On Biological Diversity, Jonathan Curci

Brigham Young University International Law & Management Review

No abstract provided.

Attack Of The Clones: Legislative Approaches To Human Cloning In The United States, Adrienne N. Cash

Duke Law & Technology Review

The legal concerns involving the application of cloning technology to humans should be of utmost concern, as the area is extremely complex. Cloning could potentially have great benefits or disastrous effects. Lawmakers have been careful to make certain that the legislation passed is comprehensive and useful for regulation of the ever-changing field of cloning. From debates on whether reproductive or therapeutic cloning should be permitted or banned, to concerns as to who has jurisdiction over cloning, the battle to develop cloning legislation has been difficult. However, this iBrief argues that the currently-proposed federal legislation is constitutional.

When The Public Does Not Have A Right To Know: How The California Public Records Act Is Deterring Bioscience Research And Development, Nader Mousavi, Matthew J. Kleiman

Duke Law & Technology Review

Many bioscience firms collaborate with public research universities to conduct innovative research through sponsored research agreements. Companies sponsoring this research usually require strict confidentiality from their academic partners in order to protect sensitive information that, if revealed, could put them at a competitive disadvantage and threaten their ability to obtain future patents. Yet, ambiguous disclosure requirements in the California Public Records Act preclude California's public research universities from guaranteeing that proprietary information provided in connection with sponsored research agreements will remain confidential. Entering into such agreements with public universities in California is therefore a risky proposition for the sponsors. This …

Taking Biologics For Granted? Takings, Trade Secrets, And Off-Patent Biological Products, Andrew Wasson

Duke Law & Technology Review

Biologics are complex medicines which are often genetically engineered, and which are sure to play an important role in curing some of humankind's worst diseases. Not surprisingly, generic companies want a part of the biologic market. The FDA believes that it has the authority to approve off-patent versions of biologics that were originally regulated under the Food, Drug & Cosmetic Act, but in order to effectively do so the FDA would have to rely on findings based on data produced by the brand name companies. This iBrief examines whether the FDA's reliance on previous findings would give rise to a …

Disclosure Of Clinical Trial Data: Why Exemption 4 Of The Freedom Of Information Act Should Be Restored, Janene Boyce

Duke Law & Technology Review

Clinical trial data generated during the FDA drug approval process can be very valuable. While patients and doctors desperately need this information to make informed choices about medical treatment, drug sponsors strive to keep this resource secret to ensure their ability to profit from their own research. In the wake of the controversy over antidepressant use in children, both the public and Congress have called for the disclosure of all clinical trial data. However, rather than taking an all-or-nothing approach that could harm the development of new drugs, this iBrief argues that Congress should address the issue of trial data …

Regulating Innovative Medicine: Fitting Square Pegs In Round Holes, Mark Lavender

Duke Law & Technology Review

Increasingly, innovative medical products are creating a quandary for the Food and Drug Administration ("FDA") because they often transcend the FDA's traditional categorical approach to regulating medical products. In a recent attempt to simplify this process, the FDA has proposed a new rule for regulating "combination products." This iBrief discusses the FDA's current approach and analyzes the possible affects of the proposed regulation. Because of the many shortcomings of both systems, this iBrief concludes that the FDA should instead stop assigning center jurisdiction based on a product's "primary mode of action," and give the Office of Combination Products internal agency …

The Medicare Prescription Drug, Improvement, & Modernization Act Of 2003: Are We Playing The Lottery With Healthcare Reform?, Melissa Ganz

Duke Law & Technology Review

With millions of Americans unable to cope with the rising costs of prescription drugs, and many even forced to go without health insurance, the mounting pressure on Congress to enact major healthcare reform culminated in the Medicare Prescription Drug, Improvement, & Modernization Act of 2003. This iBrief examines this legislation, and concludes that it provides elusive benefits for seniors and merely creates a windfall for the pharmaceutical and insurance industries.

Are Biotech Crops And Conventional Crops Like Products? An Analysis Under Gatt, Julian Wong

Duke Law & Technology Review

The transatlantic debate over the use of genetically modified organisms ("GMO"s) as food products, with the US as a proponent on one side, and the European Union ("EU") as an opponent on the other, is set to take center stage. The US has initiated formal legal action under the World Trade Organization Dispute Settlement System, charging that the EU violates several agreements of international trade law, including Article III of GATT, an anti-protectionist measure which forbids a country from favoring its own products over imported "like products." The US claims that GMOs and conventional crops are "like products,, and that …

Hatch–Waxman Reform And Accelerated Market Entry Of Generic Drugs: Is Faster Necessarily Better?, Sarah E. Eurek

Duke Law & Technology Review

Recently there has been a considerable amount of pressure to accelerate consumer access to generic drugs, which are significantly less expensive than their brand-name counterparts. One way to bring generic drugs on to the market sooner is through revision of the existing law relating to pharmaceutical patents. This iBrief describes recent regulatory changes to the Drug Price Competition and Patent Term Restoration Act (the Hatch-Waxman Act), which governs the patenting process for new drug products, as well as current legislative efforts to speed generic access through Hatch-Waxman reform. This iBrief also assesses whether these changes will be beneficial to consumers …

Reviving Informed Consent: Using Risk Perception In Clinical Trials, Dana Ziker

Duke Law & Technology Review

The current doctrine of informed consent falls far short of its potential to serve as a valuable safeguard for human research subjects. Instead of providing a channel of communication between physician and subject, informed consent is a lifeless entity responsible for a large portion of the misunderstanding existing between these parties. Acknowledging risk perception principles may help transform the informed consent process into an effective communication of health risks.

The Case For National Dna Identification Cards, Ben Quarmby

Duke Law & Technology Review

Foes of the United States have demonstrated their ability to strike at the heart of this country. Fear of renewed attacks and a desire for greater national security have now prompted many to call for improvements in the national personal identification system. In particular, the possibility of a national identification card containing the carrier's DNA information is being seriously considered. However, this raises difficult questions. Would such a card system, and the extraction of individuals' DNA it entails, violate the 4th Amendment of the Constitution? This article will show that such a card system could in fact be found to …

Patenting Genome Research Tools And The Law., Rebecca S. Eisenberg

Articles

Patenting genes encoding therapeutic proteins was relatively uncontroversial in the early days of biotechnology. Controversy arose in the era of high-throughput DNA sequencing, when gene patents started to look less like patents on drugs and more like patents on scientific information. Evolving scientific and business strategies for exploiting genomic information raised concerns that patents might slow subsequent research. The trend towards stricter enforcement of the utility and disclosure requirements by the patent offices should help clarify the current confusion.

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 …

Defining A New Ethical Standard For Human In Vitro Embryos In The Context Of Stem Cell Research, Sina A. Muscati

Duke Law & Technology Review

This iBrief discusses some of the social, ethical and legal considerations surrounding the use of unimplanted, in vitro embryos in stem cell research. It proposes that a new ethical standard be elucidated for these embryos. The iBrief gives an overview of two proposals for such a standard at opposite ends of the spectrum: treating the in vitro embryo as a legal person versus treating it as mere property. It argues against both approaches. The former can have undesirable social implications including undue interference with female reproductive autonomy, while the latter would objectify potential human life and reproductive potential. The iBrief …

Regulating Functional Foods: Pre- And Post-Market Strategy, Dana Ziker

Duke Law & Technology Review

As best we understand the government, its first argument runs along the following lines: that health claims lacking "significant scientific agreement" are inherently misleading because they have such an awesome impact on consumers as to make it virtually impossible for them to exercise any judgment at the point of sale. It would be as if the consumers were asked to buy something while hypnotized, and therefore they are bound to be misled. We think this contention is almost frivolous.

Genetic Testing In The Workplace: The Employer’S Coin Toss, Samantha French

Duke Law & Technology Review

A toss of the coin by the modern-day employer reveals two options regarding genetic testing in the workplace. The employer may choose to take advantage of increasingly precise, available, and affordable genetic testing in order to ascertain the genetic characteristics - and deficiencies - of its employees. This outcome exposes the employer to a vast array of potential litigation and liability relating to the Americans with Disabilities Act, the Fourth Amendment, Title VII of the Civil Rights Act, and state legislation designed to protect genetic privacy. Alternatively, the employer may neglect to indulge in this trend of genetic testing and …

Customizing Conception: A Survey Of Preimplantation Genetic Diagnosis And The Resulting Social, Ethical, And Legal Dilemmas, Jason Christopher Roberts

Duke Law & Technology Review

One in six American couples experience difficulties conceiving a child. With fertility rates at an all time low, the business of treating infertility is booming. However, due to the United States prohibition on government funding for embryonic research, the $4 billion industry of assisted reproductive technologies (ART) has been incompletely monitored and largely removed from oversight. Additionally, due to the fervent abortion debate, in vitro fertilization (IVF) was introduced in the United States without a research phase and procedures have been forced to evolve in the private sector. Thus, the checks and balances on medical innovation that are generally imposed …

Appropriate Aims: Setting Boundaries For Reprogenetic Technology, Dana Ziker

Duke Law & Technology Review

Not too long ago, ten fingers and ten toes defined a successful birth. Not too far from now, ten fingers and ten toes will be just the beginning. Parents always hope for a healthy baby, and medical advances continue to help secure the fulfillment of this hope. But reprogenetics, a new combination of technology and science that allows us to choose the genes, and thus the traits, of the children we create, is raising new questions about what it means to have a healthy baby.

Egregious Error Or Admirable Advance: The Memorandum Of Understanding That Enables Federally Funded Basic Human Embryonic Stem Cell Research, Amy Ligler

Duke Law & Technology Review

Nothing contained herein shall be considered to be the grant of a commercial license or right under the Wisconsin Patent Rights or to Wisconsin Materials. Furthermore, nothing contained herein shall be construed to be a waiver of WiCell's patent rights under the Wisconsin Patent Rights or WiCell's property rights in Wisconsin Materials.

Patenting Resources: Biotechnology And The Concept Of Sustainable Development, Yvonne Cripps

Indiana Journal of Global Legal Studies

No abstract provided.

A Reconsideration Of The Physicians’ Immunity Statute, Steve Dirksen

Duke Law & Technology Review

The author assesses the "physicians' immunity statute" from legal policy, ethical, and financial perspectives, and concludes that alternatives such as licensure and monetary incentives would better serve the goal of encouraging invention more effectively by rewarding it.

Preparing For Bioinformatics Litigation: How Will The Courts Confront The Next Generation Of Biotechnology Patents?, Scott D. Locke, David A. Kalow

Buffalo Intellectual Property Law Journal

No abstract provided.