Biotechnology Commons^™

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 …

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, …

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 …

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 …

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.

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.

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 …

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.

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.

The Clone Wars: The Growing Debate Over Federal Cloning Legislation, John Garvish

Duke Law & Technology Review

As readers of science fiction are well aware, the term "clone" refers to asexually produced offspring, that is, offspring produced by a process of cell-division which does not begin with the union of two sex cells. A clone is the genetic twin of the cell donor. Propagation of plants by this method is, of course, commonplace, but mammalian reproduction in this fashion would indeed be a revolutionary accomplishment, with profound and disturbing implications.

Where The Wild Wind Blows: Genetically Altered Seed And Neighboring Farmers, Jill Sudduth

Duke Law & Technology Review

In March 2001, agro-business giant Monsanto won a victory in Canadian Federal Court over Saskatchewan farmer Percy Schmeiser. This case sets international precedent for appropriated seed cases and illustrates the primary concerns American courts must face as they consider Monsanto's prosecution of 22 cases against American farmers.

The Fate Of Gene Patents Under The New Utility Guidelines

Duke Law & Technology Review

The United States Patent and Trademark Office (PTO) recently finalized its patent utility guidelines. Promulgated by the PTO, the new guidelines will be used by patent examiners in determining whether a claimed invention should be awarded patent protection ;and will be used by patent applicants and attorneys who file patent applications. The guidelines focus primarily on the utility standards for gene and gene fragment patents, an issue that was featured in the PTO's 1999 Revised Interim Utility Guidelines and has been the subject of considerable public debate.