Biotechnology Commons^™

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 …

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 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 …

Diagnostic Patents At The Supreme Court, Arti K. Rai

Faculty Scholarship

No abstract provided.

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 …

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.

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, …

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 …

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.

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.

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 …

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.