Science and Technology Law Commons^™

Maintaining Competition In Copying: Narrowing The Scope Of Gene Patents, Oskar Liivak

Oskar Liivak

In supporting gene patents, the patent office, the courts and other supporters have assumed that gene discoveries are identical to traditional inventions and therefore the patent system should treat them as identical. In other words, they have assumed that the relatively broad claims that are used for traditional inventions are also appropriate for encouraging gene discovery. This article examines this assumption and finds that gene discoveries are critically different from traditional inventions and concludes that the patent system cannot treat them as identical.

As a doctrinal matter, this article applies the generally overlooked constitutional requirements of inventorship and originality and …

Life, Death, And Neuroimaging: The Advantages And Disadvantages Of The Defense's Use Of Neuroimages In Capital Cases - Lessons From The Front, John H. Blume, Emily C. Paavola

John H. Blume

The use of neuroimaging in capital cases has become increasingly common. An informal survey of cases produced over one hundred opinions from reported decisions alone discussing the use of computed tomography (CT) scanning, magnetic resonance imaging (MRI), functional MRI, positron emission tomography (PET) scans, single-photon emission computed tomography (SPECT) scans, and similar technology in capital cases. This article gives practical advice to defense counsel considering the use of neuroimaging in a capital case. We discuss how, in the right case, this technology can be a valuable investigative tool used to produce an important component of a successful mitigation story. However, …

The Sitting Ducks Of Securities Class Action Litigation: Bio-Pharmas And The Need For Improved Evaluation Of Scientific Data, Stuart R. Cohn, Erin M. Swick

Stuart R. Cohn

Rule 10b-5, a powerful weapon against any publicly-listed company whose share price drops on adverse news, is particularly skewed against pharmaceutical and other bio-technology companies (bio-pharmas). It is not a coincidence that there is a disproportionate number of class actions filed against bio-pharmas. The volume and complexity of data underlying most bio-pharma cases create enormous outcome uncertainties, settlement pressures, and potentially huge contingent liabilities over substantial periods of time. The vulnerability and risks that bio-pharmas face in Rule 10b-5 class actions are unique among all publicly-traded industries, yet many cases proceed along traditional grounds without courts employing either their statutory …

On Patenting Human Organisms Or How The Abortion Wars Feed Into The Ownership Fallacy, Yaniv Heled

Yaniv Heled

The idea of ominous technologies that put human individuals or parts of their bodies under someone else's control has been stirring emotions and terrifying people for centuries. It was a recent offshoot of this idea--the notion of “patenting humans”--that mobilized certain members of Congress to pass legislation prohibiting the issuance of patent claims “directed to or encompassing a human organism.” The values underlying this legislation may well have been agreeable, even admirable. Yet, the actual motivation for it was misguided; its execution, deeply flawed; its potential outcomes, hazardous

This Article reviews the history and background of this prohibition. It fleshes …

Privacy, Accountability, And The Cooperating Defendant: Towards A New Role For Internet Access To Court Records, Caren Morrison

Caren Myers Morrison

Now that federal court records are available online, anyone can obtain criminal case files instantly over the Internet. But this unfettered flow of information is in fundamental tension with many goals of the criminal justice system, including the integrity of criminal investigations, the accountability of prosecutors and the security of witnesses. It has also altered the behavior of prosecutors intent on protecting the identity of cooperating defendants who assist them in investigating other targets. As prosecutors and courts collaborate to obscure the process by which cooperators are recruited and rewarded, Internet availability, instead of enabling greater public understanding, risks degrading …

The Disabling Impact Of Wrongful Birth And Wrongful Life Actions, Wendy Hensel

Wendy F. Hensel

This article explores the torts of wrongful birth and wrongful life, which primarily arise when a physician or laboratory is negligent in the context of pre-natal genetic testing. In wrongful birth actions, the parents claim that if they had been properly informed of the genetic defect, they would have aborted their now-existing child or prevented his conception. In wrongful life actions, the disabled child brings suit in his own name claiming that it would have been better if he had never existed in the first place. Central to such actions is the child's assertion that his parents rightfully should have …

On Presidents, Agencies, And The Stem Cells Between Them: A Legal Analysis Of President Bush's And The Federal Governments Policy On The Funding Of Research Involving Human Embryonic Stem Cells, Yaniv Heled

Yaniv Heled

On August 9, 2001, President George W. Bush announced his policy on research involving human embryonic stem cells and proclaimed that federal funding would be allocated only to research involving human embryonic stem cell lines produced prior to his announcement (the Directive). Immediately thereafter, the National Institutes of Health (NIH) announced that it would act in accordance and full compliance with the Directive and took action to implement it. Since then, the Directive has dictated the nature and extent of scientific research involving human embryonic stem cells. Yet, astonishingly, despite being the subject of a boisterous debate, the Directive’s legality …

Patents Vs. Statutory Exclusivities In Biological Pharmaceuticals - Do We Really Need Both?, Yaniv Heled

Yaniv Heled

On March 23, 2010, President Obama signed into law the Biologics Price Competition and Innovation Act (BPCIA) as part of the Patient Protection and Affordable Care Act (also known as the Healthcare Bill). BPCIA sets up a framework for the approval of generic biologics and provides for up to 12.5 years of market exclusivity for FDA approved bio-pharmaceutical products. The exclusivity is intended to run in parallel and in addition to any patents that may apply to such approved bio-pharmaceutical products, which would also grant the developers of these products monopolies in the underlying technologies on which such bio-pharmaceutical products …

The Regulation Of Genetic Aspects Of Donated Reproductive Tissue - The Need For Federal Regulation, Yaniv Heled

Yaniv Heled

It is estimated that egg and sperm donations account for more than 60,000 births every year in the United States. However, surprisingly, and despite common misconceptions, there are no federal requirements and barely any state requirements to screen and test sperm and egg donors for genetic diseases. The only nationwide standards for genetic screening and testing of donated reproductive tissue are guidelines created by professional organizations, but compliance with those guidelines is voluntary so they cannot be enforced effectively. Furthermore, the few reported cases involving children born from genetically-compromised reproductive tissue illustrate the court system’s failure to afford such children …

Patents V. Statutory Exclusivities In Biological Pharmaceuticals - Do We Really Need Both, Yaniv Heled

Yaniv Heled

Over the past decade or so, the United States has been the arena of a boisterous debate regarding the creation of a new regulatory framework for the approval of generic versions of biologics-based pharmaceutical products (also known as "biological products" and "biologics")--an important and increasingly growing class of drugs. The basic purpose of such a framework is to create a fast and less-costly route to FDA approval for biologics that would be similar or identical to already-approved biological products--typically ones that are sold on the market at monopoly rates--thereby allowing cheaper versions of such medicines to enter the market. One …

Healthcare Reform Creates Pathway For Biosimilar Biologics, Frederick Rein, Scott Warren, Yaniv Heled

Yaniv Heled

No abstract provided.

Response To 'Pervasive Sequence Patents Cover The Entire Human Genome', Shine Tu, Yaniv Heled

Yaniv Heled

In a widely reported article by Jeffrey Rosenfeld and Christopher Mason published in Genome Medicine, significant misstatements were made, because the authors did not sufficiently review the claims – which define the legal scope of a patent – in the patents they analyzed. Specifically, the authors do not provide an adequate basis for their assertion that 41% of the genes in the human genome have been claimed.

Why Deny Parents New Technology?, Yaniv Heled

Yaniv Heled

No abstract provided.

One Hundred Nos: An Empirical Analysis Of The First 100 Denials Of Institution For Inter Partes And Covered Business Method Patent Reviews, Jonathan R. K. Stroud, Jarrad Wood

Jonathan R. K. Stroud

Tasked in 2011 with creating three powerful new patent review trial regimes, the U.S. Patent and Trademark Office—through the efforts of their freshly empowered quasi-judicial body, the Patent Trial and Appeals Board—set to creating a fast-paced trial with minimal discovery and maximum efficiency. In the first two years of existence, the proceedings have proved potent, holding unpatentable many of the claims that reach decisions on the merits. Yet a small subsection of petitions never make it past the starting gate, resulting in wasted time and effort on the parts of petitioners—and likely sighs of relief from the rights-holders. Parties on …

Innovations In Mobile Broadband Pricing, Daniel Lyons

Daniel Lyons

No abstract provided.

Digital Innocence, Joshua A.T. Fairfield, Erik Luna

Erik Luna

Recent revelations have shown that almost all online activity and increasing amounts of offline activity are tracked using Big Data and data mining technologies. The ensuing debate has largely failed to consider an important consequence of mass surveillance: the obligation to provide access to information that might exonerate a criminal defendant. Although information technology can establish innocence—an ability that will only improve with technological advance—the fruits of mass surveillance have been used almost exclusively to convict. To address the imbalance and inform public dialogue, this Article develops the concept of “digital innocence” as a means of leveraging the tools of …

Digital Innocence, Joshua A.T. Fairfield, Erik Luna

Joshua A.T. Fairfield

Recent revelations have shown that almost all online activity and increasing amounts of offline activity are tracked using Big Data and data mining technologies. The ensuing debate has largely failed to consider an important consequence of mass surveillance: the obligation to provide access to information that might exonerate a criminal defendant. Although information technology can establish innocence—an ability that will only improve with technological advance—the fruits of mass surveillance have been used almost exclusively to convict. To address the imbalance and inform public dialogue, this Article develops the concept of “digital innocence” as a means of leveraging the tools of …

Presentation, The Perils Of Internet Interconnection Disclosure, Daniel Lyons

Daniel Lyons

No abstract provided.

Empiricism In Daubert And The California Supreme Court In Sargon, Robert Sanger

Robert M. Sanger

California has become a Daubert state. In Sargon v. The University of Southern California, the California Supreme Court held that judges are the “gatekeepers” with regard to expert or scientific evidence in this state, just as has been the case in the federal system (and many other states) since the decision in Daubert. Now that California is avowedly a Daubert state, it is important to understand why courtroom evidence – scientific, expert or, for that matter, otherwise – is properly grounded in empiricism. Empiricism is the theory that knowledge is derived from experience. Understanding this empirical basis for both Daubert …

Teaching The Biological Clock: Age-Related Fertility Decline And Sex Education, Kerry Macintosh

Kerry L Macintosh

Fertility in women declines significantly at age thirty-two and takes a sharp downward turn at age thirty-seven. Miscarriages also increase with age. In vitro fertilization cannot reverse the effects of aging, and embryo screening, egg freezing, and egg donation are imperfect solutions.

Unfortunately, many women fail to grasp these facts until it is too late. Various factors are to blame, including physicians who shy away from the topic of age-related fertility decline, persistent messaging about the need for pregnancy prevention (implying that conception is easy), and media accounts of celebrities who are pregnant in their forties.

This Article argues that …

Self-Defense Against Robots, A. Michael Froomkin, Zak Colangelo

A. Michael Froomkin

This paper examines when, under U.S. law, humans may use force against robots to protect themselves, their property, and their privacy. May a landowner legally shoot down a trespassing drone? May she hold a trespassing autonomous car as security against damage done or further torts? Is the fear that a drone may be operated by a paparazzo or a peeping Tom sufficient grounds to disable or interfere with it? How hard may you shove if the office robot rolls over your foot? This paper addresses all those issues and one more: what rules and standards we could put into place …

“Can I Profit From My Own Name And Likeness As A College Athlete?” The Predictive Legal Analytics Of A College Player’S Publicity Rights Vs. First Amendment Rights Of Others, Roger M. Groves

Roger M. Groves

Two federal court decisions during 2013 have changed the game for college students versus the schools, the NCAA and video game makers. This article explores whether for the first time in history these athletes can profit from their own name and likeness and prevent others from doing so. But those cases still leave many untested applications to new facts – facts that the courts have not faced. Particularly intriguing is how 21st Century technology will apply to this area in future litigation. No publicity rights case or article to date has explored the application of predictive analytics, computer programs, algorithms, …

The "Progress Clause": An Empirical Analysis Based On The Constitutional Foundation Of Patent Law, Lori Andrews

Lori B. Andrews

The Fashion Lottery: Cooperative Innovation In Stochastic Markets, Jonathan Barnett, Gilles Grolleau, Sana El Harbi

Jonathan M Barnett

The fashion market is an anomaly: innovation is vigorous but original producers are substantially unprotected against imitation, which proliferates under an incomplete property regime consisting of strong trademark protections and weak design protections. We account for this anomaly through a “cooperative innovation” model where producers prefer an incomplete property regime that permits some imitation to alternative regimes that permit no imitation or all imitation, independent of budget constraints. A property regime that permits positive but limited levels of imitation operates as a form of group insurance that alleviates the risk of recoupment failure in a market characterized by demand uncertainty, …

Property As Process: How Innovation Markets Select Innovation Regimes, Jonathan M. Barnett

Jonathan M Barnett

It is commonly asserted that innovation markets suffer from excessive intellectualproperty protections, which in turn stifle output. But empirical inquiries can neither confirm nor deny this assertion. Under the “agnostic” assumption that we cannot assess directly whether intellectual-property coverage is excessive, an alternative query is proposed: can the market assess if any “propertization outcome” is excessive and then undertake actions to yield a socially preferable outcome? Grounded in the “bottom up” methodology of new institutional economics, this process-based approach takes the view that innovator populations make rent-seeking investments that continuously “select” among a range of “innovation regimes” that trade off …

From Patent Thickets To Patent Networks: The Legal Infrastructure Of The Digital Economy, Jonathan M. Barnett

Jonathan M Barnett

Scholarly and popular commentary often assert that markets characterized by intensive patent issuance and enforcement suffer from “patent thickets” that suppress innovation. This assertion is difficult to reconcile with continuous robust levels of R&D investment, coupled with declining prices, in technology markets that have operated under intensive patent issuance and enforcement for several decades. Using network visualization software, I show that information and communication technology markets rely on patent pools and other cross-licensing structures to mitigate or avoid patent thickets and associated inefficiencies. Based on the composition, structure, terms and pricing of selected leading patent pools in the ICT market, …

E-Commerce Regulation: Necessity, Futility, Disconnect, Eliza Mik

Eliza Mik

Existing e-commerce regulations constitute a premature and unnecessary interference in the natural evolution of commercial practices and technologies. I question not just their quality, mainly attributable to the technological ignorance of the regulator, but their very necessity. I observe the practical futility of drafting effective regulatory instruments in areas subject to continuous and unpredictable technological change. I criticize the overly homogenous approach to "everything Internet" (i.e. everything involving the Internet requires new law) as well as the creation of new regulatory spheres and legal categories. Some might claim that it is too early for a critical retrospective of this subject. …

The Limits Of Regulatory Science In Transnational Governance Of Transgenic Plant Agriculture And Food Systems, Taiwo Oriola

Taiwo Oriola

The current national and transnational regulatory and policy framework for transgenic plant agriculture and food is arguably largely defined by science. Notably, transgenic plant agriculture policy deference to science is ostensibly premised on the general perception that science is neutral, objective, reliable, and agnostic. This is exemplified by cases ranging from Alliance for Bio-integrity v Donna Shalala, European Communities: Measures Affecting the Approval and Marketing of Biotech Products, to European Commission v Republic of Poland, in which conscientious, ethical, religious, and cultural oppositional grounds to transgenic plant agriculture and food were trumped by scientific imperatives. However, the lack of unanimity …

Drones, Henry H. Perritt Jr., Eliot O. Sprague

Henry H. Perritt, Jr.

California Egg Toss - The High Costs Of Avoiding Unenforceable Surrogacy Contracts, Jennifer Jackson

Jennifer Jackson

In an emotionally charged decision regarding surrogacy contracts, it is important to recognize the ramifications, costs, and policy. There are advantages to both “gestational carrier surrogacy” contracts and “traditional surrogacy” contracts. However, this paper focuses on the differences between these contracts using case law. Specifically, this paper will focus on the implications of California case law regarding surrogacy contracts. Cases such as Johnson v. Calvert and In Re Marriage of Moschetta provide a clear distinction between these contracts. This distinction will show that while gestational carrier surrogacy contracts are more expensive, public policy and court opinions will provide certainty and …