Science and Technology Law Commons^™

U.S. Private On-Orbit Space Situational Awareness Systems And Services: Legal And Regulatory Challenges, Michael Mineiro

Space Traffic Management Conference

One component of Space Traffic Management (STM) is on-orbit Space Situational Awareness (SSA) systems and services. Advances in technology and a growing demand for SSA services, information, and data, coupled with U.S. Government policy that promotes the purchase and use of commercial SSA capabilities, means that private commercial sector is likely to have an important role to play. To date, there is no federal agency with clear jurisdiction over on-orbit remote sensing operations. This paper examines the current regulatory framework, identifies gaps and limitations, and identifies possible ways forward.

Is Ip Law Modernization Possible? Assessing Approaches In Acta, Sopa, And Bill C-11, Lauren Gray Farrar

Georgia Journal of International & Comparative Law

No abstract provided.

Of Pornography Pirates And Privateers: Applying Fdcpa Principles To Copyright Trolling Litigation, Henry D. Alderfer

William & Mary Law Review

No abstract provided.

Making Smart Decisions About Surveillance: A Guide For Communities, Chris Conley, Matthew Cagle, Peter Bibring, Jessica Farris, Linda Lye, Mitra Ebadolahi, Nicole Ozer

Faculty Scholarship

California communities are increasingly grappling with whether to deploy new surveillance technologies ranging from drones to license plate readers to facial recognition. This is understandable, since public safety budgets are tight, technology vendors promise the ability to do more with less, and federal agencies or industry sponsors may even offer funding.

But surveillance can be both less effective and far more costly to local agencies and to the community at large than initially imagined, leaving communities saddled with long-term bills for surveillance that doesn't end up making the community safer. Surveillance can also be easily misused, leading to the erosion …

Swearing By New Technology: Strengthening The Fourth Amendment By Utilizing Modern Warrant Technology While Satisfying The Oath Or Affirmation Clause, Andrew H. Bean

BYU Law Review

No abstract provided.

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 …

The Internet Is The New Public Forum: Why Riley V. California Supports Net Neutrality, Adam Lamparello

Adam Lamparello

Technology has ushered civil liberties into the virtual world, and the law must adapt by providing legal protections to individuals who speak, assemble, and associate in that world. The original purposes of the First Amendment, which from time immemorial have protected civil liberties and preserved the free, open, and robust exchange of information, support net neutrality. After all, laws or practices that violate cherished freedoms in the physical world also violate those freedoms in the virtual world. The battle over net neutrality is “is absolutely the First Amendment issue of our time,” just as warrantless searches of cell phones were …

Blue Helmets In The Next Frontier: The Future Is Now, Sean R. Mikula

Georgia Journal of International & Comparative Law

No abstract provided.

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.

"Do No Harm": A Comparative Analysis Of Legal Barriers To Corporate Clinical Telemedicine Providers In The United States, Australia, And Canada, Ian R. Landgreen

Georgia Journal of International & Comparative Law

No abstract provided.

E-Books, Collusion, And Antitrust Policy: Protecting A Dominant Firm At The Cost Of Innovation, Nicholas Timchalk

Seattle University Law Review

Amazon’s main rival, Apple, went to great lengths and took major risks to enter the e-book market. Why did Apple simply choose not to compete on the merits of its product and brand equity (the iPad and iBookstore) as it does with its other products? Why did Apple decide not to continue to rely on its earlier success of situating its products differently in the market than other electronics and working hard to be different and cutting-edge with its e-book delivery? This Note argues that the combination of Amazon’s 90% market share, network externalities, and an innovative technology market creates …

Cgmp Violations Should Not Be Used As A Basis For Fca Actions Absent Fraud, Kyle Faget

Seattle University Law Review

Since Congress amended the False Claims Act (FCA) in 1986, the statute has evolved into a seemingly boundless weapon for enforcing other statutes and regulations applicable to every industry that accepts any form of government funding. Use of the FCA by the Department of Justice (DOJ) and by private citizens bringing actions on behalf of the U.S. government to enforce other statutes and regulations is particularly evident in the field of health care. The FCA has been utilized in actions where the allegations include off-label promotion of drugs, kickbacks, and violations of current good manufacturing practices (cGMPs) by linking the …

Ironic Simplicity: Why Shaken Baby Syndrome Misdiagnoses Should Result In Automatic Reimbursement For The Wrongly Accused, Jay Simmons

Seattle University Law Review

Shaken baby syndrome (SBS)’s shortcomings include the debatable science behind SBS theory and diagnosis—the questioning of which has grown more vociferous—and the arguably biased, discriminatory treatment of the accused. Professor Deborah Tuerkheimer notes that the evolving SBS skepticism and contentious debate has resulted in "chaos" in many SBS adjudications and within the medical and biomechanical fields, with the same SBS proponents and opponents continually crusading for and clashing over their beliefs. The issues surrounding the medical and biomechanical components of SBS diagnoses have been repeatedly examined and discussed, and are not the focus of this Note. This Note recounts those …

‘Point And Click’ Versus Byod: Student Engagement Technologies As An Ethical Imperative For Teaching Law, Elizabeth A. Kirley

Elizabeth A Kirley

What conscientious law professor of first year, large format classes in torts, contracts, or criminal law has not pondered how to better engage students while easing their reluctance to speak out in class? While many students entering law schools are quite adept with student engagement technologies (SETs) from their undergraduate studies, some law faculty seem tied to the passive environment of lectures and PowerPoint presentations and hence reject SET methodologies as so much techno-wizardry. With the entry of web-based programs into the expanding field of SETs, and increasing empirical evidence that interactive learning improves grades, closes gender gaps, and helps …

For Sale--One Level 5 Barbarian For 94,800 Won: The International Effects Of Virtual Property And The Legality Of Its Ownership, Alisa B. Steinberg

Georgia Journal of International & Comparative Law

No abstract provided.

Sexting Prosecutions: Minors As A Protected Class From Child Pornography Charges, Sarah Thompson

University of Michigan Journal of Law Reform Caveat

"Firt love is only a little foolishness and a lot of curiosity." -- George Bernard Shaw Teenagers will explore their sexuality; this is no new phenomenon. However, the ways that teens are exploring their curiosity is changing with technology. This trend has serious repercussions for teens, society, and the law. ‘Sexting’—defined as the act of sending sexually explicit photographs or messages via cell phone—is one recently-developed means of sexual exploration. The practice overlaps with the production, distribution, and possession of child pornography that is banned by both state and federal law. Due to the overlap, minors have been prosecuted under …

International Trade Law And The U.S.-Eu Gmo Debate: Can Africa Weather This Storm?, Michelle K. Mcdonald

Georgia Journal of International & Comparative Law

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 …

Regulation Of Chemical Risks: Lessons For Tsca Reform From Canada And The European Union, Adam Abelkop, John D. Graham

Adam Abelkop

The United States Congress is considering reform of the Toxic Substances Control Act (TSCA) of 1976. This Article compares recent reforms in Europe and Canada in order to draw lessons for TSCA reform. In 2006, the European Union enacted the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) regulation while Canada used existing authority under the Canadian Environmental Protection Act (CEPA) of 1999 to initiate the 2006 Chemicals Management Plan (CMP). Focusing on the tens of thousands of industrial chemicals now in use in the US, we offer several suggestions for TSCA reform based on the European and Canadian experiences. …

Innovations In Mobile Broadband Pricing, Daniel Lyons

Daniel Lyons

No abstract provided.

Legal And Scientific Flaws In The Myriad Genetics Litigation, Eric Grote

Eric Grote

In Association for Molecular Pathology v. Myriad Genetics, the Supreme Court held that Myriad’s isolated BRCA DNA patent claims were invalid because an isolated DNA with the same sequence as a natural DNA is a product of nature. The decision has two fundamental flaws. First, due to a faulty claim construction by the trial court, the Supreme Court was never informed that isolated DNA is a synthetic molecule that is not actually isolated from nature, or that isolated DNA lacks functional information encoded by chemical modifications present in natural human DNA. Second, the Court ignored a long line of …

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 …