Law Commons^™

Inventive Steps: The Crispr Patent Dispute And Scientific Progress, Jacob S. Sherkow

Other Publications

Recent decisions by patent offices in the USA and Europe concerning the revolutionary gene-editing technology, CRISPR/Cas9, have shed light on the importance — and puzzles — of one particular area of patent law: “nonobviousness”, as it known in the USA, or, in Europe, the “inventive step”. Patent law does not always neatly align itself with the realities of biological research. But these competing decisions from the U.S. Patent and Trademark Office and the European Patent Office have put those differences on parade. Unpacking these standards for CRISPR tell us a lot about how advances in biology are actually made — …

Authenticating Digital Evidence, Paul W. Grimm, Daniel J. Capra, Gregory P. Joseph

Faculty Scholarship

No abstract provided.

"Through A Glass, Darkly" Technical, Policy, And Financial Actions To Avert The Coming Digital Dark Ages, Richard S. Whitt

Santa Clara High Technology Law Journal

"Through A Glass, Darkly" Technical, Policy, and Financial Actions to Avert the Coming Digital Dark Ages

Fda’S Efforts To Tame The 'Wild West' Of Regenerative Medicine, Christopher M. Holman

Faculty Works

Stem cell-based regenerative therapies hold the potential to address a host of health concerns, particularly congenital, age-related, and trauma-induced injuries, and diseases involving organ and tissue degeneration, conditions that have proven refractory to conventional drug-based approaches. For the time being, however, there is little in the way of solid evidence supporting the safety and efficacy of most cell-based therapeutic approaches (with the notable exception of hematopoietic stem cells used to treat diseases of the blood and immune system). This Holman Report begins with an overview of the current uncertain regulatory status of regenerative medicine in the U.S., including several draft …

The Supreme Court’S Devaluation Of U.S. Patents, Christopher M. Holman

Faculty Works

In a span of three weeks during the spring of 2017, the U.S. Supreme Court issued three patent decisions, bringing the total number of patent decisions for the 2016-2017 term to six. This means that the October 2016 term ties the previous record of six patent decisions in the October 2014 term. This represents a tremendous increase in the number of patent decisions compared to earlier times, and particularly the early days of the Federal Circuit. For reference, during the first quarter of a century the Federal Circuit was in existence, the Supreme Court heard on average less than one …

Re-Framing Biotechnology Regulation, Alison Peck

Law Faculty Scholarship

Biotechnology is about to spill the banks of federal regulation. New genetic engineering techniques like CRISPR-Cas9 promise revolutionary breakthroughs in medicine, agriculture, and public health-but those techniques would not be regulated under the terms of the Coordinated Framework for Regulation of Biotechnology. This revolutionary moment in biotechnology offers an opportunity to correct the flaws in the framework, which was hastily patched together at the advent of the technology. The framework has never captured all relevant technologies, has never satisfied the public that risk is being effectively managed, and has never been accessible to small companies and publicly-funded labs that increasingly …

Privacy, Vulnerability, And Affordance, Ryan Calo

Articles

This essay begins to unpack the complex, sometimes contradictory relationship between privacy and vulnerability. I begin by exploring how the law conceives of vulnerability — essentially, as a binary status meriting special consideration where present. Recent literature recognizes vulnerability not as a status but as a state — a dynamic and manipulable condition that everyone experiences to different degrees and at different times. I then discuss various ways in which vulnerability and privacy intersect. I introduce an analytic distinction between vulnerability rendering, i.e., making a person more vulnerable, and the exploitation of vulnerability whether manufactured or native. I also describe …

Artificial Intelligence Policy: A Primer And Roadmap, Ryan Calo

Articles

Talk of artificial intelligence is everywhere. People marvel at the capacity of machines to translate any language and master any game. Others condemn the use of secret algorithms to sentence criminal defendants or recoil at the prospect of machines gunning for blue, pink, and white-collar jobs. Some worry aloud that artificial intelligence will be humankind’s “final invention.” This essay, prepared in connection with UC Davis Law Review's 50th anniversary symposium, explains why AI is suddenly on everyone's mind and provides a roadmap to the major policy questions AI raises. The essay is designed to help policymakers, investors, technologists, scholars, and …

In Defense Of Secondary Pharmaceutical Patents: Response To The Un's Guidelines For Pharmaceutical Patent Examination, Christopher M. Holman

Faculty Works

In 2015 the United Nations Development Programme issued a document entitled Guidelines for Pharmaceutical Patent Examination: Examining Pharmaceutical Patents from a Public Health Perspective (the “Guidelines”). The heart of the Guidelines is a category-by-category examination of eight types of “secondary” pharmaceutical patent claims: Markush claims; selection patents; polymorphs; enantiomers; salts; ethers and esters; compositions; doses; combinations; prodrugs; metabolites; and new medical uses. The Guidelines advise patent offices to apply heightened patentability requirements to these claims in a manner that would effectively deny patent protection to important pharmaceutical innovations currently afforded patent protection. In particular, the Guidelines postulate that many forms …

Conceptualizing Cryptolaw, Carla L. Reyes

Faculty Journal Articles and Book Chapters

Sweden transfers its real property recording system to the blockchain, a software protocol that enables public, cryptographically secure transaction verification without reliance upon a trusted third party. Dubai plans to issue blockchain-based government documents. The United States Department of Health and Human Services investigates blockchain-based systems for managing health data. Illinois explores blockchain-based applications for use in the Illinois government. News of governments and public-private partnerships developing blockchain-based legal applications increasingly splash across the headlines; however the law-makers using blockchain and other Distributed Ledger Technology (DLT) systems to implement legal processes do not systematically consider the broader implications of their …

Has The Era Of Privacy Come To An End?, Avner Levin

Canadian Journal of Law and Technology

This keynote address to the 2016 McGill Law Graduate Conference provides a brief history of privacy before discussing contemporary challenges in the form of increasing technological ability to create, store and process personal information, and powerful advocacy against privacy from both government and the private sector. In order for privacy to survive, a new set of personal information protection principles is required and new ways of enforcing these principles must be developed, which will leverage the power of technology to develop hybrid regulatory/ technological solutions, such as Google’s content removal tool.

The Lawful Access Fallacy: Voluntary Warrantless Disclosures, Customer Privacy, And Government Requests For Subscriber Information, Matthew P. Ponsford

Canadian Journal of Law and Technology

This paper explores the recent legal, political, privacy, and communications developments surrounding warrantless government requests for basic subscriber information. I assert the current practice remains marred in secrecy and therefore poses a significant threat to Canadian civil liberties and privacy rights.

Privacy And Insurance In Canada, England, And France - How Does The Responsible Insurer Put Guidelines And Procedures In Place For Retaining And Destroying Personal Information, Christopher Whitehead

Canadian Journal of Law and Technology

In this article, I will be discussing records containing personal data or information, and how ‘‘guidelines and procedures” are ‘‘put . . . in place for retaining and destroying [such] information” by private-sector insurers carrying on business in Canada, England, and France. Where I discuss Canada, I use the examples of the law of Ontario — which belongs to the English legal tradition —and of Quebec — whose private law belongs to the French legal tradition. As it happens, these are the two traditions with which I have the most experience relating to personal information.

The Data-Pooling Problem, Michael Mattioli

Articles by Maurer Faculty

American innovation policy as expressed through intellectual property law contains a curious gap: it encourages individual research investments, but does little to facilitate cooperation among inventors, which is often a necessary precondition for innovation. This Article provides an in-depth analysis of a policy problem that relates to this gap: increasingly, public and private innovation investments depend upon the willingness of private firms and institutions to cooperatively pool industrial, commercial, and scientific data. Data holders often have powerful disincentives to cooperate with one another, however. As a result, important research that the federal government has sought to encourage through intellectual property …

Problems With Using Statistics To Justify Institutional Policies, Justin Shin

Senior Projects Spring 2017

It is becoming increasingly common for institutions to use statistics to inform policy decisions. We should be prepared to ask ourselves what regulatory principles should be imposed on institutions that seek to justify certain policies through deference to a statistical analysis. This paper will examine the difficulties that come with using statistics to justify actions, and argue that certain standards of transparency and verifiability should be expected from any institution that seeks to involve a statistical analysis in the formation of policies. I will first use Market Share Liability, an established use of statistics, to draw out what responsibilities an …

Fetishizing Copies, Jessica Litman

Book Chapters

Our copyright laws encourage authors to create new works and communicate them to the public, because we hope that people will read the books, listen to the music, see the art, watch the films, run the software, and build and inhabit the buildings. That is the way that copyright promotes the Progress of Science. Recently, that not-very-controversial principle has collided with copyright owners’ conviction that they should be able to control, or at least collect royalties from, all uses of their works. A particularly ill-considered manifestation of this conviction is what I have decided to call copy-fetish. This is the …

Patenting Frankenstein's Monster: Exploring The Patentability Of Artificial Organ Systems And Methodologies, Jordana Goodman

Faculty Scholarship

The conception of Frankenstein’s monster bridges the ever-narrowing divide between man and machine. Long before Congress codified Section 33(a) of the America Invents Act (“AIA”), Mary Shelley’s vague description of the monster’s creation has left people wondering: what defines a human organism? Through an analysis of patent law and scientific progress in the development of artificial organ systems, this paper explores the boundaries of patentable subject matter in the United States and attempts to clarify Congress’s determination that “no patent may issue on a claim directed to or encompassing a human organism.” Though patent law should incentivize development of artificial …

Who's Driving You? Driver Data Remains Unprotected Under Coppa And Shine The Light, Marisa Tashman

Loyola of Los Angeles Law Review

As our lives become more driven by technology, California’s privacy laws fall short of protecting our personally identifiable information. Vehicles in particular present an increasing privacy concern, as our automobiles become more computer and less car. Cars today have increasingly sophisticated capabilities, stemming from connected technology and sensors, and their ability to capture geolocation and biometric data. This data can be used to make inferences about drivers’ behavioral patterns and daily habits. This Article analyzes whether California’s privacy laws—California Online Privacy Protection Act (“COPPA”) and Shine the Light—adequately address privacy concerns regarding driver data collected by the connected car. This …

Charting The Contours Of A Copyright Regime Optimized For Engineered Genetic Code, Christopher M. Holman

Oklahoma Law Review

No abstract provided.

Legal Pathways For A Massive Increase In Utility-Scale Renewable Generation Capacity, Michael Gerrard

Faculty Scholarship

Decarbonizing the U.S. energy system will require a program of building onshore wind, offshore wind, utility-scale solar, and associated transmission that will exceed what has been done before in the United States by many times, every year out to 2050. These facilities, together with rooftop photovoltaics and other distributed generation, are required to replace most fossil fuel generation and to help furnish the added electricity that will be needed as many uses currently employing fossil fuels (especially passenger transportation and space and water heating) are electrified. This Article, excerpted from Michael B. Gerrard & John Dernbach, eds., Legal Pathways to …

Teaching Legal Technology, Camille Broussard, Kathleen Brown, Daniel Cordova, Sarah Mauldin

Articles & Chapters

No abstract provided.

Hybrid Transactions And The Internet Of Things: Goods, Services, Or Software?, Stacy-Ann Elvy

Washington and Lee Law Review

The Internet of Things (IOT) has been described by the American Bar Association as “one of the fastest emerging,” potentially most “transformative and disruptive technological developments” in recent years. The security risks posed by the IOT are immense and Article 2 of the UCC should play a central role in determinations regarding liability for vulnerable IOT products. However, the lack of explicit clarity in the UCC on how to evaluate Article 2’s applicability to hybrid transactions that involve the provision of goods, services, and software has led to conflicting case law on this issue, which contradicts the UCC’s stated goals …

Appetite For Destruction: Symbolic And Structural Facets Of The Right To Destroy Digital Property, Joshua A.T. Fairfield

Washington and Lee Law Review

No abstract provided.

Amazon's Antitrust Paradox, Lina M. Khan

Faculty Scholarship

Amazon is the titan of twenty-first century commerce. In addition to being a retailer, it is now a marketing platform, a delivery and logistics network, a payment service, a credit lender, an auction house, a major book publisher, a producer of television and films, a fashion designer, a hardware manufacturer, and a leading host of cloud server space. Although Amazon has clocked staggering growth, it generates meager profits, choosing to price below-cost and expand widely instead. Through this strategy, the company has positioned itself at the center of e-commerce and now serves as essential infrastructure for a host of other …

The Cost Of Hope At The End Of Life: An Analysis Of State Right-To-Try Statutes, Tamara J. Patterson

Kentucky Law Journal

No abstract provided.

The Fourth Amendment In A Digital World, Laura K. Donohue

Georgetown Law Faculty Publications and Other Works

Fourth Amendment doctrines created in the 1970s and 1980s no longer reflect how the world works. The formal legal distinctions on which they rely—(a) private versus public space, (b) personal information versus third party data, (c) content versus non-content, and (d) domestic versus international—are failing to protect the privacy interests at stake. Simultaneously, reduced resource constraints are accelerating the loss of rights. The doctrine has yet to catch up with the world in which we live. A necessary first step for the Court is to reconsider the theoretical underpinning of the Fourth Amendment, to allow for the evolution of a …

The Ethical Debate On Drones, Anne Hopkins

Augustana Center for the Study of Ethics Essay Contest

No abstract provided.

Charting The Contours Of Copyright Regime Optimized For Engineered Genetic Code, Christopher M. Holman

Faculty Works

There is a growing disconnect between the traditional patent-centric approach to protecting biotechnological innovation and the emerging intellectual property imperatives of “synthetic biology,” a promising new manifestation of biotechnology that enables the design and construction of artificial biological pathways, organisms or devices, as well as the redesign of existing natural biological systems. As explained in previous articles, one way to deal with this disconnect would be to expand the scope of copyrightable subject matter to encompass engineered genetic sequences, much in the way that copyright was expanded in the 1970s and 1980s to include computer programs. The present article expands …

How Should Justice Policy Treat Young Offenders?: A Knowledge Brief Of The Macarthur Foundation Research Network On Law And Neuroscience, Bj Casey, Richard J. Bonnie, Andre Davis, David L. Faigman, Morris B. Hoffman, Owen D. Jones, Read Montague, Stephen J. Morse, Marcus E. Raichle, Jennifer E. Richeson, Elizabeth S. Scott, Laurence Steinberg, Kim Taylor-Thompson, Anthony Wagner

Faculty Scholarship

The justice system in the United States has long recognized that juvenile offenders are not the same as adults, and has tried to incorporate those differences into law and policy. But only in recent decades have behavioral scientists and neuroscientists, along with policymakers, looked rigorously at developmental differences, seeking answers to two overarching questions: Are young offenders, purely by virtue of their immaturity, different from older individuals who commit crimes? And, if they are, how should justice policy take this into account?

A growing body of research on adolescent development now confirms that teenagers are indeed inherently different from adults, …