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Technical Standards For Bioinformatics and Medical Informatics
Get PDFWith a few exceptions, the biomedical industry, and the informatics field in particular, have not been affected by the standards litigation that has plagued the ICT sector. But with the increasing adoption of standards by informatics researchers and vendors, the issues faced by ICT standards groups will become increasingly relevant. This chapter summarizes general legal issues associated with standards development, then surveys standardization efforts in the informatics space and reviews the policies and procedures adopted by SDOs operating in the informatics area. It concludes with recommendations regarding prudent policy adoption by SDOs developing standards for informatics applications
MPEG LA’s Use of a Patent Pool to Solve the CRISPR Industry’s Licensing Problems
Get PDFSince 2012, CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) technology has revolutionized how scientists approach gene editing. CRISPR allows for easier modification and alteration of the genome. This technology has potential applications ranging from correcting genetic defects to the treatment and prevention of diseases—CRISPR’s potential upside is unquestionable. However, CRISPR’s current patent landscape presents a variety of roadblocks for research, innovation, and profit. This Note discusses the potential use of a patent pool to alleviate some of these roadblocks. This Note begins with a discussion of the independent administrative body attempting to create such a patent pool, MPEG LA, before discussing the current patent landscape. Next, it discusses the licensing issues biotech products face when attempting to create a patent pool. Finally, this Note analyzes the prospects of MPEG LA’s current attempt to create a patent pool in the CRISPR arena. This analysis discusses why a CRISPR patent pool would work, as well as arguments suggesting its failure. This Note ultimately concludes that, while there are many barriers which could impede a CRSIPR patent pool’s success, MPEG LA’s patent pool is a promising approach to a complex licensing problem in a budding technological area
Consumer Financial Protection in the COVID-19 Crisis: An Emergency Agenda
Get PDFThe coronavirus pandemic is creating overwhelming needs, in three waves. First is the health crisis; second is the macroeconomic crisis created by the abrupt halt in much business activity; and now third is a consumer crisis, as households are faced with total or partial job loss, sharp income decline, and potential loss of health care. Millions of Americans are falling behind on their bills, including major obligations like mortgages, rent, car payments, and other forms of household debt. At the same time, they face a financial industry itself struggling to respond to the compounding crises and widespread confusion as to what the new rules of the road are as financial institutions, states, localities, and the federal government scramble to respond. The result is fertile ground for consumer scams. The authors call upon the Consumer Financial Protection Bureau to recognize and respond to this new consumer crisis, providing an action plan of more than a dozen practical steps that the CFPB can and must take immediately to prevent widespread consumer harm. The action plan starts with the most basic and essential step of collecting and disseminating timely and accurate information for both consumers and policymakers. The CFPB must address pressing consumer risks in four primary areas: foreclosure prevention, non-mortgage debt forbearance, oversight of debt collectors, and supervision of credit reporting companies. In each of these primary areas, and on all the issues discussed in this paper, the CFPB must use all of its authorities to ensure that crucial relief is delivered to distressed consumers
The Tribal Right to Exclude Non-Tribal Members from Indian-Owned Lands
Get PDFIn 1981, the Supreme Court issued its decision in Montana v. United States, severely restricting the ability of Indian Tribes to assume civil regulatory and adjudicatory jurisdiction over non-tribal members for activities taking place on non-Indian lands within Indian reservations. The Court in Montana stated that “it could readily agree” with the Court of Appeals’ holding that the tribe could regulate the conduct of non-member on tribal lands. Yet, twenty years later, the Court issued its opinion in Nevada v. Hicks holding that in certain circumstances, the jurisdiction of Indian tribes could also be limited even if the activities of the non-members took place on Indian-owned lands. It has been almost twenty years since Hicks and because of the cryptic and fractured nature of that decision, the federal circuits are divided and still trying to figure out under what circumstances tribal civil jurisdiction over non-members should be restricted when these activities take place on Indian-owned lands.In this Article, I argue that among all the possible interpretations of Hicks, the one adopted by the Ninth Circuit makes the most sense. Under that interpretation, the so-called Montana framework used to divest tribes of jurisdiction is not applicable to cases where a tribe has retained the right to exclude. I argue that Hicks can be reasonably conceptualized as endorsing the 9th Circuit methodology. However, I also argue that Hicks should have been decided as a state jurisdiction cases and not a tribal divestiture of inherent sovereignty case. Re-imagining Hicks as a state jurisdiction case would not have changed the outcome but would have avoided the last twenty years of confusion surrounding how Hicks should be interpreted
Learning From Our Mistakes: Conversation Analysis Reveals Best Practices for a Student-Staffed Pro Bono Project
Get PDFLaw schools make “pro bono” opportunities available to students to introduce them to the responsibilities of the profession. Often these pro bono law students help in “brief advice” projects staffed by volunteer attorneys. This staffing-supervision structure presents challenges in ensuring clients receive competent, individualized advice and the students receive adequate oversight so that this is a positive learning experience for them. This paper analyzes transcripts from 46 recorded student-client interviews and 35 student-attorney consultations. It focuses on those cases where there were “errors or omissions” -- either the client got some erroneous advice or the client did not receive complete, personalized advice -- and asks why. Conversation Analysis allows a fine-grained analysis of the interview, the student-supervisor consultation, and the final client counseling. This analysis shows where the break-downs occurred and theorizes why. The paper ultimately proposes techniques to improve the operation of a brief advice site staffed by students
Water Law and Climate Change in the United States: A Review of the Scholarship
Get PDFClimate change’s effects on water resources have been some of the first realities of ecological change in the Anthropocene, forcing climate change adaptation efforts even as the international community seeks to mitigate climate change. Water law has thus become one vehicle of climate change adaptation. Research into the intersections between climate change and water law in the United States must contend with the facts that: (1) climate change affects different parts of this large country differently; and (2) United States water law is itself a complicated subject, with each state having its own laws for surface water and groundwater and the federal government playing a significant role in interstate and international waters, in building and managing large water infrastructure, and in creating water rights for Native American tribes and other federal reservations. Within this complexity, legal research to date has tended to focus on the law governing surface water in the American West, enumerating various problems with the prior appropriation doctrine as the West grows hotter and drier and offering multiple suggestions to increase legal flexibility so that western water can be re-allocated to reflect changing social-ecological realities. These suggestions extend to new, more comprehensive, and more adaptive water governance approaches. Far less scholarly attention has focused on eastern riparian rights, the various groundwater doctrines at play in the United States, or the increasing role of tribes in managing water resources, but these areas warrant future attention
COVID, Crisis and Courts
Get PDFOur country is in crisis. The inequality and oppression that lies deep in the roots and is woven in the branches of our lives has been laid bare by a virus. Relentless state violence against Black people has pushed protestors to the streets. We hope that the legislative and executive branches will respond with policy change for those who struggle the most among us: rental assistance, affordable housing, quality public education, comprehensive health and mental health care. We fear that the crisis will fade, and we will return to more of the same. Whatever lies on the other side of this crisis, one thing is certain: one part of our government grapples with the individual consequences of inequality and oppression every day and will continue to do so with even more urgency in the future: state civil courts. Even before the pandemic, as other branches of government failed to address inequality, state civil courts became the government actor of last resort for the tens of millions of Americans each year who suffer the consequences of these failures. Now, these same courts—for the first time in history—have quickly and nimbly changed the way they provide justice. Courts’ improvisation in the face of a global public health crisis present an opportunity for social change. In contrast to burgeoning attention to state criminal courts, this role for state civil courts was hidden from those not directly involved and largely ignored by scholars. Now it is unavoidable. This essay lays out a framework for change that state civil courts should embrace as they reopen to the tidal wave of litigants
A Road Map to Net-Zero Emissions for Fossil Fuel Development on Public Lands
Get PDFAlmost one quarter of all U.S. carbon dioxide (CO2) emissions come from fossil fuels extracted from public lands, and these resources are managed by the Bureau of Land Management (BLM). The BLM has a statutory duty set forth in the Federal Land Policy and Management Act (FLPMA) to coordinate management of various resources “without permanent impairment of the productivity of the land and the quality of the environment.” Continuing to permit fossil fuel development without adhering to a carbon budget violates this statutory duty. This Article argues that the BLM must address climate change in its decisions. It also proposes a legal strategy for requiring that all new onshore oil and gas wells that tap federal resources, including those on existing leases, achieve net-zero GHG emissions (for upstream and downstream emissions) as a condition of operational approval. While the following discussion focuses on the oil and gas permitting process, the same principles could apply to other permitting decisions
Antitrust and Competition Issues
Get PDFThis Chapter offers a broad overview of the impact of U.S. antitrust laws on IP licensing and transactions. A basic understanding of antitrust law is critical to the analysis of IP licensing arrangements, whether concerning patents, copyrights or trademarks. This chapter offers a summary of the antitrust doctrines that arise frequently in IP and technology-focused transactions — price fixing and market allocation, resale price maintenance, tying, monopolization, refusals to deal, standard setting and pay-for-delay settlements, with coverage of the major cases and enforcement agency guidance. Antitrust issues also play a role in the analysis of joint ventures, which are discussed in Chapter 26, and IP pools, which are discussed in Chapter 27 (a preview of this topic is presented in Part E below)
A Historical Note on the Assignment of Pesticide Common Names
Get PDFThousands of pesticides, herbicides, and related chemical products are used today to control disease-bearing insect populations and enable large-scale agricultural production that feeds much of the world. This short note traces the history of one small but important aspect of this industry—the assignment of common names to pesticides and related products. The little-known history of pesticide common names is illustrative of a few important points. First, it demonstrates the trend exhibited in many fields for the development of standards to migrate from a governmental agency to a US-based standards organization to an international standards organization. Second, it evidences the concern that many in the standards world have had over the potential capture of common names by private firms through trademark law. The anti-trademark protections built into ANSI’s Standard K62.1-1956 sought to ensure that common names for pesticides and related chemical products would remain available for all manufacturers to use. With the demise of ANSI Committee K-62, direct US participation in the development of pesticide common names has gone by the wayside. Nevertheless, it appears that industry norms, as well as unofficial oversight by WSSA and other scientific bodies, have, thus far, deterred the capture of pesticide common names through trademark law. Even so, it is worth asking whether it is in the best interests of the US industry to cede this important function entirely to international oversight, and whether increased US participation in ISO may be warranted both in this area and others