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Color Inside the Lines: Achieving Pharmaceutical Deal Certainty when the Courts Keep Redrawing the IP Lines
Get PDFIn The Genome Defense, Jorge Contreras vividly describes the story of how gene patents were challenged in Association for Molecular Pathology v. Myriad Genetics and the U.S. Supreme Court’s reversal of the USPTO’s long-standing practice of allowing patents on human genes. This Article examines how pharmaceutical companies navigate intellectual property challenges in the wake of the Myriad decision and other landmark cases that have redrawn the boundaries of patent-eligible subject matter. Drawing on the Author’s 35 years of experience in life science transactions, the Article analyzes three key strategies that pharmaceutical companies employ: (1) adapting their business and licensing models to work within new legal constraints, (2) finding creative ways to structure deals that achieve similar objectives through alternative means, and (3) developing approaches to mitigate unavoidable risks. Through examination of specific examples—including early biotechnology licensing deals, platform technology collaborations, and innovative licensing structures, the Article demonstrates how companies maintain deal certainty while operating within evolving legal frameworks. The Article concludes by arguing that maintaining freedom to operate for basic biological targets, while protecting truly innovative developments, best serves both scientific progress and patient interests
Emerging Pollutants: Protecting Water Quality for the Health of People and the Environment
No full textThis open access book focuses on the importance of reducing pollution and protecting water resources for the health of people and the environment. Water is vital for life on Earth. The quality of the world\u27s freshwater resources is deteriorating due to the rise in pollution levels, which puts the health of people and the environment at risk. Emerging pollutants, a new class called Contaminants of Emerging Concern, pose a global water quality challenge. The identification and implementation of appropriate regulatory, monitoring, prevention, and control measures are hindered by limited scientific understanding and knowledge about sources and pathways of emerging pollutants, their behaviour and fate in the environment, and potential human and ecosystem health risks.
The book presents selected contributions to the UNESCO-IWRA Online Conference “Emerging Pollutants: Protecting Water Quality for the Health of People and the Environment,” held on 17–19 January 2023. It offers an extensive overview of current research findings on emerging pollutants in aquatic ecosystems, groundwater contamination, wastewater management and reuse, circular economy approaches to pollutant lifecycle management, and the prioritization of emerging pollutants in the hydro-cycle. Based on scientific evidence and policy-relevant research findings, the book’s concluding chapter highlights research and policy gaps, offering recommendations for strategic and practical ways to manage emerging pollutants towards sustainable water management in the face of global changes and evolving environmental threats.
This book is a scientific output in the framework of UNESCO Intergovernmental Hydrological Programme’s Ninth Phase “Science for a Water-Secure World in a Changing Environment” (IHP-IX, 2022-2029) and UNESCO-IHP’s International Initiative on Water Quality (IIWQ) in collaboration with the International Water Resources Association (IWRA)
Implications for Adjacent Waterbodies After Sackett v. EPA
Get PDFThe Supreme Court’s recent ruling in Sackett v. EPA has rolled back Clean Water Act (“CWA”) protections for many wetlands on private property. Justice Kavanaugh’s little-commented-on concurrence identifies a class of waterbodies now unprotected by the CWA that nonetheless serves vital roles in flood control, pollution management, and habitat conservation. These waterbodies are those that lack a continuous surface connection (the majority’s test) to navigable waterways but are nonetheless “adjacent” to them in that they are separated by a single barrier. Including borrow pits and swamps held behind dikes, as well as the thousands of oxbow lakes near America’s rivers, these adjacent, non-adjoining (“ANA”) waterbodies provide ecological services like flood control, pollutant storage, and habitat that also contribute a great deal of economic value to stakeholders. This Note proposes that, if the federal judiciary or Congress are (as it seems) unable to adopt a test reflecting the vitality of ANA waterbodies, state governments and market actors should implement solutions—in many cases by simply adapting strategies that have already been deployed—to secure the benefits of ANA waterbodies and continue to advance the purposes of the CWA. Indeed, scholarly literature and the history of environmental regulation in the United States suggest that states may be the best vehicle to deploy strategies, specifically incentive-based strategies, to protect ANA waterbodies
Overharvesting: The Why of Biodiversity Loss
Get PDFThis Article examines the consequences of overharvesting biodiversity, focusing on its detrimental effects on biodiversity—on the biosphere, ecosystems, communities, populations, and individual organisms. It evaluates legal mechanisms designed to protect biodiversity from overharvesting and also considers legal mechanisms that lead to overharvesting to the detriment of biodiversity. The Article compares regulations and laws from multiple jurisdictions, including Europe, Oceania, Asia, Africa, and the Americas, and analyzes how these regulations and laws seek to curb overharvesting. Examples include the United States’s Endangered Species Act, Canada’s Wild Animal and Plant Protection Act, and the European Union’s Marine Strategy Framework Directive. International conventions such as the Convention on International Trade in Endangered Species of Wild Fauna and Flora (“CITES”) are also assessed for their success in protecting species from commercial overexploitation. Drawing from these case studies, this Article identifies best practices for preventing overharvesting and proposes strategies for more effective biodiversity conservation. These proposals necessitate the implementation of ecosystem-based approaches, adaptive environmental assessment and management techniques, and stronger regulatory enforcement to secure longevity and the survival of biodiversity despite overharvesting. This Article concludes by advocating for an international legal framework that promotes resource sustainability while maintaining biodiversity. This proposal integrates precautionary principles, cross-border cooperation, and equitable resource sharing to foster a future where human resource use no longer jeopardizes biodiversity
The NIH-Moderna Public-Private Partnership: A New Contractual Model for Securing Innovation
Get PDFThe public–private partnership between the National Institutes of Health (“NIH”) and Moderna was considered “one of the few bright spots of the pandemic.” Yet as the NIH–Moderna collaboration progressed at an unprecedented pace, going from vaccine development to FDA authorization in nine months, cracks began to appear in the partnership. Public trust in vaccinations wavered, multiple patent disputes arose, and global frustration erupted over Moderna’s lack of commitment to equitable access to the vaccine that was largely paid for by U.S. taxpayers. This Article argues that the parties’ contractual agreements did shockingly little to support or, indeed, set up the public–private partnership for success in the first instance. By relying on boilerplate intellectual property clauses and foregoing any meaningful or relevant governance structures, these agreements failed to address the unique challenges and competing interests inherent in such a partnership. Drawing on an original case study of the NIH–Moderna contractual agreements and insights from relational contract theory, this Article offers a novel approach to structuring public–private partnerships. It proposes model contractual language designed to promote transparency, resolve disputes, balance incentives, and build resilient, cooperative relationships. These provisions provide a starting point for crafting more effective collaboration agreements that can maximize the potential of public–private partnerships while ensuring equitable access to the commercialized products of government-funded innovation
April 2025 Poetry Month Display Photo 01
No full textPhoto of both posters, Vol. 18 No. 3 of Constitutional Commentary containing Law Professor Gil Grantmore’s Constitutional Law Haiku on page 481, Vol. 11 of Texas Wesleyan Law Review (2005) Containing Wayne Barnes’s discussion of Hadley v. Baxendale and other Common Law Borrowings from Civil Law, Lawyers, Poets, and that World We Call Law, edited by James Elkins containing the poem Hadley v. Baxendale, Red Cardinal, White Snow (2024) by Susan Ayres, Walk Like the Bird Flies (2023) by Susan Ayres, Law & Poetry: Promises from the Preamble edited by Kristen David Adams, Poetry of the Law: From Chaucer to the Present edited by Kader & Stanford, Vol. 61 of the Bankruptcy Reporter page 558 referencing the case In re Love, The Wallace Stevens Case: Law and the Practice of Poetry by Thomas Grey, and two pictures; Susan Ayres and Kristen David Adams.https://scholarship.law.tamu.edu/poetry-month-2025-photos/1003/thumbnail.jp
Perceptions of Justice: Assessing the Perceived Effectiveness of Punishments by Artificial Intelligence versus Human Judges
No full textUsing an original experimental survey, we analyze how people perceive punishments generated by artificial intelligence (AI) compared to the same punishments generated by a human judge. We use two vignettes pertaining to two different albeit relatively common illegal behaviors, namely not picking up one’s dog waste on public roads and setting fire in dry areas. In general, participants perceived AI judgements as having a larger deterrence effect compared to the those rendered by a judge. However, when we analyzed each scenario separately, we found that the differential effect of AI is only significant in the first scenario. We discuss the implications of these findings
