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Vaccine Development, The China Dilemma, And International Regulatory Challenges, Peter K. Yu
Vaccine Development, The China Dilemma, And International Regulatory Challenges, Peter K. Yu
Faculty Scholarship
This article examines the role played by China in the development of international regulatory standards at the intersection of intellectual prop- erty, international trade, and public health. It begins by briefly discussing the role China has played in the global health arena during the COVID-19 pandemic. The article then highlights the difficulty in determining how best to engage with the country in the development of new international regula- tory standards. It shows that the preferred method of engagement will likely depend on one’s perspective on China’s potential contributions and hin- drances: a perspective that focuses on global competition—in the economic, …
Fishing And Fisheries Under International Water Law: A Dialogue Between Professor Gabriel Eckstein And Professor Paul Stanton Kibel, Gabriel Eckstein, Paul Stanton Kibel
Fishing And Fisheries Under International Water Law: A Dialogue Between Professor Gabriel Eckstein And Professor Paul Stanton Kibel, Gabriel Eckstein, Paul Stanton Kibel
Faculty Scholarship
On April 10 and 11, 2023, the Center on Urban Environmental Law (CUEL) at Golden Gate University School of Law hosted a two-day webinar on International Law Aspects of Fisheries and Hydropower in Europe. To open the webinar, Professor Gabriel Eckstein (of Texas A&M University School of Law) and Professor Paul Stanton Kibel (of Golden Gate University School of Law) participated in a keynote dialogue titled Fishing and Fisheries under International Water Law. What follows is a transcription of this dialogue between Professor Eckstein and Professor Kibel.
Environmental Law, Disrupted By Covid-19, Rebecca Bratspies, Vanessa Casado-Pérez, Robin Kundis Craig, Lissa Griffin, Keith Hirokawa, Sarah Krakoff, Katrina Kuh, Jessica Owley, Melissa Powers, Shannon Roesler, Jonathan Rosenbloom, J.B. Ruhl, Erin Ryan, David Takacs
Environmental Law, Disrupted By Covid-19, Rebecca Bratspies, Vanessa Casado-Pérez, Robin Kundis Craig, Lissa Griffin, Keith Hirokawa, Sarah Krakoff, Katrina Kuh, Jessica Owley, Melissa Powers, Shannon Roesler, Jonathan Rosenbloom, J.B. Ruhl, Erin Ryan, David Takacs
Faculty Scholarship
As we were in the final phases of editing a book on disruption in environmental law, a pandemic swept across the world disrupting daily life and the functioning of society to an extent unprecedented in living memory. The novel coronavirus known as COVID-19 was identified in China in late 2019 and by late February 2020, it had spread to every continent except Antarctica; as of April, 2021, the World Health Organization (WHO) estimated that over 148 million people had been infected worldwide with over 3 million deaths. Scientists and public health experts have raced to understand the virus—how is it …
Intellectual Property Exhaustion And Parallel Imports Of Pharmaceuticals: A Comparative And Critical Review, Irene Calboli
Intellectual Property Exhaustion And Parallel Imports Of Pharmaceuticals: A Comparative And Critical Review, Irene Calboli
Faculty Scholarship
This Chapter addresses the topic of intellectual property (IP) exhaustion in the context of the parallel trade of pharmaceuticals. These imports, which are controversial in general, are more complex with respect to pharmaceuticals, which require additional marketing and import authorizations. Nevertheless, individual countries remain free to accept these imports under the flexibility of Article 6 of the Agreement on Trade Related Aspects to Intellectual Property Rights (TRIPS Agreement). This Chapter reviews several national approaches—in developed, developing, and least developed countries (LDCs)—from the perspective of the exhaustion of patent rights as well as other IP rights. Through this review, it highlights …
Geographical Indications Of Origin, Economic Development, And Cultural Heritage: Good Match Or Mismatch?, Irene Calboli
Geographical Indications Of Origin, Economic Development, And Cultural Heritage: Good Match Or Mismatch?, Irene Calboli
Faculty Scholarship
In this article, I propose that geographical indications (GIs) carry important economic benefits. First, GIs are essential instruments to facilitate investments in high-quality products and niche markets, and promote local trade and development. Second, GIs offer an additional layer of information for consumers about the geographical origin and quality of the products they identify, in turn reducing the information asymmetries between producers and consumers. Third, because of this information function, GIs can assist in rewarding or holding producers accountable for their products based on the additional information they convey to the market. Yet, GIs can also protect culture-related interests and …
The U.S. Posture On Global Access To Medication & The Case For Change, Michael Palmedo, Srividhya Ragavan
The U.S. Posture On Global Access To Medication & The Case For Change, Michael Palmedo, Srividhya Ragavan
Faculty Scholarship
The year 2020 marks the 25th anniversary of including intellectual property rights within the larger agenda of trade. While the marriage between trade and intellectual property was always uncomfortable, COVID-19 exposed the flaws, failures and the inadequacy of the trade agenda to harmonise intellectual property rights, particularly for patents in pharmaceuticals. Typically, the United States through its questionable United States Trade Representative (USTR) process exposed the vulnerabilities of the intellectual property systems of the rest of the world. COVID-19 exposed the manner in which the so-called ‘superior’ intellectual property regime of the US left the country with a weak health-care …
Animal Agriculture Liability For Climatic Nuisance: A Path Forward For Climate Change Litigation?, Daniel E. Walters
Animal Agriculture Liability For Climatic Nuisance: A Path Forward For Climate Change Litigation?, Daniel E. Walters
Faculty Scholarship
Despite possessing statutory authority to regulate at least some contributing causes of climate change, environmental regulators in the United States have recently found themselves tied up in political gridlock. In response, advocates are turning from the regulatory track to a common law liability track, bringing public nuisance suits against fossil fuel producers and electric utilities. However, most of these public nuisance suits have met a common fate: they have been held to be displaced by the comprehensive regulatory framework for controlling greenhouse gas emissions contained in the Clean Air Act. As long as there is even the possibility of regulatory …
The (Re)Newed Barrier To Access To Medication: Data Exclusivity, Srividhya Ragavan
The (Re)Newed Barrier To Access To Medication: Data Exclusivity, Srividhya Ragavan
Faculty Scholarship
This Article is set in the background of the consequences of the WTO’s prescriptions on patenting of life-saving medications which has largely contributed to the morphing of patents o n life-saving medication into a luxury. Remarkably, there has been a transformation of the role of patents in the context of pharmaceutical innovation into a strategic business tool leading to a larger interest in creation and sustenance of regulatory rights. The biggest global development in this area is an increased effort to strengthen exclusivity using regulatory protections for all chemicals, and even, biologics, involved in all stages of drug development. Consequently, …
The Drug Debate: Data Exclusivity Is The New Way To Delay Generics, Srividhya Ragavan
The Drug Debate: Data Exclusivity Is The New Way To Delay Generics, Srividhya Ragavan
Faculty Scholarship
The article discusses the protection regime for clinical trial data internationally and outlines the applicable protection regime. In doing so, this article outlines how the data exclusivity regime can operate in parallel with the patent regime to add a layer of protection for the data. Such protection operates at a regulatory level to delay the entry of generic medications. Internationally, the data exclusivity regime, which has become an important contemporary tool in trade negotiations with poorer nations, works to detrimentally affect access to medication
Drug Product Liability And Health Care Delivery Systems, William M. Sage
Drug Product Liability And Health Care Delivery Systems, William M. Sage
Faculty Scholarship
This note will use the principles of law and economics to examine the interaction of market structures and product liability rules in a world of imperfect information. The goals of the analysis are to create incentives for optimal care by producers and consumers, induce the socially appropriate amount of consumption of each product (often referred to as the "activity level"), and minimize the costs of bearing the risk of injury. The note will conclude that the existence of health maintenance organizations ("HMOs") and similar prepaid providers with superior information capacity and total patient care responsibility may create a context in …