Intellectual Property Law Commons^™

Child-Proofing Global Public Health In Anticipation Of Emergency, Frederick M. Abbott

Scholarly Publications

No abstract provided.

Association For Molecular Pathology V. Myriad Genetics: A Critical Reassessment, Jorge L. Contreras

Michigan Technology Law Review

The Supreme Court’s 2013 decision in Association for Molecular Pathology v. Myriad Genetics is an essential piece of the Court’s recent quartet of patent eligibility decisions, which also includes Bilski v. Kappos, Mayo v. Prometheus, and Alice v. CLS Bank. Each of these decisions has significantly shaped the contours of patent eligibility under Section 101 of the Patent Act in ways that have been both applauded and criticized. The Myriad case, however, was significant beyond its impact on Section 101 jurisprudence. It was seen, and litigated, as a case impacting patient rights, access to healthcare, scientific freedom, …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

Intellectual Property As A Determinant Of Health, Ana S. Rutschman

Vanderbilt Journal of Transnational Law

Public health literature has long recognized the existence of determinants of health, a set of socioeconomic conditions that affect health risks and health outcomes across the world. The World Health Organization defines these determinants as “forces and systems” consisting of “factors combin[ing] together to affect the health of individuals and communities.” Frameworks relying on determinants of health have been widely adopted by countries in the global South and North alike, as well as international institutional players, several of which are direct or indirect players in transnational intellectual property (IP) policymaking. Issues raised by the implementation of IP policies, however, are …

The Intellectual Property Of Covid-19, Ana Santos Rutschman

All Faculty Scholarship

The response to COVID-19 is indissolubly tied to intellectual property. In an increasingly globalized world in which infectious disease pathogens travel faster and wider than before, the development of vaccines, treatments and other forms of medical technology has become an integral part of public health preparedness and response frameworks. The development of these technologies, and to a certain extent the allocation and distribution of resulting outputs, is informed by intellectual property regimes. These regimes influence the commitment of R&D resources, shape scientific collaborations and, in some cases, may condition the widespread availability of emerging technologies. As seen throughout this chapter, …

Intellectual Property As A Determinant Of Health, Ana Santos Rutschman

All Faculty Scholarship

Public health literature has long recognized the existence of determinants of health, a set of socio-economic conditions that affect health risks and health outcomes across the world. The World Health Organization defines these determinants as “forces and systems” consisting of “factors combin[ing] together to affect the health of individuals and communities.” Frameworks relying on determinants of health have been widely adopted by countries in the global South and North alike, as well as international institutional players, several of which are direct or indirect players in transnational intellectual property (IP) policymaking. Issues raised by the implementation of IP policies, however, are …

The Big Data Regulator, Rebooted: Why And How The Fda Can And Should Disclose Confidential Data On Prescription Drugs And Vaccines, Christopher J. Morten, Amy Kapczynski

Faculty Scholarship

Medicines and vaccines are complex products, and it is often extraordinarily difficult to know whether they help or hurt. The Food and Drug Administration (FDA) holds an enormous reservoir of data that sheds light on that precise question, yet currently releases only a trickle to researchers, doctors, and patients. Recent examples show that data secrecy can be deadly, and existing laws such as the Freedom of Information Act (FOIA) cannot solve the problem. We present here a wealth of new evidence about the urgency of the problem and argue that the FDA must “reboot” its rules to proactively disclose all …

Should The U.S. Government Actively Assert Its Own Patents?, Christopher J. Morten, Barry Datlof, Amy Kapczynski, Donna Meuth, Zain Rizvi

Faculty Scholarship

On March 10, 2021, our journal partnered with the Engelberg Center on Innovation Law and Policy to host a symposium addressing the role and impact of U.S. innovation policy on access to medicine. Our 2021 Symposium Issue — Volume 11, Issue 1 — captures that event.

The following article represents the second of four panels. This panel asked, “Should the U.S. government actively assert its own patents?” The panel was moderated by Christopher Morten, Deputy Director of NYU Law’s Technology Law & Policy Clinic. The panelists included Barry Datlof, Chief of Business Development and Commercialization in the Office of Medical …

The Double-Edged Sword Of Medical Patents: How Monopolies On Healthcare Products Disparately Impact Certain American Populations, Sarah Mcgraw

The University of Cincinnati Intellectual Property and Computer Law Journal

No abstract provided.

Dispute Settlement Under The African Continental Free Trade Area Agreement: A Preliminary Assessment, Olabisi D. Akinkugbe

Articles, Book Chapters, & Popular Press

The African Continental Free Trade Area Agreement (AfCFTA) will add a new dispute settlement system to the plethora of judicial mechanisms designed to resolve trade disputes in Africa. Against the discontent of Member States and limited impact the existing highly legalized trade dispute settlement mechanisms have had on regional economic integration in Africa, this paper undertakes a preliminary assessment of the AfCFTA Dispute Settlement Mechanism (DSM). In particular, the paper situates the AfCFTA-DSM in the overall discontent and unsupportive practices of African States with highly legalized dispute settlement systems and similar WTO-Styled DSMs among other shortcomings. Notwithstanding the transplantation of …

Biosimilars: The Quest For A Rational Regulatory And Intellectual Property Approach In Canada, Elizabeth S. Dipchand

LLM Theses

Biologics and biosimilars represent the promise for more effective treatments of many diseases. International treaty obligations influenced heavily by the biopharmaceutical industry and advanced through the international trade agenda may lead to an imbalance between incentivizing innovation and the public interest. Canada’s implementation of its obligations into national patent and regulatory laws encourages aggressive biologic patent protection strategies that, coupled with linked regulatory assessments, may establish compounding layers of exclusion that disproportionately disincentivizes both the biologics innovation and biosimilar development. This comparative analysis addresses the progression of international obligations and the way in which they have been implemented into Canada’s …

Who's Afraid Of Section 1498? A Case For Government Patent Use In Pandemics And Other National Crisis, Charles Duan, Christopher J. Morten

Scholarly Articles in Law Reviews & Journals

COVID-19 has created pressing and widespread needs for vaccines, medical treatments, PPE, and other medical technologies, needs that may conflict--indeed, have already begun to conflict--with the exclusive rights conferred by United States patents. The U.S. government has a legal mechanism to overcome this conflict: government use of patented technologies at the cost of government paid compensation under 28 U. S.C. § 1498. But while many have recognized the theoretical possibility of government patent use under that statute, there is today conventional wisdom that § 1498 is too exceptional, unpredictable, and dramatic for practical use, to the point that it ought …

Japanese Government Actions Against Covid-19 Under The Directives Of Constitutional And Administrative Law, Yuichiro Tsuji

Cardozo International & Comparative Law Review

This paper presents law on the State ofEmergency held jointly on June 16, 2020, by the Asian Law Center of Melbourne University and School of Law, and Vietnam National University, Hanoi.

This paper further elucidates the actions of the Japanese government against COVID-19 during the first five months of 2020. On May 25, 2020, the government fied the emergency declaration passed under the amended Art. 49(2) of the amended Influenza Special Measures Act (ISMA).

This paper argues that the effects of the Japanese government action is not unique, but is instead similar to those of other countries. In 2012, the …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

Facilitating Access To Cross-Border Supplies Of Patented Pharmaceuticals: The Case Of The Covid-19 Pandemic, Frederick M. Abbott

Scholarly Publications

The COVID-19 pandemic has brought into stark relief the gaps in global preparedness to address widespread outbreaks of deadly viral infections. This article proposes legal mechanisms for addressing critical issues facing the international community in terms of providing equitable access to vaccines, treatments, diagnostics, and medical equipment. On the supply side, the authors propose the establishment of mandatory patent pools ('Licensing Facilities') on a global or regional, or even national basis, depending upon the degree of cooperation that maybe achieved. The authors also discuss the importance of creating shared production facilities. On the demand side, the authors propose the establishment …

Multilateralism, Pushback, And Prospects For Global Engagement?, Michael Donald Kirby The Honourable

Indiana Journal of Global Legal Studies

In this article, the author draws on long engagement with multilateralism, both in domestic jurisdiction and international institutions. He describes the growth of post-War United Nations activities and the increasing impact of international law, including on universal human rights. He records international initiatives on global problems like HI V/AIDS and in individual countries, such as Cambodia and North Korea. He then describes recent examples of '"pushback" against multilateralism, especially on the part of the United States, the United Kingdom, some European countries, and Australia. He concludes with illustrations and reasons why the global community should remain optimistic about multilateralism, despite …

Trade Mark Licensing And Covid-19: Why Fashion Companies Have A Duty To Comply With Their Legal Obligations, Irene Calboli

Faculty Scholarship

For the past several months, Covid-19 has dominated the intellectual property (IP) debate. Most discussions have focused on the implications of patent protection on access to treatments against the virus and a hopefully soon to be found vaccine. In these remarks, I would like to focus on another Covid-19 crisis making headlines across the world and partially related to IP: millions of workers in the garment industry in developing countries have been fired or furloughed as fashion companies have cancelled orders due to plunging sales since the pandemic’s beginning. Famous Western groups such as Inditex (Zara), C&A, Target, and Marks …

Discrimination And Privacy Concerns At The Intersection Of Healthcare And Big Data, James Koenderman

Cardozo Law Review

No abstract provided.

Reconsidering The Rationale For The Duration Of Data Exclusivity, Jonathan Kimball, Srividhya Ragavan, Sophia Vegas

Faculty Scholarship

The paper’s focus is the singular one question of whether the 12-years of exclusivity that was needed in 2008 remains justified in 2019 given that technological advancement reduces the cost and the time for drug discovery? Basically, new and emerging technologies are deployed every day to enhance efficiencies and reduce the time it takes to bring a drug to the market. The paper asserts that as new technologies are adopted and advances in scientific understanding are leveraged, it results in shorter drug development timelines. This factum, the paper asserts should have a bearing to reduce the period of exclusivity granted …

The Intellectual Property Of Vaccines: Takeaways From Recent Infectious Disease Outbreaks, Ana Santos Rutschman

Michigan Law Review Online

In late 2019 and early 2020, a new strain of coronavirus, a family of pathogens causing serious respiratory illness, began infecting populations across the globe. A quick uptick in COVID-19, the disease caused by the novel pathogen, prompted the World Health Organization to declare the outbreak a Public Health Emergency of International Concern on January 30, 2020. By mid-February 2020, with 26 countries reporting cases of COVID-19 infection, the global case count had surpassed 50,000, and had resulted in over 1,500 deaths. The World Health Organization elevated the status of the outbreak to a pandemic in mid-March. As of early …

End Notes, Sustainable Development Law & Policy

Sustainable Development Law & Policy

No abstract provided.

State Preemption And Single Use Plastics: Is National Intervention Necessary?, Ethan D. King

Sustainable Development Law & Policy

No abstract provided.

The Right To Legally Sourced Lumber? How The Effective Enforcement Of The Lacey Act Is A U.S. Human Rights Obligation And Critical To Preventing Abuse In The Illegal Logging Industry, Melanie Hess

Sustainable Development Law & Policy

No abstract provided.

An Ace Up Their Sleeve Or A House Of Cards: Can The Epa's Affordable Clean Energy Rule Withstand Chevron Deference?, Shannon Zaret

Sustainable Development Law & Policy

No abstract provided.

Lake Erie Bill Of Rights Gets The Ax: Is Legal Personhood For Nature Dead In The Water?, Devon Alexandra Berman

Sustainable Development Law & Policy

No abstract provided.

The Use Of The Regular Militaries For Natural Disaster Assistance: Climate Change And The Increasing Need For Changes To The Laws In The United States, China, Japan, The Philippines, And Other Countries, Donald D.A. Schaefer

Sustainable Development Law & Policy

No abstract provided.

Editor's Note, Brianna Delduca, Hannah Gardenswartz

Sustainable Development Law & Policy

No abstract provided.

End Notes, Sustainable Development Law & Policy

Sustainable Development Law & Policy

No abstract provided.

How Syria's Failure To Uphold The Kyoto Protocol And Paris Agreement Exacerbated The Effects Of Climate Change In The Levant, Nivea A. Ohri

Sustainable Development Law & Policy

No abstract provided.

Continuing A Broad Application Of Section 9 Of The Esa To Prevent Future Mass Extinctions, Alicia Martinez

Sustainable Development Law & Policy

No abstract provided.