Intellectual Property Law Commons^™

Risk Regulation And Management Against Illegal Wildlife Trade: Europe And America, Olonyi Bosire

Sustainable Development Law & Policy

Introduction

The source or initial crime in the illegal wildlife trade chain is mostly committed beyond the shores of North America and Europe. However, the two regions continue to be massive destination markets and key transit hubs for illegal wildlife products. Illegal trade networks are shadowy and therefore problematic to study. This helps explain the wide valuation of illegal wildlife trade currently estimated by the Global Environment Facility (“GEF”) as ranging between 7 and 23 billion dollars per annum.

Policies and strategies to pre-empt or respond to illegal wildlife trade keep evolving as appreciation grows for the previously underestimated complexities, …

Underserved Communities Trashed By Plastic: Slowing The Proliferation Of Petroleum Based Products Through Stewardship Laws And Enhanced Back-End Regulatory Solutions, Joan F. Chu

Sustainable Development Law & Policy

Introduction

Plastic pollution has attracted a tremendous amount of attention and press coverage in early 2021 as evidenced in news stories; an episode of John Oliver’s show, “Last Week Tonight”; and a viral tweet from Greta Thunberg highlighting a study linking plastic pollution to human penises shrinking. These eye-catching pieces stemmed from Dr. Shanna H. Swan’s work that culminated in her book, Count Down: How Our Modern World Is Threatening Sperm Counts, Altering Male and Female Reproductive Development, and Imperiling the Future of the Human Race. Other articles have highlighted plastic pollution’s impact on polar bears, which causes their penis …

Opting Into Device Regulation In The Face Of Uncertain Patentability, Rebecca S. Eisenberg

Marquette Intellectual Property Law Review

This article examines the intersection of patent law, FDA regulation, and Medicare coverage in a particularly promising field of biomedical innovation: genetic diagnostic testing. First, I will discuss current clinical uses of genetic testing and directions for further research, with a focus on cancer, the field in which genetic testing has had the greatest impact to date. Second, I will turn to patent law and address two recent Supreme Court decisions that called into question the patentability of many of the most important advances in genetic testing. Third, I will step outside patent law to take a broader view of …

Patent Punting: How Fda And Antitrust Courts Undermine The Hatch-Waxman Act To Avoid Dealing With Patents, Rebecca S. Eisenberg, Daniel A. Crane

Michigan Telecommunications & Technology Law Review

Under the Hatch-Waxman Act, patent law and FDA regulation work together to determine the timing of generic entry in the market for drugs. But FDA has sought to avoid any responsibility for reading patents, insisting that its role in administering the patent provisions of the Hatch-Waxman Act is purely ministerial. This gap in regulatory oversight has allowed innovators to use irrelevant patents to defer generic competition. Meanwhile, patent litigation has set the stage for anticompetitive settlements rather than adjudication of the patent issues in the courts. As these settlements have provoked antitrust litigation, antitrust courts have proven no more willing …

Pharmaceutical Lemons: Innovation And Regulation In The Drug Industry, Ariel Katz

Michigan Telecommunications & Technology Law Review

Before a new drug can be marketed, the Food and Drug Administration must be satisfied that it is safe and effective. According to conventional wisdom, the cost and delay involved in this process diminish the incentives to invest in the development of new drugs. Accordingly, several reforms aimed at restoring such incentives have been implemented or advocated. This Article challenges the central argument that drug regulation and drug innovation are necessarily at odds with one another. Although intuitively appealing, the argument that drug regulation negatively affects the incentives to innovate does not fully capture the role that regulation plays in …

The Role Of The Fda In Innovation Policy, Rebecca S. Eisenberg

Michigan Telecommunications & Technology Law Review

This Article reexamines the role of FDA regulation in motivating investment in biopharmaceutical innovation. I begin by challenging the standard story that it is the patent system that makes drug development profitable, and drug regulation that makes it costly, by showing how patents add to costs and how drug regulation works in tandem with patents to protect profits. I then compare FDA-administered exclusive rights to patents as a means of fortifying drug development incentives, suggesting ways that FDA-administered rights might be preferable both from the perspective of policy makers and from the perspective of firms. In the remainder of the …