Law Commons^™

Suggestions For State Laws On Biosimilar Substitution, Gary M. Fox

Michigan Telecommunications & Technology Law Review

Biologic drugs offer major advancements over small-molecule drugs when it comes to treating serious diseases. Biosimilars, which mimic innovative biologic drugs, have the potential to further revolutionize the practice of medicine. States now have decades of experience regulating the substitution of generic, small-molecule drugs for their brand-name equivalents. But the complexities of biologic drugs and biosimilars force states to confront novel scientific and legal issues. Many states have begun tackling those issues by passing laws that regulate when pharmacists may substitute biosimilars for their corresponding biologic drugs. Other states have yet to do so. This Note surveys five provisions common …

Tiny Things With A Huge Impact: The International Regulation Of Nanomaterials, Dario Picecchi

Michigan Journal of Environmental & Administrative Law

Mounting evidence demonstrates that nanotechnology and nanomaterials impose severe environmental risks. To minimize these risks, the usage and handling of certain nanomaterials could be addressed under existing treaties such as the Rotterdam Convention, the Stockholm Convention, and the Basel Convention. However, even if existing treaties govern the handling of certain nanomaterials, no treaty effectively regulates all the specific challenges that nanomaterials pose to the global environment. Consequently, a completely new regulatory instrument is required. An international organization could take responsibility for developing and promoting such a nanospecific international legal framework. By incorporating the precautionary principle, a technology transfer, research cooperation, …

Beyond Rights And Welfare: Democracy, Dialogue, And The Animal Welfare Act, Jessica Eisen

University of Michigan Journal of Law Reform

The primary frameworks through which scholars have conceptualized legal protections for animals—animal “rights” and animal “welfare”—do not account for socio-legal transformation or democratic dialogue as central dynamics of animal law. The animal “rights” approach focuses on the need for limits or boundaries preventing animal use, while the animal “welfare” approach advocates balancing harm to animals against human benefits from animal use. Both approaches rely on abstract accounts of the characteristics animals are thought to share with humans and the legal protections they are owed as a result of those traits. Neither offers sustained attention to the dynamics of legal change …

Exclusion In Digital Markets, Konstantinos Stylianou

Michigan Telecommunications & Technology Law Review

This article recasts the existing analytical framework on exclusion to account for the technology-intensive nature of digital markets. It discusses:

a) technological ways that affect the competitive intensity in digital markets
b) empirical data on the durability of competitive advantage in digital markets, and
c) the nature of exclusion as a monopolization tactic from a technological point of view

The technology element is important because as a matter of order it is technological capabilities and limitations that define what the transactional overlay can be, not the other way around. Economists start from the pre-assumption that “in the beginning there [are] …

Cabining Judicial Discretion Over Forensic Evidence With A New Special Relevance Rule, Emma F.E. Shoucair

Michigan Law Review

Modern forensic evidence suffers from a number of flaws, including insufficient scientific grounding, exaggerated testimony, lack of uniform best practices, and an inefficacious standard for admission that regularly allows judges to admit scientifically unsound evidence. This Note discusses these problems, lays out the current landscape of forensic science reform, and suggests the addition of a new special relevance rule to the Federal Rules of Evidence (and similar rules in state evidence codes). This proposed rule would cabin judicial discretion to admit non-DNA forensic evidence by barring prosecutorial introduction of such evidence in criminal trials absent a competing defense expert or …

The Uneasy Case For Patent Law, Rachel E. Sachs

Michigan Law Review

A central tenet of patent law scholarship holds that if any scientific field truly needs patents to stimulate progress, it is pharmaceuticals. Patents are thought to be critical in encouraging pharmaceutical companies to develop and commercialize new therapies, due to the high costs of researching diseases, developing treatments, and bringing drugs through the complex, expensive approval process. Scholars and policymakers often point to patent law’s apparent success in the pharmaceutical industry to justify broader calls for more expansive patent rights.

This Article challenges this conventional wisdom about the centrality of patents to drug development by presenting a case study of …

The Commodification Of Cryptocurrency, Neil Tiwari

Michigan Law Review

Cryptocurrencies are digital tokens built on blockchain technology. This allows for a product that is fully decentralized, with no need for a third-party intermediary like a government or financial institution. Cryptocurrency creators use initial coin offerings (ICOs) to raise capital to build their tokens. Cryptocurrency ICOs are problematic because they do not fit neatly within either of two traditional categories—securities or commodities. Each of these categories has their own regulatory agency: the SEC for securities and the CFTC for commodities. At first blush, ICOs seem to be a sale of securities subject to regulation by the SEC, but this is …