Digital Commons Network^™

The High Cost Of Pharmaceutical Acquisitions: Increasing Social Welfare Or Furthering Inequality?, Timothy J. Haltermann

Notre Dame Journal on Emerging Technologies

This note will argue that government and regulatory authorities should focus on easing access to downstream innovation by broadening research exemptions to patent infringement. Part I of this note will focus on the current state of patent protection and exclusivity afforded to pharmaceutical companies. Part II will discuss incentives created that lead rational actors to engage in M&A instead of through internal R&D. Part III will address the development of innovation as a standalone theory of harm in merger review, and the fallacies associated with labeling certain transactions as “killer acquisitions.” Finally, Part IV of the note will look at …

Will The Government Rip Up Employment Contracts?, Christopher J. Smiley

The Journal of the Michigan Dental Association

This editorial discusses the Federal Trade Commission's proposed rule to eliminate non-compete agreements, tracing their historical origins to the apprentice system in Europe. The author explores dentists' perspectives on this potential change, considering the need for talent acquisition versus workforce preservation. The editorial highlights the FTC's rationale for banning non-compete contracts and their impact on employee wages and innovation. It also addresses issues of boilerplate contract language and excessive leverage in the dental profession. The proposed rule aims to create consistency across states while allowing non-competes in specific cases. Dentist employers are advised to review and revise their agreements in …

From Patients To Patents: The Disappearing I Of Innovation, Maggi Robert

St. Mary's Law Journal

The creation of the Mayo/Alice two-step test for patent eligible subject matter flipped the patent world upside down. Following its establishment, invalidation rates soared—particularly in the healthcare sector—impacting patients everywhere. The importance of patents in healthcare innovation and innovation generally has been emphasized as the consequences of this framework are realized.

The United States is no longer seen as a clear leader in innovation, and as a result, the economy is at risk. Start-ups and investors have turned to foreign nations where return on their investments in innovation are protected. This level of uncertainty regarding patents has never been seen …

The Impact Of Uncertainty Regarding Patent Eligible Subject Matter For Investment In U.S. Medical Diagnostic Technologies, A. Sasha Hoyt

Washington and Lee Law Review

Historically, 35 U.S.C. § 101, the statute governing patent eligible subject matter, has been construed broadly—with its legislative history indicating that it should cover “anything under the sun that is made by man.” The Supreme Court crafted three exceptions to § 101: (1) abstract ideas, (2) laws of nature, and (3) natural phenomena. In recent years, the Supreme Court’s eligibility jurisprudence has further narrowed § 101 to effectively exclude meritorious medical diagnostic methods. Indeed, since the Court’s decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., the Federal Circuit has held every single diagnostic method claim brought before it …

Treating A Public Health Crisis For Rural Moms – A Comparative Analysis Of Four Rural States Addressing Maternal Opioid Misuse With Medicaid Innovation Models, Jason Semprini

Online Journal of Rural Research & Policy

Objective As we enter the third decade of the opioid crisis, opioid misuse continues its devastating toll on young women, specifically mothers on Medicaid in rural areas. The evolving Medicaid policy landscape has led to coverage and benefit expansion, yet gaps remain for pregnant women with opioid misuse. Further, the myriad of state specific policy decisions related to maternal eligibility and substance abuse benefits have created a seemingly disjoint policy arena for tackling a specific subgroup’s unmet needs. This policy scan aims to investigate the newly implemented 1115 demonstration model for Maternal Opioid Misuse by comparing the approaches of four …

Covid-19 And Its Impact(S) On Innovation, Clark Asay, Stephanie Plamondon Bair

Utah Law Review

In previous work, we explored how certain characteristics of adversity are often more conducive to innovation than others. In this Article, prepared as part of the Lee E. Teitelbaum Utah Law Review Symposium—The Law & Ethics of Medical Research, we review some of that work and apply it specifically to the COVID-19 context. We conclude by assessing certain policy implications in light of how the COVID-19 pandemic has both spurred and hindered innovation.

Money That Costs Too Much: Regulating Financial Incentives, Kristen Underhill

Indiana Law Journal

Money may not corrupt. But should we worry if it corrodes? Legal scholars in a range of fields have expressed concern about “motivational crowding-out,” a process by which offering financial rewards for good behavior may undermine laudable social motivations, like professionalism or civic duty. Disquiet about the motivational impacts of incentives has now extended to health law, employment law, tax, torts, contracts, criminal law, property, and beyond. In some cases, the fear of crowding-out has inspired concrete opposition to innovative policies that marshal incentives to change individual behavior. But to date, our fears about crowding-out have been unfocused and amorphous; …

That Is Northern Lights Cannabis Indica . . . No, It's Marijuana: Navigating Through The Haze Of Cannabis And Patents, Dawson Hahn

Concordia Law Review

By their very nature, patents are exclusionary. A patent grants the right to exclude others from making use of an invention or process. But patents are also tools to promote innovation. However, when an invalid patent is granted, the patent becomes an exclusionary tool that also chills innovation. Invalid cannabis patents may be chilling innovation in the cannabis market, but they may not be the only thing. While the Controlled Substances Act continues to prohibit cannabis at a federal level, researchers and medical professionals will be unsure of the legality of their actions. This naturally leads to another chilling effect …

Parallel Worlds: Comparing Rural Development To Development In Global Communities, Jena Martin, Karon Powell

West Virginia Law Review

No abstract provided.

Regulating Black-Box Medicine, W. Nicholson Price Ii

Michigan Law Review

Data drive modern medicine. And our tools to analyze those data are growing ever more powerful. As health data are collected in greater and greater amounts, sophisticated algorithms based on those data can drive medical innovation, improve the process of care, and increase efficiency. Those algorithms, however, vary widely in quality. Some are accurate and powerful, while others may be riddled with errors or based on faulty science. When an opaque algorithm recommends an insulin dose to a diabetic patient, how do we know that dose is correct? Patients, providers, and insurers face substantial difficulties in identifying high-quality algorithms; they …

The Oversimplification Of Deregulation: A Case Study On Clinical Decision Support Software, Deeva V. Shah

Michigan Telecommunications & Technology Law Review

Until the December 2016 passage of the Cures Act, the FDA had regulatory power over clinical decision support (CDS) software; however, the Act removed a large group of CDS software from the FDA’s statutory authority. Congressional intent was to increase innovation by removing regulatory blockades—such as device testing and certification—from the FDA’s purview. This note argues that the enactment of this specific provision of the Act will instead stymie innovation and overlook the unfortunate safety consequences inherent in its deregulation. CDS software is a burgeoning field ripe for innovation; however, rapid innovation can often lead to a slew of mistakes—mistakes …

First-To-Invent: A Superior System For The United States., Ned L. Conley

St. Mary's Law Journal

The United States uses the first-to-invent patent system, which is a time-honored system not worth abandoning in pursuit of harmonization. First-to-invent and first-to-file patent systems incentivize different approaches to obtaining a patent. However, a first-to-invent approach is, in part, what has allowed the United States to lead the world in innovation and it should not abandon this approach. The United States patent system is unique when compared to most other patent systems used by democratic, capitalistic, developed nations. A first-to-invent system provides incentive to invent, particularly to inventors who are less well financed. The incentive to innovate is in the …

Shattered Mirrors: Our Search For Identity And Community In The Aids Era, William J. Aseltyne

Michigan Law Review

A Review of Shattered Mirrors: Our Search for Identity and Community in the AIDS Era by Monroe E. Price