Transparency is a Misplaced Regulatory Focus for Holding Adaptive Software as Medical Devices (SaMDs) Accountable
Quy Mai Adaptive Software as Medical Devices (SaMDs) play an increasingly critical role within clinical settings, assisting physicians with illness detection, diagnosis, and analysis. Use of Artificial Intelligence/Machine Learning (AI/ML) techniques, such as deep machine learning and neural networks, lends adaptive SaMDs unparalleled analytical power, but not without risks. Adaptive SaMDs are typically “black-box,” meaning that they compute data such that no one can determine how it rendered outputs. “Transparency,” in the form of explainability, is frequently raised in policy discussions as a solution to track when the SaMD has erred in computing outputs. The FDA, in seeking to uphold...
Crime and Punishment: Holding Russia Accountable for Weakening Foreign Entities’ Intellectual Property Rights
Eliot Usherenko The Russian government has deliberately weakened intellectual property right protections for entities from “unfriendly countries.” Following Moscow’s invasion of Ukraine and the subsequent imposition of economic sanctions by the United States and its allies, the Kremlin launched policies targeting Western businesses as they withdrew from the Russian market. This Article analyzes three potential recourses—bilateral, multilateral, and non-governmental—impacted corporations and individuals could execute to hold Russia accountable for its discriminatory treatment. This Article argues that corporations should form partnerships with their respective governments to promote intergovernmental dialogue through mechanisms such as treaties, as well as undertake litigation in Russia’s...
BLOG POST: The Weak “Non-obvious” Patenting Requirement is Impeding Americans from Obtaining Affordable Pharmaceuticals*
*This writing is a blog post. It is not a published IPTF Journal Article. Sydney Closs A patent grants an inventor the right to exclude others from “making, using, importing, and selling” a patented invention for a specified period of time. 35 U.S.C. § 271. This right allows an innovator to enjoy a limited monopoly over an invention, providing important incentives for innovation. See 35 U.S.C. § 103. Under current patent law, there are five principal requirements for a new innovation to be eligible to receive a patent: (1) patentable subject matter, (2) utility, (3) novelty, (4) non-obviousness, and (5)...
For My Eyes Only: How to Protect Digital Diaries of Reproductive Data in a World Without Roe
Carolyn Zaccaro In 2022, the Supreme Court overturned Roe v. Wade with its decision in Dobbs v. Jackson Women’s Health Organization, leaving many individuals anxious about the future of their privacy rights. With millions of people using period-tracking apps, there is a massive amount of sensitive data at stake, including data that criminal prosecutors could use to criminalize people for seeking or having an abortion. Some people are better protected because of their home state’s data privacy legislation, but most Americans are left with no data privacy law protecting their sensitive data. In an era of sophisticated tracking technology, the absence of comprehensive...
BLOG POST: DR. AMAZON: SHINING A LIGHT ON HIPAA INADEQUACIES THROUGH AMAZON’S EXPANSION INTO THE HEALTHCARE INDUSTRY*
*This writing is a blog post. It is not a published IPTF Journal Article. Alexa Dawid Technology giants are spending billions to enter the healthcare space.[1] Offerings like Apple’s health monitoring functions on the iPhone, Microsoft’s cloud computing services for healthcare companies, and Meta’s fitness applications through its virtual reality goggles have transformed traditional notions of doctor’s offices and paper records into convenient digital systems.[2] Amazon has been one of the most ambitious within the space, debuting six HIPAA-compliant skills for Alexa in April 2019.[3] These skills mark the first time Alexa has surpassed HIPAA requirements in utilizing HIPAA-compliant...
BLOG POST: Lessons from the China Initiative: The Perils of Pursuing Foreign Policy Through Prosecutions*
*This writing is a Blog Post. It is not a published IPTF Journal Article. Joshua Nacht One week before Jeff Sessions was fired as Attorney General, he announced the November 2018 creation of the Justice Department’s “China Initiative”.[1] The China Initiative emerged to counter myriad economic and national security threats, including intellectual property (IP) theft, forced technology transfer, cyberespionage of trade secrets and national security information, and efforts to obtain and/or penetrate critical military technology.[2] By some estimates, these PRC-linked efforts cost the United States up to $30 billion a year, and have totaled $600 billion cumulatively.[3] Under Attorney General...
BLOG POST: Promises, Patents, and the Pandemic: Moderna v. Pfizer*
Emily Stark *This Writing is a Blog Post. It is not an official IPTF Article Publication. In 2020, the world desperately needed a vaccine to address the COVID-19 pandemic.[1] Three companies: Moderna, Pfizer, and Johnson & Johnson, developed and produced vaccines that would allow people to return to their ordinary lives.[2] Two of those companies, Moderna and Pfizer, both used mRNA to develop the platforms for their vaccines.[3] Researchers had been developing mRNA vaccines for years prior to the pandemic.[4] Moderna is responsible for much of the development of the mRNA vaccine technology, and Moderna filed for patents in 2010...
Disclaimers: The Solution to Source Confusion in Sports Merchandising?
William Wheeler This Article evaluates the ramifications of modern trademark law in the context of sports apparel and logos. Collegiate and professional sports teams have utilized modern trademark law to enact a licensing regime where third-party companies must pay royalties to produce apparel with collegiate logos. This regime assumes the inherent value of trademarks on sports apparel is derived from their association with the teams they represent, not the logo itself. This Article examines various approaches courts have taken to address the dichotomy between the necessary consumer association and the reality that the logos themselves are what draw consumers. Most...
The Supreme Court’s Missed Opportunity to Save Genus Claims in Life Sciences Patents
Alexander Franzosa The life sciences industry is a vital sector of the American economy, and its success is reliant on the protection of patent holder rights. One common feature in life sciences patents is the genus claim, a claim type traditionally allowing the patent holder to claim a group of related species based on common functionality. A novel interpretation of “written description,” a required element for patent applications, has emerged in recent decisions by the Court of Appeals for the Federal Circuit. This new interpretation has caused concern among some members of the life sciences industry regarding the validity of...
“Your Honor, the Car Crashed Itself”: Navigating Autonomous Vehicle Liability in an Age of Innovation
Julia Doskoch Autonomous vehicles are increasingly permeating the consumer marketplace. This trend has caused a conundrum in tort liability law. It is standard in product liability law for manufacturers to be held strictly liable for defective products, but there is a gray area when autonomous vehicles are involved in car accidents due to defects. This Article dissects various proposals concerning how the legal system should proceed regarding autonomous vehicle liability. This Article also advocates for federal regulation to define the legal personhood of autonomous vehicles in the eyes of the law. Read Full Text Here