At the end of 2022, FDA published a draft guidance on Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers. The draft guidance explains several aspects of the VMSR Program, including FDA’s approach to determining the…
Many law firms have changed their transaction management processes significantly with recent advancements in technology, especially the development of artificial intelligence. AI and technology innovations have aided deal lawyers in…
Artificial intelligence, or AI, was the buzzword of 2023. AI has affected almost every aspect of our world. Although the legal profession has used “traditional AI” for many years, the use of generative AI is new and is evolving.... By: JAMS
Case Name: Janssen Pharms., Inc. v. Tolmar, Inc., Civ. No. 21-1784-WCB, 2024 WL 834762 (D. Del. Feb. 26, 2024) (Bryson, J.) - Drug Product and Patent(s)-in-Suit: Invega Sustenna® (paliperidone extended-release suspension); U.S. Patent No.…
Based on client inquiries and FDA actions, the Food and Drug Administration is focusing more on companies not submitting data to www.ClinicalTrials.gov. It is taking stronger action against those companies it believes are non-compliant....…
Judges are beginning to address the increasing use of AI tools in court filings—including reacting to instances of abuses by lawyers using it for generative purposes and requiring disclosures regarding the scope of AI use in the drafting…
The big news in crypto policy came out of the Senate this month. On April 17, Senators Cynthia Lummis (R-WY) and Kirsten Gillibrand (D-NY) partnered once again in the digital asset space, this time introducing the Lummis-Gillibrand Payment…
The "genome revolution" over the past 30 years has resulted in the elucidation of several species, both domesticated (see, e.g., "The Genetic Basis of Coat Variation in Dogs"; "Further and More Detailed Study of Domestic Cat Genome"; …
This presentation examines the essential role of intellectual property law in the success of inventors, entrepreneurs, and content creators. Additionally, this presentation addresses common questions and concerns within these industries,…
This article focuses on the risks associated with inputting data into GenAI tools and models. The outputs of GenAI systems also create risks; we will explore this in Part 2 of this series. A Risk Aware Approach to Data, Legal Governance,…
Patents are prohibited from claiming inventions that would have been obvious to a person having ordinary skill in the art (“POSITA”). This non-obviousness requirement is an application of the Constitution’s limitations on the scope and…
LKQ Corporation, Keystone Automotive v. GM Global Technology Operations LLC - As an initial disclaimer, Irwin IP LLP is privileged to be lead counsel for LKQ Corporation and Keystone Automotive Industries, Inc. (collectively, “LKQ”) in…
The Court of Justice of the European Union (CJEU) has made a landmark decision (7 March 2024, C-604/22) on the intricacies of adtech, personal data, and joint control against the background of the General Data Protection Regulation (GDPR).…
According to published reports, George Carlin’s estate settled right of publicity and copyright claims relating to an AI-scripted comedy special using a “sound-alike” of George Carlin which performed the generated script. The special –…
It’s official—the Cornhusker State has a new data privacy law. The Nebraska Data Privacy Act (NDPA) is now among the growing number of state laws businesses must contend with absent a federal law.... By: Osano
With the COVID pandemic, remote video depositions and trial testimony very quickly went from rare to routine. Remote testimony, for the most part, is viewed as a convenience to both witnesses and attorneys, and parties and witnesses…
In the courtroom, trial technology has emerged as a powerful tool for lawyers seeking to inform, engage, and persuade jurors. As attention spans grow shorter and jurors’ expectations for high-quality graphics increase, visual advocacy…
We carry not only Netflix and YouTube in our pockets but also the video cameras that make content creation possible. Our neighbors are TikTok influencers with a million subscribers. Our kids are YouTube sensations, streaming video game…
Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick summary of relevant…
Managing electronically stored information (ESI) is a challenge for most organizations today. Numerous, diverse data sources, from websites and social media accounts to internal chat platforms, are creating huge volumes of information,…
In the evolving landscape of digital information, eDiscovery has become an essential aspect of legal processes, serving as a crucial tool for uncovering relevant evidence in litigation. However, with the rapid growth of electronically…
President Joe Biden’s Executive Order regarding the “Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence” directs departments and agencies throughout the government, including the Department of Homeland Security …
In 1992, a jury awarded the singer Tom Waits the equivalent of $6 million in today’s dollars because Frito-Lay used a voice-alike in its Doritos ad and misappropriated his right to publicity. Bette Midler, Shirley Booth, and Bert Lahr also…
On 6 May 2024, the German data protection authorities (“DPAs”) issued an extensive guidance paper on the GDPR compliant deployment of artificial intelligence (“AI”) applications. This article summarizes the key findings of the guidance and…
Join us for the third installment of our groundbreaking webinar series, "Rise of the Machines". In previous sessions, retired Judge Ralph Artigliere, together with CodexTen’s pioneers Shawn Arnold and Clayton Romero, uncovered the…
In just the first few weeks of 2024, two separate cases of allegations of research misconduct have been publicized. In both cases, the alleged misconduct was discovered by independent “data sleuths” using artificial intelligence (AI)......…
As law firms and other businesses increasingly look to AI-driven software to drive efficiency, the importance of meticulous review of not just their capabilities and features, but also the agreements under which they are provided, becomes…
Earlier this year, we reported on the expected U.S. Food and Drug Administration (FDA) ruling concerning Laboratory Developed Tests (LDTs). The FDA has consistently shown a commitment to regulating LDTs. On May 6, 2024, the new rule that…
A recent complaint alleging trade secret misappropriation in the Eastern District of New York demonstrates the importance of combing an alleged trade secret misappropriator’s social media for subtle – and not-so-subtle – evidence of their…
Who may be interested: Registered Investment Companies, Investment Advisers, Broker-Dealers - Quick Take: The SEC settled charges in separate actions against five investment advisers (Advisers) for violations of Rule 206(4)-1 (Marketing…