Compliance Tip of the Day: Rethinking Corporate AI Governance Through Design Intelligence
Daily Compliance News: July 22, 2025, The I-9 Hell Edition
Compliance Tip of the Day: Avoiding CCO Liability
Compliance Tip of the Day: COSO Governance Framework - Part 5, People
SkadBytes Podcast | Tech’s Shifting Landscape: Five Trends Shaping the Conversation
Balch’s Consumer Finance Compass: How Standing Can Make or Break Certification for Class Action Lawsuits in Debt Collection
Top challenges with Compliance Management
Innovation in Compliance: Allison Lagosh on Proactive Compliance Planning for Regulatory Changes
Daily Compliance News: July 15, 2025, The Fighting Workplace Bullying Edition
Compliance Tip of the Day: Design - Centric Internal Controls
Treating Compliance Like an Asset
When DEI Meets the FCA: What Employers Need to Know About the DOJ’s Civil Rights Fraud Initiative
#Risk New York Speaker Series – Exploring Future Regulatory Trends and Compliance Strategies with Rory McGrath
The Capital Ratio Podcast | Entering the US Banking Market
SCOTUS Clean Air Act Cases: What’s New?
First 100 Days of the New HSR Rules with Antitrust Partner Kara Kuritz
Hospice Insights Podcast - Election Inspection: Be Proactive to Avoid Costly Election Statement Denials
From Permits to Penalties: A Deep Dive Into Coastal Development Law
Compliance into the Weeds: Boeing’s New Safety Initiatives and Compliance Reforms
PODCAST: Williams Mullen's Benefits Companion - Gag Clause Prohibitions
A recent notice from the United States Patent and Trademark Office (USPTO) informed patent owners that “Starting September 1, 2025 all Patent Trial and Appeal Board (PTAB) hearings will be held in person.” (Emphasis added)....more
On April 10, 2025, the U.S. Food and Drug Administration (FDA) announced a landmark initiative to phase out animal testing in drug development, signaling a major shift toward human-relevant, science-driven alternatives. This...more
The intersection of patent strategy and FDA regulatory strategy is a critical consideration for medical device companies. A well-integrated approach can create powerful barriers to entry, strengthen intellectual property (IP)...more
In April 2025, the U.S. Food and Drug Administration (FDA) released a landmark guidance titled “Roadmap to Reducing Animal Testing in Preclinical Safety Studies,” outlining its commitment to advancing New Approach...more
On 9 July 2025, the European Commission (EC) issued its first-ever comfort letters under the 2022 Notice on Informal Guidance. One letter endorses a joint licensing initiative for standard essential patents (SEPs) in the...more
The European Commission has issued its first-ever informal approvals of two separate sustainability initiatives among rivals under its revised Informal Guidance Notice and provided guidance on how the companies in question...more
The US Patent and Trademark Office (USPTO) has finalized a rule increasing the annual limit on accepted requests for prioritized patent examination from 15,000 to 20,000, effective with fiscal year 2025 (FY 2025). This...more
In the first half of 2025, the Rx IP Update team reported on a number of developments in Canadian life sciences IP and regulatory law. Below are our top stories....more
Cell and gene therapies represent a transformative frontier in modern medicine, offering potential cures for previously untreatable conditions. However, securing intellectual property (IP) protection for these innovations...more
In its June 2025 meeting, the European Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) adopted positive opinions for six biosimilar medicines. ...more
On 10 June 2025, the US Patent and Trademark Office (USPTO) published a Final Rule announcing the discontinuation of the Accelerated Examination program for utility applications beginning 10 July 2025. The change affects the...more
L’évolution de la technologie de l’intelligence artificielle (« IA ») entraîne des changements considérables dans bien des secteurs au Canada, au point de nécessiter une évaluation des cadres juridiques en place. Que ce soit...more
This latest edition features articles on succeeding in the current life sciences funding market, strategic and legal considerations in digital health combinations, the corporate practice of medicine and guidance for...more
Dual use technologies are innovations that have both civilian and military applications. Notable examples include advanced semiconductors, artificial intelligence (AI), encryption software, 3D printing, chemical and...more
Starting May 13, 2025, the USPTO has begun accelerating the issuance of patents after the issue fee has been paid. Specifically, the duration between the Issue Notification and the Issue Date will be reduced to approximately...more
The evolving field of artificial intelligence (AI) is significantly reshaping various sectors across Canada, prompting a critical evaluation of our legal frameworks. From intellectual property to financial markets, AI...more
May 1, 2025, marked the entry into force of most provisions of Phase I of the new Regulation (EU) 2024/2822, which forms part of the "Designs and Models Package" adopted within the European Union. This text, in addition to...more
Patent activity in the aerospace, defense, and security industries decreased during 2024, Army Technology reports. The story references statistics from GlobalData that the “global aerospace, defense & security industries...more
Starting May 13, the U.S. Patent and Trademark Office (USPTO) will accelerate the time between issue notification and the issue date of a patent. That is, the time frame will be cut from about three weeks to two weeks –...more
This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how artificial intelligence is revolutionizing research, innovation, and patient care in the life sciences....more
FDA approves Omylco® (omalizumab), first biosimilar of Xolair®. After Q1, FDA and EMA on track for a record number of biosimilar authorizations in 2025....more
The Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure is an international agreement to establish a uniform system for depositing microorganisms and other...more
Hetlioz® (tasimelteon) - Case Name: Vanda Pharms., Inc. v. FDA, Civ. No. 23-280 (TSC), 2025 WL 485401 (D.D.C. Feb. 13, 2025) (Chutkan, J.) Drug Product and Patent(s)-in-Suit: Hetlioz® (tasimelteon); U.S. Patent No. , a...more
Standard-essential patent (SEP) licensing remains a critical issue in Europe, where political bodies and national courts at times diverge in the interpretation of fair, reasonable, and non-discriminatory (FRAND) licensing...more
In July 2024, the UPC Court of Appeal (CoA) clarified its procedural rules surrounding evidence preservation and confidentiality. It confirmed that the deadline for bringing an action on the merits only starts to run after...more