When DEI Meets the FCA: What Employers Need to Know About the DOJ’s Civil Rights Fraud Initiative
The NCAA's Recent Q&A Document: Clues on What NIL Enforcement Will Look Like Post-House — Highway to NIL Podcast
Episode 376 -- DOJ's Unicat Settlement and the Future Look of Trade Enforcement Actions
False Claims Act Insights - Bitter Pills: DOJ Targets Pharmacies for FCA Enforcement
10 For 10: Top Compliance Stories For the Week Ending June 28, 2025
Everything Compliance: Episode 156, To Document or Not Edition
From Permits to Penalties: A Deep Dive Into Coastal Development Law
Compliance into the Weeds: Boeing’s New Safety Initiatives and Compliance Reforms
Podcast - FTC to Focus on Deceptive AI Claims: Compliance Management Strategies
Podcast - How Do You Define Success?
Episode 374 -- Justice Department Resumes FCPA Enforcement with New, Focused Guidance
10 For 10: Top Compliance Stories For the Week Ending June 21, 2025
2 Gurus Talk Compliance – Episode 54 – The FCPA is Back On Edition
Understanding the DOJ's Recent Corporate Enforcement Policy Changes
Daily Compliance News: June 19, 2025, The Corruption in Spain Edition
Workplace ICE Raids Are Surging—Here’s How Employers Can Prepare - #WorkforceWednesday® - Employment Law This Week®
False Claims Act Insights - Will Recent Leadership Changes Lead to FCA Enforcement Policy Changes?
All Things Investigations: Navigating New DOJ Directives - Declinations, Cooperation, and Whistleblower Programs with Mike DeBernardis and Katherine Taylor
Compliance Tip of the Day: New FCPA Enforcement Memo - What Does it Say?
On June 12, the nominee for USPTO Director John Squires was voted out of the Senate Judiciary Committee by a vote of 20-2. His nomination has been placed on the Senate’s Executive Calendar and will proceed to a floor vote....more
Antitrust scrutiny of healthcare markets is nothing new. The Biden Administration and first Trump Administration focused antitrust enforcement efforts across the healthcare and life sciences industries. The newly installed...more
Last month the Federal Circuit issued a decision in the Lashify case that significantly broadens the opportunity for companies to bring a lawsuit before the U.S. International Trade Commission (“ITC”). The ITC is known for...more
Given the continued challenges in policing the burgeoning ENDS marketplace, as previously discussed in Part I of this article, in mid-2024 FDA and DOJ announced the establishment of a federal multi-agency task force to combat...more
Earlier this month, a federal district court denied the Outsourcing Facilities Association’s preliminary injunction motion, which sought to preclude FDA from taking enforcement action against compounded tirzepatide...more
In its recent decision in Lashify, Inc. v. International Trade Commission, the Federal Circuit opened the door for patent owners to include expanded categories of domestic investment to satisfy the economic prong of the...more
Last month, the U.S. Food and Drug Administration (the “FDA”) announced in a Declaratory Order the resolution of the shortage of semaglutide injection products Wegovy and Ozempic (the “February Declaratory Order”). On March...more
Lashify, Inc. v. International Trade Commission Before: Prost, Taranto, and Chen. Appeal from ITC Investigation. The Federal Circuit expands the economic prong of the domestic-industry analysis to include domestic spending on...more
In a recent ruling, the U.S. Court of Appeals for the Federal Circuit upended years of settled law and ruled that sales and marketing expenses, by themselves, can be the basis for a finding of domestic industry in an...more
For a business planning to market a product that incorporates an invention, having an enforceable patent to protect the invention is often desirable. Two recent federal circuit cases reiterate what many patent holders and...more
In Lashify v. ITC, the Federal Circuit held that the economic prong of the domestic industry requirement, which is a precondition for obtaining International Trade Commission Section 337 relief, can be satisfied with...more
Last week, the U.S. Court of Appeals for the Federal Circuit lowered barriers that one must overcome to enforce patents at the U.S. International Trade Commission (ITC). The ITC often proves to be an effective forum to...more
For decades, the ITC’s jurisdictional requirement – known as the domestic industry requirement – effectively shut out innovators from availing themselves of the powerful remedies of the forum, in the form of an exclusion...more
For years, the U.S. International Trade Commission maintained that the potent remedies available under Section 337 were unavailable to intellectual property owners considered to be nothing more than “mere importers.” That...more
On February 12, 2025, the US District Court for the District of Delaware issued a significant ruling in the case of HE, Inc. v. Avadim Holdings Inc. and Relion Holdings LLC. This decision arose from the Chapter 11 bankruptcy...more
Section 337 investigations at the U.S. International Trade Commission (ITC) remain an efficient and powerful method for American businesses seeking relief from foreign acts of unfair competition, including infringement of...more
On Friday, Feb. 7, 2025, the Federal Circuit issued a precedential opinion in Wuhan Healthgen Biotech. Corp. v. U.S. Int’l Trade Comm’n, No. 23-1389, 2025 WL 420819 (Fed. Cir. 2025). The three-judge panel, consisting of Chief...more
Alexion Pharmaceuticals v Amgen (UPC_Coa-405/2024) and Alexion Pharmaceuticals v Samsung Bioepis NL BV (UPC_CoA-402/2024); December 20, 2024. The UPC Court of Appeal has confirmed a strict approach to correcting erroneous...more
A US Court of Appeals for the Federal Circuit panel consisting of Judges Sharon Prost, Richard Taranto, and Raymond Chen recently heard oral argument in Lashify, Inc. v. US International Trade Commission, an appeal from a...more
On December 17, 2024, the Competition Tribunal (the Tribunal) issued reasons for its decision to dismiss an application for leave to bring a private abuse of dominance action against a major pharmaceutical manufacturer. JAMP...more
To describe the rise of artificial intelligence (AI) as rapid is a vast understatement. From its ubiquitous presence assisting us in our most mundane daily tasks to its warm embrace by business leaders eager to revolutionize...more
On January 8, 2025, Administrative Law Judge (ALJ) Cameron Elliot issued a public version of the Initial Determination (ID) in Certain Video Capable Electronic Devices, Inv. No. 337-TA-1380 brought by Complainant Nokia. While...more
A trio of cases this past year illustrate a trend of increasing importance of the Patent Office’s rulemaking and enforcement. Parus Holdings, Inc. v. Google LLC, 70 F.4th 1365 (Fed. Cir. 2023) The Federal Circuit’s...more
The UPC decides that the defendant’s financial situation and location matter. On 30 October 2023, the Munich Central Division of the UPC (the Court) issued an order stating that NanoString must provide security to Harvard...more
Please join Fitch Even for a free webinar, “180 Days of UPC: How It Started… How It’s Going…,” on Wednesday, November 29, at 9:00 a.m. PST / 10:00 a.m. MST / 11:00 a.m. CST / 12 Noon EST. The Unified Patent Court (UPC)...more