Episode 369 -- Stepping Into the Enforcement Spotlight -- Customs and Border Patrol and Import Enforcement
Tariffs and Trade Series: What Investors Need to Know
Compliance Tip of the Day: Using Supply Chain to Innovate in Compliance
State AGs Unite: New Privacy Task Force Signals Shift in Regulatory Power Dynamics — The Consumer Finance Podcast
Early Returns Podcast - Oliver Roberts: AI and the Law, and an Education
Compliance into the Weeds: Leaving on a (Qatari) Jet Plane
(Podcast) California Employment News: Back to the Basics of Employee Pay Days
Compliance Tip of the Day: Multiplying the Influence of Compliance
Innovation in Compliance: Navigating Regulatory Changes and Compliance in Trade and Data Privacy with Stephanie Font
Compliance tip of the Day: Communication Through Persuasion
All Things Investigations: Task Force Strategies - Addressing New Government Priorities
10 For 10: Top Compliance Stories For the Week Ending May 10, 2025
Compliance Tip of the Day: Middle Managers as the Eyes and Ears of Compliance
Everything Compliance: Episode 153, The CW 25 Edition
ADA Compliance for Medical and Dental Practices: Responding to Inquiries and Investigations
Innovation in Compliance: Exploring the Intersection of Compliance, Technology, and AI with Ben Sperry
Compliance Tip of the Day: Elevating Compliance Through Connected Middle Managers
Understanding Human Trafficking and Modern Slavery: A Business Imperative with Clint Palermo
Shout Outs and Rants: Episode 153, The CW 25 Edition
Daily Compliance News: May 6, 2025 the Made in China Edition
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
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
On March 26, 2025, the United States Patent and Trademark Office (USPTO) announced changes to the Patent Trial and Appeal Board (PTAB) trial institution process, creating a new bifurcated approach to institution decisions....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
On March 13, 2025, the Federal Circuit issued a decision in Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc., No. 23-2254 (Fed. Cir. 2025) that clarifies how patent term extension (PTE) is calculated for reissue...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
On Friday afternoon, February 28, 2025, the United States Patent and Trademark Office (USPTO) issued a brief “bulletin” rescinding a memorandum issued by the former Director Kathy Vidal (“Vidal Memo”) providing guidance 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
On this episode of Ropes & Gray's ITC-focused podcast series, Talkin' Trade, IP litigators Matt Rizzolo, Matt Shapiro, and Patrick Lavery discuss a groundbreaking Federal Circuit decision in Lashify v. ITC. This pivotal...more
On March 5, the Federal Circuit held that sales, marketing, warehousing, quality control, or distribution expenditures may count as “employment of labor or capital” for purposes of satisfying the economic domestic industry...more
Late last year we reported on the United States Court of Appeals for the Federal Circuit decision holding that certain device patents should not have been listed in the FDA’s Orange Book since the claims of the patents in...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
On March 5, 2025, the United States Court of Appeals for the Federal Circuit issued a precedential opinion that will change the way the U.S. International Trade Commission addresses the threshold “domestic industry...more
Obesity and diabetes have been two of the greatest public health challenges for decades. Many different diets and fads have promised the public a quick fix and a path to losing excess weight or resolving their diabetic...more
Takeaways - - Requestor submissions in reexamination proceedings are exempt from triggering IDS size fees. - Correcting filing benefit claims in reissue triggers the new continuing application fee. As we noted in our...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
Entresto® (sacubitril/valsartan) - Case Name: Novartis Pharms. Corp. v. Becerra, Civ. No. 24-cv-2234 (DLF), 2024 WL 4492072 (D.D.C. Oct. 15, 2024) (Friedrich, J.) Drug Product and Patent(s)-in-Suit: Entresto®...more
This month the Supreme Court denied certiorari on Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., and in doing so, seemingly indicated its support for a broad interpretation of the Hatch-Waxman safe harbor...more
On January 20, 2025, Justice O’Reilly of the Federal Court dismissed Bayer’s judicial review of the Minister of Health’s decision to list Canadian Patent No. 2,970,315 (315 Patent) on the Patent Register eight days after it...more
Last year was a surprisingly big one for legal decisions impacting the biotechnology transactions and licensing space. Given that most biotech deals are subject to confidential alternative dispute resolution, it is unusual...more
The landscape of design protection has seen significant developments on both sides of the Atlantic, with the U.S. undergoing a pivotal shift in design patent law following the Federal Circuit’s decision in LKQ Corporation v....more
In Teva Branded Pharmaceutical Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC, the Federal Circuit jumped on the bandwagon of scrutinizing the types of patents that can be listed in the Food & Drug...more
The Federal Circuit affirmed in part, reversed-in-part and remanded-in-part the Board’s decision in the inter partes review of U.S. Patent No. 8,265,096 (the “’096 patent”), and affirmed the Board’s decision as to the cross...more
As mentioned in last month’s IP Practice Tips, reissue applications are subject to additional legal doctrines founded in requirements of 35 U.S.C. § 251. One doctrine that has been operative since the first reissue statute...more
Section 337 investigations at the ITC have proven to be an efficient and powerful method for Complainants seeking relief from unfair importation. The Commission’s injunctive powers provide an attractive forum for Complainants...more