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
Kilpatrick’s Kris Doyle, David Reed, Kate Klein, and Ditty Shrivastava recently presented at the annual Kilpatrick Intellectual Property Seminar Series on the topic of “Recent Changes with Respect to the New Administration.”...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
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
The Federal Circuit upheld the ITC Commission’s discretionary power not to issue sua sponte orders to show cause why a party has not committed sanctionable conduct under Commission Rules or to explain its reason for not...more
The Federal Circuit held in Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc., 23-2254 that a reissued patent receives patent term extension (PTE) based on the issue date of the original patent, not the reissue patent,...more
On March 17, 2025, Senators Chuck Grassley (R-IA), John Cornyn (R-TX), Richard Blumenthal (D-CT), and Richard Durbin (D-IL) re-introduced the “Affordable Prescriptions for Patients Act” (“APPA”), which previously passed the...more
The recent uptick and rise in popularity of GLP-1 drugs for addressing weight loss and obesity has led to an increase in U.S. litigation involving this class of drugs. Over the past few years, litigation has focused on a wide...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
Tax developments - Actavis and deductible expenses - On March 21, 2025, the Court of Appeals for the Federal Circuit released a decision in Actavis Laboratories FL, Inc. v. United States, holding that taxpayers could...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
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
On February 28, 2025, the U.S. Patent and Trademark Office announced that it was rescinding a 2022 memorandum that provided guidance regarding the application of the Apple v. Fintiv decision to the Patent Trial and Appeal...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
Two recent Federal Circuit decisions open the doors of the United States International Trade Commission (“ITC”) to smaller companies that are threatened by unfair imports....more
On February 28, 2025, the acting director of the US Patent & Trademark Office (PTO) announced that the agency will revert to previous guidelines for discretionary denials of petitions for post-grant proceedings where there is...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 February 28, the US Patent and Trademark Office (USPTO) rescinded former Director Kathi Vidal’s 2022 memorandum on discretionary denials in Patent Trial and Appeal Board (PTAB) post-grant proceedings running parallel to...more
Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...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