AI Today in 5: August 7, 2025. The US v. China Episode
AI Today in 5: August 6, 2025, The Rethinking Compliance Episode
AI Today in 5: August 5, 2025, The AI at the SEC Episode
FCPA Compliance Report: Navigating Corporate Scandals: Insights on Governance, Compliance, and Recovery with Steve Vincze
Podcast - Regulating AI in Healthcare: The Road Ahead
Life With GDPR: Episode 114: Navigating GDPR in Global Outsourcing with Inge Zwick
Daily Compliance News: June 27, 2025, The ABB Gets Out of DPA Edition
Regulatory Ramblings: Episode 72 - Cultural Roots, Belonging, and the Fear of Change: What’s Next for Inclusion?
(Podcast) The Briefing: The Ninth Circuit Puts the Brakes on Eleanor’s Copyright Claim
Compliance Tip of the Day: AI, Behavioral Analytics and Cyber Security
Performance Reviews: Lessons from Severance — Hiring to Firing Podcast
FCPA Compliance Report: Recent DOJ Policy Announcements
Culture Crafters: Navigating Business Volatility Through Corporate Culture
Upping Your Game: Harnessing AI to Revolutionize Third-Party Risk Management
Compliance and AI: Using AI for Data Loss Prevention Systems with Vinay Goel
The JustPod: Prosecutor-Initiated Resentencing: A Discussion with Hillary Blout
CareYaya: A Revolutionary Approach to Elder Care
Independent Contractor Rule, EEO-1 Reporting, and New York Labor Law Amendment - #WorkforceWednesday® - Employment Law This Week®
Podcast - Betty... embargaron Ecomoda
Sunday Book Review: May 11, 2025, The Celebrating Texas Writer’s Month Edition
Novartis markets and sells a combination therapy of valsartan and sacubitril under the brand name Entresto® for the treatment of various forms of heart failure. MSN submitted an Abbreviated New Drug Application seeking...more
In H. Lundbeck A/S, et al. v. Lupin Ltd., et al., Nos. 2022-1194, 2022-1208, and 2022-1246 (December 7, 2023), the Federal Circuit held that generic pharmaceutical companies may continue to use skinny labels to avoid...more
As part of the Hatch-Waxman Act, given the lack of information on the allegedly infringing product, courts have found that patentees can satisfy the pleading requirements of Twombly/Iqbal without having access to the accused...more
Case Name: Sanofi-Aventis U.S. LLC v. Sandoz, Inc., No. 20-804-RGA, 2023 WL 4175334 (D. Del. June 26, 2023) (Andrews, J.) Drug Product and Patent(s)-in-Suit: Jevtana® (cabazitaxel); U.S. Patent No. 10,716,777 (“the ’777...more
Coreg® (carvedilol) - Case Name: GlaxoSmithKline LLC v. Teva Pharms. USA, Inc., No. 2018-1976, -2023 (Fed. Cir. Oct. 2, 2020) (Circuit Judges Prost, Newman, and Moore presiding; Opinion by Newman, J.; Dissent by Prost, C.J.)...more
The Federal Trade Commission carried out an (in)famous crusade against reverse payment (more provocatively, "pay for delay") settlements in ANDA litigation for almost a decade before eventually having the Supreme Court see...more
What Quantum of Culpable Conduct Is Required for an ANDA Applicant to Induce Infringement? The back-and-forth, (almost) cat-and-mouse-like competition between branded innovator and generic drug makers sanctioned under the...more
THE COURT GRANTED PLAINTIFFS’ MOTION TO DISMISS DEFENDANT’S ANTITRUST AND PATENT MISUSE COUNTERCLAIMS AND RELATED AFFIRMATIVE DEFENSES. Case Name: Duke Univ. v. Akorn, Inc., Civ. No. 3:18-cv-14035-BRM-TJB, 2019 U.S. Dist....more
Can a party that did not submit an abbreviated biologics license application or an abbreviated new drug application, but will market the biosimilar or generic product after U.S. Food and Drug Administration approval, be sued...more
Case Name: Teva Pharms. USA, Inc. v. Sandoz Inc. (In re Copaxone Consol. Cases), 906 F.3d 1013, Fed. Cir. No. 2017-1575, 2018 U.S. App. LEXIS 28751 (Fed. Cir. Oct. 12, 2018) (Circuit Judges Reyna, Bryson, and Stoll; Opinion...more
Case Name: GlaxoSmithKline LLC v. Teva Pharms. USA, Inc., Civ. No. 14-878-LPS-CJB, 2016 U.S. Dist. LEXIS 94438 (D. Del. July 20, 2016) (Burke, M.J.) - Drug Product and Patent(s)-in-Suit: Coreg® (carvedilol); U.S....more
On March 18, 2016, the Federal Circuit held that filing an abbreviated new drug application (“ANDA”) with the FDA for a generic drug product, and thus indicating an intention to sell that product in every state (including...more
In an opinion handed down Friday that will continue the trend of forum shopping, the Federal Circuit in Acorda Therapeutics Inc. v. Mylan Pharmaceuticals, Inc., 2015-1456, (Fed. Cir. 2016) held that the filing of an...more
On March 12, the United States District Court for the Southern District of Indiana joined the District of Delaware and Eastern District of Texas as the first courts to consider a generic drug manufacturer’s motion to dismiss...more
In This Issue: - INTRODUCTION - WHAT ARE REVERSE PAYMENT SETTLEMENT AGREEMENTS? ..The Basic Framework of Hatch-Waxman Litigation ..The Federal Trade Commission’s View of Reverse Payment Settlements and Its...more