#WorkforceWednesday®: What the FTC Non-Compete Ban Block Means for Employers - Employment Law This Week®
Podcasting for Business - The Book: Metrics That Matter, Part 1 - Referrals, Sales Cycle, Promos, SEO and Product Creation
Innovation in Compliance: The Evolution of Compliance and Technology: An Interview with Stuart Breslow
The Magnificent 7 Rides Again: Elaine Capers on Artistic Inspirations from West Texas
Consumer Finance Monitor Podcast Episode: Why do Fintechs Want to Become Banks?
From Paper to Digital: The California DMV's Leap Into Blockchain Technology — The Crypto Exchange Podcast
Compliance Tip of the Day: Bank of America, Culture and Internal Controls
Corruption, Crime and Compliance: SEC Suffers Dismissal of Claims in Solarwinds Securities Fraud Case
Regulatory Ramblings: Episode 51 - The EU AI Act: Why it Matters for Asia and Beyond with Michael Borrelli (AI & Partners) and Anandaday Misshra (AMLEGALS)
The Woody Report: The Solar Winds Dismissal
Life With GDPR: AI Regulation in The EU
The Power of Genuine Networking for Entrepreneurs With OneSixOne Ventures with Pablo Casilimas and Justis Mendez
Innovation in Compliance: Unpacking Healthcare Compliance with Maria Villanueva
Corruption, Crime and Compliance: The Boeing Plea Agreement
Riskology by Infortal: Episode 30 – Boeing’s Future: Failure is Not an Option with Tom Fox and Christopher Mason
Daily Compliance News: August 12, 2024 – The Bribery Alleged Edition
2 Gurus Talk Compliance: Episode 34 – The Whistleblower Edition
It’s art, let’s talk about it: Behind The Easel: A Chat with Bill Kalwick
#WorkforceWednesday: What Is the Future of Non-Compete Agreements for Employers? - Spilling Secrets Podcast
The FTC and Connecticut Join Forces for Action Against Nissan Dealer
It has been a busy year for issues related to drug pricing, and with the election around the corner, litigation issues that have been developing over the last few years are likely to be a key focus for the second half of...more
Last September, the Federal Trade Commission (FTC) promulgated a “policy statement” entitled “Statement Concerning Brand Drug Manufacturers’ Improper Listing of Patents in the Orange Book,” regarding the FTC’s allegations...more
Calls for Removal of Device Patents Listed in the Orange Book Continue. FTC and Congressional action scrutinizing allegedly “improper” Orange Book listings continued apace in the first few months of 2024. ...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
In the ten years since the Supreme Court ruled in Federal Trade Commission v. Actavis that reverse payment settlements—or settlements where a patent holder pays an accused patent infringer cash or other consideration to end...more
The European Commission (EC) has fined five pharmaceutical companies a total of EUR13.4 million for participating in a cartel concerning N-Butylbromide Scopolamine/Hyoscine (SNBB) – an active pharmaceutical ingredient (API)...more
I. Introduction - No pharmaceutical antitrust decision has had more impact than the Supreme Court’s 2013 decision in Federal Trade Commission v. Actavis, a decision which officially defined the term “reverse payment...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
The U.S. Department of Justice Antitrust Division ("DOJ") recently resolved a criminal case with Teva Pharmaceuticals and Glenmark Pharmaceuticals via deferred prosecution agreements ("DPAs"), which include a novel remedy for...more
Below are highlights from the Rx IP’s team’s 2022 updates (see also our Top 10 Rx IP Update Reads of 2022): Contents: 1. Patent decisions on the merits 2. PMNOC Regulations: Fifth-year anniversary of major amendments,...more
The China National Intellectual Property Administration, a newly established administrative authority on patent infringement disputes, recently issued its first decisions, addressing questions many companies had on the...more
In the first half of 2022, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. The Rx IP Update team at Smart & Biggar has collected the top stories from January to July and...more
Through nearly 19 years, ACI’s FDA Boot Camp has been the training grounds for life sciences attorneys and executives to master the fundamentals of FDA regulation. Don’t miss your opportunity to join their ranks....more
On May 4, 2022, House Energy and Commerce (“E&C”) Committee leaders unveiled the legislative package to reauthorize the U.S. Food and Drug Administration (“FDA” or the “Agency”) user fee agreements (the “House Draft”)...more
As we close out another calendar year, we look back at the top legal developments of 2021 that could influence the market for biologics and biosimilars. There were many interesting decisions and other developments in district...more
This week in Washington: Reconciliation markups begin. Congress - Upcoming Hearings/Markups - House - • Need for Continuing Resolution to Fund the Government...more
On 4 March 2021, the European Commission (Commission) opened a formal investigation into alleged anti-competitive conduct by the pharmaceutical company Teva. The Commission suspects Teva of having deployed a strategy with the...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
In 2020, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. We review top developments below: Table of Contents 1. COVID-19: CIPO, Federal Courts, Health Canada 2. PMPRB:...more
On December 3, 2020, the Federal Trade Commission (FTC) published its annual report on pharmaceutical patent settlements filed with the FTC under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003...more
On 26 November 2020, the European Commission (Commission) issued a decision fining pharmaceutical companies Teva and Cephalon EUR60.5 million for infringing Article 101 TFEU by agreeing to delay the entry of a cheaper generic...more
The U.S. Court of Appeals for the Federal Circuit (CAFC) recently decided (2-1) in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc. that a labeling carve-out by a generic drug sponsor did not preclude a finding of...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
In a recent decision, the Federal Circuit affirmed Delaware District Court’s finding of invalidity based on failure to define the scope of the invention and to meet the written description requirements of 35 USC § 112. IBSA...more