Build America Buy America What is it? How to qualify.
Podcast - The FTC Takes Action Against Old Southern Brass for False "Made in the USA" Claims
Powering Through the Environmental Challenges of EV Development - Energy Law Insights
Wiley's 10 Key Trade Developments: The CHIPS Act and Inflation Reduction Act (IRA)
Perfecting High-Performance Battery Chemistry With John Kem, American Battery Factory — Battery + Storage Podcast
Hot Topics in international trade
Video: Making Trade Inclusive for All Americans: A Conversation with AAEI's Eugene Laney Jr., Ph.D.
(Podcast) The Briefing: Are LEGO Creations Based on Religious Texts Eligible for Copyright Protection?
The Briefing: Are LEGO Creations Based on Religious Texts Eligible for Copyright Protection?
Hot Topics in International Trade A Year in Review (Quickly)
Domesticating the Battery Supply Chain With ENTEK and KORE Power — Battery + Storage Podcast
What to Do if Your Suppliers Are in Distress - Is It Time to Find a New Supplier?
What to Do if Your Suppliers Are in Distress - Candid Conversations with Suppliers in Distress
What to Do if Your Suppliers Are in Distress - Identifying Suppliers in Distress
Podcast: The Legal Battle Over Mifepristone - Diagnosing Health Care
Podcast - Made in the USA Claims
The Labor Law Insider: Union Activity, Employment Engagement, and Changes in the Manufacturing Industry
WorldSmart: The Move to Mexico— Why Companies are Setting Sights on Mexico Post COVID
Proposition 65 – Changes That Will Impact the Cannabis Sector
Five Questions, Five Answers: Driving the I-75 with Rick Walker of GAMA Georgia
The Affordable Prescriptions for Patients Act (APPA) of 2023 unanimously passed the Senate on July 11, 2024. The APPA was first introduced to the House on January 30, 2023 by Representative John Cornyn (R-Tx), with the aim of...more
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
Pharmaceutical manufacturers are increasingly finding themselves defending decisions to list in the U.S. Food and Drug Administration's (FDA) Orange Book patents that they assert are associated with their products. The...more
As we recently discussed, the Federal Trade Commission (“FTC”) sent warning letters to certain drug manufacturers regarding their purportedly improper listing of device patents in the Food and Drug Administration’s (“FDA”)...more
Clients often ask if a law firm can represent both brand and generic drug manufacturers. It’s a reasonable question, particularly when the popular perception is that potential conflicts pigeonhole law firms, forcing them to...more
In the latest attempt to promote generic drug competition and reduce drug prices, and consistent with broader efforts to enforce the antitrust laws more aggressively, the Federal Trade Commission (FTC) announced on November...more
UNIFIED PATENT COURT - The Unified Patent Court (UPC) should become a reality in 2022 or in the first few months of 2023. The Protocol on Provisional Application (PPA) of the Agreement on a Unified Patent Court (AUPC)...more
Four months ago, the U.S. became one of 100 countries supporting the proposal presented a year ago to the World Trade Organization (WTO) by India and South Africa that intellectual property protection for COVID-19 vaccines be...more
In this new episode of OnAir: Health Care, Akin Gump health care senior policy advisor Matthew Hittle and consultant Dr. Mario Ramirez welcome Akin Gump public law and policy partner Clete Willems and Centrient...more
On 25 March 2021 the European Court of Justice (ECJ) dismissed all the appeals brought by Danish pharmaceutical company H. Lundbeck A/S (Lundbeck) and five generic manufacturers against the judgments of the General Court of...more
As previously reported... on September 16, 2020, Canada’s Minister of Health approved an Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (the ISAD Interim Order), which...more
The Federal Circuit’s October 2020 split decision in GSK v. Teva made waves throughout the pharmaceutical industry and among Hatch-Waxman litigators. In the broadest reading, some see the majority opinion as rendering any...more
ACI’s FDA Boot Camp returns in a completely interactive virtual format to help life sciences attorneys and executives to master the fundamentals of FDA Regulation... Gain essential working knowledge of core FDA concepts,...more
In February 2020, the U.S. Court of Appeals for the First Circuit found that Sanofi improperly listed U.S. Patent No. 8,556,864 (“the ’864 patent”)—which claims aspects of a drive mechanism of the Lantus® SoloSTAR® insulin...more
For over 15 years, ACI’s FDA Boot Camp has been the Training Grounds for Life Sciences Attorneys and Executives to Master the Fundamentals of FDA Regulation. Now the conference returns for its 37th iteration, in a fully...more
Azurity Pharmaceuticals, Inc. — a pioneer drug company that markets its FDA-approved oral vancomycin hydrochloride solution, FIRVANQ® — has sued Edge Pharma, LLC, an outsourcing facility operating pursuant to section 503B of...more
On November 6, 2019, the bonds between the U.S. government and pharmaceutical companies were stretched when the U.S. Department of Health and Human Services (“HHS”) filed a patent infringement lawsuit against Gilead Sciences...more
When Big Pharma insists its sky-high prices are justified, patients may want to keep in mind key findings just revealed about prescription drugs and their makers...more
Legal, Regulatory and Commercial Perspectives on the International Biosimilars Marketplace - The Global Biosimilars market is expected to grow robustly. Market watchers anticipate that Europe in particular will experience...more
Addressing an appeal from four related actions concerning Orange Book patents covering Suboxone® sublingual film, the US Court of Appeals for the Federal Circuit affirmed the district court’s judgments that certain generic...more
Newly issued EU Regulation 2019/933 provides supplementary protection certificate exemptions for exporting and stockpiling active pharmaceutical ingredients and medicinal products if certain anti-abuse requirements are met....more
The SPC Manufacturing Waiver (the "Waiver") is now in force, effective from 1 July 2019 (Regulation 2019/933 amending the SPC Regulation 2009/469). The Waiver has been introduced with the stated aim of putting EU generic and...more
Addressing the validity of patents involved in a Hatch-Waxman litigation, the US Court of Appeals for the Federal Circuit held that claims were invalid for lack of an adequate written description because the specification...more
Manufacturers who want to introduce generic drugs face a special delay and enjoy a corresponding special right to challenge patents on branded drugs based on the great compromise in the Hatch-Waxman Act. ...more
Five years after the U.S. Supreme Court found in FTC v. Actavis, 570 U.S. 136 (2013), that large and unjustified payments from a brand pharmaceutical manufacturer to prevent generic entry can provide a basis for an antitrust...more