On November 5, 2020, in Valeant Pharms. N. Am. LLC v. Mylan Pharms. Inc., No. 2019-2402, the Federal Circuit held that venue in Hatch-Waxman cases brought under 35 U.S.C. § 271(e)(2)(A) is proper “only in districts where actions related to the submission of an Abbreviated New Drug Application (‘ANDA’) occur, not in all locations where future distribution of the generic products specified in the ANDA is contemplated.” Slip op. at 3 ...
The Ohio Department of Health’s July 23, 2020 Order regarding facial covering mandates has been amended in light of the increasing number of COVID-19 cases in Ohio. The order became effective today, Nov. 16, 2020. See the order here. This new order includes the following additional mandates for retail stores (enterprises offering goods to the public) only. 1. Each business will be required to post at all public entrances to the store: A. A face covering requirement sign; B ...
On November 16, 2020, the Department of Health and Human Services Office of Inspector General (HHS OIG) issued Special Fraud Alert: Speaker Programs (Fraud Alert) to “highlight the fraud and abuse risks associated with the offer, payment, solicitation, or receipt of remuneration relating to speaker programs by pharmaceutical and medical device companies ...
A minority of states have enacted statutes and taken other action to protect business owners from claims by persons who allegedly were infected by COVID-19 on their premises.1 The purpose of this article is to compare these statutes and discuss some of the differences between them. This article addresses statutes in effect as of October 27, 2020. The article does not address pending legislation ...
Under the Medicare Secondary Payer Act (MSPA), a Medicare Secondary Payer is the entity which has an obligation to pay medical expenses before Medicare. In the face of rising costs, legislation was passed in 1980 making Medicare a secondary payer to various primary plans in order to shift medical expenses to those Medicare believed should be the primary source of payment ...
Shoosmiths’ digital media expert and Partner, Sherif Malak, examined the multitude of predicted developments in retail, and the legal challenges that accompany them, in an article published in the Lawyer. Here we reiterate Sherif’s published thoughts on likely trends. Introduction The COVID-19 crisis has brought a renewed focus to the role of retail technology and models, as the industry seeks to reimagine the retail landscape over the next year and beyond ...
In this report, you will find a summary of two important decrees published yesterday in the Official Gazette. Regulatory Decree of Law No. 27,350 of medical and scientific research on the medicinal use of the cannabis plant and its derivatives By means of Executive Branch’s Decree No ...
The HHS Office for the National Coordinator of Health Information Technology issued an interim final rule on October 29, 2020, extending the compliance date for the information blocking rule under the 21st Century Cures Act to April 5, 2021 ...
The Joint Resolution No ...
Introduction The rapid spread of COVID-19 pandemic has led to a significant increase in demand for medical devices (MDs) and personal protective equipment (PPE), masks for social use (textile articles) and other products destined to prevent the spread of the disease. As a result, it became clear that there was insufficient supply to meet existing needs during the state of emergency and the subsequent period ...
The Sharjah Court of Appeal recently declined to apply the principle of separability of an arbitration clause, on the basis that the underlying agreement (i.e. in which the arbitration clause was contained) was not defective or argued to be invalid by the appellant. This judgment has potentially significant implications for parties who intend to rely on an agreement which contains an arbitration clause to assert claims in court ...
IP landscape While the world is in the grip of the deadly COVID-19 pandemic, the patenting of pharmaceutical and biological compositions and the launch of generic products is even more hotly debated than before, particularly in the world's developing and least-developed countries ...
On November 5, 2020, the Washington Supreme Court altered a 60-year provision of Washington’s Minimum Wage Statute when it issued its decision in Martinez-Cuevas v. DeRuyter Brothers Dairy. The court held that the agricultural overtime exemption at RCW 49.46.130(2)(g), which exempted agricultural employers from paying overtime at a rate of 1.5 times the regularly hourly rate, violated article I, section 12 of the Washington State Constitution as applied to dairy workers ...
If a branded medicine and its generic version are put on the EEA market by economically linked undertakings, is a parallel importer then allowed to rebrand and repackage the imported generic version as the branded reference medicine? This has been a hotly debated issue in recent years and recently led the Brussels Court of Appeal (CoA) to refer three questions to the European Court of Justice (ECJ) (Cases C-253/20 and C-254/20) ...
The Retail Industry team would like to provide you with an update on legal developments in the retail and consumer products industries as posted on the Hunton Retail Law Resource blog. If you wish to receive email alerts when new posts are published, please visit our blog and enter your email address in the subscribe field ...
In the age of COVID-19, demand for surface wipes, sprays and similar products is at record levels. Retail stores have struggled to keep supplies stocked and shelves may once again be emptied when the winter flu season arrives. If schools and businesses reopen concurrently, the prospects of securing these products becomes even bleaker, which may re-fuel consumer stockpiling ...
In Brown v. Morehouse College, a False Claims Act (FCA) retaliation action, the U.S. Court of Appeals for the Eleventh Circuit affirmed the case’s dismissal, agreeing with the district court that while the plaintiff’s ethics complaints may have led to retaliation against him by the College, the complaints did not allege FCA fraud and therefore were not protected by the statute. No. 19-13773, 2020 U.S. App. LEXIS 33444 (11th Cir. Oct. 23, 2020) ...
Belgium is, for the second time, in lockdown. The new Ministerial Decree of 1 November 2020 stipulates that, as from today until 13 December 2020, all workers are obliged to telework. However, an exception applies when either the employee’s role or the continuity of business operations, activities and services does not allow for teleworking ...
On October 20, 2020, San Francisco County was upgraded to the “minimal” tier within the California COVID-19 tracking system, meaning it has the fewest restrictions on reopening all businesses as promulgated by the State of California. In order to qualify for the “minimal” tier, a county must have an infection rate of less than one daily new positive COVID case per 100,000 residents and have a positive test rate of less than 2% for two consecutive weeks ...
On October 20, 2020, San Francisco County was upgraded to the “minimal” tier within the California COVID-19 tracking system, meaning it has the fewest restrictions on reopening all businesses as promulgated by the State of California. In order to qualify for the “minimal” tier, a county must have an infection rate of less than one daily new positive COVID case per 100,000 residents and have a positive test rate of less than 2% for two consecutive weeks ...
Michigan has joined the majority of jurisdictions in holding that a general liability policy may provide coverage for claims for property damage allegedly caused by the defective work of a subcontractor ...
When crafting a liquidation or “pass-through” agreement for a subcontractor claim against the government, the key provision from the prime contractor’s perspective is a release from liability for the subcontractor’s claim with the exception of amounts recovered from the government related to that claim. If the release language is too broad, however, the agreement may provide the government a legal defense to the pass-through claim known as the Severin doctrine ...
The U.S. Department of Justice (DOJ) announced on October 29, 2020 it reached a more than $9.2 million settlement with Medtronic USA Inc. to resolve allegations it violated the False Claims Act (FCA) and Open Payment Program.[1] Specifically, Medtronic agreed to pay $8.1 million to resolve FCA allegations it paid kickbacks to induce a South Dakota neurosurgeon to use its SynchroMed II intrathecal infusion pumps ...
The U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) released an interim final rule on October 29, 2020, delaying the implementation of the information blocking rule under the 21st Century Cures Act (Information Blocking Rule) ...
