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 ...
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 ...
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) ...
This alert provides links to the latest insights and commentary on key energy and environmental issues from the Hunton Andrews Kurth team. Links to our most recent posts on the Nickel Report Blog for this month are below. Please subscribe to receive alerts when new posts are published by visiting our blog and entering your email address in the subscribe field or by following us on Twitter. For current Covid-19 related news updates please read more here ...
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 ...
For most of the last three decades, Florida, Georgia, and Alabama have waged a multifront water war, filing cases in federal courts across the United States. This war, and these cases, turn on apportionment of two river basins: the Apalachicola-Chattahoochee-Flint (ACF) River Basin and the Alabama-Coosa- Tallapoosa (ACT) River Basin. At the heart of this legal tug of war lie competing uses—and visions—for the basins ...
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 ...
Most employers are familiar with the role of the Occupational Safety and Health Administration (OSHA) in enforcing standards to ensure that the working men and women in the United States have a safe and healthy workplace. The current COVID-19 pandemic has presented new challenges to OSHA for reviewing how employers are protecting their employees ...
Although the U.S. Department of Justice (DOJ) reported a slight decrease in settlements with life sciences companies in FY2019 (the most recent year for which data is available),[1] this likely will be a temporary trend. Several significant settlements and investigations in 2020 provide key insights into government enforcement priorities as we look toward 2021 ...
On September 30, 2020 important changes to the Agricultural Land Commission Act, [SBC 2002] Chapter 36 and the associated regulations came into force that may significantly affect the prospects for removal of private land from the Agricultural Land Reserve (“ALR”). These changes are of particular note to private owners of ALR lands slated for future development ...
On October 01, 2020, Law No. 17 ...
Presidential Decree no. 229/20 of 8 September 2020 has been published and its aim is to reassess the measures imposed by Presidential Decree no. 142/20, considering the evolution of the epidemiological situation. The new decree renews most of the measures already in force, although it also eases some restrictions ...
Coronavirus Digest no. 4 Patents and other intellectual property rights 1. Patents Moderna reveals that it may not hold the patent rights for the vaccine against Covid-19, because it was not the first to file the patents. This came after the US National Institute of Health claimed co-ownership of the rights to this vaccine. Read more here ...
On September 1, the California legislature sent to the Governor amendments to California’s Hazardous Waste Control Law. Once signed by the Governor, AB 2920 will allow retail hazardous waste to be shipped on a “consolidated manifest.” This simplified procedure has been available for specific types of hazardous waste such as used oil, but this is the first time it has applied a broad, general category such as “retail hazardous waste ...
For the past decade or so, the regulated community and federal courts alike grappled with the outer reaches of the Clean Water Act (CWA) point source permitting program. The core of the program—the National Pollutant Discharge Elimination System (NPDES)—is clear enough. Under the NPDES program, discharges from point sources to navigable waters (what qualifies as “navigable waters,” i.e ...
The popularity of smokable hemp has rapidly increased since the 2018 Farm Bill legalized hemp at the federal level. But the Farm Bill allows states to regulate hemp production in ways “more stringent” than federal law, and some states have used this leeway to ban smokable hemp to some degree. The result is a patchwork of state laws regarding smokable hemp’s legality, adding complexity to a legal landscape that was already nuanced enough ...
A wastewater facility on the island of Maui, Hawaii, collects sewage, treats it, and pumps the treated water through underground wells. The water then travels half a mile, through groundwater, into the Pacific Ocean. Must the facility possess an EPA permit to do this? In April, the Supreme Court of the United States answered this question with a rather drawn-out "maybe ...
Key Points A permitting agency's blanket designation of an entire category of permit decisions as ministerial for purposes of the California Environmental Quality Act (CEQA) may be held to be improper if the agency has the ability to modify or deny the permit based on any concern that may be examined under CEQA review. Courts will afford a larger degree of deference to an agency’s designation of a single permit decision as ministerial on a case-by-case basis ...
The Department of Justice is stepping up its scrutiny of health-care fraud, especially in testing laboratories, during the Covid-19 pandemic. Former federal prosecutor Jason Mehta, a partner with Bradley, says now is not the time to tout profits over patient care and offers insights on compliance. In the midst of a global pandemic, much attention and praise is rightfully being showered on health-care providers ...
