The Department of Health and Human Resources (“DHHR”) was West Virginia’s largest executive agency until the Legislature passed House Bill 2006 earlier this month. For several years now, West Virginia lawmakers have been looking into how to handle the enormous agency, improve its function and oversight, and improve the management of the wide range of health and social programs administered by the DHHR. With an annual budget topping $7 ...
Apple Inc. v. Vidal, Appeal No. 2022-1249 (Fed. Cir. Mar. 13, 2023) In our Case of the Week, the Federal Circuit allowed Apple’s challenge to the Patent Trial and Appeal Board’s (“PTAB”) Fintiv rules to proceed, at least on limited grounds regarding whether in promulgating the guidelines the USPTO failed to follow notice-and-comment rulemaking requirements under the Administrative Procedures Act ...
On March 8, 2023, the Oregon Senate passed Senate Bill 592, which, if passed by the House and signed by the governor, would significantly increase the penalty amounts that the Oregon Occupational Safety and Health Division (Oregon OSHA) could impose on an employer for workplace safety violations. In addition, SB 592 would require Oregon OSHA to conduct comprehensive inspections of a workplace under specific circumstances, greatly expanding the number of inspections that an employer could face ...
Many construction contracts used in the industry include clauses mandating that any disputes be decided by binding arbitration rather than a jury or bench trial. The standard AIA forms provide the parties with the option of court or arbitration. Trial courts, overwhelmed by a flood of cases and supported with strong caselaw and statutory precedent, regularly enforce arbitration clauses ...
On January 30, 2023, the Court of Appeal of Quebec rendered a decision in Commission scolaire De La Jonquière c. Intact Compagnie d?assurance.1 The key issues in this case are the potential for conflicts arising from liability insurance policies and the obligation to disclose documents where insurers? duty to defend conflicts with their duty to indemnify insureds ...
On February 17, 2023, the China Securities Regulatory Commission (CSRC) announced rules related to the registration-based stock issuance system, marking a full transition to the "registration-based" era, 33 years after the establishment of China's capital markets ...
Following a wave of recent prosecutions in relation to cash fraudulently obtained through the various Covid-19 support schemes, we consider the criminal and civil ramifications on a legitimate business which has received cash from someone who has been prosecuted and offer some helpful tips to reduce the risk of your business inadvertently laundering the proceeds of crime ...
Prepare for another big shift in health care operations. On January 30, 2023, President Joe Biden announced he would not extend the COVID-19 Public Health Emergency (PHE) beyond its current expiration date of May 11. The PHE was declared by former President Donald Trump in March of 2020 as COVID-19 began to spread around the nation. The waivers and other regulatory changes instituted in its wake have impacted nearly every facet of health care services ...
Regents of the University of Minnesota v. Gilead Sciences, Inc., Appeal No. 21-2168 (Fed. Cir. Mar. 6, 2023) The Federal Circuit’s only precedential patent opinion this week focuses on the written description requirement in the context of an anticipation analysis in the chemical arts. Specifically, it concerns whether disclosures in asserted prior art were sufficient to disclose a claimed molecular structure ...
On January 19, the Federal Trade Commission (FTC) published its proposed rule barring most non-compete agreements that would apply to employees. We previously summarized the proposed rule here and here. The original deadline for comments on the proposed rule was March 20. On March 6, the FTC announced it is extending the deadline to submit comments to April 19. As of March 9, a total of 16,965 comments (8,848 electronically) have been received on the proposed rule ...
Chapter 8: Technical Barriers to Trade This chapter provides rules to facilitate trade by eliminating unnecessary technical barriers, improving transparency, and promoting greater regulatory cooperation. It applies to the elaboration, approval and application of technical regulations, standards, conformity assessment procedures and trade authorization for pharmaceuticals, cosmetics and medical devices ...
Compliance related themes have become a widely discussed and increasingly important topic for corporates around the world. Increased ESG requirements and awareness have made companies rethink what responsible corporate everyday life looks like. At the same time corporate crimes and, for example, cyber-attacks and data breaches are ever increasing and may lead to detrimental consequences on business ...
After a long pause, we are pleased to release a new version of our regulatory Guides. To cover the gap since the last publication, we would like to devote this Guide to an overview of key changes and trends that took place in 2022. 2022 was a challenging year for many companies working on the Russian market as well as for the Russian market and economy as a whole ...
Dear Readers, ALRUD Regulatory practice has prepared a new version of our regulatory Guides. This Guide is devoted to an overview of key changes and trends that took place in 2022. The review was published with the participation of ALRUD experts - Maxim Alekseev, Senior Partner and Head of ALRUD Regulatory practice,Dina Kravchenko, Senior Associate, andBoris Pribylov, Senior Associate. Follow the link below to learn more ...
This is the third alert in a series designed to inform physicians and other health care providers of what to do in the event of a State Medical Board of Ohio (“Board”) investigation, how to potentially avoid an investigation and what to expect during a license disciplinary case ...
Illinois has the strictest biometric privacy law in the country with the Biometric Information Privacy Act (“BIPA”). The BIPA requires employers who collect employees’ biometric data to follow a number of protocols. These protocols include (1) maintaining a written policy about the collection and storage of employee biometric data, (2) providing employees with written notice of that policy, and (3) obtaining informed consent from employees to collect biometric data ...
Nearly 106,000 Americans are currently on waiting lists for donor organs and 17 die each day while waiting. The holy grail for rising to meet this demand and end this suffering will be the ability to “print” the organs, muscles, and tissues from individually grown cells, lowering the need for human donors and the complicated and sometimes unbearable stress that goes along with donor wait lines ...
Over the weekend, the EU announced its 10th sanctions package against Russia as a response to the invasion of Ukraine. The timing of the 10th sanctions package coincides with the anniversary for Russian invasion of Ukraine. The measures implemented in the new sanctions package include, inter alia: Additional sanction listings of 121 individuals and entities ...
On February 20 of this year, the Public Health Institute (hereinafter "ISP"), approved through Exempt Resolution No. 401/23 the technical guide for the sanitary registration of allergens with the purpose of establishing the guidelines and requirements for the sanitary registration of these products (the "Guide") ...
On February 20 of this year, the Public Health Institute (hereinafter "ISP"), approved through Exempt Resolution No. 405/23 the technical guide on homeopathic products with the purpose of providing the guidelines and requirements for the request of the sanitary registration of these pharmaceutical products in order to provide complete and updated information that supports the quality, safety and efficacy of these products (the "Guide") ...
February 27, 2023 By: Leah Lively and Jack Darrington All employers should be aware of the recent decision by the United States Supreme in Helix Energy Solutions Group Inc. v. Hewitt dealing with exemptions under the Fair Labor Standards Act (“FLSA”). The Hewitt court held that a well-compensated employee paid a daily rate, rather than a fixed weekly or monthly salary, was not exempt from the FLSA and its rules regarding overtime pay ...
Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC, Appeal No. 2023-1186 (Fed. Cir. Feb. 24, 2023) In this week’s Case of the Week, the Federal Circuit affirmed a permanent injunction requiring appellant Jazz Pharmaceuticals to de-list its U.S. Patent No. 8,731,963 from the Food and Drug Administration’s (FDA) Approved Drug Products with Therapeutic Equivalents Evaluation publication, colloquially known as the “Orange Book ...
While a recent Pennsylvania ruling issued In February 2023 has been hailed as a victory for the underfunded school districts in the state, it could be a long road ahead before meaningful change makes its way to the students, teachers, and schools who need it the most ...
