The Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (“SUPPORT Act”)[1] was enacted on October 24, 2018. Among other things, the SUPPORT Act amended the Physician Payments Sunshine Act (“Sunshine Act”)[2] to expand the definition of “covered recipients”[3] for payment tracking and reporting purposes ...
The Ohio Department of Commerce (Department) recently announced licensed medical marijuana cultivators who are maxing out their grow area capacity will be permitted to apply for an expansion. Presently, there are 20 Level I cultivators capable of growing up to 25,000 square feet of medicinal marijuana, and 15 Level II cultivator licensees that are smaller in scale and permitted up to 3,000 square feet of grow capacity ...
Months into the United States’ trade dispute with China, and there is no end in sight to the dispute. There are three significant deadlines for U.S. importers to consider involving the tariffs the U.S ...
The International Trade Commission (ITC) sits in a nondescript office building about a block farther south of the National Mall than tourists usually care to venture. Patent owners come from around the country to this tree-lined street in Washington, D.C., to seek a powerful remedy to protect their patented products: an exclusion order. An exclusion order directs U.S. Customs and Border Protection to block infringing imports at the United States border ...
A private sale may start an inventor’s one-year filing clock, but it likely won’t save a patentee from an intervening prior art reference. On July 31, 2024, in a precedential decision, the U.S. Court of Appeals for the Federal Circuit (CAFC) elaborated on the prior art public sale exception set forth in 35 U.S.C. §102(b)(2)(B). Specifically, the CAFC affirmed that a secret sale of a product would not be sufficient to pre-date a prior art reference under 35 U.S ...
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 ...
Regulation (EC) 2017/746 of 5 April came into force on 26 May 2022 and it establishes the regulatory framework for in vitro diagnostic medical devices (IVDs). In doing so, it replaces the previous regulations in Directive 98/79/EC of 27 October 1998 ...
Introduction An EU Regulation on the making available on the Union market as well as export from the Union of certain commodities and products associated with deforestation and forest degradation (“Deforestation Regulation”) was agreed upon by the EU legislators in December 2022. The European Parliament has now green-lighted the Provisional Agreement at this month’s plenary session ...
Judgments of the European Court of Justice in Merk, Sharp & Dohme BV v. Etat Belge (C-245/03) and Glaxosmithkline SA v. Etat Belge (C-296/03) of 20 January 2005 Directive 89/105, on the transparency of medicines pricing and reimbursement rules (hereinafter the “Directive”) was first interpreted in 2001 and 2002, when the European Court of Justice (hereinafter the “ECJ”) rendered two decisions regarding the implementation of the Directive in Austria and in Finland ...
The European Commission has presented its Proposal for a Regulation on the European Health Data Space (the “Proposal”). While it aims to strengthen the rights of individuals and unlock data’s potential for research purposes, it also adds complexity to an already extensive legal framework. Here is what you need to know: In its 2020 Data Strategy, the European Commission outlined a plan to unlock the untapped potential of the EU data economy ...
The sector inquiries "into a particular sector of the economy or into a particular type of agreements cross various sectors", set in Article 17 of EC Regulation 1/2003, are one of the tools available to the European Commission to enforce Competition Policy ...
An analyst estimates that the market value in 2023 for digital advertising will be US$701 billion. The EU’s Digital Markets Act (DMA) is a legislative competition law 'key' to 'unlocking' the big-data relating to digital advertising held in the ‘safe’ owned by BigTech. Advertising agencies are potentially one class of beneficiary (see link for article - The Digital Markets Act - Strategy reboot for online advertising) ...
Call-off stock or consignment stock is specifically regulated, changes are introduced into chain sales, and requirements are laid down for applying the exemption to intra-Community supplies of goods ...
During the press conference of 13 March 2020, Executive Vice-President Margrethe Vestager made a statement regarding the enforcement of EU State aid in connection with measures adopted by Member States to combat the negative repercussions of COVID-19 on the economy ...
The EU regulator has harmonized the maximum levels for tetrahydrocannabinol (THC) in hemp seeds throughout the Union within the food contaminants framework. This EU harmonization puts pressure on conservative national food laws such as the Belgian Royal Decree of 31 August 2021, which treats hemp seeds as a prohibited food.The situation in Belgium, however, is changing to better align it with EU law ...
As a consequence of a number of copyright rulings from the CJEU, the Swedish threshold of originality requirement is being superseded by an EU originality criterion. In this article, Henrik Bengtsson, IP expert at Delphi in Stockholm, reports on the development and the possible impact on the harmonisation of Swedish copyright law ...
The European Commission has opened an in-depth merger investigation into the planned acquisition of Cemex Croatia by Duna-Drava Cement ('DDC'). Registered in Hungary, DDC is jointly controlled by German construction material producers HeidelbergCement and Schwenk. DDC inter alia operates a cement plant in Kakanj, Bosnia and Herzegovina. Cemex Croatia, an arm of the international cement heavyweight Cemex, controls three cement plants in the Croatian coastal city of Split ...
On Dec. 22, 2021, Ohio Governor Mike DeWine signed “Esther’s Law,” allowing long-term care residents to install and use video cameras and recording devices in their rooms. The law is named for Esther “Mitzi” Piskor, who was a victim of elder abuse at a nursing home in Cleveland. Esther’s Law is intended to combat elder abuse and neglect and will likely lead to increased enforcement actions against Ohio nursing homes and long-term care facilities ...
As seen in Law Journal Newsletters The False Claims Act (FCA or Act) can be a real punch in the gut for businesses on the wrong side of an FCA claim. The Act, codified at 31 U.S.C. §§ 3729-3733, is designed to prevent private companies contracting with the government from knowingly submitting false or fraudulent claims for their services ...
LAVERY follows the evolution of consumer law closely, its specialized expertise in the fields of retailing and class actions has been confirmed many times by stakeholders in the milieu ...
The Patient Protection and Affordable Care Act ("ACA") has significantly changed the healthcare industry in the United States. Among the many changes is the new requirement that healthcare providers must provide all "Food and Drug Administration approved contraceptive methods, sterilization procedures, and patient education counseling for all women with reproductive capacity."77 Fed. Reg. 8725 (Feb. 15, 2012); see 42 U.S.C. 300gg-13(a)(4), 45 C.F.R. § 147.130(a)(1)(iv) ...
Expectations are increasing and there is mounting pressure from investors and consumers for private and public sector organisations and charities to be seen to be doing something about ESG factors, including equality, diversity and inclusion. Diversity and inclusion are increasingly recognised as crucial factors in building sustainable and successful supply chains in the private, public and charity sectors ...
Key Points Employers may mandate employee COVID-19 vaccination programs, subject to certain exemptions. When requiring employee vaccinations, employers should consider the fact that these COVID-19 vaccines are currently approved under the FDA's Emergency Use Authorization (EUA). Mandatory employer COVID-19 vaccination programs must include religious and disability-related employee exemptions. INTRODUCTION On Dec ...
