In M&K Holdings, Inc., v. Samsung Electronics Co., Ltd., 2020-1160 (Fed. Cir. Feb. 1, 2021), the Federal Circuit found that the Patent Trial and Appeal Board (Board) violated the Administrative Procedure Act (APA) by finding a patent claim unpatentable using a “markedly” different theory from the one the patent challenger presented. In this case, the patent challenger (i.e ...
Social bonds, which raise funds for new or existing projects seeking to address social issues, continue to soar in popularity among investors – but how is “social bond” designation achieved? The primary criteria for social bond designation is established by the United Nations Sustainable Development Goals (UNSDG) ...
Historically, New York State has not required the registration of investment adviser representatives (IARs). New York has adopted regulations providing registration and examination requirements for IARS. This article focuses upon the examination and registration requirements applicable to IARs of federally covered investment advisers. The newly adopted regulations became effective Feb. 1, 2021 ...
U.S. Citizenship and Immigration Services (USCIS) released long-awaited guidance on the 2021 H-1B lottery process. The service announced it would continue with a random-selection lottery for 2021. The registration system will be open from noon Eastern March 9, 2021 to noon Eastern March 25, 2021 and the entry fee will be $10 for each case entered into the system. USCIS also announced plans to delay the Trump-era wage-based lottery registration through Dec ...
Physicians, physician assistants, and advance practice nurses who have sought to treat opioid-addicted patients with Schedule III-V Controlled Substances that have been approved by the United States Food and Drug Administration for that indication have had to apply for a waiver under the Drug Addiction Treatment Act of 2000. Eligible medications are presently limited to buprenorphine-containing products such as Suboxone and Subutex ...
The Oil Can published an article by Dinsmore partner Mark Boos this week in its Spring 2021 edition about the importance of indemnification provisions are essential in commercial contracts, an excerpt of which is below. Indemnification provisions are part of virtually every commercial contract. Ironically, they’re also among the contract elements most likely to be overlooked by the parties ...
On Jan. 29, 2021, the Occupational Safety and Health Administration (OSHA) released updated guidance regarding mitigating and preventing the spread of COVID-19 in the workplace. Important highlights are as follows. First, the guidance emphasizes that employers should implement a COVID-19 prevention program for the workplace ...
On Jan. 19, 2021, the two recent final rules issued by the Department of Health and Human Services Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) regarding changes to the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (Stark Law) regulations (respectively the OIG Rule and the CMS Rule, collectively the Final Rules) became effective ...
In a recent press release, the U.S. Department of Health and Human Services Office of Inspector General (HHS/OIG) announced five additional guilty pleas relating to a $1 billion telepharmacy fraud scheme. However, unlike many health care fraud cases, this particular case was investigated over the course of three years by an interagency team comprised of personnel from HHS/OIG, the U.S. Department of Justice (DOJ), the U.S. Food and Drug Administration (FDA), the U.S ...
In a decision that could be a game-changer for cookie and candy manufacturers, the Third Circuit has recently denied trade dress protection for the shape of the popular Pocky cookie. The Pocky is a long, thin Japanese cookie stick that is almost completely dipped in chocolate, except for the very bottom. Ezaki Glico created the Pocky in 1966 and obtained two trade dress registrations to protect the configuration of the cookie ...
An Eleventh Circuit panel has breathed new life into a long-running, $248 million False Claims Act (FCA) qui tam case, United States ex rel. Bibby v. Mortgage Investors Corp.,[1] reversing the district court’s grant of summary judgment for the defendants.[2] Materiality lay at the heart of the case, which involved allegations that the defendant finance companies misled the U.S ...
An Eleventh Circuit panel has breathed new life into a long-running, $248 million False Claims Act (FCA) qui tam case, United States ex rel. Bibby v. Mortgage Investors Corp.,[1] reversing the district court’s grant of summary judgment for the defendants.[2] Materiality lay at the heart of the case, which involved allegations that the defendant finance companies misled the U.S ...
Two federal cases in the Northern District of Ohio recently reached very different conclusions on whether the state’s COVID-19 shutdowns of restaurants permit valid claims for business interruption insurance coverage. Reviewing essentially the same facts and policy provisions, one court found for the insurer, holding no coverage to exist. The other found for the policyholder, awarding coverage. The opposite results will no doubt lead to further upcoming appellate activity in Ohio ...
The Biden administration implemented a regulatory rule freeze affecting all federal agency rules that had not gone into effect as of Jan. 20, 2021. At its core, the regulatory rule freeze requires all pending final rules to be delayed at least 60 days in order for the Biden administration to review and opine on the necessity and scope of affected rules. During this delay period, the administration may review, revise, and possibly rescind federal administrative rules ...
The U.S. Department of Justice (DOJ) has just released its annual statistical overview[1] of False Claims Act (FCA) and other fraud actions for Fiscal Year 2020 (FY2020)[2], and the numbers tell a mixed story. The total of just over $2.2 billion in settlements and judgments represents a decline of more than one-quarter in recoveries from FY2019,[3] likely reflecting workforce, logistical, and judicial impacts of the COVID-19 pandemic ...
Effective Jan. 26, 2021, all air passengers traveling to the United States will be required to get a viral test for current infection within the three days before their flight to the U.S. is scheduled to depart, and provide written documentation of their laboratory test results (paper or electronic copy) to the airline ...
In the state of Ohio, a light-duty job offer is a strategic way to either bring an injured worker back to the workforce or bar temporary total compensation, should the injured worker reject a valid offer. Either way, it can aid employers in eliminating, minimizing, and/or stopping temporary total disability compensation from being paid in a claim ...
In July 2020, Florida changed its contractor licensing statute to make it easier for contractors who have been licensed in other states for at least 10 years to obtain a Florida contractor license without having to take a licensing exam. While Florida has not entered into any formal reciprocity agreements with other states, we do finally have guidance on exactly how to apply for a Florida contractor license using an existing license from another state ...
This is a summary of the Annual Report. Click here to access the full guide. The 2020 proxy season shareholder proposals were already submitted before the COVID-19 shadow loomed large over the season; however, such shadow likely impacted how shareholders voted on the proposals themselves, impacted business throughout 2020, and continues to jolt 2021 and the forthcoming 2021 proxy season ...
On Dec. 22, the Ohio Senate passed the Employment Law Uniformity Act – HB 352. Governor Mike DeWine signed the bill into law on Jan. 12, 2021. The bill is the culmination of 20 years of work by the Ohio Chamber of Commerce to address expansion of Ohio’s anti-discrimination statute resulting from Ohio Supreme Court decisions that interpreted Ohio Revised Code Section 4112 expansively ...
On Nov. 20, 2020, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) issued two final rules, which implement changes to the Anti-Kickback Statute (AKS) and Physician Self-Referral Law (Stark Law) regulations (respectively the OIG Final Rule and the CMS Final Rule, collectively the Final Rules) ...
As employers adapt to the impacts of COVID-19, wage and hour compliance continues to present unique challenges. To help employers navigate these uncertain times, government enforcement agencies and legislatures have continued to issue new laws, opinion letters, and guidance all employers should understand and act upon ...
The State of Ohio Board of Pharmacy (OBP) is required to adopt a resolution specifying the required types of credentials for the responsible person of each business type of (i) terminal distributors of dangerous drugs and (ii) distributor of dangerous drugs. Only individuals who meet the credentials specified may be the responsible person for that type of business. On Jan ...
For several years, pursuant to the Food Drug and Cosmetic Act and Federal Trade Commission Act,[i] the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) have issued joint warning letters to CBD companies alleging labeling claims they made are false or misleading. According to the agencies, the claims being made by these CBD companies include assertions that their CBD products will treat or cure serious health conditions ...
On Dec. 16, 2020, OCIE issued a new Risk Alert focused on the compliance efforts of investment advisers and broker-dealers regarding Rule 13h-1 (the Rule). The Rule was enacted in order to help the SEC identify market participants that conduct significant amounts of trading activity in national market system (NMS) securities. Generally, NMS securities are exchange-listed equity securities and standardized options ...
