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Travel to India during COVID-19
Kochhar & Co. Advocates & Legal Consultants, February 2021

This article has been updated based on the available information until 20th February 2021. As Government notifications are constantly revised, it is advisable to consult your attorney or visit the website of the relevant Government agency prior to travelling. Further, in additional to the guidelines published by the Central Government, passengers are also requested to refer to State specific official websites to be well informed about any additional requirements...

Bulletin Real Time: Latest News
Brigard Urrutia, February 2021

1. Historic: First vaccine administered in Colombia. A nurse in the Caribbean region of Sincelejo was the first Colombian to be vaccinated in the country. The original plan had been to begin the nationwide vaccination program on Saturday (February 20), but things have moved faster. Sincelejo and Montería began vaccinating today. Bogotá, Medellín, Cali, Barranquilla, Bucaramanga and Cartagena begin tomorrow...

China Finally Amends its Patent Law – Part 2: Design
Deacons, February 2021

Did you know? China’s new patent law, which comes into effect on 1 June 2021, will significantly change the design patent regime and will see the introduction of partial design protection, the extension of the design patent term from 10 years to 15 years and the acceptance of domestic Chinese design patent filings as a basis for priority...

Justices Should Weigh In On FCA Objective Falsity Standard
Bradley Arant Boult Cummings LLP, February 2021

In its conference on Feb. 19, the U.S. Supreme Court is scheduled to consider two pending petitions for certiorari that could resolve a critical but deeply disputed issue that impacts both the False Claims Act and health care law. The cert petitions in those cases — U.S. v. Care Alternatives,[1] and Winter v...

WEBINAR - Online intellectual property threats and best practices amid Covid-19 in the Asia Pacific region
Shearn Delamore & Co., February 2021

Dear valued clients, colleagues and business partners, You are invited to join a remarkable panel of speakers who will discuss some of the latest trends in online infringement related to Covid-19 pandemic and best practices for developing a sound brand protection strategy for your intellectual property...

COVID-19 Measures in Dubai and Abu Dhabi
Afridi & Angell, February 2021

New measures to curb the “second wave” of COVID-19 cases have been introduced by the Dubai Supreme Committee of Crisis and Disaster Management (the Dubai Committee) and the Abu Dhabi Emergency Crisis and Disasters Committee for COVID-19 Pandemic (the Abu Dhabi Committee)...

Bulletin Real Time: Latest News
Brigard Urrutia, February 2021

Modifications to the obligation to disclose information by issuers of securities The National Government issued a new rule that modifies the provisions relating to the obligation to disclose information by issuers of securities, in accordance with the parameters set by the International Organization of Securities Commissions...

Must AstraZeneca Supply the European Union with Sufficient COVID-19 Vaccines under Belgian Law?
ALTIUS/Tiberghien, February 2021

Introduction On 27 August 2020 the European Commission, on behalf of EU member states, entered into an advance purchase agreement (APA) with AstraZeneca for the production, purchase and supply of the Anglo-Swedish company's COVID-19 vaccine in the European Union.(1) The APA provides for: AstraZeneca's supply of 300 million doses of its COVID-19 vaccine (the initial Europe doses); and an option for the European Union to order an additional 100 million doses (the optional doses)...

Occupational Doctors' Enhanced Role in Combating COVID-19: Contact Tracing, Quarantine Certificates and Testing
ALTIUS/Tiberghien, February 2021

Introduction On 21 January 2021 a new royal decree was published in the Official Gazette which has temporarily extended occupational doctors' role in combating the COVID-19 pandemic in the workplace...

Coronavirus: Restrictions on Exports of Vaccines Against COVID 19
PLMJ, February 2021

Following the differences that came to light with AstraZeneca at the end of last week, the European Commission approved Implementing Regulation (EU) 2021/111 of 29 January 2021, which came into force on Saturday, 30 January. The Regulation prohibits the unauthorised exportation of vaccines against SARS-CoV-2 outside the European Union...

Could This Little-Used FDA Submission Process Help Secure Approval for Your Medical Device?
Dykema, February 2021

The de novo medical device process is a little-used but potentially valuable means of securing approval for your medical device. The pathway was established in 1997 subject to the Federal Food Drug & Cosmetic Act, Section 513 (f) (2). It was designed to employ a risk-based strategy for novel devices that have not yet been classified. Basically, it establishes a new device type including classification, regulation, appropriate controls and product code...

X-Waiver Changes Axed: Federal Government Backtracks on Previously Announced Rescission of Waiver Requirements
Dinsmore & Shohl LLP, February 2021

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...

Why Indemnification Provisions Are Too Important to Leave to the Lawyers
Dinsmore & Shohl LLP, February 2021

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...

Coronavirus: Restrictions on Exports of Vaccines against COVID-19
PLMJ, February 2021

Brief notes on Commission Regulation 2021/111 of 29 January 2021 Following the differences that came to light with AstraZeneca at the end of last week, the European Commission approved Implementing Regulation (EU) 2021/111 of 29 January 2021, which came into force on Saturday, 30 January. The Regulation prohibits the unauthorised exportation of vaccines against SARS-CoV-2 outside the European Union...

Significant Buy American Amendments are Here
Bradley Arant Boult Cummings LLP, February 2021

Aron Beezley of Bradley Arant Boult Cummings LLP enumerates the key impacts of the Federal Acquisition Regulation Council's final rule adopting mandates of the executive order Maximizing Use of American-Made Goods, Products, and Materials. The Federal Acquisition Regulation (FAR) Council recently issued a final rule1 that implements the requirements of the Maximizing Use of American-Made Goods, Products, and Materials Executive Order...

New Stark Law Makes Practical Changes to Key Concepts
Dinsmore & Shohl LLP, February 2021

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...

Interagency Fraud Enforcement Action Highlights Telepharmacy Compliance Risks
Dinsmore & Shohl LLP, February 2021

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...

Pocky Ruling Denies Trade Dress Protection for the Useful, Though Not Essential, Shape of Cookie
Dinsmore & Shohl LLP, February 2021

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...

Major Changes Coming to Prop 65 “Short-Form” Warnings
Buchalter, February 2021

California’s Office of Environmental Health Hazard Assessment (OEHHA) has proposed sweeping changes to the popular “short-form” Proposition 65 warning. On January 8, 2021, OEHHA issued a proposal to amend Article 6 “Clear and Reasonable Warnings” Section 25601. This Article sets forth “safe harbor” warning methods, including warnings for consumer product exposures...

Alabama on the Brink of Adopting Medical Cannabis
Bradley Arant Boult Cummings LLP, January 2021

When Alabama’s Legislature convenes for its annual session on February 2, lawmakers will once again be asked to consider a bill that would provide certain Alabamians with access to medical cannabis...

Enhanced Role for the Occupational Doctor in Combatting Covid-19: Contact Tracing, Quarantine Certificates and Testing
ALTIUS/Tiberghien, January 2021

A new Royal Decree published on 21 January 2021 in the Belgian Official Gazette has temporarily extended the occupational doctor's role in combatting the Covid-19 virus...

What Changes Are in Store for the FDA Under the Biden Administration?
Dykema, January 2021

A change in administrations from Republican to Democratic usually ushers in increased enforcement, regulation and strategic initiatives. Most of the Trump regulations and initiatives will likely be scrapped where possible. They will be replaced by rules and guidance documents that have been held in abeyance during the previous administration, as well as numerous new initiatives...

Intellectual Property Update and Year in Review
Dykema, January 2021

CONGRESS PASSES TRADEMARK MODERNIZATION ACT LEGISLATION In December 2020, the U.S. Congress took action that will have a significant effect on brand holders. At the end of the year, Congress passed the Trademark Modernization Act (“TMA”) that, inter alia, provides additional tools to the USPTO to respond to the rise in improper behavior in trademark filings including filing fraudulent claims of use...

HHS Freezes Rule Affecting Community Health Center’s 340B Drug Discounts
Dinsmore & Shohl LLP, January 2021

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...

California Proposes Significant Change to Limit Use of Short-Form Proposition 65 Warning For Consumer Products
Hanson Bridgett LLP, January 2021

Article PDFJust when businesses thought they had figured out their Proposition 65 compliance strategies, the State of California, through the Office of Environmental Health Hazard Assessment (OEHHA), has proposed a substantial change that will drastically limit the use of the short-form safe harbor warning first authorized in 2018...

 

 

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