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Invoking Copyright to Block the Submission of Evidence? Nice Try, But No Cigar!
ALTIUS/Tiberghien, November 2020

The Court of Justice of the European Union delivers judgments regarding the concept of “communication to the public” faster than legal scholars can read and dissect them. While we are eagerly awaiting the Court’s analysis of different types of hyperlinking, it has taken less than two months to follow Advocate General Hogan’s opinion regarding the emailing of evidence containing copyrighted works to a court in legal proceedings...

OIG Takes Aim at Speaker Programs in Special Fraud Alert
Bradley Arant Boult Cummings LLP, November 2020

On November 16, 2020, the Office of Inspector General of the Department of Health and Human Services (OIG) issued a Special Fraud Alert addressing the fraud and abuse risks of speaker programs that are commonplace in the pharmaceutical and medical device industries...

FTC Sues to Block Methodist Le Bonheur-St. Francis Transaction
Bradley Arant Boult Cummings LLP, November 2020

On November 12, 2020, the Federal Trade Commission (FTC) sued to block the acquisition of two Memphis-area hospitals by Methodist Le Bonheur Healthcare. Eleven months earlier, on December 12, 2019, Methodist entered into an agreement with Dallas-based Tenet Healthcare Corporation to purchase Saint Francis-Memphis and St. Francis-Bartlett (along with their associated physician practices, urgent care centers, and other ancillary care providers) for $350 million...

For the First Time Since TC Heartland, the Federal Circuit Addresses Venue in an ANDA Case – the Holding May Also Impact BPCIA Litigation
Patterson Belknap Webb & Tyler LLP, November 2020

On November 5, 2020, in Valeant Pharms. N. Am. LLC  v. Mylan Pharms. Inc., No. 2019-2402, the Federal Circuit held that venue in Hatch-Waxman cases brought under 35 U.S.C. § 271(e)(2)(A) is proper “only in districts where actions related to the submission of an Abbreviated New Drug Application (‘ANDA’) occur, not in all locations where future distribution of the generic products specified in the ANDA is contemplated.”  Slip op. at 3...

The Proposed Indian Copyright Amendment Rules and Suggestions for Further Amendment
Kochhar & Co. Advocates & Legal Consultants, November 2020

The Copyright Office of the Department for Promotion of Industry and Internal Trade (DPIIT) has invited comments and suggestions to amend the Copyright Act before November 30, 2020. Mid last year, the DPIIT proposed a set of amendments to the Indian Copyright Rules. While these amendments sought to increase transparency and provide clarity for right holders, many other essential modifications were overlooked...

Defence: Key Changes in the Regulatory Landscape Pursuant to Atmanirbhar Bharat
Kochhar & Co. Advocates & Legal Consultants, November 2020

The Government of India has been very active in putting in place the necessary framework to implement the objectives of the ‘Atmanirbhar Bharat Abhiyan’. The ‘Atmanirbhar Bharat Abhiyan’ or a program of self-reliance announced by the Government of India intends to focus on the five key pillars of economy, infrastructure, system, vibrant demography, and demand...

Healthcare & Life Sciences Department Report
Beccar Varela, November 2020

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...

Moving from Brexit 1.0 to Brexit 2.0
Shoosmiths LLP, November 2020

What will UK data protection look like after Brexit 2.0 on 31 December 2020? Regime 1: the 'UK GDPR': the UK's new bespoke version together with the Data Protection Act 2018 The UK GDPR will be the UK data protection regime based on the 'EU GDPR' (see below)...

Joint Resolution No. 1/2020: Health Emergency - Maximum Prices for Certain Drugs
Beccar Varela, November 2020

The Joint Resolution No...

Michigan Voters Add Constitutional Protections for Electronic Data and Communications
Dykema, November 2020

While public attention focused on the federal and state elections, Michigan voters made an important decision—they adopted Proposal 20-2, which amended Michigan’s Constitution to extend its protection from unreasonable searches and seizures to electronic data and communications...

Exceptional Rules for Products to Prevent Spread of COVID-19
PLMJ, November 2020

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...

The Separability of an Arbitration Clause - The Sharjah Court of Appeal Sets Liimits
Afridi & Angell, November 2020

The Sharjah Court of Appeal recently declined to apply the principle of separability of an arbitration clause, on the basis that the underlying agreement (i.e. in which the arbitration clause was contained) was not defective or argued to be invalid by the appellant. This judgment has potentially significant implications for parties who intend to rely on an agreement which contains an arbitration clause to assert claims in court...

Battling COVID-19: Mechanisms for Access to Antiviral Products and Diagnostics
ENSafrica, November 2020

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...

Know Your Contract: Case Law Highlights
MinterEllisonRuddWatts, November 2020

New Zealand’s construction industry and projects have weathered a turbulent year with a consistent flow of seminal judicial decisions addressing issues arising in the life cycle of a project...

Michigan Increasing Enforcement of Emergency COVID-19 Rules to Ensure In-Person Work Happening Only When Strictly Required
Dykema, November 2020

Governor Whitmer announced last week that MIOSHA is increasing enforcement of its October 14 Emergency COVID-19 Rules, with a focus on promoting more remote work for offices...

Understanding the Impact of the 2020 Federal Elections
Dykema, November 2020

After months of predictions of a possible Democratic wave,Tuesday’s election delivered mixed results. Joe Biden appears poised to narrowly defeat President Trump after one of the most contentious election cycles in recent memory. Republicans are favored to retain their Senate majority despite having to defend twice as many seats as their Democratic counterparts...

Further Extension of Temporary Layoff Period for Federally Regulated Employers
Lawson Lundell LLP, November 2020

On November 9, 2020, the federal government announced a further temporary extension to permitted layoff periods for federally regulated private-sector employees. Background In June of 2020, the federal government extended the time periods for layoffs under the Canada Labour Standards Regulations to allow federally regulated private-sector employers more time to recall laid-off employees...

Hospital Price Transparency Rule: Full Steam Ahead
Verrill, November 2020

Neither COVID-19 nor continued legal challenges appear likely to derail the Centers for Medicare & Medicaid Services (CMS) Hospital Price Transparency Rule from going into effect on January 1, 2021. Hospitals therefore should continue to comply with the requirements by the deadline...

Washington Supreme Court Alters State's Agricultural Exemption in the Minimum Wage Statute
Schwabe, Williamson & Wyatt, November 2020

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...

SEC Disclosure Requirement Amendments to Regulation S-K: Description of Business, Legal Proceedings, and Risk Factors
Dinsmore & Shohl LLP, November 2020

Effective Nov. 9, 2020, the Securities and Exchange Commission’s (SEC) amendments to “modernize the description of business, legal proceedings, and risk factor disclosures” required under Regulation S-K take effect. These amendments largely follow the proposed amendments, dated Aug. 8, 2019,[1] with some clarifications. The intent of the amendments is to improve the disclosure regime, which has not had a major overhaul in over thirty years...

Illinois 2020 Election Ramifications
Dykema, November 2020

While a few legislative races are still being tabulated, Democrats maintained their supermajority status in both the Illinois House of Representatives and Senate in this election cycle. Current projections, that are subject to change pending mail-in ballots, are for a Democrat supermajority of 72-46 in the House and 41-18 in the Senate. This was not an unexpected outcome, though most pre-election predictions had the Democrats achieving an even wider gap in the Legislature...

Home Office - A Risk for Privacy and Cyber Security? What Companies Need To Do
Heuking Kühn Lüer Wojtek, November 2020

The Coronavirus pandemic has caused a shift in the paradigm of modern-day workplaces. Companies across the globe have seen a rapid and widespread shift to remote work, making compliance with the GDPR harder than ever. The Federal Office of Information Security (BSI), in its recent report on the ‘State of IT Security in Germany 2020’, expressed its concern and indicated a ‘tense situation’ for data protection in the country...

Can Parallel Importers Rebrand Generic Medicines?
ALTIUS/Tiberghien, November 2020

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)...

The Dome Report - West Virginia Turns a Brighter Shade of Red
Spilman Thomas & Battle, PLLC, November 2020

While yesterday’s federal election results from West Virginia were not a surprise, the down ballot races, especially for the State Legislature, clearly demonstrated what was a strong red wave that engulfed incumbents, swept away open seats, and cemented what may be durable majorities in both chambers for years to come.   As around the country, early voting enthusiasm also gripped West Virginia...

In Morehouse, Eleventh Circuit Underscores Threshold Test for FCA Retaliation Claims
Dinsmore & Shohl LLP, November 2020

In Brown v. Morehouse College, a False Claims Act (FCA) retaliation action, the U.S. Court of Appeals for the Eleventh Circuit affirmed the case’s dismissal, agreeing with the district court that while the plaintiff’s ethics complaints may have led to retaliation against him by the College, the complaints did not allege FCA fraud and therefore were not protected by the statute. No. 19-13773, 2020 U.S. App. LEXIS 33444 (11th Cir. Oct. 23, 2020)...

 

 

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