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European Companies Appeal ECHA Titanium Dioxide Decision

The European Chemicals Agency (ECHA) published on November 3, 2014, an announcement of appeal of a June 17, 2014, contested decision following a compliance check of the Registration, Evaluation, Authorization and Restriction...more

As Bitcoin Gains Momentum, Focus on Regulation Increases

The virtual currency market has emerged in the United Arab Emirates with Dubai’s first Bitcoin ATM introduced in April 2014. Middle East entrepreneurs have begun launching Bitcoin payment products and SMEs are beginning to...more

Main giveaways from our “Second Screen” webinar

No doubt, Second Screen, Social TV and other enhanced broadcasting applications are increasingly popular. Here are some giveaways from our “Second Screen” webinar. - Trends. As stated by Accenture’s Francesco...more

Beyond Borders: The Power to Block the International Flow of Digital Files

With the advance of digital technology, courts are being forced to deal with the legal ramifications beyond the borders of the United States. In a previous post, we discussed the potential impact of the decision in Motorola...more

IMDRF Releases International Framework for Regulating Device Software

On October 14, 2014, the International Medical Device Regulators Forum (IMDRF) issued a final version of “Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations” (“the...more

IP Newsflash - October 2014

Federal Circuit Affirms Inequitable Conduct Based On “Intentionally Selective” Disclosure - On September 26, 2014, a divided Federal Circuit panel affirmed the unenforceability of three American Calcar patents,...more

EU Set to Strengthen Data Protection Laws

Businesses that operate in the European Union (EU) may soon face a new set of data protection regulations. High-level discussions about a proposal to consolidate all individual EU-member nations’ data protection regulations...more

FDA Regulatory and Compliance Monthly Recap

Mobile health industry could get a boost as FDA draft guidance exempts certain medical devices, including digital health devices - The FDA’s decision to not require a number of mobile health devices to go through the...more

EU Environment Report

In this issue: *Chemicals: ..Commission amends Annex XVII to REACH Regulation as regards 1,4-dichlorobenzene ("DCB") in relation to air fresheners and deodorisers ..Commission adopts Delegated...more

Europe: National data protection authorities should be independent

Following a series of previous judgments, the Court of Justice of the European Union (CJEU) confirmed in the case of the Commission v Hungary (case C-288/12) the independence of national data protection authorities in the...more

One Step Away: European Parliament Approves New Clinical Trials Regulation

On April 2, 2014, the European Parliament approved the new clinical trials regulation (the “Regulation”) for the European Union (“EU”), with 594 votes in favor, 17 opposed and 13 abstentions. The European Parliament approved...more

FDA Releases Unique Device Identification Final Rule, Draft Guidance

On September 24, 2013, the Food and Drug Administration (FDA) published a Final Rule, which will, over the next several years, require many medical devices distributed in the U.S. to carry a unique device identifier (UDI)....more

EU Data Protection Reform – Interview with Susan Foster, Member, Mintz Levin [Video]

Attorney and Solicitor Susan Foster, Member of Mintz Levin's Corporate & Securities Practice, discusses the proposed changes to the EU’s data protection and privacy rules. ...more

United States of America v. Ross William Ulbricht

Federal indictment against Silk Road founder Ross Ulbricht for narcotics trafficking, computer hacking, and money laundering

Full text copy of the federal indictment filed September 27, 2013 against Silk Road founder Ross Ulbricht – aka Dread Pirate Roberts, DPR, and Silk Road – for narcotics trafficking, computer hacking, and money laundering (the...more

"Ranbaxy Resolves Criminal and Civil Charges Through Record Settlement"

Executive Summary - On May 13, 2013, generic drug manufacturer Ranbaxy USA Inc. (Ranbaxy), a subsidiary of Indian generic drug manufacturer Ranbaxy Laboratories Limited, pled guilty to seven felony charges as part of a...more

China SFDA Creates New Regulatory Pathways for Transfer of Drug Licenses

To accelerate GMP compliance by domestic pharmaceutical companies, the Chinese State Food and Drug Administration (“SFDA”) published a notice on February 22, 2013 (the “Notice”) clarifying the regulatory pathways for...more

Obama Administration Reports on Efforts to Prevent Trade Secret Misappropriation

The Obama Administration issued a Report earlier this month, entitled "Administration Strategy on Mitigating the Theft of U.S. Trade Secrets," that sets forth its efforts to prevent trade secret misappropriation. The Report...more

EU Proposed Directive on Network and Information Security

On 7 February, the European Commission (EC) published an EU Cyber Security Strategy encompassing a proposed Directive on Network and Information Security (NIS Directive). The aim of the Strategy and NIS Directive is to...more

The Patent Prosecution Highway Pothole for Pharmaceutical Patents

The USPTO promotes the Patent Prosecution Highway (PPH) as a way to “fast-track” a U.S. patent application when a corresponding foreign application has been allowed, or when a corresponding PCT application has received a...more

Privacy in Latin America

Originally published in Privacy & Security Law Report on January 7, 2013. The privacy landscape in Latin America is undergoing significant changes. With the enactment or implementation of laws in Colombia, Costa Rica,...more

This Week in Washington - January 11, 2013

In This Issue: - DOMESTIC POLICY MATTERS - Congress is in recess this week. The House returns on Monday, and the Senate returns January 21st. Debt Ceiling, Budget & the Economy. The President’s Fiscal...more

Chinese Government Decision May Help Brands Protect Themselves

Anyone trying to stop Chinese counterfeiters learns almost immediately that most of the information that would ordinarily identify China-based owners of a URL or website is false. That makes it costly or impossible to...more

Random Border Searches of Electronic Devices - Is an End in Sight?

Since 2008, if you or your employees are traveling into the United States with a laptop, tablet or other electronic device, that device may be searched by border crossing agents, without cause or justification for suspicion....more

Marks of Excellence – the Lakers 33 Game Winning Streak and FCPA Compliance Tools

Sorry Bill Simmons, but today we celebrate one of the great modern day records of any American sports franchise. On this day 41 years ago, the Milwaukee Bucks beat the Los Angeles Lakers to end the Lakers 33 game winning...more

CFIUS Annual Report Shows Increase in Notified Transactions in 2011

The Committee on Foreign Investment in the United States (CFIUS) recently released the unclassified version of its annual report to Congress for transactions notified to CFIUS during the calendar year 2011. Most notably, the...more

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