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Growing Issues In A Miniature World: Nanomaterials Registers In The European Union

Many scientists believe that the highest growth potential for improved applications lies in nanomaterials. This technology is not without controversy and the law is only now trying to catch up with the technological...more

United States Completes Deposit for Hague Agreement for Industrial Designs

Today, February 13, 2015, the United States deposited with the World Intellectual Property Organization (WIPO) its instrument of accession to the Hague Agreement Concerning International Registration of Industrial Designs...more

FDA Requests Comments on WHO Recommendation to Classify Two Common Industrial Solvents as Psychotropic Substances

On January 27, 2015, the Food and Drug Administration (“FDA”) requested comments on a recommendation by the World Health Organization (“WHO”) to classify two common industrial solvents – gamma-butyrolactone (“GBL”) and...more

US Dept. of Commerce Initiates 2nd Administrative Review for 2012 Chinese Solar CSPV Products Antidumping Duty and Countervailing...

On February 4, 2015, the U.S. Department of Commerce (through the International Trade Administration or ITA, part of the U.S. Department of Commerce) published a notice initiating the 2nd annual Administrative Review for the...more

The USPTO Giveth and Taketh Away: New PTA Rules Following Novartis v. Lee

On January 9, 2015, the final rules were published regarding patent term adjustment (PTA) following the decision in Novartis AG v. Lee 740 F.3d 593 (Fed. Cir. 2014)....more

SEC Charges Chilean Citizens With Insider Trading Concerning Tender Offer for Chilean

The Securities and Exchange Commission recently filed suit in the US District Court for the Southern District of New York, alleging that defendants, Juan Cruz Bilbao Hormaeche and Thomas Andres Hurtado Rourke, both Chilean...more

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

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