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Can the U.S. – EU Safe Harbor Weather the Storm?

On 24 March, the Court of Justice for the European Union (CJEU) heard argument on a case that could significantly impact, if not invalidate altogether, the Safe Harbor framework that facilitates the flow of personal data from...more

Restrictions Eased for Communications-Related Items Exported to Sudan

On February 18, 2015, in a coordinated action, the Commerce Department's Bureau of Industry and Security (BIS) and Treasury Department's Office of Foreign Assets Control (OFAC) announced and implemented changes to the...more

EUROPE: EU-US data flows at risk? European Court of Justice today heard Facebook case.

Yesterday, the Schrems v. Irish Data Protection Commission case was brought before the Court of Justice of the European Union (‘CJEU’) for an oral hearing, following referral by the Irish High Court. While the final ruling by...more

U.S. International Trade Commission Institutes Investigation Under 100-Day Pilot Program Examining Complainant’s Standing to File...

The U.S.I.T.C. instituted its first investigation under its 100-day pilot program for early determination of a specific potentially case-dispositive issue....more

The SEC and the Pharmaceutical Industry - Recent Commentary by the SEC's Enforcement Director Identifies Areas of SEC Focus...

Recently, the United States Securities and Exchange Commission’s (“SEC”) Enforcement Director, Andrew Ceresney (“Ceresney”), spoke to pharmaceutical compliance personnel at the CBI’s Annual Pharmaceutical Compliance Congress...more

Guest Blog Post: Changes to the Polish Data Protection Act

On 1st January 2015 amendments to the Polish Data Protection Act of 29th August 1997 came into force. These amendments (the “Amendments”) impact: (i) the role played by the “administrator bezpieczenstwa informacji,” (“DPO”)...more

Can The FDA Do That?

A little like one of those peanut-shaped asteroids, today’s post cobbles together a couple of recent developments that, other than having relevance to the FDA, do not have all that much in common....more

FCA publishes Memorandum of Understanding between the FCA and ICO

On 28 January 2015, the Financial Conduct Authority (FCA) published the Memorandum of Understanding (MoU) which it entered into with the Information Commissioner’s Office (ICO) (dated 29 September 2014)....more

China Announces Final Biosimilars Guideline

The Center for Drug Evaluation (the “CDE”) under the China Food and Drug Administration published final biosimilars guidance on February 28 with immediate effect. Officially titled the Technical Guideline for the Research,...more

MBHB Snippets: Review of Developments in Intellectual Property Law: Winter 2015 - Vol. 13, Issue 1

In This Issue: - Tips for Developing a Cost-Effective Foreign Patent Strategy - Supreme Court Holds that Trademark Tacking Should be Decided by a Jury in Hana Financial, Inc. v. Hana Bank - Amending...more

How Data Privacy Regulations Changed Across Asia-Pacific in 2014

2014 saw a large number of significant developments in data privacy laws across Asia-Pacific. However, unsurprisingly there has not been a consistent approach across Asia-Pacific towards the development of data privacy...more

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

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