International Trade Administrative Agency Science, Computers & Technology

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FCC Enters Into $25 Million Settlement Following Cell Phone Carrier Data Breach

On April 8, the Federal Communications Commission (FCC) announced a $25 million settlement with an international telecommunications carrier concerning the unauthorized release of the personal information of nearly 280,000...more

Section 337’s Potential for Defending Biologics Market Share Against Biosimilars

Enforcement of biologic patents at the United States International Trade Commission under Section 337 provides certainty and tactical advantages to patent holders that are unavailable in district court under the BPCIA. For...more

Generic Drug Manufacturers to be Investigated by HHS for Recent Price Hikes

On April 13, 2015, the Inspector General (IG) of the Department of Health and Human Services announced in a letter to Senator Bernard Sanders (I. VT), that it would investigate recent price hikes for generic drugs. Generic...more

Assuring Regulatory Compliance Doesn’t Get Lost in Translation

With the expansion of large multinational corporations into developing countries such as Russia, Brazil, India, Mexico and China, a proliferation of global regulatory enforcement actions, including anti-bribery and...more

Canada Issues First Penalties Under Anti-Spam Law

CRTC imposes over US$900,000 in fines against two companies, reminding U.S.- and foreign-based businesses about possible liability under Canada’s Anti-Spam Law - This month marks the issuance of the first two enforcement...more

European Generics and Biosimilars – Legal Trends and More Discussed at 11th Annual Legal Affairs Forum – Part Two of Two

On the second day of the 11th Annual Legal Affairs Forum held by the European Generic and Biosimilar Medicines Association, additional exclusivity and intellectual property concerns were covered, including key case updates...more

Health Alert (Australia) - March 30, 2015

In This Issue: Judgments; Legislation; and Reports. Excerpt from Judgments: New South Wales - 25 March 2015 - Smythe v Burgman (No 2) [2015] NSWSC 150 - The New South Wales Supreme Court has held...more

China Issues Revised Hazardous Chemicals Inventory; Enforcement Likely to Increase

On February 27, 2015, ten departments under China’s central government jointly issued a revised list of hazardous substances, the Inventory of Hazardous Chemicals (“Inventory"), which will become effective May 1, 2015. ...more

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

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

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