Under the Patient Protection and Affordable Care Act (“PPACA”), an employer that employs an average of at least 50 full-time and full-time equivalent employees (a “Large Employer”) during 2013 may be subject to a penalty in 2014 if the Large Employer fails to offer “minimum essential coverage” to all but 5 percent (or, if greater, five) of its full-time employees (“No Coverage Penalty”) ...
The long awaited Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Regulation amendments (the “Changes”) to incorporate the changes made by Health Information Technologyfor Economic and Clinical Health (HITECH) in 2009 as part of the American Recovery and Reinvestment Act and by the Genetic Information Nondiscrimination Act (“GINA”) were recently released ...
The wait is over. On January 17, 2013, the Department of Health and Human Services’ ("HHS’") Office for Civil Rights ("OCR") released its long-anticipated megarule ("Omnibus Rule") amending the HIPAA Privacy, Security, Breach Notification and Enforcement Rules. These amendments implement and expand on the requirements of the Health Information Technology for Economic and Clinical Health ("HITECH") Act and the Genetic Information Nondiscrimination Act of 2008 ...
On December 28, 2012, the Standing Committee of the National People’s Congress (“NPC”) of the People’s Republic of China passed the Resolution of the Standing Committee of the NPC Relating to Strengthening the Protection of Information on the Internet (the “Regulations”). The Regulations contain significant and far-reaching requirements applicable to the collection and processing of electronic personal information via the Internet ...
On 3 December 2012 Guernsey brought into force its new image rights legislation which allows, for the first time anywhere in the world, for such rights to be registered. Gary Assim, Shoosmiths In essence this law has created a new form of intellectual property right for anyone, anywhere in the world, who is famous, or might be in the future, to protect their image by registering it ...
The U.S. District Court for the Eastern District of Virginia recently overturned the United States Patent & Trademark Office ("USPTO") interpretation of the patent term adjustment ("PTA") statute in Exelixis, Inc. v. Kappos. Similar to Wyeth v. Kappos, where a previous USPTO interpretation of the PTA statute was overturned, the Exelixis decision promises to add months and even years to the patent term of many patents ...
Narrow Construction of Food & Drug Act Undermines FDA Regulation, Class Actions A divided panel of the Second Circuit Court of Appeals in New York overturned on First Amendment grounds the conviction of a pharmaceutical sales representative for conspiracy to introduce a misbranded drug into interstate commerce, an offense more commonly referred to as off-label marketing. The decision, United States v. Caronia, No. 09-5006-cr (2d Cir. Dec ...
A sports agent by nature is a mediator or ‘go-between’ between the player, and in most instances, a sports club. In general, the agent provides a service, for example, the recruitment of a player, who will enter into a legal relationship with a club. Often a club will pay a sports agent a recruitment fee, which will normally include a signing-on fee that has to be paid over by the sports agent to the player ...
On November 26, 2012, the Department of Health and Human Services’ Office of Civil Rights (“OCR”) published guidance on the two methods for de-identifying protected health information (“PHI”) in accordance with the HIPAA Privacy Rule ...
On November 19, 2012, 40 German advertising associations launched the “German Data Protection Council for Online Advertising,” a new initiative to coordinate and enforce self-regulation in the German online behavioral advertising (“OBA”) sector. The initiative is linked to the European Interactive Digital Advertising Alliance (“EDAA”), which manages the self-regulation efforts of the European online advertising industry ...
The rapid growth of the hospice industry has attracted the attention of Congress and federal and state healthcare regulatory and enforcement agencies. The Patient Protection and Affordable Care Act (the “ACA”), signed into law by President Obama on March 23, 2010, included several provisions aimed at hospice providers ...
According to a group of women who filed a lawsuit last week, Maybelline should pay up for making false claims about its “Super Stay” lipstick products. Filed in federal court in Manhattan, the complaint seeks declaratory relief and damages under several states’ consumer protection laws. From the defense perspective, this is the latest attempt at a “no injury” class action where no actual injuries or damages exist ...
In an increasingly online world, international businesses can no longer rely on discrete legal advice relevant to only one jurisdiction. It is crucial to know where best to bring (or threaten) legal proceedings to achieve maximum impact globally. Two recent, high profile cases have thrown the spotlight on what can be achieved by courts of different jurisdictions to defend online reputations ...
The General Medical Council has issued definitive guidance on doctors' duties when they fear a child in their care is suffering from abuse. The GMC's 2012 Guidance on Child Protection came into effect on 3 September 2012 after a two-year working group - chaired by a senior family court Judge, the Right Honourable Lord Justice Thorpe - listened to evidence given by child protection experts ...
On 15 October 2012, the Federal Government announced the appointment of an expert panel to review pharmaceutical patents in Australia (Review). The Review will focus particularly on the extension of term provisions in Chapter 6, Part 3 of the Patents Act 1990 (Cth). Those provisions currently allow the extension of pharmaceutical patents up to five years beyond their standard 20-year term ...
Currently a large part of politicians, economists and lawyers are working hard to ensure that a recent Lithuania’s bank bankruptcy story would not repeat itself. Sometimes people still associate the term “bank” with instability, possibility to lose something or lack of transparent governing. Maybe this is the reason why there are no biobanks in Lithuanian which are widespread in the EU and other countries of the world ...
On September 17, 2012, the Department of Health and Human Services (“HHS”) announced a $1.5 million settlement with the Massachusetts Eye and Ear Infirmary and Massachusetts Eye and Ear Associates Inc. (“MEEI”) for potential violations of the HIPAA Security Rule ...
The papers are reporting that Northhampton rugby player, Brett Sharman, is subject to a disciplinary enquiry from his racist tweet abou Mo Farah ...
The film industry in the Dominican Republic has substantially expanded in large measure because the country has different and diverse natural scenery, from beaches to mountains, and buildings that were constructed in colonial times as well as more recently. Costs to film and produce movies are lower in the Dominican Republic than in many other places, too ...
On January 24, 2011 the Attorney General of the Federal Republic of Brazil signed a document restricting the powers of ANVISA (Brazil’s regulatorybody) in the examination of pharmaceutical applications, giving the rights to the Brazilian PTO to do so without any interference of ANVISA. The dispute between ANVISA and the Brazilian PTO in the examination of pharmaceutical applications had apparently been solved ...
New amendments to the Regulation on Health Conformity of Dietetic Products have entered into force on 28 May 2012. Here are some of the most significant changes that are prescribed by these amendments to the Regulation. As a reminder, this is a regulation that introduced the obligation of the registration of dietetic products (including supplements) in July 2010, and is a regulation that regulates the issues of labelling and the composition of these products in details ...
The provision of gifts and hospitality to public officials has recently been the subject of a number of news stories in the Serbian media, covering not only the official reports on the variety of protocol gifts received by the high ranking officials from the leaders of other countries, but also the alleged corruption affairs involving the potential bribing of various lower-level officials by companies and individuals seeking an unfair advantage in the market ...
Serbia Karanovic and Nikolic IP Regional Partner to attend 134th International Trademark Association’s (INTA) Annual Meeting in Washington DC IP Regional Partner in the Karanovic and Nikolic Law Office, Mr. Dragomir Kojic, along with Mrs. Mirna Lalic from our Sarajevo office, attended the 134th Annual INTA Meeting held in Washington DC. The Conference was very successful ...
Three recent decisions bolster a generic manufacturer’s ability to challenge Orange Book listings and obtain ANDA approval through section viii “carve-outs.” In Caraco v. Novo Nordisk1 the U.S. Supreme Court unanimously held Caraco could use the Hatch-Waxman’s counterclaim provision to correct Novo’s overbroad use code. In AstraZeneca v. Apotex, the U.S ...
Financial Information Units (FIUs) are agencies created according to FATF-GAFI recommendations that receive reports of suspicious transactions from financial institutions and other persons and entities, analyze them, and disseminate the ensuing intelligence to local law-enforcement agencies and foreign FIUs in order to fight against money laundering and terrorism. The Argentine FIU is controlled by the Ministry of Justice and Human Rights ...
