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 ...
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 ...
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 ...
Skilled nursing facilities (SNFs) billed one-quarter of all claims in error in 2009 – resulting in $1.5 billionin inappropriate Medicare payments – according to a report released by the Department of Health and Human Services’ Office of Inspector General (OIG) on November 9, 2012. The OIG noted that the majority of the inappropriate claims were upcoded, and many involved claims for so-called “ultrahigh therapy ...
On November 15, 2012, the Office of Inspector General of the U.S. Department of Health and Human Services (OIG) issued a report titled “Personal Care Services: Trends, Vulnerabilities, and Recommendations for Improvement,” which included a response from the Centers for Medicare and Medicaid Services (CMS) ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
A small nonprofit hospice in Idaho became the first healthcare provider to settle a potential violation of the HIPAA Security Rule affecting fewer than 500 individuals. On January 2, 2013, Hospice of North Idaho agreed to a settlement in the amount of $50,000 with the Department of Health and Human Services, Office of Civil Rights (OCR) following an investigation relating to a 2010 breach involving a stolen, unencrypted laptop containing patient information ...
Omnibus HIPAA Rule, Including Significant Breach Notification Rule Changes, Released by HHS - The long-awaited final rule modifying the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules (the Rule) was released on January 17, 2013 by the Department of Health and Human Services (HHS) ...
Legislators filed bills before the official start date of the 83rd Texas Legislative Session; many of the bills already filed address healthcare issues. 1. The Budget. Texas legislative leaders recently approved a self-imposed budget cap for the 2014-2015 biennium based on a conservative estimate of growth in the state’s economy, holding lawmakers to not more than a 10 ...
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 ...
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 ...
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”) ...
As you may well be aware of, the Manta Multipurpose Deepwater Terminal Concession project was awarded to Hutchison by November 17, 2006. I personally assisted Hutchison in the process, from the time immediately after tendering its offer to the time the concession agreement was executed. then, Hutchison took its own path and, eventually, the relationship between the Port Authority and Hutchison was over ...
Sixteen years since the enactment of Law No. 7 of 1996 regarding Food (“the 1996 Food Law”), the Government issued the new Food Law (ie Law No. 18 of 2012) (“Food Law”) on 18 October 2012, two days after World Food Day. The Food Law replaces The 1996 Food Law. The Food Law covers three significant areas which were not governed by the 1996 Food Law, ie imports of food; the halal requirement; and the establishment of a new non-ministerial agency in-charge of food matters ...
A new program taking effect in March provides hospitals with a new option to secure funds for financing acquisitions and refinancing debt. On February 5, 2013, the Office of Hospital Facilities published a new rule that will enable qualifying hospitals to finance their acquisitions and/or refinance their existing debt with FHA insurance even if the hospitals do not have FHA-insured mortgages ...
Shipment in Indonesia is regulated by the Indonesian Commercial Code (“ICC”) and Law No. 17 of 2008 (the “Shipping Act”), which spawned a variety of implementing regulations. After 2008 a package of new implementing regulations to the Shipping Act sought to regulate a broad spectrum of water transportation aspects, including: • Port Affairs (Government Regulation No ...
It took thirteen years, four months, and five days of heated debates and passionate protests before the country’s first reproductive health law was passed. Four days shy of Christmas last year, President Aquino finally signed the 24-page bill into law. It is now Republic Act No. 10354 or The Responsible Parenthood and Reproductive Health Act of 2012 (RH Law). The passing of the RH Law, however, does by no means close this chapter of Philippine history ...
