We’ve written about the new Generic Top Level Domains (gTLDs) on more than one occasion. This refers, of course, to the process whereby companies and organisations can register names – generic words, geographical names, brand names - as top level domain names. So, in the same way that there’s long been .com, .net and .info, you can now have .bank, .google and .capetown. Some 1900 applications have already been filed ...
Physician-owned distributorships (PODs) and other physician-owned entities (POEs) have emerged as a favored vehicle to reduce costs, but the popularity of PODs and POEs has led to increased scrutiny by federal regulators. In June 2011, the United States Senate called on the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) and Centers for Medicare & Medicaid Services to investigate the proliferation of PODs and corresponding utilization practices ...
These days, it seems as if every passing week brings with it a new story in the press about the legal risks of engaging with social media. We have heard much recently about the dangers of defamation on Twitter.Earlier this year, Sally Bercow learned to her cost just how easy it can be to libel someone without explicitly accusing them of anything, after sharing a message about Lord McAlpine with her Twitter followers: "Why is Lord McAlpine trending? *innocent face*" ...
On October 18, 2013, the Centers for Medicare & Medicaid Services (CMS) published Survey & Certification Letter 14-01-NM, which clarified the obligations of a skilled nursing facility (SNF) or nursing facility (NF) (collectively “nursing homes”) to provide cardiopulmonary resuscitation, or CPR, to its residents ...
Rapid innovation and convergence in the TMT space in Australia, together with an ever-changing legal and regulatory environment, means that TMT organisations must constantly re-evaluate, and in some cases entirely re-engineer, their business models and strategies. This chapter, contributed by partners Anthony Lloyd, Paul Kallenbach and Paul Schoff, discusses the different laws and regulations that impact the TMT space in Australia ...
In a statement issued by the National Regulatory Agency, Control and Surveillance (ARCSA), drugs that are sold in Ecuador must have labels stating the words 'generic', otherwise it can not be marketed as of January 24, 2014 ...
On October 22, 2013, the National Institute of Standards and Technology (“NIST”) issued the Preliminary Cybersecurity Framework (the “Preliminary Framework”), as required under Section 7 of the Obama Administration’s February 2013 executive order, Improving Critical Infrastructure Cybersecurity (the “Executive Order”). The Preliminary Framework includes standards, procedures and processes for reducing cyber risks to critical infrastructure ...
The European Court of Human Rights (the ECHR), in Delfi AS v Estonia, has upheld unanimously a finding of liability against an Internet news portal regarding offensive comments that were posted online by one of its readers. The ECHR held that making Delfi AS liable for the comments was a justified and proportionate interference with its right to freedom of expression and that there was no violation of Article 10 (freedom of expression) of the European Convention on Human Rights (the Convention) ...
To the average internet user the few little letters at the end of the domain name they have just searched must seem rather trivial. Little do they know of the struggle of numerous corporations to obtain those little letters in an effort to try to stamp their individuality on the internet. Companies such as "donut.com" (who focus on registering as many as these generic top level domains or gTLDs as possible) insist that "the current Internet namespace, like ...
On 25 January 2012, the European Commission decided that a substantial overhaul of data protection regulation is required and issued its proposals for change. The proposals are currently making their way through the legislative process in Brussels but, once approved, are expected to take effect at some point in 2014 ...
Never has there been a more controversial law in the past decade than the Reproductive Health Law (“RH Law”). After a long and contentious battle in Congress, the law was finally passed. But the fervent opposition by the so-called Pro-life groups (chief among them the Catholic Church) endures. Four days after the approval of the law’s Implementing Rules and Regulations (“IRR”), the Supreme Court on March 19, 2013, halted its implementation, issuing a 120-day status quo ante order ...
BackgroundFollowing much anticipation on the part of health care industry members, CMS released its long-awaited final rule on the Physician Payment Sunshine Act in February 2013, supplying clarification and guidance on new financial disclosure requirements governing pharmaceutical and medical device manufacturers. The rule includes extensive and potentially time-consuming mandates for drug and device companies, including reporting of annual payments to physicians and teaching hospitals ...
Use of a domain name: is it a form of advertising? Following the decision in Case C-657/11 (Belgian Electronic Sorting Technology BV v Bert Peelaers, Visys NV), the rules of fairness imposed by European Directives 84/450 and 2006/114 on misleading and comparative advertising will extend to cover not just the content of a web site, but the domain name at which it is registered as well. See our commentary here ...
Under EU Directive 2001/29 on the harmonisation of copyright law, Member States grant authors, performers, producers and broadcasting organisations exclusive rights to authorise or prohibit reproductions of their own works ...
Businesses in the UK have for some time been subject to strict rules on misleading advertising, contained in the Business Protection from Misleading Marketing Regulations 2008 (the “BPRs”) ...
Personal data regulation is a recently developed topic in the legal realm. In 1970, the first laws on the matter were issued in Europe and North America. Specifically, the first data protection law called the Bundesdatenschutzgesetz was issued in Germany on October 7, 1970, and the same year the United States Congress issued the Fair Credit Reporting Act, which controls the collection, use and redistribution of any consumer information ...
In Novozymes A/S v. DuPont Nutrition Biosciences APS, 2012-1433 (Fed. Cir. July 22, 2013), the Federal Circuit affirmed the district court’s grant of DuPont’s post-trial motion for judgment as a matter of law holding that Novozymes’ U.S. Patent No. 7,713,723 (“the ’723 patent”), directed to a variant of alpha-amylase, was invalid under 35 U.S.C. § 112, first paragraph, for failing to satisfy the written description requirement.2 (Slip op. at 18) ...
ICANN is expected to announce the first set of successful applications and list of new generic top level domains later this summer. Before the new generic top level domains can be delegated, the applications need to go through an initial evaluation phase and any objections against those applications need to be addressed. Infact, the first decisions on legal rights objections to applications for new generic top level domains were only recently published by WIPO ...
Minister of Health Regulation No. 30 of 2013 on The Inclusion of Information on Sugar, Salt, and Fat Content, and Health Impact Messages for Processed and Fast Foods is aimed at lowering the exposure of the public to the risk of non-contagious disease such as hypertension, stroke, diabetes and heart attacks, which can be caused by the excessive consumption of processed or fast foods ...
The Minister of Health has issued Regulation No. 28 of 2013 on Affixing Health Warnings and Information on Tobacco Product Packaging which came into force on 12 April 2013, as a further implementation of Government Regulation No. 109 of 2012 on Control of AddictiveSubstances in the Form of Tobacco Products. The Regulation requires tobacco producers and importers to affix pictorial health warnings and health information on their tobacco products packaging ...
The Head of the National Drug and Food Control Agency (Badan Pengawas Obat dan Makanan – “BPOM”) recently issued Regulation No. 27 of 2013 on The Supervision of Drugs and Food Imports into Indonesian Territory which came into effect on 28 May 2013. This Regulation repeals and replaces the previous regulations on Imports of Processed Foods, Cosmetics and Drugs ...
Don't bank just yet on putting your marketing muscle behind the safe and effective off-label uses of your FDA-approved drugs, or defending your next mass consumer class action on First Amendment grounds. But you can start giving those multi-billion dollar prospects some serious thought, because constitutional winds are blowing through the Code of Federal Regulations ...
Myriad Genetics is known as a leader in the market for diagnostic testing of BRCA1 and BRCA2 gene mutations that have been linked to breast and ovarian cancer. These same diagnostic tests were recently in the celebrity press, as Angelina Jolie announced she had been tested positive for the mutations, resulting in her electing to have a preventative double mastectomy ...
