On 13 June 2013, the Supreme Court of the United States handed down its unanimous decision in the ongoing case of Association for Molecular Pathology et al v Myriad Genetics, Inc. et al 12-398, 569 US __ (2013). This case is the first brought in the US directly challenging the patentability of human genes and for that reason is extremely important to any entity involved in the biotechnology industry which relies on human genetics research as part of innovation strategy ...
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 ...
One way to change the law fast is to amend or repeal statutes in budget legislation. That is what the federal government of Canadadid in 2009, 2010 and 2011. Federal programs, staff positions and budgets for environmental science, conservation and protection have been eliminated. That leaves a lot of responsibility with the provinces and territories, and many open questions for industry. This article describes what has happened and identifies what to look out for ...
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 ...
Governor Perry recently signed four bills into law designed to combat Medicaid fraud, waste, and abuse. The bills are a mixed bag of enhanced enforcement capabilities for the state and a few new protections for healthcare providers. Most notably, the legislature made several changes to the Texas Medicaid Fraud Prevention Act (TMFPA), bringing the statute more in line with the federal False Claims Act. Changes to the Medicaid Fraud Laws On the enforcement side, S.B ...
In Wyeth and Cordis Corp. v. Abbott Laboratories, 2012-1223, -1224 (Fed. Cir. June 26, 2013), the Court of Appeals for the Federal Circuit affirmed the district court’s grant of summary judgment in favor of the defendants, holding method of treatment claims invalid under 35 U.S.C. § 112(a) (2012) as not being enabled for their full scope. (Slip op. at 3) ...
On June 13, 2013, in the highly anticipated decision for Ass’n for Molecular Pathology v. Myriad Genetics, Inc., the Supreme Court shed some light on the future of genetic patenting to companies and scientists working in the personalized medicine and genetics industry. The personalized medicine industry seeks to revolutionize patient care by using genetic sequencing and testing to predict disease likelihood, severity, progression, and/or treatment response ...
You’ve seen all the articles about the Supreme Court’s decision in Assoc. for Molecular Pathology v. Myriad Genetics Inc. and the end of DNA patents, but what does this mean outside the biotech world? It means more insight into patent eligibility under 35 U.S.C. § 101. While Myriad does not affect business method and software patents, it is indicative of the general trend of the Supreme Court with respect to the threshold required to obtain a valid patent ...
In a decision that will likely have a significant impact on the pharmaceutical industry (and possibly broader implications for patent, antitrust, and high technology), the Supreme Court yesterday refused to exempt so-called reverse payment (or "pay for delay") patent settlements from antitrust scrutiny. Prior to yesterday’s ruling in FTC v. Actavis, Inc., 570 U.S. ___ (2013), most of the circuit courts to have considered the issue (i.e ...
It’s been well reported that the singer Rihanna has sued the UK retail chain Topshop for US$5 million in damages for the unauthorised use of her image on a t-shirt. Rihanna is apparently suing for passing-off, the argument being that people seeing the t-shirt are likely to assume that she has endorsed the brand. This may have got you wondering what the law is in South Africa on the issue of unauthorised endorsement ...
Domain names and trade marks are inextricably linked. The reason for this is simple – when a company needs to decide on a name at which it wants people to find it on the Internet, it generally opts for one of its own trade marks. As a result, the issues that crop up in trade mark disputes often crop up in domain name disputes too ...
The KZN High Court handed down a really interesting judgment in May 2013 in the case of Distell v KZN Wines & Spirits. The decision’s interesting because it not only looks at the issues that need to be considered in a trade mark infringement claim, but it also highlights the differences between trade mark infringement and passing off ...
