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 ...
Introduction:The Consumer Protection Act, Cap. 326D (‘the Act’) aims at protecting consumer rights by, among other things, prohibiting and penalizing the use of unfair contract terms by suppliers of services. The Act is administered and enforced by the Fair Trading Commission (‘the FTC’). This article summarises the effect of the Act on how service providers can legally contract with their customers. This article does not focus on suppliers of goods ...
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) ...
The insolvency of one or other of the parties to a dispute has become commonplace in recent times, particularly in construction related disputes. Practitioners are becoming increasingly knowledgeable about the implications of insolvency on procedure and the potential remedies available ...
Internal investigations are a central part of the crisis management response, and whilst the form and structure of the investigation will depend on the type of crisis, investigations will generally focus on identifying root causes and those with responsibility for the crisis ...
South Africa has a rapidly evolving climate change policy environment, which is in-keeping with the country¡¦s view of itself as a developing country leader in the climate change arena. Part of the policy environment includes attention to financial mechanisms that can be marshaled in support of the response to climate change ...
After a slight pause, the Baltic States – Estonia, Latvia and Lithuania - are continuing on their path to entering the euro zone, which was first entered by Estonia in 2011 ...
Statute of limitations for appeal of public auction contractsThe Higher Commercial Court recently clarified several issues relating to the statute of limitations for appeals of public auction contracts. (Higher Commercial Court of Ukraine Resolution 10 ("On Certain Practical Issues of Statute of Limitation Application"), May 29 2013 ...
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 ...
A recent ruling by the Court of Justice of the European Union (CJEU) could mean trouble for many Community trade marks. There is now a heightened risk that national courts will invalidate these trade marks if they have not been used extensively enough in the European Union. Is broader protection better? A Community trade mark (CTM) confers protection in all 27 EU member states ...
While arbitration offers an excellent means for parties to get their disputes settled faster than in traditional courts, how you draft the arbitration clause in a document is critically important for a positive outcome – should a dispute arise. Legal agreements often have a clause indicating that parties agree to settle any disputes arising from the arrangement in arbitration. The text for this clause is frequently supplied by a local arbitration institute ...
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 ...
As Panama became part of a number of industrial property related treaties, our internal laws have become more territorial; the use of a trademark is territorial again and registration becomes imperative for protection. In Panama, as happens in most of the countries around the world, the right to register a trademark is acquired by its first use in commerce ...
Legal succession of banksUkrainian legislation prescribes a special reorganisation procedure for banks that, among other things, requires banks to:• develop a reorganisation plan;• obtain approval for internal statute changes from the National Bank of Ukraine; and• conduct an audit to ensure the correctness of transfers (for mergers and acquisitions) or the demerger balance sheet (for spin-offs and transfers) ...
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 ...
PrefaceThis guide is written as an introduction to Ukrainian legal system from the viewpoint of foreign investors, in particular Chinese ones, and will help you in deciding whether to do a deal in Ukraine and what strategy should be chosen when investing in this country. The digest of key legal issues may be found helpful both at the stage of initial investment research and in the course of a particular investment project ...
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) ...
I OVERVIEWChile continues to offer an attractive business environment. Chile was the first Latin American economy to join the Organization for Economic Cooperation and Development, and is party to dozens of free trade agreements (including with the United States, the European Union, Mexico, South Korea and Brazil) ...
At the end of May, the U.S. District Court for the Southern District of Florida sentenced a Florida import company president to 22 months in federal prison for violating consumer product safety and other laws. His wife, an executive of a related company, was sentenced to a year of probation. The case is significant because it involves a criminal prosecution of importers of unsafe children’s products ...
