As you no doubt already know, the Pharmaceutical Industry in Argentina is a strictly controlled industry. Said control is held by the ANMAT Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) and it spreads from the first authorisation of a laboratory to act as such in the country, moving through the authorisations to commercialise products, up to pharmacovigilance of products that have already been commercialised ...
On 3 March 2014, the Government presented the bill ”Enhanced competition supervision” (Sw: “Förbättrad konkurrenstillsyn”) (Governmental Bill, prop. 2013/14:135) which contains several suggested changes to the Swedish Competition Act which relate, inter alia, to leniency and the possibility to suspend time limits during merger control assessments ...
In one of the few decisions of its kind, the UK High Court recently assessed the damages to be paid to a generic pharmaceutical company under a cross-undertaking in damages. While some aspects of the decision are specific to the UK pharmaceutical reimbursement scheme, the judgment will be a useful reference point for parties involved in similar litigation in Australia ...
As we indicated a few months ago, the partial reform of the intellectual property law continues its journey towards the Lower House of the Spanish Parliament. On Friday, February 14, the Cabinet approved the text of the preliminary bill, which must now get the green light from the consultative bodies and be debated in Parliament as a bill before its definitive approval. The main lines of the approved text are those we advanced in our previous post: 1 ...
On February 21, 2014, the Federal Circuit’s 6-4 majority en banc ruling in Lighting Ballast Control vs. Philips Electronic North America retained the standard of de novo appellate review of district court claim construction rulings, whereby the scope of the patent grant is reviewed as a matter of law ...
There are many famous cases where trademarks and passing off come into contact with unofficial merchandising and the right holder has been unsuccessful. They range from the fictional character Tarzan, to the rock band Linkin Park, to Diana Princess of Wales. There is no such thing as a matter of UK law as a free standing general right by a famous person (or anyone else) to control the reproduction of their image ...
On March 5, 2014, the US Supreme Court rendered a 7-2 decision reinstating a $185 million arbitration award in favor of the BG Group against Argentina under the UK-Argentina bilateral investment treaty (BIT). The Supreme Court held that the Court of Appeals for the DC Circuit erred in deciding de novo, and without deference to the tribunal’s award, the issue of the arbitrators’ jurisdiction ...
There are many famous cases where trademarks and passing off come into contact with unofficial merchandising and the right holder has been unsuccessful. They range from the fictional character Tarzan, to the rock band Linkin Park, to Diana Princess of Wales. There is no such thing as a matter of UK law as a free standing general right by a famous person (or anyone else) to control the reproduction of their image ...
Misrepresentations and unfounded assertions of fact made to a party during pre-contractual negotiations can come back to bite you if they induce that party to enter into the contract. The Supreme Court case has emphasised that misrepresentations made to a non-contracting party can also result in liability for the party that made the misrepresentation ...
Unlike in federal court, it is unclear in Florida state courts when the duty to preserve evidence arises. Ostensibly, under Florida law, there is no legal duty to preserve evidence until a discovery request is made. While there is no doubt that a party can be sanctioned for failing to preserve evidence after it has a duty to do so, several Florida courts have sanctioned parties for failing to preserve evidence even when there was no such duty under Florida law ...
Following a period of consultation, the Government has confirmed that legislative changes will be made to ensure that “protected persons” will not be affected by the statutory amendment power being introduced as part of the abolition of defined benefit contracting-out ...
CMS recently announced yet another delay to the full implementation of “two midnight rule,” which revises its longstanding guidance to hospitals and physicians relating to when hospital inpatient admissions are deemed to be reasonable and necessary for payment under Medicare Part A. Specifically, this latest “delay” is the result of CMS’s extension of the “Probe & Educate Period,” a period of partial non-enforcement for the two midnight rule requirements, until September 30, 2014 ...
On January 31, 2014, the Supreme Court of Canada released its decision in A.I. Enterprises Ltd. v. Bram Enterprises Ltd., 2014 SCC 12. This is an important commercial decision as it clarifies and narrows the scope of the tort of unlawful interference in economic relations. Canadian businesses will also welcome the Court's reference to commercial certainty as one of the principal reasons to clarify and limit the scope of this tort ...
When Shakespeare said we should kill all lawyers he was not referring to Magic Circle corporate or TMT partners, they had not been invented yet; and conveyancing and private client work were in their infancy. No, what he had in his sights were litigators and two hundred and fifty years later Dickens aimed his withering fire at the chancery lawyers in Bleak House ...
Reprinted with permission from the February 7, 2014 issue of Corporate Counsel. © 2014 ALM Media Properties, LLC. Further duplication without permission is prohibited. All rights reserved. On Nov. 12, 2013, the U.S. Supreme Court declined to grant a writ of certiorari in Cariou v. Prince, leaving intact the decision by the U.S. Court of Appeals for the Second Circuit on copyright fair use in the context of appropriation art ...
Many companies provide annual earnings guidance and quarterly updates to the analyst and investor communities. Guidance is also frequently updated during industry conferences and in nondeal roadshows. A failure to meet the market’s earnings expectations can negatively impact management’s credibility and, in turn, the price of the company’s common stock. The importance of earnings guidance is heightened during an equity offering when a company is actively soliciting investors ...
False labeling of products, fake or inferior materials and components used to make products, and the misappropriated use of another’s trademark are examples of how counterfeit goods and the theft of intellectual property are hurting consumers and companies. The world markets and global supply distribution chains provide opportunities for companies to grow and prosper. Sales through the Internet allow for products to be sold and sent to almost anywhere in the world ...
The Affordable Care Act, in a largely overlooked provision, bestowed broad powers on the Centers for Medicare and Medicaid Services (CMS) to impose a moratorium on the enrollment of new Medicare or Medicaid providers, including whole categories of providers in certain geographic locations ...
The Serbian Government has taken first steps of implementing a new court system with the passing of a new Law on Seats, Jurisdictions of Courts and Public Prosecution Offices (Official Gazette RS no. 101/2013), and amendments to the Law on Organisation of Courts (Official Gazette RS no. 116/2008, 104/2009, 101/2010, 31/2011, 78/2011 101/2011, 101/2013), which came into force on 1 January 2014 ...
St. Luke’s Health System’s 2012 acquisition of Saltzer Medical Group, Idaho’s largest independent multi-specialty physician practice group, violated federal and state antitrust laws according to a U.S. District Court holding issued on Friday, January 24, 2014. The Court ordered divestiture of the practice. The FTC and the Idaho Attorney General filed the Complaint seeking to block the sale on March 12, 2013. In response, St ...
Most marketers and retailers know that the consumer protection laws require that their advertising claims be substantiated, truthful and not misleading. But the new year is a good time to take stock of advertising campaigns, practices and procedures to make sure they pass muster under the Federal Trade Commission’s (FTC’s) latest guidance. The FTC’s recent enforcement actions provide a starting point ...
The dispute resolution terms of engineering contracts can cause problems. An example is the recent case of Tubular Holdings (Pty) Ltd v DBT Technologies (Pty) Ltd, an unreported decision of South Gautend High Court. DBT Technologies - a subcontractor to Eskom in the Kusile Project 0 further contracted to Tubular Holdings in a deal worth some R 1.3 billion. Contract FIDIC's clause 20 governs the dispute resolution procedure. Clause 20 ...
On January 13, 2014, the Food and Drug Administration ("FDA" or "the Agency") announced the availability of a much-anticipated draft guidance on its intended regulation of product promotion conducted via social media, titled Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics ...
