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 not uncommon for a company that owns intellectual property (IP) such as trade marks, patents and copyright to grant another company the right to use that IP. The grant of the right to use IP is referred to as a ‘licence’, the company that grants the right is referred to as the ‘licensor’, and the company that gets the right is referred to as the ‘licensee’ ...
The Supreme Court held today in FTC v. Actavis that so-called “reverse payment” settlement agreements are subject to antitrust law’s “rule of reason” analysis. The Court, however, largely downplayed whether such analysis would require inquiry into what Justice Scalia deemed “the elephant in the room” at oral argument: the strength of the patent at issue ...
On June 10, 2013, a unanimous Supreme Court in Oxford Health Plans LLC v. Sutter, 569 U.S. ___ (2013), held that an arbitrator’s decision to allow class arbitration cannot be overturned if the decision was based on the interpretation of the parties’ contract. Even if the interpretation is incorrect, the Court will not overturn the arbitrator’s decision given its limited scope of review allowed under §10(a)(4) of the Federal Arbitration Act (FAA) ...
The Supreme Court has unanimously upheld an arbitrator’s ruling that a contract that required arbitration of "any dispute" constituted an agreement to class-wide arbitration. The Court’s narrow ruling turns on the parties’ express agreement to allow the arbitrator to decide whether their contract, which contained an arbitration provision but did not mention class proceedings, authorized class arbitration ...
As discussed in our previous Alert, the French government has imposed Sunshine-like obligations on the pharmaceutical industry. Article 2 of Law No 2011-2012 of 29 December 2011 on the Strengthening of Health Protection for Medicinal and Health Products ("loi relative au renforcement de la sécurité sanitaire du médicament et des produits de santé" or "Loi Bertrand") inserted Articles L. 1453-1 in the French Code of Public Health ("Code de la santé publique" or "CSP"). Article L ...
An interview with Michał Barłowski, the partner in charge of the Bankruptcy and Restructuring practices at Wardyński & Partners, about planned amendments to Poland’s Bankruptcy & Rehabilitation Law. Restructuring is an alternative to bankruptcy. So why do we hear so little about effective restructuring and so much about liquidating bankruptcies? Michał Barłowski: The reasons are many and have various sources ...
Here are select March 2013 rulings of the Supreme Court of the Philippines on commercial law:Corporation; separate personality. A corporation is an artificial entity created by operation of law. It possesses the right of succession and such powers, attributes, and properties expressly authorized by law or incident to its existence. It has a personality separate and distinct from that of its stockholders and from that of other corporations to which it may be connected ...
Here are select March 2013 rulings of the Supreme Court of the Philippines on civil law:Civil CodeContracts; contract of sale; perfection; essential elements; stages. A contract of sale is perfected at the moment there is a meeting of minds upon the thing which is the object of the contract and upon the price ...
I. Background: 2010-2011 and the “First Wave” of Say-on-Pay SuitsIn 2010 and 2011, after the enactment of federal “say-on-pay” legislation in the Dodd-Frank Wall Street Reform and Consumer Protection Act,1 shareholder plaintiff firms filed several actions alleging breaches of fiduciary duties by directors of companies experiencing unfavorable say-on-pay votes during proxy season ...
On May 30, 2013, as had long been expected, the staff in the Division of Corporation Finance of the Securities and Exchange Commission released Frequently Asked Questions concerning the SEC’s conflict minerals rules.1 The FAQs do not address some of the thorniest interpretive issues under the conflict minerals rules, but they do reinforce a number of developing practices and provide helpful guidance on a number of topics for SEC reporting companies.2 We summarize some of the key FAQs below ...
The First Circuit recently held that complaints filed first under the False Claims Act’s first-to-file rule do not need to satisfy Federal Rule of Civil Procedure 9(b)’s particularity requirement. See United States ex rel. Heineman-Guta v. Guidant Corp., 2013 WL 2364172 (1st Cir. May 31, 2013) ...
Attorney; a lawyer shall not assist in the unauthorized practice of law. Atty. Bancolo admitted that the Complaint he filed for a former client before the Office of the Ombudsman was signed in his name by a secretary of his by Text-Enhance" href="http://lexoterica.wordpress ...
On May 28, 2013, the US Food and Drug Administration (FDA) published a draft guidance entitled "Contract Manufacturing Arrangements for Drugs: Quality Agreements."1 The draft guidance describes FDA’s views on defining, establishing and documenting the responsibilities of parties that are involved in the contract manufacturing of drugs that are subject to current good manufacturing practice (cGMP) requirements ...
Dear Reader, We have the pleasure to present the new edition of Doing Business in the Baltics. We hope that the information presented in this publication will provide businesses, investors and their advisers a better understanding of the advantages that the Baltic States have to offer ...
As previously described, in the fall of 2012 the NYSE and NASDAQ markets previously issued rules concerning the independence of compensation committee members and advisers as required by the Dodd-Frank Wall Street Reform and Consumer Protection Act. These rules were approved by the Securities and Exchange Commission in January 2013 ...
On April 11 2013, the Philippine Bureau of Internal Revenue issued Revenue Regulations No 6-2013 (RR 6-2013) amending certain provisions of Revenue Regulations No 6- 2008, which provides for, among other things, therules involving the determination of the fair market value of shares of stock not listed and traded in the local stock exchanges ...
After the Netherlands, Slovakia, and the UK, it is now France’s turn to impose Sunshine-like obligations on the pharmaceutical industry. Soon, similar obligations will apply to all EU countries, after EFPIA, the European trade association for the pharmaceutical industry, adopts a code of conduct on disclosure of transfers of value between pharmaceutical companies and health care professionals or institutions ...
The Turks & Caicos Islands (TCI) has recently introduced a raft of legislation to enhance its existing comprehensive anti-money laundering regime. The provisions largely follow the “Review of Financial Regulation in the Caribbean Overseas Territories and Bermuda” recently conducted for the British Government by KPMG (generally known as “the KPMG Report”) ...
Canada’s new anti-spam law (the CASL) is expected to come into force later this year. This Act is designed to create a safer online environment for individuals and businesses in Canada. From a business perspective, it will change how some routine daily activities – such as distributing commercial electronic messages (CEM) to customers – are executed. Currently, a majority of businesses rely on implied consent when they send CEM to customers ...
Last week, a federal jury in South Carolina found that Tuomey Healthcare System, Inc. violated the Stark Law and the False Claims Act by submitting false claims for reimbursement to the United States, resulting in $39 million in damages to the government. United States ex rel. Drakeford v. Tuomey Healthcare Sys., Inc., No. 3:05-2858-MBS (D.S.C. May 8, 2013) ...
It is expected that Canada's new Anti-Spam Legislation (CASL) will come into force later this year, and with it will come significant changes for how businesses and individuals may send people "commercial electronic messages" (CEM), including emails or text messages.CASL aims to create a safer online environment by targeting issues relating to spam, such as unsolicited commercial messages, phishing and unauthorized installation of software ...
