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 ...
On July 2, 2013, the U.S. District Court for the District of Columbia1 (the “District Court”) vacated Rule 13q-1 (the “Rule”) under the Securities and Exchange Act of 1934, as amended (the “Exchange Act”) ...
On July 10, 2013, the United States Securities and Exchange Commission (the “SEC”) adopted amendments to Rule 506 of Regulation D under the Securities Act of 1933, as amended, that will lift the ban on general solicitation for certain private offerings, including offerings of private fund interests (“New Rule 506(c)”). New Rule 506(c) will become effective 60 days after publication in the Federal Register ...
On July 10, 2013, the Securities and Exchange Commission (SEC) adopted the new, much-anticipated rules that lift the ban on general solicitation and advertising in connection with certain private offerings of securities ...
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 ...
Court decisions regarding company names are rare. So the recent decision of the Western Cape High Court in the case of Bloomberg’s Posterity Investments (Pty) Ltd v The Registrar of Companies and Bloomberg LLP is worth discussing. What makes company name cases interesting from an intellectual property (IP) law point of view is that they deal with issues that are very similar to the issues that are dealt with in trade mark infringement and passing-off cases ...
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 ...
After the recent downturn, examiners have been placing more emphasis on reputation risk. This emphasis, however, is being applied paternalistically, in a way that is limiting legitimate transactions. I have heard of examiners advising bankers to terminate relationships with payday lenders because of reputation risk. The examiners are implicitly saying the risk of such association will so damage an institution's reputation as to jeopardize safety and soundness ...
On June 19, 2013, the West Virginia Supreme Court of Appeals (“the Court” or “WVSCA”) issued an important decision that bolsters the ability of financial institutions and other defendants to enforce arbitration agreements. Credit Acceptance Corporation v. Front, Docket Nos. 11-1646, 12-0545 (W. Va. June 19, 2013), Slip Op. Spilman consumer finance attorneys were pleased to obtain this victory on the consolidated appeal of two orders denying arbitration ...
Frequently asked questions on new foreign exchange rules: What currency should be used to pay the salaries of employees in Angola?The salaries of employees who are foreign exchange residents in Angola, irrespective of the sector of activity, must be paid in Kwanzas, the national currency. When Will i start to receive my salary in Kwanzas? As of 1 July 2013, in accordance with the implementation calendar of Law 2/12 of 13 January, defined by Order no ...
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 14, 2013, the Act respecting insurance (Quebec) (the "Act") was amended by sections 1 to 5 of An Act to amend various legislative provisions mainly concerning the financial sector. The new sections, 66.1.1 to 66.1 ...
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 ...
In January 2012, the Electronic Commerce Committee of the Canadian Council of Insurance Regulators (CCIR)1 released an issue paper entitled “Electronic Commerce in Insurance Products”, through which it invited insurers and intermediaries to provide feedback on certain targeted issues respecting online insurance distribution.Many stakeholders responded; 25 submissions were sent to the CCIR ...
Recently, the Court of Québec reminded merchants of their responsibility to ensure that consumers are cognizant of important contractual clauses at the time a contract is entered into. In the case of 159191 Canada inc. (Discount Location d’autos et camions) c. Waddell1, the Court had to decide whether a clause in a two-page vehicle rental contract which excluded insurance coverage in a specific situation was valid under Québec law. FACTSThe facts of the case are as follows ...
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 ...
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 ...
Last fall, I wrote an article for Carolina Banker magazine excitingly titled “Bank Liability to Non-Customers in a Ponzi Scheme.” The crux of it concerns the potential liability to banks in Ponzi schemes and the precautions banks should take to mitigate that risk ...
As anticipated, on May 29, 2013, the Consumer Financial Protection Bureau delivered the final version of amendments to its January 2013 Ability-to-Repay/Qualified Mortgage rules (the bureau released an early draft of the amendments when the original rule was published). For more information about the Ability-to-Pay/Qualified Mortgage rules, see our prior alerts.1 The rules, as well as the amendments, take effect on January 10, 2014 ...
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 ...
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 ...
A recent posting on a popular intellectual property (IP) blog raised an issue that’s becoming increasingly important in the couch-potato / global- village world we now live in: what, if any, legal protection does a TV format enjoy? In South Africa we often watch local versions of foreign TV programs, be they ‘reality’ shows like Big Brother or Come Dine WithMe, ‘talent’ shows like Idols or Masterchef,or game shows like The Weakest L
