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 ...
IntroductionOn 6 June 2013 the Council of Ministers approved the bill to finalise the transposition of Directive 2003/49/ EC of the Council of 3 June into the IRC (corporate income tax) Code. The Directive, which establishes a common system of taxation applicable to interest and royalty payments made between associated companies of different Member States, is commonly known as the ‘Interest & Royalties Directive’ ...
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) ...
Law 55-A/2012 of 29 October – published last year as part of the package of measures to combat the financial crisis – made ownership, use or surface rights of residential urban properties with an official taxable value (valor patrimonial tributário) equal to or greater than EUR 1 million subject to Stamp Duty, calculated at the rate of 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 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 ...
In the clearest sign yet that some buoyancy has returned to the TCI real estate market, the TCI Government has announced changes to TCI’s stamp duty regime ...
CONTENTS Life Insurance Policy: How to Extract Funds from a Corporation with No Tax ImpactConstructive Dismissal Analyzed in the Context of a Business AcquisitionThe Right of Withdrawal, a Controlled Form of Contractual FreedomTransfers of Residences Involving a Spousal Testamentary Trust LIFE INSURANCE POLICY: HOW TO EXTRACT FUNDS FROM A CORPORATION WITH NO TAX IMPACTLuc Pariseau with the collaboration of Martin Bédard, articling studentIndividual shareholders who wish to withdraw
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 ...
Here are select February 2013 rulings of the Supreme Court of the Philippines on tax law: National Internal Revenue Code; documentary stamp tax; issuance of promissory notes; persons liable for the payment of DST; acceptance ...
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 ...
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) ...
The Panamanian Limited Liability Partnership has been a part of Panama’s trade laws since 1916, when the Panamanian Commercial Code was issued. However, during 2009 it was subject to a profound reform in order to adapt it to an always demanding and changing market. As its “younger sister”, the worldwide famous “Sociedad Anonima” (1927), the limited liability partnership shall be filed at the Public Registry ...
On April 17, 2013, the Health and Human Services Office of Inspector General (OIG) released an Updated Provider Self-Disclosure Protocol (SDP), which replaces the original SDP published in 1998. The SDP is used by providers and suppliers to voluntarily disclose violations of the fraud and abuse laws. According to the OIG, it has received more than 800 disclosures since the SDP’s inception, resulting in more than $280 million in recoveries ...
The decision of the Indian Supreme Court to deny Novartis’s application for patent protection for an improved version of its patented Glivec drug – the culmination of a seven-year battle - has certainly made the headlines. There are a number of reasons for this. First, Glivec is a well-known drug – described by some as a ‘wonder drug’ – that’s used to combat cancer, including leukaemia and gastro-intestinal cancer ...
Gift Tax Return Requirement for 2012 TransactionsDuring 2012, uncertainty about future estate and gift tax exemptions and rates led many of our clients to make substantial gifts during 2012 to their descendants or to trusts for descendants ...
Contents Part XII.2 Tax Applicable to Trusts: a Potentially Expensive Tax Which Is Often Overlooked Application of the Anti-avoidance Rule in Subsection 83(2.1): Caution Is Required in the Context of the Acquisition of a Private Corporation Revenu Québec to Scrutinize Trusts Directors’ Liability for the Debts of a Corporation Payable to Employees for Services Rendered During the Directors’ Term of Office PART XII ...
