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 ...
On May 28, 2013, the US Food and Drug Administration (FDA) published a draft guidance entitled "Contract Manufacturing Arrangements for Drugs: Quality Agreements."1 The draft guidance describes FDA’s views on defining, establishing and documenting the responsibilities of parties that are involved in the contract manufacturing of drugs that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 ...
The Libyan Trade Mark Office (“LTMO”) has resumed the process of trade mark searching since April 2013 and will reportedly be accepting new applications for the registration of trade marks in May 2013. This after the LTMO had ceased its operations in January 2011 due to civil unrest in the country. There has, however, been some uncertainty with regard to the LTMO’s acceptance of new trade mark applications ...
The Comoro Islands, situated off the south-east coast of Africa, has ratified the Bangui Agreement, thereby becoming one of the 17 member countries of The African Intellectual Property Organisation (OAPI). The Bangui Agreement, once consented to, requires that the member states accede to the international treaties and conventions listed in the Agreement ...
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) ...
Increase in the Registration of Patents, Trademarks and Property Protected by Copyright - The various plans and the range of measures included in them that have been described have produced practical results, particularly an increase in the applications for registration of patents, trademarks and protection by copyright, specifically for property such as software. In terms of applications for patents registered in 2011, China came in first place above the USA and Japan ...
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 $280 million in recoveries ...
The decision of the Indian Supreme Court to deny Novartis’s application for patent protection for an improved version of its patented Glivec drug – the culmination of a seven-year battle - has certainly made the headlines. There are a number of reasons for this. First, Glivec is a well-known drug – described by some as a ‘wonder drug’ – that’s used to combat cancer, including leukaemia and gastro-intestinal cancer ...
Mobilizing the Money: A New Investment Program President Dilma Rousseff has launched an ambitious investment program in infrastructure, transport, logistics, and energy that will cost US$ 235 billion. The president and the entire government have been mobilized in the search for these investments, from domestic, foreign, public, and private sources ...
The Obama Administration has announced its intention of entering into negotiations with the European Union (“EU”) for a Transatlantic Trade and Investment Partnership (“TTIP”) aimed at achieving a substantial increase in transatlantic trade and investment between the world’s two largest economies. In the Federal Register of April 1, the United States Trade Representative solicited comments from the public with respect to U.S. negotiating objectives ...
On 28 January 2013 the «Diário da República» (official gazette) published a set of measures1 - that came into force the following day - to improve and streamline the special scheme2 for granting a Portuguese ‘investment residence permit’ (“IRP”) to foreign nationals to enable them to make certain investments in the country ...
The Committee on Foreign Investment in the United States The Exon-Florio Amendment to the 1988 U.S. Defense Production Act established the Committee on Foreign Investment in the United States ("CFIUS"). CFIUS is composed of representatives of several U.S. Government agencies, including the Departments of Treasury, State, Defense, Homeland Security, Labor and Commerce ...
A March 7, 2013 piece on Morning Edition, the morning news program from National Public Radio, raised a lot of questions. “In A Grain Of Golden Rice, A World Of Controversy Over GMO Foods” told the story of golden rice, a beautiful yellow rice enhanced with beta-carotene, or Vitamin A. This rice was ostensibly developed to be grown in developing countries, where foods high in Vitamin A either are uncommon or are expensive ...
A federal court jury in Illinois found that nursing home operator Momence Meadows fraudulently billed Medicare and Medicaid for “worthless services” and falsely certified compliance with health care laws and regulations, resulting in $28 million in damages to the government. United States ex rel. Absher v. Momence Meadows Nursing Ctr., Inc., No. 2:04-cv-02289 (C.D. Ill. Feb. 8, 2013) ...
It took thirteen years, four months, and five days of heated debates and passionate protests before the country’s first reproductive health law was passed. Four days shy of Christmas last year, President Aquino finally signed the 24-page bill into law. It is now Republic Act No. 10354 or The Responsible Parenthood and Reproductive Health Act of 2012 (RH Law). The passing of the RH Law, however, does by no means close this chapter of Philippine history ...
The Philippine Supreme Court has issued a decision that may have a significant impact on how local nationality requirements (i.e., constitutional and statutory provisions requiring minimum Filipino ownership in certain industries) must be construed and applied. Enterprises such as telecommunications, media, advertising and land ownership are subject to such nationality requirements.The case of Gamboa v. Teves, et al. (G.R. No ...
Sixteen years since the enactment of Law No. 7 of 1996 regarding Food (“the 1996 Food Law”), the Government issued the new Food Law (ie Law No. 18 of 2012) (“Food Law”) on 18 October 2012, two days after World Food Day. The Food Law replaces The 1996 Food Law. The Food Law covers three significant areas which were not governed by the 1996 Food Law, ie imports of food; the halal requirement; and the establishment of a new non-ministerial agency in-charge of food matters ...
After lengthy discussions among regulators and politicians on ownership of commercial banks, Bank Indonesia issued its Regulation No. 14/8/PBI/2012 regarding Ownership of Shares in Commercial Banks (“BI Regulation No. 14”) which came into effect on 13 July 2012.In general, BI Regulation No. 14 provides rules that restrict ownership of commercial banks by individuals or corporations either on an individual or joint basis. BI Regulation No ...
Under the Patient Protection and Affordable Care Act (“PPACA”), an employer that employs an average of at least 50 full-time and full-time equivalent employees (a “Large Employer”) during 2013 may be subject to a penalty in 2014 if the Large Employer fails to offer “minimum essential coverage” to all but 5 percent (or, if greater, five) of its full-time employees (“No Coverage Penalty”) ...
