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 ...
On May 28, 2013, the US Food and Drug Administration (FDA) published a draft guidance entitled "Contract Manufacturing Arrangements for Drugs: Quality Agreements."1 The draft guidance describes FDA’s views on defining, establishing and documenting the responsibilities of parties that are involved in the contract manufacturing of drugs that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 ...
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) ...
Battered women who fear for their safety, mothers unable to support their children, dysfunctional families in need. A reality for many women is the presence of domestic violence in their lives. This situation, although occurring in all social and economic levels, is much more obvious and has more serious consequences in low-income communities ...
The Office of the Civil Registrar General of the National Statistics Office promulgated Administrative Order No. 1 series of 2012 (AO 1) on October 24, 2012. The AO implements the provisions of Republic Act 10172, the amendatory law to Republic Act 9048, and supplements Administrative Order 1 series of 2001, which, in turn, implements RA 9048. Both statutes provide a means of correcting erroneous entries in the civil registry without need of judicial action ...
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 ...
Traditional knowledge (TK), for example folklore, is a controversial issue and we’ve written about it before. The government feels that TK should be legally protected, and that this should be achieved through amendments to the intellectual property (IP) statutes. The IP community has no issue with TK being protected, but it’s not very comfortable with this being done through IP legislation ...
The New Amparo Law-On April 2, 2013, the Amparo Law, Regulatory of Articles 103 and 107 of the Constitution of the United Mexican Estates, was published in the Official Gazette of the Federation. This new law broadens the constitutional defense of rights, since more individuals can have access to the amparo actions ...
On March 22, 2013, the Department of Homeland Security ("DHS") announced that it will submit to the Office of Management and Budget ("OMB") a new Information Collection Request ("ICR") related to the implementation of the Chemical Facility Anti-Terrorism Standards ("CFATS") Personnel Surety Program ("PSP"). DHS is soliciting comments during a 60-day public comment period (which ends May 21, 2013) prior to the submission of the ICR to OMB ...
In 2008 the government introduced important intellectual property (IP) legislation. The Intellectual Property Rights from Publicly Financed Research and Development Act 51 of 2008 - which only came into force on 2 August 2010 – governs the ownership and exploitation of IP which flows from publicly financed research and development (R&D) ...
In 2008 the government introduced important intellectual property (IP) legislation. The Intellectual Property Rights from Publicly Financed Research and DevelopmentAct 51 of 2008 - which only came into force on 2 August 2010– governs the ownership and exploitation of IP which flows from publicly financed research and development (R&D) ...
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) ...
The Comelec promulgated Resolution No. 9615 on 15 January 2013. This Resolution implements the provisions of Republic Act No. 9006, more popularly known as the Fair Election Act, for purposes of the 2013 national and local mid-term elections ...
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 ...
On February 12, 2013, in conjunction with the release of the Executive Order on Improving Critical Infrastructure Cybersecurity (the Executive Order), President Obama signed a Presidential Policy Directive/PPD-21 on Critical Infrastructure Security and Resilience. The PPD revokes the 2003 Homeland Security Presidential Directive-7 (issued by President George W ...
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 ...
On February 12, 2013, the Obama Administration released an executive order, Improving Critical Infrastructure Cybersecurity (the "Executive Order"), which is focused primarily on government actions to support critical infrastructure owners and operators in protecting their systems and networks from cyber threats ...
