On May 28, 2013, the US Food and Drug Administration (FDA) published a draft guidance entitled "Contract Manufacturing Arrangements for Drugs: Quality Agreements."1 The draft guidance describes FDA’s views on defining, establishing and documenting the responsibilities of parties that are involved in the contract manufacturing of drugs that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) ...
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 ...
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 ...
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 $280 million in recoveries ...
The decision of the Indian Supreme Court to deny Novartis’s application for patent protection for an improved version of its patented Glivec drug – the culmination of a seven-year battle - has certainly made the headlines. There are a number of reasons for this. First, Glivec is a well-known drug – described by some as a ‘wonder drug’ – that’s used to combat cancer, including leukaemia and gastro-intestinal cancer ...
Traditional knowledge (TK), for example folklore, is a controversial issue and we’ve written about it before. The government feels that TK should be legally protected, and that this should be achieved through amendments to the intellectual property (IP) statutes. The IP community has no issue with TK being protected, but it’s not very comfortable with this being done through IP legislation ...
Mobilizing the Money: A New Investment Program President Dilma Rousseff has launched an ambitious investment program in infrastructure, transport, logistics, and energy that will cost US$ 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 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 ...
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 ...
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) ...
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 ...
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) ...
