In recent months, in a unanimous decision authored by Justice Thomas, the Supreme Court issued its much-awaited decision in Sandoz Inc. v. Amgen Inc. et al., No 15-1039, considering two critical questions in the biosimilar approval mechanisms adopted in the Biologics Price Competition and Innovation Act of 2009 (“BPCIA” or “Biosimilars Act”) ...
On June 17, the Trump Administration announced a new policy on Cuba, partially reversing certain of the market-opening measures that had been adopted by the Obama Administration during its final two years ...
Getting the Deal Through – Shipbuilding is part of the series of Getting the Deal Through law guides published by Law Business Research that provide an overview of specialist areas of the law in a variety of international jurisdictions.It is published annually and the sixth edition, published in June 2017, covers 14 jurisdictions. Leading practitioners from each jurisdiction answer the same key questions ...
The shock result in the UK General Election has caused further political and economic upheaval with no single party controlling the House of Commons. Serious questions are now being raised over the UK’s approach to Brexit with negotiations set to commence next week ...
India and Japan share a long history. Buddhism, which was born in India, travelled to Japan around the 6th century. The first major interaction between Japan and India seems to have been Japanese assistance to Shri Subhash Chandra Bose in the fight for Indian independence (1943-45). Post WWII, Japan and India signed a peace treaty and established diplomatic relations on 28th April, 1952 ...
FBC & Co examine the business and legal aspects of investing in one of the world’s most technologically advanced economies. Established in 1948, Israel is the world’s only Jewish state, and the sole democracy in its vicinity. Israel has a diverse open market economy. Being a relatively young state, Israel is recognized as a developed market by many major indices. Israel has been a member of the high-income sector of the OECD since 2010 ...
Long-term care (LTC) facilities received a boost last week when the Centers for Medicare and Medicaid Services (CMS) reversed its position regarding the use of arbitration agreements in this setting. On June 8, 2017, CMS published a proposed rule amending LTC facilities’ conditions of participation in the Medicare and Medicaid programs to remove prohibitions on binding pre-dispute arbitration agreements ...
Changes to North American Free Trade Agreement (NAFTA) have been anticipated since the moment of President Trump’s election. When U.S. Trade Representative Robert Lighthizer notified Congress of the Administration’s intent to renegotiate NAFTA, he triggered the 90-day consultation period before formal negotiations can begin ...
“It is a treasured value in humanity … that no parent would want her child to grow up thinking that she (the child was) a mistake." - Justice Choo Han Teck In 2010, a Chinese woman, trying to conceive a child with her Caucasian husband, underwent an in vitro fertilisation (“IVF”) procedure at a clinic. Like the previous time she bore a child through IVF at that clinic in 2006, no third party’s gametes were meant to be used ...
The Office of the United States Trade Representative (USTR) has published in the Federal Register a Notice of a “Request for Comments on Negotiating Objectives Regarding Modernization of the North American Free Trade Agreement With Canada and Mexico.” In the Notice, USTR advises that it will accept written comments by June 12, 2017 and will hold a public hearing at the U.S ...
"WHAT BELT AND ROAD SNUB MEANS FOR SINGAPORE’S TIES WITH CHINA" Thus the headline from the South China Morning Post (SCMP) on 18 May 2017.China had concluded its Belt and Road Forum, to which 29 other heads of government were invited. Only 3 from 10-member ASEAN were excluded: Singapore, Thailand and Brunei. Even smaller nations, with less-established diplomatic ties to Beijing, sent their heads of government ...
On Wednesday, April 26, 2017, the Supreme Court heard oral argument in Sandoz Inc. v. Amgen Inc. et al., a landmark case that many hope will provide clarity and guidance for consumers and the pharmaceutical industry on the regulatory approval pathway for biosimilar drugs under the Biologics Price Competition and Innovation Act of 2009 (“BPCIA” or “Biosimilars Act”) ...
Once the new Commercial Companies Law was enacted as Federal Law No. 2 it gave existing companies time to achieve compliance with its terms. Article 374 provides that a further one-year extension could be granted by Resolution of the Cabinet, and such an extension was in fact granted. Article 374 also provides that a company that fails to achieve compliance shall be deemed dissolved ...
ANGOLA: Budget Law, 2017 details publishedOn 10 February 2017, the provisions of Budget Law, 2017, enacted on 31 December 2016, were published. In terms of the Budget Law, 2017 the 10% withholding tax on technical services and management fees paid to non-residents for the provision of foreign technical assistance or management services (Contribuição Especial sobre as Operações Cambiais de Invisíveis Correntes), which was introduced by Law No ...
In the 2017 South African Budget Review, specific statements were made from a tax and exchange control perspective in relation to fund managers. We briefly consider below whether these statements constitute a relaxation of the exchange control restrictions applicable to South African residents, and the taxes to be considered ...
As published in international media, Brazil is still facing economic problems related, for example, to economic growth rate and unemployment. However, Brazil remains a country where investment opportunities continue to exist. Brazil has the advantage of having a large internal market due to the size of its population and of being well positioned geographically in South America, so the country can be a platform for the export of products to other countries in the region ...
On the eve of the provisional entry into force of the Canada-Europe Free Trade Agreement, understanding its implications should be a top priority for any company wishing to expand its activities over the course of the next few years. The vote held at the European Parliament in favour of the ratification of the Agreement makes its entry into force imminent ...
Upon reconsideration in Gerard v. Orange Coast Memorial Medical Center, Case No. G048039 (March 21, 2017) (Gerard II), the Fourth Appellate District decided that IWC Wage Order 5 is valid and that healthcare employees may waive one of their two required meal periods on shifts longer than 8 hours ...
Few areas of law have proven more dynamic over the last few years than the interplay between state tort laws and the federal regulation of pharmaceutical drugs and medical devices. During its last two terms, the United States Supreme Court has issued three separate opinions addressing federal preemption of state law claims under the Federal Food, Drug, and Cosmetic Act ...
The Patient Protection and Affordable Care Act ("ACA") has significantly changed the healthcare industry in the United States. Among the many changes is the new requirement that healthcare providers must provide all "Food and Drug Administration approved contraceptive methods, sterilization procedures, and patient education counseling for all women with reproductive capacity."77 Fed. Reg. 8725 (Feb. 15, 2012); see 42 U.S.C. 300gg-13(a)(4), 45 C.F.R. § 147.130(a)(1)(iv) ...
The Treasury Department has announced further extensions for medium-sized and large-sized employers for compliance with the “employer mandate” of the Affordable Care Act (“ACA”). The employer mandate requires employers with a threshold level of employees to provide affordable health insurance to 95% of their full-time employees. Under the ACA, a full-time employee is defined as any employee who works on average 30 or more hours per week ...
In our previous articles (part one, part two and part three), we discussed ways in which trademarks are maintained and protected through filings that are mandatory and which filings would result in abandonment or cancellation if not timely submitted. There are also optional filings a trademark owner can take advantage of to optimize and secure its rights under a U.S. trademark registration. An Affidavit of Incontestability Under Section 15 is one such method ...
The September 23, 2013 deadline for covered entities, business associates and their subcontractors to implement the new HIPAA rules is approaching quickly. In case you missed it, on January 25, 2013, the U.S. Department of Health and Human Services issued an omnibus final rule modifying the Health Insurance Portability and Accountability Act of 1996 ...
by Eric E. Kinder President Bush signed the ADA Amendments Act into law. The ADAAA significantly increases the scope of the Americans with Disabilities Act of 1990 as it has been interpreted by federal courts by overturning several United States Supreme Court decisions regarding the Act. According to the Congressional Committees that oversaw the passage of the ADAAA, these amendments will restore the original Congressional intent behind the ADA ...
