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Practice Industry: Crossborder Trade & Investment, Healthcare & Pharmaceuticals, Life Sciences
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Deacons | August 2005

The Taiwan Financial Supervisory Commission ("FSC") on 2 August 2005 promulgated new rules governing the offering of overseas funds in Taiwan ("the New Rules"). The New Rules take immediate effect and significantly change the existing rules and landscape for overseas funds being offered in Taiwan ...

Deacons | August 2021

Did you know? At the end of last year, US Customers and Border Protection officers seized around US$1.3 million worth in China counterfeit toys at the Port of New York and New Jersey. The seizure included more than 141,000 counterfeit UNO card games, 9,600 "LOL Surprise! Under Wraps” balls and almost 2000 “LOL Surprise!” capsule toys ...

A&L Goodbody LLP | February 2005

Introduction Advocate General Jacobs, in delivering his Opinion in Syfait and others v Glaxosmithkline (Case C-53/03, 28 October 2004), has found in favour of Glaxosmithkline (GSK) by stating that the refusal by a dominant pharmaceutical company to fulfil all orders from wholesalers does not automatically constitute an abuse of a dominant position, despite such refusal clearly limiting parallel trade of the products in question ...

The Philippine Government has issued a slew of resolutions and circulars as part of its response to the COVID 19 pandemic and unsurprisingly, a number of legal and practical issues have beset businesses and persons under the Luzon-wide enhanced community quarantine (ECQ)1. Like the rest of the world, the country is bracing itself for a new normal – in the way enterprises are run, services are rendered, everyday tasks are undertaken ...

Covid-19 is upending capitalism as we know it. Amid the pandemic, how can businesses rewrite their rule books so as to emerge stronger? Americans have allegedly outbid the French for masks “right on the tarmac” just as the goods were to be flown off to their destination. From Amazon to Rakuten to Carousell, traders exploited fears by price-gouging on masks and hand sanitisers ...

Shoosmiths LLP | June 2021

More recently, many more people are using fertility treatment to conceive; particularly same sex couples, single women and surrogates (Human Fertilisation and Embryology Authority data). This echoes a societal shift in so far as relationships, the formation of families and lifestyles are concerned. As such, there needs to be more emphasis on the development and evolution of the law and sector generally ...

On May 16, 2022, the Colorado Supreme Court issued an opinion that serves as a cautionary tale for health care providers hoping to bill patients at chargemaster rates. The court’s decision in French v. Centura Health turned on the meaning of the phrase “all charges of the Hospital,” as set forth in the hospital service agreement (HSA) signed by Ms. French. Centura argued that the phrase “unambiguously refers to a hospital’s chargemaster rates.” Ms ...

Dykema | June 2022

Hidden among its flurry of end-of-term blockbusters, on June 27, 2022, the U.S. Supreme Court issued a long-awaited opinion inRuan v. United States. InRuan,the Supreme Court addressed the issue of whatmens reaa physician must possess to be guilty of illegally distributing controlled substances through the use of allegedly improper prescriptions ...

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 ...

Dinsmore & Shohl LLP | July 2023

A month after nixing the “objectively reasonable interpretation” (Safeco) defense under the False Claims Act, the Supreme Court has vacated and remanded two other cases for further consideration of the defendant’s subjective state of mind when it filed payment claims with the government. The Fourth Circuit in Sheldon and the Eleventh Circuit in Olhausen will provide the first tests of the High Court’s newly minted FCA intent standard ...

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 ...

Dinsmore & Shohl LLP | June 2024

In a unanimous decision today, the Supreme Court rejected efforts to limit access to the abortion pill mifepristone, overturning an earlier decision by the 5th Circuit Court of Appeals. The Supreme Court ruled that the physicians and medical associations who brought the case did not have the right to challenge the FDA's regulation of the drug. To have standing, plaintiffs must show they have a “personal stake” in the case ...

Makarim & Taira S. | May 2012

The Supreme Court has struck down the core provisions of the Trade Minister Regulation which allowed producers to import finished goods (No. 39/M-DAG/PER/10/2010). The regulation will cease to have legal effect as of 8 May 2012. The Ministry of Trade is reported to be currently considering an amendment which aims to accommodate the interests of both producers and traders but may have to draw it more narrowly than the original version. Decision No ...

ALRUD Law Firm | February 2024

The Supreme Court has considered the Westwalk case and ruled that foreign companies can be legally recognized as bankrupt if there is a "close connection" with Russia. Bankruptcy of foreigners was first commenced in 2016, but for a long was applied only to individuals1. The Arbitrazh Court of the Chelyabinsk Region opened Pandora's box in 2022 with respect to a company from the island of Nevis, which was only formally registered there ...

Haynes and Boone, LLP | March 2016

The FDA’s Proposals on the Revision of the Nutrition and Supplement Facts Labels In early 2014, first lady Michelle Obama announced upcoming changes to the FDA’s Nutrition Facts label, and in March 2014, the FDA issued a proposed rule on the revision of Nutrition and Supplement Facts labels “to assist consumers in maintaining healthy dietary practices ...

Shoosmiths LLP | November 2023

This week marks National Fertility Awareness Week in the UK. This annual event, organised by Fertility Network UK, a national charity dedicated to supporting individuals on their fertility journeys, aims to change perceptions and raise awareness for those undergoing fertility treatment. The theme for this year is "Forward4Fertility," emphasising progress and inclusivity in the journey towards parenthood. The staggering fact that over 3 ...

Dinsmore & Shohl LLP | October 2018

In a rare bipartisan and bicameral compromise, Congress has passed the “Substance Use–Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act,” shortened to the “SUPPORT Act.” The bill was signed by President Trump on October 24, 2018 ...

Schwabe, Williamson & Wyatt | December 2022

As previously discussed, the federal district court deciding Christian Bruckner’s lawsuit to enjoin the Infrastructure Investment and Jobs Act’s set-aside of 10% (around $37 billion) of transportation funding for “small business concerns” owned and controlled by “socially and economically disadvantaged individuals” issued an order directing (1) the parties to submit supplemental briefing describing the “administrative and implementation of the DBE p

Schwabe, Williamson & Wyatt | September 2021

Summary On September 9, 2021, President Biden issued his Executive Order on Ensuring Adequate COVID Safety Protocols for Federal Contractors (the “Executive Order”) that, when implemented, will require most federal contractors to comply with all guidance for federal contractor and subcontractor workplace locations published by the Safer Federal Workforce Task Force (see www.saferfederalworkforce.gov) ...

Dinsmore & Shohl LLP | March 2020

In the early hours of Saturday, March 14, 2020, the United States House of Representatives passed the Families First Coronavirus Response Act (FFCRA), which is designed to expand relief in response to the COVID-19 outbreak, through access to free testing, enhancing food assistance, increasing Medicaid funding, and providing paid sick leave and unemployment benefits to workers ...

Hanson Bridgett LLP | April 2019

In a recent case involving a health care facility, the NLRB issued a 3-1 decision that significantly changed a successor employer's bargaining obligations before imposing the initial terms and conditions of employment on a unionized workforce. While seemingly favorable to employers, the decision also serves as a reminder to companies that they should act cautiously and consult with counsel before they take over a business with a unionized workforce ...

A&L Goodbody LLP | November 2017

 Last month, the UK Financial Conduct Authority (FCA) published its "Regulatory Sandbox – Lessons Learned Report". In the Report, the FCA evaluated the progress of the UK financial regulatory sandbox during its first year of operation and tentatively concluded that the initiative has so far been a success ...

PLMJ | August 2022

Proposal for a regulation of the European Parliament and of the Council on standards of quality and safety Current regulatory framework and scope of application The EU regulatory framework on substances of human origin (“SoHO”) is reflected in Directives 2002/98/EC for blood and 2004/23/EC for tissues and cells ...

Dinsmore & Shohl LLP | July 2021

Dinsmore's Chris Cashen, Anne Guillory, Chris Jackson, and Kyle Bunnell were published in dri Strictly Speaking, Vol. 18 Issue 1. Their article, "States’ COVID-19 Immunity Statutes and Product Liability Claims Related to COVID-19," examines states’ COVID-19 immunity statutes for product designers, manufacturers, and distributors concerning COVID-19-related lawsuits. An excerpt is below ...

A minority of states have enacted statutes and taken other action to protect business owners from claims by persons who allegedly were infected by COVID-19 on their premises.1 The purpose of this article is to compare these statutes and discuss some of the differences between them. This article addresses statutes in effect as of October 27, 2020. The article does not address pending legislation ...

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