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Shoosmiths LLP | December 2021

Part 1 of this insight focused some of the current immigration routes for consideration by Scottish employers to mitigate the Scottish labour shortage. Part 2 of this insight explores some of the new routes expected to be opened up by Spring 2022. Innovation visas Global Business Mobility Route In spring 2022, the Home office is due to launch the new Global Business Mobility route ...

Schwabe, Williamson & Wyatt | December 2021

AstraZeneca AB v. Mylan Pharmaceuticals Inc., Appeal No. 2021-1729 (Fed. Cir. Dec. 8, 2021) Our Case of the Week again focuses on numerical values in claims. Last week we addressed a case involving whether there was written description support for a number in a claim, and we addressed a similar issue the week before. This week, our case focuses on the meaning and scope of a number in a claim ...

Shoosmiths LLP | December 2021

Since the UK left the European Union, new rules have come into force surrounding the travel of pets. This article outlines the current position on bringing cats, dogs and ferrets into England, Scotland and Wales. Prior to Brexit, UK pet owners could travel freely with their cats and dogs between EU countries, provided their pet was microchipped and also had a pet passport ...

Shoosmiths LLP | December 2021

On 12 May 2021, Prime Minister Boris Johnson committed to holding a Public Inquiry into COVID-19 that will place "the state's actions under the microscope". Demonstrating that it is independent, objective and fair is fundamental to an Inquiry’s purpose. We take a look at the extent to which the State can effectively examine itself in a Public Inquiry when it has ultimate responsibility for determining the remit, and therefore inevitably the scope of any conclusions ...

Dinsmore & Shohl LLP | December 2021

On Nov. 30, 2021, the U.S. Supreme Court heard oral arguments from a coalition of hospital plaintiffs who are challenging Medicare’s nearly 30% reduction in outpatient drug reimbursement rates for 340B Program-participating hospitals ...

Schwabe, Williamson & Wyatt | December 2021

Biogen International GMBH v. Mylan Pharmaceuticals Inc., Appeal No. 2020-1933 (Fed. Cir. Nov. 30, 2021) For the second time in two weeks, our Case of the Week focuses on the written description requirement, in particular where the patent claims a range.  In fact, all three precedential decisions issued this week concern issues relating to patents that claim numerical ranges.  Below, we discuss two of those cases in our “Also This Week” section ...

Tennessee healthcare providers now have a very different certificate of need (CON) law to consider when they plan new facilities or expand services. Tennessee's legislature and governor recently enacted the Health Services and Planning Act of 2021 (Public Chapter 557 or "the Act"), which became fully effective Oct. 1, 2021. The Act changes the substantive requirements for CON approval, as well as the application process to obtain a CON ...

Hunton Andrews Kurth LLP | November 2021

phttps://www.huntonak.com/en/insights/medical-timeshares-require-more-than-what-you-learned-in-kindergarten-american-health-law-association ...

Hanson Bridgett LLP | November 2021

On October 6, 2021, Governor Gavin Newsom signed Assembly Bill 45 (AB 45) into law. AB 45 permits the manufacture and sale of a wide range of products containing regulated amounts of industrial hemp. Below is a brief overview: What is industrial hemp? “Industrial hemp” is defined as cannabis plants that have no more than 0.3% tetrahydrocannabinol (THC) ...

Simonsen Vogt Wiig AS | November 2021

The Norwegian government, as owners of the frigate, has held the owners of the tanker liable for the collision and presented a claim of some NOK 13 billion for the loss of the frigate and an additional NOK 770 million for costs related to removing the wreck. Liability is disputed and is due to be adjudged next year. Simonsen Vogt Wiig acts for the owners of the Sola TS ...

Simonsen Vogt Wiig AS | November 2021

The dispute relates to MV «Cheshire» incident in 2017, where a cargo of 42,000 metric tons of fertiliser was subject to a major decomposition incident off Gran Canaria, during a voyage from Norway to Thailand. The fertiliser was completely damaged and the vessel was declared a total loss. The cargo owners held the ship owners jointly liable for the cargo damage. Bibby Transport Ltd and a number of H&M insurers held the fertiliser producer liable for the damaged vessel ...

Dinsmore & Shohl LLP | November 2021

On Nov. 17, 2021, the United States Drug Enforcement Administration (DEA) released an advanced notice of proposed rulemaking (the Notice) concerning its potential development of telepharmacy regulations ...

Dinsmore & Shohl LLP | November 2021

On Oct. 19, 2021, the U.S. Food and Drug Administration (FDA) issued a proposed rule that would establish a new category of over-the-counter (OTC) hearing aids. The rule came in response to President Joe Biden’s July 9 executive order, which among other things, calls for wide availability of low-cost hearing aids in order to promote economic competition ...

Dinsmore & Shohl LLP | November 2021

In order to continue addressing the impacts of COVID-19 on nursing home residents, the Centers for Medicare & Medicaid Services (CMS) recently issued a memo updating guidance for nursing home visitation. You can read the full memo here. Early in the pandemic, CMS implemented visitation restrictions to mitigate the risk of visitors introducing COVID-19 to nursing homes. Now, CMS is updating its guidance and allowing visitation for residents at all times ...

Schwabe, Williamson & Wyatt | November 2021

Those of you working in the transportation, ports, and maritime industry have a lot to look forward to as America’s roads, railways, ports, and other transportation infrastructure are expected to see improvements now that Congress passed the $1.2 trillion Infrastructure Investment and Jobs Act, H.R. 3684 ...

Dinsmore & Shohl LLP | November 2021

On Nov. 8, 2021, the U.S. Department of Health & Human Services Office of the Inspector General (OIG) updated and renamed its Provider Self-Disclosure Protocol. Now called the Health Care Fraud Self-Disclosure Protocol (SDP), the OIG’s revisions are the first changes to the SDP since 2013. We report on the key elements of these changes below ...

Schwabe, Williamson & Wyatt | November 2021

University of Strathclyde v. Clear-Vu Lighting LLC, Appeal No. 2021-2243 (Fed. Cir. Nov. 4, 2021) In this week’s Case of the Week, the Federal Circuit reversed an inter partes review decision finding claims directed to light-based disinfecting methods to be obvious over the prior art.  This case provides a helpful example of how negative claim limitations can affect an obviousness determination ...

Dinsmore & Shohl LLP | November 2021

On Nov. 4, 2021, the Centers for Medicare and Medicaid (CMS) released a new Interim Final Rule (IFR) regarding staff vaccination at facilities that participate in the Medicare and Medicaid programs. The IFR requires covered employers to ensure that staff receive their first dose no later than Dec. 5, 2021 and achieve full vaccination no later than Jan. 4, 2022. The vaccine rule that was also released on Nov ...

Shoosmiths LLP | November 2021

In association with Macmillan Davies and led by Employment Partner, Emma Morgan and Associate, Lauren Bholé, this webinar focused on the menopause in the workplace. With World Menopause Day having just passed (18 October 2021) and a parliamentary debate on the menopause having entered the House of Commons in September 2021, the menopause has been a focal point for media coverage ...

OSHA’s long-anticipated (as we have previously discussed) COVID-19 Emergency Temporary Standard ("ETS") is out and, as promised, it will require companies with at least 100 employees – across all facilities – to either institute a vaccine mandate or compel unvaccinated employees to submit to weekly testing and workplace masking for at least the next six months ...

Some West Virginia businesses have implemented COVID-19 vaccine mandates for employees. While the West Virginia COVID-19 Jobs Protection Act (W. Va. Code § 55-19-1 through § 55-19-9) protects people, businesses, and entities from some COVID-19 related claims, the Act does not address whether employees who suffer an injury from a COVID-19 vaccine mandated by their employers may bring a workers' compensation claim ...

On Monday, November 1, 2021, CNBC reported the Office of Management and Budget ("OMB") completed its review of OSHA's Emergency Temporary Standard ("ETS") that will require larger employers to either adopt a policy for mandatory employee vaccinations or an alternative allowing weekly testing and masking for all unvaccinated employees. OMB approval of the ETS is the last step prior to finalizing the rule and its publication in the Federal Register ...

Carey | November 2021

On October 29, 2021, the following resolutions were published in the Official Gazette: Exempt Resolution No. 1,080 of the Undersecretary of Public Health amending Exempt Resolution No. 994, of 2021, of the Ministry of Health, which establishes the fourth Step-by-Step Plan; and Exempt Resolution No. 1,079 of the Undersecretary of Public Health, which amends Exempt Resolution No. 672, of 2021, of the Ministry of Health, which establishes the Protected Borders Plan ...

Dinsmore & Shohl LLP | October 2021

About a year ago, on Nov. 20, 2020, the Department of Health and Human Services Office of Inspector General and the Centers for Medicare and Medicaid Services (CMS) issued two final rules implementing sweeping changes to the Physician Self-Referral Law (Stark Law) and the Anti-Kickback Statute regulations. For the most part, those new rules went into effect on Jan. 19, 2021 ...

Shoosmiths LLP | October 2021

Freeports are obviously of immediate interest to importers, exporters, and manufacturers, as they allow the import of materials and manufacture or incorporation of those materials into items which are then exported, all without incurring tariffs and with minimal regulation. The government’s stated objectives in establishing Freeports were to establish national hubs for global trade and investment across the UK, promote regeneration and job creation and create hotbeds for innovation ...

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