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 ...
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 ...
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 ...
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The Tourism Authority of Thailand (“TAT”) announced via the Royal Thai Government Gazette on 30 October 2021 that as of 1 November 2021, earlier COVID-19-related restrictions would be lifted in the case of four designated ‘Blue Zone’ provinces: Bangkok, Krabi, Phang-Nga, and Phuket ...
We are very excited to be supporting the UN Global Compact Network UK’s ‘Transitioning to a Net Zero’ webinar series ...
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) ...
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 ...
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 ...
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 ...
Following the government’s consultation on calorie labelling for food and drink served outside of the home in 2018, qualifying businesses in the out of home (OOH) sector will be required to display calorie information per portion from 6 April 2022. What is changing? Currently, businesses serving non-prepacked food and drink in the OOH sector are not required to provide calorie (energy) information ...
In Kabab-Ji SAL v Kout Food Group, the UK Supreme Court recently considered the question of which system of law the English courts must apply to decide whether there is an enforceable arbitration agreement. This case illustrates the different approaches taken in determining questions of applicable law and the consequences this can have for both annulment and enforcement proceedings in different countries ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
The high street will of course evolve according to prevailing consumer habits. That evolution has been brought into sharp focus by the pandemic, where retailers have had to adapt to the restrictions imposed on non-essential retail at certain times combined with the general growth of e-commerce. That said, the retail market in Guernsey compares well to the UK market and is seen as an attractive opportunity for retailers, both for well-known UK brands and local independents alike ...
Marks & Spencer breached a court order to enforce a “keep-open” provision in one of its leases, when it carried on business only in a “half-hearted” manner ...
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 ...
Author(s) Senior Partner, Nishant Menon and Associate, Nikhil Bhatia The Supreme Court of India on 6th August 2021 in Amazon.com NV Investment Holdings LLC v Future Retail Limited & Others handed down a seminal decision in relation to enforcement of an Emergency Arbitrator’s (“EA”) award. The ruling has great significance as it furthers India’s mission of being a pro-arbitration State where there is greater ease of doing business ...
