Novartis Pharmaceuticals Corporation v. Accord Healthcare, Inc., Appeal No. 2021-1070 (Fed. Cir. Jan. 3, 2022) In this week’s Case of the Week, the Federal Circuit affirmed a district court’s bench trial finding that claims of a pharmaceutical patent were supported by adequate written description under 35 U.S.C. § 112(a) ...
On Dec. 22, 2021, Ohio Governor Mike DeWine signed “Esther’s Law,” allowing long-term care residents to install and use video cameras and recording devices in their rooms. The law is named for Esther “Mitzi” Piskor, who was a victim of elder abuse at a nursing home in Cleveland. Esther’s Law is intended to combat elder abuse and neglect and will likely lead to increased enforcement actions against Ohio nursing homes and long-term care facilities ...
The Fit for 55-package To achieve EU’s Paris climate goals, the EU Commission presented in December 2019 the European Green Deal, including a commitment to reduce greenhouse gas emissions by at least 55% by 2030 (compared to 1990 levels) and become carbon neutral by 2050 ...
Media DNS-blocking of gaming sites proposal The Ministry of Culture submitted a proposal on 21 September 2021, which seeks to give the Norwegian Gambling Authority cause to force ISPs to enforce DNS blocking of unlicensed gaming sites that market their services to Norwegian players ...
Although the deadline for “incurring” CARES Act funds has passed, Alaska Native Corporations can still use CARES Act funds to pay for administrative and compliance related expenditures in 2022, including staff time spent administrating programs and CARES Act expenses incurred by December 31, 2022. According to U.S ...
With yet another recent uptick in COVID-19 cases, the need for additional health care practitioners in the state of Ohio continues to grow. Recognizing that this shortage will not be resolved in the near future, the Ohio General Assembly has eliminated another barrier for physicians with a prior history involving a substance use disorder to seek licensure in Ohio ...
The transaction pace and volume of 2021 was the silver lining of the Covid-19 overcast, keeping our clients and us busy and productive. Particularly the container ship market has been steaming hot, with rapidly increasing prices and high transaction volume. The bulker market has also seen the highest prices for the last decade, with correspondingly high transaction volume ...
As we get ready to turn the page to 2022, one hesitates to continue to discuss the COVID-19 pandemic. However, the fallout continues, with fresh ramifications for the long-term care industry. The industry continues to receive heightened scrutiny following the pandemic, and New York's legislative answer to the concerns are set to hit nursing home businesses in New York as of Jan. 1, 2022, with a cap on allowable profits. The impact on capital outlays and acquisitions remains to be seen ...
On Dec. 14, 2021, the Centers for Medicare and Medicaid Services (CMS) unexpectedly issued a letter to U.S. Senator Ron Widen (D-OR)[1] indicating that CMS plans to use its “administrative authority to issue proposed rulemaking” addressing price concessions and direct and indirect remuneration (DIR) fees that pharmacy benefit managers (PBMs) have increasingly charged to specialty and retail pharmacy providers in Medicare and other pharmacy benefit programs in recent years ...
Prior to the onset of the COVID-19 pandemic, the use of telehealth across Ohio and the United States was steadily increasing. However, out of necessity over the last two years, telehealth has expanded exponentially in order to reduce risks of COVID-19 transmission to practitioners and patients alike. Nearly overnight, the health care community was forced to change the way services were accessed, delivered, and received ...
On Dec. 21, 2021, the Office of Inspector General (OIG) released a Health & Human Services (HHS) OIG Data Brief on genetic tests provided under Medicare Part B. The goal of the OIG in reviewing this data was “to analyze nationwide trends in genetic tests provided and payments made under Medicare Part B.”[1] As a result of this analysis, the OIG determined that there is a significant risk of overuse and misuse of genetic testing ...
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 ...
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 ...
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 ...
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 ...
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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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) ...
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 ...
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 ...
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 ...
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 ...
