Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC, Appeal No. 2023-1186 (Fed. Cir. Feb. 24, 2023) In this week’s Case of the Week, the Federal Circuit affirmed a permanent injunction requiring appellant Jazz Pharmaceuticals to de-list its U.S. Patent No. 8,731,963 from the Food and Drug Administration’s (FDA) Approved Drug Products with Therapeutic Equivalents Evaluation publication, colloquially known as the “Orange Book ...
The System for Award Management (SAM.gov) is an official website of the U.S. government that federal contractors must use to register to do business with the federal government, including updating and maintaining their entity registration and including representations and certifications regarding size, location, and socio-economic status. In order to maintain and update an entity’s SAM.gov registration, federal contractors assign Entity Administrator, Data Entry, or Viewer to individuals ...
As a new wave of book banning appears to be to be sweeping the nation, public school libraries are relying on a 1982 plurality opinion for guidance and coming up with more questions than answers ...
In 2018, second-term Governor Roy Cooper issued climate-related Executive Orders, which was followed in 2019 by the state’s clean energy plan ...
Federal infrastructure funding is coming to North Carolina and Pennsylvania! Recently, Transportation Secretary Pete Buttigieg announced an award of $1.2 billion in grants for nine projects around the country. This includes projects in North Carolina and Pennsylvania. The funding for these projects is coming from the new National Infrastructure Project Assistance (Mega) discretionary grant program ...
On 16 June 2022, the Vietnamese National Assembly officially approved the amended Intellectual Property Law (“Amended IP Law”). This marks the third time the Vietnamese IP Law has been amended and supplemented since its promulgation in 2005. Its latest update contains revisions and supplements more than 100 articles, marking the most expansive overhaul of this law to date ...
On 21 February 2023, Government published its much-anticipated response to its consultation on biodiversity net gain (BNG) regulations and implementation from January 2022 - Government response and summary of responses - GOV.UK (www.gov.uk) (“the Response”). This was accompanied by refreshed government guidance to developers and local authorities - Biodiversity net gain - GOV.UK (www.gov.uk) (“the Guidance”) ...
Construction continues to be one of the deadliest industries in the United States, and the Occupational Safety and Health Administration (“OSHA”) is heavily targeting construction workplaces. In 2022, OSHA inspected construction workplaces more than any other industry, and OSHA’s focus on construction employers is expected to continue this year ...
The Equal Employment Opportunity Commission (“EEOC”) plans to prioritize its efforts to correct discrimination and harassment in the construction industry following a review of data that revealed the construction sector to be one of the most challenging areas in terms of discrimination and harassment cases ...
On December 29, 2022, the Modernization of Cosmetics Regulation Act (“MoCRA”) was signed into law.[1] MoCRA is the first federal cosmetics law since 1938 and will impose a number of new requirements on cosmetic products and the facilities where they are manufactured. Specifically, MoCRA requires the Food and Drug Administration (FDA) to implement enhanced oversight and regulation of cosmetic manufacturing facilities and products by December 29, 2023 ...
The direct overseas offering and listing by domestic entities refers to the overseas offering and listing by joint-stock companies registered and incorporated domestically in China (the "Direct Overseas Listings"), which is currently one of the main ways for domestic entities to be listed overseas. Prior to the implementation of the New Filing Rules, the Direct Overseas Listings are subject to the examination and approval by both the CSRC and the overseas securities regulatory authorities ...
Due to changes to the migration law that took effect on 29 December 2021 and have been modified several times since then, ALRUD has updated the checklist below. This checklist will be useful for foreign nationals, company managers, HR directors, compliance officers, as well as heads of legal departments and other persons interested in or responsible for hiring foreign workers in Russia ...
In the latest report published in December 2022 by the Fraud Advisory Panel in conjunction with BDO LLP, 100 UK based charities were surveyed. 69% said that they had experienced financial loss due to fraud. 58% said they believed that the risk of fraud will increase over the next 12 months ...
On February 17, 2023, the New Filing Rules was released by the China Securities Regulatory Commission ("CSRC"), which will come into force on March 31, 2023. In the meantime, the Notice of the State Council on Further Strengthening the Administration of Overseas Stock Issuance and Listing (State Council Announcement [1997] No. 21) (the "97 Red Chip Guidelines") will be repealed on the effective date of the New Filing Rules ...
Lite-Netics, LLC v. Nu Tsai Capital LLC, Appeal No. 2023-1146 (Fed. Cir. Feb. 17, 2023) In an appeal from the U.S. District Court for the District of Nebraska, the Federal Circuit addressed whether the district court properly granted a preliminary injunction restricting Lite-Netics, LLC’s patent-related speech ...
Hydrogen's potential to support the UK’s journey to net-zero depends in large part on how carbon-intensive the hydrogen we produce is. One of the challenges this presents is transparency. Much like electrons in a wire look the same (whether generated from coal or from wind), a hydrogen molecule looks the same whether produced by electrolysis powered by renewables or from carbon-intensive steam methane reforming ...
It's the final countdown to the new Consumer Duty. After what feels like a lifetime of consultations, responses and commentary on the FCAs new Consumer Duty, the final countdown is upon us. With just over 5 months to go before the Consumer Duty comes into force, the big question is.. ...
The window for low-income service providers to take advantage of funds available through the Oregon Solar+ Storage Rebate Program is closing. Each year, 25 percent of the program’s budget is allocated to low-income and moderate-income homeowners and service providers. This year, the non-income-restricted funds have already been disbursed, and only low-income and moderate-income restricted funds remain ...
February 17, 2023 By: Alexander Davis and Manuel Fishman Update This article is partly a republication of a Client Alert that was issued on December 6, 2022 titled “San Francisco’s Commercial Vacancy Tax.” Readers who have already read the original article can simply read ahead to the sections labeled “Update.” Commercial Vacancy Tax In March 2020, the voters of San Francisco approved Proposition D, also known as the Commercial Vacancy Tax ...
1. The legislative regime In conjunction with the VASP Act, the FSC also published Guidance on the Application for Registration of a Virtual Assets Service Provider (the “VASP Registration Guidance”) (available to view here), and the Virtual Assets Service Providers Guide to the Prevention of Money Laundering, Terrorist Financing and Proliferation Financing (available to view here) ...
In some ways, the 2023 proxy season might be met with a sigh of relief as some extraneous factors impacting United States capital markets—such as the COVID-19 pandemic and ongoing Russo-Ukrainian conflict—have stabilized in terms of their increased effect. In that same vein, some changes that may have once been viewed as “trends” in disclosure are very much here to stay ...
The number of knife offences is going down but are still higher than at the start of the pandemic. Will the new Sentencing Guidelines for sales of knives to those younger than 18 (which come into effect on 1 April 2023) reduce the number further? Certainly, that would appear to be the intention of the Guidelines which significantly increase the potential consequences for retailers who break the law ...
