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 ...
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”) ...
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 ...
Over the past few weeks, the investigation of sexual misconduct cases by the State Medical Board of Ohio (“Board”) has continued to make headlines across Ohio. Due to an increased public outcry as a result of the recent media attention, as well as the previous revelations of the Board’s handling of the Dr ...
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 ...
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 ...
On the occasion of Children’s Day on January 12, 2023, Kudun and Partners launched an internal donation drive on January 12 to rally firm members to support children’s centers in Bangkok and Hat Yai. The donation drive was initiated as part of the firm’s continuous aspiration to contribute back the society ...
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 ...
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.. ...
On February 14 of this year, the Public Health Institute ("ISP") approved -by means of Ex. Res. No. 369/2023- a new guideline regarding the performance of post-authorization safety studies of pharmaceutical products (the "Guideline") ...
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 ...
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 ...
Blowing a whistle remains the most effective means of being heard above the crowd and drawing attention to an issue. Speaking up can help charities to do their work even better. The relevance of whistleblowing to charities A private member’s bill is wending its way through Parliament at the moment, looking to establish an Office of the Whistleblower ...
On December 2, 2022, President Biden signed the Medical Marijuana and Cannabidiol Research Expansion Act (“Marijuana Research Act” or “Act”) into law. The Act aims to help facilitate research on marijuana, directs the Drug Enforcement Administration (DEA) to follow new procedures to register practitioners to conduct marijuana research, and improves the supply of marijuana for research ...
