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 ...
The implementation of the Building Safety Act 2022 (‘the Act’), aimed to reform building safety legislation following the Grenfell Tower fire in 2017, is now well underway. The requirements set out in the Act will affect everyone in the built environment industry, and not just in respect of higher-risk buildings ...
Once again, the grocery sector is coming under the spotlight. At a time when the UK’s inflation rate has started to slow a little, it still remains in double-digits with food prices rising to their highest since 1977[1]. Continual increases in grocery prices are undoubtedly a huge concern for consumers, as considerable amounts of the average household’s monthly income goes on food ...
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 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 ...
The MFSA published a Consultation Document on proposed amendments to the Insurance Business Act (hereinafter referred to as the “IBA”) and the Insurance Distribution Act (hereinafter referred to as the “IDA”) on the 22nd of February. The MFSA also made available the draft legislation, as well as a podcast laying down the proposed amendments ...
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 ...
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 ...
U.S. businesses should take note of the enhanced benefits now available to companies that self-disclose misconduct or otherwise cooperate with the U.S. Department of Justice (DOJ) under the DOJ Criminal Division’s new Corporate Enforcement Policy.[1] The policy, as revised, governs not only the DOJ’s handling of matters under the Foreign Corrupt Practices Act (FCPA),[2] but also the DOJ’s handling of matters under other federal criminal statutes as well ...
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 ...
Introduction Recent years have seen the UAE making regular updates to its laws in order to guarantee a legal regime that is forward-looking, and consistent with international standards and principles. The leaders of the UAE have been particularly cognizant of the need to have a robust criminal law regime to encourage legitimacy in business, and dissuade any unscrupulous activities that could reflect negatively on the UAE as a determined and fast-developing economy ...
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 ...
In the past week, there were several important updates made to the Federal Acquisition Regulations (FAR) by the Department of Defense (DoD), General Services Administration (GSA), and the National Aeronautics and Space Administration (NASA) ...
In the past week, there were several important updates made to the Federal Acquisition Regulations by the Department of Defense (DoD), General Services Administration (GSA), and the National Aeronautics and Space Administration (NASA) ...
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 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 ...
The Digital Markets Act (DMA) – which is underpinned by competition law - allows access to third parties to data previously held only by ‘Gatekeepers’, namely, large digital platforms, such as Google or Facebook ...
