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 ...
Green tech presents a growth area and one in which the UK could flourish, but to do so requires capital investment and a clear strategy alongside developing the necessary skillset of the UK workforce. So how realistic is this in the current climate? Experience to date would suggest that the UK is lagging behind other countries in this sector and that unless more is done, we will miss out on the opportunity green tech offers ...
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 ...
From television commercials to naming rights for arenas, the topic of cryptocurrency has been hard to avoid. While cryptocurrency may be virtual, its creation or ’mining’ occurs in the real world. This mining poses a credit risk for utility companies, given the incredible amount of electricity required to operate a “mining” facility. For example, crypto mining company Core Scientific, Inc ...
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 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 ...
If the draft EU regulation on Artificial Intelligence (“AI”) titled ‘Proposal for a Regulation laying down harmonised rules on artificial intelligence’ (the “draft EU AI Act”) becomes law, investment funds could have an additional risk which would need consideration, namely, the AI risk ...
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 ...
The non-fungible token (NFT) boom among luxury fashion brands recently made headlines again with a highly publicised trial involving the French fashion brand Hermès and its iconic Birkin handbags in New York. The case involved a prominent figure in the world of NFTs, digital artist Mason Rothschild. NFTs are digital assets that are unique, verified, and securely stored on a blockchain (a type of decentralised public digital database) ...
This article discusses the recent Insight Paper on Web3 (“Paper”) which was published by the Digital Regulation Cooperation Forum (“DRCF”) on 3 February 2023. It explores the regulatory perspective on the future vision of the internet and what the next steps are for the regulators and interested stakeholders ...
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 ...
As a starting point, money in a bank account is nothing more than a contract with a promise to pay (the bank being the debtor/payer and the account holder the creditor/payee); it is a claim against the bank (an IOU issued by the bank, Norwegian: enkelt krav) held by the account holder ...
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 ...
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 ...
The registered fund regime offers a significantly faster approval process than that of authorised funds (other than QIFs): three days for RCIS Funds and one day for PIFs, relying in each case upon increased due diligence obligations on the part of the fund’s administrator ...
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 ...
17 February, 2023, marks the deadline for providers of online platforms to publish information on the average monthly active recipients of their services in the European Union (EU), as required by the Digital Services Act (Regulation (EU) 2022/2065) (DSA). The DSA defines online platforms as providers of hosting services that publicly disseminate users’ information ...
