On 17 May 2023, the Belgian Medicines Agency (FAMHP) announced that marketing authorisation holders (MAHs) have three years to comply with the prohibition of “negative formulations” on the packaging of medicinal products for human use. Such negative formulations include “gluten-free”, “lactose-free”, “ethanol-free” or “no colourings” ...
The President of the Russian Federation instructed the Government to consider the opportunity of granting clearance for the sale of Russian legal entities controlled by “unfriendly” entities only with the consent of senior officials of the Russian regions where such entities are located. The Government should issue a report on this matter by June 15, 2023 ...
Business reorganization is a commonly utilized strategy to enhance efficiency and reduce costs within a business. Reorganization not only impacts corporate changes, but also has an effect on labour relations, which can pose certain risks. We have summarized the key labour issues that illustrate the red flags associated with corporate transactions, along with practical issues that should be taken into consideration. More details here ...
The SEC has published its final rule for the modernization of share repurchase disclosures. The final rule will require additional details of an issuer’s share repurchase activity. Unlike the previous requirements for share repurchase reporting, the final rule will require daily repurchase data, reported either quarterly or semi-annually, and eliminates the previous requirement for the publication of an issuer’s repurchase data by month in its 10-Qs and 10-Ks ...
No-fault attendance policies may be on a watchlist for the U.S. Equal Employment Opportunity Commission. A recent matter before the U.S. Court of Appeals for the Eleventh Circuit, EEOC v. Eberspaecher North America Inc., suggests that the EEOC is interested in how those policies work. It seems the EEOC wants to determine if such policies potentially violate the Americans with Disabilities Act, and the agency may want to pursue that interest on a national scale ...
In an opinion issued on June 5, 2023, the Federal Circuit provided a useful framework for overcoming obviousness rejections during patent prosecution, where a proposed modification to a prior art reference renders it unsatisfactory for its intended purpose.[1] Appropriately applying this framework may provide a strong position against a motivation to combine references, or otherwise modify a prior art device in an obviousness rejection. In Medtronic, Inc. v. Teleflex Innovations S.A.R.L ...
Overview On 22 February 2023, the Ministry of Commerce (“MOC”) issued a new regulation on the Forms and Procedures for Issuance of Temporary Suspension Measures and/or Decisions by the Cambodia Competition Commission (“CCC”) to strengthen the enforcement of the Law on Competition (“Competition Law”) in Cambodia ...
The pensions dashboards connection deadline will be pushed back to 31 October 2026 under the Pensions Dashboards (Amendment) Regulations 2023 which were laid before Parliament on 8 June 2023. The new regulations follow Pensions Minister Laura Trott’s 2 March announcement that the Pensions Dashboard Programme (PDP), the body responsible for delivering the digital architecture which underpins pensions dashboards, was to be reset ...
The British Standards Institution (BSI) has released a new workplace standard relating to menstruation and menopause. The BSI standard (BS 30416) aims to support the health and well-being of all employees who menstruate or experience peri/menopause. The standard suggests that there are many actions that employers can take to improve the accommodation of all its employees ...
What do a squeak toy, whiskey, and dog poop have in common? If you are silently thinking to yourself “absolutely nothing,” it may surprise you to hear that the U.S. Supreme Court has spent months considering this question. On June 8, 2023, in a long-awaited win for trademark owners, SCOTUS ruled that a lower court erred when it issued a decision finding that a dog toy that parodies a famous liquor bottle, was covered by First Amendment free speech protections ...
When the Supreme Court in 2020 issued its decision in Liu v. SEC, placing limits upon the Securities and Exchange Commission's ability to obtain disgorgement, many observers believed that the decision would significantly diminish the SEC's capability to seek and obtain significant disgorgement recoveries in civil enforcement actions alleging violations of the securities laws ...
On May 31, 2023, the Centers for Medicare & Medicaid Services (“CMS”) released a Final Rule (the “Final Rule”) that withdraws the mandatory vaccination requirement for employees of CMS-certified healthcare facilities, which includes hospitals, critical access hospitals, long term care facilities, home health agencies, hospices, and ambulatory surgical centers ...
In May, the Supreme Court of the United States handed down its decision in Amgen Inc. v. Sanofi, which addressed the statutory enablement requirement for patents. The decision is consistent with ongoing efforts to strike a balance between innovation and competition, while preventing the extension of monopolies beyond the invention disclosure ...
June 5, 2023 By: Joshua Robbins and Stephanie Shea While we wait for the U.S. Supreme Court to decide the fate of the Chevron doctrine governing courts’ deference to agencies’ interpretations of law, its recent decision in another case has flown under the radar. In Calcutt, III v. FDIC, 598 U.S ...
On June 1, 2023, the United States Supreme Court issued an important decision addressing the intent element of the False Claims Act (“FCA”) in United States ex rel. Tracy Schutte v. SuperValu Inc. and United States ex rel. Thomas Proctor v. Safeway, Inc. The FCA imposes liability on anyone who “knowingly” submits a false claim to the federal government and defines “knowingly” to include actual knowledge, deliberate ignorance, or recklessness ...
On 16 March 2023, in Joined Cases C‑438/21P to C‑440/21P, the Court of Justice of the European Union (CJEU) interpreted the concept of a ‘global marketing authorisation’. It held that Article 6(1) of Directive 2001/83 (the Community Code) sets out exhaustively the line extensions for which the marketing authorisations (MAs) will fall under the same global MA as the initial MA ...
On June 1, 2023, China's Ministry of Science and Technology ("MOST") officially released the Implementation Rules for the Regulation of Human Genetic Resources Administration ("Implementation Rules"), which will come into effect on July 1, 2023 ...
On May 30, 2023, National Labor Relations Board (“NLRB”) General Counsel Jennifer Abruzzo took yet another step to ban restrictive covenants in the employment context. In a memo issued to all regional offices, she set forth her view that nearly all non-compete provisions, with very limited exceptions, violate the National Labor Relations Act (“NLRA”) ...
May 31, 2023 By: Stephanie Shea The California Unruh Act (specifically, California Civil Code § 51) prohibits “all business establishments of every kind whatsoever” from discriminating based on citizenship or immigration status, among other things. That protection applies to all persons within the jurisdiction of California. At the federal level, (simply put,) the federal civil rights statute (specifically, 42 U.S.C. § 1981), prohibits alienage discrimination ...
May 31, 2023 By: Marissa Alkhazov Governor Jay Inslee signed HB 1047, Washington State’s Toxic-Free Cosmetic Act (the Act) into law on May 15, 2023. The Act bans some of the most concerning chemicals added into cosmetic and personal care products, including PFAS, phthalates, formaldehyde and formaldehyde releasing agents ...
On 7 April 2023, the Belgian Cour de Cassation reversed its long standing case law and decided that (from now on) disputes concerning the termination of exclusive distribution agreements are eligible to be settled by arbitration. 1. The legal background The Belgian Economic Code (previously known as the 1961 Distributorship Act – the “Act”) provides special protection against the unwarranted termination of an exclusive distribution agreement ...
May 24, 2023 By: Peter McGaw When Potentially Responsible Parties (PRPs) settle CERCLA cases, they want finality. They don't expect to be asked to pay a second time for a claim they have already resolved by settlement. However, a concurring opinion in a recent Ninth Circuit decision casts doubt on the ability of a PRP to achieve finality through settlement. The Ninth Circuit’s decision in GP Vincent II v Beard was issued on May 17, 2023 ...
