The SEC’s litigation against the largest digital asset exchanges in America has been unfolding for over a year, beginning with the agency suing various Binance entities in June 2023, followed by actions against Coinbase Inc./Coinbase…
Last month, multiple car dealerships and auto repair shops filed federal lawsuits against CDK Global LLC, a technology company providing software to the automotive, heavy truck, recreation, and heavy equipment industries, as a result of a…
On June 21, 2024, the US Department of the Treasury issued a Notice of Proposed Rulemaking (“Proposed Rule”) to implement Executive Order 14105 (“EO”) establishing a new Outbound Investment Program ("OIP") to prohibit or require…
Case Name: Amarin Pharma, Inc. v. Hikma Pharms. USA Inc., No. 2023-1169, 2024 WL 3152087 (Fed. Cir. June 25, 2024) (Circuit Judges Moore, Lourie, and Albright presiding; Opinion by Lourie, J.) (Appeal from D. Del., Andrews, J.) - Drug…
During this session, the panelists discussed how stakeholders in the clinical research market can leverage new technologies to better identify subjects, optimize trial conduct and reduce costs. For example, common use cases of artificial…
As implementation of the EU’s Digital Operational Resilience Act (DORA) approaches, financial market participants and their technology service providers (both in and out of Europe) face a critical compliance deadline. The new law will…
In 2023, we discussed the uptick in data privacy and cybersecurity class action lawsuits; as expected, this trend has persisted throughout 2024 as plaintiffs continue to test new theories of liability and the boundaries of constitutional…
On April 3, 2024, the United States Patent and Trademark Office (USPTO) issued a notice of rulemaking setting out the fees that it proposes for the fiscal year starting on September 29, 2024. Although the proposed fees are subject to…
The case of Amarin Pharma, Inc. and its affiliates versus Hikma Pharmaceuticals USA Inc. and Hikma Pharmaceuticals PLC presents a fascinating intersection of patent law, FDA regulatory strategy, and pharmaceutical marketing. Central to…
ollowing the approval and launch of Bitcoin Exchange Traded Funds (EFTs) in January 2024, the U.S. Securities and Exchange Commission (SEC) approved eight Ethereum ETFs for listing and trading on SEC-regulated exchanges on May 23, 2024.…
A recent Federal Circuit decision overturning the long-standing obviousness test for design patents could have wide-ranging implications for design patent owners. The en banc decision in LKQ Corp. et al v. GM Global Technology Operations…
Two years ago, Congress greatly expanded the authority of the U.S. Food and Drug Administration (FDA) by enacting the Modernization of Cosmetics Regulation Act (MoCRA). This Act requires companies to register each facility with the FDA…
On July 11, 2024, Senators Maria Cantwell (D-WA), Marsha Blackburn (R-TN), and Martin Heinrich (D-NM) introduced the Content Origin Protection and Integrity from Edited and Deepfaked Media Act (COPIED Act).... By: Mintz - ML Strategies
An invention disclosure form is a document used to capture detailed information about a new invention or discovery. The first step in the patent application process, the form plays a crucial role in protecting intellectual property. A well…
The American Chemistry Council (“ACC”) submitted a June 24th response to the United States Department of Energy’s (“DOE”) Request For Information (“RFI”) titled: Transforming Energy: Strategies for Decarbonization.... By: Mitchell,…
Bleeping Computer has reported that Rite Aid has disclosed a data breach affecting 2.2 million individuals. According to the report, Rite Aid stated in its filing with the Maine Attorney General that “We determined by June 17, 2024, that…
The USPTO provides new subject matter eligibility guidance, along with three new examples, specifically focused on inventions related to artificial intelligence. As part of its ongoing effort to provide education and training on the…
On July 11, the U.S. Environmental Protection Agency issued updated recommendations under the Clean Water Act for contaminants that states, Tribes, and territories should consider monitoring in locally caught, freshwater fish. For the…
The Digital Operational Resilience Act (DORA) regulation is part of the European Union’s (EU) strategy to enhance the overall stability of the EU financial system by ensuring that financial entities are resilient to digital operational…
In an era defined by rapid digital transformation and heightened concerns over personal data security, the landscape of consumer data privacy laws in the United States has evolved significantly. As of this writing, a patchwork of eighteen …
The US Patent & Trademark Office (PTO) issued a request for comments concerning the public’s views on the common law experimental use exception and whether Congress should enact a statutory experimental use exception. 89 Fed. Reg. 53963 …
Given the heightened terrorism threat level, comparable to that of 9/11, and the recent assassination attempt on former President Trump, it’s crucial for corporate security to prioritize comprehensive preparedness for all potential threats…
The U.S. Department of Defense (DoD) has been focused on AI and recently integrated its AI strategy with its data strategy. The announcement by DoD's Chief Digital and AI Officer regarding the testing of commercial AI prototypes appears to…
The U.S. Department of the Treasury (“Treasury”) issued a Notice of Proposed Rulemaking (“NPRM”) to implement Executive Order 14105 (“EO 14105”) “Addressing United States Investments in Certain National Security Technologies and Products…
What is digital accessibility? At its core, digital accessibility aims to ensure that digital products and services are accessible to all, including those who experience physical, hearing, vision, speech or physical disabilities. Whether…
On June 25, 2024, the Ocean State dove into the growing sea of state consumer data privacy laws with the Rhode Island Data Transparency and Privacy Protection Act (RIDPA), becoming the 19th state to pass a comprehensive privacy law. While…
The number of virtual currency types has added to this problem. According to TIGTA, the number of virtual currencies has grown significantly since April 2020, from 5,000 to over 26,000 (420 percent) as of July 2023. The two most dominant…
The emergence of generative artificial intelligence (AI) is driving a surge in demand for power-hungry data centre capacity in Europe. This demand faces a number of obstacles including grid capacity constraints and an energy mix that is…
On July 17, 2024, the Federal Communications Commission (FCC or Commission) released a draft Notice of Proposed Rulemaking (draft NPRM) that would, among other things, propose new rules to regulate AI-generated calls and texts and seek…
The California Privacy Protection Agency (“CPPA”) discussed at its July 16 meeting new enforcement focuses in addition to current goals. While the new focuses are largely in line with general trends, they also serve as a reminder that…