Listen to this conversation between Michael Volkov and Halyna Senyk in which they focus on Ukraine's anti-corruption efforts amidst the backdrop of its ongoing war with Russia. Halyna Senyk, an expert from the CEELI Institute, details…
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…
In a recently published Request for Information (RFI), the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) seeks public comment on options to potentially streamline and reduce the regulatory…
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…
Chairwoman Rosenworcel announced at the FCC’s July 16 open meeting that the Commission is considering adoption of a Notice of Proposed Rulemaking (“NPRM”) seeking comment on proposals to regulate AI-generated robocalls. The draft NPRM,…
Whether you run a business or work in marketing or operations, you may have witnessed a new trend: rather than allocate resources towards onboarding a new employee, many businesses are choosing to “hire” something that won’t need a…
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…
The Federal Aviation Administration (FAA) is responsible for licensing the companies that charter private space transportation. To issue a license for commercial space travel, the FAA is required under the National Environmental Policy Act…
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 US Court of Appeals for the Federal Circuit applied the Alice/Mayo framework to assess whether claims directed to remote gambling were patent eligible under 35 U.S.C. § 101 and determined that the claims were directed to a patent…
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…
SEC Issues New Guidance as to 8-K Disclosures Relating to Cybersecurity Incidents - On June 27, 2024, the U.S. Securities and Exchange Commission (the “SEC”) issued new guidance on the agency’s guidelines for cybersecurity incident…
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…
The EU Artificial Intelligence (AI) Act is set to become the world’s first comprehensive regulation on AI. After extensive negotiations, the European Parliament, Commission, and Council reached a political agreement on the AI Act in…
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 popularity of Artificial Intelligence (AI), particularly OpenAI's ChatGPT, has rapidly increased since its release in November 2022. In healthcare, Generative AI (GAI) tools like ChatGPT can revolutionize workflows by summarizing…
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 …