Insights

The Orders represent FinCEN’s first actions using new special measures authority under the Fentanyl Sanctions Act and FEND Off Fentanyl Act of 2024 (codified at 21 U.S.C. § 2313a) (the “Fentanyl Act”) and continue the Trump Administration’s broader efforts against transnational cartels and narcotics trafficking.

Merger consent orders are back at the FTC, and the FTC’s most recent action showcases how the current leadership is analyzing divestiture proposals. Last week, the FTC approved a proposed consent agreement in Alimentation Couche-Tard Inc.’s (ACT) acquisition of retail fuel outlets from Giant Eagle, Inc. that paired standard retail divestitures with a “prior notice” requirement that ACT notify the agency of future acquisitions in certain markets regardless of size. This FTC has signaled greater acceptance of remedies than the prior administration, and this most recent consent puts that on display, with Commissioner Meador providing merging parties guidance on designing effective remedies.

Section 230 of the Communications Decency Act of 1996 has been credited with “creating” the internet by immunizing websites and platforms from lawsuits arising from the content posted by third-party users. Specifically, an internet company is not liable for publishing or posting content drafted by another person under conventional common law tort theories such as defamation or slander, however loathsome, violent or otherwise hateful that content is.  At the same time, Section 230 also immunizes a website or platform that engages in good-faith moderation of content it deems to violate its terms of use/conditions or community standards. 

On June 27, 2025, the Supreme Court upheld the constitutionality of the USPSTF and its role in identifying preventive services for coverage under the ACA in Kennedy v. Braidwood Management.[1]In the case, the Supreme Court considered whether the Secretary of HHS’s appointment of USPSTF members without the advice and consent of the Senate complied with the Appointments Clause in Article II of the United States Constitution. The Supreme Court found that USPSTF members were “inferior Officers” under the Appointments Clause who did not require Senate confirmation because the Secretary of HHS had the authority to remove USPSTF members at will and “to directly review and block Task Force recommendations before they take effect.” The Supreme Court therefore affirmed that the USPSTF as currently structured may legally recommend preventive services for coverage without cost-sharing requirements under the ACA.

On June 10, 2025, the United States Patent and Trademark Office (USPTO) published a final rule that will discontinue the Accelerated Examination program for utility applications, beginning July 10, 2025. The final rule also modifies the rules of practice to clarify the grounds for which a petition to make special may be granted and when a fee is required for such a petition. Currently, Applicants have several ways to expedite examination of their patent applications. For example, an Applicant can expedite examination of utility patent applications by either petitioning to make their application special through the Accelerated Examination program or by applying through the Prioritized Patent Examination Program (“Track One” program).

On June 23, 2025, the DoD issued a memorandum, “Implementation of Department of Government Efficiency Cost Efficiency Initiative,” to establish a new DOGE approval process for unclassified IT consulting and management services (ITC&MS) contracts or task orders (TOs), and advisory and assistance services (A&AS) contracts or TOs.  The memorandum establishes a formal approval process, which directs DOGE to review and provide input for certain contract requirement packages included in Defense Secretary Pete Hegseth’s May 27, 2025 directive, “Implementation of Executive Order 14222 – Department of Government Efficiency Cost Efficiency Initiative” (“Contract Guidance”). 

On June 23, 2025, the Ninth Circuit issued a long-awaited decision in Island Industries Inc. v. Sigma Corp. affirming a $26M False Claims Act (“FCA”) judgment against the defendant importer.  Sigma had appealed the judgment after a jury found the company violated the FCA by failing to pay customs duties owed to U.S. Customs and Border Protection (“CBP”).  The Ninth Circuit’s decision addresses an important jurisdictional issue and illustrates the significant financial exposure importers can face under the FCA at a time of increased tariffs and enforcement by the government.  

Last week, artificial intelligence companies won two significant copyright infringement lawsuits brought by copyright holders, marking an important milestone in the development of the law around AI. These decisions – Bartz v. Anthropic and Kadrey v. Meta (decided on June 23 and 25, 2025, respectively), along with a February 2025 decision in Thomson Reuters v. ROSS Intelligence – suggest that AI companies have plausible defenses to the intellectual property claims that have dogged them since generative AI technologies became widely available several years ago. Whether AI companies can, in all cases, successfully assert that their use of copyrighted content is “fair” will depend on their circumstances and further development of the law by the courts and Congress.

On June 4, 2025, after nearly two years of intense debate and negotiation between the 27 EU Member States, the Council of the European Union adopted its position on the proposed overhaul of the EU general pharmaceutical legislative framework known as the new Pharma Package.

In a somewhat ambiguous press release on Wednesday, June 18, 2025, the Food and Drug Administration (FDA) announced a halt and “immediate review” of new clinical trials where American patients’ cells are sent to China or other “hostile countries” for genetic engineering with the expectation that the cells will be infused back into U.S. patients.[1] A subsequent podcast published by the agency also said that therapies that involved cells that were sent to China for genetic engineering and intended for subsequent infusion into U.S. patients would not be approved going forward. The announcement said that there is “mounting evidence” that some clinical researchers failed to obtain informed consent from trial participants about the international transfer and manipulation of biological material.

The U.S. Court of Appeals for the Federal Circuit has relaxed the standard and clarified the analysis for the showing of a nexus to a patented invention when patent licenses are presented as objective indicia of nonobviousness.

Crowell attorneys have closely monitored developments related to the California Invasion of Privacy Act (“CIPA”). In particular, we have watched plaintiffs attempt to extend this wiretapping law to encompass website chatbot communications that are managed by third parties.

On June 2, 2025, U.S. Customs and Border Protection (“CBP”) issued its first ever Withhold Release Order (“WRO”) and Finding Modifications Guide (“Guide” or “the Guide”). The Guide serves as a roadmap for importers facing a possible WRO or Finding due to allegations of forced labor in the supply chain of their goods imported into the U.S. It provides guidance on information to be included in a modification petition, identifies possible cases in which CBP might request additional information, and provides resources for importers facing a WRO or Finding.

You want to own electric generation or energy storage facilities that are used to sell power to data centers or other end user parties (e.g., other types of industrial or commercial customers, institutional entities, traditional utilities, or RTO/ISO markets).  Will Federal Energy Regulatory Commission (FERC) regulation apply to you?     

Underscoring the Administration’s intention to eradicate DEI preferences and mandates, the Department of Justice (DOJ) launched a new Civil Rights Fraud Initiative (Initiative) to be co-led by DOJ’s Civil Rights Division and Fraud Section. In response, Crowell launched its own DEI and Civil Fraud Initiative to support clients in managing the heightened risks associated with this new enforcement landscape.

On June 6, 2025, Judge Claudia Wilken issued final judgment in the In re College Athlete NIL Litigation, No. 4:20-cv-03919 (N.D. Cal.), approving the Fourth Amended Settlement Agreement commonly known as the “House Settlement.” The House Settlement drastically changes how Division I athletes are compensated, and will likely have far-reaching implications for higher education NCAA-member institutions and student-athletes.

The flow of data across borders is essential to our global economy. As companies grow more and more dependent on cross-border data transfers to conduct business, two parallel legal trends have emerged:

On May 13, 2025, Crowell & Moring and The George Washington University Competition Law Center hosted the Sixth Annual Antitrust and Tech Conference, which provided a platform for discussing pivotal issues in antitrust policy at this time of transition in leadership.

Acting USPTO Director Coke Morgan Stewart issued a Director Discretionary decision on June 6, 2025, in iRhythm Technologies Inc. v. Welch Allyn Inc., IPR2025-00363, -00374, -00376, -00377, and -00378 Paper 10 (PTAB June 6, 2025). This decision granted Patent Owner’s request for discretionary denials of institution in five related IPR challenges.  It follows several recent Director decisions that have all discretionarily denied petitions for reasons other than the substantive merits of the challenges. However, this decision is the first one that relies upon “[s]ettled expectations of the parties, such as the length of time the claims have been in force,” a new consideration that was first articulated in the USPTO’s “Interim Process for PTAB Workload Management” memorandum (“Interim Memo”) dated March 26, 2025.

On June 9, 2025, the General Services Administration (GSA) Federal Acquisition Service (FAS) quietly announced that Transactional Data Reporting (TDR) would be exiting “pilot” status; under Refresh 27 to the Multiple Award Schedule (MAS), TDR will be mandatory for all eligible Special Item Numbers (SINs), effective beginning in the next sales reporting quarter after each contractor accepts the modification, with remaining SINs to be added in future refreshes.