Insights

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.

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.

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?     

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.

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, U.S. Department of Justice (“DOJ”) Deputy Attorney General Todd Blanche issued new Foreign Corrupt Practices Act (“FCPA”) enforcement guidelines (“the Guidelines”). DOJ issued the Guidelines in response to the Trump Administration’s February 2025 Executive Order (“EO”), which paused FCPA enforcement pending the issuance of new guidance from the Attorney General. The new Guidelines resolve lingering doubts about the future of FCPA enforcement under the Trump administration and provide important insights into the key factors DOJ will consider when deciding whether to pursue FCPA investigations or enforcement actions.

On 2 June 2025 the Civil Justice Council (a UK public body that advises on civil justice and civil procedure) (“CJC”) issued its Review of Litigation Funding Final Report (the “Report”). The CJC has provided comprehensive recommendations on the regulation and reform of litigation funding in England and Wales. The highlight recommendation of the Report is for the UK Government to remove third party litigation funding from the regulations and requirements of the Damages-Based Agreements Regulations 2013 (“DBA Regulations”), reversing the judgment of the Supreme Court in PACCAR.[1] Meanwhile, the UK Court of Appeal has recently endorsed a position that the Competition Appeal Tribunal (“CAT”) may order that third party funders of collective proceedings be paid first from litigation proceeds before claimants according to waterfall provisions in their funding agreements.

Acting USPTO Director Coke Morgan Stewart recently issued a Director Review decision on May 19, 2025, in Ecto World, LLC v. RAI Strategic Holdings, Inc, IPR2024-01280, Paper 13 (PTAB May 19, 2025), that was subsequently designated as precedential by the Patent Trial and Appeal Board (PTAB). The decision seeks to eliminate inconsistencies amongst PTAB panels in using its discretion to deny institution under 35 U.S.C. § 325(d). 

The Supreme Court last week blessed a broad reading of the federal wire fraud statute, resolving a circuit split over whether economic loss is an element of fraudulent inducement and bolstering the Government’s future enforcement of procurement fraud. In Kousisis et al. v. United States (unanimous in judgment), the Court upheld the conviction of a government contractor for falsely representing compliance with disadvantaged business enterprise (DBE) requirements in contracts awarded by the Pennsylvania Department of Transportation (PennDOT), despite completing the contracts to PennDOT’s satisfaction. The Court held that a material misrepresentation used to deceive someone into parting with money or property is sufficient for a federal wire fraud conviction, regardless of whether the victim suffered any economic loss.

On May 20, 2025, former Missouri congressman, Billy Long, appeared before the Senate Finance Committee for his confirmation hearing as President Donald Trump’s nominee for IRS Commissioner.  Senators questioned Long about his role in promoting questionable tax credits, including Employee Retention Tax Credits (“ERTC”) after leaving the House of Representatives in 2023.  Long also disclosed receiving financial compensation from these entities for his work promoting ERTC.  Given Long’s support for ERTC, there is speculation that the IRS could ease enforcement activity directed towards these credits.

On May 15, 2025, U.S. Department of Energy (“DOE” or the “Agency”) issued a memorandum outlining the Agency’s new policy for evaluating financial assistance awards (e.g., grants, cooperative agreements, and technology investment agreements) to identify waste, fraud, and abuse. Businesses, universities, non-profit organizations, and other entities that have received DOE financial assistance awards now face increased risk of investigation and potential award termination, withholding of funding, and project modification.

On May 13, the House Ways and Means Committee passed “The One, Big Beautiful Bill.” This bill includes several provisions that, if enacted, will be important to businesses claiming research and development incentives:

The Departments of Labor (“DOL”), Health and Human Services (“HHS”), and Treasury (the “Tri-Agencies”) have signaled that changes may be coming to the Mental Health Parity and Addiction Equity Act (“MHPAEA”) Final Rule issued on September 8, 2024. On May 9, 2025, the Tri-Agencies filed a Motion for Abeyance in a lawsuit brought by the ERISA Industry Committee (“ERIC”) challenging the 2024 final MHPAEA regulations in the United States District Court for the District of Columbia.[1] The Motion, which was granted by the Court, indicated that the Tri-Agencies intend to “reconsider” the Final Rule, including “whether to issue a notice of proposed rulemaking rescinding or modifying the Final Rule.” Yesterday, on May 15, 2025, the Tri-Agencies issued a notice of non-enforcement stating that they “will not enforce the 2024 Final Rule or otherwise pursue enforcement actions, based on a failure to comply that occurs prior to a final decision in the litigation, plus an additional 18 months.”

In a May 12, 2025 speech that signaled both a recalibration of and recommitment to prosecuting white-collar crime, Matthew R. Galeotti, the newly appointed Head of the Department of Justice’s Criminal Division, said that the Division is “turning a new page” and embracing an enforcement approach that aims to elevate efficiency, predictability, and fairness. The changes he outlined aim to incentivize self-reporting, narrow corporate monitorships, and refocus whistleblowers.

On 24 April 2025, the UK Serious Fraud Office (“SFO”) unveiled its new External Guidance on Corporate Co-Operation and Enforcement in relation to Corporate Criminal Offending (the “Guidance”)[1]to enhance corporate compliance, transparency and cooperation in combatting fraud, bribery and corruption in the UK. This comprehensive guidance is critical for both UK-based entities and international companies operating under UK jurisdiction.