Insights

On the morning of December 12, 2025, the Eleventh Circuit heard argument in United States ex rel. Zafirov v. Florida Medical Associates, LLC, et al., No. 24-13581 (11th Cir. 2025). This case concerns the constitutionality of the False Claims Act (FCA) qui tam provisions and a groundbreaking September 2024 opinion in which the United States District Court for the Middle District of Florida held that the FCA’s qui tam provisions were unconstitutional under Article II. See United States ex rel. Zafirov v. Fla. Med. Assocs., LLC, 751 F. Supp. 3d 1293 (M.D. Fla. 2024). That decision, penned by District Judge Kathryn Kimball Mizelle, was the first success story for a legal theory that has been gaining steam ever since Justices Thomas, Barrett, and Kavanaugh indicated they would be willing to consider arguments about the constitutionality of the qui tam provisions in U.S. ex rel. Polansky v. Exec. Health Res., 599 U.S. 419 (2023). In her opinion, Judge Mizelle held (1) qui tam relators are officers of the U.S. who must be appointed under the Appointments Clause; and (2) historical practice treating qui tam and similar relators as less than “officers” for constitutional purposes was not enough to save the qui tam provisions from the fundamental Article II infirmity the court identified. That ruling was appealed and, after full briefing, including by the government and a bevy of amici, the litigants stepped up to the plate this morning for oral argument.

In March 2025, President Trump nominated John A. Squires for the positions of Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office (USPTO). After being approved by the Senate Judiciary Committee by a vote of 20-2, Squires was confirmed by the Senate on September 17, 2025, by a vote of 51-47 after anti-filibuster measures were invoked. During and after the confirmation process, Squires emphasized several goals for the USPTO during his time as Director. Such goals included:

On 4 December 2025, the Court of Justice of the EU (CJEU) issued a landmark judgment in the joined cases C-580/23 (Mio v. Asplund) and C-795/23 (USM v. Konektra) concerning copyright protection for “works of applied art” (i.e., utilitarian objects such as tables, furniture, lighting fixtures, sofas, chairs, kitchen appliances, vases, and fashion items).

On December 8, 2025, the U.S. District Court for the District of Massachusetts in State of New York v. Trump held unlawful and vacated the U.S. Department of the Interior’s “Wind Order” implementing President Trump’s January 20, 2025, “Temporary Withdrawal of All Areas on the Outer Continental Shelf From Offshore Wind Leasing and Review of the Federal Government’s Leasing and Permitting Practices for Wind Projects,” 90 Fed. Reg. 8363 (Wind Memo, discussed further in a prior alert). This lawsuit, brought by a coalition of states with Alliance for Clean Energy New York intervening on their behalf, challenges Interior’s implementation, through the Wind Order, of the Wind Memo’s direction to pause processing permits and other approvals necessary to onshore and offshore wind energy development. Notably, the lawsuit does not challenge the other element of the Wind Memo, which withdrew unleased offshore areas from future leasing under the Outer Continental Shelf Lands Act (OCSLA). (Note, even though the Wind Order indicates its effect is temporary, the Wind Memo instructs relevant agencies not to advance wind development projects until a “comprehensive assessment” is completed, and the district court’s order confirms that the affected agencies had no plans to restart permitting activities until that assessment was complete.)

On December 5, 2025, the Small Business Administration (SBA) sent letters to 4,300 current and recent participants in the 8(a) Business Development Program requiring production by January 5, 2026, of financial records, contracting and subcontracting agreements, and employee records.  Below we discuss the genesis of the U.S. Government’s focus on fraud in small business programs, the new SBA request for documents, the coming Treasury audit of preference-based contracts, and more.

In an effort to boost its clinical research industry, Germany has enacted the Medical Research Act or “MRA” (Medizinforschungsgesetz). The MRA introduces significant changes to various German healthcare laws and procedures.

This news bulletin is provided by the International Trade Group of Crowell & Moring. If you have questions or need assistance on trade law matters, please contact Anand Sithian or Simeon Yerokun or any member of the International Trade Group.

California continues its blistering pace in enacting artificial intelligence regulations. In 2024 alone, California enacted 18 AI-related bills seeking to regulate AI tools and increase transparency around AI data disclosure.

On November 12, 2025, Judge King in the U.S. District Court for the Western District of Washington granted in part Haldiram India Ltd.’s (“Plaintiff” or “Haldiram”) motion for a preliminary injunction against Punjab Trading, Inc. (“Defendant” or “Punjab Trading”), a seller alleged to be importing and distributing gray market snack food products not authorized for sale in the United States. The court found that Haldiram was likely to succeed on the merits of its trademark infringement claim because the products at issue, which were intended for sale in India, were materially different from the versions intended for sale in the U.S., and for this reason were not genuine products when sold in the U.S. Although the court narrowed certain overbroad provisions in the requested order, it ultimately enjoined Punjab Trading from importing, selling, or assisting others in selling the non-genuine Haldiram products in the U.S. market.

On November 26, 2025, the Centers for Medicare & Medicaid Services (CMS) published its Proposed Rule for the Medicare Program; Contract Year 2027 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, and Medicare Cost Plan Program (the “CY 2027 NPRM” or “proposed rule”) for public comment. In addition to outlining prospective policy and technical changes to Medicare Advantage (Part C), the Medicare Prescription Drug Benefit (Part D), and Medicare Cost Plan regulations, the proposals showcase the government’s plans to make comprehensive updates in response to statutory changes—notably the Inflation Reduction Act of 2022 (IRA)—as well as feedback from interested parties, and current federal deregulatory priorities.

As we have reported previously, California has enacted a pair of climate-related reporting laws that apply to large entities doing business in California (SB 253 and SB 261, as modified by SB 219). This alert provides an update on only the most recent events; please see previous alerts for a broader overview of the laws’ requirements.

Major changes have been proposed to EU AI, data and wider digital laws. On 19th November 2025, the European Union Commission issued its much anticipated Digital Omnibus Regulation Proposal, (the “Digital Omnibus”) and also its Digital Omnibus on AI Regulation Proposal, (the “AI Omnibus”). The mooted changes potentially impact the “Brussels effect” seen post GDPR and add potential complexities to the compliance efforts of businesses.

Rule 16.1 of the Federal Rules of Civil Procedure, titled “Multidistrict Litigation,” takes effect today, December 1, 2025. The adoption of this rule provides a long-awaited framework specific to district courts’ management of MDL proceedings. However, many critics of the new rule are concerned that it does not impose mandatory obligations on MDL courts, and thus lacks the teeth required to establish meaningful change.

Patent claims must be clear and definite, as they set the boundaries of the patentee’s rights. Occasionally, however, claim language contains errors, such as typographical mistakes or incorrect numbering. Courts possess very limited authority to correct such errors. The United States Court of Appeals for the Federal Circuit has emphasized that judicial correction is appropriate only in rare circumstances, where (1) the error is evident from the face of the patent, and (2) the proposed correction is the sole reasonable interpretation in view of the claim language, specification, and prosecution history. See Group One, Ltd. v. Hallmark Cards, Inc., 407 F.3d 1297, 1303 (Fed. Cir. 2005) and Novo Indus., L.P. v. Micro Molds Corp., 350 F.3d 1348, 1357 (Fed. Cir. 2003).

On Friday, November 21, the Centers for Medicare & Medicaid Services (CMS) noticed its appeal of the Northern District of Texas’ decision in Humana Inc. et al. v. Becerra et al.

On November 13, 2025, the president of the French-speaking Brussels Enterprise Court ruled in the long-running battle between Sandoz and Regeneron about the correct interpretation of the EU’s Supplementary Protection Certificate (SPC) Manufacturing Waiver Regulation regarding exports to a non-EU market. The Brussels Court dismissed Regeneron’s claim that Sandoz had provided a defective notification and agreed with Sandoz’s interpretation of the Regulation.

Utah Attorney General Derek Brown (R) and North Carolina Attorney General Jeff Jackson (D) have announced a nationwide bipartisan “AI Task Force,” in partnership with major AI developers (including OpenAI and Microsoft) and the Attorney General Alliance (AGA), a bipartisan nonprofit that serves as a forum for attorneys general around the United States to discuss and collaborate on policy and enforcement initiatives.

President Trump is preparing to sign an Executive Order that would seek to forestall state regulation of artificial intelligence (AI) by threatening federal lawsuits and the withholding of some federal funds. The draft, unsigned six-page Executive Order, “Eliminating State Law Obstruction of National AI Policy” (EO), the text of which has been circulating publicly since November 19, would declare it the policy of the Administration “to sustain and enhance America’s global AI dominance through a minimally burdensome, uniform national policy framework for AI.”

On 5 October 2025, His Highness Sheikh Tamim bin Hamad Al Thani enacted Law No. (22) of 2025 concerning Persons with Disabilities (the “Law”)— a landmark step toward strengthening social inclusion and equal opportunities for individuals with disabilities in Qatar. 

On November 7, 2025, in Thornton v. National Academy of Sciences, No. 25-cv-2155, 2025 WL 3123732 (D.D.C. Nov. 7, 2025), the District Court for the District of Columbia dismissed a False Claims Act (FCA) retaliation complaint on the basis that the plaintiff’s allegations that he was fired after blowing the whistle on purported illegally discriminatory use of federal funding was not sufficient to support his FCA claim. This case appears to be one of the first filed, and subsequently dismissed, following Deputy Attorney General Todd Blanche’s announcement of the creation of the Civil Rights Fraud Initiative on May 19, 2025, which “strongly encourages” private individuals to file lawsuits under the FCA relating to purportedly discriminatory and illegal use of federal funding for diversity, equity, and inclusion (DEI) initiatives in violation of Executive Order 14173, Ending Illegal Discrimination and Restoring Merit-Based Opportunity (Jan. 21, 2025). In this case, the court dismissed the FCA retaliation claim and rejected the argument that an organization could violate the FCA merely by “engaging in discriminatory conduct while conducting a federally funded study.” The analysis in Thornton could be a sign of how forthcoming arguments of retaliation based on reporting allegedly fraudulent DEI activity will be analyzed in the future.