Insights

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.

Design patents offer protection for the ornamental appearance of a product, focusing on aspects like its shape and surface decoration, as opposed to the functional aspects protected by utility patents. The scope of a design patent is defined by the drawings and any descriptive language within the patent itself. Recent decisions by the Federal Circuit emphasize the need for clarity in the prosecution history of a design patent in order to preserve desired scope to preserve intentional narrowing (and to avoid unintentional sacrifice of desired claim scope).

A decision in May from the Federal Circuit Court of Appeals has extended the long-standing and well-publicized dispute over inventorship of use of CRISPR-Cas9 technology in eukaryotic cells. When final resolution comes, it will have important implications for users of this technology. Companies currently licensing CRISPR-Cas9 from one of the two groups claiming ownership rights to the fundamental patents covering this technology and those considering licenses or investment in users of the technology should review existing or proposed licenses to better prepare for the potential outcomes of the dispute.

The facts before the Third Circuit in the recently decided case of Patel v. United States illustrate how parties can put themselves in a bind if they make factual admissions when resolving a criminal case involving fraud on the government while not simultaneously resolving the government’s civil claims under the False Claims Act (FCA) for the same underlying conduct.

On November 14, 2025, the U.S. Department of Justice (DOJ) announced a sweeping series of enforcement actions, including four guilty pleas and more than $15 million in civil forfeitures against the  Democratic People’s Republic of Korea (DPRK or North Korea) for remote information technology (IT) worker schemes. These actions underscore the federal government’s escalating focus on the exposure of U.S. companies to North Korean IT worker infiltration, following a series of U.S. Government action against the DPRK.

On 12 November, the highly anticipated Cyber Security and Resilience (Network and Information Systems) Bill (“Bill”) was introduced to Parliament, representing a significant expansion and modernisation of the UK’s cyber security rules. Building on the foundation set by the Network & Information Systems Regulations 2018 (“NIS”), the Bill aims to enhance national security and safeguard essential services. The Department for Science, Innovation and Technology (“DSIT”) has published a policy paper detailing the Bill’s objectives.

Claim construction is a key stage of most patent litigations, where the court must decide the meaning of any disputed terms in the patent claims.  Generally, claim terms are given their plain and ordinary meaning except under two circumstances: (1) when the patentee acts as its own lexicographer and sets out a definition for the term; and (2) when the patentee disavows the full scope of the term either in the specification or during prosecution.  Thorner v. Sony Comput. Ent. Am. LLC, 669 F.3d 1362, 1365 (Fed. Cir. 2012).  The Federal Circuit’s recent decision in Aortic Innovations LLC v. Edwards Lifesciences Corp. highlights that patentees can act as their own lexicographers through consistent, interchangeable usage of terms across the specification, effectively defining terms by implication.

Microplastics pollution has emerged as a significant issue as the public learns more about the presence of microplastics in the environment and how they may enter the human body.

On November 12, 2025, the Tax Court issued a reviewed opinion in Patel v. Commissioner holding in favor of the IRS that the taxpayers’ transaction lacked economic substance, and therefore the taxpayers were liable for penalties under the codified economic substance doctrine at the increased penalty rate, as well as accuracy-related penalties. The Court previously held in a separate opinion that the taxpayers’ purported captive transactions did not constitute insurance because they failed to distribute risk, and in the alternative, that the micro-captives did not act as an insurer commonly would.