Insights

On September 29, 2025, the U.S. Department of Commerce Bureau of Industry and Security (BIS) announced a sweeping Interim Final Rule (IFR), (the “Affiliates Rule”) expanding which entities qualify as Entity List or Military End-User entities, thereby subjecting those entities to elevated export control restrictions under the Export Administration Regulations (EAR). U.S. export restrictions applicable to entities on the Entity List, Military End-User (MEU) List, and Specially Designated Nationals and Blocked Persons (SDN List) now apply to foreign affiliates that are, in the aggregate, owned 50% or more by one or more of the aforementioned entities. An entity that becomes subject to these restrictions because of its ownership structure will be subject to the most restrictive controls that attach to any of its parent entities, regardless of ownership stakes.

On September 25, 2025, the Northern District of Texas granted plaintiffs’ motion for summary judgment in Humana v. Becerra, vacating CMS’s 2023 Final Rule regarding risk adjustment data validation (RADV) audits. In the litigation, Humana challenged CMS’s decision in the Final Rule to not continue applying a Fee-for-Service (FFS) adjuster to its RADV audit methodology.

On August 28, 2025, France, Germany, and the UK (the E3) initiated the process to reinstate (or snapback) UN sanctions on Iran. The snapback mechanism (which was set to expire on October 18, 2025) is outlined in UN Security Council Resolution 2231 (UNSCR 2231).

Although the Supreme Court’s 2014 decision in Alice v. CLS Bank and its progeny affected the issuance and enforcement of software patents and led to a major shift in U.S. patent policy, software patents still have value today and such protection therefore should be pursued.

On August 28, the U.S. Department of Commerce Bureau of Industry and Security (BIS) published a final rule that modifies the Export Administration Regulations (EAR) to reduce the number of export control restrictions on Syria, in alignment with Executive Order 14312, Providing For The Revocation of Syria Sanctions. The key adjustments made by this rule include the addition of new or expanded license exception eligibility for exports and reexports to Syria (which significantly broadens the number of items that can be exported or reexported to Syria) and the adoption of more permissive license review policies for exports and reexports to Syria.

CMS is well underway in initiating and conducting its Risk Adjustment Data Validation (RADV) audits of Medicare Advantage (MA) organizations for PY 2019, and PY 2020 audit notices are likely to arrive by the end of September. The timing for subsequent PY audits is less clear, but notices will likely be coming soon given CMS’s announced plans to complete all remaining audits by early 2026, including all contracts for PY 2020 and beyond. This approach marks a significant deviation from the agency’s prior policy of reviewing only a fraction of contracts and at a much slower pace.

The Ninth Circuit ruled that NFTs are not just digital collectibles but legally recognized goods under the Lanham Act. Yuga Labs, Inc. v. Ryder Ripps and Jeremy Cahen, Case No. 24-879 (9th Cir. July 23, 2025). NFTs are intangible, fully virtual, authenticating software code that is associated with separate digital or physical content. Although the Ninth Circuit found that there were genuine issues of material fact that precluded summary judgment on the issue of likelihood of confusion, the court recognized that NFTs are commercial products with tangible value subject to trademark protection. This means that NFT creators and projects can now claim trademark rights in their collections’ names, logos, and associated marks.

In the last few months, both Washington State and Pennsylvania enacted significant legislation addressing the malicious use of deepfakes—artificial intelligence-generated or manipulated media. These new laws reflect a growing national and state-level trend to regulate AI-generated content, especially when used to harm individuals or mislead the public.

On July 28, 2025, Cadence Design Systems Inc. (“Cadence” or “the Company”), a global electronic design automation (“EDA”) technology company based in San Jose, California, agreed to plead guilty in a settlement with the U.S. Department of Justice’s National Security Division (“NSD”) and the U.S. Attorney’s Office for the Northern District of California. Through its guilty plea, Cadence agreed to resolve charges that it committed criminal violations of export controls by selling EDA hardware, software, and semiconductor design intellectual property (“IP”) technology to the National University of Defense Technology (“NUDT”), a Chinese military university on the U.S. Entity List since 2015 due to its involvement in military and nuclear simulation activities. In addition, Cadence simultaneously resolved a civil enforcement action brought by the U.S. Department of Commerce, Bureau of Industry and Security (“BIS”) related to the same underlying conduct.

The Southern District of New York issued a recent opinion in Lehrman et al v. Lovo, Inc., 1-24-cv-03770 (SDNY Jul. 10, 2025) (J. Paul Oetken) regarding copyright infringement issues involving artificial intelligence models, focusing this time on voice cloning. Two voice-over actors, Paul Lehrman and Linnea Sage, filed a lawsuit against Lovo, Inc., a company specializing in AI-driven text-to-speech services. The Plaintiffs alleged that Lovo used artificial intelligence to clone their voices without authorization, raising complex legal questions regarding intellectual property and privacy rights in the age of AI.

On July 23, 2025, the White House released Winning the Race: America’s AI Action Plan (“the Plan”) the Trump Administration’s most significant policy statement on artificial intelligence to date.

The USPTO is actively implementing and seeking out technologies to enhance the speed, accuracy, and consistency of the examination of patent applications.

Applicants entering the U.S. national phase of an international (PCT) application have two options: enter the national stage under 35 U.S.C. §371 or file a “bypass” national application under 35 U.S.C. § 111(a). A bypass application allows applicants to file a new U.S. application that claims priority to the PCT application, treating the PCT application as a U.S. parent and bypassing the traditional national phase entry. Depending on the applicant’s goals and strategy, bypass applications can be filed as a continuation, divisional, or continuation-in-part (CIP).

On June 30, 2025, President Trump issued Executive Order 14312 effectively lifting (or beginning the process of lifting) most of the sanctions on Syria. Executive Order 14312 cites the leadership changes and the policies of the new Syrian government under President Ahmed al-Sharaa as the reasons for the removal of sanctions. On the same day, the Department of the Treasury’s Office of Foreign Assets Control (OFAC) and the Department of State took steps to implement the termination of the program by, among other actions, delisting appropriate individuals and entities from the List of Specially Designated Nationals and Blocked Persons (SDN List). These actions followed the initial sanctions relief provided on May 23, 2025 by OFAC, the Financial Crimes Enforcement Network (FinCEN), and the State Department.

Twenty years ago, the Supreme Court held that “one who distributes a device with the object of promoting its use to infringe copyright, as shown by clear expression or other affirmative steps taken to foster infringement, is liable for the resulting acts of infringement by third parties.” MGM Studios, Inc. v. Grokster, Ltd., 545 U.S. 913, 919 (2005). In the Grokster case, the Supreme Court found that peer-to-peer file sharing companies could be liable for copyright infringement for their users’ deployment of file sharing software. There, the Court found that liability was warranted because the file sharing companies knew that its users were infringing, and the companies materially contributed to that infringement.

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).

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.

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.

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).