Insights

Can a business patent an invention developed using artificial intelligence? Potentially, yes. Using AI does not, by itself, prevent patent protection. But only human beings can be named as inventors, and the key question remains whether the human contributors conceived the invention claimed in the patent application. For businesses using AI in research and development, the priority is to identify and document that human conception.[1]

As of November 4, 2026, the state attorney general elections point to increased enforcement in 2027, particularly in consumer protection, antitrust, AI, health care, and data centers.[1] Businesses should prepare for more investigations under existing laws and proposals for new legislation or rules. Campaign commitments indicate priorities, but their timing and implementation remain uncertain.[2]

The U.S. Food & Drug Administration (FDA) recently issued final guidance — Regulatory Considerations for Prescription Drug Use-Related Software (PDURS) — to address when and how software disseminated by (or on behalf of) sponsors fits into existing drug-labeling requirements. The agency describes this as a response to longstanding uncertainty and a push toward a clearer, more consistent approach across FDA’s drug and device centers. 

On October 29, 2026, the U.S. Department of Labor’s (DOL) Employee Benefits Security Administration (EBSA) issued a 350-page final rule requiring providers of pharmacy benefit management services and their affiliated brokers and consultants to disclose fees and compensation received to fiduciaries of covered large, self-insured ERISA group health plans. According to DOL’s accompanying fact sheet, the disclosures will give employers more visibility into the payments PBMs may receive from various sources and help fiduciaries evaluate and monitor arrangements over time. 

The Ruling, in Plain Terms 

On October 20, 2026, the U.S. Department of Justice’s (DOJ) National Fraud Enforcement Division announced a new whistleblower rewards initiative, the Fraud Whistleblower Incentive Program (WHIP). Assistant Attorney General Colin M. McDonald issued a directive earlier this month directing Division leadership to design and implement policies and programs that incentivize whistleblowers to bring forward credible information pertaining to fraud. The new WHIP incentive pays awards of $10,000 to $30,000 for qualifying tips at or around the time criminal charges are filed or unsealed, rather than years later at case resolution.

On October 16, 2026, the U.S. Centers for Medicare and Medicaid Services (CMS) issued a proposed rule implementing key sections of the Consolidated Appropriations Act (CAA) of 2026, Section 6224 (“Modernizing and Ensuring Pharmacy Benefit Manager Accountability”). The agency also proposes a conforming change mandated by section 6219 of the CAA (“Adjustments to Medicare Part D Cost-Sharing Reductions for Low-Income Individuals”) that would reduce the generic-drug copayment from $1 to $0 for full-benefit dual eligible individuals. Comments to the proposed rule are due December 15, 2026.   

Crocs, Inc. recently filed a petition for a writ of certiorari before the U.S. Supreme Court (No. 26-421), asking the Court to review and resolve the question: “Whether an agency disposition is final as to some issues, thus triggering deadlines for judicial review, while other issues decided in the same disposition remain subject to further executive or administrative review.”

On September 16, 2026, California became the second state in the country to require disclosures of AI-generated synthetic performers in advertising. Governor Gavin Newsom signed into law SB 1050 — a measure that prohibits advertisers from publishing advertisements prominently featuring AI-generated synthetic performers without a clear and conspicuous disclosure — effective January 1, 2027.

Senator Maria Cantwell (D-Wash), the ranking member of the Senate Committee on Commerce, Science, and Transportation, recently outlined a comprehensive artificial intelligence (AI) governance framework designed to drive legislative and executive actions. The framework is built on six principles and is being introduced at a time when federal AI legislation is actively being debated. While the framework is a proposal, it reflects priorities that have bipartisan resonance and signals where lawmakers are likely to focus. For health insurance payors, several elements of the framework are directly relevant to existing and planned AI deployments, particularly in utilization management, claims processing, and member-facing services.

The Sedona Conference has published its Defend Trade Secrets Act Model Jury Instructions: DTSA 10th Anniversary Commemorative Edition, the product of Working Group 12’s consensus process. Earlier this year, we alerted clients to the draft instructions. The final publication cautions that the instructions are a starting point only, not binding law, and must be tailored to the facts, claims, and governing law of each case. 

Guidehouse served as the prime contractor responsible for technology services used in administering New York’s Emergency Rental Assistance Program (“ERAP”). Under Guidehouse’s contract with the State of New York, the online ERAP portal was to undergo cybersecurity testing in its pre-production environment before it was launched to the public, and Guidehouse was required to certify that the system met the contract’s requirements. Within hours of going live, the ERAP portal exposed certain applicants’ personally identifiable information and was shut down.

On October 1, 2026, the U.S. Department of Justice’s (DOJ) National Fraud Enforcement Division issued Directive 26-12: Corporate Enforcement in the Fight Against Fraud. Assistant Attorney General Colin M. McDonald’s October directive follows his August 2026 memorandum setting the Division’s enforcement priorities. The directive signals — in the DOJ’s words — “an aggressive, all-tools” enforcement posture across the Division’s health care, government contracting, tax, and trade fraud priorities, while simultaneously supporting the incentives designed to promote transparency, reward cooperation, and encourage voluntary disclosure of misconduct. 

On September 8, 2026, the U.S. Department of Labor's (DOL) Employee Benefits Security Administration (EBSA) issued “Field Assistance Bulletin No. 2026-03” to clarify compliance with the Mental Health Parity and Addiction Equity Act (MHPAEA) and nonquantitative treatment limitations (NQTL). Under the 2013 final rule implementing MHPAEA, health plans and issuers must use comparable processes, strategies, evidentiary standards, or other factors when applying NQTLs and they cannot apply such methods more stringently to benefits for mental health and substance use disorder (MH/SUD) compared to benefits for general medical and surgical care. While the bulletin doesn’t break much new ground on compliance, it does reaffirm existing enforcement priorities and expectations. 

In a significant and unanimous ruling, the D.C. Circuit upheld the Environmental Protection Agency’s (“EPA”) final rule designating perfluorooctanoic acid (“PFOA”) and perfluorooctanesulfonic acid (“PFOS”) as “hazardous substances” under the Comprehensive Environmental Response, Compensation, and Liability Act (“CERCLA”), denying the petitions of seven industry groups seeking to overturn that designation.[1] CERCLA, also known as the “Superfund Statute,” allows EPA to require potentially responsible parties to fund cleanup of hazardous substances.

On July 28, 2026, the Federal Communications Commission (FCC) updated its Covered List, established through the Secure and Trusted Communications Networks Act to include foreign-produced connected power inverters and advanced robotic devices. The designation of these products to the Covered List follows an Executive Branch national security determination that they “pose unacceptable risks to the national security of the United States or the safety and security of United States persons.” Equipment listed on the Covered List is ineligible for FCC equipment authorization, effectively prohibiting the import, sale, or marketing of those products absent an exception or approval. This action comes only months after the FCC added consumer-grade routers to the Covered List on March 23, 2026 and uncrewed aircraft systems (UAS) on December 22, 2025. Taken together, these actions reflect the FCC’s increasingly expansive approach to using its authorities to guard against foreign produced connected technologies that may create vulnerabilities enabling disruption of critical infrastructure, unauthorized access to sensitive information, or cyber intrusions. The shift is a departure from the FCC’s previous focus on equipment and services produced by certain PRC and Russian companies.

On June 18, 2026, the Illinois Department of Labor took a long-anticipated step by adopting comprehensive amendments to 56 Ill. Adm. Code Part 320, the administrative rules implementing the pay transparency requirements of the Illinois Equal Pay Act of 2003 (820 ILCS 112, the Act).

The Department of War (DoW) is immediately suspending Cybersecurity Maturity Model Certification (CMMC) Phase II requirements, which had been scheduled to take effect on November 10, 2026.

On June 4, 2026, Rep. Scott Fitzgerald (R-WI-5) introduced a bill that would limit the ability of people and entities seen as threats to U.S. national security to obtain and enforce patents. If enacted, the Prohibiting Adversarial Patents Act of 2026 (H.R. 9142) would leverage use of patent law as a national security tool, with consequences for companies operating in technology-intensive sectors, including drones, telecommunications, semiconductors, artificial intelligence, and advanced manufacturing. The proposed legislation, currently under review by the U.S. House Judiciary Committee, is particularly focused on persons and entities with connections to the People’s Republic of China.

If a court finds that a patent applicant intentionally misrepresented or withheld material information from the USPTO with the intent to deceive, the consequences are severe, leading to unenforceability of the entire patent (and likely any later patents claiming priority to the unenforceable patent).