Regulating AI: A Thoughtful Approach?

Tom Wheeler at the Brookings Institution has published an excellent short paper titled, “Governing the AI Transition: Lessons from the 1996 Telecommunications Act.”  Mr. Wheeler states, in part:

The relevance of the Telecom Act of ’96 to the policy challenges of AI is not because AI is telecom, but because technological transitions produce bottlenecks that become the birthplace of durable private power. 

In 1996, Congress sought to legislate a transition by prioritizing competition. Now, in the AI era, we face an even more consequential transition. The stakes are not merely market structure or consumer pricing. The stakes extend to labor markets, intellectual property, national security, democracy, and the control of the tools of knowledge itself. 

The paper is available, here. 

US FTC Sends Letter to Data Brokers concerning Disclosing Sensitive Data to Foreign Adversaries

The Federal Trade Commission has sent a warning letter to Data Brokers about violating the Protecting Americans’ Data from Foreign Adversaries Act of 2024.  The FTC Press Release states, in part:

The Federal Trade Commission sent letters to 13 data brokers warning them of their responsibility to comply with the Protecting Americans’ Data from Foreign Adversaries Act of 2024 (PADFAA).

PADFAA prohibits data brokers from selling, releasing, disclosing, or providing access to personally identifiable sensitive data about Americans to any foreign adversary, which include North Korea, China, Russia, and Iran, or any entity controlled by those countries. The law defines personally identifiable sensitive data to include health, financial, genetic, biometric, geolocation, and sexual behavior information as well as account or device log-in credentials and government-issued identifiers such as Social Security, passport, or driver’s license numbers.

“The FTC is committed to enforcing PADFAA and ensuring companies are complying with its requirements,” said Christopher Mufarrige, Director of the FTC’s Bureau of Consumer Protection. “These letters should send a message to all data brokers to be aware of the law’s requirements and ensure they are not engaging in practices that violate it.”

The letters note that the agency has identified instances in which some of the letter’s recipients have “offered solutions and insights involving the status of an individual as a member of the Armed Forces. Such information is subject to PADFAA’s requirements.”

The letters warn the companies to conduct a comprehensive review of their business practices to ensure they comply with PADFAA, adding that a violation of the act may result in an enforcement action by the FTC, which could include civil penalties of up to $53,088 per violation.

Jury Convicts Former Google Engineer of Economic Espionage concerning AI

The U.S. Department of Justice has announced in a press release the conviction of a former Google software engineer of economic espionage concerning the theft of trade secrets about artificial intelligence.  The Press Release states:

Yesterday, a federal jury in San Francisco convicted former Google software engineer Linwei Ding, also known as Leon Ding, 38, on seven counts of economic espionage and seven counts of theft of trade secrets for stealing thousands of pages of confidential information containing Google’s trade secrets related to artificial intelligence technology for the benefit of the People’s Republic of China (PRC). The jury’s verdict follows an 11-day trial before U.S. District Judge Vince Chhabria for the Northern District of California.

“This conviction exposes a calculated breach of trust involving some of the most advanced AI technology in the world at a critical moment in AI development,” said Assistant Attorney General for National Security John A. Eisenberg. “Ding abused his privileged access to steal AI trade secrets while pursuing PRC government-aligned ventures. His duplicity put U.S. technological leadership and competitiveness at risk. I commend the trial team and investigators whose exceptional work resulted in this conviction.”

“In today’s high-stakes race to dominate the field of artificial intelligence, Linwei Ding betrayed both the U.S. and his employer by stealing trade secrets about Google’s AI technology on behalf of China’s government,” said Assistant Director Roman Rozhavsky of the FBI's Counterintelligence and Espionage Division. “Not only does this case mark the first-ever conviction on AI-related economic espionage charges, but it also demonstrates the FBI’s unwavering dedication to protecting American businesses from the increasingly severe threat China poses to our economic and national security. We remain committed to working closely with our partners across the private sector to protect our nation’s innovation, safeguard our trade secrets, and hold our foreign adversaries accountable.”

“Silicon Valley is at the forefront of artificial intelligence innovation, pioneering transformative work that drives economic growth and strengthens our national security.  The jury delivered a clear message today that the theft of this valuable technology will not go unpunished. We will vigorously protect American intellectual capital from foreign interests that seek to gain an unfair competitive advantage while putting our national security at risk,” said U.S. Attorney Craig H. Missakian for the Northern District of California.

“This conviction reinforces the FBI’s steadfast commitment to protecting American innovation and national security. The theft and misuse of advanced artificial intelligence technology for the benefit of the People’s Republic of China threatens our technological edge and economic competitiveness,” said FBI Special Agent in Charge Sanjay Virmani for the San Francisco Field Office. “The FBI San Francisco division serves Silicon Valley and the companies who lead the world in innovation, and we are committed to safeguarding their work. This case demonstrates the strength of collaboration between the FBI and the private sector, including leading companies like Google, whose partnership is critical to protecting sensitive U.S. technology. Today’s verdict affirms that federal law will be enforced to protect our nation’s most valuable technologies and hold those who steal them accountable.”

Ding was originally indicted in March 2024. A superseding indictment returned in February 2025 described seven categories of trade secrets stolen by Ding and charged Ding with seven counts of economic espionage and seven counts of theft of trade secrets.

According to the evidence presented at trial, between approximately May 2022 and April 2023, while a Google employee, Ding stole more than two thousand pages of confidential information containing Google’s AI trade secrets from Google’s network and uploaded them to his personal Google Cloud account. Ding also secretly affiliated himself with two PRC-based technology companies while he was employed by Google: around June 2022, Ding was in discussions to be the Chief Technology Officer for an early-stage technology company based in the PRC; by early 2023, Ding was in the process of founding his own technology company in the PRC focused on AI and machine learning and was acting as the company’s CEO. In multiple statements to potential investors, Ding claimed that he could build an AI supercomputer by copying and modifying Google’s technology. In December 2023, less than two weeks before he resigned from Google, Ding downloaded the stolen Google trade secrets to his own personal computer.

The jury found that Ding stole trade secrets relating to the hardware infrastructure and software platforms that allow Google’s supercomputing data center to train and serve large AI models. The trade secrets contained detailed information about the architecture and functionality of Google’s custom Tensor Processing Unit chips and systems and Google’s Graphics Processing Unit systems, the software that allows the chips to communicate and execute tasks, and the software that orchestrates thousands of chips into a supercomputer capable of training and executing cutting-edge AI workloads. The trade secrets also pertained to Google’s custom-designed SmartNIC, a type of network interface card used to facilitate high speed communication within Google’s AI supercomputers and cloud networking products.  

In presentations to investors, Ding called out the PRC’s national policies prioritizing AI development and innovation in the PRC, and in late 2023 Ding applied for a government sponsored “talent plan” in Shanghai, PRC. The jury heard evidence pertaining to the PRC government’s establishment of talent plans to encourage individuals to come to China to contribute to the PRC’s economic and technological growth. Ding’s application for this talent plan stated that he planned to “help China to have computing power infrastructure capabilities that are on par with the international level.” The evidence at trial also showed that Ding intended to benefit two entities controlled by the government of China by assisting with the development of an AI supercomputer and collaborating on the research and development of custom machine learning chips.

Ding is next scheduled to appear at a status conference on Feb. 3, 2026. Ding faces a maximum sentence of 10 years in prison for each count of theft of trade secrets in violation of 18 U.S.C. § 1832 and 15 years in prison for each count of economic espionage in violation of 18 U.S.C § 1831. Any sentence following conviction would be imposed by the Court only after consideration of the U.S. Sentencing Guidelines and the federal statute governing the imposition of a sentence, 18 U.S.C. § 3553.  

Assistant U.S. Attorneys for the Northern District of California Casey Boome, Molly K. Priedeman, and Roland Chang are prosecuting this case, with assistance from Veronica Hernandez and Trial Attorney Yifei Zheng from the Counterintelligence and Export Control Section, National Security Division.  The prosecution is the result of an investigation by the FBI.

US DOJ files action requiring divestiture by Chinese Company of U.S. Company

The U.S. Department of Justice has filed a complaint against China based Suirui Group’s acquisition of California’s Jupiter Systems based on national security concerns.  According to the press release, this is the first time an action like this has been filed. The Press Release states: 

Yesterday, the United States filed a complaint under section 721 of the Defense Production Act of 1950 to enforce a presidential order prohibiting Suirui Group’s acquisition, through Suirui International, of California-based Jupiter Systems and compelling Suirui to divest from Jupiter Systems. On July 8, 2025, the President issued the Order based on his findings that the transaction “threatens to impair the national security of the United States.” This is the first such action ever filed in federal district court.

While foreign direct investment is important to the United States’ economy, foreign investment in certain companies and certain industries, particularly those involved in defense or critical infrastructure, can pose national security concerns. To address these concerns, the President has the authority to take such action for such time as the President considers appropriate to suspend or prohibit such a transaction that threatens to impair the national security of the United States. The Committee on Foreign Investment in the United States (CFIUS) is empowered to review and investigate such transactions.

According to the Complaint, in 2020, Suirui Group, a Chinese company, through its Hong Kong subsidiary Suirui International, acquired all of Jupiter Systems, which provides video communications hardware and software to commercial and U.S. Government customers. On July 8, 2025, the President issued an Order prohibiting the transaction and, among other things, requiring Suirui to divest all its interests in Jupiter Systems within 120 days. According to the Complaint, despite CFIUS granting two extensions of the divestment deadline, to Feb. 3, Suirui and Jupiter Systems have failed to comply with the Order. The United States thus filed this action to protect the country’s national security interests.

The Justice Department’s Civil Division, Federal Programs Branch is handling the matter.  The case is captioned United States v. Suirui Group Co., Ltd., et al., No. 26-cv-00369 (D.D.C.). . . .

USPTO Proposes Rule Requiring Representation by Registered USPTO Practitioner for All Foreign Applicants and Patent Owners

The United States Patent and Trademark Office issued a press release concerning a new rule regarding foreign applicants and patent owners that is open for comment.  Details can be found here.  The press release states:

USPTO issues NPRM requiring foreign patent applicants to be represented by registered practitioners

Today, the United States Patent and Trademark Office (USPTO) is issuing a notice of proposed rulemaking (NPRM) directed to requiring foreign applicants and patent owners to be represented by a registered patent practitioner before the Office. 

The USPTO is proposing to amend the Rules of Practice in Patent Cases before the Office to require patent applicants and patent owners whose domicile is not located within the United States or its territories to be represented by a registered patent practitioner. The proposed requirement would bring the United States in line with the predominant global practice in jurisdictional patent offices that maintain requirements that such parties be represented by a licensed or registered person of that country. Moreover, this requirement would additionally increase efficiency and enable the USPTO to better use available mechanisms to enforce compliance with U.S. statutory and regulatory requirements and practice in patent matters and to respond and take appropriate actions with respect to false certifications, misrepresentations, and fraud.

Trump Executive Order Attempts to Stymie State AI Legislation

On December 11, 2025, President Trump issued an Executive Order titled, “Ensuring a National Policy Framework for Artificial Intelligence.”  The Executive Order is designed to address the proliferation of state laws concerning artificial intelligence.  The National Conference of State Legislatures has a database tracking state laws introduced in state legislatures generally concerning artificial intelligence.  There are over 1,000 laws introduced in state legislatures in 2025 alone related generally to artificial intelligence in that database (many of those laws were not enacted or are pending).  And, that database does not include separately tracked artificial intelligence legislation concerning specific technology such as autonomous vehicles, deep fakes or facial recognition.  What are the positives of such state legislation?  Some include the following, first, it is much harder for an industry to capture 50 state legislatures than one U.S. Congress.  Second, as laboratories of democracy, states can create legislation concerning artificial intelligence that are tried out and perhaps be a good model for federal adoption.  The Trump Executive Order states, in relevant part:

 

Section 1.  Purpose.  United States leadership in Artificial Intelligence (AI) will promote United States national and economic security and dominance across many domains.  Pursuant to Executive Order 14179 of January 23, 2025 (Removing Barriers to American Leadership in Artificial Intelligence), I revoked my predecessor’s attempt to paralyze this industry and directed my Administration to remove barriers to United States AI leadership.  My Administration has already done tremendous work to advance that objective, including by updating existing Federal regulatory frameworks to remove barriers to and encourage adoption of AI applications across sectors.  These efforts have already delivered tremendous benefits to the American people and led to trillions of dollars of investments across the country.  But we remain in the earliest days of this technological revolution and are in a race with adversaries for supremacy within it. 

To win, United States AI companies must be free to innovate without cumbersome regulation.  But excessive State regulation thwarts this imperative.  First, State-by-State regulation by definition creates a patchwork of 50 different regulatory regimes that makes compliance more challenging, particularly for start-ups.  Second, State laws are increasingly responsible for requiring entities to embed ideological bias within models.  For example, a new Colorado law banning “algorithmic discrimination” may even force AI models to produce false results in order to avoid a “differential treatment or impact” on protected groups.  Third, State laws sometimes impermissibly regulate beyond State borders, impinging on interstate commerce.

My Administration must act with the Congress to ensure that there is a minimally burdensome national standard — not 50 discordant State ones.  The resulting framework must forbid State laws that conflict with the policy set forth in this order.  That framework should also ensure that children are protected, censorship is prevented, copyrights are respected, and communities are safeguarded.  A carefully crafted national framework can ensure that the United States wins the AI race, as we must.

Until such a national standard exists, however, it is imperative that my Administration takes action to check the most onerous and excessive laws emerging from the States that threaten to stymie innovation.

Sec. 2.  Policy.  It is the policy of the United States to sustain and enhance the United States’ global AI dominance through a minimally burdensome national policy framework for AI. 

Sec. 3.  AI Litigation Task Force.  Within 30 days of the date of this order, the Attorney General shall establish an AI Litigation Task Force (Task Force) whose sole responsibility shall be to challenge State AI laws inconsistent with the policy set forth in section 2 of this order, including on grounds that such laws unconstitutionally regulate interstate commerce, are preempted by existing Federal regulations, or are otherwise unlawful in the Attorney General’s judgment, including, if appropriate, those laws identified pursuant to section 4 of this order.  The Task Force shall consult from time to time with the Special Advisor for AI and Crypto, the Assistant to the President for Science and Technology, the Assistant to the President for Economic Policy, and the Assistant to the President and Counsel to the President regarding the emergence of specific State AI laws that warrant challenge.

Sec. 4.  Evaluation of State AI Laws.  Within 90 days of the date of this order, the Secretary of Commerce, consistent with the Secretary’s authorities under 47 U.S.C. 902(b), shall, in consultation with the Special Advisor for AI and Crypto, the Assistant to the President for Economic Policy, the Assistant to the President for Science and Technology, and the Assistant to the President and Counsel to the President, publish an evaluation of existing State AI laws that identifies onerous laws that conflict with the policy set forth in section 2 of this order, as well as laws that should be referred to the Task Force established pursuant to section 3 of this order.  That evaluation of State AI laws shall, at a minimum, identify laws that require AI models to alter their truthful outputs, or that may compel AI developers or deployers to disclose or report information in a manner that would violate the First Amendment or any other provision of the Constitution.  The evaluation may additionally identify State laws that promote AI innovation consistent with the policy set forth in section 2 of this order.

Sec. 5.  Restrictions on State Funding.  (a)  Within 90 days of the date of this order, the Secretary of Commerce, through the Assistant Secretary of Commerce for Communications and Information, shall issue a Policy Notice specifying the conditions under which States may be eligible for remaining funding under the Broadband Equity Access and Deployment (BEAD) Program that was saved through my Administration’s “Benefit of the Bargain” reforms, consistent with 47 U.S.C. 1702(e)-(f).  That Policy Notice must provide that States with onerous AI laws identified pursuant to section 4 of this order are ineligible for non-deployment funds, to the maximum extent allowed by Federal law.  The Policy Notice must also describe how a fragmented State regulatory landscape for AI threatens to undermine BEAD-funded deployments, the growth of AI applications reliant on high-speed networks, and BEAD’s mission of delivering universal, high-speed connectivity.

(b)  Executive departments and agencies (agencies) shall assess their discretionary grant programs in consultation with the Special Advisor for AI and Crypto and determine whether agencies may condition such grants on States either not enacting an AI law that conflicts with the policy of this order, including any AI law identified pursuant to section 4 or challenged pursuant to section 3 of this order, or, for those States that have enacted such laws, on those States entering into a binding agreement with the relevant agency not to enforce any such laws during the performance period in which it receives the discretionary funding.

Sec. 6.  Federal Reporting and Disclosure Standard.  Within 90 days of the publication of the identification specified in section 4 of this order, the Chairman of the Federal Communications Commission shall, in consultation with the Special Advisor for AI and Crypto, initiate a proceeding to determine whether to adopt a Federal reporting and disclosure standard for AI models that preempts conflicting State laws. 

Sec. 7.  Preemption of State Laws Mandating Deceptive Conduct in AI Models.  Within 90 days of the date of this order, the Chairman of the Federal Trade Commission shall, in consultation with the Special Advisor for AI and Crypto, issue a policy statement on the application of the Federal Trade Commission Act’s prohibition on unfair and deceptive acts or practices under 15 U.S.C. 45 to AI models.  That policy statement must explain the circumstances under which State laws that require alterations to the truthful outputs of AI models are preempted by the Federal Trade Commission Act’s prohibition on engaging in deceptive acts or practices affecting commerce.

Sec. 8.  Legislation.  (a)  The Special Advisor for AI and Crypto and the Assistant to the President for Science and Technology shall jointly prepare a legislative recommendation establishing a uniform Federal policy framework for AI that preempts State AI laws that conflict with the policy set forth in this order.

(b)  The legislative recommendation called for in subsection (a) of this section shall not propose preempting otherwise lawful State AI laws relating to:

(i)    child safety protections;

(ii)   AI compute and data center infrastructure, other than generally applicable permitting reforms;

(iii)  State government procurement and use of AI; and

(iv)   other topics as shall be determined.

Sec. 9.  General Provisions.  (a)  Nothing in this order shall be construed to impair or otherwise affect:

(i)   the authority granted by law to an executive department or agency, or the head thereof; or

(ii)  the functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.

(b)  This order shall be implemented consistent with applicable law and subject to the availability of appropriations.

U.S. National Institute for Standards and Technology Releases Cybersecurity Framework Profile for AI

The U.S. National Institute for Standards and Technology has released the draft, “Cybersecurity Framework Profile for Artificial Intelligence,” which is subject to public comment. The abstract states:

The Cybersecurity Framework Profile for Artificial Intelligence (AI) Profile (“Cyber AI Profile” or “The Profile”) will provide guidelines for managing cybersecurity risk related to AI systems as well as identifying opportunities for using AI to enhance cybersecurity capabilities. The Profile is organized using the NIST Cybersecurity Framework 2.0 outcomes (Functions, Categories, and Subcategories). This Preliminary Draft is shared along with a request for public comment to solicit feedback on the planned direction and content. Comments received will inform the initial public draft. More information about this project, including a roadmap, is available on the National Cybersecurity Center of Excellence (NCCoE) Cyber AI Profile project page.

Notably, the Cyber AI Profile addresses standard essential patents:

Call for Patent Claims

This public review includes a call for information on essential patent claims (claims whose use would be required for compliance with the guidance or requirements in this Information Technology Laboratory (ITL) draft publication). Such guidance and/or requirements may be directly stated in this ITL Publication or by reference to another publication. This call also includes disclosure, where known, of the existence of pending U.S. or foreign patent applications relating to this ITL draft publication and of any relevant unexpired U.S. or foreign patents.

ITL may require from the patent holder, or a party authorized to make assurances on its behalf, in written or electronic form, either:

a) assurance in the form of a general disclaimer to the effect that such party does not hold and does not currently intend holding any essential patent claim(s); or

b) assurance that a license to such essential patent claim(s) will be made available to applicants desiring to utilize the license for the purpose of complying with the guidance or requirements in this ITL draft publication either:

i. under reasonable terms and conditions that are demonstrably free of any unfair discrimination; or

ii. without compensation and under reasonable terms and conditions that are demonstrably free of any unfair discrimination.

Such assurance shall indicate that the patent holder (or third party authorized to make assurances on its behalf) will include in any documents transferring ownership of patents subject to the assurance, provisions sufficient to ensure that the commitments in the assurance are binding on the transferee, and that the transferee will similarly include appropriate provisions in the event of future transfers with the goal of binding each successor-in-interest. The assurance shall also indicate that it is intended to be binding on successors-in-interest regardless of whether such provisions are included in the relevant transfer documents. Such statements should be addressed to: cyberaiprofile@nist.gov

USPTO Issues New Guidance on AI Assisted Inventions

The USPTO has rescinded its prior guidance on AI assisted inventions which relied on the Pannu factors when determining if a human sufficiently contributed to an AI-assisted invention to be considered an inventor.  The USPTO will continue to look to the Pannu factors in cases involving multiple humans to determine joint inventorship.  The USPTO will now focus on conception as the main test to determine whether a human is an inventor when using AI.  I understand why the USPTO is following this approach, but I did find the Pannu test helpful for ascertaining inventorship with AI assisted inventions.  My belief is that the USPTO’s new approach will result in more AI assisted inventions resulting in patentability.  The guidance applies to utility, design and plant patents.  Here is the updated guidance:

Revised Inventorship Guidance for AI-Assisted Inventions

AGENCY: United States Patent and Trademark Office, Department of Commerce. ACTION: Examination guidance.

SUMMARY: The United States Patent and Trademark Office (USPTO) had issued inventorship guidance for AI-assisted inventions on February 13, 2024.1 The USPTO hereby rescinds the previously published Inventorship Guidance for AI-Assisted Inventions and replaces it with the guidance below. . . .

I. Purpose

This notice provides further guidance on the proper legal standard for determining inventorship in patent applications for AI-assisted inventions.

II. Recission of Prior Guidance

The guidance issued on February 13, 2024, titled “Inventorship Guidance for AI-Assisted Inventions” is rescinded in its entirety. The approach set forth in that guidance, which relied on the application of the Pannu factors to AI-assisted inventions, is withdrawn. The Pannu factors only apply when determining whether multiple natural persons qualify as joint inventors. Pannu is inapplicable when only one natural person is involved in developing an invention with AI assistance because AI systems are not persons and therefore cannot be “joint inventors” so there is no joint inventorship question to analyze.

III. Governing Legal Standards

The same legal standard for determining inventorship applies to all inventions, regardless of whether AI systems were used in the inventive process. There is no separate or modified standard for AI-assisted inventions.

The Federal Circuit has held that AI cannot be named as an inventor on a patent application (or issued patent) and that only natural persons can be inventors. Artificial intelligence systems, regardless of their sophistication, cannot be named as inventors or joint inventors on a patent application as they are not natural persons.

The Federal Circuit has centered its inventorship inquiry around “conception,” characterizing conception as “the touchstone of inventorship.” Conception is “the formation in the mind of the inventor, of a definite and permanent idea of the complete and operative invention, as it is hereafter to be applied in practice.” Conception is complete when “the inventor has a specific, settled idea, a particular solution to the problem at hand, not just a general goal or research plan.”

Determining inventorship is highly fact intensive. The question is whether the natural person possessed knowledge of all the limitations of the claimed invention such that it is so “clearly defined in the inventor’s mind that only ordinary skill would be necessary to reduce the invention to practice, without extensive research or experimentation.” Analysis of conception turns on the ability of an inventor to describe an invention with particularity. Absent such a description, an inventor cannot objectively prove possession of a complete mental picture of the invention at a later time.

IV. Inventorship Guidance for AI-Assisted Inventions

Generally, the USPTO presumes those inventors named on the application data sheet or oath/declaration are the actual inventor or joint inventors of the application. A rejection under 35 U.S.C. 101 and 115, or other appropriate action, should be made for all claims in any application that lists an AI system or other non-natural person as an inventor or joint inventor.

AI systems, including generative AI and other computational models, are instruments used by human inventors. They are analogous to laboratory equipment, computer software, research databases, or any other tool that assists in the inventive process. As the case law establishes, inventors may “use the services, ideas, and aid of others” without those sources becoming co-inventors. The same principle applies to AI systems: they may provide services and generate ideas, but they remain tools used by the human inventor who conceived the claimed invention. When one natural person is involved in creating an invention with the assistance of AI, the inquiry is whether that person conceived the invention under the traditional conception standard set forth above in Section III.

When multiple natural persons are involved in creating an invention with AI assistance, the traditional joint inventorship principles apply, including the Pannu factors to determine whether each person qualifies as a joint inventor. Each purported inventor must “(1) contribute in some significant manner to the conception or reduction to practice of the invention, (2) make a contribution to the claimed invention that is not insignificant in quality, when that contribution is measured against the dimension of the full invention, and (3) do more than merely explain to the real inventors well-known concepts and/or the current state of the art.” The fact that AI tools were used in the development process does not change the joint inventorship analysis among the human contributors. . . .

Teva Pharmaceuticals will remove over 200 improper patent listings from the Orange Book

On December 10, 2025, the FTC announced that Teva Pharmaceuticals will “[r]emove. . .  Over 200 Improper Patent Listings” to improve generic competition.  The Press Release states:

FTC investigation prompts Teva request for removal of patents from Orange Book, paving the way for generic competition

After a challenge from the Federal Trade Commission, Teva Pharmaceuticals has requested that the Food and Drug Administration (FDA) remove more than 200 improper patent listings from the FDA’s Orange Book. The FTC sent a series of warning letters in May 2025 to Teva and several other pharmaceutical companies, which have also withdrawn most of the disputed listings.

These challenges are part of the FTC’s broader efforts to promote competition and lower drug prices in keeping with President Trump’s Executive Order on Lowering Drug Prices. Improper patent listings can limit competition by preventing generic alternatives from entering the market. This can keep drug prices artificially high and prevent patients from accessing lower-cost alternatives. The removals of more than 200 improper listings will pave the way for greater competition for generic alternatives for more than 30 asthma, diabetes, and COPD drugs and epinephrine autoinjectors.

“President Trump has promised Americans access to prescription drugs at lower costs. The FTC is fighting to help deliver on that promise,” said FTC Chairman Andrew N. Ferguson. “When improper patent listings limit competition from generic alternatives, it hurts Americans’ bank accounts and more importantly, it can endanger their health. The Trump-Vance FTC is working hard to ensure that Americans have access to the affordable prescription drugs they need.”

The FTC’s 2025 challenges followed a decision from the U.S. Court of Appeals for the Federal Circuit decision that affirmed that Teva’s patents were improperly listed, consistent with an amicus brief filed by the FTC. The FTC will continue to monitor the pharmaceutical industry for other improper listings and anticompetitive conduct.

The Federal Trade Commission works to promote competition, and to protect and educate consumers. The FTC will never demand money, make threats, tell you to transfer money, or promise you a prize. You can learn more about how competition benefits consumers, file an antitrust complaint, or comment on a proposed merger. For the latest news and resources, follow the FTC on social media, subscribe to press releases, and read our blog.