Medicaid to Receive Most Favored Nation Pricing on Pfizer Drugs

The White House has announced that President Trump has made a deal with Pfizer for state Medicaid to receive most favored nation pricing on Pfizer pharmaceuticals.  This is welcome news; however, I do wonder if the rest of the world’s pharmaceutical prices will rise.  The White House has released a fact sheet that states:

ADVANCING MOST-FAVORED-NATION PRICING: Today, President Donald J. Trump announced the first agreement with a major pharmaceutical company, Pfizer, to bring American drug prices in line with the lowest paid by other developed nations (known as the most-favored-nation, or MFN, price).

• The agreement will provide every State Medicaid program in the country access to MFN drug prices on Pfizer products, resulting in many millions of dollars in savings and continuing President Trump’s historic efforts to strengthen the program for the most vulnerable.
• The agreement ensures foreign nations can no longer use price controls to freeride on American innovation by guaranteeing MFN prices on all new innovative medicines Pfizer brings to market. 
• The agreement requires Pfizer to repatriate increased foreign revenue on existing products that Pfizer realizes as a result of the President’s strong America First U.S. trade policies for the benefit of American patients. 
• The agreement requires Pfizer to offer medicines at a deep discount off the list price when selling directly to American patients.

 
DELIVERING REDUCED COSTS: Today’s actions will result in tangible cost savings to American patients and the healthcare system as a whole. Taken together, more than 100 million patients are impacted by the diseases Pfizer’s medicines treat, and many of those will benefit from the President’s successful negotiation of lower prices for Americans. Examples include:

• Eucrisa, a topical ointment for atopic dermatitis, will be made available at an 80% discount to patients purchasing directly.
• Xeljanz, a widely used oral medication for rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis, will be available at a 40% discount to patients purchasing directly.
•  Zavzpret, a commonly utilized treatment for migraines, will be sold directly to patients at a 50% discount.

 
ENDING GLOBAL FREELOADING ON AMERICAN PHARMACEUTICAL INNOVATION:  President Trump is taking decisive action to rebalance a system that allows pharmaceutical manufacturers to offer low prices to other wealthy nations while charging Americans significantly higher prices.  

• According to recent data, the prices Americans pay for brand-name drugs are more than three times the price other Organization for Economic Cooperation and Development nations pay, even after accounting for discounts manufacturers provide in the U.S. 
• The United States has less than five percent of the world’s population, yet roughly 75% of global pharmaceutical profits come from American taxpayers.
• Drug manufacturers benefit from generous research subsidies and enormous healthcare spending by the U.S. Government. Instead of passing that benefit through to American consumers, drug manufacturers then discount their products abroad to gain access to foreign markets and subsidize those discounts through high prices charged in America. Americans are subsidizing drug-manufacturer profits and foreign health systems, both in development and once the drugs are sold. 

 
DELIVERING ON PROMISES TO PUT AMERICAN PATIENTS FIRST: President Trump is delivering on promises for American patients that the political establishment did not believe were possible.

• On May 12, 2025, President Trump signed an Executive Order titled: “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients” directing the Administration to take numerous actions to bring American drug prices in line with those paid by similar nations.
• On July 31, 2025, President Trump sent letters to leading pharmaceutical manufacturers outlining the steps they must take to bring down the prices of prescription drugs in the United States to match the lowest price offered in other developed nations 
• President Trump has been relentless in his effort to address the unfair and outrageous prices Americans pay for prescription drugs:

o   President Trump: “In case after case, our citizens pay massively higher prices than other nations pay for the same exact pill, from the same factory, effectively subsidizing socialism aboard [abroad] with skyrocketing prices at home. So we would spend tremendous amounts of money in order to provide inexpensive drugs to another country. And when I say the price is different, you can see some examples where the price is beyond anything — four times, five times different.”

AI Patent Claims are 101 Patent Eligible Subject Matter

In the matter of ex parte Desjardins et al., the Appeals Review Panel vacates the Patent Board of Appeals decision that claims concerning machine learning are not patent eligible subject matter.  The Appeals Review Panel included Under Secretary of Intellectual Property John Squires who is also Director of the United States Patent and Trademark Office.  The Appeals Review Panel criticized the Patent Board of Appeals for not adequately considering the teachings of the Federal Circuit’s Microsoft v. Enfish decision and stated:

Under a charitable view, the overbroad reasoning of the original panel below is perhaps understandable given the confusing nature of existing § 101 jurisprudence, but troubling, because this case highlights what is at stake. Categorically excluding AI innovations from patent protection in the United States jeopardizes America's leadership in this critical emerging technology. Yet, under the panel's reasoning, many AI innovations are potentially unpatentable-even if they are adequately described and nonobvious-because the panel essentially equated any machine learning with an unpatentable "algorithm" and the remaining additional elements as "generic computer components," without adequate explanation. Dec. 24. Examiners and panels should not evaluate claims at such a high level of generality.

The reasoning of the Appeals Review Panel is based upon the USPTO approach to patent eligible subject matter analysis. 

Anthropic Settles Copyright Suit

Wired Magazine reports that the class action copyright suit involving Anthropic in the Northern District of California (Bartz v. Anthropic) has been settled (for the most part) for around $1.5 billion US.  The article is available, here.  

The practical implications of the settlement on positioning in other copyright suits involving generative artificial intelligence remain to be seen.  In June, Judge Alsup issued an order stating, in part:

. . . This order grants summary judgment for Anthropic that the training use was a fair use. And, it grants that the print-to-digital format change was a fair use for a different reason. But it denies summary judgment for Anthropic that the pirated library copies must be treated as training copies.

We will have a trial on the pirated copies used to create Anthropic's central library and the resulting damages, actual or statutory (including for willfulness). That Anthropic later bought a copy of a book it earlier stole off the internet will not absolve it of liability for the theft but it may affect the extent of statutory damages. Nothing is foreclosed as to any other copies flowing from library copies for uses other than for training LLMs.

Decluttering the US Trademark Register from Fraudulent Filings

The United States Trademark Office has terminated over 52,000 trademark pending registrations and registrations based on widespread fraud by a foreign-filing entity.  Notably, the sanctions order states the following administrative sanctions:

(1) Permanently preclude Respondents from submitting trademark-related documents on behalf of Respondents or others; (2) Strike or otherwise give no weight to all trademark-related documents submitted by Respondents; (3) Deactivate any USPTO accounts in which contact information related to Respondents appears, and take action to prevent Respondents from creating or activating further accounts; (4) Block future financial transactions from credit cards used to pay filing fees associated with the improper submissions and/or associated with Respondents; (5) Terminate all pending proceedings identified by Serial Numbers in Exhibit A because they contain submissions filed by Respondents. . .; (6) For trademark proceedings later found to involve Respondents or containing submissions filed by Respondents, continue to strike documents, remove information, deactivate accounts, block financial transactions, and terminate proceedings.

The Press Release states:

On August 6, 2025, the U.S. Patent and Trademark Office (USPTO) issued sanctions against a foreign filing firm and terminated over 52,000 applications and registrations connected to the firm. The firm submitted documents on behalf of others without the proper authority or qualifications. To conceal this, they: Sought out the cooperation of U.S.-licensed attorneys and then misused their credentials and faked their electronic signatures; Repeatedly signed documents using other people’s names; Submitted fake specimens of use; and Misused USPTO.gov accounts. By removing these records from the trademark register, the USPTO is helping ensure the register accurately reflects trademarks that are actually being used in commerce.

Report Shows Growth in Investment in Intangible Assets

An article titled, Investment in Intangible Assets Surges, led by Funding for Software and Databases Amid AI Boom, which discusses a report by WIPO and Italy’s Luiss Business School, states, “that in the last year alone, intangible investment across 27 high-and middle-income economies grew by about 3 percent in real terms, reaching USD 7.6 trillion in 2024, up from USD 7.4 trillion in 2023.”  The article additionally states that, “investment in intangible assets has . . . increase[ed] at a compound annual rate of about 4 percent between 2008 and 2024, far outpacing tangible investment growth of just 1 percent.”  The article can be found, here. 

Free LES Webinar on IP Valuation in M&A Deal Making

The Silicon Valley Chapter of LES is hosting a free webinar titled, IP Valuation in Special Situations: Closing the Intangible Value Gap in M&A Deal Making on Tuesday, June 24 at 9:00 am to 10:30 pm Pacific Time.  The notice concerning the webinar states:

“Efrat [Kasznik] will present four unique strategies for integrating IP assets in M&A deal pricing without disrupting deal workflows, while addressing the needs of both sellers and buyers. Topics to be covered include: Current trends in M&A deals How are companies valued in M&A deals? Why is there an intangible valuation gap in M&A deals? Seller and buyer M&A deal pricing considerations Strategies for bridging the intangible valuation gap Personal Insights from an M&A deal where the valuation gap was addressed using IP Make connections to help discover and drive deals. Engage 75+ registered participants —innovators, investors, IP management experts from startups and established SV organizations, and many more.  Online via Zoom” The Registration Link is, here.

FBI Reports Hacker Group After US Law Firms (Again)

The U.S. Federal Bureau of Investigation (FBI) Cyber Division (Internet Crime Complaint Center) has issued a warning that certain malicious cyber actors are targeting law firms.  Law firms are a ripe target for valuable information concerning clients, including intellectual property.  The warning states, in part:

The cyber threat actor Silent Ransom Group (SRG), also known as Luna Moth, Chatty Spider, and UNC3753, is targeting law firms using information technology (IT) themed social engineering calls, and callback phishing emails, to gain remote access to systems or devices and steal sensitive data to extort the victims. While SRG has historically victimized companies in many sectors, starting Spring 2023, the group has consistently targeted US-based law firms, likely due to the highly sensitive nature of legal industry data. . . .

As of March 2025, SRG was observed changing their tactics to calling individuals and posing as an employee from their company’s IT department. SRG will then direct the employee to join a remote access session, either through an email sent to them, or navigating to a web page. Once the employee grants access to their device, they are told that work needs to be done overnight. Once in the victim’s device, a typical SRG attack involves minimal privilege escalation and quickly pivots to data exfiltration conducted through “WinSCP” (Windows Secure Copy) or a hidden or renamed version of “Rclone.” If the compromised device does not have administrative privileges, WinSCP portable is used to exfiltrate victim data. Although this tactic has only been observed recently, it has been highly effective and resulted in multiple compromises. Similar to their phishing emails posing as a company with a subscription, once SRG exfiltrates data, they extort the victim by sending them a ransom email threatening to sell or post the data online. SRG will also call employees at a victim company to pressure them into engaging in ransom negotiations. SRG has developed a publicly available site to post victim data, however, they are inconsistent in their use of the site, and do not always follow through on posting victim data.

Governmental Best Practices Report on AI Data Security

U.S., UK, Australian and New Zealand government cybersecurity related agencies have recently released a joint report titled, “AI Data Security Best Practices for Securing Data Used to Train & Operate AI Systems.”  The report provides advice for addressing potential threats to AI data security.  Notably, for the U.S., the report provides minimum security standards that may be applicable in subsequent litigation and important in drafting contracts concerning AI use and adoption.  The report states:

Data security is of paramount importance when developing and operating AI systems. As organizations in various sectors rely more and more on AI-driven outcomes, data security becomes crucial for maintaining accuracy, reliability, and integrity. The guidance provided in this CSI outlines a robust approach to securing AI data and addressing the risks associated with the data supply chain, malicious data, and data drift. Data security is an ever-evolving field, and continuous vigilance and adaptation are key to staying ahead of emerging threats and vulnerabilities. The best practices presented here encourage the highest standards of data security in AI while helping ensure the accuracy and integrity of AI-driven outcomes. By adopting these best practices and risk mitigation strategies, organizations can fortify their AI systems against potential threats and safeguard sensitive, proprietary, and mission critical data used in the development and operation of their AI systems.

U.S. Department of Homeland Security Revokes Harvard's Ability to Enroll Foreign Students

The U.S. Department of Homeland Security press release states:

Harvard University Loses Student and Exchange Visitor Program Certification for Pro-Terrorist Conduct

Harvard is being held accountable for collaboration with the CCP, fostering violence, antisemitism, and pro-terrorist conduct from students on its campus.

WASHINGTON – Today, Homeland Security Secretary Kristi Noem ordered DHS to terminate the Harvard University’s Student and Exchange Visitor Program (SEVP) certification.

This means Harvard can no longer enroll foreign students and existing foreign students must transfer or lose their legal status.

Harvard’s leadership has created an unsafe campus environment by permitting anti-American, pro-terrorist agitators to harass and physically assault individuals, including many Jewish students, and otherwise obstruct its once-venerable learning environment. Many of these agitators are foreign students. Harvard’s leadership further facilitated, and engaged in coordinated activity with the CCP, including hosting and training members of a CCP paramilitary group complicit in the Uyghur genocide.

“This administration is holding Harvard accountable for fostering violence, antisemitism, and coordinating with the Chinese Communist Party on its campus,” said Secretary Noem. “It is a privilege, not a right, for universities to enroll foreign students and benefit from their higher tuition payments to help pad their multibillion-dollar endowments. Harvard had plenty of opportunity to do the right thing. It refused. They have lost their Student and Exchange Visitor Program certification as a result of their failure to adhere to the law. Let this serve as a warning to all universities and academic institutions across the country.”

On April 16, 2025, Secretary Noem demanded Harvard provide information about the criminality and misconduct of foreign students on its campus. Secretary Noem warned refusal to comply with this lawful order would result in SEVP termination.

This action comes after DHS terminated $2.7 million in DHS grants for Harvard last month.

Harvard University brazenly refused to provide the required information requested and ignored a follow up request from the Department’s Office of General Council. Secretary Noem is following through on her promise to protect students and prohibit terrorist sympathizers from receiving benefits from the U.S. government.

Facts about Harvard’s toxic campus climate:

• A joint-government task force found that Harvard has failed to confront pervasive race discrimination and anti-Semitic harassment plaguing its campus.
• Jewish students on campus were subject to pervasive insults, physical assault, and intimidation, with no meaningful response from Harvard’s leadership.
• A protester charged for his role in the assault of a Jewish student on campus was chosen by the Harvard Divinity School to be the Class Marshal for commencement.
• Harvard’s own 2025 internal study on anti-Semitism revealed that almost 60% of Jewish students reported experiencing “discrimination, stereotyping, or negative bias on campus due to [their] views on current events.”
• In one instance, a Jewish student speaker at a conference had planned to tell the story of his Holocaust survivor grandfather finding refuge in Israel. Organizers told the student the story was not “tasteful” and laughed at him when he expressed his confusion. They said the story would have justified oppression.
• Meanwhile, Pro-Hamas student groups that promoted antisemitism after the October 7 attacks remained recognized and funded.

Instead of protecting its students, Harvard has let crime rates skyrocket, enacted racist DEI practices, and accepted boatloads of cash from foreign governments and donors.

• Crime rates at Harvard increased by 55% from 2022 to 2023.

o   From 2022 to 2023 aggravated assaults increased 295% and robberies increased 560%

• Harvard has adopted race-conscious hiring policies, potentially in violation of civil rights law.
• Harvard Received $151 Million From Foreign Governments Since January 2020 — making up more than 13 percent of the total $1.1 billion received from foreign donors over the same period.
• Harvard hosted and trained members of the Xinjiang Production and Construction Corps (XPCC), a CCP paramilitary group complicit in the Uyghur genocide, even after its 2020 designation on the U.S. Treasury’s Specially Designated Nationals List, with engagements continuing as recently as 2024.
• Harvard researchers collaborated with China-based academics on projects funded by an Iranian government agent and partnered with Chinese universities tied to military advancements, including aerospace and optics research, using U.S. Department of Defense funds.
• Harvard partnered with individuals linked to China’s defense-industrial base, including conducting robotics research with military applications.

U.S. Budget: Artificial Intelligence and University Endowments

The U.S. budget reconciliation bill is moving through the U.S. Congress.  One part getting attention concerns artificial intelligence.  First, subsections (a) and (b) provide for funding to upgrade the federal information technology system with artificial intelligence.  Importantly, the funding should provide better cybersecurity protection for federal information technology systems.  Second, subsection (c) seems to provide a ban on enforcement of state or local regulation of artificial intelligence.  A draft of the proposed section is below.

PART 2—ARTIFICIAL INTELLIGENCE AND INFORMATION TECHNOLOGY MODERNIZATION

Section 43201. Artificial intelligence and information technology modernization initiative.

Subsection (a) would appropriate $500,000,000 to the Department of Commerce for fiscal year 2025, to remain available through September 30, 2035, for the purpose of modernizing and securing federal information technology systems through the deployment of commercial artificial intelligence, automation technologies, and the replacement of antiquated business systems.

Subsection (b) states that the Secretary of Commerce shall use these funds to support the replacement and modernization of legacy business systems with state-of-the-art commercial artificial intelligence systems and automated decision systems, the adoption of artificial intelligence models that increase operational efficiency and service delivery, and improve the cybersecurity posture of Federal information technology systems through modernized architecture, automated threat detection, and integrated artificial intelligence solutions.

Subsection (c) states that no state or political subdivision may enforce any law or regulation regulating artificial intelligence models, artificial intelligence systems, or automated decision systems during the 10-year period beginning on the date of the enactment of this Act.

Subsection (d) provides definitions for key terms used in the Act, including “artificial intelligence”, “artificial intelligence model”, “artificial intelligence system”, and “automated decision system”.

The House Ways and Means Committee has a list of other parts of the proposed budget bill of interest, including taxation of university endowments:

• Holds woke, elite universities that operate more like major corporations and other tax-exempt entities accountable, ensuring they can no longer abuse generous benefits provided through the tax code.
• Increases the university endowment tax and subjects the largest endowments to the corporate tax rate.
• Increases tax on massive non-profits that resemble hedge funds and pay their employees huge salaries.

The National Conference of State Legislatures states: “[This a]dds to the current 1.4% excise tax on net investment income from private universities endowments that are greater than $500,000 per student. The new tax rate is based on a tiered, student-adjusted system. Universities with per-student endowments above $2,000,000 are taxed at a 21% rate, between $1,250,000 and $1,999,999 at 14%, and between $750,000 and $1,249,999 at 7%.” 

Reducing Anticompetitive U.S. Regulations Process Continues

The U.S. Federal Trade Commission (FTC) and the U.S. Department of Justice Antitrust are continuing their work to address anticompetitive regulations across the U.S. government.  The FTC press release states:

Today, the Federal Trade Commission and the Department of Justice Antitrust Division issued a joint letter directing the heads of agencies across the federal government to create a list of anticompetitive regulations that reduce competition, entrepreneurship, and innovation.

FTC Chairman Andrew N. Ferguson and Assistant Attorney General Abigail Slater of the DOJ’s Antitrust Division issued the letter, which advances President Trump’s Executive Order on Reducing Anticompetitive Regulatory Barriers.

The Executive Order directs all agency heads to provide a list identifying anticompetitive regulations within their agency’s rulemaking authority to the FTC and DOJ. Along with each regulation identified, the agency must include a recommendation for deletion; a recommendation for specific modifications; or a justification for the potential anticompetitive effects.

The joint letter follows a recent Request for Information launched by the FTC inviting members of the public to comment on how federal regulations can harm competition in the American economy.

Following public feedback and the lists of anticompetitive regulations from agency heads, the FTC and DOJ will provide the Director of the Office of Management and Budget a consolidated list of regulations that should be rescinded or modified, along with recommended modifications.

Steve Blank Sounds Warning for U.S. Academic Research Decline

The very talented Steve Blank has laid out a case for why U.S. academic research is in serious trouble based on recent U.S. policy changes.  As he states, once you lose your advantage it's unlikely to be regained.  My guess is that there's a certain point at which the lead is lost and is too difficult to regain.  A March 2025 Nature article reports on a poll which indicates that of 1,600 scientists surveyed around 75% are contemplating moving with Canada or Europe as top destinations. I wonder what unintended consequences--particularly those that are beneficial for the United States--may exist in distributing U.S. researchers around the world. Could they be lured back in three years and seven months?  And, what could be some unintended negative consequences?  Do we really want to lose our best researchers during a military build-up around the world?  Gee whiz, it seems like almost everything is a national security issue and all technology is dual use.  Steve Blank's blog post is available, here.  

U.S. Department of Justice Creates Anticompetitive Regulation Task Force

On March 27, 2025, the U.S. Department of Justice launched the Anticompetitive Regulations Task Force.  The Task Force is soliciting public input concerning regulations that may hinder competition.  I wonder if IP-related laws will be examined.  The Press Release states:

Today, the Justice Department launches an Anticompetitive Regulations Task Force to advocate for the elimination of anticompetitive state and federal laws and regulations that undermine free market competition and harm consumers, workers, and businesses. The Antitrust Division has a long history of advocacy against laws and regulations that create unnecessary barriers to competition.  The Task Force will surge resources to these efforts and invite public comments to support the Administration’s mission to unwind laws and regulations that hinder business dynamism and make markets less competitive.    

“Realizing President Trump’s economic Golden Age will require unwinding burdensome regulations that stifle free market competition. This Antitrust Division will stand against harmful barriers to competition whether imposed by public regulators or private monopolists,” said Assistant Attorney General Abigail Slater of the Justice Department’s Antitrust Division. “We look forward to working with the public and with other federal agencies to identify and eliminate anticompetitive laws and regulations.”

On Jan. 31, President Trump signed Executive Order 14192 declaring “the policy of the executive branch” to be that federal agencies should “alleviate unnecessary regulatory burdens placed on the American people.” Consistent with this policy, on Feb. 19, President Trump signed Executive Order 14219 directing agencies to “initiate a process to review all regulations” and identify regulations that, among other things, “impose undue burdens on small businesses and impede private enterprise and entrepreneurship.” Consistent with longstanding practice, the Antitrust Division will support federal agencies’ deregulatory initiatives by sharing its market expertise on regulations that pose the greatest barriers to economic growth.

Regulatory capture is a well-studied phenomenon in which agencies become “captured” by special interests and big businesses, rather than serving the interests of the American people. But when regulations serve the few and impose undue burdens on small businesses, private enterprise, and entrepreneurs, they also harm competition and ultimately hurt American consumers, workers, and businesses. For example, regulations can increase compliance costs, preventing businesses from competing on a level playing field with powerful corporations. Regulations can also discourage or even intentionally prohibit small businesses and new products from entering markets and lowering prices for American families. In contrast, eliminating unnecessary anticompetitive regulations makes it easier for businesses to compete. More competition empowers the American people — not government regulators — to drive economic progress and innovation. When every American has a fair opportunity to enjoy the benefits of competitive free markets, every American has an opportunity to realize the American dream.

By identifying and working with state and federal agencies to revise or eliminate these laws and regulations, the Anticompetitive Regulations Task Force will contribute to making the American dream a reality. As a first step, the Antitrust Division will initiate a public inquiry to identify unnecessary laws and regulations that raise the highest barriers to competition. In particular, the Division will seek information from the public about laws and regulations that make it more difficult for businesses to compete effectively, especially in markets that have the greatest impact on American households, including:

• Housing: Americans spend more than one-third of their monthly income on housing, and the cost of owning or renting a home continues to rise. Laws and regulations in housing markets can contribute to these problems by making it more difficult for companies to build and ordinary Americans to rent or buy.
• Transportation: Laws and regulations in areas like airlines, rail, and ocean shipping can grant antitrust immunities, outright monopolies, or safe harbors for conduct that undermines competition. As a result, Americans pay more for travel, fuel, and a variety of other products.
• Food and Agriculture: By the end of the Biden-Harris Administration, grocery prices were 27% higher than at the end of the first Trump Administration. Eliminating unnecessary anticompetitive regulations will help farmers, growers, and ranchers increase the amount of food they produce and unlock lower prices for American consumers.
• Healthcare: Laws and regulations in healthcare markets too often discourage doctors and hospitals from providing low-cost, high-quality healthcare and instead encourage overbilling and consolidation. These kinds of unnecessary anticompetitive regulations put affordable healthcare out of reach for millions of American families.
• Energy: Reliable and affordable energy is essential to modern American life — whether in homes, businesses, manufacturing plants, schools, hospitals, sporting events, or data centers. Laws and regulations can undermine reliability and affordability by protecting incumbent electricity providers from competition or disruptive innovation.

The public will have 60 days to submit comments at www.Regulations.gov (Docket No. ATR-2025-0001), no later than May 26. Once submitted, comments will be posted to Regulations.gov. All market participants are invited to provide comments in response to this inquiry, including consumers, consumer advocates, small businesses, employers, trade groups, industry analysts, and other entities that are impacted by anticompetitive state or federal laws and regulations.

In addition to reviewing responses from the public, the Task Force will bring together attorneys, economists, and other staff from across the Division, together with interagency partners, to identify state and federal laws and regulations that unnecessarily harm competition. The Antitrust Division will then take appropriate action, including helping agencies revise or eliminate these regulations.

The Task Force will also consider other ways to advocate for the removal of anticompetitive laws and regulations. The Division routinely files amicus briefs and statements of interests in private litigation, and it will continue to do so to promote competition and oppose anticompetitive laws and regulations. The Division also provides comments on proposed legislation in the states on the request of state legislators. These efforts will continue with an eye toward protecting competition and interstate commerce in light of dormant Commerce Clause principles.

The Justice Department has a long history of serving as the Executive Branch’s chief competition advocate by working with agencies to identify and eliminate unnecessary regulations. In 2018, the Justice Department released a report on how regulations can harm competition. Following this report, the Justice Department submitted dozens of comments to federal agencies supporting efforts to eliminate unnecessary regulations and increase competition. For example, the Justice Department, in consultation with the Federal Trade Commission, submitted a comment opposing  regulations that would have protected incumbent electricity transmission companies from much-needed competition in energy markets across the country. The Justice Department filed comments aimed at making it easier for individuals and small businesses to navigate the federal government bureaucracy. The Justice Department also provided technical assistance and trainings to federal agencies to help them analyze how new and existing regulations might affect competition, or whether competition may be a better alternative to regulation altogether.

The Anticompetitive Regulations Task Force will continue these efforts, supporting ongoing efforts across the Trump Administration to unleash competition by eliminating unnecessary, burdensome, and wasteful government regulations. For more information on the Task Force, including contact information, see Anticompetitive Regulations Task Force page on the Division’s website.

Bad Timing: Starving the University Technology Transfer System

A group of over 1000 scientists who are elected members of the National Academy of Sciences, Engineering and Medicine has released a letter expressing concern with the Trump Administration’s handling of research funding.  The letter states, in part:

If our country’s research enterprise is dismantled, we will lose our scientific edge. Other countries will lead the development of novel disease treatments, clean energy sources, and the new technologies of the future. Their populations will be healthier, and their economies will surpass us in business, defense, intelligence gathering, and monitoring our planet’s health. The damage to our nation’s scientific enterprise could take decades to reverse. 

The AUTM, the Association of University Technology Managers, noted that the Great Recession would have been much worse if it had not been for university technology transfer.  Harming the engine that’s been creating innovation and new business may not be such a good thing right now.  Besides pushing us into a recession, I do wonder what the political fallout will be of the increased removal of research funding from universities.  Not only do universities spin-off companies to varying degrees of success but there are universities located in many, many congressional districts--and those universities are major regional employers.  The full letter is available, here.  The Scientific American discusses the full letter, here. 

US Copyright Office Report on Copyrightability of AI Output

The U.S. Copyright Office has released a report titled, “Copyright and Artificial Intelligence: Part 2 Copyrightability.”  The report is in response to comments by interested parties concerning the copyrightability of AI generated outputs.  The report has a helpful summary of the approach of other countries.  The full report is available, here.  The report makes several conclusions and recommendations:

• Questions of copyrightability and AI can be resolved pursuant to existing law, without the need for legislative change.

• The use of AI tools to assist rather than stand in for human creativity does not affect the availability of copyright protection for the output.

• Copyright protects the original expression in a work created by a human author, even if the work also includes AI-generated material.

• Copyright does not extend to purely AI-generated material, or material where there is insufficient human control over the expressive elements.

• Whether human contributions to AI-generated outputs are sufficient to constitute authorship must be analyzed on a case-by-case basis.

• Based on the functioning of current generally available technology, prompts do not alone provide sufficient control.

• Human authors are entitled to copyright in their works of authorship that are perceptible in AI-generated outputs, as well as the creative selection, coordination, or arrangement of material in the outputs, or creative modifications of the outputs.

• The case has not been made for additional copyright or sui generis protection for AI generated content.

Addressing Insider Threats: CIA Analyst Divulges Confidential Information

One of the most difficult cybersecurity issues concerns predicting insider threats -- identifying the person or persons in your organization who are likely to divulge personal data or intellectual property.  The U.S. Department of Justice issued this press release recently: 

A former CIA analyst pleaded guilty today to retaining and transmitting Top Secret National Defense Information to people who were not entitled to receive it, information which was publicly posted on a social media platform in October 2024.

According to court documents, Asif William Rahman, 34, of Vienna, was an employee of the CIA since 2016 and had a Top-Secret security clearance with access to Sensitive Compartmented Information (SCI).

. . .

According to court documents, on Oct. 17, 2024, Rahman accessed and printed two Top Secret documents containing National Defense Information regarding a U.S. foreign ally and its planned actions against a foreign adversary. Rahman removed the documents, photographed them, and transmitted them to individuals he knew were not entitled to receive them. By Oct. 18, 2024, the documents appeared publicly on multiple social media platforms, complete with the classification markings.

After Oct. 17, 2024, Rahman deleted and edited journal entries and written work product on his personal electronic devices to conceal his personal opinions on U.S. policy and drafted entries to construct a false narrative regarding his activity. Rahman also destroyed multiple electronic devices, including a personal mobile device and an internet router he used to transmit classified information and photographs of classified documents, and discarded the destroyed devices in public trash receptacles in an effort to thwart potential investigations into him and his unlawful conduct.

Beginning in the spring of 2024 and continuing through November 2024, Rahman repeatedly accessed and printed classified National Defense Information, including documents classified up to the Top Secret level, to take them to his residence. There, Rahman reproduced the documents and, while doing so, altered them in an effort to conceal their source and his activity. Rahman then communicated Top Secret information that he learned in the course of his employment to multiple individuals he knew were not entitled to receive it.

Rahman was indicted by a grand jury on Nov. 7, 2024, and was arrested by the FBI as he arrived to work on Nov. 12, 2024. He has remained in custody since his arrest.

Rahman pleaded guilty to two counts of willful retention and transmission of classified information related to the national defense. He is scheduled to be sentenced on May 15, 2025. He faces a maximum penalty of 10 years in prison for both counts in the plea agreement. A federal district court judge will determine any sentence after considering the U.S. Sentencing Guidelines and other statutory factors.

American Intellectual Property Law Association Releases IP Wishes Letter to Incoming Trump Administration

The AIPLA has released a letter to the Trump Administration that highlights concerns with the IP system in the United States.  The letter addresses patent eligibility, patent quality, AI and IP, digital piracy and counterfeiting, trade secrecy and international IP harmonization.  The letter is available, here. 

White House Releases Fact Sheet on US India Strategic Technology Collaboration

The White House released a Fact Sheet outlining collaboration efforts concerning national security and technology with India on January 6, 2025.  The Fact Sheet states in relevant part:

Today, U.S. National Security Advisor (APNSA) Jake Sullivan met with Indian National Security Advisor (NSA) Ajit Doval, Indian External Affairs Minister S. Jaishankar, and Prime Minister Modi in New Delhi as the United States and India continue to forge a strategic technology partnership that benefits both of our countries and our partners around the world.  APNSA Sullivan and NSA Doval launched the U.S.-India initiative on Critical and Emerging Technology (iCET) in 2022 at the direction of President Biden and Prime Minister Modi.  In the intervening years, our two nations have taken significant steps forward together to integrate our technology and defense supply chains in recognition that, now more than ever, we need to work with our partners to build a trusted and resilient innovation base.

During their capstone meeting, APNSA Sullivan and NSA Doval underscored the vital importance of our efforts to jointly produce and develop strategic technologies that will allow us to deliver secure, reliable, and cost-competitive technology solutions for the world. As the United States and India deepen collaboration across key sectors – from space to semiconductors, biotechnology, cybersecurity, advanced telecommunications, and clean energy – we have seen the promise of our partnership deliver results.  Our partnership has also anchored multilateral work with like-minded nations from across the Indo-Pacific and Europe, including the Bio-5 Biopharmaceutical Supply Chain Consortium, the U.S.-India-ROK Technology Trilateral, and ongoing cooperation with Australia and Japan through the Quad.

Finally, APNSA Sullivan and NSA Doval reaffirmed our shared resolve to adapt and strengthen our technology protection toolkits and discussed efforts to address national security concerns associated with overcapacity in key technology sectors.  At the same time, they commended the progress we have made to address long-standing barriers to bilateral strategic trade, technology, and industrial cooperation.

The two national security leaders expressed their confidence that the bridges we have built across our governments, industry, and academia will endure and reflected on the significant achievements we have driven across every dimension of the technological enterprise – from the seabed to the stars, and beyond.  This includes:

Launching a New Era in Space Technology Cooperation

• Announcing the first-ever joint effort between American and Indian astronauts at the International Space Station with the launch of Axiom-4 scheduled to take place this spring, which will mark a significant milestone in the U.S.-India human spaceflight partnership and space exploration; 
• Reducing barriers to collaboration around commercial space technology following the U.S. government’s recent conclusion of updates to Missile Technology Control Regime export policy, which will open the door to additional technology licensing and co-development opportunities in support of the U.S.-India space partnership;
• Working toward the launch of a new bilateral space accelerator to promote commercial space cooperation, including around lunar exploration, human spaceflight, geospatial data and services, and the co-development of technology;
• Celebrating the conclusion of a Strategic Framework for Human Spaceflight Cooperation to deepen interoperability in space and working toward the imminent completion of additional agreements to commence advanced training for ISRO astronauts and ground personnel at the NASA Johnson Space Center and for joint experiments at the International Space Station;
• Preparing for the launch of the NASA-ISRO Synthetic Aperture Radar, a jointly developed satellite that will map the entirety of the Earth’s surface twice every 12 days as the United States and India work together to combat climate change and other global challenges, this spring;
• Deciding to hold the first bilateral experts’ exchange on space situational awareness and space traffic coordination in the first half of this year.  This exchange builds upon the two nations’ shared commitment to pursue opportunities for deeper collaboration to ensure safe and sustainable space operations;
• Exploring additional avenues for cooperation in space exploration technologies, including docking and interoperability demonstration missions, as well as India’s participation in the United States Traffic Coordination System for Space program. 

Deepening Defense Innovation and Industrial Cooperation

• Welcoming the advancement of discussions between Ultra Maritime and Bharat Dynamics Limited to enhance undersea domain awareness through a first-of-its-kind partnership on co-production of U.S. sonobuoys in support of the U.S. and Indian defense industrial bases;
• Welcoming India’s acquisition of the MQ-9B platforms, the possible co-production of land warfare systems, and progress on other co-production initiatives outlined in the U.S.-India Roadmap for Defense Industrial Cooperation;
• Celebrating the third edition of the India-U.S. Defense Acceleration Ecosystem (INDUS-X) Summit which took place at Stanford University in September 2024, and highlighting the continued progress under INDUS-X, including the Gurukul Educational Sessions and the launch of a third joint challenge on space situational awareness in low earth orbit;
• Welcoming the completion of an upgraded Memorandum of Understanding between the Defense Innovation Unit and the Defense Innovation Organization to expand cooperation on defense innovation and deepen collaboration between the U.S. and Indian startup ecosystems;
• Deepening cooperation between the U.S. Defense Innovation Unit and India’s Innovations for Defense Excellence to accelerate the joint adoption of cutting-edge commercial technologies for military solutions and capability enhancement of both countries’ defense ecosystems;
• Noting continued progress in the discussions between GE Aerospace and Hindustan Aeronautics Limited for the co-production of GE F414-INS6 engines to power India’s future fighter fleet;
• Expanding defense industrial partnerships, such as the launch of an AI Multi-Doman Situational Awareness product jointly developed by General Atomics and 114ai to support joint all domain command and control.

Building a Clean Energy and a Critical Minerals Partnership for the 21^st Century

• Advancing discussions to unlock new commercial partnerships around the deployment of small modular reactor technology in India;
• Reflecting the progress the United States and India have made—and will continue to make—as strategic partners and countries with a shared commitment to peaceful nuclear cooperation, NSA Sullivan announced US efforts to finalize necessary steps to delist Indian nuclear entities, which will promote civil nuclear cooperation and resilient clean energy supply chains;
• Commending the signing of a bilateral Critical Minerals Memorandum of Understanding between the U.S. Department of Commerce and the Indian Ministry of Commerce and Industry and the Ministry of Mines, and driving additional areas of cooperation in critical mineral supply chains such as for graphite, gallium, and germanium;
• Advancing collaboration between U.S. and Indian organizations and companies for carrying out research studies for beneficiation and co-development of processing technologies for critical minerals, including lithium, titanium, gallium, and vanadium;
• Building a collaborative program between the Geological Survey of India and the U.S. Geological Survey on exploration, characterization and evaluation of rare earth elements and critical mineral deposits.

Promoting Strategic Semiconductor Supply Chain Partnerships

• Advancing a strategic semiconductor partnership between the U.S. Space Force and 3rdiTech to establish a compound semiconductor fabrication plant in India to manufacture infrared, gallium nitride, and silicon carbide semiconductors that will be used in national security-relevant platforms; this includes favorably reviewing a technical assistance agreement and export licenses to promote technology transfers;
• Building on the U.S.-India Semiconductor Supply Chain and Innovation Partnership MOU and promoting secure, resilient, and sustainable semiconductor supply chains through continued collaboration between the U.S. Department of Commerce and the India Semiconductor Mission, Ministry of Electronics and Information Technology including facilitating investments in semiconductor manufacturing and strengthening R&D collaboration around state-of-the-art semiconductor and packaging technologies.

Building New Collaboration around AI, Advanced Computing, and Quantum

• Developing a government-to-government framework for promoting reciprocal investments in AI technology and aligning protections around the diffusion of AI technology;
• Strengthening cooperation around the national security applications of AI, following the U.S. government’s recent issuance of a National Security Memorandum on AI last fall, and promoting safe, secure, and trustworthy development of AI;
• Noting the importance of sustained engagement for cooperation on Quantum Information Science and Technology (QIST) as agreed to in the second meeting of the U.S.-India Quantum Coordination Mechanism held last August, during which both countries committed to achieving concrete outcomes;
• Initiating new cooperation in quantum science and technology, including through a workshop on post-quantum cryptography and quantum hardware held at the University of California, Los Angeles in September 2023 and facilitating visits of Indian technical experts from academia and the private sector to visit U.S. national laboratories and quantum institutions.

Bridging our People, Talent, and Innovation Bases

• Celebrating progress toward opening U.S. Consulate Bengaluru in early 2025 and continuing work to establish new Indian Consulates in Boston and Los Angeles;
• Advancing a “Bio-X” initiative that would promote biotechnology cooperation by leveraging the synergies between domestic programs and enhancing the competitiveness of the biotechnology industries in both countries;
• Celebrating steps that expand of the ability of top AI scientists, engineers, and entrepreneurs from India to come to the United States, including rulemaking that modernized the U.S. H-1B application process, recent clarifications of the rules for O-1 visas and other visa categories, and other efforts that have streamlined visa processing;
• Noting the recently launched U.S.-India Advanced Materials R&D Forum, which convened its inaugural meeting in November 2024, to expand collaboration between U.S. and Indian universities, national laboratories, and private sector researchers.

U.S. Department of Justice Releases Final Rule on Protecting Personal Data in Bulk Transfers

The Department of Justice recently issued a final rule preventing access to U.S. citizens personal data.  The Press Release states, in relevant part:

. . . Today, the Justice Department issued a comprehensive final rule carrying out Executive Order (E.O.) 14117 “Preventing Access to Americans’ Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern.” The E.O. charged the Justice Department with establishing and implementing a new regulatory program to address the urgent and extraordinary national security threat posed by the continuing efforts of countries of concern (and covered persons that they can leverage) to access and exploit Americans’ bulk sensitive personal data and certain U.S. Government-related data.. . .

“This final rule is a crucial step forward in addressing the extraordinary national security threat posed of our adversaries exploiting Americans' most sensitive personal data,” said Assistant Attorney General Matthew G. Olsen of the Justice Department’s National Security Division. “This powerful new national-security program is designed to ensure that Americans' personal data is no longer permitted to be sold to hostile foreign powers, whether through outright purchase or other means of commercial access.”

The Final Rule implements the E.O. by promulgating generally applicable rules for certain categories of data transactions that pose an unacceptable risk to the national security of the United States. As described in the E.O., countries of concern and covered persons can use their access to this data to engage in malicious cyber-enabled activities and malign foreign influence activities, bolster their military capabilities, and track and build profiles on U.S. persons (including members of the military and U.S. Intelligence Community, as well as other Federal employees and contractors) for illicit purposes such as blackmail, coercion, and espionage, and to bolster their military capabilities. Countries of concern and covered persons can also exploit this data to collect information on activists, academics, journalists, dissidents, political opponents, or members of nongovernmental organizations or marginalized communities to intimidate them; curb political opposition; limit freedoms of expression, peaceful assembly, or association; or enable other forms of suppression of civil liberties.

The Final Rule reflects the risk highlighted in the E.O. that the vulnerability of Americans’ bulk sensitive data is exacerbated because countries of concern are increasingly using bulk sensitive personal data to develop and enhance artificial intelligence (AI) capabilities and algorithms that, in turn, enable the use of large datasets in increasingly sophisticated and effective ways to the detriment of U.S. national security. Countries of concern can use AI in conjunction with multiple unrelated data sets, for example, to identify U.S. persons whose links to the federal government would be otherwise obscured in a single dataset and who can then be targeted for espionage or blackmail.

Among other things, the Final Rule identifies countries of concern and covered persons to whom the Final Rule applies, and designates classes of prohibited, restricted, and exempt transactions. The Final Rule establishes bulk thresholds for certain sensitive personal data, including human ‘omic data, biometric identifiers, precise geolocation data, personal health data, personal financial data, and certain covered personal identifiers. The Final Rule also prescribes processes to obtain licenses authorizing otherwise prohibited or restricted transactions; protocols for the designation of covered persons; and provides advisory opinions, and recordkeeping, reporting, and other due diligence obligations for covered transactions.

The Final Rule is consistent with the United States’ commitment to promoting an open, global, interoperable, reliable, and secure internet; protecting human rights online and offline; supporting a vibrant, global economy by promoting cross-border data flows that are required to enable international commerce and trade; and facilitating open investment. Notably, the Final Rule does not impose generalized data localization requirements regarding the physical or electronic storage of Americans’ bulk sensitive personal data or U.S. Government-related data, nor does it require locating computing facilities within the United States to process such data. The Final Rule does not prohibit U.S. persons from conducting medical, scientific, or other research in countries of concern, or from partnering or collaborating with covered persons to share data to conduct researching, if that activity does not involve the exchange of payment or other consideration as part of a covered data transaction. The Final Rule also does not broadly prohibit U.S. persons from engaging in commercial transactions, including exchanging financial and other data as part of the sale of commercial goods and services with countries of concern or covered persons, or impose measures aimed at a broader decoupling of the substantial consumer, economic, scientific, and trade relationships that the United States has with other countries.

The Final Rule further exempts several classes of data transactions from the scope of its prohibitions and restrictions, including personal communications and certain financial services transactions, corporate group transactions, transactions authorized by Federal law and international agreements, investment agreements subject to a Committee on Foreign Investment in the United States (CFIUS) action, telecommunication services, biological product and medical device authorizations, clinical investigations, and others.

The Final Rule’s prohibitions and restrictions are consistent with other access restrictions on sensitive personal data that have been imposed in other contexts, including transactions reviewed by the CFIUS and the Committee for the Assessment of Foreign Participation in the U.S. Telecommunications Services Sector (Team Telecom).

Lastly, under the Final Rule, parties engaging in vendor agreements, employment agreements, and investment agreements involving access by countries of concern or covered persons to bulk U.S. sensitive personal data or U.S. Government-related data would be restricted transactions that must comply with the separate security requirements that have been developed by the Department of Homeland Security’s Cybersecurity and Infrastructure Security Agency (CISA) in coordination with the Justice Department. These security requirements include organizational and system-level requirements (such as ensuring that basic organizational cybersecurity policies, practices, and controls are in place), and data-level requirements (such as data minimization and masking, encryption, and privacy-enhancing techniques). These critical requirements will be published separately by CISA through the Federal Register and on CISA’s website.

In connection with the Final Rule, the Justice Department will publish compliance, enforcement, and other guidance, which will be located at www.justice.gov/nsd/data-security.. . .