Tuesday, September 30, 2025

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. 

Friday, September 5, 2025

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.


Tuesday, August 12, 2025

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. 

 

 

Thursday, July 31, 2025

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

Friday, June 20, 2025

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.

Thursday, May 29, 2025

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.

Wednesday, May 28, 2025

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.

Thursday, May 22, 2025

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.

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