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 Trial and Appeals Board 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 PTAB 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.