The following is a lightly edited transcript of this week’s podcast:
GoozNews: Hello and welcome to the GoozNews Podcast for Saturday, November 22nd, 2025.
Affordability has become the number one issue for most Americans as we head into this holiday season. Homes and rents have become unaffordable, especially for young people.
Food prices remain stubbornly high. The price of every imported good, like many of the Christmas toys that people are going to be buying for their kids over the next couple of months, has skyrocketed because of President Trump’s across-the-board tariffs.
And the price of healthcare just keeps going up.
It’s not just for the 24 million on Obamacare plans who are seeing massive price spikes in their premiums because the GOP run Congress failed to renew subsidies that make those plans affordable. Higher healthcare prices are also hitting the 164 million people who get their health insurance through [00:01:00] their employers.
Co premiums for those plans - the amount taken out of paychecks each period - will rise on average nearly 7% next year, three times the rate of inflation. Why? Because the cost of healthcare, the services your insurance buys are going up at a similar rate.
There are several drivers behind the rising cost of care. Hospital and physician prices keep going up. The cost of those new weight loss drugs have been set ridiculously high. And the price of new cancer drugs can reach into the tens of thousands of dollars every month a patient is on chemotherapy.
The Biden administration and the Democratic Party gave Medicare the right to negotiate drug prices. But that will only affect a handful of the most expensive drugs. While that will help some, it doesn’t affect the largest part of drug spending, the part that has become one of the biggest drivers of higher healthcare costs. [00:02:00]
I’m talking about specialty drugs.
Those are new and very expensive drugs developed in recent decades that are used to treat many cancers, arthritis, psoriasis, and many rare diseases. Specialty drugs account for just 5% of all prescriptions in the U.S. But those prescriptions generate half of the drug industry’s revenue. That’s how expensive they are.
About 15 years ago, Congress passed a set of laws designed to ensure that these new drugs would eventually become affordable. The law was supposed to guarantee that after the specialty drug patents expire, which on average is about a dozen years after they come to market, generic drug manufacturers could enter the market.
When generics enter the market, it always results in sharp and immediate reductions in price. But that promise was never fulfilled except in a handful of cases. And as I reported earlier this week, under the new rules recently imposed by [00:03:00] the Trump administration, the substitution of cheap generics for high price specialty drugs could grind to a near halt.
What are those new rules? They came out of an agency that most people never even think about. The U.S. Patent and Trademark Office. To explain how the patent system and those new rules will impact the price of drugs, I’ve invited onto the podcast this week Professor Sean Tu, who teaches at the University of Alabama Law School.
Sean has written numerous articles in recent years about how the patent system is being gamed by the drug industry so their prices remain high long after their original patents have expired. Sean, welcome to the GoozNews Podcast.
Sean Tu: All right. Thank you so much for having me on. I want to bring home how important this is and the scope of this problem.
Ben Rome (?) from Harvard had done a study showing that the median launch price of a drug in 2008 was about [00:04:00] $2,000 for a year’s supply. In 2021, that price had jumped to $180,000 per year for a drug. That to me is unfathomable. Who can afford that kind of drug price?
Another example I give is the example of Humira, which is one of these specialty drugs used to treat psoriasis and Crohn’s disease. In 2020 it made about $22 billion. That’s $57 million a day. To put that in perspective, that drug made as much as McDonald’s did that same year. So every Big Mac, every fry, every shake, every coffee Humira made that much money. And that’s just one of 42 drugs that AbbVie had in its, portfolio.
This has become unaffordable for Americans. When you prevent generics from coming onto the market, even by a month for the example of [00:05:00] Humira, that is almost $2 billion? So becomes really significant.
It’s been shown that here in the U.S. the main way we lower drug prices is via generic competition. Our generic market is actually very robust compared to the rest of the world. Drug firms have become wise to understanding how patents can play a big role in delaying and deterring generic and biosimilar entry. Biosimilars are just the generic versions of biologics. When I mention generic, I’m going to include both biosimilars and generics.
How do they do that? We’ve moved from one or two patents per drug to seven or eight in the small molecule realm. Humira had over 150 patents for that product. And this really causes some delay. In Europe [00:06:00] they had like 30. And what did that mean? In Europe, they had biosimilar versions of Humira, three years earlier than in the U.S. And those prices went down significantly when those biosimilars came onto the market.
So this and other studies have shown that after the primary patent, the active ingredient patent, expires in Europe, generics come onto the market plus or minus three months from that primary patent expiration date.
Patents are there to incentivize innovation. They’re crucial for drug companies. We should protect that real innovation by having a strong patent system that protects that active ingredient. But all of the games that happen afterwards, the method of use, these formulation claims, the dosage counters, the inhalers, the propellants, all of this other stuff, is really incremental innovation.
We should be paying for incremental innovation, but we shouldn’t be paying monopoly pricing for the active ingredient. [00:07:00] If the drug company comes up with a dosage counter on an inhaler for asthma, that’s valuable to me. I might be willing to pay, an extra five or six bucks per inhaler. But I shouldn’t be paying $180 extra for that active ingredient. That’s how much the new active ingredient costs.
GoozNews: So these are dozens and dozens of patents that are filed after the original invention, which is the drug itself. We need few definitions for people who are not expert in the drug industry. When you talk about generics for small molecule drugs, we’re generally talking about the ingredients that go into pills or capsules. And when we talk about biologics, we’re talking about things that are usually injected or through IV drips because there are large proteins. They are biologic products.
Either way, as you pointed out, the new prices on these drugs are going up and up and up. Fantastic numbers. But it’s supposed to be for a limited time. You mentioned a lot of things, [00:08:00] you know, inhalers and process patents and routes of administration. What is the purpose?
Why are drug companies filing all of these patents for a technology that is very old, yet is being treated like it’s a new drug? Why does the patent office even approve these patents for these drugs? And, on the drug industry side, what is the purpose from trying to get this many patents?
Sean Tu: You can make an argument that these are innovations, right? These are incremental innovations. When I put a dosage counter on an inhaler, that’s something new and useful that wasn’t present before. And so the patent office reviews technology for all sorts of stuff, and you can imagine if I’m reviewing an inhaler dosage counter, I’m not really concerned about the albuterol. I’m just looking at that myopic dosage counter in respect to an inhaler product that is used for asthma,
I published a paper in New England Journal of Medicine a few years back. We showed that albuterol, which has been around since 1980, was around $180 per inhaler, which was expensive in 80s dollars. Then that price went down to about $7 per inhaler because generic competition came in. Then Congress said these chlorofluorocarbons (CFCs) are destroying the ozone layer, so we’re going to force inhaler companies to change their propellant.
Even though these companies promised they wouldn’t raise the prices after they lobbied for this switch, they started charging, not in the $7 or $8 range. They patented the bejesus out of the new propellant, which is HFA and raised the prices again to over $180 per inhaler.
We showed that cost the American public about $4 billion over five or six years. Those [00:10:00] prices are only now starting to come back down. Why? Because of generic competition. Because those HFA patents are slowly expiring. Now they’re lobbing again to switch because HFA is not ideal either. They say we need a new propellant and they’re lobbying Congress to change it again.
GoozNews: Congress passed laws, close to 15 years ago now, in order to get rid of what are called patent thickets, all these patents that delay the arrival of generics. Tell us a little bit about what those laws were and how those laws are now being subverted.
Sean Tu: In 1984, the Hatch Waxman Act was there to help generics get onto the market. They say you need to list all of the relevant patents in this thing called the Orange Book. And then, if a generic maker wants to get onto the market early, you can challenge one of these Orange Book patents that may be getting in the way.
In the 1980s and 1990s, [00:11:00] we only saw one or two patents per product, typically for the active ingredient. Generic firms would just wait until they expired and then go on the market. Or they would challenge one or two patents that were gunking up the system.
In 2005 to 2010, we saw a real jump in the number of patents per product. This really increases litigation costs. Challenging one or two patents is one thing. Challenging seven or eight patents is a, is a different beast. Challenging a hundred patents is cost prohibitive. Apatent cost about $20,000 top to bottom to get. So, if I’m making $57 million a day, I can get as many patents as I want. We’ll just take a day’s profit and file for a thousand patents.
That really makes it difficult for generic drug companies to come on the market. There are two bills and a withdrawn U.S.P.T.O. rule that deals with these thickets. There’s the ETHIC Act, the Eliminating Thickets to Increase [00:12:00] Competition Act, sponsored by Arrington and Welsh.
They say, we understand that these patents could be innovative. Instead of suing on all 100 of these patents, pick your best one or two and sue on that. But once that’s done, let’s move on from the litigation and this kind of patent gamesmanship. The Cornyn Bill focuses just on biosimilars. It has a bunch of exceptions that gut the rule. But the idea was that you bring only your top 20 patents, so pick your 20 best and then litigate. The best rule actually was AUSPTO rule, but it was recently withdrawn when the new administration gave a lot of pushback to that rule and ended up dropping it.
That rule said that if any progenitor patent claim was found invalid, anything that depended on that particular patent downstream became invalidated. And that’s [00:13:00] really the problem. We have patents that are great, great, great grandchildren, five generations of patents that basically say the same thing. The patent office said if you invalidate that great, great grandfather patent then anything that depends on that is unenforceable.
GoozNews: A 2011 law that created an internal process at the Patent and Trademark office, the PTO, for them to avoid costly litigation. What is that rule about and what has happened to that under the Trump administration?
Sean Tu: This was under the American Invent Act and it created a new system called the Inter Partes Review (IPR) and Post-Grant review procedure. Those are administrative ways to challenge erroneously granted patents. I mentioned that a typical drug litigation costs about $6.2 million. And IPR costs about $700,000.
GoozNews: Review this new process. [00:14:00]
Sean Tu: So IPR costs less. It goes faster by statute. Once it’s instituted, you have a year to wrap it up. Litigation could take three to five years, sometimes 10 years. It’s reviewed by three administrative law judges who are patent experts. They not only experts in patent law, they typically have the technology background.
So they’re subject matter experts as well as legal experts. When you go to a jury or a judge, very rarely will they have the scientific background to understand a lot of these technologies. Patent law is complex, so you want to have a legal expert who understands not only the law, but the technology.
In this new administrative procedure created in 2011 under the American Invents Act, by all metrics, it was doing very well. It was invalidating erroneously granted patents. Consumers should rejoice when that happens because that means we get earlier competition. In addition, people should rejoice [00:15:00] because we’re getting new inventions because we’re not having these weak patents blocking other people’s from inventing new things in the same field.
GoozNews: It was working well. But what happened when the Trump administration came in?
Sean Tu: They started weakening the system pretty dramatically. The institution rate of IPRs was about 70, 80%, from 2013 all the way to last year, which is 2024. In other words,
GoozNews: 70 to 80% of all these patent thickets that were challenged through this IPR in partis review process were being invalidated?
Sean Tu: No, not invalidated, but they were allowed to proceed forward.
GoozNews: Okay.
Sean Tu: The invalidation rate was about 60%. Still pretty high. We moved from. 60, 70% allowed to go forward to now it’s 30%. Then Squires just took over in September and it’s sitting at around 0% now.
GoozNews: This is John [00:16:00] Squires. He’s the new head of the PTO, a Trump appointee. Tell us a little about him and what his background is because it has nothing to do with drugs, even though that is one of the main users of this IPR process.
Sean Tu: Interestingly, he comes from a tech background. I think he has an engineering degree. But he also helped create Fortress IP, which is pejoratively called a patent troll, which is one of these patent aggregators, a non-practicing entity. Typically these guys buy up a bunch of patents and then assert them against, companies infringing these now aggregated patents. If I get 50, 60 patents in a field and then sue a small company, I say, “Hey, give me $50,000 to license these 50 patents. I’m not sure if these patents are valid or I’m not even sure if you infringe on these patents, but there are a lot of patents in there in your technology group. Maybe, you [00:17:00] should pay me $50,000 to license these patents. And, by the way, litigation is going to cost you a hundred, two hundred thousand dollars.”
So it cheaper for you just to license this and go away. And if I do that with 50, 60 companies, that becomes real money.
GoozNews: Are these patent trolls often going after big high-tech firms like Meta, Apple or Google?
Sean Tu: They go after everybody. From what I understand. the whole point of this is to go after as many people as they can.
GoozNews: These big high-tech firms were big users of this IPR process. Were they not?
Sean Tu: Yes, they use it more than the drug companies do, significantly more. And they have also taken the real brunt of these discretionary denials.
GoozNews: What has Squire’s done to the IPR process that might benefit these trolls, but have a different effect in the pharmaceutical space?
Sean Tu: Either way, it weakens the patent system because it [00:18:00] allows erroneously granted patents to survive.
GoozNews: What did he do?
Sean Tu: He now has created what’s called summary notices where he just gives a thumbs up or a thumbs down. There’s no explanation, no decision.
So, we have no idea if the IPR is now being rejected because of whim, because of political decisions, because he likes certain technologies and wants to protect them from challenges. We just don’t know. And it’s becomes really hard to challenge that and say that this decision is made arbitrarily or capriciously and needs judicial review when I just have a statement that says this IPR is not getting granted.
And, by the way, in the 34 IPR decisions that he has granted these summary notices thumbs up or thumbs down, a hundred percent have been thumbs down. He has not granted one.
GoozNews: Every potentially invalid patent has been essentially left in place and the internal challenge [00:19:00] process has gone away. The only option for a generic drug manufacturer at this point is to go back into court and start filing potentially dozens of lawsuits challenging different patents, which is exactly what the IPR process was trying to avoid. What’s this going to do to the introduction of biologics or specialty drugs? There are also small molecule drugs that also are quite expensive and need generic competition when their legitimate patents run out. What impact is it going to have on the introduction of …
Sean Tu: Generics? It’s going to take a longer amount of time, and when we see it, it’s going to cost more. So, it’s going to cost more for patients for a longer period of time.
GoozNews: I know you’ve also done some research on where the generics have come in over the past 6, 7, 8 years, finally, under biosimilar laws that were passed around the same time as this IPR process was set up. What has been the [00:20:00] savings when generics in the biologic or specialty drug space come to market?
Sean Tu: I don’t have the actual numbers. The Access to Affordable Medicines, trade group has done that. I think the number is like hundreds of billions of dollars, close to a trillion dollars over the course of five to 10 years. It is very significant.
GoozNews: Right. the price drops, percentage wise, what are they in percentage terms?
Sean Tu: So it depends on how many competitors you have? If you have one or two competitors, the price drops by about 20 to 30%. If you have five or six competitors, the price drops like 80 or 90%.
Albuterol is a great example, it originally cost when it was under patent, like 200, $300, Without patents it cost like 7 or $8. I’ll give you another example, which is another poster child for bad behavior.
Gilead has a new drug Sovaldi that is used to treat hepatitis [00:21:00] C., a terrible disease. It causes liver cirrhosis and has a very high, mortality rate. If you don’t fix this, you’re going to die. When it first came on the market, they charged $80,000 for a 12 week treatment.
This is a drug that cures your disease. That doesn’t happen very often that we can cure disease with very little side effects because the drug is so targeted. Great drug, right? But why is it that you need to charge $80,000 for a drug that costs about 60, $70 to manufacture.
Look at what happened in Egypt. Egypt said we have a real problem with hepatitis C in our country. We’re not going to recognize your patent rights. So they just started making generic versions of this drug Sovaldi. They charge about $84 for a 12-week treatment. They have almost eliminated hepatitis C in that country. They just prioritize their citizens over the [00:22:00] profits of these companies.
I think we need to have profits for these companies to incentivize them to make these drugs. But the prices are like no other industry that I know of.
GoozNews: Is Sovaldi still on patent?
Sean Tu: It is actually still on patent, although there are more competitors that have come onto the market. We are getting a deal now instead of $80,000 for a 12-week treatment, it costs about $20,000 for a 12-week treatment because we have three competitors instead of just one.
GoozNews: But they are different drugs that do the same thing. This is called me too competition in the drug space. Sovaldi has at least been around for 15 years or so. It was probably in development when they filed for the patent. So the original patent is probably well over the original 20 year term, I’m guessing.
Sean Tu: Yeah. I think it’s going off patent pretty soon. The way they have [00:23:00] extended this monopoly through patents is by adding new drugs that are combination therapies.
They have Harvoni, which is a combination of Sovaldi and I can’t remember what the other drug is. But it’s a two-drug combination. And then they have a new drug that’s a three-drug combination. Each of those new drugs has its own patent. This is called product topping.
So, I’m going to hop you from the one drug to the two-drug, and then I hop you from the two-drug to the three-drug. Sovaldi has like a 80% efficacy rate, and then I think Harvoni has a 95% efficacy rate. There’s some benefit, but then Epclusa has a 98% efficacy rate. Maybe I’d be okay taking the Harvoni and getting a slightly worse drug, but at a much more affordable price. But those are two drugs that are still under patent. They’re probably not going to go down.
GoozNews: I think you’ve also written about Humira, [00:24:00] which is one of the major biotech drugs that was extremely expensive for rheumatoid arthritis. It started there and then it’s being used for other conditions as well. Tell us what’s happened with Humira after the entry of generics to its pricing.
Sean Tu: When Humira came on the market, its patents were supposed to expire I think in 2018 or 2019. We did not see generic competition in the US until 2023, much later than Europe. When biosimilars did come on the market, we didn’t get a huge amount of decrease. It was these pharmacy benefit managers, or the middlemen, because they’re so vertically integrated. They put these specialty drugs on drug lists where the PBMs has no incentive to switch to the biosimilar versions. Because of that, we didn’t see the price drops that we wanted to. So even though biosimilars were charging much less. The middleman had [00:25:00] incentives to choose the more expensive pricing.
This shows you how complex this field is, right? Not only do we have the patent issue, which is typically the rate limiting step, but we also now have this middleman, which has tons of decision making and monopoly power. Congress is really pushing back against these PBMs.
I think there are three or four bills in the works to try to rein in what they call spread pricing. PBMs sometimes make their money by saying we’re going to offer you this huge discount. And we’ll get a percentage of the discount. If that is the way I get paid, I actually want the price to be really high so that I can get the difference in the spread pricing, right?
That incentive harms the purchaser, the insurer. So there’s some thought that we should really stop that kind of gamesman shift.
GoozNews: So this is an example of how the middlemen, even if you can get through all the patent thickets and finally get a generic [00:26:00] onto the market, they get in the way of adoption.
Sean Tu: How do we know that’s true? Some of these middlemen, some of these PBMs, actually purchased the biologic company and started making their own version of Humira. And guess what? When that happened, they switched to that version and the prices went down.
That’s an example of the middlemen being so powerful that they can buy their own biosimilar company and manufacture the biosimilar themselves. When that happens, they’ll choose that version.
GoozNews: We only have a few minutes left. Put your policy hat on. You’ve outlined a number of the games that big drug companies play with patent thickets. They keep filing patent over patent on minor and sometimes no innovation at all, simply to frustrate generic entry. They create new products, combination products, that create this product hopping strategy to delay the adoption of generics. What should Congress do to unravel [00:27:00] these thickets, this patent hopping?
Sean Tu: I have some pie in the sky ideas, and some boots on the ground ideas. Here’s the big pie in the sky idea, most of our drug costs come from these brand drug companies, right? So why is it that they’re charging so much?
The actual reason is because they can. And consumers really don’t see the true cost of a lot of these drugs because even though they are costing 180 to $200,000 for a year’s supply, the patient, if they have employer insurance, once they hit their out-of-pocket maximum, that’s all they see.
But who’s picking up the rest of the bill? It’s the taxpayers, the insurers, the employers. That’s why these insurance rates are going up dramatically. How would I address the issue? I think the government should get into the brand manufacturing business. In many ways, a lot of these innovations come from [00:28:00] universities that are sponsored by the government already. Ozempic is a great example. Semaglutide was discovered in a university lab. Another example is Sovaldi. That drug was also discovered in a university lab. If the taxpayers could get a piece of that pie right at the beginning, maybe the government starts patenting, and then also creating brand drugs through a government sponsored firm putting out new drugs.
And what’s nice about that is, the government would then set the price for a HepC drug. And then all of the competitors couldn’t price way higher than that drug, as long as it was as effective. The government would become a price setter. These are public goods, right?
The health of our citizens is too important to give to private industry. My pie in the sky idea is to get the government into the brand drug manufacturing business. Is that going to happen? No, probably not because it’s going to cost a [00:29:00] ton of money initially. But you can see in five, 10 years that that may pay for itself. The Sovaldi example is a great example, because the government was thinking about buying Gilead because it would be cheaper to buy Gilead than to buy the drug at the end of the day.
You could strengthen the patent system and try to stop these weak patents from issuing. That would mean strengthening the IPR process; strengthening the examination process; allowing the FDA to give information to the PTO to help with these decisions. Make the whole process more transparent.
GoozNews: I want to thank Sean of the University of Alabama for being with us today, Sean. I hope that your ideas get some traction with at least some of the folks up on Capitol Hill.
Sean Tu: This is something that I think the American people deserve, and need, because we just can’t afford the way it’s currently going.
GoozNews: This has been a GoozNews [00:30:00] podcast.
