Why drugs cost so much, 101: Medicine monopolies

S15-Ep05_Patents-101 Apr 3

Dan: Hey there–

We are kicking off a new series here — We’re calling it An Arm and a Leg 101.

We’ve spent years of reporting on two huge questions: Why does health care cost so freaking much? And what can we maybe do about it?

We’ve been chasing answers one story, one question at a time.

Now, we’re pulling together some of what we’ve learned. Digging a little deeper, going a little broader.

Starting with why so many drugs cost so much.

One of the first questions I ever asked — one of our first stories — was: How can insulin be so expensive? Wasn’t it discovered in the early 20th century? Shouldn’t it be a generic drug by now?

You know, cheap? 

And part of the answer I got was: Insulin has been transformed since the early 20th century. A lot.

A medical researcher named Jing Luo told me: Today’s insulins are a long way from what we had a hundred years ago.

Jing Luo: They’ve been really modified at a molecular level. It’s cool stuff. It’s super cool stuff. And you know, there are multiple Nobel prizes in physiology and medicine that have made this happen.

Dan: And all that super-cool stuff, those amazing discoveries, got patented.

Meaning: The patent-holders– the pharma companies — got a monopoly on those amazing discoveries.

The pharma companies claimed patents — and monopolies– on a bunch of other things too. Not all of them amazing.

But each new patent can mean another delay for a generic version coming to market.

Jing Luo: Companies can stack dozens of patents on top of each other to try to thwart generic competition because they can say, look, we’ve got three patents on the active ingredient. We’ve got patents on the medical uses of the active ingredient. We’ve got patents on the non-active excipient associated with this ingredient. We’ve got multiple patents on the devices, and so you who are trying to enter this space will sue you for patent infringement on all of them.

Dan: A patent guarantees you at least a 20-year monopoly. Drugs can generally get an extra five. 

And these extra patents — secondary patents –can keep you protected LONGER. If you don’t file them at the same time as the original: 

To talk about a drug that’s in the news right now. The original patent on the active ingredient in Wegovy and Ozempic actually expired this year.. The extra five years extends it to the early 2030s. 

But dozens of extra patents — secondary patents, filed later — mean that here in the U.S., we might not see cheaper generic versions until 2042. Or later.

And as Jing Luo told me: This strategy isn’t a secret. It’s an industry cornerstone. 

Jing Luo: When you listen to these like CEOs of pharma companies being interviewed at CNBC, you know, they’d be like, well, what about generic competition for this product? And they’ll just keep saying, no, no, no. We’ve got this really robust patent portfolio. We can withstand any challenge. We’re gonna tie this up in courts forever and don’t worry about it.We’re gonna continue this gravy boat for a long, long time. That’s the way they reinsure investors.

Dan: A robust patent portfolio. ?Or what researchers and advocates call a patent thicket.

They say quality matters less than quantity. 

The numbers are wild. 

According to one study, the 10 best-selling drugs for 2021 — drugs for cancer, HIV, arthritis — were protected by a combined total of seven hundred and forty-two patents. With hundreds more “pending.”

When these add-on patents get challenged in court, they actually get tossed out more often than primary patents..

But lawsuits cost money. A robust patent portfolio — a patent thicket — means generic companies would need to be ready to file a LOT of them.

So, we wanted to know: How did all this happen? How did these games get started?

It turns out, there is one guy who can tell you the story from the beginning, for better and for worse. Who helped shape it. Made millions of dollars from it. Saw its flaws. And has spent most of the last 30 years trying to fix them. Hie’s a lawyer named Al Engelberg, and he’s 86 years old.

Alfred Engelberg: I tell people all the time, I live in a world, a pharma world where half the people think I’m dead and the other half wish I was.  

Dan: Al Engelberg’s story is the story  of generic drugs in America. And it’s a wild ride. 

This is An Arm and a Leg — a show about why health care costs so freaking much, and what we can maybe do about it. I’m Dan Weissmann. I’m a reporter, and I like a challenge. So the job we’ve chosen here is to take one of the most enraging, terrifying, depressing parts of American life, and bring you something entertaining, empowering, and useful.

?Al Engelberg’s parents fled Nazi Germany in the late 1930s.

He was born here, less than a year after they arrived. They had nothing.

And  here’s where they made their new life. 

Retro news reel: We are flying over a well-known eastern city. That is remarkable because manufacturing is almost non-existent. A city whose principle business is the entertainment of millions. Atlantic city, often called the vacation capital of the nation

Dan: Al likes to say he learned most of what he knows about practicing law on the Atlantic City boardwalk, by the time he was 16. 

Alfred Engelberg: We grew up very, very fast there. I started working when I was about nine or 10 and, and there were lots of opportunities on the boardwalk. 

Dan: His first “job” was crawling around under the boardwalk, looking for loose change.

Alfred Engelberg: But I went on to work at hotdog stands and at an illegal bingo game for the local mob.

Dan: And in every job, Atlantic City drove home its major lesson: Cheating — hustling — is something you’ve gotta expect. 

At this illegal bingo parlor, Al’s job was walking between tables, doling out bingo cards for a dime apiece. The bosses hired college kids to walk behind kids like Al, to keep him honest.

Alfred Engelberg: I mean, these guys are running an illegal game, but they still need to count, and they still inherently don’t trust anybody. 

Dan: Which was correct. Al says the college kids had their own hustle: They’d have him set aside a dollar or two before turning in his dimes — split that dollar with him fifty-fifty — and tell the bosses Al’s count was fine.

Alfred Engelberg: And everybody knowing that the counts were wildly inaccurate anyway ‘cause the little old ladies were, were stealing cards. Everybody in the room had their own thing going, you know, from the customers on.

Dan: After Al made it out of Atlantic City, his unique on-the-job education continued. He studied chemical engineering at Drexel, then took a job as a patent examiner while going to law school at night.

And at that job, he learned: The patent system was ripe for hustling.

Partly because most of his colleagues weren’t necessarily giving the job their all. 

Like him, most patent examiners were working their way through law school. And they were sneaking time to study on the job.

Alfred Engelberg: We used to be able to cut our notes down so they fit in these file drawers with the patents. And we would be reading your notes and if your boss came by, you would just drop a patent on top of the notes.

Dan: You could say it was Atlantic City all over again. Everybody in the job is sneaking something for themselves — in this case, time.

And Al Engelberg could see that, even if his colleagues gave it their all, they were too green to do their job well. 

A patent examiner’s job — deciding whether a proposed invention deserves a monopoly (which at that time was 17 years) — means deciding whether the idea for that invention would be obvious to “a person of ordinary skill in that field.”

Alfred Engelberg: And most of the examiners had never worked in that field and had absolutely no idea. And this is the big leagues. You’re granting somebody a monopoly for 17 years, and it seemed ridiculous on its face.

Dan: Al cut his own path at the patent office. He’d worked his way through engineering school, in manufacturing plants, he saw what people of ordinary skill in that field solve problems every day. So he specialized in examining patents he actually knew something about.

That got him promoted, then it got him recruited by a corporate lawyer.. After the company paid his way through the rest of law school, he jumped to the Justice Department. 

He was ambitious– he wanted experience junior lawyers don’t usually get — like trying cases of his own.

After a few years doing just that, he took a job with a small law firm in New York City in 1968.

Alfred Engelberg: I came to New York to private practice at the age of 30 and I was ready to go. I mean, I was ready to, to tear the world apart and I did.

Dan: Patents were still a specialty. Then, in 1973, he gets a call that leads to his first generic drug case.

Generic drugs were not a hot market at the time.

Alfred Engelberg: ?The generic drug industry in 1970s was essentially, a half a dozen, privately owned family businesses, mostly in the metropolitan New York area. And most of the drugs that they were selling were drugs that were approved before 1962. 

Dan: Yeah. 1962 is when the FDA made it harder to get a new drug approved — you had to go through long clinical trials to show that your drug was safe and effective. 

Even if your drug was a generic version of an existing drug. Those little companies didn’t have the capital to run those trials, so they were stuck selling those old drugs.

Not much of a business. Maybe 20 percent of prescriptions were for generic drugs.

So when Al Engelberg got a call for his first generic drug case, that was the context. And the case itself did not sound promising. For one thing:

Alfred Engelberg: The call wasn’t even from the client. It was from a bank. The client was bankrupt. 

Dan: The client was bankrupt. This bankrupt client, Premo Pharmaceuticals, was getting sued for patent infringement. The bank was willing to put up ten thousand dollars for a defense. Nowhere near enough to actually try a case. Oh, and…

Alfred Engelberg: From what they told me, the information they gave me, we didn’t have a very good defense.

Dan: But Al Engelberg saw an opening. He could see that his opponents have weaknesses too.

Alfred Engelberg: The patent owners were in a very strange position. If they won, they got nothing because we were already bankrupt. Two, they were gonna have to spend the legal fees to win.

Dan: Win against a young lawyer named Al Engelberg who already had a rep as a tough opponent. So they could lose.

Alfred Engelberg: And if they lost, they would lose millions and millions of dollars in business because there wouldn’t be a patent. And they’d have competition from generic drugs.

Dan: And meanwhile, Al Engelberg is also sizing up the judge. He knows the guy doesn’t love patents.

So Al shows up to the first conference and he bluffs. 

Alfred Engelberg: I said to the judge, oh, your Honor, you know, it’s another one of those patents. They’re all invalid. And I said, we don’t need very much discovery. We’re, we’ll be ready to go to trial in a few months. Just set a trial date.

Dan: The other side walks out beside themselves.

And within a couple of weeks they call Al to say: Hey, how about this? You guys just acknowledge our patent is OK, and we’ll give you the money we would’ve spent litigating. Call it 400,000 bucks?

Alfred Engelberg: I called the client and said, how’s $400,000? He said, are you kidding?

Dan: They didn’t just get out of trouble — they got out of bankruptcy, with $400,000 in their pockets. Because Al Engelberg knew how to size up a situation.   

Alfred Engelberg: You don’t learn that in law school. That’s not what they teach.

Dan: Word gets  around about that case, and pretty soon everybody in the generic drug world is calling him.

It’s a small world, but by the end of the 1970s, there may be room for it to start getting bigger. 

People are starting to notice: Drugs are expensive. Maybe there should be more cheap generics. 

Some generic drug companies form an association and start lobbying: Make it easier to get generic drugs to market without having to go through all those trials.

The brand-name drugmakers push back: They say it takes so long to run the trials and get their drugs approved, they don’t get enough time to make money before those patents expire.

In 1983, Democratic Representative Henry Waxman steps in to broker a compromise, with Republican Senator Orrin Hatch.

And Mr. Engelberg goes to Washington. To run strategy for the generic drugmakers. 

Alfred Engelberg: In a lot of ways , that’s where my Atlantic City training really helped me at the end of the day

Dan: There were a lot of people, with a lot of interests. A lot of angles. ?He starts commuting from New York to Washington DC a couple times a week — for months and months, more than a year.

And Al Engelberg says: This time, it wasn’t just about winning a case.

Alfred Engelberg: I was in the back of a cab the way I remember, with the senior partner of the law firm. And he says to me, why are you breaking your ass going to Washington two or three times? Why don’t you send an associate? You know, it’s just like, it’s just another case. And I said. I said, are you kidding? I said, you know, how many lawyers ever get to do what I’m doing right now? To be at the table influencing what may be a major law that’s gonna have major consequences is, is like something I never thought my whole life I’d be doing.

Dan: A kid from Atlantic City was exactly the right person to try to balance all the angles, negotiate a compromise. It took more than a year. It almost didn’t happen. But then it did. Congress passed the bill, and President Ronald Reagan got in front of cameras to sign it.

Ronald Reagan: Let me turn my attention to the real reason we’re here this afternoon, signing into law the Drug Price Competition and Patent Term Restoration Act of 1984. 

Dan: better known as Hatch-Waxman.

Hatch Waxman had three basic components:

One: Brand drugmakers got a few extra years on their patents.

Two: Generic drugmakers got a pathway to get FDA approval.

And three –The new law laid out rules for a generic drugmaker when they wanted to CHALLENGE an existing patent. 

Negotiating that third part was the part where Al Engelberg’s education on the Atlantic City boardwalk, and the U.S. patent office, and the generic drug industry came together: The result would make him millions and millions of dollars — and blow a giant hole into the grand bargain he had worked so hard to bring about.

That’s coming right up.

This episode of An arm and a Leg is produced in partnership with KFF Health News. That’s a nonprofit newsroom covering health issues in America. The folks at KFF Health News are amazing journalists — their work wins all kinds of awards, every year. We are honored to work with them.

So. The brand-name drug makers and the generic drug makers struck a deal. That deal was good for them. Both sides got something big out of it. The public was supposed to get something out of it too.

And, to be fair, we did: Remember, back then, maybe one out of five prescriptions was for a generic drug. Now it’s nine out of ten.

But we pay more than ever for drugs. Mostly for branded, patent-protected drugs. And the biggest, most-important, most profitable drugs get locked behind patent thickets.

How did that happen? 

Well, to understand that, it helps to know what Al Engelberg got out of the whole bargain.

Al had been there at the bargaining table, on behalf of the generics. 

One day, during those negotiations, he was in the office with Henry Waxman’s lead counsel, a guy named Bill Corr, when Corr got a call from someone on the other side.

Corr starts pointing at the phone, pointing to Al — indicating: This guy is talking about you.

When Corr gets off the phone he says: That guy’s not sure about this deal where bad patents could be challenged. He’s suspicious about where you might take this. Like, are you just gonna set up a bounty-hunting operation, to get patents declared invalid?

And Corr said, Al, would you do that? 

Alfred Engelberg: And I said, you know, Bill, until this moment, I’ve never given it any thought, but it’s a hell of a good idea. Maybe I’ll look at it. 

Dan: And he did. Starting almost as soon as Hatch-Waxman became law.

Alfred Engelberg: And we sat in the rose garden, September 23rd, 1984, watched Reagan sign the bill. And in December of that year, I sat down at my kitchen table with a yellow pad and I laid out a strategy.

Dan: If you were gonna set up a bounty-hunting operation, how would you do it?

Al Engelberg knew a lot of patents were garbage. Knew it from his time in the patent office, knew it from practicing law. And he knew how much money a successful patent challenge could be worth.

The way Hatch-Waxman worked: If a generic drug company challenged a patent and won, they would get six months before any OTHER generic drugmakers could get a crack at the market.

So their only competition would be the brand. If a pill cost two cents to make, and the brand was selling for a dollar a pill — that’s 98 cents of profit for every pill.

You’re the only competitor? You could charge 75 cents a pill and get 73 cents of profit. On a hit drug, you could make millions and millions — just in those six months. 

Al’s idea was this: Partner up with a generic drugmaker. Go find cases– drugs with weak patents. Win ’em. 

And split those millions in potential profits fifty-fifty. 

Al pitched a generic drugmaker — they were ready to go — and brought the deal to his law firm. .

Alfred Engelberg: As it turned out, my partners weren’t interested in having me do this. They tried to talk me out of it.

Dan: But they couldn’t. So he left. Went out on his own. All on his own.

Alfred Engelberg: I never hired a single soul, not even a secretary. And I couldn’t type. I still can’t type.

Dan: But he hunted and pecked his way through brief after brief. He bought an early portable computer — it weighed thirty pounds — and lugged it around in the back of his car. For ten years.

Alfred Engelberg: It was stupid. I almost killed myself. But, it worked out okay.

Dan: Yeah. Turns out Al was really good at finding the problems with drug patents.

In one of his first cases, Al Engelberg personally made more than 70 million dollars. Others settled: A few million here, a few million there– it adds up.

And then…

Alfred Engelberg: It got to be the mid nineties, and I was working on a case called Buspar. 

Dan: The Buspar case ended up a big winner for Al Engelberg and his generic drug partners. 

But it had consequences that went way beyond a single case. And led to big losses for the public.. Here’s how it went.  

Alfred Engelberg: Buspar was an anti-anxiety drug. And by all accounts not a very good one.

Dan: But Bristol Meyers Squibb invested in big advertising and marketing campaigns.

Speaker 5: I feel anxious. I can’t concentrate. 

Speaker 6: I’m so irritable. If you. You suffer from excessive worry. It can feel like a mountain of anxiety. 

Speaker 5: I’ll never get it all done. I’m overwhelmed. 

Speaker 6: But a prescription medication called buspar can help.

Dan: And all that marketing did its job. By the mid-1990s, Buspar was making more than 200 million dollars a year for Bristol.

Alfred Engelberg: The only problem for them was that the drug was not new. 

Dan: The active ingredient was well-known in medical literature as a tranquilizer. Nobody had bothered to market it.

So Bristol Myers Squibb filed a patent on it, claiming it had discovered a new use for this well-known tranquilizer: Treating anxiety.

Al Engelberg says when he read the patent application, he could barely believe it: What do tranquilizers do if not… treat anxiety?

It’s like saying: There’s this stuff called sugar. We’re gonna take out a patent on using it as a sweetener.

This looked like a case for a guy from Atlantic City. 

Alfred Engelberg: I did something that lawyers don’t. That’s just the way I was built. 

I filed a motion with the court and basically said, we don’t need any evidence.

You just have to read the patent. If you believe it’s true, the patent’s invalid. Just, you know, all you need is a dictionary basically.

Dan: Al says Bristol was eager to settle. 

Alfred Engelberg: We get into a settlement discussion and we keep saying, no, no, no, no.

Dan: Al’s partners had done the math: They figured they stood to make a hundred million dollars or more once they won. So when the other side offered 25 million, no was the easy answer.

Alfred Engelberg: We said, why are we gonna take this? You know, it’s crazy. There’s a reward here we know what it is. We’re gonna get it eventually.

Dan: Al sits down with a lawyer from the other side, a guy he knows, explains how he sees the math.

And soon the other side comes through with a much bigger offer: 72 million dollars – almost three times as much. 

Alfred Engelberg: And I’m sitting there like, what are you crazy? But then think about it from their point of view. 

Dan: Paying 72 million dollars is nothing, compared to what Bristol stands to gain if this lawsuit goes away. 

With their monopoly, Bristol Meyer Squibb is making more than 200 million dollars a year on Buspar. And unless somebody else lines up to do what Al Engelberg had done, expect to keep that monopoly for years.

Charging whatever they want. Two dollars a pill, three dollars a pill. Which Al Engelberg says is exactly what happened.

In fact, they kept that monopoly for like five years. 

Alfred Engelberg: As it turned out, nobody came behind us. And so, they had that monopoly until 2000. So they got five years of 2 billion, in gross profits. 

Dan: They made out.

Alfred Engelberg:  For the cost of $75 million. And you know, the public got screwed ’cause they are continuing to pay, you know, $2 a pill or $3 a pill for a drug that eventually ends up being available for 20 or 30 cents. Um, so that’s, that’s how it works.

Dan: That’s how it works. The branded company and the generic company both make out great. Cheaper generic versions of a drug get delayed. 

That amazing payday for Al Engelberg and his partners at the generic drug company turned into a model a template for the kind of deal that every generic drug company would want in on.

It got a nickname: Pay for delay.

Alfred Engelberg: That spread through the industry like wildfire, those numbers, you know, you don’t make those numbers half a cent at a time on, on pills,

Dan: Lawsuits were way more profitable.

But Al Engelberg wasn’t filing them.

A year or so after the Buspar case settled, sparking the Pay for Delay gold rush, he retired. He had plenty of money and nothing to prove.

And in retirement, he started evaluating what he’d accomplished, for better and for worse.

For better, generic drugs had more than doubled their share of the market since Hatch-Waxman took effect.

For worse, he could see two places where — despite all of his Atlantic City training — he had missed a couple of angles in negotiating Hatch-Waxman. 

One was: this whole pay-for-delay scheme. Turned out, in balancing incentives for brands and generic makers, he’d left open this perverse incentive that left the public out. 

And the second was a loophole  that Hatch-Waxman had left open.: 

It created a process where players like Al and his generic partners could challenge patents on drugs like Buspar, that they thought didn’t deserve protected monopolies. It removed some friction for those attacks. 

The drug companies developed a way to add more friction:  stacking extra patents — secondary patents — on every drug.

Developing patent thickets.

Even if a secondary patent is trivial  — and lots of them do get tossed out — challenging it means a court fight. And that costs money.

Alfred Engelberg: It caused the big drug companies to just get more and more patents. Because why not? You know, there was nothing standing in the way.

Dan: I mean, nobody knows better than Al Engelberg: Patent examiners don’t exactly stand in the way. 

And those patent thickets and pay for delay, they feed on each other. 

Alfred Engelberg: The economics of the business, caused these kinds of settlements to reach epic proportions. So the generic companies would, challenge these secondary patents and, the drug companies would pay them off.

Dan: In 1999 he published an article in a scholarly journal arguing that Hatch-Waxman needed a reboot. Even the six-month head start for a successful challenge could probably go. 

And ever since — for more than twenty-five years — he’s poured millions of dollars into efforts to tighten the rules. Funding research. A public-information campaign from Consumer Reports. Even a center for IP law at his alma mater, NYU.

It hasn’t always gone his way. 

Pay for delay has gotten much bigger since Al Engelberg wrote his first article calling for reform: He wrote in 1999 that about two dozen patent challenges had been filed.

Now he estimates that number at twelve thousand.

Alfred Engelberg: I can’t tell you how many tens of billions of dollars in legal fees that is. It’s one of the fastest growing and and steadiest industries for big law.

Dan: A Hatch-Waxman litigation forum on LinkedIn has more than fourteen thousand members.

And Hatch-Waxman doesn’t cover many of today’s the top-selling drugs– the biggest moneymakers. They belong to a class called “biologics.”

That includes famously-expensive rheumatoid arthritis drugs like Humira and Enbrel — and insulin. 

Biologics weren’t a category forty years ago when Hatch-Waxman got negotiated. Congress passed a new law to deal with them in 2010 — ?the Biologics Price Competition and Innovation Act.

Al Engelberg is not a fan of that law.

Alfred Engelberg: Whatever mistakes were made in Hatch Waxman, they were multiplied by 10 and deliberately in the biologics law

Dan: He says the all but encourages patent thickets. And doesn’t provide a pathway to challenge them.

He says it reminds him of some of his early days practicing law.

Alfred Engelberg: Back in the seventies, we used to have small startup clients in the computer field, and they would get letters from IBM. It says, we are ready to inform you that you may be infringing one or more of the following patents. And there was a 10 page list of patents attached. And the startup would come to us and say, you know, what should we do? And we would say, find another line of work, you know, what are you gonna do?

Dan: But he has not given up. In 2025, he published a book: Breaking the Medicine Monopolies.

It tells the story of his career — and lays out his prescriptions for fixing the problem.

He doesn’t JUST focus on plugging the holes in Hatch-Waxman and the biologics law.

Alfred Engelberg: You know, we don’t actually need a generic drug industry. We need generic drug pricing. 

Dan: He’s got proposals for an increased government role in negotiating and regulating prices — and more than that.

He argues that a 1980 law allows the government to commisssion generic versions of drugs that were developed using public research dollars.

He also says the FDA rules that protect secondary patents on drugs — that allow patent thicketing — are based on a completely wrong interpretation of Hatch-Waxman.

And tells us he’s working up a challenge, with help from AI tools like Claude. 

He’s 86 years old. And he doesn’t seem inclined to stop.

Alfred Engelberg: It so changed my life and I did so well by it, I thought, how can I not take on this problem? Who’s gonna do it if I don’t do it?

Dan: He’s got the time. Money’s no object. And he knows the territory as well as anybody. He helped create it. 

Alfred Engelberg: So it’s, it’s my obligation really. It’s that sort of Jewish guilt. What can I tell you? I’m paying back for the bingo game.

Dan: So we’ve gone back more than fifty years on the question: Why aren’t there more generic drugs? We’ve learned why we’ve got the ones we have, and what stands in the way of getting more.

And that is just in time. Because this spring the U.S. Supreme Court will hear arguments in a case that could restrict the generic drug pipeline even further. It could have major implications.

And understanding what they are requires all of the 101 we’ve covered here. We’ll have that story for you in a few weeks. Til then, take care of yourself. 

This episode of An Arm and a Leg was produced by Emily Pisacreta, with help from Dan Weissmann— and edited by Ellen Weiss. 

Adam Raymonda is our audio wizard.

Our music is by Dave Weiner and Blue Dot Sessions. 

Claire Davenport is our engagement producer.

Sarah Ballema is our Operations Manager. Bea Bosco is our consulting director of operations. 

This series — An Arm and a Leg 101 — is made possible in part by support from Arnold Ventures. 

An Arm and a Leg is produced in partnership with KFF Health News. That’s a national newsroom producing in-depth journalism about health issues in America and a core program at KFF, an independent source of health policy research, polling, and journalism.

 Zach Dyer is senior audio producer at KFF Health News. He’s editorial liaison to this show.

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