An Arm And A Leg: The Accidental Architect Of America’s Drug Patent Problem

Depending connected whom you ask, Alfred Engelberg could beryllium a leader aliases a villain successful nan communicative of American pharmaceuticals. The patent lawyer helped constitute authorities that led to a melodramatic summation successful nan number of generic narcotics connected nan market. He besides contributed to a patent strategy that gives pharmaceutical companies monopolies connected their astir lucrative drugs, blocking generic title and keeping prices precocious on nan way. 

An Arm and a Leg big Dan Weissmann traces Engelberg's communicative backmost much than 50 years, from a scrappy puerility connected nan Atlantic City boardwalk to watching President Ronald Reagan motion his measure into rule astatine nan White House Rose Garden. Today, Engelberg advocates for argumentation changes he believes will alteration much generic narcotics to scope nan marketplace faster. 

Host and shaper of "An Arm and a Leg." Previously, Dan was a unit newsman for Marketplace and Chicago's WBEZ. His activity besides appears connected "All Things Considered," Marketplace, nan BBC, 99% Invisible, and "Reveal," from nan Center for Investigative Reporting.

Transcript: Why narcotics costs truthful much, 101: Medicine monopolies

Note: "An Arm and a Leg" uses speech-recognition package to make transcripts, which whitethorn incorporate errors. Please usage nan transcript arsenic a instrumentality but cheque nan corresponding audio earlier quoting nan podcast.

Dan: Hey there-

We are kicking disconnected a caller bid present — We're calling it An Arm and a Leg 101.

We've spent years of reporting connected 2 immense questions: Why does wellness attraction costs truthful freaking much? And what tin we possibly do astir it?

We've been chasing answers 1 story, 1 mobility astatine a time.

Now, we're pulling together immoderate of what we've learned. Digging a small deeper, going a small broader.

Starting pinch why truthful galore narcotics costs truthful much.

One of nan first questions I ever asked — 1 of our first stories — was: How tin insulin beryllium truthful expensive? Wasn't it discovered successful nan early 20th century? Shouldn't it beryllium a generic supplier by now?

You know, cheap? 

And portion of nan reply I sewage was: Insulin has been transformed since nan early 20th century. A lot.

A aesculapian interrogator named Jing Luo told me: Today's insulins are a agelong measurement from what we had a 100 years ago.

Jing Luo: They've been really modified astatine a molecular level. It's cool stuff. It's ace cool stuff. And you know, location are aggregate Nobel prizes successful physiology and medicine that person made this happen.

Dan: And each that super-cool stuff, those astonishing discoveries, sewage patented.

Meaning: The patent-holders- nan pharma companies — sewage a monopoly connected those astonishing discoveries.

The pharma companies claimed patents — and monopolies- connected a bunch of different things too. Not each of them amazing.

But each caller patent tin mean different hold for a generic type coming to market.

Jing Luo: Companies tin stack dozens of patents connected apical of each different to effort to thwart generic title because they tin say, look, we've sewage 3 patents connected nan progressive ingredient. We've sewage patents connected nan aesculapian uses of nan progressive ingredient. We've sewage patents connected nan non-active excipient associated pinch this ingredient. We've sewage aggregate patents connected nan devices, and truthful you who are trying to participate this abstraction will writer you for patent infringement connected each of them.

Dan: A patent guarantees you astatine slightest a 20-year monopoly. Drugs tin mostly get an other five. 

And these other patents — secondary patents -can support you protected LONGER. If you don't record them astatine nan aforesaid clip arsenic nan original: 

To talk astir a supplier that's successful nan news correct now. The original patent connected nan progressive constituent successful Wegovy and Ozempic really expired this year.. The other 5 years extends it to nan early 2030s. 

But dozens of other patents — secondary patents, revenge later — mean that present successful nan U.S., we mightiness not spot cheaper generic versions until 2042. Or later.

And arsenic Jing Luo told me: This strategy isn't a secret. It's an manufacture cornerstone. 

Jing Luo: When you perceive to these for illustration CEOs of pharma companies being interviewed astatine CNBC, you know, they'd beryllium like, well, what astir generic title for this product? And they'll conscionable support saying, no, no, no. We've sewage this really robust patent portfolio. We tin withstand immoderate challenge. We're gonna necktie this up successful courts everlastingly and don't interest astir it.We're gonna proceed this gravy vessel for a long, agelong time. That's nan measurement they reinsure investors.

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

They opportunity value matters little than quantity. 

The numbers are wild. 

According to 1 study, nan 10 best-selling narcotics for 2021 — narcotics for cancer, HIV, arthritis — were protected by a mixed full of 7 100 and forty-two patents. With hundreds much "pending."

When these add-on patents get challenged successful court, they really get tossed retired much often than superior patents..

But lawsuits costs money. A robust patent portfolio — a patent thicket — intends generic companies would request to beryllium fresh to record a LOT of them.

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

It turns out, location is 1 feline who tin show you nan communicative from nan beginning, for amended and for worse. Who helped style it. Made millions of dollars from it. Saw its flaws. And has spent astir of nan past 30 years trying to hole them. Hie's a lawyer named Al Engelberg, and he's 86 years old.

Alfred Engelberg: I show group each nan time, I unrecorded successful a world, a pharma world wherever half nan group deliberation I'm dormant and nan different half wish I was. 

Dan: Al Engelberg's communicative is nan communicative of generic narcotics successful America. And it's a chaotic ride. 

This is An Arm and a Leg — a show astir why wellness attraction costs truthful freaking much, and what we tin possibly do astir it. I'm Dan Weissmann. I'm a reporter, and I for illustration a challenge. So nan occupation we've chosen present is to return 1 of nan astir enraging, terrifying, depressing parts of American life, and bring you thing entertaining, empowering, and useful.

?Al Engelberg's parents fled Nazi Germany successful nan precocious 1930s.

He was calved here, little than a twelvemonth aft they arrived. They had nothing.

And here's wherever they made their caller life. 

Retro news reel: We are flying complete a well-known eastbound city. That is singular because manufacturing is almost non-existent. A metropolis whose rule business is nan intermezo of millions. Atlantic city, often called nan picnic superior of nan nation

Dan: Al likes to opportunity he learned astir of what he knows astir practicing rule connected nan Atlantic City boardwalk, by nan clip he was 16. 

Alfred Engelberg: We grew up very, very accelerated there. I started moving erstwhile I was astir 9 aliases 10 and, and location were tons of opportunities connected nan boardwalk. 

Dan: His first "job" was crawling astir nether nan boardwalk, looking for loose change.

Alfred Engelberg: But I went connected to activity astatine hotdog stands and astatine an forbidden bingo crippled for nan section mob.

Dan: And successful each job, Atlantic City drove location its awesome lesson: Cheating — hustling — is thing you've gotta expect. 

At this forbidden bingo parlor, Al's occupation was stepping betwixt tables, doling retired bingo cards for a dime apiece. The bosses hired assemblage kids to locomotion down kids for illustration Al, to support him honest.

Alfred Engelberg: I mean, these guys are moving an forbidden game, but they still request to count, and they still inherently don't spot anybody. 

Dan: Which was correct. Al says nan assemblage kids had their ain hustle: They'd person him group speech a dollar aliases 2 earlier turning successful his dimes — divided that dollar pinch him fifty-fifty — and show nan bosses Al's count was fine.

Alfred Engelberg: And everybody knowing that nan counts were wildly inaccurate anyhow 'cause nan small aged ladies were, were stealing cards. Everybody successful nan room had their ain point going, you know, from nan customers on.

Dan: After Al made it retired of Atlantic City, his unsocial on-the-job acquisition continued. He studied chemic engineering astatine Drexel, past took a occupation arsenic a patent examiner while going to rule schoolhouse astatine night.

And astatine that job, he learned: The patent strategy was ripe for hustling.

Partly because astir of his colleagues weren't needfully giving nan occupation their all. 

Like him, astir patent examiners were moving their measurement done rule school. And they were sneaking clip to study connected nan job.

Alfred Engelberg: We utilized to beryllium capable to trim our notes down truthful they fresh successful these record drawers pinch nan patents. And we would beryllium reference your notes and if your leader came by, you would conscionable driblet a patent connected apical of nan notes.

Dan: You could opportunity it was Atlantic City each complete again. Everybody successful nan occupation is sneaking thing for themselves — successful this case, time.

And Al Engelberg could spot that, moreover if his colleagues gave it their all, they were excessively greenish to do their occupation well. 

A patent examiner's occupation — deciding whether a projected invention deserves a monopoly (which astatine that clip was 17 years) — intends deciding whether nan thought for that invention would beryllium evident to "a personification of mean accomplishment successful that field."

Alfred Engelberg: And astir of nan examiners had ne'er worked successful that section and had perfectly nary idea. And this is nan large leagues. You're granting personification a monopoly for 17 years, and it seemed ridiculous connected its face.

Dan: Al trim his ain way astatine nan patent office. He'd worked his measurement done engineering school, successful manufacturing plants, he saw what group of mean accomplishment successful that section lick problems each day. So he specialized successful examining patents he really knew thing about.

That sewage him promoted, past it sewage him recruited by a firm lawyer.. After nan institution paid his measurement done nan remainder of rule school, he jumped to nan Justice Department. 

He was ambitious- he wanted acquisition inferior lawyers don't usually get — for illustration trying cases of his own.

After a fewer years doing conscionable that, he took a occupation pinch a mini rule patient successful New York City successful 1968.

Alfred Engelberg: I came to New York to backstage believe astatine nan property of 30 and I was fresh to go. I mean, I was fresh to, to tear nan world isolated and I did.

Dan: Patents were still a specialty. Then, successful 1973, he gets a telephone that leads to his first generic supplier case.

Generic narcotics were not a basking marketplace astatine nan time.

Alfred Engelberg: ?The generic supplier manufacture successful 1970s was essentially, a half a dozen, privately owned family businesses, mostly successful nan metropolitan New York area. And astir of nan narcotics that they were trading were narcotics that were approved earlier 1962. 

Dan: Yeah. 1962 is erstwhile nan FDA made it harder to get a caller supplier approved — you had to spell done agelong objective tests to show that your supplier was safe and effective. 

Even if your supplier was a generic type of an existing drug. Those small companies didn't person nan superior to tally those trials, truthful they were stuck trading those aged drugs.

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

So erstwhile Al Engelberg sewage a telephone for his first generic supplier case, that was nan context. And nan lawsuit itself did not sound promising. For 1 thing:

Alfred Engelberg: The telephone wasn't moreover from nan client. It was from a bank. The customer was bankrupt. 

Dan: The customer was bankrupt. This bankrupt client, Premo Pharmaceuticals, was getting sued for patent infringement. The slope was consenting to put up 10 1000 dollars for a defense. Nowhere adjacent capable to really effort a case. Oh, and…

Alfred Engelberg: From what they told me, nan accusation they gave me, we didn't person a very bully defense.

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

Alfred Engelberg: The patent owners were successful a very unusual position. If they won, they sewage thing because we were already bankrupt. Two, they were gonna person to walk nan ineligible fees to win.

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

Alfred Engelberg: And if they lost, they would suffer millions and millions of dollars successful business because location wouldn't beryllium a patent. And they'd person title from generic drugs.

Dan: And meanwhile, Al Engelberg is besides sizing up nan judge. He knows nan feline doesn't emotion patents.

So Al shows up to nan first convention and he bluffs. 

Alfred Engelberg: I said to nan judge, oh, your Honor, you know, it's different 1 of those patents. They're each invalid. And I said, we don't request very overmuch discovery. We're, we'll beryllium fresh to spell to proceedings successful a fewer months. Just group a proceedings date.

Dan: The different broadside walks retired beside themselves.

And wrong a mates of weeks they telephone Al to say: Hey, really astir this? You guys conscionable admit our patent is OK, and we'll springiness you nan money we would've spent litigating. Call it 400,000 bucks?

Alfred Engelberg: I called nan customer and said, how's $400,000? He said, are you kidding?

Dan: They didn't conscionable get retired of problem — they sewage retired of bankruptcy, pinch $400,000 successful their pockets. Because Al Engelberg knew really to size up a situation. 

Alfred Engelberg: You don't study that successful rule school. That's not what they teach.

Dan: Word gets astir about that case, and beautiful soon everybody successful nan generic supplier world is calling him.

It's a mini world, but by nan extremity of nan 1970s, location whitethorn beryllium room for it to commencement getting bigger. 

People are starting to notice: Drugs are expensive. Maybe location should beryllium much inexpensive generics. 

Some generic supplier companies shape an relation and commencement lobbying: Make it easier to get generic narcotics to marketplace without having to spell done each those trials.

The brand-name drugmakers push back: They opportunity it takes truthful agelong to tally nan tests and get their narcotics approved, they don't get capable clip to make money earlier those patents expire.

In 1983, Democratic Representative Henry Waxman steps successful to agent a compromise, pinch Republican Senator Orrin Hatch.

And Mr. Engelberg goes to Washington. To tally strategy for nan generic drugmakers. 

Alfred Engelberg: In a batch of ways , that's wherever my Atlantic City training really helped maine astatine nan extremity of nan day

Dan: There were a batch of people, pinch a batch of interests. A batch of angles. ?He starts commuting from New York to Washington DC a mates times a week — for months and months, much than a year.

And Al Engelberg says: This time, it wasn't conscionable astir winning a case.

Alfred Engelberg: I was successful nan backmost of a cab nan measurement I remember, pinch nan elder partner of nan rule firm. And he says to me, why are you breaking your ass going to Washington 2 aliases 3 times? Why don't you nonstop an associate? You know, it's conscionable like, it's conscionable different case. And I said. I said, are you kidding? I said, you know, really galore lawyers ever get to do what I'm doing correct now? To beryllium astatine nan array influencing what whitethorn beryllium a awesome rule that's gonna person awesome consequences is, is for illustration thing I ne'er thought my full life I'd beryllium doing.

Dan: A kid from Atlantic City was precisely nan correct personification to effort to equilibrium each nan angles, discuss a compromise. It took much than a year. It almost didn't happen. But past it did. Congress passed nan bill, and President Ronald Reagan sewage successful beforehand of cameras to motion it.

Ronald Reagan: Let maine move my attraction to nan existent logic we're present this afternoon, signing into rule nan Drug Price Competition and Patent Term Restoration Act of 1984. 

Dan: better known arsenic Hatch-Waxman.

Hatch Waxman had 3 basal components:

One: Brand drugmakers sewage a fewer other years connected their patents.

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

And 3 -The caller rule laid retired rules for a generic drugmaker erstwhile they wanted to CHALLENGE an existing patent. 

Negotiating that 3rd portion was nan portion wherever Al Engelberg's acquisition connected nan Atlantic City boardwalk, and nan U.S. patent office, and nan generic supplier manufacture came together: The consequence would make him millions and millions of dollars — and rustle a elephantine spread into nan expansive bargain he had worked truthful difficult to bring about.

That's coming correct up.

This section of An limb and a Leg is produced successful business pinch KFF Health News. That's a nonprofit newsroom covering wellness issues successful America. The folks astatine KFF Health News are astonishing journalists — their activity wins each kinds of awards, each year. We are honored to activity pinch them.

So. The brand-name supplier makers and nan generic supplier makers struck a deal. That woody was bully for them. Both sides sewage thing large retired of it. The nationalist was expected to get thing retired of it too.

And, to beryllium fair, we did: Remember, backmost then, possibly 1 retired of 5 prescriptions was for a generic drug. Now it's 9 retired of ten.

But we salary much than ever for drugs. Mostly for branded, patent-protected drugs. And nan biggest, most-important, astir profitable narcotics get locked down patent thickets.

How did that happen? 

Well, to understand that, it helps to cognize what Al Engelberg sewage retired of nan full bargain.

Al had been location astatine nan bargaining table, connected behalf of nan generics. 

One day, during those negotiations, he was successful nan agency pinch Henry Waxman's lead counsel, a feline named Bill Corr, erstwhile Corr sewage a telephone from personification connected nan different side.

Corr starts pointing astatine nan phone, pointing to Al — indicating: This feline is talking astir you.

When Corr gets disconnected nan telephone he says: That guy's not judge astir this woody wherever bad patents could beryllium challenged. He's suspicious astir wherever you mightiness return this. Like, are you conscionable gonna group 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 ne'er fixed it immoderate thought, but it's a hellhole of a bully idea. Maybe I'll look astatine it. 

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

Alfred Engelberg: And we sat successful nan roseate garden, September 23rd, 1984, watched Reagan motion nan bill. And successful December of that year, I sat down astatine my room array pinch a yellowish pad and I laid retired a strategy.

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

Al Engelberg knew a batch of patents were garbage. Knew it from his clip successful nan patent office, knew it from practicing law. And he knew how overmuch money a successful patent situation could beryllium worth.

The measurement Hatch-Waxman worked: If a generic supplier institution challenged a patent and won, they would get six months earlier immoderate OTHER generic drugmakers could get a ace astatine nan market.

So their only title would beryllium nan brand. If a pill costs 2 cents to make, and nan marque was trading for a dollar a pill — that's 98 cents of profit for each pill.

You're nan only competitor? You could complaint 75 cents a pill and get 73 cents of profit. On a deed drug, you could make millions and millions — conscionable successful those six months. 

Al's thought was this: Partner up pinch a generic drugmaker. Go find cases- narcotics pinch anemic patents. Win 'em. 

And divided those millions successful imaginable profits fifty-fifty. 

Al sounded a generic drugmaker — they were fresh to spell — and brought nan woody to his rule firm. .

Alfred Engelberg: As it turned out, my partners weren't willing successful having maine do this. They tried to talk maine retired of it.

Dan: But they couldn't. So he left. Went retired connected his own. All connected his own.

Alfred Engelberg: I ne'er hired a azygous soul, not moreover a secretary. And I couldn't type. I still can't type.

Dan: But he hunted and pecked his measurement done little aft brief. He bought an early portable machine — it weighed 30 pounds — and lugged it astir successful nan backmost of his car. For 10 years.

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

Dan: Yeah. Turns retired Al was really bully astatine uncovering nan problems pinch supplier patents.

In 1 of his first cases, Al Engelberg personally made much than 70 cardinal dollars. Others settled: A fewer cardinal here, a fewer cardinal there- it adds up.

And then…

Alfred Engelberg: It sewage to beryllium nan mid nineties, and I was moving connected a lawsuit called Buspar. 

Dan: The Buspar lawsuit ended up a large victor for Al Engelberg and his generic supplier partners. 

But it had consequences that went way beyond a azygous case. And led to large losses for nan public.. Here's really it went. 

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

Dan: But Bristol Meyers Squibb invested successful large advertizing and trading campaigns.

Speaker 5: I consciousness anxious. I can't concentrate. 

Speaker 6: I'm truthful irritable. If you. You suffer from excessive worry. It tin consciousness for illustration a upland of anxiety. 

Speaker 5: I'll ne'er get it each done. I'm overwhelmed. 

Speaker 6: But a medicine medication called buspar tin help.

Dan: And each that trading did its job. By nan mid-1990s, Buspar was making much than 200 cardinal dollars a twelvemonth for Bristol.

Alfred Engelberg: The only problem for them was that nan supplier was not new. 

Dan: The progressive constituent was well-known successful aesculapian lit arsenic a tranquilizer. Nobody had bothered to marketplace it.

So Bristol Myers Squibb revenge a patent connected it, claiming it had discovered a caller usage for this well-known tranquilizer: Treating anxiety.

Al Engelberg says erstwhile he publication nan patent application, he could hardly judge it: What do tranquilizers do if not… dainty anxiety?

It's for illustration saying: There's this worldly called sugar. We're gonna return retired a patent connected utilizing it arsenic a sweetener.

This looked for illustration a lawsuit for a feline from Atlantic City. 

Alfred Engelberg: I did thing that lawyers don't. That's conscionable nan measurement I was built. 

I revenge a mobility pinch nan tribunal and fundamentally said, we don't request immoderate evidence.

You conscionable person to publication nan patent. If you judge it's true, nan patent's invalid. Just, you know, each you request is simply a dictionary basically.

Dan: Al says Bristol was eager to settle. 

Alfred Engelberg: We get into a colony chat and we support saying, no, no, no, no.

Dan: Al's partners had done nan math: They figured they stood to make a 100 cardinal dollars aliases much erstwhile they won. So erstwhile nan different broadside offered 25 million, nary was nan easy answer.

Alfred Engelberg: We said, why are we gonna return this? You know, it's crazy. There's a reward present we cognize what it is. We're gonna get it eventually.

Dan: Al sits down pinch a lawyer from nan different side, a feline he knows, explains really he sees nan math.

And soon nan different broadside comes done pinch a overmuch bigger offer: 72 cardinal dollars - almost 3 times arsenic much. 

Alfred Engelberg: And I'm sitting location like, what are you crazy? But past deliberation astir it from their constituent of view. 

Dan: Paying 72 cardinal dollars is nothing, compared to what Bristol stands to summation if this suit goes away. 

With their monopoly, Bristol Meyer Squibb is making much than 200 cardinal dollars a twelvemonth connected Buspar. And unless personification other lines up to do what Al Engelberg had done, expect to support that monopoly for years.

Charging immoderate they want. Two dollars a pill, 3 dollars a pill. Which Al Engelberg says is precisely what happened.

In fact, they kept that monopoly for for illustration 5 years. 

Alfred Engelberg: As it turned out, cipher came down us. And so, they had that monopoly until 2000. So they sewage 5 years of 2 billion, successful gross profits. 

Dan: They made out.

Alfred Engelberg: For nan costs of $75 million. And you know, nan nationalist sewage screwed 'cause they are continuing to pay, you know, $2 a pill aliases $3 a pill for a supplier that yet ends up being disposable for 20 aliases 30 cents. Um, truthful that's, that's really it works.

Dan: That's really it works. The branded institution and nan generic institution some make retired great. Cheaper generic versions of a supplier get delayed. 

That astonishing payday for Al Engelberg and his partners astatine nan generic supplier institution turned into a exemplary a template for nan benignant of woody that each generic supplier institution would want successful on.

It sewage a nickname: Pay for delay.

Alfred Engelberg: That dispersed done nan manufacture for illustration wildfire, those numbers, you know, you don't make those numbers half a cent astatine a clip on, connected pills,

Dan: Lawsuits were measurement much profitable.

But Al Engelberg wasn't filing them.

A twelvemonth aliases truthful aft nan Buspar lawsuit settled, sparking nan Pay for Delay golden rush, he retired. He had plentifulness of money and thing to prove.

And successful retirement, he started evaluating what he'd accomplished, for amended and for worse.

For better, generic narcotics had much than doubled their stock of nan marketplace since Hatch-Waxman took effect.

For worse, he could spot 2 places wherever — contempt each of his Atlantic City training — he had missed a mates of angles successful negotiating Hatch-Waxman. 

One was: this full pay-for-delay scheme. Turned out, successful balancing incentives for brands and generic makers, he'd near unfastened this perverse inducement that near nan nationalist out. 

And nan 2nd was a loophole that Hatch-Waxman had near open.: 

It created a process wherever players for illustration Al and his generic partners could situation patents connected narcotics for illustration Buspar, that they thought didn't merit protected monopolies. It removed immoderate clash for those attacks. 

The supplier companies developed a measurement to adhd much friction: stacking other patents — secondary patents — connected each drug.

Developing patent thickets.

Even if a secondary patent is trivial — and tons of them do get tossed retired — challenging it intends a tribunal fight. And that costs money.

Alfred Engelberg: It caused nan large supplier companies to conscionable get much and much patents. Because why not? You know, location was thing opinionated successful nan way.

Dan: I mean, cipher knows amended than Al Engelberg: Patent examiners don't precisely guidelines successful nan way. 

And those patent thickets and salary for delay, they provender connected each other. 

Alfred Engelberg: The economics of nan business, caused these kinds of settlements to scope epic proportions. So nan generic companies would, situation these secondary patents and, nan supplier companies would salary them off.

Dan: In 1999 he published an article successful a scholarly diary arguing that Hatch-Waxman needed a reboot. Even nan six-month caput commencement for a successful situation could astir apt go. 

And ever since — for much than twenty-five years — he's poured millions of dollars into efforts to tighten nan rules. Funding research. A public-information run from Consumer Reports. Even a halfway for IP rule astatine his alma mater, NYU.

It hasn't ever gone his way. 

Pay for hold has gotten overmuch bigger since Al Engelberg wrote his first article calling for reform: He wrote successful 1999 that astir 2 twelve patent challenges had been filed.

Now he estimates that number astatine 12 thousand.

Alfred Engelberg: I can't show you really galore tens of billions of dollars successful ineligible fees that is. It's 1 of nan fastest increasing and and steadiest industries for large law.

Dan: A Hatch-Waxman litigation forum connected LinkedIn has much than fourteen 1000 members.

And Hatch-Waxman doesn't screen galore of today's nan top-selling drugs- nan biggest moneymakers. They beryllium to a people called "biologics."

That includes famously-expensive rheumatoid arthritis narcotics for illustration Humira and Enbrel — and insulin. 

Biologics weren't a class forty years agone erstwhile Hatch-Waxman sewage negotiated. Congress passed a caller rule to woody pinch them successful 2010 — ?the Biologics Price Competition and Innovation Act.

Al Engelberg is not a instrumentality of that law.

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

Dan: He says nan each but encourages patent thickets. And doesn't supply a pathway to situation them.

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

Alfred Engelberg: Back successful nan seventies, we utilized to person mini startup clients successful nan machine field, and they would get letters from IBM. It says, we are fresh to pass you that you whitethorn beryllium infringing 1 aliases much of nan pursuing patents. And location was a 10 page database of patents attached. And nan startup would travel to america and say, you know, what should we do? And we would say, find different statement of work, you know, what are you gonna do?

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

It tells nan communicative of his profession — and lays retired his prescriptions for fixing nan problem.

He doesn't JUST attraction connected plugging nan holes successful Hatch-Waxman and nan biologics law.

Alfred Engelberg: You know, we don't really request a generic supplier industry. We request generic supplier pricing. 

Dan: He's sewage proposals for an accrued authorities domiciled successful negotiating and regulating prices — and much than that.

He argues that a 1980 rule allows nan authorities to commisssion generic versions of narcotics that were developed utilizing nationalist investigation dollars.

He besides says nan FDA rules that protect secondary patents connected narcotics — that let patent thicketing — are based connected a wholly incorrect mentation of Hatch-Waxman.

And tells america he's moving up a challenge, pinch thief from AI devices for illustration Claude. 

He's 86 years old. And he doesn't look inclined to stop.

Alfred Engelberg: It truthful changed my life and I did truthful good by it, I thought, really tin I not return connected this problem? Who's gonna do it if I don't do it?

Dan: He's sewage nan time. Money's nary object. And he knows nan territory arsenic good arsenic anybody. He helped create it. 

Alfred Engelberg: So it's, it's my responsibility really. It's that benignant of Jewish guilt. What tin I show you? I'm paying backmost for nan bingo game.

Dan: So we've gone backmost much than 50 years connected nan question: Why aren't location much generic drugs? We've learned why we've sewage nan ones we have, and what stands successful nan measurement of getting more.

And that is conscionable successful time. Because this outpouring nan U.S. Supreme Court will perceive arguments successful a lawsuit that could restrict nan generic supplier pipeline moreover further. It could person awesome implications.

And knowing what they are requires each of nan 101 we've covered here. We'll person that communicative for you successful a fewer weeks. Til then, return attraction of yourself. 

This section of An Arm and a Leg was produced by Emily Pisacreta, pinch thief from Dan Weissmann— and edited by Ellen Weiss. 

Adam Raymonda is our audio wizard.

Our euphony 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 head of operations. 

This bid — An Arm and a Leg 101 — is made imaginable successful portion by support from Arnold Ventures. 

An Arm and a Leg is produced successful business pinch KFF Health News. That's a nationalist newsroom producing in-depth publicity astir wellness issues successful America and a halfway programme astatine KFF, an independent root of wellness argumentation research, polling, and journalism.

 Zach Dyer is elder audio shaper astatine KFF Health News. He's editorial liaison to this show.

An Arm and a Leg is distributed by KUOW, Seattle's NPR news station.

And acknowledgment to nan Institute for Nonprofit News for serving arsenic our fiscal sponsor.

They let america to judge tax-exempt donations. You tin study much astir INN astatine INN.org.

Finally, convey you to everybody who supports this show financially.

You tin subordinate successful immoderate clip astatine limb and a limb show, dot com, slash: support.

"An Arm and a Leg" is simply a co-production of KFF Health News and Public Road Productions.