The Supreme Court case that could slow generic drugs

Dan: Hey there– 

Dr. Anmol Gupta is a resident physician at the University of Michigan. One day a week, he drives thirty miles north of Ann Arbor to a rural clinic and for a lot of his patients there, it’s the only doctor they can get to within an hour.

Dr. Gupta: They have to travel the furthest. They’re often the ones that are uninsured or on Medicaid. They often are coming and seeking care later than you’d wish they had access to care.

Dan: So they’re sicker. And the cost of prescription drugs comes up in like every single visit.

Dr. Gupta: I’m meeting patients who are just now being able to afford medications who maybe weren’t able to five, 10 years ago who needed it then.   

Dan: Take statins, the cholesterol-lowering drugs. One of the most popular brand-name versions, Crestor, finally went generic in 2016. Before that, a lot of patients like Dr. Gupta’s simply couldn’t afford it.. So now he wants generic versions for today’s expensive drugs to reach his patients as soon as possible. 

Dr. Gupta: We’re trying to prevent long term risks here. The faster we can start these medications, the better the outcomes in hopefully preventing devastating things like heart attacks and strokes.

Dan: Which is why what’s about to happen at the Supreme Court matters so much to him — and to millions of patients like his.

This spring — actually, this week — the court is hearing arguments in a case that could make it harder, and slower, for cheaper generic drugs to become available to patients.

This is An Arm and a Leg, a show about why health care costs so freaking much, and what we might be able to 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.

Our show’s senior producer, Emily Pisacreta, flagged this Supreme Court case for us months ago.

Emily, you’ve been reporting the heck out of it ever since. 

Emily: Dan, I talked with lawyers. I talked with doctors. I talked with one guy who is both a lawyer and a doctor. And the good news is, you don’t need to be any of those things to understand what’s going on here.

Dan: Great — take it away.

Emily: Let’s start with the basics. When a drug company invents a new medicine, they get a patent – basically an exclusive right to sell it for about twenty years – sometimes a couple extra years.  Exclusive, without competition. That’s part of why brand-name drugs cost so much.

But when the patent expires, other companies can make a generic version of the exact same drug. Those generics usually sell for much cheaper. The legal rules of this brand vs. generic deal got hashed out back in 1984, in a law called Hatch-Waxman. We talked all about that in our last episode – but don’t worry if you missed it.

Sean Tu: Hatch-Waxman made this balance between giving protection to brand-name manufacturers to innovate and create new drugs, but then once their patents expire, the idea is we open it up for generic competition.

Emily: That’s Professor Sean Tu. He teaches law at the University of Alabama. He also has a PhD in pharmacology and a history working in the biotech industry. Sean helped write a legal brief in this case on the side of the generic drug maker.

He says this case is about that balance that Hatch Waxman tried to create. Because, drug companies don’t just file one patent and leave it at that. They file a whole stack of them… Starting with a patent on the drug itself —  the “molecule” – And then a second patent on how the drug is used. So when the first patent runs out, they might still have years of protection left on the second one. 

But it doesn’t end there. They can also patent new uses of that drug.

Sean Tu: Here’s an example and I’m just gonna make one up. I have a drug X that was first approved for diabetes. But let’s say the patent expires in 2000. And then later on I get a new patent for that same drug to treat cancer but that patent doesn’t expire until 2020.

Emily: Hatch-Waxman’s rules say generic drugmakers don’t have to wait until 2020 to sell a generic for treating diabetes. 

But they do have to be careful with their generic drug’s label. 

In the world of Hatch Waxman, the label is not just the white sticker on the orange bottle you get from the pharmacy.  

The label means all that folded-up paperwork full of small type that comes with your prescription.

It’s full of technical information about the drug. So if a generic drug-maker sells a version of Sean Tu’s made-up drug for diabetes, they have to make sure that “label” doesn’t mention that the drug can also treat cancer. In the industry they call this a ‘skinny label” 

And skinny labels are a BIG part of getting generic drugs to market — making them available– quickly. The industry says four out of ten generics get launched with a skinny label.

 So, skinny labels are the big legal idea at the heart of this supreme court case. 

Now let’s talk about the specific drug in this legal tug-of-war. It’s called Vascepa.

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Emily: Vascepa’s made by a company called Amarin,  and it’s their only product. It comes from fish oil, and it’s been approved by the FDA for two different uses — well, kind of different. 

First, in 2012, to treat a rare condition involving dangerously high levels of a certain kind of fat in the blood. 

A few years later, Vascepa got approved for another condition, one that affects a lot more people: people with only slightly too much of that fat in their blood. 

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Emily: That second approval meant a second patent for the second use. Meanwhile the patent on the first use was set to expire. When that happened, a generic manufacturer called Hikma jumped at the chance  to come to market with a cheaper, generic version. 

Newscaster: ??Finally talk quickly about Hikma Pharmaceuticals. London listed under the code HIK, but founded in Jordan [fade under] …

Emily: In 2020, Hikma launched their generic with a skinny label on the packaging. They say that skinny label was carefully written: That it only described the unpatented original use. That they definitely left out any mention of the second use– the one that’s still patented.

But Amarin — the brand name manufacturer — didn’t see it that way…and they sued them.

Amarin’s argument has two parts. First, they say Hikma’s label, even though it left out the patented use, still referenced a study that was only conducted for that still-patented use. Second, they say that in press releases, on their website, and on investor calls, Hikma described their product a little too broadly,  including calling it, quote, “the generic version of Vascepa.”

Amarin says: put those two things together, and Hikma was effectively encouraging doctors to prescribe it for the use that’s still under patent. 

The legal term for this is ‘inducing infringement’.

There’s a pretty-famous Supreme Court case about inducing infringement –at least maybe famous to legal nerds:  It involved a file-sharing service called Grokster. The whole product was basically built to help people swap pirated music and movies. But instead of my entire high school graduating class getting sued for copyright infringement, Grokster did. For inducing it.

Sean Tu says induced infringement means YOU didn’t infringe the patent yourself, but you nudged someone else into doing it. On purpose.

Sean Tu: You have to have the intent to induce somebody to actually infringe the patent. Looking at the label, looking at these fairly innocuous marketing statements, I don’t think any of them induce a doctor to prescribe for the patented indication.

Emily: And here’s the thing, some of the people who agree with Sean Tu — they aren’t who you’d expect.

Greg Chopskie: Yeah. Amarin would have you believe that doctors pay attention to investor relations calls when making their prescribing decisions.

Emily: Greg Chopskie is a patent attorney who works mostly for brand-name drug companies. About a decade ago, he was part of a team that won a $2.15 billion settlement. It was one of the biggest brand-versus-generic lawsuits ever. So, he’s not exactly a cheerleader for generic drug makers.

But he says, until recently, a case like Amarin’s wouldn’t have legs. Except things took a big turn in 2021. 

That year a big brand-name drug company, GlaxoSmithKline, – we’ll call them GSK for short – they won $235 million in damages from a generic maker called Teva. The accusation: Induced infringement. Greg Chopskie says GSK’s victory really shook things up.

Greg Chopskie: What it did was make mundane market activities potential bases for infringement claims.

Emily: Mundane marketing activities like calling your drug the generic version of something. Saying it’s been rated equivalent by the FDA. Normal things generic companies say all the time. But now…

Greg Chopskie: The focus is on what’s printed on the label, what’s being said in the market, what your detailers are telling physicians, what you’re telling investors… a much bigger scope of activities could be used to find infringement.

Emily: Teva appealed their case to the Supreme Court, but the court took a pass on hearing it. Greg thinks the Court taking up the Hikma vs. Amarin case is a sign they regret that decision.

Greg Chopskie: I think this is a little bit of buyer’s remorse from the Supreme Court that they did not take the GSK case.

Emily: So just how important is this case? And what could it mean for us? That’s next.

Emily: 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, and we’re honored to work with them.

Emily: How big of a deal is Hikma versus Amarin?

Sara Koblitz: So it’s, it’s a pretty big deal.

Emily: Sara Koblitz is a lawyer whose firm works with both brand-name and generic drug companies. She’s been watching this case closely, because however it goes, she says it changes how everybody in the industry operates.

And Sara says part of the reason it’s a big deal is because of how early in the process this case is being heard. No jury has weighed in. There hasn’t even been any discovery, no documents exchanged, there haven’t been any depositions. 

The question before the court is: Should this case just get tossed out without even having a trial?

Sara Koblitz: So it is deciding whether the case can continue and Amarin can continue to make those allegations against Hikma.

Emily: ?If it rules for Hikma, the generic company, the court could say, this KIND of a case just shouldn’t be a thing: Claiming “induced infringement” over what experts like Sara and Greg Chopskie say have been totally normal skinny-label practices for decades. 

The court could say: there’s no “there” there — and not just to Amarin.

Sara Koblitz: Theoretically, other companies should be on notice that they can’t bring induced infringement cases on such little evidence.

Emily: On the other hand, if the court rules AGAINST Hikma, that would be a big worry for every generic drug maker

Sara Koblitz: the idea that you can have a case go with very little evidence about what has been said to induce infringement will mean that it’s really easy to bring litigation against these generic companies. 

Emily:  Easy to bring litigation that would cost those generic companies millions of dollars to fight, Big money. And that’s just the cost if they win. If they lose… 

Sara Koblitz: The ramifications for being found guilty of induced infringement are really significant. It’s treble damages, so it’s three times the amount that the company would have made, but for the introduction of the generic drug. 

Emily: Which raises the big question here: If the Supreme Court rules against Hikma, and opens the door to lots of “induced infringement” cases, would generic companies keep trying to use a skinny label at all, or would they decide it’s just not worth the risk? 

And if they decide it’s not worth the risk and instead wait for all the patents to expire, does that mean we have to wait longer for generics?  

A 2019 study estimated that skinny labels come out an average of 3 years earlier than generics that come out after all of the patents have expired. And as Sara points out, that’s the average. Not the limit.

Sara Koblitz:  In some situations you, it could save you 10 years. You could be getting a product 10 years earlier than you would’ve gotten it if you had otherwise ?waited until the product was off patent to come to market.

Emily: And Sara is not the only one worried. In 2024, the FDA warned Congress that the GSK decision – the earlier case that set the stage for this fight – could “significantly impact the timely availability of generic drugs.” 

There’s already SOME data, from a very small study, suggesting generic companies are pulling back. Before the GSK ruling in 2021, about 43 percent of eligible drugs came to market with a skinny label. By 2023, researchers from Harvard found that only one out of five eligible drugs did so. 

Sara thinks that trend is the result of uncertainty after the GSK decision. And that Hikma vs. Amarin – no matter how the court rules – will clear away some confusion.

Sara Koblitz: ?I think that this case in particular is really important for generic companies so they can have certainty about what they’re doing and saying.

Emily: And if the Supreme Court rules in Amarin’s favor, Sean Tu worries that brand companies will get more creative about blocking skinny label competition – by filing more patents on how the drug is used–  patents that are so similar to each other that it’s almost impossible to write a label for just one of them.

Sean Tu: In the Amarin v Hikma case, the actual indication is  ‘really bad heart disease’ and ‘slightly bad heart disease’ – and then ‘preventing heart disease.’ That’s the kind of games I think are going to happen in the future.

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Emily: Oral arguments are Wednesday, April 29th. We’ll be listening. 

And you know who else will be listening? Dr. Gupta –the hospital resident we met at the very beginning of this episode. Along with his job practicing medicine, he volunteers with a group called Doctors for America — thats a group advocating for access to affordable health care. Including drugs.   

And he’s hoping the justices understand just what’s at stake for his patients.

Dr. Gupta: You know, as a doctor, when I’m sitting in front of a patient, right, I’m trying to figure out what’s the best medication for your disease. I see the benefit of generics when they come around. I’m seeing that now, but there’s still so many common medications that aren’t generics yet that people struggle to afford.

And if we can find a medication that you can afford, that’s best, right? 

Dan: Emily, thank you so much for getting us this story. 

Emily: Yeah, you bet. 

Dan: We’ll be back with another episode in a few weeks. Until then Take care of yourself.

This episode of An Arm and a Leg was produced by Emily Pisacreta, with help from Claire Davenport and me, 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. 

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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