Opinion | Pharma Companies Abuse the Patent System, and Patients Pay the Price

In this video, Jeremy Faust, MD, editor-in-chief of MedPage Today, discusses the U.S. patent system with Priti Krishtel, JD. Krishtel is the co-founder of I-MAK, a non-profit focused on building a more just and equitable medicines system in the U.S.

Krishtel reveals how the patent system rewards pharmaceutical companies that try to prevent competition and keep prescription drug prices artificially high.

The following is a transcript of their remarks:

Faust: Hello, this is Jeremy Faust, medical editor-in-chief of MedPage Today. Thank you for joining us.

We’re joined today by Priti Krishtel, a health justice lawyer. She’s the co-founder and co-executive director of I-MAK, Initiatives for Medicines, Access, and Knowledge. This is a non-profit that works on equitable medicines systems and patents and issues surrounding that. Priti Krishtel is also the recent recipient of the MacArthur Genius Award.

Well, thank you so much for joining us.

Krishtel: Thanks for having me.

Faust: Let’s dive into your work and what you do. Obviously COVID changed everything in terms of how I spend my time, and to some extent how you spend your time, I imagine. Can you tell me how we are doing in terms of your area of expertise and interest, which is patents and sharing of information so that everybody has access to life-saving therapeutics and vaccines. How are we doing compared to a year or 2 ago?

Krishtel: You know, in some ways — my work is on systems change, and not a whole lot has changed. We still live in the same system where when a pandemic hits, some people are going to get medication first, some people are going to get testing or vaccines first, and some people aren’t going to get it at all. That’s just the reality.

I think the hope that I saw through COVID, though, was how many people mobilized to change that situation. How many people became awake to understanding that the system is actually designed to serve commercial interests first and not to serve equitable access. So, we now have thousands of people who have joined the access to medicines movement who weren’t part of it before, which is really beautiful.

Faust: I want to address the idea of patents being a problem, because, in a way, you sort of come at it as someone who might have been predisposed to not think so based on your background. Tell us a little bit about how you started.

Krishtel: Yeah. I grew up as the daughter of a pharmaceutical scientist. You know, we used to talk about science everyday at the dinner table. I grew up with a reverence really for finding cures, and for patents as an instrument of really showing that you had achieved a big milestone. That’s what it was for me growing up.

I decided to go into health law, and I became a legal aid lawyer to work with communities living under the poverty line. When I was doing that in the early years as a lawyer, I came to realize that part of the reason that medication was unaffordable or inaccessible was because of the way the patent system was actually being gamed. So it was a big “aha” moment for me.

I was in the early years when I met my co-founder, Tahir Amin, and he was an intellectual property lawyer who had come over from the private sector, and I was working in legal aid, and my office’s clients were people living with diseases who couldn’t afford their medication. So, we teamed up to sort of investigate the problem and realized that IP was at the heart of it and that the system was being used for purposes that it wasn’t intended for.

Faust: I’ve heard you speak a lot on these issues and one thing that always gets asked, and I will ask it again, is really about whether you make a distinction between situations in which a private company received government funding. In other words, the venture risk capital was actually taxpayer-driven.

Krishtel: That’s right.

Faust: And then, those who didn’t. So in other words, there’s always a concern that the risk is public, but the reward is private. Do you make a distinction when there are companies that haven’t necessarily received tons of government funding in terms of what they owe the rest of the world?

Krishtel: So, I think it depends on the situation. What we saw with COVID, for example, in the case of Moderna, was that Moderna received nearly 100% of its funding from government funding, and the government didn’t keep any of that return on investment. So, we’re in a position today where Moderna’s on track to make $40 billion by the end of this year. They’re predicted to have a $100 billion in market cap in the coming years because they’re taking that technology, which was taxpayer funded, and they’re applying it to other disease areas. And they’re going to make a whole lot of money.

So what we always say is that there’s not an investor alive who would take a bet like that, and yet the federal government keeps using our dollars in this way. The situation could have looked very different, where if the government had retained some rights in that proprietary technology, it could have decided how to deploy that technology worldwide and how to use it to save more lives.

So I think when it comes to public funding, there’s a need for a real paradigm shift.

Faust: Would you say like a better deal would be, and I’m just spitballing here, we will give you the research and development money, the NIH will pay for that, and the first $10 billion of profit is yours. But after that, we’ve got to split it or we’ve got to take this portion and put it back into investing in the people who paid for this, including people who don’t have access to it. Would you support some kind of system like that?

Krishtel: Yeah, that’s a great idea. I think the money is one issue, and definitely taxpayers should get a return on their investment. So, something like what you’re proposing sounds good.

I also think there is the matter of whose technology is it then? Because if the federal government had access to it, it would be able to redeploy it. What we saw happen during COVID is that Moderna kept claiming that companies in other countries did not have capability to make vaccines. Now we all know that’s not true. Studies have come out doing supplier landscapes showing how many companies could have been up and running if Moderna was willing to share knowledge and share its IP.

So I think that kind of thing, the money is one dimension of it that’s important. We should make sure that Moderna is rewarded for the work that it did. The technology and the sharing of knowledge is the other piece.

Faust: You talk to governments, you talk to officials and leaders. Do they have a sense that what you are proposing isn’t just humanitarian, but actually just is a national security interest for us? In other words, nobody’s safe until everybody’s safe. Do they understand that?

Krishtel: That’s been a tricky question. During COVID, I think there was a significant base of support that got activated, including world leaders, around that idea. But it never quite caught on here in the U.S. — that deeper understanding that we actually aren’t going to be able to take on and prepare for pandemics as well as we could by taking care of the rest of the world.

So that, I think, is going to be a major challenge that we’re going to have to figure out how to solve for in the coming years.

Faust: Moderna had said in the past that they wouldn’t be really enforcing their patent during the pandemic. How’s that playing out?

Krishtel: That’s tricky. You know, we’ve seen that language in prior pandemics before. I think the devil’s really in the details on that one. You may not enforce some of your patents, you may enforce other IP. What does it mean to be “during the pandemic”? Is the pandemic over? It’s up to the initiative of the company in that case.

I think what we’ve seen with voluntary actions by the pharmaceutical companies over the last 2 decades with HIV and with hepatitis C is that you actually need a system. It can’t be up to the individual goodwill of the companies, because it’s not going to get us as far as we need to go in terms of health outcomes.

Faust: Your audience is often, again, governments, leaders, people who come in all varieties of political bent. Do you ever get the feedback, “Oh, this is just anti-capitalist?”

Krishtel: Yeah, I think there are people who think that when they read or hear about the work secondhand. Usually when people meet us, they don’t walk away feeling that.

For example, in our work in the United States, we’ve been doing a series of investigations over the last 4 years called “Overpatented, Overpriced,” where we’ve systematically been able to show that there’s — so on Wall Street, they call it the “patent cliff.” It’s the point at which patents on a drug are supposed to expire and competition is supposed to enter the market. Our investigations have really revealed that companies are not only filing dozens or even hundreds of patents on the top-selling drugs, there’s a sharp acceleration post-FDA approval and before the patent is supposed to expire so that that exclusivity period or that monopoly can be extended out as far as possible. And it’s costing us hundreds of billions of dollars as a country.

I think in that body of research and in that education work we’ve been able to do, our message is not, “Oh, we shouldn’t be giving out patents at all.” Our message is, “Something’s gone off the rails here.”

You know, Jeremy, that prescription drug spend is poised to reach a trillion dollars they’re saying by 2030. Well, let’s look at where a lot of this cost is coming from on prescription drugs. So we’re saying we need some regulation to correct for what’s happening in order to be able to ensure that competition enters the market in a timely way.

Faust: Do you think that there’s some problem with the pharmaceutical companies essentially replacing their old compound with a new one, and the new one might work 2% better, but it costs a thousand times as much? In reality, nobody wants to say, “Oh, we should give the thing that’s sort of off-patent, that’s 98% as good,” because everyone deserves the best. But in a way, is the problem that we keep creating medicines that are much, much more expensive than they are in terms of the incremental benefit that they give us?

Krishtel: Yeah, there are some really great experts out there who talk about this issue. From my perspective on the patent side, I definitely think we’re seeing a lot of patenting activity where even that marginal benefit to the patient doesn’t exist. We’re seeing just the proliferation of patents that look different and feel different, but it doesn’t necessarily add value.

It becomes part of what we call a “patent thicket,” where it’s not that each patent in the thicket necessarily has that kind of value for the patient, but because they’re amassing so many … For example, in the case of Humira [adalimumab], I think they filed for over 300 patents. They’ve gotten 166 to date. When you have that many patents, it’s just a deterrent to competitors who want to enter, to take on the risk of being litigated against. The question you raised is important. What are we rewarding?

From the patent perspective, I would say we’re rewarding a whole lot less with a whole lot more. Because what we’re seeing is the amount of money you can make, in the case of Humira again, in the years that drug was supposed to come off patent, the Europeans saw competition starting in 2018, we’re not going to get competition until next year. Now, this is after the initial set of patents expired. They’re making two-thirds of their U.S. sales during this time period, when Europeans have already gotten competition. That’s $100 billion they’re poised to make during this time.

So again, it just goes back to this idea: What are we actually rewarding? Are we incentivizing the right thing?

Faust: In terms of what physicians or physician leaders can do, because that’s really this audience, obviously there’s advocacy and there’s knowing this stuff and there’s education that they can have. I looked at your website, you have an amazing tool showing who owns the patent and how much the price has gone up. I really encourage people to check that out, because it’s eye-opening.

But is a lot of the answer also in our physician hands, where it’s what we decide to put on formulary? Because if we decide, look, we’re just not going to spend this much money for something that doesn’t even really benefit the patient other than some trial that was really designed to show some tiny little incremental thing. Can we really make a difference on that, or is it more like this is a legal, political battle and physicians are essentially pawns?

Krishtel: I think it’s both. One of the examples that comes to mind is when drugs are going off patent, for example, in Europe, but we’re getting a delay.

You know, I think this happened recently on both Xarelto [rivaroxaban] and Eliquis [apixaban], the cardiovascular drug. They do a strategic patent filing, and then they delay the moment when competition should be entering. It’s patients who are feeling that, right?

Providers are on the front lines to be able to see, “Wait, copays were supposed to come down, people were supposed to be able to get choice in what they’re going to take.” So, I think lending your voices to the overall call for patent reform becomes very important, because you all understand the real impact on patients’ lives when that happens.

Faust: All right. Well, you’re doing important work. We support you. It’s provocative, it’s forward-thinking. Thank you so much for joining us on MedPage Today.

Krishtel: Thank you, Jeremy.