Policy Solutions and Reforming Innovation

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More at nYsci dot org d WNYC Studios is supported by Con Edison New York, if your AC is always turned up, well, your energy bills are likely to go up too Luckily, C Eedisine has ways to help Try their personalized energy saving tips, or explore budget billing, which helps to spread out your biggest payments Visit coned. com slash Bill helpelp to get started. because taking control is New York. Hey, it's Flura Lichman and you're listening to Science Friday Americans pay roughly three times as much for prescription meds compared to other wealthy and developed nations. It's an issue that cuts across party lines. Both the Biden and Trump administrations rolled out their own proposals to address this problem persists. So Why are our drugs so expensive? My next guest argues it's largely to do with how our patent systems work If that sounds wonky, hang with us. It's actually really interesting. and Tahir Amin will tell you why. He has a really unique perspective because he's been on both sides of this issue. He's spent a decade as an intellectual property lawyer helping corporations use patents to protect their bottom lines Then he moved to India and saw firsthand how the global patent system hampered access to HIV drugs. And so he started an advocacy organization to make access to medicines more equitable He lays it all out in a new book called Pharma Monopoly The Battle for the Future of Medicines T here, welcome to Science Friday Thank you, Flora. Thanks for having me. Let's just step back for a second. We have this patent system. What was the original intent of it So The pated system is was created to incentivize invention And so the incentive was you come up with a new novel invention, something that is not obvious to somebody in that field. Obviously you invest some of your time and money into that. And then we the system provides you with a limited time of exclusivity So what you have now is a system where from a data filing a patent, You get twenty years of Exclusivity R it The probleblem is today, phharmaceutical companies and other compomanies in different fields have worked out that I can actually have overlapping patterns that extend that period of protection in order to keep competition out. And so this is overlapping patents for the same drug So for example, yeah So if I've come up with invention for a compound that goes to make the actual product, the medicine I call it the active ingredient Let's say It gives the sort of curative effect or the therapeutic effect And then what I do then is, oh well, I need to, if I'm a company I need to then get this drug into the body. so I'll come up with a formulation. And then I realized this drug can also be used on several different indications, different conditions So for example, I know the mechanism of action of the molecule can be used to treat, let's say, inflammation So I all tested on all the different types of inflammation. It's the same drug But each time I get an FDA approval for each of those conditions I get a separate pattern And this then adds on the layers. And then I can also formulate it so that When I rele when I launched the product for its first form, it might be an intraveneous form And then I can switch it to a injectable form And that adds on new life to the patent. Now the argument from the industry is well, eventually the patent on the original form will run out so that competitors can use that The market is much more complicated than that because what companies do is they switch patients onto the new form until the clock restarts again and the monopoly restarts again. A great example of that is the drug, the Cancer drrug K Truder, which is on the market, one of the best selling drugs ever and what Merc has done is they've now launched a injectable form of the drug previously delivered in an IV form. so now they're trying to switch the whole market overver to the injectable form before its patents run out, so then they've got a new level of protection around the injectible form and then the clock restarts and they've basically cannibalized any market that might exist for any competitor come in comeing in Is there any limit to the number of patents that a company can attach to a single active ingredient? There is a limit to the active ingredient that a company can apply for So you get the original patent, which covers the active ingredient. But beyond that, there is no limit on the variations you can file patents for. There are an endless, there's a whole menu of variations you can apply patnents for. And this is why companies can rack up anywhere up to three hundred maybe even more patents filings on a particular drug. We found that with the GLP one drugs, for example, SMPIic, Magovi obvious drug humera had over three hundred patent applications by our account at least And then the upshot is that this prevents cheaper generics from going to market, right Absolutely, what ends up playing out is compompanies, competitors have to then litigate through all these patteratnents because inevitably it's going to become a litigation game So think about it this way, it could cost a branded pharmaceutical company around about thirty to forty thousand dollars to file and get a patent It costs millions to litigate each one and as a competitor I basically say, it's not worth my while trying to battle all the way through all these patents And what ends up happening is companies settle. and usually with some kind of settlement There's a delay when the competitor can enter because that's the agreement. You know, the counter argument I've heard is that you know, companies invest all this money. to develop new drugs. What is your perspective on that argument So I think we often take as given. it takes billions to deevelop a drug That is a figure that has been thrown around for almost two decades now But I would actually like to reframe that Oh argument and saying How can we know how much these? druk cost to develop when we have never seen the actual figures These are non transparent, numbers, they live in a black box. It's a guarded commercial secret. And so really, I think We can say yes It does cost a lot of money because obviously testing clinical trials and research will cost money but is it the billions that we're often told? that then justify all these practices that the industry then uses to be able to say, charge high prices. We want more patents, we want more longer monopolies No one knows how to make policy in this in this area when you're not actually seeing The evidence We're taking the industry's world. at the gospel You know, I wanted to ask you about a specific anedote that came up on the show very recently. I talked to a researcher who is studying how the Shingles vaccine has been correlated with lower dementia risk. He was like, and I hope someone listens to this because I can't get a clinical trial started because there's no financial incentive to do it because the Shingles vaccine patent expired. which seemed wild because of the number of people that are affected by dementia. Is this a representative story? and is there something to do about that That's a great example. I think a lot of diseases which are not profitable in the market or because there's no patent to basically allow a company to profit from it get left by the wayside interesterestingly with the Ebola issue coming at the moment as We have a couple of vaccines in the marketplace, but back in twenty fourteen when the first breakout happened There was basically this monoclonal antibody, I believe, that was sitting on the shelf And it only actually got utilized at the very last minute and it wasn't utilized in the air in West Africa where it was needed. It was only when I think there was a Western doctor that contracted Ebola was flying to the US and that's when it was used And so really there's a whole bunch of conditions which don't actually get investment in because there's no market for these companies to make profits. And so that then begs the question, What kind of system do we have? and unless the companies can plethora of patents around it. they're not interested So they're only interested in how do I make more money out of this Right, which is not necessarily how do I solve the biggest problem No, and that is the problem with the measure of our pharmaceutical industry today is not how many lives I can save is how much wealth I can for my shareholders, for my For dividends that I give back. that's what the CEOs are measured byy. in terms of their performance, their CEOs, their salaries are measured by that That's actually the measure of the pharmaceutical industry today. That's what they measure themselves by Um, Are there low is there low hanging fruit here in terms of changes we should make in terms of solutions like one patent per active ingredient What do you think? whereere do we start? So that is a great suggestion. There are academics who have call this one and done. You get one exclusivity. You have to remember Patent is not the only exclusivity system in the game A drug getess approved. The FDA grants what is called the marketing exclusivity So this idea there We need all these exclusivities to give the ROI that these companies, We've actually over incentivized a minute. And so basically a one exclusivity system would be great. But I think we need to go further that We need to build public manufacturing systems that basically can provide a counterbalance to the private sector. They're never going to behave unless there's actually an alternative. And we need to startance creating that alternative and Some of the things that have happened in California, for example, with CalRX where public production of insulin But how do we develop drugs through public channels from beginning to end There's so many options on the table. It just needs political will to create an alternative system that would push back against the private strangle ho that we're in to your old Brt Like intellectual property, lawyer friends like to argue with you across the dinner table about this Oh yeah, no, I I I you know, actually what's interesting is is I've sat with a lot of scientists at pharmaceutical companies, I've sat with a lot of lawyers. and many lawyers actually secretly they'll never go on record, but secretly say actually the system's a mess So even the mall reasonable corporate IP lawyer recognizes there are fundamental problems. And then you speak to scientists, I mean, I have scientists on my team who haveve worked in the industry for over forty years. who say a lot of the stuff that we graant patnents for They're not novel They're not new But what we've done is we've