Giachino (00:05.0059 - 00:24.0290)
Welcome to IP Protection Matters. I'm your host, Renee Giachino.
Today, we are joined by David Williams. David is the President of Taxpayers Protection Alliance. To follow his organization, you can find them at protectingtaxpayers.org. Welcome to the program. Thanks so much for joining me, David.
Williams (00:24.0600 - 00:34.0250)
Thanks for having me. IP, or intellectual property, protection is so important when we talk about so many aspects of what the government is doing and what the private sector is doing.
Giachino (00:34.0580 - 00:55.0459)
Let's talk first a little bit about what TPA is doing in that arena. I want to talk with you about why politicians should reject compulsory licensing, price fixing and patent confiscation schemes - all things that I know you have worked on. What else is going on at the Taxpayers Protection Alliance?
Williams (00:55.0610 - 01:35.0400)
There is a lot going on at the Taxpayers Protection Alliance. We are a government watchdog. We look at spending, regulation, taxation and transparency. There are a lot of transparency issues at every level of government and we are a rapid response taxpayer group. That means we get things done quickly and we react to things quickly. Unfortunately, things happen very quickly in Washington, DC and across this country. A lot of those things are bad and that’s why we have to react quickly. I’m really excited about this IP discussion and the importance that intellectual property has in the economy and what the government can do to really strengthen IP.
Giachino (01:35.0410 - 02:16.0964)
When people think about IP, oftentimes they think about drugs. Rightfully so. Can you walk us through, whether it's an over-the-counter or a prescription drug ... the entire process that a drug has to undergo to get to market. I think it's a good place to start our conversation because I think it helps people understand why IP protection matters so much. Without it we wouldn't have the innovators and the investors. Can you give us the hornbook version, the short version of what it takes for a drug to get to market?
Williams (02:17.0244 - 03:45.0490)
People would be amazed as to how long it takes and how much it costs to get a drug to market. We're talking about $2 billion over a 12-year period. A company has to spend that money and time to get it through the Food and Drug Administration. And there are some very high hurdles to get a drug approved and actually get it into the market.
Listen, those high hurdles are important, right? We want efficacy and we want safety from medication and medicine or even some of the new cutting-edge technology like gene replacement therapy. We want to make sure that there are high hurdles to get over. But at times those hurdles are preventing some medication and life-saving techniques from being brought to market. There has to be some common sense. We want safety. We want efficacy, but there has to be some sort of common sense when it means getting these drugs to market. Protecting IP is at the heart of all of this because if you're going through a process, if you're spending $2 billion and a decade of your life getting a product through, you want to make sure that once that product is through that you can make money off of that product. You need these intellectual property protections to ensure that someone else doesn't steal it. And if they do try to steal it, then there's a remedy for that. There's a way to make sure that a court system will remedy those problems.
Giachino (03:45.0679 - 04:32.0179)
You have written and talked a lot about some of the disturbing and potentially deadly efforts that are underway by some lawmakers to replace IP rights. As you just pointed out, those rights are what allow the investors and the innovators to recoup some of the costs of bringing that product to market. What they seem to be calling for is almost like a free-for-all system that would invalidate these patents and allow the rivals to profit off of the drugs that the rivals did not create. Share with us what you hear that is happening in and around Washington, DC as it relates to these deadly efforts to replace IP rights.
Williams (04:32.0450 - 06:06.0119)
I think a lot of politicians have really taken for granted what we have in the market right now, whether it's pharmaceuticals, or any other company that invests in IP. I think they have taken this for granted because we have such better medications than we did 15, 20 or 30 years ago. And every year we're getting more efficient and more effective drugs. They look at these companies and they say, well, everyone should have access to them. I absolutely agree that everyone should have access to drugs, but not the underlying intellectual property.
I think that's the line of demarcation here. When you have a company that spends its time and money to come up with these life-saving drugs, it has to be protected. Otherwise, they won't produce them. I think that’s important for lawmakers and everyone to understand. If you don't have a system in place to protect these patents, to protect this intellectual property, you're not going to have new medication. You're not going to have the next generation coming out.
We have a lot of members of Congress who are trying to undermine intellectual property. What they're doing is this thing called compulsory licensing, which is that if you are a drug company, you have to give up those IP rights or those IP protections. So other companies or countries can pretty much piggyback on the money and the time that you spent without spending the money or the time. It disincentivizes the next generation of drugs.
Giachino (06:06.0279 - 06:31.0470)
David, would compulsory licensing in the IP world lead to lower prices or greater availability? I know that's an argument that a lot of the supporters of trying to undo the rigor that exists in terms of IP protection argue. They say that by undoing some of it, we'll see lower prices and greater availability. Is that true?
Williams (06:32.0029 - 07:21.0329)
That's what they want you to believe. Actions have consequences. You can't say that if you move forward with compulsory licensing, which the United Nations and other world bodies want to do, that it is going to bring down prices and availability. We have seen the opposite happen and there's going to be less availability. I look at it from a practical standpoint. If I am a company and I am building any sort of product, in this case drugs. If I'm creating a drug that helps cancer or blood pressure, or you name it, and I am told that I can only sell it at a certain price, well, I am not going to produce as much of that drug or I'm not going to put in the research and development dollars into the next generation of that treatment or that drug.
Williams (07:21.0489 - 08:24.0925)
So that's where the availability comes in. You're going to make it less available. That's where the lawmakers and decisionmakers really don't understand that concept. Actions have consequences. When you force companies to do something, especially compulsory licensing, you're going to have fewer drugs available. This is also tied into price controls and price fixing.
We've seen this in Australia. I love to point to examples because these are real life examples. Australia had price controls on a certain migraine medication and they thought that this was going to bring down the price and make it more available. Well, that medication is no longer available in Australia because they pulled it from the market because they weren't able to make money.
Making money is not a bad thing. Actually, it's a good thing because the more money you make, the more you put into innovation for the next generation of products. Obviously a lot to unpack with what I just said, but I think that you're going to have less availability with compulsory licensing.
Giachino (08:24.0936 - 08:57.0359)
America has been the world leader in biomedical innovation. I think that a lot of the credit goes back just over 40 years to the Bayh-Dole Act. But now we’ve got a push for compulsory licensing, we've got efforts for price fixing and now we have the “march in” provisions under the Bayh-Dole Act that were intended to be used sparingly and only in rare cases. Is the Biden Administration reinterpreting that law?
Williams (08:57.0698 - 09:53.0395)
100% they're reinterpreting Bayh-Dole. The fact of the matter is, this is an example of mission creep. You have Bayh-Dole and they're taking it more liberally than it was supposed to be taken. This is what government does, though. Not to use a thing from childhood, but give them an inch, they take a mile. That's what we're seeing with this and it's really going to have a fundamental bad effect on the economy.
First and foremost, it's going to have a negative effect on innovation in the drug market. And that's my primary concern. Listen, I'm getting older so I might need some of these drugs as I get older. So I want the biggest and the best medication. But even for people who are young, we're not going to see the next generation of innovative drugs if the government continues to take away and weaken IP protections.
Giachino (09:53.0664 - 10:01.0890)
How do we stop this creep against what has been this robust intellectual property system that we've had in the United States?
Williams (10:02.0330 - 11:15.0843)
First and foremost, I think that there needs to be more education of members of Congress. That’s the first thing we really have to do. And we've been doing that. There's been a coalition inside and outside of Washington, DC that are dedicated to this sort of education. I think there needs to be some common sense. We need to look at the landscape.
If you look at any sort of medication that was produced in the 1980s versus today, it's different. It's more effective. We have gene replacement therapy now. This is cutting edge stuff we're talking about. Gene replacement therapy was just a dream 20 or 30 years ago, but this is happening, especially in this country. It's happening in the United States because there are strong IP protections. In countries that don't have these protections, there is zero innovation. There is zero cutting edge technology or research and development. The rest of the world needs to look at the U.S.
Listen, I have a lot of problems with what the FDA is doing, but we do have strong intellectual property protections and Congress needs to uphold those, defend those and not weaken them.
Giachino (11:15.0953 - 12:00.0729)
Our guest is David Williams, President of Taxpayers Protection Alliance. You can follow him and the work of his organization at protectingtaxpayers.org.
David, you talk about educating lawmakers. I read a wonderful piece that you authored that was titled, “Summer Reading: Intellectual Property.” I want to change that title to Fall Reading. We need folks reading this. I think you do an excellent job in the piece of educating lawmakers. One of the things that I found quite interesting is how you noted that the attack on patents ignores a wealth of empirical evidence on the importance of IP rights for drug innovation. Can you share some of the data that you reported in that piece?
Williams (12:01.0150 - 12:38.0789)
This was really an important piece for us to write and we do this every year. Until TPA is no longer here, we will do this every year because it's important. We have members on both sides of the political aisle that have attacked intellectual property. We need to remind everybody. I think education also begins with people/consumers. I think at times we take for granted that the next generation is of drugs that are going to be there. But we can't take that for granted at all.
Giachino (12:38.0840 - 13:45.0179)
I love that because I think it really emphasizes the point of why should we care about IP protection. When you hear about IP protection, people are thinking about big businesses, but it starts very often with a very small startup with a very small idea. And that's not just in the pharmaceutical arena. That's across the board. I think we need to do a better job of educating ourselves and educating our lawmakers on the wide range of products that come to market.
I spoke with Jaci McDole recently and we talked about recipes. How a restaurant, oftentimes what starts out small for somebody, may copyright or trademark a family recipe that they use. That's important to be able to protect. As you've pointed out in our discussion today, it helps us to better understand why we even as consumers need to care about IP protection.
Williams (13:45.0500 - 14:50.0950)
Think about this. When we talk about physical property rights - someone owning a home, a piece of property - everyone is in agreement that it is theirs and they are able to protect that. So we need the same logic when it comes to intellectual property. If someone comes up with the new software or secret sauce, that's IP. That is intellectual property. This is what makes companies innovate. It's really what helps and drives the economy.
When the government gets involved in this, the government seizure of patents is associated with a 5% decrease in innovation. Think about that. The government seizing patents means there's going to be a 5% decrease in innovation. This was actually a study that Princeton did. Don't take my word for it, but take Princeton's word for it. They studied this. Government seizure of patents really weakens innovation in the whole economy, not just for drugs, but the whole economy, smartphones, you name it across the board.
Giachino (14:50.0960 - 15:06.0739)
David, we thank you so much for your time today. We appreciate all the work that you and Taxpayers Protection Alliance are doing in this arena. I want to leave the mic open for any parting thoughts that you might have on why IP protection matters.
Williams (15:06.0750 - 15:28.0880)
I am so glad we're having this discussion and this needs to happen more often. We need to talk to lawmakers, decisionmakers, and again, consumers. I will guarantee you that the more you talk to consumers about this, the more they will be in agreement that the government needs to protect, not weaken these intellectual property protections.
Giachino (15:29.0130 - 15:35.0440)
David, thank you for your time today. Thank you for the work that you and your organization are doing. We'd love to have you join us again soon.
Williams (15:35.0450 - 15:36.0539)
Happy to join again.