S1E75: Vaccinating the World Part I: The Problem with Patents / Chris Morten, Priti Krishtel, Rohit Malpani

“It’s a triumph of science and engineering that we now have multiple effective COVID vaccines. We just need to find the political will to invest a bit more money and deploy them around the world.” -Chris Morten

President Joe Biden said the United States would be the world’s “arsenal of vaccines” but critics say current plans to donate 80 million doses around the world are not enough. Instead, countries like India and South Africa are calling for a waiver on vaccine patents so they can make their own. In this episode we’re going to look at the controversy around patent protections for vaccines during the pandemic and what the U.S. government could do to improve access to vaccines around the world. We’ll hear what tools the U.S. government has to pressure companies to share their vaccine tech and learn about some ideas on how the patent system could be re-imagined to ensure life-saving technology is more equitably distributed.

This podcast was created by Just Human Productions. We’re powered and distributed by Simplecast. We’re supported, in part, by listeners like you.

Rohit Malpani: The problem in this pandemic is the knowledge being hoarded by only a few countries and not being shared.

Chris Morten: It’s a triumph of science and engineering that we now have multiple effective COVID vaccines. We just need to find the political will to invest a bit more money and deploy them around the world, and we can actually take this virus out.

Céline Gounder: You’re listening to EPIDEMIC, the podcast about the science, public health and social impacts of the coronavirus pandemic. I’m your host, Dr. Céline Gounder.

Patents have been an important driver of scientific discovery, invention, and economic growth ever since the United States was founded. The Patent and Trade Office is even listed in Article 1 of the Constitution.

Chris Morten: Patents are designed really to create monopolies on knowledge.

Céline Gounder: This is Christopher Morten. He’s the Deputy Director of the Technology Law and Policy Clinic at NYU’s law school.

Chris Morten: They’re limited in time, they only last 20 years, so you don’t get to keep your invention proprietary forever, but for some fixed amount of time, you get a legal right to prevent others from using your invention without your permission.

Céline Gounder: Christopher recently co-authored a report about one very important patent.

Céline Gounder: What is US patent number 10,000,916,070? I guess you guys generally call it patent ‘070. Um, what is this?

Chris Morten: So this particular patent I think is tremendously important.

Céline Gounder: Now, what exactly is the patent for it? My understanding is it has something to do with stabilizing the spike protein, but if you could explain that to us.

Chris Morten: The ‘070 patent is entitled “Pre-fusion Coronavirus Spike Proteins and Their Use.” Which as you say, gives you a clue.

Céline Gounder: At this point we’ve all heard the phrase “spike protein” more than we’d like, but here it is again: The spike protein is what the SARS-CoV-2 virus uses to latch onto and infect our cells.

Chris Morten: The problem with naturally occurring coronavirus spike proteins is that when you isolate them, they tend not to spend much time in the particular conformation, particular shape that invades human cells and that best sparks immune response.

Céline Gounder: Basically, the spike protein is floppy and changes shape. This patented technology keeps the spike protein in the right position to trigger the best possible immune response.

Chris Morten: And they were doing this work back in 2015, 16, I think, into ’17, long before SARS-CoV-2, long before COVID-19 emerged.

Céline Gounder: Back then, researchers were worried about other coronaviruses… like SARS or MERS. Really the only organizations studying this stuff at the time were the National Institutes of Health and research universities like Dartmouth and Scripps College. Millions of dollars in taxpayer money went into developing this technology. And so when the pandemic hit… it was ripe for the picking… for pharmaceutical companies to take advantage of it.

Chris Morten: It looks like the technology that’s described and claimed in this patent is incorporated in every single dose of the Moderna vaccine, the Pfizer BioNTech vaccine, the J&J vaccine, and others as well.

Céline Gounder: But that’s not the only thing Christopher was interested in when it came to patent ’070.

Chris Morten: It is an important and untapped source of economic leverage or financial leverage that the US government has over some of the companies that are today making and profiting from coronavirus vaccines. And I think this patent is an important tool in the Biden administration’s toolbox that it should be using to expand access.

Céline Gounder: Vaccines are now widely available in the United States. But for the rest of the world… where vaccines are still largely unavailable… the pandemic is now worse than ever.

NEWS CLIPS

CNN: Right now, India is experiencing the world’s worst Coronavirus outbreak. It is the 5th day with more than 3,000 reported deaths in that country.

DW: There are new calls for India’s Prime Minister to implement a nation-wide shutdown this morning, as COVID spreads at a break-neck speed.

CBS Morning News: With international schemes set up to ensure equal access to vaccines, it is currently 140 million doses short, and that is due to the continuing crisis in India.

BBC: As the death toll mounts, disposing of the dead is becoming increasingly difficult.

Céline Gounder: Most countries can’t buy the vaccines they need. Wealthier nations in Europe and North America have bought up so much of the supply it’s hard to get more… even for those that can pay for it. Other countries can’t manufacture the vaccines because of the patent protections on them… as well as raw material shortages… and other bottlenecks. At the current rate, it will take years to get the rest of the world vaccinated.

Chris Morten: All of us who live in the United States, even if we have vaccines in our arms now should be concerned about the plight of other countries because if people continue getting sick around the world, variants are going to continue to emerge and those variants are going to come back to the United States.

Céline Gounder: So, back in October, India, South Africa, and other nations asked that the patents on these life-saving vaccines be temporarily lifted so more people could get vaccinated faster. In this episode we’re going to look into the controversy around patent protections for vaccines during the pandemic… and what the U.S. government could do to improve access to vaccines around the world. We’ll learn how patents have changed in recent decades…

Priti Krishtel: Now there’s this sort of unchecked ability to get patents. Patents are given out for anything and everything.

Céline Gounder: What tools the U.S. government has to pressure companies to share their vaccine technology…

Chris Morten: Would the U.S. government actually file a lawsuit, a patent infringement lawsuit against the drug company? And the answer is yes.

Céline Gounder: And hear some ideas on how the patent system could be re-imagined to make sure life-saving technology is more equitably distributed.

Rohit Malpani: What many are focused on is this idea of de-linking, or separating, the cost of research and development from the product price. So, not using monopolies. And the promise of high prices to pay for research and development.

Céline Gounder: Today on EPIDEMIC, vaccinating the world. 

On May 17th, President Joe Biden announced the United States would become the world’s “arsenal of vaccines” in the fight against the coronavirus.

President Biden: This means over the next six weeks, the United States of America will send 80 million does overseas, just as in World War II, America was the arsenal of democracy. In the battle against the COVID-19 pandemic, America is going to be the arsenal of vaccines for the rest of the world.

Céline Gounder: So far, much of the discussion around vaccine supply to the developing world has focused on donating excess doses. And those 80 million doses might sound like a lot. But the reality is that it’s not nearly enough.

Priti Krishtel: And this is where the conversation has been a little frustrating for us to be honest, because a lot of people want to have the conversation about supply without talking about intellectual property.

Céline Gounder: This is Priti Krishtel. She’s the co-founder of I-MAK. It’s an organization dedicated to making access to medicines more equitable.

Priti Krishtel: They don’t want to talk about ownership rights. They want to just talk about every single other thing it would take in at the end of the day, what we know from working on hepatitis B vaccines, avian flu, HIV, all of the pandemics of the last two decades, we know that you cannot sidestep the intellectual property conversation because it is fundamentally about how do we get knowledge out there so that more manufacturers can scale and get vaccines and medicines in the hands of people.

Céline Gounder: Priti says there have always been problems with patents. Historically, women and people of color were blocked from being able to get patents on their work. But about 30 years ago, there was a shift in the way corporations started to think about patents.

Priti Krishtel: Somewhere in the late seventies, early eighties, a shift happened where the patent systems started to evolve, to be leveraged, to become the engine of corporate America.

Céline Gounder: This goes for universities too. The number of patents granted has skyrocketed in the last 30 years.

Priti Krishtel: And what’s happened is that now there’s this sort of unchecked ability to get patents. Patents are given out for anything and everything.

Céline Gounder: Part of the problem is baked into how the Patent and Trade Office or PTO operates.

Priti Krishtel: The PTO runs off of the revenue it gets from granting patents. The problem with that is that we have thousands, even millions of patents being granted and we don’t know whether they are actually high quality.

Céline Gounder: Priti says this creates bad incentives for companies and the Patent Office. She calls it “over patenting.”

Priti Krishtel: Over patenting is top on my list of the type of action I’m talking about, where we’re not incentivizing what we actually want to see, which is that people getting the fruits of this scientific progress in a timely fashion; people getting these drugs once they come to market without monopolies restricting the number of suppliers, blocking competition and keeping prices high for far too long.

Céline Gounder: For critics of the patent system as it operates today, patents have become a tool to drive revenue, not innovation.

Priti Krishtel: That’s domestically what I would say here in the United States. But what we’re seeing here during the pandemic is much more profound. It’s raising philosophical questions actually, of  knowledge is meant to be developed in collaboration or in competition? Is knowledge meant to be held on to with a time-limited monopoly? Or in a global catastrophe like this is knowledge meant to be shared freely to help save humanity?

Céline Gounder: India, South Africa, and over one hundred other countries requested that the World Trade Organization issue a TRIPS waiver on vaccines. TRIPS stands for Trade-Related Aspects of Intellectual Property Rights. Rohit Malpani has been working to build support for the waiver. He’s a public health consultant and advocate who sits on the board of a United Nations agency called Unitaid.

Rohit Malpani: And the last six months has involved increasing support for the TRIPS waiver amongst low and middle income countries, but resolute opposition by high-income countries and the pharmaceutical industry.

Céline Gounder: Historically, high-income countries like the United States have balked at waiving intellectual property rights during pandemics. This is what happened during the height of the AIDS crisis in the 1990s. At the time, the antiretroviral drugs developed to treat HIV were very expensive and developing countries could not afford them.

Rohit Malpani: When you look in the early years of the HIV pandemic, the pharmaceutical industry said, “if we share our intellectual property, or if we allow for global production of these medicines, essentially the sky will cave in and innovation will stop. You’ll get no new antiretrovirals.” And of course the opposite has happened.

Céline Gounder: Developing countries like India and Brazil started manufacturing their own generic, low-cost antiretrovirals, the drugs we use to treat HIV. This was game changing… paving the way for massive expansion of HIV treatment programs around the world. Meanwhile dozens of new antiretrovirals and combination pills have since been developed. So much for stifling innovation. But the story with our latest pandemic might be different.

US stance on TRIPS waiver NEWS CLIP

DW: We begin with what could  be a big breakthrough in the drive to boost the world’s Coronavirus vaccine supply. The White House has announced support for waiving vaccine patent protections.

Céline Gounder: In early May, U.S. Trade Representative Katherine Tai released a statement saying the Biden administration supported waiving intellectual property protections for COVID vaccines.

Rohit Malpani: This is a really an important moment in some respects, in terms of how the pandemic could eventually evolve and the ability to ensure access to medical technologies, but I think in a larger sense also in terms of the orientation of the US government towards the issue of intellectual property.

Céline Gounder: U.S. support for the waiver may be historic, but Rohit says there’s still a lot of work left to do. Countries like Germany and Japan still oppose the waiver.

Rohit Malpani: mRNA platforms are very valuable. They will be very profitable in the future for other infectious diseases or even for things such as cancer. And so for a lot of the companies now that have sort of succeeded in bringing these first products to the market, they will be very reluctant to lose control of these platforms because they are seeing already their valuations for their companies on the stock market, going up significantly.

Céline Gounder: To some, it might sound extreme to suspend patent protections — even during a pandemic. But Rohit points out that this was not the first option. A year ago, early in the pandemic, there were calls to establish something called a technology access pool.

Rohit Malpani: The Costa Rican government and then eventually 40 other governments supported this technology access pool as a means of really allowing companies, on their own terms and conditions, to contributes their technology, their data, their know-how, really anything that could help to scale up these, these technologies and a year later into the pandemic, we still do not have a single company or even a single public institution that has contributed to this pool. And I think that’s a real disappointment and a real indication as to why the waiver was necessary.

Céline Gounder: Christopher Morten says another hurdle is that even if patents are shared… they might not be useful.

Chris Morten: Patents do not disclose all the information that the public that competitors need to actually make and use and enjoy the invention that is covered by the patent.

Céline Gounder: Patents offer protections to inventors… giving them the exclusive right to make use of their discovery or innovation until the patent expires. But a right to make a drug or vaccine is not the same thing as knowing how to do so.

Chris Morten: The criticism is that the TRIPS waiver will lower patent barriers, but it won’t do anything to compel companies like Moderna to share their secrets. And so you need something more. You need an extra something, some kind of government intervention on top of the TRIPS waiver to get the secret knowledge out of the big vaccine makers.

Céline Gounder: These are trade secrets. Proprietary information that’s needed to manufacture the vaccine but not included in a patent.

Chris Morten: So Moderna, like most of our corporations, like most sophisticated corporations generally kind of double dips. They get patents but they withhold important details of the invention from the patent document. So they’re not disclosed and instead they’re kept secret.

Céline Gounder: One of the arguments I hear against sharing, whether it’s patent technology or the trade secrets, so to speak for manufacturing processes, is that once you share that technology, here’s no taking it back. Is that a legitimate argument?

Chris Morten: My short answer is, no, I think that argument is wrong. There are lots of ways that a company like Moderna could share its secrets with the US government and not have the secrets then shared with everyone under the sun.

Céline Gounder: Christopher says companies like Moderna have contracts with manufacturers all over the world to produce their COVID vaccine.

Chris Morten: If they were really unconvinced that it’s possible to share secret manufacturing information without it getting loose, then they wouldn’t contract with anyone, ever.

Céline Gounder: He argues that there are legal agreements that could be made to extend IP and trade secrets to countries in need while still protecting Moderna’s investment. But companies like Moderna aren’t the only ones with important patents on these vaccines. Remember patent ’070?

Chris Morten: So this is a government owned patent that Moderna is using without a license from the U.S. government.

Céline Gounder: Christopher thinks that patent ’070 may be a way to bring companies to the table and share how to make their vaccines with other countries. We’ll hear how… after the break.

***

Céline Gounder: Patent ’070 is a critical piece of technology in many of the most widely available vaccines.

Céline Gounder: So who, who owns this patent?

Chris Morten: Yeah, the patent is jointly owned, by three entities; by Dartmouth, Scripps, and the U.S. government. And you can see that just reading the, what we’ve called a face, the front page of the patent.

Céline Gounder: There are three names on the patent but Christopher says the U.S. government is the senior partner. That means they control the rights to the patent. Things like how it can be used and how they would be compensated for licensing that technology.

Chris Morten: The most common structure for a license is that the patent holder and the company using the patent technology sit down and negotiate a deal where the company using the patented technology pays a set royalty, some fraction of the sales price of every product that embodies the patent. The NIH typically charges between 1% and 10% royalties on products that incorporate or rely on patented NIH technology.

Céline Gounder: This patent is worth billions. Companies like Pfizer-BioNTech, for example, have said in public documents that they are paying royalties for its use in their vaccines.

Chris Morten: But one very notable vaccine maker, Moderna, does not have the US government’s permission to use the patent and it doesn’t have a license.

Céline Gounder: Moderna. The Boston-based pharmaceutical company that developed its vaccine in partnership with the NIH.

Céline Gounder: Why isn’t Moderna paying royalties, but other companies like Pfizer are?

Chris Morten: Yeah… We don’t know, Moderna has been scrupulously silent. I think there’s strong anecdotal evidence that Moderna knows that this patent is significant. It knows that the government could take it to court. The government could demand over a billion dollars in compensation.

Céline Gounder: For Priti Krishtel, there’s no excuse for Moderna to not participate in these efforts to expand vaccine manufacturing when its success is due in part to taxpayer-funded research.

Priti Krishtel: This is a classic example of what has gone wrong with the vaccine system in this pandemic.

Céline Gounder: Priti says that for a long time, the vaccine business wasn’t attractive to big companies like Pfizer and J&J. As a result, the government was often an important funder of basic research into things like coronaviruses.

Priti Krishtel: Wall Street analysts are saying that Moderna’s market cap is going to increase to a hundred billion dollars in the next few years. Now, how do we reconcile that with the fact that the US government made such a significant investment of $2.5 billion providing nearly 100% of the R&D funding for the vaccine that we’re all now taking here in the States. This is a case where the U.S. government should actually step back in if Moderna is not willing to share this technology worldwide and make sure that the mRNA vaccine that we, the taxpayers, funded is available.

Céline Gounder: So, how could the U.S. government use this lever to bring Moderna to the table? Christopher says that Moderna’s alleged infringement of the ’070 patent could be cause to take the company to court.

Chris Morten: One question that we’ve gotten is would the US government ever actually do this, would  the US government actually file a lawsuit, a patent infringement lawsuit against the drug company? And, the answer is yes.

Céline Gounder: In 2019, the U.S. government sued the drug manufacturer Gilead Sciences. The government   that Gilead had infringed on U.S.-owned patents when it sold its HIV prevention drug, Truvada.

Chris Morten: So the goal of that litigation against Gilead isn’t just a collective payday for the US government. The goal is to use this patent infringement lawsuit as a way to discipline Gilead’s pricing, as a way to bring Gilead to the negotiation table and negotiate a better deal for the American public.

Céline Gounder: Christopher wants to see something similar happen with Moderna’s vaccine.

Chris Morten: So the Biden administration could cut a deal with Moderna that gives Moderna the license that it needs and, in exchange, Moderna could agree to certain steps that would benefit COVID vaccine access in the US around the world. It could agree, for example, to share some of it’s secret manufacturing steps, share some of its know-how. Perhaps share some samples of its manufacturing process with the US government. And that can be a kind of non-monetary compensation for use of the American government’s patent.

Céline Gounder: Rohit Malpani says the pandemic response is an opportunity to rethink the incentives that have created these patent roadblocks.

Rohit Malpani: The wider approach takes the idea of not using intellectual property as a means of encouraging research and development, but really trying to create different incentives. And what many have focused on is this idea of de-linking or separating the cost of research and development from the product price. So not using monopolies and the promise of high prices to pay for research and development, but finding other incentives that can pay for research and development.

Céline Gounder: One option is “push funding.” This would come from philanthropies or public institutions to help pay for research and steer markets to specific health problems, like vaccines or neglected diseases. Another option is “pull funding.”

Rohit Malpani: So instead of providing a prize, essentially in the form of a patent, you could provide a large cash prize, for instance, for developing a new drug. And in exchange for a prize, you would surrender the intellectual property or license out the intellectual property.

Céline Gounder: But he acknowledges that businesses are not going to be interested in these tradeoffs. So, there has to be a change in the rules of the game.

Rohit Malpani: What we do need though is the willingness of governments to set out clear rules, to make investments where there is a market failure. And to ensure that when new products come to the market, that those can ultimately be brought to the market in a way that’s equitable, that’s affordable and that’s appropriate for different populations. And that requires governments setting rules. That will be opposed by industry, but placing a larger premium on the public good instead of just private profit.

Céline Gounder: In the meantime, Priti Krishtel wants the discussions around the TRIPS waiver to move as quickly as possible.

Priti Krishtel: I think it’s important to remember that President Biden’s announcement about supporting the TRIPS waiver is not the same thing as a magic wand, where all IP barriers have suddenly been removed. The best way to understand that is that the President has set a table, a new kind of table and said, “I’m willing to sit down and have a conversation.” And so I think it’s a hugely important step and that’s a historic step because we haven’t seen it before and at the same time, this is the beginning of a very long road.

Céline Gounder: Priti says that a lot of time has been lost already. But it’s not too late to take action.

Priti Krishtel: When India and South Africa asked for the waiver in October, we should have said yes immediately. Companies would be up and running by now, had we done that. But we are where we are. And today, if we put our weight behind unlocking global manufacturing capacity, we will come out of this sooner. It is not too late. Our families in India and in other places are waiting to get vaccinated. There is no way out of this pandemic without achieving vaccine equity. We need strong leadership. We need decisive leadership, and I am hopeful that this is going to get done.

CREDITS

EPIDEMIC is brought to you by Just Human Productions. We’re funded in part by listeners like you. We’re powered and distributed by Simplecast.

Today’s episode was produced by Zach Dyer and me. Our music is by the Blue Dot Sessions. Our Production and Research Associate is Temitayo Fagbenle. Our interns are Annabel Chen, Bryan Chen, and Sophie Varma.

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I’m Dr. Celine Gounder. Thanks for listening to EPIDEMIC.

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