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

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

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.

You're listening to Epidemic, the podcast about the science, public health, and social impacts of the coronavirus pandemic. I'm your host, Dr. Celine 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 I of the Constitution.

Patents are designed really to create monopolies in knowledge.

This is Christopher Morton. He's the Deputy Director of the Technology Law and Policy Clinic at NYU's Law School.

They are 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.

Christopher recently co-authored a report about one very important patent. What is US patent number 10,960,070? I guess you guys generally call it patent 070. What is this?

So this particular patent, I think, I think is tremendously important.

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

The patent, the 070 patent, is entitled "Pre-Fusion Coronavirus Spike Proteins and Their Use," which as you say gives you a clue.

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.

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.

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.

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

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.

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.

But that's not the only thing Christopher was interested in when it came to Patent 070.

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.

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.

Right now, India is India is experiencing the world's worst coronavirus outbreak. Today is the 5th day with more than 3,000 reported deaths in that country.

There are new calls for India's Prime Minister to implement a nationwide shutdown this morning as COVID spreads at a breakneck speed. Well, the international scheme set up to ensure equal access to vaccines is currently 140 million doses short, and that's due to the continuing crisis in India.

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

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.

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.

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 vaccines during the pandemic and what the US government could do to improve access to vaccines around the world. We'll learn how patents have changed in recent decades.

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

What tools the US government has to pressure companies to share their vaccine technology.

Would the US government actually file a lawsuit, patent infringement lawsuit against a drug company? And the answer is yes.

And here's some ideas on how the patent system could be imagined to make sure life-saving technology is more equitably distributed.

What many have focused on is this idea of delinking 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.

Today on Epidemic, Vaccinating the World. On May 17th, President Joe Biden announced the United States would become the world's, quote, arsenal of vaccines in the fight against the coronavirus.

This means over the next 6 weeks, the United States of America will send 80 million doses overseas. Just as in World War II, America was the arsenal of democracy in the battle against COVID-19 pandemic. Our nation is going to be the arsenal of vaccines for the rest of the world.

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.

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.

This is Preeti Krishthal. She's the co-founder of IMAQ. It's an organization dedicated to making access to medicines more equitable.

They don't want to talk about ownership rights. They want to just talk about every single other thing it would take. And 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.

Preeti 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.

Somewhere in the late '70s, early '80s, a shift happened where the patent system started to evolve to be leveraged to become the engine of corporate America.

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

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.

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

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.

Preeti says this creates bad incentives for companies and the Patent Office. She calls it over-patenting.

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 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.

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

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 is knowledge meant to be developed in collaboration or in competition? Is knowledge meant to be held onto with a time-limited monopoly? Or in a global catastrophe like this, is knowledge meant to be shared freely to help save humanity?

India, South Africa, and over 100 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.

And the last 6 months has involved increasing support for the TRIPS waiver amongst low- and middle-income countries, but resolute opposition by high-income countries in the pharmaceutical industry.

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.

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, innovation will stop, you'll get no new antiretrovirals. And of course, the opposite has happened.

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

This is a really 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.

US 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.

mRNA platforms are very valuable. They will be very profitable in the future for other infectious diseases or even for things such as cancer. So for 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.

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.

The Costa Rican government and eventually 40 other governments started this technology access pool as a means of really allowing companies on their own terms and conditions to contribute their technology, their data, their know-how, really anything that could help to scale up the use of 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.

Christopher Morton says another hurdle is that even if patents are shared, they might not be useful.

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.

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.

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.

These are trade secrets, proprietary information that's needed to manufacture the vaccine but not included in a patent.

So Moderna, like most drug companies, like most sophisticated corporations generally, kind of double dips. They get patents, but they withhold important details of the patented invention from the patent document. So they're not disclosed. Instead, they're kept secret.

One of the arguments I hear against sharing, whether it's patent technology or the trade secret, so to speak, for manufacturing processes, is that once you share that technology, that know-how, there's no taking it back. Is that a legitimate argument?

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 those secrets then shared with everyone under the sun.

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

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.

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?

So this is a government-owned patent that Moderna is using without a license from the US government.

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. Patent 070 is a critical piece of technology in many of the most widely available vaccines. So who owns this patent?

Yeah, the patent is jointly owned by 3 entities, by Dartmouth, Scripps and the US government. And you can see that just reading the, what we call the face, the front page of the patent.

There are 3 names on the patent, but Christopher says the US government is the senior partner. That means they control the rights to the patent, things like how it can be used and how they could be compensated for licensing that technology.

The most common structure for a license is that The patent holder and the company using the patented 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, that rely on patented NIH technology.

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.

But one very notable vaccine maker, Moderna, does not have the US government's permission to use the patent. It doesn't have a license.

Moderna, the Boston-based pharmaceutical company that developed its vaccine in partnership with the NIH. Why isn't Moderna paying royalties, but other companies like Pfizer are?

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 $1 billion in compensation.

For Preeti Krishnan, 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.

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

Preeti 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.

Wall Street analysts are saying that Moderna's market cap is going to increase to $100 billion in the next few years. Now, how do we reconcile that with the fact that the U.S. 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 US 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.

So how could the US 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.

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 a drug company? And the answer is yes.

In 2019, the US government sued the drug manufacturer Gilead Sciences. The government alleged that Gilead had infringed on US-owned patents when it sold its HIV prevention drug, Truvada.

So the goal of that litigation against Gilead isn't just to collect a big payday from Gilead. The goal is to use this patent infringement lawsuit as a way to discipline Gilead's pricing, a way to bring Gilead to the negotiation table and negotiate a better deal for the American public.

Christopher wants to see something similar happen with Moderna's vaccine.

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 and around the world. It could agree, for example, to share share some of its secret manufacturing steps, share some of its know-how, perhaps even share some samples of its manufacturing process with the U.S. government. And that would be a kind of non-monetary compensation for use of the American government's patent.

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

The wider approach takes the idea of not using intellectual property as a means of encouraging research and development, but really really trying to create different incentives. And what many have focused on is this idea of delinking 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.

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.

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.

But he acknowledges that businesses are not going to be interested in these trade-offs. So there has to be a change in the rules of the game.

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.

In the meantime, Preeti Krishchel wants discussions around the TRIPS waiver to move as quickly as possible.

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.

Preeti says that a lot of time has been lost already, but it's not too late to take action.

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.

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