In the coming days, a patent will finally be issued on a five-year-old invention, a feat of molecular engineering that is at the heart of at least five major Covid-19 vaccines. And the United States government will control that patent.
The new patent presents an opportunity — and some argue the last best chance — to exact leverage over the drug companies producing the vaccines and pressure them to expand access to less affluent countries.
The question is whether the government will do anything at all.
The rapid development of Covid-19 vaccines, achieved at record speed and financed by massive public funding in the United States, the European Union and Britain, represents a great triumph of the pandemic. Governments partnered with drugmakers, pouring in billions of dollars to procure raw materials, finance clinical trials and retrofit factories. Billions more were committed to buy the finished product.
But this Western success has created stark inequity. Residents of wealthy and middle-income countries have received about 90 percent of the nearly 400 million vaccines delivered so far. Under current projections, many of the rest will have to wait years.
to help an Indian company produce about 1 billion doses by the end of 2022 and his administration has donated doses to Mexico and Canada. But he has made it clear that his focus is at home.
“We’re going to start off making sure Americans are taken care of first,” Mr. Biden said recently. “But we’re then going to try and help the rest of the world.”
Pressuring companies to share patents could be seen as undermining innovation, sabotaging drugmakers or picking drawn-out and expensive fights with the very companies digging a way out of the pandemic.
As rich countries fight to keep things as they are, others like South Africa and India have taken the battle to the World Trade Organization, seeking a waiver on patent restrictions for Covid-19 vaccines.
as part of their vaccine diplomacy. The Gamaleya Institute in Moscow, for example, has entered into partnerships with producers from Kazakhstan to South Korea, according to data from Airfinity, a science analytics company, and UNICEF. Chinese vaccine makers have reached similar deals in the United Arab Emirates, Brazil and Indonesia.
Canada to Bangladesh say they can make vaccines — they just lack patent licensing deals. When the price is right, companies have shared secrets with new manufacturers in just months, ramping up production and retrofitting factories.
pressured Johnson & Johnson to accept the help and is using wartime procurement powers to secure supplies for the company. It will also pay to retrofit Merck’s production line, with an eye toward making vaccines available to every adult in the United States by May.
Despite the hefty government funding, drug companies control nearly all of the intellectual property and stand to make fortunes off the vaccines. A critical exception is the patent expected to be approved soon — a government-led discovery for manipulating a key coronavirus protein.
This breakthrough, at the center of the 2020 race for a vaccine, actually came years earlier in a National Institutes of Health lab, where an American scientist named Dr. Barney Graham was in pursuit of a medical moonshot.
‘We’d already done everything’
For years, Dr. Graham specialized in the kind of long, expensive research that only governments bankroll. He searched for a key to unlock universal vaccines — genetic blueprints to be used against any of the roughly two dozen viral families that infect humans. When a new virus emerged, scientists could simply tweak the code and quickly make a vaccine.
In 2016, while working on Middle East Respiratory Syndrome, another coronavirus known as MERS, he and his colleagues developed a way to swap a pair of amino acids in the coronavirus spike protein. That bit of molecular engineering, they realized, could be used to develop effective vaccines against any coronavirus. The government, along with its partners at Dartmouth College and the Scripps Research Institute, filed for a patent, which will be issued this month.
another virus when the outbreak in China inspired his team to change focus. “We just flipped it to coronavirus and said, ‘How fast can we go?’” Dr. Graham recalled.
filed such a lawsuit in 2019 against the drugmaker Gilead over H.I.V. medication.
being lured to the United States.
“We funded the research, on both sides of the Atlantic,” said Udo Bullmann, a German member of the European Parliament. “You could have agreed on a paragraph that says ‘You are obliged to give it to poor countries in a way that they can afford it.’ Of course you could have.”
A People’s Vaccine
In May, the leaders of Pakistan, Ghana, South Africa and others called for governments to support a “people’s vaccine” that could be quickly manufactured and given for free.
They urged the governing body of the World Health Organization to treat vaccines as “global public goods.”
Though such a declaration would have had no teeth, the Trump administration moved swiftly to block it. Intent on protecting intellectual property, the government said calls for equitable access to vaccines and treatments sent “the wrong message to innovators.”
World leaders ultimately approved a watered-down declaration that recognized extensive immunization — not the vaccines themselves — as a global public good.
grant language requiring equitable access to vaccines. As leverage, the organization retains some right to the intellectual property.
Dr. Slaoui, who came to Warp Speed after leading research and development at GlaxoSmithKline, is sympathetic to this idea. But it would have been impractical to demand patent concessions and still deliver on the program’s primary goals of speed and volume, he said.
“I can guarantee you that the agreements with the companies would have been much more complex and taken a much longer time,” he said. The European Union, for example, haggled over price and liability provisions, which delayed the rollout.
In some ways, this was a trip down a trodden path. When the H1N1 “swine flu” pandemic broke out in 2009, the wealthiest countries cornered the global vaccine market and all but locked out the rest of the world.
Experts said at the time that this was a chance to rethink the approach. But the swine flu pandemic fizzled and governments ended up destroying the vaccines they had hoarded. They then forgot to prepare for the future.
The International View
For months, the United States and European Union have blocked a proposal at the World Trade Organization that would waive intellectual property rights for Covid-19 vaccines and treatments. The application, put forward by South Africa and India with support from most developing nations, has been bogged down in procedural hearings.
“Every minute we are deadlocked in the negotiating room, people are dying,” said Mustaqeem De Gama, a South African diplomat who is involved in the talks.
But in Brussels and Washington, leaders are still worried about undermining innovation.
During the presidential campaign, Mr. Biden’s team gathered top intellectual property lawyers to discuss ways to increase vaccine production.
“They were planning on taking the international view on things,” said Ana Santos Rutschman, a Saint Louis University law professor who participated in the sessions.
Most of the options were politically thorny. Among them was the use of a federal law allowing the government to seize a company’s patent and give it to another in order to increase supply. Former campaign advisers say the Biden camp was lukewarm to this proposal and others that called for a broader exercise of its powers.
The administration has instead promised to give $4 billion to Covax, the global vaccine alliance. The European Union has given nearly $1 billion so far. But Covax aims to vaccinate only 20 percent of people in the world’s poorest countries this year, and faces a $2 billion shortfall even to accomplish that.
Dr. Graham, the N.I.H. scientist whose team cracked the coronavirus vaccine code for Moderna, said that pandemic preparedness and vaccine development should be international collaborations, not competitions.
“A lot of this would not have happened unless there was a big infusion of government money,” he said.
But governments cannot afford to sabotage companies that need profit to survive.
Dr. Graham has largely moved on from studying the coronavirus. He is searching for a universal flu vaccine, a silver bullet that could prevent all strains of the disease without an annual tweak.
Though he was vaccinated through work, he spent the early part of the year trying to get his wife and grown children onto waiting lists — an ordeal that even one of the key inventors had to endure. “You can imagine how aggravating that is,” he said.
Matina Stevis-Gridneff and Monika Pronczuk contributed reporting.