Patents in hand, wealthiest nations have signed away opportunity to vaccinate the world
Residents of wealthy and middle-income countries have received about 90 of the nearly 400 million vaccines delivered so far.
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 US government will control that patent. The new patent presents an opportunity 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 of the nearly 400 million vaccines delivered so far. Under current projections, many of the rest will have to wait years.
A growing chorus of health officials and advocacy groups worldwide are calling for Western governments to use aggressive powers — most of them rarely or never used before — to force companies to publish vaccine recipes, share their know-how and ramp up manufacturing.
Governments have resisted. By partnering with drug companies, Western leaders bought their way to the front of the line. But they also ignored years of warnings — and explicit calls from the World Health Organization — to include contract language that would have guaranteed doses for poor countries or encouraged companies to share their knowledge and the patents they control.
Western health officials said they never intended to exclude others. But with their own countries facing massive death tolls, the focus was at home. Patent-sharing, they said, simply never came up.
President Joe Biden has promised 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,” 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.
Russia and China, meanwhile, have promised to fill the void as part of their vaccine diplomacy.
Addressing patents would not by itself solve the vaccine imbalance. Retrofitting or constructing factories would take time. More raw materials would need to be manufactured. Regulators would have to approve new assembly lines.
And as with cooking a complicated dish, giving someone a list of ingredients is no substitute for showing them how to make it.
To address these problems, the WHO created a technology pool last year to encourage companies to share know-how with manufacturers in lower-income nations.
Not a single vaccine company has signed up.
Drug company executives told European lawmakers recently that they were licensing their vaccines as quickly as possible but that finding partners with the right technology was challenging.
But manufacturers from 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.
Despite the hefty government funding, drug companies control nearly all 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.
For years, Graham 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 the 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 30 March.
When Chinese scientists published the genetic code of the new coronavirus in January 2020, Graham’s team had their cookbook ready.
Within a few days, they emailed the vaccine’s genetic blueprint to Moderna to begin manufacturing. By late February, Moderna had produced enough vaccines for government-run clinical trials.
Exactly who holds patents for which vaccines will not be sorted out for months or years. But it is clear now that several of today’s vaccines — including those from Moderna, Johnson & Johnson, Novavax, CureVac and Pfizer-BioNTech — rely on the 2016 invention. Of those, only BioNTech has paid the US government to license the technology.
Patent lawyers and public health advocates say it is likely that other companies will either have to negotiate a licensing agreement with the government or face the prospect of a lawsuit worth billions.
The National Institutes of Health declined to comment on its discussions with the drugmakers but said it did not anticipate a dispute over patent infringement.
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 WHO to treat vaccines as “global public goods.”
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.
That same month, the WHO launched the technology access pool and called on governments to include clauses in their drug contracts guaranteeing equitable distribution. But the world’s richest nations roundly ignored the call.
In the United States, Operation Warp Speed, a Trump administration program that funded the search for vaccines in the United States, disbursed more than $10 billion to hand-picked companies and absorbing the financial risks of bringing a vaccine to market. The deals came with few strings attached.
Large chunks of the contracts are redacted, and some remain secret. But public records show that the government used unusual contracts that omitted its right to take over intellectual property or influence the price and availability of vaccines. They did not let the government compel companies to share their technology.
By comparison, one of the world’s largest health financiers, the Bill & Melinda Gates Foundation, includes grant language requiring equitable access to vaccines. As leverage, the organization retains some right to the intellectual property.
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 involved in the talks.
But in Washington, leaders are still worried about undermining innovation.
During the presidential campaign, Biden’s team gathered top intellectual property lawyers to discuss ways to increase vaccine production. 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. But Covax aims to vaccinate only 20% of people in the world’s poorest countries this year and faces a $2 billion shortfall even to accomplish that.
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