The U.S. pharmaceutical industry warned this week that the Biden administration’s support for waiving intellectual property rights for coronavirus vaccine manufacturing worldwide risked wiping out investment in future innovation and disrupting the response to the pandemic.
Biden’s move gave countries in the Southern Hemisphere greater bargaining leverage in negotiations before the WTO. But the odds continue to favor the industry’s lobbying power, which dovetails with a historical desire by the United States and other countries with innovation economies to protect global intellectual property rights.
“The United States has unfortunately chosen to set a dangerous precedent with these actions,” Michelle McMurry-Heath, president and chief executive of the Biotechnology Innovation Organization, an industry trade group, said in response to Biden’s move. “But how we negotiate with the WTO moving forward will be critical in mitigating this myopic decision and its effects on patients around the world.”
The outcome of those negotiations also will determine whether Biden sets a precedent for future pandemics in his bid to share American scientific know-how during the current worldwide health emergency.
In agreeing with advocates and liberal Democrats to back global patent waivers, the president is trying to correct a worldwide imbalance in availability of coronavirus vaccine. Rich countries have snapped up the majority of supply, and poor countries are at the back of the line. The populations of some poor nations are not expected to be substantially vaccinated until 2023. Biden has been inhibited in sending larger direct shipments to disadvantaged populations because of concerns about a domestic political backlash.
But patent waivers will only work as part of a broader plan to transfer technology, say industry experts, patent scholars, and global health advocates.
“One way you could look at this is as a lever that can be used to strengthen the negotiating position of low- and middle-income countries to get to voluntary licensing agreements more effectively. They have a bigger stick,” said Krishna Udayakumar, director of the Duke Global Health Innovation Center.
“At the end of the day, the patents on their own are not going to be adequate. It’s still not clear to me how you force someone to take the knowledge in their head and share it involuntarily,” Udayakumar said.
Winning the right to make a vaccine without fear of legal repercussions is simply a starting point. A company that wants to make vaccines in the developing world also will need specialized training, costly and scarce equipment, and, above all, the transfer of technical know-how from existing patent holders including Pfizer, Moderna, AstraZeneca and Johnson & Johnson.
Vaccines are much more difficult to manufacture than a small-molecule pill, such as a generic anti-cholesterol tablet, for instance, which can be reverse-engineered from a single sample and made by combining chemicals.
Without the cooperation of big drug companies, patent waivers are unlikely to expand global supply of coronavirus vaccines, said Kristopher Howard, a pharmaceutical industry consultant and former operations manager for the drugmaker Merck’s vaccine business in the developing world.
“Information in the patent doesn’t teach you how to make the product,” he said. “A non-willing partner is no partner at all.”
Export bans on raw materials and specialized equipment, imposed by the United States and other countries, also would need to be relaxed. Already, a scarcity of bioreactor bags for fermenting vaccine and specialized lipids needed for mRNA vaccines have been cited as bottlenecks.
The member nations of the WTO will be negotiating terms of a potential agreement in coming weeks, and possibly months, with many opportunities for continued industry lobbying, specialists say. The original proposal for emergency patent waivers drafted by India and South Africa is likely to be considerably watered down, they said.
Foreign competition enabled by waivers, if new foreign manufacturers can overcome the numerous technical and supply hurdles, is unlikely to emerge until at least 2022. And when that production does come on line, supplies are likely to be aimed at developing nations that cannot afford the higher prices paid by wealthy countries, said Polk Wagner, a patent law expert and professor at the University of Pennsylvania Carey Law School.
In the meantime, billions of dollars in vaccine sales will continue to be logged by the big drug companies in the United States, Europe, Canada, Australia, Japan and other wealthy nations.
“My view is that it is extremely unlikely in the current set of circumstances that it will have a lot of impact on these vaccine companies. For one thing, they are already being paid enormous sums by most of the wealthy countries, anyway,” Wagner said.
Pfizer estimates that sales of the mRNA vaccine it developed in conjunction with the German firm BioNTech will be $26 billion in 2021, which would make it the highest-selling pharmaceutical product ever, and Pfizer predicts strong demand next year for boosters as immunity wanes and coronavirus variants proliferate. Moderna, the other company with a successful mRNA vaccine, raised its vaccine revenue estimates Thursday to $19.2 billion this year.
Even as the Biotechnology Innovation Organization (BIO) and PhRMA, the two main industry groups, warned that Biden’s move will have devastating impacts on the industry, the view from Moderna was rosy.
A possible patent waiver “doesn’t change anything for Moderna,” chief executive Stéphane Bancel said on a conference call with investors Thursday, according to Bloomberg News. “We saw the news last night, and I didn’t lose a minute of sleep.”
U.S. Trade Representative Katherine Tai set off an uproar in the industry Wednesday when she announced that the United States was going to drop its strict opposition to WTO intellectual property protection waivers. BIO and PhRMA did not respond to requests for interviews Thursday.
In their statements on Wednesday, they warned that giving developing nations the rights to make their own vaccines could create new competition for scarce equipment and raw materials, as well as create more opportunities for vaccine counterfeiters.
The industry also has argued that waivers would chill private investment in vaccine development to confront future pandemics.
In the coronavirus pandemic, billions of dollars in government subsidies have been crucial to jump-starting development for most vaccine manufacturers. Pfizer is the one company that shunned government assistance, although its vaccine, like others, does rely on a spike protein developed at the University of Texas with government grants.
BIO also laid out its lobbying agenda for the upcoming waiver negotiations before the WTO, including preventing the “expropriation” of vaccine and drug technology that could be used to compete against patent holders in the future. The statement reveals industry fears about the implications of a waiver precedent on new technologies.
The mRNA vaccines, which deliver an RNA payload that instructs human cells to create a coronavirus spike protein, are being manufactured on an industrial scale for the first time during the pandemic. The success has been stunning. Their 95 percent efficacy rate and speedy development have boosted interest in their promise for future vaccines as well as drugs.
“They are going to want to make sure they have protection and maintain protection over these technologies to protect themselves as the industry changes,” Wagner said.
Pfizer is leading in the race to ramp up production capacity, projecting 2.5 billion coronavirus vaccine doses this year. It has achieved its success with a tightly controlled, in-house production regime for bulk vaccine centered on Pfizer factories in Belgium and Michigan. Moderna has said it will make 800 million to 1 billion doses in 2021; it has mostly relied on a single contract manufacturer, Lonza, for bulk vaccine.
AstraZeneca and Johnson & Johnson had made large-scale pledges for global manufacturing with networks of contract manufacturers around the world. But those companies, using a viral vector technology that is slower than mRNA vaccine production, have struggled.
AstraZeneca and Johnson & Johnson vaccine production has been suspended at the contract manufacturer Emergent’s Baltimore plant because of cross-contamination of the vaccines. AstraZeneca’s supply failures have been exacerbated by the coronavirus crisis in India. The Serum Institute of India, a key supplier of vaccine for much of Asia, Africa and South America, has been prohibited by the Indian government from exporting vaccine.
The huge gaps in global supply mean many people in the developing world are not expected to receive vaccine until 2023. The inequities have generated global outrage, putting greater pressure on Biden to endorse patent waivers. But observers say Biden’s waivers will do nothing to ease the vaccine gap in the short term. Advocates have called on the president to share surplus vaccine doses produced in the United States, either directly or through Covax, the program affiliated with the World Health Organization that is procuring shots for developing countries.
“It would be a shame if this takes the heat off the United States and other high-income countries to do everything else that is required urgently,” said Duke center director Udayakumar. “This didn’t add a single dollar of financing to Covax. This didn’t result in the sharing of a single dose from any high-income country.”
