Democrats in Congress, activist groups and developing countries are lobbying President Joe Biden to weaken intellectual property protections for COVID-19 vaccines, a move that could expand global supplies but would anger the drugmakers that partnered with the government to create the life-saving shots.
The drugmakers argue that stripping them of their patent protections could backfire at a time when they are working to produce boosters to combat virus variants. And they say there are better ways to ensure the vaccines reach the world's population.
The debate will come to a head over the next few weeks as Biden makes critical decisions about who owns the knowledge associated with COVID-19 drug inventions that could impact vaccine pricing and production for years to come.
Vaccines are free to all Americans during the emergency pandemic period, and Biden says the country will have more than enough supply to vaccinate everyone currently eligible. But vaccines may not be free in the future should Americans need boosters, and a pending Trump-era proposed rule could take away the government's ability to step in and reduce costs.
"You're going to see in a relatively short amount of time what is the position of the president of the United States on these issues," said James Love, the director of Knowledge Ecology International, an activist group that wants Biden to take steps to lower the price of the vaccines by permitting generic drugmakers to make them.
Biden will soon have to decide what to do about a rule proposed by the National Institute of Standards and Technology in the final weeks of Donald Trump's presidency that could help drug companies maintain complete control over drug prices, even when taxpayer dollars have funded much of the research and development.
The 1980 Bayh-Dole Act allows for the government to "march in" and issue a compulsory license for a federally funded invention if the invention is not available to the public under reasonable terms. Practically, this means the federal government could break patents for federally funded drugs or vaccines to authorize generic competition if regulators determine the price is exorbitantly high. Trump's proposed rule would modify the Bayh-Dole Act in ways that weaken this ability by saying the government cannot use its march-in authority solely based on price. Comments on the proposed rule closed April 5.
Some Democrats in the House and Senate are trying to block the rule. House Ways & Means Health Subcommittee Chair Lloyd Doggett, D-Texas, Sens. Bernie Sanders, I-Vt., Elizabeth Warren, D-Mass., Tammy Baldwin, D-Wis., and Jeff Merkley, D-Ore., and 31 other House Democrats asked the Biden administration to withdraw the rule. The government has never before exercised its march-in rights, but these lawmakers said having the option was especially important during the pandemic because taxpayers invested in COVID-19 therapeutics and vaccines.
"Pharmaceutical companies extract the highest prices from the sick and dying, and this proposal would embolden them to charge even higher prices by allowing them to price gouge with impunity," the Democrats wrote in their comment on the proposed rule.
Health and Human Services Secretary Xavier Becerra is an advocate of march-in rights. Before joining the Biden administration, he led a coalition of states asking the Trump administration to use march-in rights to lower the cost of the COVID-19 drug remdesivir or allow states to take action.
HHS did not respond to requests for comment on Becerra's view on the NIST proposed rule.
Joe Allen, executive director of the Bayh-Dole Coalition, whose members include drugmakers, says these lawmakers' efforts could backfire. Allen argues that Congress never intended the government to set prices on products and the law makes no reference to a reasonable price dictated by the government. He says advocates and Democrats have been purposefully misinterpreting the law for years.
"It will stop collaboration," Allen said, of enforcing march-in rights. "The danger is the next time you have a pandemic, are companies going to jump in to partner with you?"
COVID-19 drug and vaccine contracts vary on march-in rights. Moderna's contract contains the standard march-in clause, and Novavax's vaccine contract generally tracks with the Bayh-Dole Act, according to Knowledge Ecology International, a nonprofit group whose precursor organization was founded by consumer advocate Ralph Nader. Johnson & Johnson's contract limits march-in rights to during the pandemic. Pfizer's vaccine was developed entirely with private funds and prohibits the government from marching in.
Advocates and developing nations are lobbying the World Trade Organization, which arbitrates international patent disputes, to suspend some intellectual property rights for COVID-19 vaccines and treatments, and some House Democrats are urging Biden to have the United States join the effort. Many wealthy countries have begun their vaccine rollout, but less developed nations have not and could take three to four years to fully vaccinate their citizens.
India and South Africa are leading a multi-country push to get the WTO to waive drugmakers' exclusive rights to manufacture COVID-19 vaccines and therapies to increase supply quickly. The United States, the European Union and the United Kingdom do not support this initiative, but advocates want the Biden administration to reconsider it.
Rep. Rosa DeLauro, D-Conn., is leading a group of House Democrats pushing Biden to support the waiver and circulated a sign-on letter to garner support, but the letter is not yet public. Reps. Jan Schakowsky, D-Ill., Earl Blumenauer, D-Ore., Lloyd Doggett, D-Texas, Adriano Espaillat, D-N.Y., and Andy Levin, D-Mich., have all signed on. DeLauro's office said House Speaker Nancy Pelosi supports the effort, but Pelosi's office did not respond to requests for comment.
"As we see everyday, the COVID-19 pandemic knows no borders. Our globalized systems cannot recover if only parts of the world are vaccinated and have protection against the virus," DeLauro said.
But drugmakers and businesses say waiving intellectual property protections would not speed up production and would cause more harm than good.
The WTO has been discussing the issue since October but does not have a deadline for approving or rejecting the waiver. DeLauro and her allies believe Biden's support for the developing countries would create pressure.
But drugmakers are pushing back. "Eliminating those protections would undermine the global response to the pandemic, including ongoing effort to tackle new variants, create confusion that could potentially undermine public confidence in vaccine safety, and create a barrier to information sharing," the Pharmaceutical Research and Manufacturers of America, the drug industry trade group, wrote in a letter to Biden asking him not to support the waiver.
A coalition of business groups, including the trade groups for biotechnology firms and medical device makers, Bio and AdvaMed, also sent a letter to the Biden administration asking it to help increase vaccine production through partnerships between private companies, and not by breaking patents. Scaling up vaccine production is complex, and they argue that creating partnerships between drugmakers is much more efficient than releasing a vaccine's recipe to the public.
"In reality, the waiver would undermine the global response to COVID-19 and would not achieve its stated goal to expand vaccine production rapidly," the business groups wrote.
Robert Grant, an international affairs specialist with the Chamber of Commerce, a business group that counts drugmakers among its members, said that intellectual property has not been a barrier to distributing vaccines in the past. He urged the Biden administration to focus on licensing and partnerships, rather than waiving patents.
"It's much, much easier for a government to work cooperatively with an industry partner rather than issue a compulsory license [to force a drugmaker to allow other firms to manufacture its product] because in those situations, a company is not doing it under duress," Grant said.