
Intellectual-property disputes throughout the drug supply chain could hold back a Covid-19 shot.
Inside the race to develop a vaccine for the coronavirus is another contest worth keeping a close eye on: the rush to patent any discoveries. The frenzy to protect intellectual property brings with it the potential to impede access to what will likely be the world’s most in-demand shots.
Dozens of companies and academic labs are working to find a vaccine. In early May the U.S. government waived fees for speedy Covid-related patent reviews, easing the research and development path for smaller teams that might not have been able to afford the extra charges, which average about $2,100. All companies prize intellectual property, but for small ones it’s especially vital. IP gives them a way to value their inventions when seeking a development partner or buyer. And they almost always need help to finance the kind of large-scale trials required to seek approval for a drug.
When defending high drug prices, the industry has always argued that without generous rewards, there would be no innovation. But governments around the world know there’s a risk in giving any one business veto power over a Covid cure. Canada and Germany have already threatened to override patents if necessary to get access to vaccines. In March, Israel issued an order to permit the import of a generic version of AbbVie Inc.’s antiviral Kaletra for use against the disease. The government said AbbVie couldn’t supply enough Kaletra, which is still under patent in Israel. After the order, AbbVie said it would “remove any potential barriers to alternate sources of supply.” The drug hasn’t been shown to be effective against Covid-19.

Seeing the potential pitfalls early on, the World Health Organization in May formed a patent pool—essentially asking researchers to share proprietary information, while not giving up royalties, to make it easier for vaccine researchers to replicate one another’s work. As of July, many countries had signed on, but no drugmakers had, nor had the U.S.
A group of U.S. academics and engineers formed a patent coalition with a similar intent, and Amazon.com, Facebook, Microsoft, and other giants agreed to participate. No pharma companies joined. “Our guess is their position is, ‘Covid-19 is a legitimate market—it could be a big market for us—so why give that up?’ ” says one of the pool’s creators, Jorge Contreras, a patent law professor at the University of Utah.
In signing a $2 billion deal to supply their experimental vaccine to the U.S., Pfizer Inc. and BioNTech SE set a price ceiling of less than $20 a dose. During an early August conference call with investors, Moderna Inc. Chief Executive Officer Stéphane Bancel laid out the company’s strategy. “During the pandemic, we are priced well below value with preapproval supply agreements, mostly to governments … executed between $32 and $37 per dose,” he said. While “larger volume agreements under discussion will be at a lower price,” he said, after the worst phase of the pandemic ends, “pricing considerations will follow traditional dynamics and market forces.”
Beyond price, complications could arise because drug companies often rely on outside manufacturers to produce medicines in large quantities. In this scenario, it might not be patents but trade secrets that create the headaches. There have been some signs of cooperation within the industry. In August, Pfizer Inc. said it had reached a multiyear agreement with Gilead Sciences Inc. to manufacture and supply its antiviral remdesivir. But one vaccine developer, Inovio Pharmaceuticals Inc., has already sued its contract manufacturer for refusing to provide information about a manufacturing process Inovio says it will need to scale up production of a theoretical vaccine. “You can’t put up these roadblocks when public health, the greater good, is in play,” CEO J. Joseph Kim said after suing in June. “It’s appalling and shocking to me.” The defendant says the information is protected as trade secrets, and the Pennsylvania courts have let those trade secrets stand while allowing the case to proceed.
Large pharma companies have also started adding manufacturing capacity before they’ve developed a viable vaccine, and it’s possible one could build a plant but not succeed with its shot. In that scenario, governments would want that company to offer its facility to a competitor with a viable product. But both parties could easily refuse such an arrangement if it seems to put patents or trade secrets at risk. “If, for example, it turns out that AstraZeneca can’t produce enough for the government,” says Arti Rai, a law professor at Duke, “the question will become, will they license their intellectual property to other manufacturers? There could be patents or trade secrets, because manufacturing vaccines can be quite complex.”
The U.S. government has some options. In instances in which it helped pay for research, it can exercise what are known as “march-in” rights under the 1980 Bayh-Dole Act to wrest control of patented inventions and let others use them. Bayh-Dole hasn’t been used on drugmakers. Even in instances where the government didn’t fund research, it has the power to issue a compulsory license, letting others manufacture the drug. The patent owners would be entitled to a “reasonable royalty.” The Pentagon regularly exercises such powers in defense contracts, such as for stealth technology in the F-22 fighter jet and helmet-mounted displays in the F-35 Joint Strike Fighter.
In a confrontation during the anthrax scare of 2001, the government threatened to override Bayer AG’s exclusivity rights to the antibiotic ciprofloxacin. Bayer instead increased production and lowered prices on its own.
There are reasons to believe the government won’t intervene directly this time. The nonprofit group Knowledge Ecology International, through a Freedom of Information Act request, uncovered industry-friendly details in government deals with drugmakers. In contracts with Johnson & Johnson for a vaccine and Regeneron Pharmaceuticals Inc. for a treatment, the U.S. government either narrowed or gave up its march-in rights.
“There’s no rationale to say this should be outside of the Bayh-Dole Act,” Contreras says. “This is why the Bayh-Dole Act was passed.” J&J says that it’s committed to making a vaccine available and that these kinds of contracts “strengthen” private-public engagement for research. A Regeneron spokeswoman says its contract “allows the government to access these technologies in order for us to work together to quickly address” the pandemic.
Patients Over Pharma and other consumer advocacy groups are urging the government to build some price guarantees into vaccine contracts or at least offer some transparency into what taxpayers are going to have to pay. “Any successful vaccine would be developed with taxpayer investments,” says Eli Zupnick, spokesman for Patients Over Pharma. “There absolutely should be those kinds of protections baked into the contracts.” —With Susan Decker