The Covid-19 pandemic, devastating as it is, is producing some triumphs of collaborative research and innovation, as everyone from the World Health Organization to national laboratories, pharmaceutical companies, and Facebook groups of engineers race to fight the virus. But lurking behind this remarkable work is a threat: Some individuals or companies may exploit patents to profiteer off the crisis and could slow these innovative efforts to a crawl.
In this time of crisis, lawmakers must be wary of patents and be flexible and proactive in using the many legal tools available to check their harmful use.
Patent law grants inventors exclusive rights to the new technologies they develop, encouraging invention. Yet patents can block others from using these inventions, even when those other uses may be the key to stopping infections and saving human lives.
Patents have threatened public health in the past. After the Sept. 11, 2001, attacks on the World Trade Center and the Pentagon, credible threats were made of bioterrorist anthrax attacks that could have infected millions. Pharmaceutical giant Bayer held the patent to ciprofloxacin, the only approved anthrax treatment, but claimed it needed 20 months to meet the government-estimated requisition for the drug. Generic manufacturers offered to manufacture the same number of doses in just three months. But despite the Bush administration’s pleas, Bayer refused to allow generic ciprofloxacin or to lower its own high prices. Only after the government threatened to “break” Bayer’s patent to enable generic competition did the company concede to a fire-sale 50% discount and ramped up production.
With the coronavirus that causes Covid-19, patents could cause similar harm. Technology abounds in the response efforts to Covid-19 — vaccines, diagnostic tests, computer models, ventilators, N95 masks, and more. Those who hold patents on these technologies could easily run amok.
Already, a shady enterprise named Labrador Diagnostics has used a patent lawsuit (since dropped) to try to block a Covid-19 testing firm, and another patent holder may have threatened an Italian hospital trying to repair ventilators.
If the United States wants to stop this pandemic as quickly as possible, it needs to brace itself against profit-motivated patent assertion that could harm public health. We see at least four strategies that can help.
First, federal leaders must be prepared to use all tools available to overcome patents that interfere with the pandemic response. For more than a century, the law has allowed the government “to appropriate any invention necessary or convenient for natural defense or for beneficent public use, … without previous arrangement or negotiation with the owner.”
This law, known as section 1498, is what finally gave the federal government the leverage it needed over Bayer on ciprofloxacin. The Trump administration should exercise this power promptly if the makers of patented tests, treatments, vaccines, or devices (such as ventilators) overcharge for these products, or cannot keep up with demand, and to thwart patent trolls who assert patents to frustrate a public health response. We agree with the editors of the Financial Times, who wrote: “[T]rade rules allow compulsory licensing. If necessary, it must be used.”
Second, federal leaders must avoid rigid pro-patent positions that could limit their ability to respond nimbly to crises. Bayer’s patent stymied the Bush administration because the administration had previously denounced powers like section 1498 in trade negotiations over AIDS treatments.
The Trump administration has, admirably, taken a different tack: Last November, it filed a remarkable lawsuit, currently pending, alleging that Gilead has “profited from research funded by hundreds of millions of taxpayer dollars and reaped billions” by selling HIV drugs based on that research back to the American public, at very high prices. Actions that challenge pharmaceutical monopolies, rather than entrench them, are necessary to protect public health.
Third, states have a vital role to play in policing the use of patents. Under constitutional principles of federalism and sovereign immunity, states may not be liable for patent infringement as long as they offer adequate compensation for doing so. States hardest hit by Covid-19, or best positioned to combat price gouging or shortages, should explore their options under sovereign immunity — including doing their own manufacturing — especially if the federal government is unwilling or gridlocked, as happened during the anthrax crisis.
Fourth, President Trump and members of Congress should be wary of patent owners and their allies trying to use the pandemic to expand already strong patent protections. Some experts who represent biotech and pharmaceutical companies have called for broadening patents on diagnostic testing; other experts seek to increase the patent term for vaccines (already often as long as 25 years), and the pharmaceutical industry wasted no time inserting favorable patent language into a Covid-19 spending bill. Rather than helping the Covid-19 crisis, history shows that these changes would raise prices, reduce access to medicines and diagnostic tests, inhibit scientific research, and delay innovation.
It only takes one patent to throw a wrench into the public health machine. As Americans learned in 2001 and must remember now, protecting the people takes a resolute government, willing to stand up to powerful patent interests and to put public health first.
Christopher Morten is the supervising attorney at the Technology Law and Policy Clinic at the NYU School of Law and a fellow at NYU’s and Yale’s law schools. Charles Duan is the director of technology and innovation policy at the R Street Institute, a think tank based in Washington, D.C.