You probably don’t remember the day the White House issued its 2013 open access memo, but I’ll never forget it. That’s the rule that requires any research funded by the federal government to be made available to the public one year (at most) after publication. I was working back then at Creative Commons, an organization that advocates for strong open access policies. I remember saying to a colleague, “Well, time to find a new cause.”
An oversimplification? Sure, myopia is an occupational hazard in my field. But I believed then that the right to knowledge was the panacea—that if we could remove the legal and institutional barriers between those who could access the world’s research and those who couldn’t, then everything else would fall into place. After all, restricting access to knowledge is one of the most obvious ways that those in power have historically protected that power.
I thought we’d won. I was wrong.
The fight wasn’t over—it was just moving into a different battlefield. Today, patent abuse undermines that goal of letting the public fully enjoy the innovation that it pays for. In light of the race to develop treatments and vaccines for COVID-19, governments and other funders of science must make a change.
Take remdesivir, one of several experimental drugs being tested for treating COVID-19. The U.S. government helped fund the research that led to the development of the drug. But in March, pharmaceutical giant Gilead received an unfair monopoly on it in the form of “orphan drug” status. The orphan drug designation grants special rights to the owner of a patent on treatments for a disease that affects fewer than 200,000 people in the United States. The idea is that if a pharmaceutical company offers a treatment for a disease that affects only a small number of people, it may not be able to recoup its costs if it has to compete with generic manufacturers. The absurdity of using orphan drug status in the current crisis should be obvious. There were fewer than 200,000 COVID-19 cases in the U.S. when Gilead asked for orphan drug status, but we blew past that number weeks ago. It took a public outcry to force Gilead to ask the U.S. government to rescind the orphan drug designation.
Remdesivir may or may not be the key to treating COVID-19, but suppose it is. What would have happened if Gilead hadn’t relinquished the orphan drug status? To put the question more bluntly, why should our chances at fighting COVID-19 depend on one company’s public relations department? After all, the research that led to the development of remdesivir was partially funded by the federal government.
Scientific research that is funded by the public should be available to the public. That commonsense principle is no more apparent than in the middle of a public health crisis. And for the most part, researchers and journal publishers are doing what they can to make papers related to COVID-19 available to the public. Several countries have committed to making the coronavirus-related research they fund available to the public. Even the big academic publishers—notoriously reluctant to adopt open access policies—are making COVID-19-related research available to the public without the embargo period allowed under current law.
But a series of administrative and legislative decisions has led to an odd disparity in which patents on inventions that arise from government-funded research are treated very differently from published papers that arise from that same research. Over the past decade, new rules at the federal and state level have guaranteed that the bulk of government-funded scientific research is available to the public that paid for it (albeit with that pesky one-year embargo period). But over that time period, universities and other government grantees have ever more aggressively filed patents on that same body of research. And unfortunately, some of those patents have fallen into the hands of bad actors. Even as open access has made strides toward becoming the default for government-funded research, patent trolls have made it more difficult for practicing companies to use that knowledge.
As researchers around the world work together to bring a coronavirus vaccine to market, the governments and institutions that fund them should adopt policies that prioritize access for everyone, not exclusive licenses for one manufacturer or country. But that’s not enough. This moment in history doesn’t just demand that a few new treatments be opened to generic manufacturers; it demands a major shift in how governments and other funders approach patents altogether.
It’s not enough that the government ensure that new treatments or vaccines for COVID-19 be made affordably available to a broad public. Old patents can do just as much damage as new ones. Remember Theranos, the scammy blood-testing company that the Securities and Exchange Commission investigated for fraud? In mid-March, the patent troll that ended up owning Theranos’ old patents used them to sue a practicing company that plans to administer COVID-19 tests. In other words, a company with no business model besides legal bullying sued a company at the front lines of the fight against the coronavirus, using the patents from a defunct outfit whose product never worked in the first place.
We can do something about this kind of abuse without changing the law. A neglected section of patent law allows the government to step in and grant others a license to a U.S. patent—thus making itself, rather than the medical industry, the defendant in an infringement suit over that patent.
It’s not only biotech patents that can create obstacles for public health, either. A patent troll called My Health sued numerous companies that provide services for doctors and patients to communicate with each other over the internet. Its patent simply described routine processes in the telehealth industry. My Health kept demanding payments until a company had the guts—and resources—to go to court and have the patent invalidated.
Like many medical technology patents, the My Health patent was originally issued to a research university—in this case, the University of Rochester. Once again, academia’s relentless push toward more aggressive patenting—and its failure to ensure that those patents would be used ethically—created obstacles for the public and undermined a university’s social mission.
Which brings us back to the current pandemic. The government must exercise the legal tools already at its disposal to stop patent abuse against health care companies, providers, and researchers working to provide tests and treatment to the public. It also must take steps now to keep the research it funds from becoming a tool of abuse.
A global group of intellectual property experts recently launched the Open COVID Pledge, a license that lets the public use all of the licensor’s material and inventions covered by copyright, patents, or other IP rights, for the purpose of fighting COVID-19. The license ends one year after the World Health Organization says that the pandemic is over.
But it takes more than an opt-in pledge. Governments, universities, corporations, and other institutions that fund research should immediately make a broad license like the Open COVID Pledge a condition of their funding. What’s more, the U.S. government should exercise the legal tools already at its disposal to stop patent abuse against health care companies, providers, and researchers working to provide tests and treatment to the public.
At its core, the patent system is about sharing knowledge and encouraging innovation. A patent represents a societal bargain: You share information with the public about how an invention works, and in return, the public gives you temporary, limited rights to get compensation from others who use that invention. But the patent system can be abused—and is being abused to take advantage of this global crisis.