Last week, the United States publicly announced its support for waiving intellectual property protections for COVID-19 vaccines. A coalition of countries led by India and South Africa argued that waiving those rights would allow for increased production of vaccines. Pharmaceutical companies that own the patents argued that even if they waived the patents, it wouldn’t be very helpful, as developing countries still wouldn’t have the resources or the training to be able to begin producing vaccines right away. Everyone is beefing on the global stage, and the U.S. just threw their weight behind one side. But what does any of this even mean?
Equipped with knowledge from one Law and Society class, some understanding of measles and no fear of having 10 million tabs open, I’ll take you through it.
The Basics: Intellectual Property and Patents
According to Cornell’s Legal Information Institute, intellectual property, or IP, comprises “products of human intellect” that are protected by law, as dictated in the Constitution. It’s like more tangible property laws, except it’s supposedly meant to encourage people to create things for the public while still benefiting from the fact that they created it. There are four types: copyright, trademark, trade secrets and patents. You’ve probably heard of the first two. Copyright stops you from uploading an entire movie to YouTube. You may remember that The Ohio State University tried to trademark the “The” in The Ohio State University.
The IP for vaccines falls under the last category: patents. Patent holders can stop other people from “making, using, importing, and selling” their invention for a set period of time. Most patented items, including vaccines, have utility patents, which cover most new inventions and last for 20 years. If you invent a new plant or a new font, however, that’s a different kind of patent.
In the United States, inventors must apply for a patent through the U.S. Patent and Trademark Office (PTO). Applicants have to prove their good is useful, the idea is new and it is not something someone could reasonably stumble upon on their own. They also have to include a detailed description of their invention, including how it works, that is good enough that someone familiar with the general concepts would be able to replicate it. The PTO then examines the application and may or may not grant the patent. This process can take a while, but there have been “fast-tracked” exceptions, like those for cancer treatments.
The Food and Drug Administration (FDA) also needs to approve medical innovations, which is a long process on its own. Like with patents, though, new medical inventions can be granted Accelerated Approval or, in the case of COVID-19 vaccines, Emergency Use Authorization (EUA). Medical products made under EUAs still go through a lot of testing and clinical trials but are not officially approved by the FDA. More simply put, the FDA decides that the benefits outweigh the risks and give producers the go-ahead.
It’s possible that different parts of vaccines could have different patents with different owners, according to an amazingly clunky looking 2010 presentation from the World Health Organization. But, according to Pritzker professor Laura Pedraza-Fariña, who specializes in intellectual property and patents, this isn’t an issue unique to vaccines.
“[Patent fragmentation] happens all the time with innovation,” Pedraza-Fariña said. “You know who the players are, you can potentially get individual licenses… The problem, I think, is more ‘Will you get the licenses,’ right? And how expensive the licenses will be.”
Whew, that was a lot. Let’s take a breather. Get yourself some water and a snack after reading all that, you deserve it.
Up until this point, we were only talking about IP and patents in the United States. But the U.S. is part of a global economy, so there are considerations to be made between countries as well as within them.
To allegedly be able to smooth out the process of trading of knowledge and encourage innovation, members of the World Trade Organization (WTO) have an agreement on the Trade-Related Aspects of Intellectual Property Rights (TRIPS). Full transparency: even the few, specific sections on patents that I read made my head turn a bit. The short version of it is that countries must allow intellectual property laws in their country.
Pedraza-Fariña stressed that patents are national, even though TRIPS is an international agreement. It’s more about “creating a floor for patent protection,” she said.
This also means a particular country can issue something called a compulsory license. This exception was added as an amendment to TRIPS in response to ongoing public health emergencies, like the HIV/AIDS crisis. Compulsory licenses basically mean that generic manufacturers can produce a copy of a drug without a license from the company that owns the patent in their own country. Think sertraline instead of Zoloft, or tretinoin instead of Retin-A, or the Target brand of tissues instead of Kleenex.
Now, you might be thinking: this pandemic is totally a global health crisis, so countries should be able to compel access to patents. Pedraza-Fariña agrees.
“I doubt that a WTO dispute resolution body would not agree that it applies in this particular case,” she says. “So a country can issue a compulsory license to have their own country’s generic manufacturers make that particular vaccine.”
The key there is their own country. I’m really hammering this home because I read into all this the wrong way while I was researching. Here’s the sitch: the United States cannot compel Moderna to allow generic manufacturers in India to make a copy of its vaccine. It could compel Moderna to do that in the U.S., but that doesn’t necessarily solve the problem of easily getting vaccines to other countries.
There are moral questions around the patenting of medical technology, including vaccines. Jonas Salk, the inventor of the polio vaccine, famously refused to patent his invention. When asked who owned the patent, he said, “Well, the people, I would say … There is no patent. Could you patent the sun?” A baller move by Salk, but it seems to be an anomaly in the history of vaccine production.
Finally, back to COVID vaccines. (Bless.)
Now, knowing all the things we know about intellectual property law and TRIPS, we can finally zero in on the COVID-19 vaccines. It’s easy to figure out the main players, as their names are attached to the vaccines they own: Pfizer-BioNTech, Moderna, Johnson & Johnson, AstraZeneca and more.
In early October 2020, Moderna issued a statement saying they wouldn’t enforce COVID-19 related patents “upon request we are also willing to license our intellectual property for COVID-19 vaccines to others for the post pandemic period.” That sounds great, but it’s complicated by the fact that even if they waive their patent, it may still not include everything others may need to know to make a copy of the vaccine.
You might be thinking, “What?” Believe me, I did too. What’s the point of all this patent talk if it’s not even going to solve the thing it’s supposed to solve? There’s a few reasons for this, but one of the biggest issues according to Pedraza-Fariña is the transfer of “manufacturing know-how.”
“You have a patent on a process, you publish the patent, so anybody can read the patent … Simply reading the patent is not enough to teach you how to make the right product,” she said. “Especially in the area of COVID-19, where you have vaccine technology that’s never been used before, there’s almost zero chance that a generic manufacturer who gets the patents would be able to make the vaccine without additional help from Pfizer or Moderna.”
This sort of know-how can also fall under the different intellectual property law of trade secrets. You know, trade secrets. The only type of intellectual property law we didn’t get into earlier. Ha. Trade secrets, as defined by the Uniform Trade Secrets Act (UTSA), covers info that gains value by staying a secret and can be kept secret without having to go to extremes. Luckily, the proposal to waive the IP protections covers trade secrets. Unfortunately, that still may not be enough.
In the wake of the Biden administration supporting the move, pharmaceutical companies are not happy. To quote a statement from the chairman of the Biotechnology Innovation Organization, a trade association for the biotech industry: “In the future, this decision will act as a disincentive to companies to respond to the next pandemic.” It’s funny, though, because, according to Pedraza-Fariña, patents may not even be the best way to incentivize vaccines.
“[For traditional drugs,] you have a market, and you have people who will be continuously buying the drug,” she says. “Vaccines are hard. Because, you know, once you get rid of a disease, you’re done with your market.”
To make a long story short (too late!), waiving a patent just means a company will not sue if someone else uses it. It doesn’t mean the company will hold a generic manufacturer’s hand as it recreates the vaccine.
There are a few plans in the works to solve this problem. One is the COVID-19 Vaccines Global Access initiative, or COVAX, which is co-led by the World Health Organization and has UNICEF acting as its “delivery partner.” It seems like the gist is getting companies in wealthy countries to cooperate and send vaccines to developing countries that need them. Even on the site’s landing page, though, the initiative’s floor for doses is 20% of the population of a country. It’s not nothing, but it’s also not a lot. It also leaves developing countries at the mercy of developed countries to send vaccines.
Another, newer idea is what the WHO is calling a “vaccine technology transfer hub.” This would be a mechanism, facilitated by WHO, by which technology could be transferred, free of IP protections, to other countries. This is meant to help increase global production of vaccines. They posted an ‘expression of interest’ in early April, basically to see if drug manufacturers and NGOs would be into it. It’s kind of like the global health version of passing someone a note that says, ‘Do you like me? Check yes or no.’
Governments could also pay pharmaceutical companies enough to cover research and development, so patents are no longer required to recoup that money. But something that we’ve seen, both in the language of United States intellectual property law and TRIPS is that there seems to be a perception that for people to be pushed to innovate, there needs to be some sort of guarantee of profit – not just recouping. Capitalism strikes again.
To my extreme frustration, believe me, I don’t necessarily have an answer for you. It’s possible that there will be a TRIPS waiver on vaccines patents, but, as we’ve seen, that won’t mean that countries will be able to start manufacturing it the next day.
It’s almost like the conversation has been about the wrong thing all along: it’s not about who has access to the info on vaccines, but who has all the resources to make it.