The vaccine rollout has generated a slew of controversies, including whether companies should waive their right to patent protection in order to allow other companies to produce generic versions and accelerate distribution. GBH Morning Edition host Joe Mathieu spoke with Northeastern University law professor and GBH News legal analyst Daniel Medwed to learn more about U.S. intellectual property law and at least one effort underway to get companies to share their vaccine formulas. The transcript below has been edited for clarity.
Joe Mathieu: Give us the foundation here — how the patent process works in the U.S. — and then we'll drill down from there.
Daniel Medwed: Well, how it works or doesn't work, I guess. So to safeguard your invention, you might want to seek a patent from the U.S. Patent Office, which if given to you, provides a number of intellectual property rights, including the right to exclude others from making or selling it or importing it into the country. Now, our patent process derives from the Constitution. Article 1, Section 8 vests Congress with the power to pass patent laws, and Congress has done so repeatedly over the last 200 years. At the moment, your patent lasts for 20 years and there are various types of patents. You can get a patent for a design for a particular plant. A utility patent is the one that probably applies here. It relates to any new and useful process or composition of matter. The key word, of course, is "new" — you have to have something new to get a patent.
Mathieu: So for people asking why this even exists, why it should keep others from producing or selling something, the rationale for impairing the free market is to create incentives for entrepreneurs to develop new products, invent new things?
Medwed: Absolutely. That's the basic rationale, this idea that you should be able to reap the rewards of your intellectual efforts, and that without this backend protection — the promise of a patent at the end of the rainbow — people wouldn't foot the bill for that upfront investment of research and development of intellectual and financial capital without the promise that their investment essentially will pay off. The patent system incentivizes people to take risks and invent new things. At least, that's the rationale.
Mathieu: There's a lot of talk about speeding up the vaccine rollout by forcing patent holders to give up, essentially, their intellectual property rights. Is that actually possible, Daniel, and what mechanisms are available to make it happen?
Medwed: It is possible and it's very controversial. So on the one hand, on the domestic front, there are several federal laws that give the federal government what are called "march-in rights," literally the ability to march in and demand licensing rights to a patented product in certain situations. The federal government seldom, if ever, exercises these rights. They're very controversial for obvious reasons, and I doubt they'll be used here because the rollout, even though it's not going as quickly as a lot of people would like, at least in this country is happening. On the other hand, there's growing international pressure, especially from countries that are developing, to get companies to waive their patent rights [and] to allow for the production of generics more quickly and perhaps more cheaply. This debate at the moment is really raging in the World Trade Organization.
Mathieu: Well, what exactly is happening at the World Trade Organization?
Medwed: It's pretty remarkable. So led by India and South Africa, about 80 countries have formally requested a modification of the WTO's TRIPS Agreement — Trade-Related Apects of Intellectual Property — that would basically waive patent protection for the COVID-19 vaccine. Most of the wealthy Western nations like the U.S., Britain and Switzerland have opposed this request, citing the justification we just discussed: the need to incentivize research and development. But they've had eight really intense discussions about this so far. It's on the agenda again in April. I doubt it will pass because you need consensus in the WTO from all 164 countries to get something like this passed, but we're just going to have to see how it plays out.
