Several biotech companies have been making the news over the last couple months as they move at unprecedented speed to develop a potential coronavirus vaccine. The science behind developing a vaccine is incredible complicated, and so are the legal issues that surround the process. WGBH Morning Edition host Joe Mathieu spoke with Northeastern University law professor and WGBH News legal analyst Daniel Medwed about basic intellectual proprty law related to developing such a vaccine. The transcript below has been edited for clarity.
Joe Mathieu: Let's say you're one of the hundreds of tech companies out there rushing to create a vaccine for COVID-19. We hear a lot about one in our own backyard, Moderna in Cambridge. [I'm] assuming it would make sense to get a patent, if not a massive priority here, with such important intellectual property. How does that start here in the U.S.?
Daniel Medwed: Well, to protect any invention, including conceivably a vaccine, it might make sense to seek a patent from the U.S. Patent Office. If granted, a patent confers a property right to the inventor. That is a right to, "exclude others from making, using, offering for sale or selling" the invention in the U.S. or importing it into the country. It's not a right to sell it here so much as it is a right to stop others from doing so. Our patent process has a very storied history; it dates back to the Constitution. Article 1, Section 8 vests Congress with the authority to pass laws to protect inventors, and it has done so repeatedly over the past 200 years. Now generally, a patent only lasts for 20 years and there are a couple different types of patents. You could get a patent for a design, for a plant or — and I think this is the one most applicable here — what's called a utility patent that covers any new and useful process, article of manufacture or composition of matter.
Mathieu: I know there's a moral aspect to this whole thing and whether we should be talking about patents when the whole planet needs a vaccine, but are there other forms of intellectual property protection that might be important?
Medwed: I wouldn't claim to be an intellectual property expert, but I imagine some companies could try to characterize a vaccine as a trade secret, which has some advantages. For one thing, there's no rigorous governmental registration process like going through the U.S. Patent Office, and there's no limit on the duration of trade secret protection — it doesn't expire after 20 years. In addition, trade secrets are generally immune from government intervention, unlike patents, because there are federal laws that give the government what are called march-in rights. They can demand licensing rights from patented products in certain extreme situations. Conceivably, a COVID-19 scenario.
Mathieu: Given what you just said, would it make sense then for these drug makers or these biotechs to avoid the patent process [and] maybe categorize any nascent vaccine as a trade secret?
Medwed: Well, that's an important question, and I don't want to give the impression that trade secrets are perfect. For one thing, trade secrets only work as long as the product remains confidential. If you can crack the code and reverse engineer the product, then the company is basically left without a legal defense. Think about the famous formula to Coca-Cola. If you could figure that out, Coke would be in a lot of trouble. So I think at bottom, whether you seek patent protection or trade secret protection, there are pros and cons to both routes. But I do hope, and you alluded to this earlier, that companies would prioritize global health over profit and maybe pool information down the road.
Mathieu: So how realistic is that? Consider what's at stake here, the amount of money that could be made for companies to basically let down their guard.
Medwed: Well, we've had some promising signs so far. Certainly these companies are in the business of making profits. But recall that Gilead, the company that holds the patent for Remdesivir, the antiviral drug that's shown some promise in combating the effects of COVID-19, got into a bit of a pickle with a Chinese company that sought to recreate the drug. And the Gilead CEO took the high road and said "I don't want to get into a patent dispute. Too much is at stake now." It's important to keep in mind that Jonas Salk, the inventor of the polio vaccine, never sought to patent that vaccine because he believed it belonged to the people. So we have some examples of people taking the high road and acting in an altruistic fashion. Maybe that's what will happen here. We can hope.
