David Silverstein, JD, MS, a partner in Axinn’s Intellectual Property Practice Group and FDA practice groups, discusses the challenges posed by the White House’s support for the proposal to the WTO to waive IP protections for COVID-19 vaccines.
Pharmacy Times interviewed David Silverstein, JD, MS, a partner in Axinn’s Intellectual Property Practice Group and FDA practice groups, on the implications of the White House support for the proposal presented to the World Trade Organization (WTO) to waive intellectual property (IP) protections for COVID-19 vaccines, changing the United States’ original position on the issue.
This announcement comes as the pandemic continues to rage in India, one of the original countries that called on the WTO to suspend COVID-19 vaccine IP protections to increase vaccine production.
Alana Hippensteele: Do you see this decision by the White House potentially affecting the US's role in the field of immunization globally?
So, for example, if the White House was looking specifically to provide direct vaccine distribution to other countries—I know it has been discussed for Mexico and Canada—do you see this affecting the US's role in this space?
David Silverstein: Yeah, no doubt. If this proposal is adopted, it'll definitely have an effect on the US's role.
The pending waiver, as written, is to be negotiated over the phone in the coming months, but it doesn't limit exports. So, it'll allow developing countries and WTO members with major vaccine in pharmaceutical industries, for example, India, Russia, and China, to export to other WTO markets. That would in a sense displace the US's current leading role in providing vaccines.
One thing to keep in mind as well is there is licensing already going on between US vaccine manufacturers and companies in other countries. There's export going on, and there's many US manufacturers providing contracts they've entered.
So, I guess the US, if this were to be adopted as written currently, it stands to reason that US's role would be somewhat attenuated. But by itself, I think at the moment there isn't an immediate impact of this other than perhaps signaling a policy shift towards the US's desire to be even more involved in the international scene.
So, this could be a tip of an iceberg, and we'll see more policies unveiled in the coming weeks or months.
Alana Hippensteele: Yeah. Is there any reason to think that this decision to support waiving IP protections would disincentivize companies from funding research into the further development of COVID-19 vaccines, or into the development of other vaccines as well?
David Silverstein: I think that's a very good question—another highly debated topic.
I think certainly it adds further complexity to the economics of the decision-making that goes into pharmaceutical development. Is it going to eviscerate the entire pharma industry overnight? Probably not.
On the other hand, is it going to have absolutely no effect on the incentive structures that are in place already through the quid pro quo of disclosing to the public your technology and in return for getting a patent on it, having a monopoly on it? I mean, it'll definitely have an effect on that.
So, I think it will to some extent disincentivize pharma companies who tend to be conservative when it comes to thinking of return on investments. On the other hand, do I think from a policy standpoint striking a balance that gives to the rest of the world some of the benefits and some of the technologies that have been developed here? I think I can see that there's a public outcry for it, and there's incentive to do it.
My worry is especially in light of the fact that the patents, the IP are not the real barrier here, that we're rushing into unbalancing a system that may not be perfect as it currently exists, but it may need improvement.
I think there's a need to optimize it thoughtfully and carefully and not under duress, so to speak, not to do it hastily during the pandemic. Especially given that there's a general consensus on this.
It's not the IP that's the real barrier. It's so much more. It's access to supply chains, and all the things we discussed earlier. So, what is the real long-term risk of perturbing that incentive structure? it does have risk.
Alana Hippensteele: Yeah. What issues may the pharmaceutical industry face as drug companies continue to put effort into developing and delivering vaccines on a global scale?
David Silverstein: Well, as I mentioned, the strain on supply chains. Even before this move, Novavax, which is one of the US vaccine developers, they've been having a very difficult time securing raw material, and that's to make their class-leading vaccine so they can make it available to the masses.
So, they're still awaiting final approval or even emergency use authorization, and so by opening the floodgates of acquiring the capabilities to manufacture vaccines, no doubt they're scooping up raw materials right now to be prepared for that. So, that's going to hamper the ability of the already approved vaccines to be made and to be distributed around the world.
Alana Hippensteele: Right, what are some of the potential challenges around sharing IP in a pandemic setting if this were to occur down the line, other than some of the issues you addressed around IP not being the real problem in terms of circulating ideas and connecting with resources? What do you think might be some of the problems?
David Silverstein: Well, one of the benefits of this pandemic occurring when it did is that if it occurred 20 or 30 years ago, the pharma industry wasn't as connected as it is now.
Without the internet, this would be a different story. So even though there's a pandemic, we can freely share information with each other around the world without risking the health of the individuals involved.
But still, in order to really increase the vaccine manufacturing capabilities, more than just waiving IP or even more than just sharing of trade secrets if it came to that, you need full tech transfer of regulatory dossiers and that's something that I'm not aware of that ever occurring remotely.
It it's typical, if not required, that there's some in-person exchanges. You go on site, set up inspections done internally within organization training of individuals. It's hard to imagine all of that being done over Zoom.
So, that's certainly a challenge, and it's another tick mark in the column of the WTO's third way of encourage licensing and companies working together. Perhaps that's one of the biggest benefits of the threat of these proposals of waiving all IP, it's almost a nuclear option.
In the meantime, I would not be surprised if the vaccine manufacturers are upping their game to see what we can do to sort of license this to more companies, work collaboratively with more companies, and make a public show of it to say that you don't have to go and drop the nuclear bomb like we're doing everything in our power to ensure that there's greater access to these vaccines around the world. Maybe it's a third way.
Alana Hippensteele:What is your outlook on the COVID-19 vaccine development space in light of some of these shifts in this space in the future?
David Silverstein: Well, I think, and maybe this circles back a little bit to the disincentives. As currently written, this proposal will require unanimous consensus of the WTO general counsel in order to stop the waiver.
So, currently what's in everyone's mind is well how do we start the waiver and everything we've discussed so far relates to that. But if, and I don't think it's going to be adopted as written, but for sake of argument, if it were adopted as written, you have to unwind this, and that requires unanimous consent. So, that's going to have a tremendous impact on when is the end of the pandemic as we've seen just within the United States.
The difficulty that's the scientific community, much less the journalistic community, is when does the first wave end and the second wave begin for these outbreaks of COVID-19? It's very hard to define and so imagine on the international stage, when is the pandemic over so that we can stop the waiver?
This can be very difficult to get agreement on. So, if there's a waiver, it's going to stretch well into the future of years and then what impact does that have on vaccine developers? When do we get sort of sole access again to our trade secrets? When do we have sole access again to our patented technology?
If it's stretching on for years, I think it creates a strong incentive really to, given the choice, protect the next innovation with trade secrets rather than patents because the world doesn't know about the trade secrets, the world knows about the patents and could come back and say that needs to be wrapped into this waiver that was enacted.
But the trade secrets, they'd get the benefit of their own trade secrets without having to share them. So, in essence, that kind of chips away at the purpose of patents to begin with. In return for you publicly disclosing your invention, you'll get a limited monopoly. That's preferred for innovation as a society rather than everyone working in silos secretly with their trade secrets
So, it's to circle back on the earlier question of how could this impact the incentive structure, if there's a difficult way to put an end on the waiver, I could certainly see that affecting some structures.
Alana Hippensteele: Fascinating, yeah. Thank you so much for taking the time to speak with me today, David.
David Silverstein: My pleasure.