David Silverstein, JD, MS, a partner in Axinn’s Intellectual Property Practice Group and FDA practice groups, discusses the implications of the White House support for the proposal presented 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: What does White House support for waiving intellectual property protections for COVID-19 vaccines mean, and are there any immediate changes occurring in light of this support?
David Silverstein: Sure, well thank you for having me on your program again. It's a very important topic, and a very timely topic.
Since October 2020, the WTO has been considering this extremely broad proposal, as you said by India and also South Africa. I think what's missed in a lot of the headlines is it isn't just about patents. The scope of the IP that they're seeking to wave under the TRIPS Agreement are our patents, but also industrial designs, copyrights, protections of undisclosed information, or some of the word trade secrets.
The scope of technologies that are implicated is much broader than merely vaccines. It also extends to research and development activities, manufacturing supply of medical products, therapeutics, personal protective equipment, even COVID-19 tests and medical devices. So, this is very broad and unprecedented in scope, frankly, in these sort of proposals.
Until last week, the United States was a staunch opponent of this proposal. At this point, it's largely a symbolic gesture. In order to be adopted at the WTO, consensus is needed by all member states. So, as far as immediate effects, it's more of a ripple effect on the policy front that this has created. It's not going to create a run on vaccine technology overnight.
Alana Hippensteele: Right, that's interesting. So, what does this support from the United States potentially mean for global support of the proposal put before the WTO?
David Silverstein: Well, it is part of that consequence of that ripple effect. It sends a strong shift, a strong message that the United States has shifted its policy stance in an effort to help the international community tackle this pandemic.
I think the rest of the world was very surprised when Ambassador Tai reversed course last week announcing the Biden administration's support. Up to that point, there were about 60 co-sponsors to the proposal out of 164 member states, and so those are mostly from developing countries, and the opponents were key countries, in addition to the United States, from the developed world, such as the UK, the EU, Japan, Switzerland, Singapore, and South Korea.
Since the United States has shifted its stance, what we've seen, at least publicly, is a softening of the rhetoric. Angela Merkel's administration came out and said that while they don't support the proposal, they're willing to discuss. Whereas I think what we saw in the headlines at least 2 weeks ago was a staunch this is dead on arrival, we're not willing to entertain it. So, there's a bit more discussion to be had. I think that's going to change the dynamic as the member states negotiate this.
Another thing that may not be apparent to people who aren't steeped in this is that this is the start of a negotiation phase that will take several months. Much like any domestic legislation, there's going to be a lot of log rolling and give and take of the starting point, which is extremely broad. From what the developed world is signaling, they're willing to discuss, but they're no doubt going to require a winnowing of the scope of this.
Alana Hippensteele: Interesting, yeah. Would the action of waving IP protections need to be a global effort in order for it to actually work in assisting other countries in their vaccination efforts, or could this be a decision that the United States could do individually in order to have those ripple effects like you're talking about?
David Silverstein: Well, the well-defined IP, setting aside trade secrets, that are within the scope of this proposal are territorial. So, the United States, even outside of this, could enact what we call marching rights, so they can say within the United States we're no longer going to allow the enforcement of certain patents or certain copyrights, if you will—that would have an impact on the ability of manufacturers within the United States to make their vaccines and export them, and they wouldn't be blocked by the owners of those patents.
What effect would it have worldwide? Certainly, it wouldn't have the effect the proponents of this proposal would hope. So, for that, I mean you could block an Astrazeneca patent in the United States, but if Astrazeneca has similar patents in India, good luck importing it to India unless India also does marching rights or waves the IP there.
You end up with a patchwork system where you'd effectively lower the IP barriers to getting vaccines in some countries but not others and it'd be very hit and miss. It certainly wouldn't be as blanket of an effect as this proposal to WTO.
It's kind of a loaded question in that it's hotly disputed whether waiving IP protections is at all necessary in order to assist other countries in their vaccination efforts. It's been extensively written on, and I've spoken on a number of times as well, that the patents are not the real barrier to manufacturing and distributing these vaccines. There are much deeper issues.
Last time we spoke about selling gene therapies on your program, and the host of complexities that come with those products that just aren't found with small molecules, for example. That's definitely at play here.
Even if you gave the blueprints, the secret sauce, and the recipe of how to make these vaccines, you can't just export that to a third-world country and say knock yourselves out and make as much as you want. You need specialized equipment, you need specialized and trained personnel, and you need access to supply chains.
So that's mixed in with this dispute of whether this is really advancing the ball of getting more people around the world vaccinated or not is what is the follow-on effect of if we create this gold rush of newcomers to the vaccine space to rush out and hope to make this, they're scooping up crucial ingredients that are needed for the current manufacturers to make their vaccines.
Frankly, we're already seeing a bottle neck in vaccine manufacturing capacity, and so it could exacerbate that. So, there's a big debate over whether it's necessary to get most people vaccinated.
Alana Hippensteele:That's really interesting yeah and it does change the conversation around this discussion proposed to the WTO.
In regard to the IP protections issue, why do you think there has been a shift in thinking around IP protections for vaccines, specifically in the United States, and could this potentially have broader implications for something like this occurring again in the future with other vaccines?
David Silverstein: I think really what comes down to is politics. We are starting to get the virus under control here. Unfortunately, demand for the vaccine is dropping off, especially in the face of increasing manufacturing capacity of vaccine here. So, it's I think it's natural for our political leaders to start turning more and more of their attention towards what can we do in other parts of the world.
I mean the reality of these pandemics is you can't just get the pathogen under control in your country and ignore and bury your head in the sand. What will happen is it'll continue being transmitted from person to person in these other countries. With every transmission comes the chance of mutation, and with mutation comes the chance of new variants forming, and even vaccine resistant variants.
So, it's natural, I think, for the politicians to say, ‘Okay, now that we're sort of getting our feet under us here, let's do what we can to keep it from returning to our shores, let's snuff this out in other parts of the world.’ I think it's a sort of natural evolution of the political landscape. But this is an essentially unprecedented move that will definitely have implications for the manufacturing distribution of other vaccines in the future.