“[T]here are lots of reasons to believe that the ‘waiver’ is more good politics than anything else. Vaccinating the planet will still depend on exporting hundreds of millions, probably billions, of doses from the U.S., Europe and India, not on a loosening of any patent rights.” – Justin Hughes, LMU Loyola Law School
Bloomberg first reported today that U.S. Trade Representative Katherine Tai said that the United States will back a proposal by India and South Africa last year to waive intellectual property protections under the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement. The proposal calls for the suspension of international protections for patents, copyrights, industrial designs, trade secrets and proprietary materials, “in relation to the prevention, containment, or treatment of COVID-19 until widespread vaccination is in place globally and the majority of the world’s population has developed immunity.”
Tai reportedly said “We are for the waiver at the WTO, we are for what the proponents of the waiver are trying to accomplish, which is better access, more manufacturing capability, more shots in arms.”
The Bloomberg report added that the Biden administration will take an active role in the negotiations on the text of the waiver and “encourage other countries to back it.”
In the USTR’s formal statement issued later on Wednesday, Tai added:
This is a global health crisis, and the extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures. The Administration believes strongly in intellectual property protections, but in service of ending this pandemic, supports the waiver of those protections for COVID-19 vaccines. We will actively participate in text-based negotiations at the World Trade Organization (WTO) needed to make that happen. Those negotiations will take time given the consensus-based nature of the institution and the complexity of the issues involved.
The Administration’s aim is to get as many safe and effective vaccines to as many people as fast as possible. As our vaccine supply for the American people is secured, the Administration will continue to ramp up its efforts – working with the private sector and all possible partners – to expand vaccine manufacturing and distribution. It will also work to increase the raw materials needed to produce those vaccines.
IPWatchdog has published many perspectives on this issue. Most in the IP community feel the solution is shortsighted and will not produce the desired results. Earlier today, Eva Bishwal of Uttar Pradesh, India-based Fidus Law Chambers wrote that “the real blockades to vaccine access are state inaction, dearth of raw materials and low production capacity.
Hans Sauer, Deputy General Counsel and Vice President for Intellectual Property at the Biotechnology Innovation Organization (BIO), explained that the proposal presents many practical problems, including that:
Even if it were to pass out of the WTO, the waiver would still have to be implemented under the national laws of the WTO member countries. No explanation has been provided as to how up to 164 countries would be expected to quickly amend multiple statutes in their legal codes, or which form these amendments would take. Curiously, close to half of the waiver-supporting countries are already exempt from TRIPS anyway, and are effectively demanding to be free of rules that don’t apply to them.The most likely result of the proposed waiver would be a chaotic global patchwork of national laws that would linger at various stages of national implementation for years after the end of the pandemic.
Patrick Kilbride of the Global Intellectual Property Center at the U.S. Chamber of Commerce wrote:
Weakening intellectual property protections, as the WTO waiver proposal would do, will not increase access to the tools we need to fight COVID-19; in fact, they would hinder access to the COVID-19 tools we’ve discovered already, and it will stop the search for new tools right in its tracks. Put simply, weakening intellectual property protections won’t help us, and it will hurt us.
Others have taken a less dire view of the proposal. Rachel Thrasher of the Boston University Global Development Policy Center wrote in March that innovation would survive a TRIPS waiver:
In a world where the standard approaches are not doing enough, the TRIPS Waiver is a necessary first step toward facilitating increased, rapid production of vaccines. Rather than undermining the value of innovation or making it less likely in the future, the proposal demonstrates how, for many countries, the traditional balance between innovation and access has tipped toward prioritizing access for the time being.
But many in the IP community will undoubtedly be upset over the remarks. IPWatchdog founder and CEO Gene Quinn said the announcement “signals dark days ahead for the IP world under the Biden Administration”:
If it were not for innovators supported by intellectual property rights, we would never have been in a position to have the vaccine within a year. This is a head in the sand decision by those who care more about being politically correct than being right. Patent owning corporations were already doing everything they could and patent rights were not getting in the way of anyone getting the vaccine. Will this make it easier or quicker for anyone to be vaccinated? No! This is a mistake of epic proportions. Cutting out the innovators and manufacturers will not result in safe vaccines around the world; it is the equivalent of playing Russian roulette with the health of those in undeveloped countries.
Statements on both sides have come in throughout the evening. Here are a few:
Senators Thom Tillis (R-NC) and Tom Cotton (R-AR):
Today’s disastrous decision by President Biden will do little to end the COVID-19 pandemic and help developing nations, but it will hand over America’s medical technology to adversarial states like China and Russia. We support distributing vaccines to countries that need them, but not in a way that jeopardizes America’s successful vaccine development. It’s astonishing that President Biden is now providing the Chinese Communist Party with access to America’s intellectual property, medical research, and innovation.
Justin Hughes, LMU Loyola Law School:
This represents a major change in U.S. policy, one that shows the willingness of the Biden administration to engage with partners internationally to bring an end to the pandemic. But there are lots of reasons to believe that the ‘waiver’ is more good politics than anything else. Vaccinating the planet will still depend on exporting hundreds of millions, probably billions, of doses from the U.S., Europe and India, not on a loosening of any patent rights.
U.S. Chamber of Commerce Executive Vice President and Chief Policy Officer, Neil Bradley:
The administration has gotten this issue wrong; undermining intellectual property rights for complex, hard to manufacture vaccines will not accelerate global production, instead it will take us off track in the ongoing and successful efforts to license and scale global production of vaccines that individuals can be confident are safe and effective. Make no mistake, this move will undermine the global fight against COVID and it will diminish our ability to prepare for and respond to the next pandemic. We urge the administration to reverse course and work with the business community to deliver on the President’s recent promise to make America the ‘arsenal of vaccines.’
Sean Flynn, Director of American University’s Program on Information Justice and Intellectual Property:
Over a year into the COVID-19 pandemic, with a fraction of the world having received available vaccines, it’s time for the members of the WTO to quickly draft a WTO TRIPS waiver to remove all intellectual property barriers in order to stop the COVID-19 pandemic. Emergency measures opening up greater access to vaccines, treatments and research would benefit the entire world and bring us closer to the end of the pandemic…. The statement implicitly supports an intellectual property waiver beyond patents. By signaling support for a waiver of ‘intellectual property for COVID-19 vaccines,’ the statement would presumably extend, for example, to the copyright protection that can exist on the computational algorithms needed to produce mRNA vaccines.
Dr. Kevin P. Gallagher, Director of the Boston University Global Development Policy Center and Professor of Global Development Policy at Boston University:
President Biden took a bold and important step today by choosing multilateralism and humanity over special interest group pressure both inside and outside of his administration. This is a breakthrough that will help the world attack the virus on a global scale so we can collectively focus on building back a better global economy and the set of rules to govern it. The EU, UK, Brazil, Norway and Japan need to follow suit and put humanity first over special interests.
Re:Create Executive Director Joshua Lamel:
U.S. support for the WTO TRIPS waiver is a momentous step forward for balancing intellectual property with the needs of our society at this historic time. Re:Create is encouraged to see the Biden Administration support expanding access to COVID care around the world. This decision puts the lives of people above the interests of IP lobbyists.
But it’s important to remember that the WTO TRIPS Waiver should cover more than just vaccines – it should cover other important issues like access to research and medical equipment right-to-repair. We urge President Biden, U.S. Trade Representative Katherine Tai and other policymakers to clarify and expand their support to encompass a waiver for all IP barriers, including copyright, to prevent, contain and treat COVID-19.
ITIF Vice President of Global Innovation Policy, Stephen Ezell:
The Biden administration’s announcement that it will support a World Trade Organization Trade-related Aspects of Intellectual Property Rights (TRIPS) petition to waive intellectual property (IP) rights on COVID-19-related products and technology represents a shortsighted and misguided effort to meaningfully impact the continuing COVID-19 pandemic.
IP rights have been indispensable to the development of COVID-19 vaccines, therapeutics, and diagnostics to date; they have also further facilitated the 200+ voluntary licensing agreements that COVID-19 innovators have entered into with contract manufacturers worldwide to dramatically scale COVID-19 vaccines and therapeutics manufacturing. Endorsing this waiver petition succumbs to the fundamental fallacy that IP rights represent any kind of significant barrier to access and manufacturing of the medicines needed to overcome this crisis.
While the Biden administration is to be commended for its commitment to helping other nations amidst this crisis, as ITIF has written, there are far better ways to do so rather than abrogating IP rights; some of these include significantly increasing U.S. contributions to COVAX, exporting excess vaccine supply from its stockpile, identifying supply chain bottlenecks, and investing more domestically to dramatically scale up U.S. biopharmaceutical manufacturing capacity of these medicines.
This article was updated on May 5 at 9:20pm
Join the Discussion
24 comments so far.
AnonMay 7, 2021 03:30 pm
I am not following how you arrive at that conclusion. Can you explain?
Model 101May 7, 2021 01:41 pm
This is more crook stuff..
__tr__May 7, 2021 01:04 pm
Why does it feel like we are letting the interests of national tech companies influence a decision about global healthcare IP rights?
Josh MaloneMay 7, 2021 11:57 am
So multi-billion dollar drug companies will have effectively the same patent rights as independent inventors and startups in all other fields?
JacekMay 6, 2021 08:27 pm
And who is going to introduce legislation to suspend IP rights?
Interesting, what is going to be there in amendments?.
The whole idea comes from Big Tech teaching that Patents are BAD (for big tech) taking hold in the US.
Maybe this is an opportunity to show the truth about private property rights.
Is Biden going to take what is not his and give it to the “COMMUNITY”?
Congress has to approve.
AnonMay 6, 2021 02:18 pm
“What is stopping vaccines from being manufactured elsewhere is probably trade secrets, and the proposals of which I’m aware don’t appear to require tech transfer”
Maybe you should look again. The proposals on the table (notwithstanding any binding items yet to have their details ironed out) ALL include IP well beyond ‘just patents’ and include tech transfer and know how (including Trade Secrets).
As I have also noted previously, EVEN IF there was only (at first) a move by the US (and others) to say, “Well, OK, we wave patents,” the truth of the matter is that such would merely be the Camel’s Nose under the tent, and the next inevitable ploy would be a World Public Opinion ploy of “they held the good stuff back, and we NEED that other stuff to actually fight this deadly world-wide pandemic, so GIVE IT TO US NOW.”
Pro SayMay 6, 2021 11:42 am
The cry from some for the vaccine innovators to give up their IP rights is a Trojan Horse.
As others have pointed out, the great majority of countries simply don’t have the wherewithal to produce their own vaccines. And even if they did, the current innovators are the ones who will have produced all the vaccine supply needed — months and years quicker.
The real reason for the waiver cry is this:
To open the door and smooth the path to future innovation grabs.
The Trojan Horse.
TFCFMMay 6, 2021 10:31 am
I’ll bet ten-to-one that this merely more empty posturing by the Biden administration, trying to appear to do the “politically correct” thing while actually doing nothing at all.
It will take weeks or months for the WTO to hammer out some sort of consensus waiver — IF it ever does so (with many non-US governments keeping their wits about them regarding the sensibility of maintaining IP protection).
Even if that happens, nations wanting to implement the waiver will take additional time to change their laws, regulations, and procedures to effect that implementation, and further weeks or months to actually implement it in practice.
Even if secret info is “liberated” in this way, it will take additional weeks and months for recipients of the info to sort through and make sense of the formerly-protected information, and ONLY THEN can they try to apply the information to the still-at-least-months-long process of developing a vaccine/therapeutic (assuming the info can be applied in this way at all).
I’d characterize this virtue-signaling-exercise as an imaginary nothingburger, wrapped in the holier-than-thou wrapper so favored by American political liberals, that has no possible fate other than to die on the vine.
In short, with apologies to Billy S, “…a tale told by an idiot, full of sound and fury, signifying nothing.“
AnonMay 6, 2021 10:22 am
“Is this a clue as to what the waiver requester’s really want – access to technology without fair compensation?”
American CowboyMay 6, 2021 10:16 am
If somebody has to give up their property rights, why not make it the manufacturers who would use the Covid vaccine inventions without the patentee’s approval? Make them turn over their factories to the patent holders, who know what they are doing.
CuriousMay 6, 2021 10:16 am
by the time all the particulars are sorted out the pandemic will be so long in the rear view mirror this action will do nothing other than be a patent grab
This is likely accurate. However, an important point is that there are no “patents” to grab. I have followed this issue for some time, and I have yet to see identified any particular patent/family of patents/whatever that are stopping COVID vaccines from being manufactured elsewhere.
What is stopping vaccines from being manufactured elsewhere is probably trade secrets, and the proposals of which I’m aware don’t appear to require tech transfer. Regardless, as you stated, the pandemic will be in the rear view mirror by the time anything substantive happens.
In my eyes, this is more about improving public relations between countries than it is about seriously impacting IP rights. If that changes, I reserve the right to change my mind about these action. However, in the absence of such changes, this is a big, fat, nothing-burger in my book.
Anon-QMay 6, 2021 10:08 am
Does this mean that the free COVID-based prioritized examination I got (and patent issued) was a government conspiracy to steal my client’s invention? Let’s hear it for QAnon and StopFakes.gov.
“Independent inventors and small businesses are often the difference makers when it comes to cutting-edge innovation and the growth of our economy,” said Andrei Iancu, Under Secretary of Commerce for Intellectual Property and Director of the USPTO. “They are also in most need of assistance as we fight this pandemic. Accelerating examination of COVID-19-related patent applications, without additional fees, will permit such innovators to bring important and possibly life-saving treatments to market more quickly.”
JLMay 6, 2021 09:34 am
Is there are real constraint on what patents can be stolen now? Will telecommunications technology, self-driving vehicles, and advanced database systems all be viewed as essential for enhanced distribution of vaccines? Will advanced metallurgy that might be useful in needle manufacture also be excused from patent protection?
XtianMay 6, 2021 08:26 am
Does anyone know the extent to which AI algorithms pay a role in mRNA sequence production. Mr. Flynn’s comments on copyrights piqued my interest. He wanted copyright protection waived for computational algorithms. If this is done, how does one limit the use of these algorithms just for COVID? Why would you need the algorithm anyway if the COVID vaccine is already deduced? Is this a clue as to what the waiver requester’s really want – access to technology without fair compensation?
xtianMay 6, 2021 08:22 am
@Noel “Otherwise, the fastest path under the current draft WTO waiver to get increased, safe vaccines that will be acceptable to the public still seems to involve a negotiated license from the innovator to get the tech transfer.”
Actually the fastest path is to continue to have Pfizer ramp up production and export made vaccine to those countries. If the countries cannot pay, they can trade natural resources!
Markus MobiusMay 6, 2021 12:10 am
This is a terrible decision by the administration. It will make generics manufacturers rich and take rewards away from the companies that created these technologies in the first place. It would be much more effective to license these vaccines close to cost to countries that need them – and vaccine manufacturers have been doing exactly that. There is no need destroy the phaemaceutical patent system. Unlike software inventions (which are relatively cheap to create) inventions in pharmaceutical products is hugely expensive and only worth while with patents. Pharmaceuticals are the poster child for successful IP protection and I find it shocking that this golden goose is now at risk.
NeweraMay 5, 2021 10:29 pm
Tai: “We will support large Internet-based service monopolies against taxation by India and others because those monopolies are anti-patent but pro-patent pharma, we can’t support that, their position is contrary to our masters”.
NeweraMay 5, 2021 10:12 pm
Thank googleness she fought the digital services tariffs! And, at least Afeyan got recognition of Armenian genocide. Pure politics.
Noel CourageMay 5, 2021 10:03 pm
Anon @5. Thank you for the feedback. The US govt statement and the proposed WTO waiver text that I saw referred to a waiver of rights, with no requirement for an innovator company to do a tech transfer. So that practical reality of the WTO draft text is why my article repeatedly emphasizes that we should be trying to facilitate innovator licenses (including tech transfer), to capable manufacturers in order to get vaccines ramped up. If you have seen more than a waiver being on the table (as opposed to merely people wanting mandatory tech transfer to be on the table), pls post that info. Otherwise, the fastest path under the current draft WTO waiver to get increased, safe vaccines that will be acceptable to the public still seems to involve a negotiated license from the innovator to get the tech transfer. We are both in favour of ramping up vaccination ASAP, and it remains a complex logistical issue how to do it best, even if the waiver passes. The debate on both sides should be more constructive, less polarized.
AnonMay 5, 2021 09:02 pm
With all due respect, Mr. Courage, it has never been about waiving of ONLY patents, and a clip from your third article has a subtle clue (emphasis added): “As noted in prior parts of this article, licensing and technology transfer from innovator companies is faster and safer than overriding patents and waiting on “home brew” solutions to arrive.”
As I have duly noted, “patents” was never going to get the world (and certain countries in particular) to their desired point: the transfer of the NON-patent know how.
I have even pointed out just why even “just” a Camel’s Nose under the tent was not the end game – even as my early posts attempted to reveal that the nature and scope of the problem was going to bull doze those would voice a “just patents” point of view.
I do grant that your addition to the discussion – with the carefully thought out three prongs of your articles articulating a reasoned approach IS a valuable add to the “reasoning” column of the ledger, but to the extent that it would deny the existence of emotional drivers, it is flawed as a realistic view of unfolding events.
AnonMay 5, 2021 08:46 pm
Gene — have you read my comments? Does it appear as if I am saying that this is a “good thing?”
My comments speak more to the world wide social dynamics unfolding in front of us.
“Good” — especially in view of strong protection of innovation is just not the dynamic that I have been addressing — and is exactly why I quipped that the article appears to have been in a hurry, as it misses the substance of my comments across several threads here and in the patent blogosphere.
Noel CourageMay 5, 2021 06:30 pm
My Canadian patent attorney viewpoint on how to get vaccine supply up:
Gene QuinnMay 5, 2021 06:18 pm
My comments are not in haste, and anyone who thinks this is a good thing is simply blinded by political correctness. As Hans points out, by the time all the particulars are sorted out the pandemic will be so long in the rear view mirror this action will do nothing other than be a patent grab. Furthermore, anyone who thinks cutting out the manufacturers and innovating pharma companies and allowing countries to simply make themselves has no sense of what it takes. The waiver is not going to force companies into compulsory service, it will allow unqualified manufacturers without the complete knowledge and information to attempt to make the vaccines. What could possibly go wrong?
AnonMay 5, 2021 06:09 pm
Sadly – this article appears to have been written in such haste as to miss the multiple points that I have been sharing on the topic.