How would a "waiver" work? Last I understood about law, a country can't take away the rights of companies (or people) without their consent or modifying the patent laws.
Or is this a matter where because it has to do with overseas patent protection, the US could decline to enforce certain agreements?
And don't companies have patent protection in every country they seek to do business anyway?
If you are knowledgeable on this, please could you write a short list of the total amount of patents the vaccine currently consists of, or link to a good source?
That’s not easy information to get. Startups pay a lot of money to do a “freedom to operate” study to see what patents are out there and who owns what. You can pay companies for high level info, but it’s not easy at all.
> There are plenty of other parents needed to make the actual vaccine
So asking for the other patents involved is a reasonable question, especially since your assertion presumably involves knowing - at least vaguely - what said patents might be.
This is good summary of the intellectual property situation for mRNA vaccine. The link was posted 2 weeks ago on the Twitter stream of Katalin Kariko, pioneer of mRNA vaccine technology and VP at BioNTech.
The NIH has claims on the 2P mutation in the spike that appears to make it better. Cellscript holds the N1mPsi patent (may not be essential, watch for CureVac p3 read out soon). The ionizable lipids currently have composition of matter coverage for a few companies, which is probably the crux of the discussion. Everything else is confidential know-how, which is already scaling as fast. I'm not sure exactly what this gets anyone...
Doesn't really matter, waiver or not. It's not like most industries or people can go about making this vaccines themselves. That's why I sometimes laugh about these folks that what to invalidate patents and have everything in the open. If Toyota posted schematics of their trucks online, do you think, you and I could build one without throwing resources, time, and money down a toilet? I would have better luck growing my own lettuce and raising my own cows to beat McDonald's at the hamburger game.
They rightly fear that in 2-3 years, when the pandemic is likely over everywhere and other people have figured out how to commercialize the IP, they won't be the only ones producing their vaccines.
This isn't going to help India or anyone in the short term and there'll be more than enough doses for every person on Earth by next year. Why should they not retain the IP rights to make a profit on new generations that need to be vaccinated or potential booster shots? The manufacturing capacity will have been built up so scarcity won't be a problem at that point.
Is it reasonable to believe that the knowledge that the USA doesn't intend to support the pursuit of damages for patent violation would have an impact on manufacturers now.
If you held a firm conviction that in the near future you'd be able to act on the IP without being in violation, would you be more motivate to progress toward doing so more swiftly?
As a patent holder, would you feel more secure that you could issue cease and desist notices and peruse damages after the waiver is lifted?
Simple, the Indian vaccine factories already have licenses to produce these vaccines but are struggling to scale up production: https://www.bbc.co.uk/news/world-asia-india-55571793 (in part because they can't get some of the supplies needed, which maybe could be helped if the patents for those are also waived and other factories can help to make those...)
This is about mRNA vaccines, but similar things exist for viral vector vaccines as well. Technology transfer, bioreactor bags, fill-finish capacity, all of these things are bottlenecked till next year basically.
India is manufacturing AstraZeneca and other vaccines for export. Prior pandemic India manufactured 2.3 billion vaccines annually. Patent fees are big part of expenses.
RNA based experiments are doable in most university labs. It is 2021.
I know enough financially broke startups to confirm that a working prototype is only a small part of a successful business.
The approach to intellectual property in China is much more open, partly because the leaders understand that technical expertise is more than just a one-off design, and competitors probably can't enter the market without significant capital investment and risk. In the case of healthcare, I suspect that regulators will prevent any vaccines manufactured with sub-standard procedures, such as those made in university labs.
It feels like the people saying that have a stake in the existing vaccine manufacturers.
There is a pharmaceutical industry in India that is not being given the opportunity to get in this fight and some people say they could help and others say they can’t.
> It feels like the people saying that have a stake in the existing vaccine manufacturers.
Yes, the most likely reason why someone would have a different opinion is because they're somehow invested - emotionally, financially, whatever - in the existing vaccine manufacturers.
How much do you think this factory would charge for a vaccine? How much would it cost to standup a factory and if it was simple, why hasn't it been stood up already?
> a country can't take away the rights of companies (or people) without their consent or modifying the patent laws.
That's not a problem, modifying laws is the default way how countries do things - if a country says "we'll do X" they most likely mean "we'll modify our laws so that X will happen".
But IIRC the patent laws of many countries already contain specific clauses for a simplified process to void patents for lifesaving reasons if they want to do it.
And it's worth noting that patents aren't a right, it's a privilege selectively granted by the government because the government expects that the process as a whole benefits the general society (by facilitating innovation and publishing of technical innovations instead of hiding them), not because the patent owners have a right to require it. The government does not have to offer patent protection; it chooses to grant a temporary monopoly for a limited time if certain conditions are met, and it can (essentially arbitrarily) decide what those conditions are.
A country can take away whatever rights it wants to within its borders. That's the whole point of sovereignty.
Patent laws are also not some natural, inalienable right. They are artificial constructs, provided as a courtesy, because the government feels that in the general case, they are more beneficial than harmful.
In a particular case, they might be more harmful than beneficial.
What do you make of the move corporations are making away from the use of patents, towards the use of a hybrid ‘trade secret + patent‘ sandwich? Is there a scenario where it does not stifle innovation?
I’m asking because I personally don’t see any. As you said these systems are artificial constructs, and at the worst this taking away as trade secrets is theft on an enormous scale.
The internet allows mass collaboration, and I believe we are still in the very early stages of developing this infrastructure.
> What do you make of the move corporations are making away from the use of patents, towards the use of a hybrid ‘trade secret + patent‘ sandwich? Is there a scenario where it does not stifle innovation?
I take that it's not happening to the extent claimed, and that those claims are largely self-serving propaganda used as justification for a legal land-grab.
Of course patent owners are going to argue that their patents should be valid for fifty thousand years, with the figleaf that it protects 'innovation'. What else would they say? That they'd like IP law tilted in their favour because it would make them more money?
> I take that it's not happening to the extent claimed, and that those claims are largely self-serving propaganda used as justification for a legal land-grab.
Patents are monopolies give by States. In fact in the past, in countries like France, patents were sold to the highest bidder, like the patent for manufacturing straw baskets or ceramic containers.
Basically, if you did not pay the King,or someone else paid the King more, the State will destroy your business.
The modern idea of patents comes from that, adding the requirement to document an innovation instead of just paying money to the King.
The State can do end the monopoly at any given time. They have done lots of times in the past, specially in wars.
Patents are a distraction tactic, including this move by the US. The real power that corporations exert today comes from trade secrets (laws/system):
> Hiding inventions as trade secrets acts to protect these huge multinational corporations [...] This is the reason that huge multinationals lobby so hard for strong trade secret laws and weak patent laws. This is clearly shown in Musk’s low valuation of his patents and high valuation of trade secrets.
> Trade secret protection for inventions that could otherwise be patented is bad public policy because it stifles the progress of innovation [as the knowledge does not end up in the public domain as happens when patent claims expire] and it consolidates money, markets and power into a few huge corporations [...]
The author in this article goes into more detail on the pattern (and history) of human discovery and scientific breakthroughs by using some great examples like the development of the sewing machine, as well as Musk’s purchase of the trade secrets of Maxwell Technologies.
Waiver is a euphemism that implies the states discussing this own the patents. It would more accurately be described as a confiscation. It also seems like the best way to ensure the next pandemic doesn’t get a vaccine.
I believe that yes, the angle on this is overseas patent protection, as moderated by the WTO.
This "waiver" seems like it would essentially be the WTO member states unanimously agreeing that they won't be using any of the usual tools / threats of sanctions they could normally bring to bear as a collective to squash violations of IP for these patents.
The US cannot act unilaterally in this regard - the WTO members would all have to agree to it for it to work effectively - but the US staking out its position may help to drive a consensus position.
I feel like this is killing the goose that laid the golden egg. The Covid vaccines are one of the greatest success stories of modern medicine ever, and are literally worth trillions.
I want the companies and investors in the pharmaceuticals that have made these to become fabulously wealthy as an incentive for companies to invest in the capabilities to produce these.
I want creating a successful vaccine to be a bigger deal economically than creating a worldwide social network.
Who is doing a better job of increasing human well-being, Facebook or Moderna?
The stock of these companies dropped on this announcement. Long term this kind of patent waiver will drive investment and at some level smart people from these companies.
I absolutely agree. What confuses me is that removing patent protection strikes me as the strongest weapon in the arsenal. Before doing that, wouldn't it be possible to enforce sublicensing or other such contracts that would allow third party manufacturers to produce the vaccine whilst still ensuring revenue for its patent holders?
> I feel like this is killing the goose that laid the golden egg. The Covid vaccines are one of the greatest success stories of modern medicine ever, and are literally worth trillions.
And it took a global pandemic for pharma to realize it so maybe they aren't totally up to the task. And it seems the consensus is that states provided much needed money to turn mrna vaccines into a real thing.
no, it is that state money make faster. try many alternative at once with promise of some payment even in failure, run trial in parallel, these thing. same result would have reached, just taking more time. or maybe they would find private investing, we are not knowing.
Moderna themselves have pledged (temporarily) not to enforce their COVID-19 patents anyways, so I’m not sure who you’re defending.
If McDonalds gave out their hamburger recipe today, I don’t think they’d be on the brink of bankruptcy tomorrow.
I would imagine stopping a global pandemic is in the best interest of everyone, including the creators of any vaccine. They’ve made a killing so far and will continue to make plenty of money, patents or not.
> I feel like this is killing the goose that laid the golden egg.
That is quite hyperbolic, because at worst it will reduce profits, but hardly "kill" them.
> I want the companies and investors in the pharmaceuticals that have made these to become fabulously wealthy as an incentive for companies to invest in the capabilities to produce these.
The incentive to invest is the chance of future profits. Those still exists, as the technology has a lot of use-cases beyond covid-19 vaccines. The vaccine is just the show-case of that.
> The stock of these companies dropped on this announcement.
Short-term developments are hardly a good indicator for future development.
> Long term this kind of patent waiver will drive investment and at some level smart people from these companies.
You really think, losing the ability to profit more from a, hopefully, once in a century event will determine, if someone invests in something in the future? And by that not being able to profit from the technology in all the other areas they can improve?
> Having the rules change in the middle of the game won’t affect investments?
The rules of the game change all the time. Every business plan has to take into consideration the risks/benefits of possible regulatory changes. And yes, changes will affect investment. But the hypothesis is, it will drive investment away to the extent that it will "kill the goose...". I would phrase it less hyperbolic as "in a significant way".
To reiterate: We are talking here (up to now) a about once in a life-time event. And that is both the Covid crisis, as well as being able to profit from.
> I mean, what if the next company comes up with a cure for AIDS. Are they confident the IP won’t be broken either?
So the classical slippery slope argument. The whole point why governments are bringing the option on the table is, because it is an exceptional event. So, it doesn't translate to AIDS/HIV.
Will people believe that? That's anyones guess. Do you believe anyone will forgo possible profits from the whole range of possibilities of treatments based on mRNA because of that precedent? I seriously doubt that.
I do not see those risks, but then I also do not see much the benefit either. It isn't like just the patents are the limiting factor, and you could ramp up a production of those vaccines from one day to the other.
There were plenty of agreements/contracts drawn up with nation states that meant they had definite buyers and a definite income from those contracts. Their R&D costs were assured of a return due to the install base. They are already being rewarded financially, they weren't making and distributing these out of the goodness of their hearts.
So they dont need to become fabulously wealthy, they just need to turn a decent profit. Which they are doing. And right now I would suggest that AstraZeneca, Pfizer and Moderna are 3 of the most well known pharma companies, because they were first to market with working vaccines, there are plenty of pharma companies that tried, failed and thus you dont even know their names. So those successful firms are already being rewarded. No need to call for outsized returns for these companies.
My initial, knee-jerk view was that the government is stealing private property. Bad, bad government screwing with the free market!
But here we are talking about Intellectual Property and patents. Which themselves are a government-granted monopoly...
Truth is patents are mostly used to stifle innovation while their original purpose was to encourage it. A company inventing something novel will have a pretty nice advantage over the competition even without the government's help. That's not even taking into consideration that besides patents there are other tons of difficulties when copying a product. Manufacturing alone is pretty huge. Then marketing: the original vs the cheap knock-offs.
When in doubt, I think it's better to err on the side of the free market and of non-intervention. But, to come full circle, in this case the government encouraged companies to publish their research with the promise to protect it. So my only conclusion is, again, to never trust the government.
How does the knowledge that the USA alone put up $9 billion distributed to seven companies to aid development of the vaccines effect your position, and that the waiver is intended to be only temporary?
Depends. Did they put that money through market-approved means, like investments or advance payments for future contracts? Then it's fine. Not different than say Apple helping out one of its suppliers.
Did they use some of their other, shady, pork-like ways? Then things are even more murky and muddled and anything is allowed I guess.
Lets not forget that the actual market for these vaccines was not free but completely FUBAR: I could not buy one anywhere and at any price.
Pandemic has shown that mRNA vaccination manufacturing is a question of national security. I do not think those patents will be enforceable, if another pandemic starts, and countries decide to make their own vaccines. And countries like India, China, Thailand or Russia have pretty advanced biotech manufacturing and research.
Currently vaccine companies such as the German Curevac (which is the vaccine company Trump famously tried to buy) is being held back by lack of core ingredients which are under American export bans.
The US still upholds the export bans setup by the Trump administration. Biden can just revoke those. Yet he promotes the idea of waivering vaccine patents knowing well how hard that would be to do in practice.
And exactly how is it supposed to work? Will Pfizer no longer have to pay license fees to BioNTech?
I believe this is exactly the reason why the US promotes it and Germany opposes it. It's mainly a discussion about whether Pfizer (US) has to pay licensing fees to Biontech (DE).
Yes, it seems pointless if there’s no generics being made, but I would be very concerned about assuming a generic of a vaccine is the same. We already have enough vaccine hesitancy, adding in extra variables doesn’t seem great.
Is there anywhere I can read more about this? In the grand scheme of American healthcare costs I don’t think the ~$20 Pfizer/BioNTech vaccine is where we should suddenly try to cut costs by stiffing the scientists who did all the hard work over a decade to make it happen. I’m assuming the current $20 price tag already includes BioNTech’s fees?
Yeah, and if Trump was still in power I have zero doubt the media would call him out on what a cynical stunt this is - but Biden is in charge now, and that makes a huge difference to how they report on everything.
Well, Trumps actions would have been self-serving and cynical (as they all were). Biden hasn't shown those 'qualities'. Which is why I (and the WHO) give him the benefit of the doubt in this case.
But somehow some random "throwaway" account on a forum has more info than all of Biden's advisers? "Benefit of the doubt" is just a cover. We must assume competence and intent on the administration's part and hold them accountable for it (or give them credit), otherwise we're letting our bias/favoritism show through.
Let's be fair. We all gave Trump the benefit of the doubt. It was only after years of broken promises, and angry outbursts that some people turned against him by default.
Give Biden at least 1 year, and you'll see that some people are reflexively critical of him too.
Centrist voters may have given him some benefit of the doubt, but the news media never did and were never going to.
Conservatives knew that ahead of time, which is why they voted for someone prone to angry outbursts.
Biden isn't exactly an outsider, and is just the face for scores of actual decision-makers in his administration; I don't think one more year is going to surprise anybody.
Let me remind you, in case you forgot, that the Muslim ban EO happened 7 days into Trump's tenure (as well as shithole countries remark). That's about all the "chance" I was prepared to give.
If that's how you lead foreign policy 7 days in, you don't deserve to be president. Full stop.
By "Muslim ban" you mean the travel restrictions of on citizens of the seven countries that Barak Obama also had restrictions on? It wasn't a muslim ban as nowhere in the language or practice did it ban muslims form entering the US. It restricted entry from people from seven countries that were listed by the Obama administration as having high rates of terrorist links. Hillary Clinton would likely have taken the same step if she had become president.
It must sting that the (arguably) only successful thing to come out of this America First policy is now being credited to the Biden administration.
For all the mess Biden has inherited, he also inherited a near perfect vaccine production program. The reversals issued in the first 100 days did not reverse any export bans or regulations the Trump admin put in place for the vaccine production and rollout.
The vaccines first got approval in December 2020, it wasn't failing it was just starting up. European vaccine rollout also had starting aches but was then very quickly limited by the supply-side.
> The vaccine program was failing to rollout when Biden inherited it.
Regardless of what you think of Joe Biden or Donald Trump, this statement is categorically false.
There are enough legitimate things to criticize Donald Trump for that we don't need to make things up. As others have pointed out, the vaccine program was just starting up at the end of the Trump administration. Besides, much of the actual logistics were, and are, handled at the state level.
To revert self-serving orders, require extraordinary political clout above and beyond. Can that be done regarding every "bad" decision? A competent administration must not undo the "good" decisions as well.
I think it's ridiculous to say "they, the media" here when media in the US is so often blatantly partisan. I don't believe it's difficult to find media that calls out Biden.
Please stop with this false narrative. American conservatives have giant and pervasive media organizations that cover Biden negatively 24/7. You're selectively choosing which "media" to criticize.
Fox news is the only "giant" media corporation promoting the conservative side and there are several individuals there that praise Biden. Everything else is left to far left, including our education system and the largest corporations in this country.
So, take your own advice and stop promoting this false narrative that there's negative Biden coverage anywhere near the amount that Trump had. It's absolutely obvious that's not true.
Let us not forget the climate that Trump created for himself. Much of that constant negative coverage was more about his antics and absurdities, and at some point, it became impossible for him to do/say much of anything without completely deserved backlash.
With that said, I can’t claim there is no media bias re: Biden, but we should not pretend that the circumstances are even close to similar.
That only happened because conservatives gave up trying to please a hostile audience. Reagan was Satan incarnate, until 20 years later, when he was a voice of reason compared to Dubya. Rinse and repeat.
Nobody cares about your conservative victomhood complex. If your leaders aren't mature enough to do their job without throwing a temper tantrum whenever someone says something mean about them, then sit the fuck down and let the adults handle it.
Yes but the media was biased before Trump, it just became glaringly obvious during his administration because they were profiting off of his antics. Their viewership has plummeted post Trump and you can see them grasping at anything to sensationalize and garner more views.
This reminds of the old quip about the founding of Fox News. Roger Ailes and Rupert Murdoch claimed they had found an untapped niche market in American broadcasting, "Half the country".
I never see your conservative media in any of my feeds unless I specifically go out and look for it. To us Europeans it looks like you Americans blindly approve of everything Biden does because that is the news you choose to show us.
I don't think it is healthy that you need to go to the other sides newspapers in order to get a proper evaluation of what Biden does, why should I have to dig through fox news to understand the narrative?
Opening up the IP is a 'win' for almost everyone but the companies making vaccines, so there's not much downside.
Exporting individual vaccines might break contracts, and because it's a little bit zero-sum, the public at large may hold him in contempt for not putting 'America first'.
Biden would 100% be against it if it was an American company that held the patents. He'd say that we shouldn't throw the company that worked so hard to provide us with a vaccine under the buss just to save money.
Removing the patent doesn't save more people, just as many vaccines would get produced, it just shifts money from the company to the state that pays for the vaccine.
I share your cynicism, but it actually will change the vaccine equation.
Money and risk is a very material part of the equation, now that the dynamics have changed, a lot more speculative money will be available. Supply and Demand works on cash just as it does for other things.
Also I don't think it has a populist aspect.
Exporting 'already made vaccines' does have a populist risk - a lot of Americans may 'get really mad!' if the US is seen to be exporting vaccines to other places before the US is fully vaccinated, irrespective of whether their chagrin is misplaced or not, the news cycle populism may have a field day with that. And there's the contractual stuff which he cannot 'waive'.
USA has the means to produce a lot of it, Europe had the means to develop it. Doesn't make sense that USA gets to enjoy all the benefits of producing without giving Europe any credit for developing it. Why should EU share its research with USA in the future if USA doesn't want to reciprocate?
So first, Supply and Demand is not just about 'means', it's about process, risk etc.. Removing a major barrier increases potential.
Second, it's a lot to do with the 'rest of the world' not really the US.
Third, AZ was UK not Europe, J&J was Neterhlands but owned by an American firm, Pfizer/BioNTech was both, Moderna was USA. So I don't see how this is a 'Europe victim' scenario.
The US put an export ban on basically everything regarding vaccines, very early on. If you look at the amount of vaccines produced, the US and EU are fairly close to each other.
The difference in Vaccine rollout comes from the fact that the EU exports vaccines to other countries while the US does not.
As a European I would've been in favour of more export controls, but a total ban seems to go too far. Why should 18 years olds in the EU/US receive a vaccine before 75 year olds in other countries?
Then again, the EU exported to countries that are now further ahead than the EU itself, which seems the other extreme end.
> Why should 18 years olds in the EU/US receive a vaccine before 75 year olds in other countries?
I don’t know what the EU governments kicked in, but the US basically threw tens of billions of dollars at the US pharma giants to bankroll the wide-scale rollout of not one but three vaccines. The patents are largely European, but the rapid scale-up of production was only possible because of US contributions (true on both sides of the ocean as the US paid to build factories in Europe too in exchange for priority access).
But on a larger scale, individual outcomes are somewhat meaningless in the scope of government. Each country’s government has a duty to protect the public health of its citizens, which means trying to get to herd immunity within its own population. It’s like putting on your own mask before helping someone else.
The EU approached the vaccine production with hopeless naivete while the UK and US approached it like they were at war.
Biden speaks in a nicer manner but he is still doing the policies of Trump's America First.
IMHO we in Europe should return the favour and start working with the Chinese on vaccine production. They are the only ones with an industrial capacity comparable to the US.
The US and UK approach it as if they are at war with everyone else. It is very sad to see where their priorities really are when this is a global issue not separated by borders.
The resulting chip shortage and the state which India is in will also affect the US and UK even if they don't think it will.
The West has a deep obligation to end the pandemic globally, but it also has every right to end the pandemic at home first. Israel, the US, and the UK are acting like they're at war against the pandemic, and finally, they're winning.
But other countries have acted as though there was an infectious disease outbreak, haven't had the deaths and don't need to "win" because they didn't "loose" in the first place.
Yes, China was very successful at containing the outbreak by welding the ill into their apartment buildings. Australia and New Zealand had the benefit of their rather extreme isolation from the rest of the world. India looked like it was doing great til it wasn't.
> Why should 18 years olds in the EU/US receive a vaccine before 75 year olds in other countries?
Because a nation state has a duty to protect the safety of its own citizens first and foremost. If a government continuously puts the needs of other countries over the needs of its own citizens, who is going to support a system like that long-term? Perhaps a handful of upper-middle-class idealists, but not most people. Right or wrong, that's just not human nature.
> Because a nation state has a duty to protect the safety of its own citizens first and foremost.
I strongly agree, but that does not mean it has to be completely amoral in its interactions with other nations. Its own citizens may in fact be in favor of taking on some risk to help people beyond their borders.
There is also a pragmatic side to this. A nation that acts too selfishly may soon find itself without allies.
Perhaps I didn't put enough nuance in my response, you're absolutely right. A nation state should put it's citizens first, but that should not preclude helping others.
> As a European I would've been in favour of more export controls, but a total ban seems to go too far. Why should 18 years olds in the EU/US receive a vaccine before 75 year olds in other countries?
I don’t know if my intuition is correct, but reigning in COVID’s R₀ worldwide at once seems like a moonshot in current state of civilization (keeping in mind its mutations and all).
Meanwhile, for better or for worse, the planet isn’t a single community: given border controls that can serve as a barrier to virus spread, it might just be more realistic to get things under control in smaller disconnected populations, which can then “bubble up”, restore quality of life and allow freedom of movement between themselves while at the same time helping bring other parts of the world back up to speed.
And yes, this does smell of the trolley problem and I wouldn’t want to be the person who would have to make such a decision.
>Currently vaccine companies such as the German Curevac (which is the vaccine company Trump famously tried to buy) is being held back by lack of core ingredients which are under American export bans.
I had the exact same question. What I could find was
this Reuters article [0] which lists nucleotides and special plastic containers as two of the items in short supply.
Indian pharmacies already disregard medication patents without anybody's permission.
Vaccine manufacturing is just a way more involved process than anything what an average organic synthesis shop can handle. Dealing with antibodies, proteins, plasmids, or RNA requires real factories rather than garage labs.
What one need is a complete process transfer: instructions on setting up every process, along with supplies needed, and operation training, and supervision.
I would love it if somebody would post a more detailed explanation of the mRNA vaccine manufacturing process here on HN. The news media keeps mumbling vague terms like "ingredients", and it's frustrating.
Conventional vaccine production is a highly biological process... chicken eggs being used to make the flu vaccines and so forth. I was under the impression that the mRNA vaccines are chemically much simpler -- just strands of a particular RNA sequence (swapping Pseudouridine for Uracil), encapsulated in a very clever lipid coat.
Presumably the biotech industry is really really good at manufacturing strands of RNA by now, right? I mean that seems like it's something they would've been doing every day for the last 20 years.
So are the only novel manfuacturing steps the Pseudouridine substitution and the lipid coat?
It's still a biological molecule, with all resulting side effects: i.e., it wanting to fall apart under every imaginable influence when isolated, and concentrated outside of a living cell.
I would want to know how they do it (mRNA isolation) too, but nobody will share that knowledge for free.
Even most simple methods like inactivation require a cell culture tech, which means lots of expensive bioreactors, and extreme levels of sterility.
As I understand it, the big problem isn't so much chemical as physical - they need to encapsulate the mRNA evenly within lipid particles of a reasonably uniform size, and there's some pretty advanced microfluidic technology involved in doing this. Conventional vaccine production has the advantage that biology takes care of all that pesky encapsulation business.
They brew them. A DNA sequence that encodes the intended mRNA strand is embedded into a bacterial plasmid. Bacteria take in that plasmid and reproduce, making a bunch of plasmids with the mRNA encoding DNA embedded in them. The bacteria are killed and broken open and the plasmids are purified.
The DNA sequence is then cut out of the plasmids and transcribed into mRNA.
That's the easy part (literally possible in a home laboratory: https://youtu.be/2hf9yN-oBV4), the encapsulant and microfluidics for getting the mRNA into it seems to be the hard part.
Wow, very surprised to hear that those mRNA come from actual living, metabolizing, (albeit single-cell) organisms.
Why do they do it that way?
When you order DNA plasmids from places like Addgene the stuff they ship you is chemically synthesized using enzymes rather than and entire complete living cell, right? I would've thought Pfizer would do the same thing and then transcribe that DNA into mRNA.
Is it because of the massive quantities of material they need to produce?
Okay, this is the best article of them all, the one I was wishing for. Congratulations, you win ten thousand Internets!
Best part (although the whole thing is totally worth reading):
As Neubert says, “Welcome to the bottleneck!” Turning a mixture of mRNA and a set of lipids into a well-defined mix of solid nanoparticles with consistent mRNA encapsulation, well, that’s the hard part. ... Everyone is almost certainly having to use some sort of specially-built microfluidics device ... These will be special-purpose bespoke machines, and if you ask other drug companies if they have one sitting around, the answer will be “Of course not”. This is not anything close to a traditional drug manufacturing process. And this is the single biggest reason why you cannot simply call up those “dozens” of other companies and ask them to shift their existing production over to making the mRNA vaccines.
Wow, this is a much better article than the one from the NYTimes. Thank you. Especially for this gem:
Supplies of raw materials such as nucleotides are also tight. According to Dr Zarur, Thermo Fisher, an American chemical-supplies company, has spent $200m on a new facility in Lithuania to make these molecules, though the firm itself would not confirm this.
I would not have expected this, but it definitely explains a whole lot of otherwise-cryptic claims being made in the WTO debate. I guess it does sort of make sense. The worldwide demand for pure bulk nucleotides probably shot up hundreds or thousands-fold as a result of COVID-19 vax manufacturing.
The graphics are cute, but the article left me with way more questions than answers. It spent most of its time trying to impress the reader with how much interstate shipping was involved in the process (who cares?).
No details on which ingredients are the ones causing so much consternation at the WTO right now, nor any answer to the obvious question "why aren't the DNA plasmids made the same way other commercial plasmid services make them"?
But hey, it's the NYTimes. They have to hold the attention of an audience that mostly has no science background.
Just saying generics of vaccines are allowed seems pointless, how will these others get the correct recipe? Seems like it could be potentially very problematic should these vaccines not work if much less problematic than COVID.
How does patent waiving work? It makes the patent invalid? Is it for a specific amount of time or do vaccines become CC0? What will happen when other countries start selling the vaccines (new covid vaccines will be the norm every year)? What about vaccine supplies ?
Considering that the inventors are Biontech, oxford/AZ and Moderna (who won't enforce their patent), it seems like an easy decision for the US to make.
This seems like a performative move that does nothing at best, and destroys the credibility of mRNA vaccines at worst.
The manufacture of these vaccines is not simple. It is not simply a matter of the US “waiving” a patent. However if other countries decide to participate in this performance, they may end up just manufacturing a vaccine which doesn’t work.
The virus is killing thousands per day. Do you really think a major country like India isn’t manufacturing the cure simply because of a patent?
China blatantly, openly, and proudly flaunts patents as a core part of their manufacturing economy. Why aren’t they manufacturing the mRNA vaccines, giving it away to countries that want it, and looking like the good guy here?
Because waiving the patent does nothing but generate positive press. It’s a fugazi.
If as you state, countries like India are going to ignore the patent anyway, doesn’t it make sense to give it to them and help ensure they produce it successfully to save the world from the pandemic?
Unless their is some mixing of terms here, a patent is already public data. India isn’t actually being given anything at all other than a suggestion that we might not support a lawsuit against them for making the vaccine.
Moderna already waved their rights last year [0]. But the production of such vaccines is not easy and I believe that an organization grows and learns as a whole as a solution so complex is developed. Consequently it is not easy to replicate what they do. I think at best this puts a cap on the vaccine's price since "in theory" given enough financial incentive the vaccine can be reproduced. That's my theory, feel free to prove me wrong.
Imho: If this becomes real, don't expect big benefits. I appreciate what Moderna did but forcing other companies to do the same may be overkill for little benefit and I wonder what the long term effect is on companies' willingness to focus on a vaccine for the next pandemic. Perhaps companies realize that waiving IP rights is good PR, or they can do it for parts of the process that is easier to scale or outsource to 3rd parties.
What happens to startups that do find an easy to copy vaccine production process and they know their IP will be taken from them? I honestly don't know but I feel that they should be fairly compensated... But what's fair. IP is just so difficult. I wonder what a world without it would look like. More company secrets, that's for sure.
All these interesting theoretical arguments while people are dying in droves... India was EXPORTING vaccine to the UK until not so very long ago. Maybe they don't have the capacity to produce the mRNA vaccines, but they most certainly have the capacity to produce viral vector vaccines such as AstraZeneca or Johnson & Johnson.
I strongly believe it is our moral duty to buy-out or invalidate the IP of (at the very least) these viral vector vaccines lest even more people die unnecessarily, while we are having interesting theoretical armchair arguments from the comfort of our increasingly vaccinated western societies.
I agree with you, this situation warrants a breaking of all our rules. And I hope that something good will come of it, other that then increased number of produced vaccines.
I know it's theoretical, I'm just saying, perhaps it will not be all good. But we'll deal with that when we get to it. Maybe viral vaccines should be an organized governmental effort from now on. Coordinated by WHO or something.
But how will waiving the IP help India to produce more? They already have all the licenses they need. It is a resource constraint, not a license/IP issue.
If US/UK would finally allow vaccine exports like the EU does, _that_ would help India.
I’m not sure I understand why we aren’t? In my area it seems there are now plenty of vaccine doses to go around now. Anyone can walk in to one of the various vaccine clinics set up by the county and get it. No appointment, no ID, no insurance needed. When I went they were practically begging me to spread the word to friends and family.
I think you've hit it exactly. There's no reason to think that resolving IP concerns will speed up production and deployment in India. Problems there have more to do with the state of their logistical and healthcare infrastructure than the (very impressive) vaccine production capabilities of the Serum Institute of India.
It's also maybe a little relevant that the Modi government didn't order nearly enough vaccines early enough.
In India currently die ~2 people per 100k per week on Corona. In Germany it was over triple that in December. The total Corona mortality in India is also way way lower as in Germany (16.842/100k vs 100.35/100k).
I am not sure that the moral panic is even justified.
You'er basing that on official figures from a country which has cities whose healthcare systems collapsed.
Makeshift funeral pyres in the middle of a city street don't happen in a country where something hasn't gone terribly wrong
Delhi's official death rate of the last 7 days was 9 per 100k, and University of Michigan are estimating real rates at 2-5 times higher than that for India as a whole.
> Makeshift funeral pyres in the middle of a city street don't happen in a country where something hasn't gone terribly wrong
The same was said in Germany/Saxony (crematoria capacity reached), however they plain omitted the fact that usually these were outsourced to Czech Republic, but borders were closed. Cherry-picking parts of the story but omitting others is so common that I am hesitant to take it as is.
It would be certainly better to have overall mortality, so it would be easier to reason about the veracity of COVID mortality, however I am not convinced by obvious emotional manipulation.
> Delhi's official death rate of the last 7 days was 9 per 100k, and University of Michigan are estimating real rates at 2-5 times higher than that for India as a whole.
9/100k/w is not very high for cities given they are drastically more affected by pandemics in general. 2-5 times is quite a big margin, but I would be interested in how they came to these numbers.
In Kerala the all-cause mortality decreased from 2019-2020[0] - something you could observe in Germany as well. Kerala is said to be more advanced than other states in India, however it lends some credence to the official numbers.
“It’s a complete massacre of data,” said Bhramar Mukherjee, an epidemiologist at the University of Michigan who has been following India closely. “From all the modeling we’ve done, we believe the true number of deaths is two to five times what is being reported.”
Imagine how much it would help to take your house away from you (without compensating you) to build that Highway. So many people would benefit from it. Perhaps even save lives by removing that dangerous crossing.
> These will be special-purpose bespoke machines, and if you ask other drug companies if they have one sitting around, the answer will be “Of course not”. This is not anything close to a traditional drug manufacturing process. And this is the single biggest reason why you cannot simply call up those “dozens” of other companies and ask them to shift their existing production over to making the mRNA vaccines. There are not dozens of companies who make DNA templates on the needed scale. There are definitely not dozens of companies who can make enough RNA. But most importantly, I believe that you can count on one hand the number of facilities who can make the critical lipid nanoparticles.
Also see this article[1] which details the supply chain of mRNA vaccines as well as the bottleneck of lipid nanoparticle assembly. These mRNA vaccines also have strict requirements for storage/distribution, preventing them from wider usage.
> These will be special-purpose bespoke machines, and if you ask other drug companies if they have one sitting around, the answer will be “Of course not”
I'm going to take a guess, but maybe in ten years time, the answer will be "Of course, yes".
Hopefully, yes. With the advances in sequencing I see a lot of potential for things like small clinics providing personalized cancer vaccines, for example.
The incentives for saving the world just went down.
There sane way to do this is to buy the patents for a few hundred billions. A small price compared to the benefit these companies have provided the world.
These companies quite literally saved the world as we know it.
If I was the CEO or the President of those companies I'd close shop and go start a cryptocurrency instead
You are sending the message that if the problem is too important, then you should not work on it because as soon as you find a solution you'd be held at gunpoint to make it availible for free.
There will be a huge slowdown in Selfdriving cars tech as well. If Waymo or Amazon come up with the tech , then you'd see people screaming :
"40,000 deaths per year! Young children, pregnant mothers!!! Release the IP, now!!"
And of course government would follow the mob and force them to do so.
Again, off they go to start a cryptocurrency or in the internet advertising business.
The biggest hurdle to getting more vaccine manufacturing capacity online is probably the hysteria around "China might steal our vaccine technology!!!!".
There is no other country with the experience of rapidly scaling up manufacturing supply chains. But in the case of these vaccines, especially the mRNA ones, very hard to do without exact specifications of the microfluidics and process parameters needed.
Patent & copyright nationalism is one hell of a drug.
China stealing our vaccine technology has got to be the least convincing threat I've seen. So what if they do? What are they going to do with it? Cure diseases?
Are patents really the barrier here? Are there factories out there, in countries that aren't currently producing vaccine, and are unable to purchase it? I seriously doubt it. Making these vaccines is not trivial. The facilities required can't be whipped up overnight. The skilled staff can't be pulled out of thin air.
Most countries capable of producing vaccines like this are already doing so, as fast as possible, and exporting them to the rest of the world at an incredible rate. Sure, more and faster would be better. Sure, countries are prioritizing their own citizens. But giving away all the IP is not going to change much at all.
By the time the few other countries who are even capable of manufacturing vaccines are able to bring production online, there's likely to already be a glut of extra doses on the market. The US has vaccinated nearly half of adults. Most of those remaining are voluntarily avoiding it. Vaccine shortage isn't a problem in the US at this point. US manufacturers are still increasing output, and soon there will be tens of millions of doses being exported every month, far more than any currently-nonexistent manufacturing facility could hope to produce within the next year.
Two of the worst-off countries that could most-benefit from more vaccine are India and Brazil. India has the means, doesn't really care about IP much in the first place, and already has facilities licensed to produce, but completely failed to plan. They can solve this problem if they get their shit together; the IP isn't a barrier whatsoever. Brazil has an even bigger failure of leadership and failure of public will, and already isn't taking advantage of vaccine that they have, so again, IP isn't the problem.
The simple truth is that anyone who can make these vaccines already is. Look what happened at the Emergent plant in Maryland when they tried to make the J&J vaccine. Even in the US, with good existing facilities and--at least on paper--qualified staff, production was a failure, and many months later, it still isn't producing any vaccine.
My cynical take after having worked close to the industry:
- this was not done without some level of agreement (probably not enthusiastic agreement)from the companies affected
- other companies can use the IP, if they can make it work (major challenge with the mRNA vaccines)
- for the mRNA vaccines this will have little to no impact; other companies can use the IP but it will take a year or more before they can start producing vaccines, and by then we’ll be onto v2.0
- the IP holders will enter into licensing agreements before any IP is broken (in exchange for technical help). Companies won’t miss out on much revenue since these werent priority markets anyways
Basically the manufacturers will keep the wealthy western markets to themselves where all the profit is while gaining PR by opening up more access for developing countries
This kind of lip-service to global equality and fairness is very typical of United States in general. The difference being that DJT was very vocal whereas during tenures of established politicians the packaging around these intentions is much much better. Problem with Trump was that he was crass. Biden isnt. So if people are wondering why would you support this waiver while withholding export bans is that pledging support to something that isn't possible is a much easier way to earn brownie points than comitting to something actionable.
How is this supposed to work really? The President is not above the law (as Justice Kagan famously put it 2 years ago). He can't just suspend the patent law. He can ask the Congress to revoke the law, but that would be going forward, it would not act retroactively (as per the Article 1 of the Constitution). Let's just say the President issues some type of Executive Order to overrule the patent protections for the Covid vaccines. Would the companies not sue? Would they not go all the way to the Supreme Court? Would all the courts agree with the President that he can just make the law go poof when he feels there is a moral obligation to do so?
The patent waiver doesn't require any Congressional changes to US patent law or require the President to unilaterally overrule US patent laws. US patent law only covers patents in the US.
The US and almost all other countries are in the World Trade Organization (WTO). The WTO has an agreement called TRIPS which covers IP requirements of member states. Part of the requirements of TRIPS is that most member states have to reciprocate patent rights for patents issued by other member states. The WTO can waive this requirement with a vote of the WTO General Council. This is what is being proposed and Biden has declared that the US now supports doing so. This is completely within his powers as President.
The problem is not just the intellectual property right now, it is also all the supply chain for its components plus the training and equipment. I can give you the recipe for a truffle egg omelet... Now you need the truffles, the eggs and a way to cook it. In the long term however I hope we are going to start rethinking durg pricing and intellectual property. They had people convinced that making a drug is expensive and they need that to pay for R&D, now that we know it is not what is happening, we can move on.
It's ridiculous in the first place that BioNTech received almost half a billion in public funding specifically to develop the vaccine and yet own 100% of the rights privately.
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[ 2.6 ms ] story [ 217 ms ] threadOr is this a matter where because it has to do with overseas patent protection, the US could decline to enforce certain agreements?
And don't companies have patent protection in every country they seek to do business anyway?
> There are plenty of other parents needed to make the actual vaccine
So asking for the other patents involved is a reasonable question, especially since your assertion presumably involves knowing - at least vaguely - what said patents might be.
https://www.ipwatchdog.com/2021/04/11/mrna-ip-competitive-la...
https://www.ipwatchdog.com/2021/04/21/mrna-ip-competitive-la...
https://www.ipwatchdog.com/2021/04/30/mrna-patent-competitiv...
This isn't going to help India or anyone in the short term and there'll be more than enough doses for every person on Earth by next year. Why should they not retain the IP rights to make a profit on new generations that need to be vaccinated or potential booster shots? The manufacturing capacity will have been built up so scarcity won't be a problem at that point.
If you held a firm conviction that in the near future you'd be able to act on the IP without being in violation, would you be more motivate to progress toward doing so more swiftly?
As a patent holder, would you feel more secure that you could issue cease and desist notices and peruse damages after the waiver is lifted?
Why not? I’m not hearing a clear argument or evidence to support that withholding the patent recipe wouldn’t save millions of lives?
India now has a very high number of cases. As it stands now, your argument just sounds to me like:
“yes human lives, but... profit“.
Please could you elaborate on your argument and/or provide examples of what you’re describing happening in other cases?
This is about mRNA vaccines, but similar things exist for viral vector vaccines as well. Technology transfer, bioreactor bags, fill-finish capacity, all of these things are bottlenecked till next year basically.
RNA based experiments are doable in most university labs. It is 2021.
There is a huge difference between doing RNA experiments versus manufacturing millions of doses of mRNA vaccine without errors or contamination.
The approach to intellectual property in China is much more open, partly because the leaders understand that technical expertise is more than just a one-off design, and competitors probably can't enter the market without significant capital investment and risk. In the case of healthcare, I suspect that regulators will prevent any vaccines manufactured with sub-standard procedures, such as those made in university labs.
There is a pharmaceutical industry in India that is not being given the opportunity to get in this fight and some people say they could help and others say they can’t.
So give them a chance and test if they can!
Yes, the most likely reason why someone would have a different opinion is because they're somehow invested - emotionally, financially, whatever - in the existing vaccine manufacturers.
That's not a problem, modifying laws is the default way how countries do things - if a country says "we'll do X" they most likely mean "we'll modify our laws so that X will happen".
But IIRC the patent laws of many countries already contain specific clauses for a simplified process to void patents for lifesaving reasons if they want to do it.
And it's worth noting that patents aren't a right, it's a privilege selectively granted by the government because the government expects that the process as a whole benefits the general society (by facilitating innovation and publishing of technical innovations instead of hiding them), not because the patent owners have a right to require it. The government does not have to offer patent protection; it chooses to grant a temporary monopoly for a limited time if certain conditions are met, and it can (essentially arbitrarily) decide what those conditions are.
Patent laws are also not some natural, inalienable right. They are artificial constructs, provided as a courtesy, because the government feels that in the general case, they are more beneficial than harmful.
In a particular case, they might be more harmful than beneficial.
What do you make of the move corporations are making away from the use of patents, towards the use of a hybrid ‘trade secret + patent‘ sandwich? Is there a scenario where it does not stifle innovation?
I’m asking because I personally don’t see any. As you said these systems are artificial constructs, and at the worst this taking away as trade secrets is theft on an enormous scale.
The internet allows mass collaboration, and I believe we are still in the very early stages of developing this infrastructure.
Elaboration on what exactly I mean by ‘patent + trade secret’ sandwich here: https://www.ipwatchdog.com/2019/02/19/dont-fooled-patent-pur...
I take that it's not happening to the extent claimed, and that those claims are largely self-serving propaganda used as justification for a legal land-grab.
Of course patent owners are going to argue that their patents should be valid for fifty thousand years, with the figleaf that it protects 'innovation'. What else would they say? That they'd like IP law tilted in their favour because it would make them more money?
Really? What you are basing this off of?
Basically, if you did not pay the King,or someone else paid the King more, the State will destroy your business.
The modern idea of patents comes from that, adding the requirement to document an innovation instead of just paying money to the King.
The State can do end the monopoly at any given time. They have done lots of times in the past, specially in wars.
> Hiding inventions as trade secrets acts to protect these huge multinational corporations [...] This is the reason that huge multinationals lobby so hard for strong trade secret laws and weak patent laws. This is clearly shown in Musk’s low valuation of his patents and high valuation of trade secrets.
> Trade secret protection for inventions that could otherwise be patented is bad public policy because it stifles the progress of innovation [as the knowledge does not end up in the public domain as happens when patent claims expire] and it consolidates money, markets and power into a few huge corporations [...]
The author in this article goes into more detail on the pattern (and history) of human discovery and scientific breakthroughs by using some great examples like the development of the sewing machine, as well as Musk’s purchase of the trade secrets of Maxwell Technologies.
Source: https://www.ipwatchdog.com/2019/02/19/dont-fooled-patent-pur...
This "waiver" seems like it would essentially be the WTO member states unanimously agreeing that they won't be using any of the usual tools / threats of sanctions they could normally bring to bear as a collective to squash violations of IP for these patents.
The US cannot act unilaterally in this regard - the WTO members would all have to agree to it for it to work effectively - but the US staking out its position may help to drive a consensus position.
I want the companies and investors in the pharmaceuticals that have made these to become fabulously wealthy as an incentive for companies to invest in the capabilities to produce these.
I want creating a successful vaccine to be a bigger deal economically than creating a worldwide social network.
Who is doing a better job of increasing human well-being, Facebook or Moderna?
The stock of these companies dropped on this announcement. Long term this kind of patent waiver will drive investment and at some level smart people from these companies.
And it took a global pandemic for pharma to realize it so maybe they aren't totally up to the task. And it seems the consensus is that states provided much needed money to turn mrna vaccines into a real thing.
If McDonalds gave out their hamburger recipe today, I don’t think they’d be on the brink of bankruptcy tomorrow.
I would imagine stopping a global pandemic is in the best interest of everyone, including the creators of any vaccine. They’ve made a killing so far and will continue to make plenty of money, patents or not.
That is quite hyperbolic, because at worst it will reduce profits, but hardly "kill" them.
> I want the companies and investors in the pharmaceuticals that have made these to become fabulously wealthy as an incentive for companies to invest in the capabilities to produce these.
The incentive to invest is the chance of future profits. Those still exists, as the technology has a lot of use-cases beyond covid-19 vaccines. The vaccine is just the show-case of that.
> The stock of these companies dropped on this announcement.
Short-term developments are hardly a good indicator for future development.
> Long term this kind of patent waiver will drive investment and at some level smart people from these companies.
You really think, losing the ability to profit more from a, hopefully, once in a century event will determine, if someone invests in something in the future? And by that not being able to profit from the technology in all the other areas they can improve?
I really doubt that.
I mean, what if the next company comes up with a cure for AIDS. Are they confident the IP won’t be broken either?
The rules of the game change all the time. Every business plan has to take into consideration the risks/benefits of possible regulatory changes. And yes, changes will affect investment. But the hypothesis is, it will drive investment away to the extent that it will "kill the goose...". I would phrase it less hyperbolic as "in a significant way".
To reiterate: We are talking here (up to now) a about once in a life-time event. And that is both the Covid crisis, as well as being able to profit from.
> I mean, what if the next company comes up with a cure for AIDS. Are they confident the IP won’t be broken either?
So the classical slippery slope argument. The whole point why governments are bringing the option on the table is, because it is an exceptional event. So, it doesn't translate to AIDS/HIV.
Will people believe that? That's anyones guess. Do you believe anyone will forgo possible profits from the whole range of possibilities of treatments based on mRNA because of that precedent? I seriously doubt that.
I do not see those risks, but then I also do not see much the benefit either. It isn't like just the patents are the limiting factor, and you could ramp up a production of those vaccines from one day to the other.
So they dont need to become fabulously wealthy, they just need to turn a decent profit. Which they are doing. And right now I would suggest that AstraZeneca, Pfizer and Moderna are 3 of the most well known pharma companies, because they were first to market with working vaccines, there are plenty of pharma companies that tried, failed and thus you dont even know their names. So those successful firms are already being rewarded. No need to call for outsized returns for these companies.
They were already fabulously wealthy. Moderna alone had $232 million revenue last year.
That is nowhere near fabulously wealthy, especially as it is revenue and not profit.
https://investors.modernatx.com/news-releases/news-release-d...
[1] https://www.macrotrends.net/stocks/charts/JNJ/johnson-johnso...
But here we are talking about Intellectual Property and patents. Which themselves are a government-granted monopoly...
Truth is patents are mostly used to stifle innovation while their original purpose was to encourage it. A company inventing something novel will have a pretty nice advantage over the competition even without the government's help. That's not even taking into consideration that besides patents there are other tons of difficulties when copying a product. Manufacturing alone is pretty huge. Then marketing: the original vs the cheap knock-offs.
When in doubt, I think it's better to err on the side of the free market and of non-intervention. But, to come full circle, in this case the government encouraged companies to publish their research with the promise to protect it. So my only conclusion is, again, to never trust the government.
/rant
https://www.usatoday.com/story/news/health/2020/08/08/feds-s...
Federal spending on COVID-19 vaccine candidates tops $9 billion, spread among 7 companies
Did they use some of their other, shady, pork-like ways? Then things are even more murky and muddled and anything is allowed I guess.
Lets not forget that the actual market for these vaccines was not free but completely FUBAR: I could not buy one anywhere and at any price.
Currently vaccine companies such as the German Curevac (which is the vaccine company Trump famously tried to buy) is being held back by lack of core ingredients which are under American export bans.
The US still upholds the export bans setup by the Trump administration. Biden can just revoke those. Yet he promotes the idea of waivering vaccine patents knowing well how hard that would be to do in practice.
And exactly how is it supposed to work? Will Pfizer no longer have to pay license fees to BioNTech?
Give Biden at least 1 year, and you'll see that some people are reflexively critical of him too.
Biden isn't exactly an outsider, and is just the face for scores of actual decision-makers in his administration; I don't think one more year is going to surprise anybody.
Now, granted, Murdoch wasn't always in favor of Trump, he still fell into line after the guy got elected.
Seriously? Nothing of the sort happened. There was constant negative media and calls for impeachment immediately.
If that's how you lead foreign policy 7 days in, you don't deserve to be president. Full stop.
For all the mess Biden has inherited, he also inherited a near perfect vaccine production program. The reversals issued in the first 100 days did not reverse any export bans or regulations the Trump admin put in place for the vaccine production and rollout.
Regardless of what you think of Joe Biden or Donald Trump, this statement is categorically false.
There are enough legitimate things to criticize Donald Trump for that we don't need to make things up. As others have pointed out, the vaccine program was just starting up at the end of the Trump administration. Besides, much of the actual logistics were, and are, handled at the state level.
To revert self-serving orders, require extraordinary political clout above and beyond. Can that be done regarding every "bad" decision? A competent administration must not undo the "good" decisions as well.
So, take your own advice and stop promoting this false narrative that there's negative Biden coverage anywhere near the amount that Trump had. It's absolutely obvious that's not true.
With that said, I can’t claim there is no media bias re: Biden, but we should not pretend that the circumstances are even close to similar.
When Trump didn't condemn Saudi Arabia it was the worst thing any US president had done, when Biden does the same it's crickets.
Like, I hated Trump and I'm pretty happy with Biden, but to say that there isn't a substantial difference in media coverage is really just not true.
I don't think it is healthy that you need to go to the other sides newspapers in order to get a proper evaluation of what Biden does, why should I have to dig through fox news to understand the narrative?
What difference? Were they calling those bans a stunt before? No. You don't need to be hypothetical. This policy wasn't a secret.
The media didn't have to dig this deep when drinking bleach and injecting light were the topics du jour.
Exporting individual vaccines might break contracts, and because it's a little bit zero-sum, the public at large may hold him in contempt for not putting 'America first'.
Removing the patent doesn't save more people, just as many vaccines would get produced, it just shifts money from the company to the state that pays for the vaccine.
Money and risk is a very material part of the equation, now that the dynamics have changed, a lot more speculative money will be available. Supply and Demand works on cash just as it does for other things.
Also I don't think it has a populist aspect.
Exporting 'already made vaccines' does have a populist risk - a lot of Americans may 'get really mad!' if the US is seen to be exporting vaccines to other places before the US is fully vaccinated, irrespective of whether their chagrin is misplaced or not, the news cycle populism may have a field day with that. And there's the contractual stuff which he cannot 'waive'.
Second, it's a lot to do with the 'rest of the world' not really the US.
Third, AZ was UK not Europe, J&J was Neterhlands but owned by an American firm, Pfizer/BioNTech was both, Moderna was USA. So I don't see how this is a 'Europe victim' scenario.
The difference in Vaccine rollout comes from the fact that the EU exports vaccines to other countries while the US does not.
As a European I would've been in favour of more export controls, but a total ban seems to go too far. Why should 18 years olds in the EU/US receive a vaccine before 75 year olds in other countries?
Then again, the EU exported to countries that are now further ahead than the EU itself, which seems the other extreme end.
I don’t know what the EU governments kicked in, but the US basically threw tens of billions of dollars at the US pharma giants to bankroll the wide-scale rollout of not one but three vaccines. The patents are largely European, but the rapid scale-up of production was only possible because of US contributions (true on both sides of the ocean as the US paid to build factories in Europe too in exchange for priority access).
But on a larger scale, individual outcomes are somewhat meaningless in the scope of government. Each country’s government has a duty to protect the public health of its citizens, which means trying to get to herd immunity within its own population. It’s like putting on your own mask before helping someone else.
Biden speaks in a nicer manner but he is still doing the policies of Trump's America First.
IMHO we in Europe should return the favour and start working with the Chinese on vaccine production. They are the only ones with an industrial capacity comparable to the US.
The resulting chip shortage and the state which India is in will also affect the US and UK even if they don't think it will.
Because a nation state has a duty to protect the safety of its own citizens first and foremost. If a government continuously puts the needs of other countries over the needs of its own citizens, who is going to support a system like that long-term? Perhaps a handful of upper-middle-class idealists, but not most people. Right or wrong, that's just not human nature.
I strongly agree, but that does not mean it has to be completely amoral in its interactions with other nations. Its own citizens may in fact be in favor of taking on some risk to help people beyond their borders.
There is also a pragmatic side to this. A nation that acts too selfishly may soon find itself without allies.
EU has 2x the number of people.
I don’t know if my intuition is correct, but reigning in COVID’s R₀ worldwide at once seems like a moonshot in current state of civilization (keeping in mind its mutations and all).
Meanwhile, for better or for worse, the planet isn’t a single community: given border controls that can serve as a barrier to virus spread, it might just be more realistic to get things under control in smaller disconnected populations, which can then “bubble up”, restore quality of life and allow freedom of movement between themselves while at the same time helping bring other parts of the world back up to speed.
And yes, this does smell of the trolley problem and I wouldn’t want to be the person who would have to make such a decision.
Do you know specifically which materials?
[0] https://www.reuters.com/business/healthcare-pharmaceuticals/...
Vaccine manufacturing is just a way more involved process than anything what an average organic synthesis shop can handle. Dealing with antibodies, proteins, plasmids, or RNA requires real factories rather than garage labs.
What one need is a complete process transfer: instructions on setting up every process, along with supplies needed, and operation training, and supervision.
Conventional vaccine production is a highly biological process... chicken eggs being used to make the flu vaccines and so forth. I was under the impression that the mRNA vaccines are chemically much simpler -- just strands of a particular RNA sequence (swapping Pseudouridine for Uracil), encapsulated in a very clever lipid coat.
Presumably the biotech industry is really really good at manufacturing strands of RNA by now, right? I mean that seems like it's something they would've been doing every day for the last 20 years.
So are the only novel manfuacturing steps the Pseudouridine substitution and the lipid coat?
I would want to know how they do it (mRNA isolation) too, but nobody will share that knowledge for free.
Even most simple methods like inactivation require a cell culture tech, which means lots of expensive bioreactors, and extreme levels of sterility.
The DNA sequence is then cut out of the plasmids and transcribed into mRNA.
https://www.nytimes.com/interactive/2021/health/pfizer-coron...
I bet getting that batch of bacteria to grow and make lots of the desired plasmids is a nice trick to pull off.
Getting sufficient production of the target isn't easy. The guy at your link includes 'countless failures' in his intro!
Why do they do it that way?
When you order DNA plasmids from places like Addgene the stuff they ship you is chemically synthesized using enzymes rather than and entire complete living cell, right? I would've thought Pfizer would do the same thing and then transcribe that DNA into mRNA.
Is it because of the massive quantities of material they need to produce?
[1] https://blogs.sciencemag.org/pipeline/archives/2021/02/02/my...
[2] https://blogs.sciencemag.org/pipeline/archives/2021/02/22/mo...
Okay, this is the best article of them all, the one I was wishing for. Congratulations, you win ten thousand Internets!
Best part (although the whole thing is totally worth reading):
As Neubert says, “Welcome to the bottleneck!” Turning a mixture of mRNA and a set of lipids into a well-defined mix of solid nanoparticles with consistent mRNA encapsulation, well, that’s the hard part. ... Everyone is almost certainly having to use some sort of specially-built microfluidics device ... These will be special-purpose bespoke machines, and if you ask other drug companies if they have one sitting around, the answer will be “Of course not”. This is not anything close to a traditional drug manufacturing process. And this is the single biggest reason why you cannot simply call up those “dozens” of other companies and ask them to shift their existing production over to making the mRNA vaccines.
The Economist isn't a technical publication but it is known to do its homework and get details like this right.
Supplies of raw materials such as nucleotides are also tight. According to Dr Zarur, Thermo Fisher, an American chemical-supplies company, has spent $200m on a new facility in Lithuania to make these molecules, though the firm itself would not confirm this.
I would not have expected this, but it definitely explains a whole lot of otherwise-cryptic claims being made in the WTO debate. I guess it does sort of make sense. The worldwide demand for pure bulk nucleotides probably shot up hundreds or thousands-fold as a result of COVID-19 vax manufacturing.
https://www.nytimes.com/interactive/2021/health/pfizer-coron...
No details on which ingredients are the ones causing so much consternation at the WTO right now, nor any answer to the obvious question "why aren't the DNA plasmids made the same way other commercial plasmid services make them"?
But hey, it's the NYTimes. They have to hold the attention of an audience that mostly has no science background.
Good on them. I wish patents on medication were disregarded universally.
I very much doubt we’d have these fancy new mRNA vaccines if that had been the case the last 20 years.
Considering that the inventors are Biontech, oxford/AZ and Moderna (who won't enforce their patent), it seems like an easy decision for the US to make.
The manufacture of these vaccines is not simple. It is not simply a matter of the US “waiving” a patent. However if other countries decide to participate in this performance, they may end up just manufacturing a vaccine which doesn’t work.
The virus is killing thousands per day. Do you really think a major country like India isn’t manufacturing the cure simply because of a patent?
China blatantly, openly, and proudly flaunts patents as a core part of their manufacturing economy. Why aren’t they manufacturing the mRNA vaccines, giving it away to countries that want it, and looking like the good guy here?
Because waiving the patent does nothing but generate positive press. It’s a fugazi.
Patents read like a menu item. “Chocolate cake with peanut butter and strawberries.”
Or “Adenovirus #16 with coronavirus XXX sample modification.”
To make the vaccine you also need—“whip up 2 eggs, 4 cups of flour and a 30 ml of oil.”
Companies often withhold this info so that they can keep the edge and to make the cost of copy much higher.
I'm pretty sure you meant "flouts" here.
https://www.fiercebiotech.com/biotech/fosun-follows-biontech...
https://www.wsj.com/articles/china-plans-to-approve-first-fo...
Imho: If this becomes real, don't expect big benefits. I appreciate what Moderna did but forcing other companies to do the same may be overkill for little benefit and I wonder what the long term effect is on companies' willingness to focus on a vaccine for the next pandemic. Perhaps companies realize that waiving IP rights is good PR, or they can do it for parts of the process that is easier to scale or outsource to 3rd parties.
What happens to startups that do find an easy to copy vaccine production process and they know their IP will be taken from them? I honestly don't know but I feel that they should be fairly compensated... But what's fair. IP is just so difficult. I wonder what a world without it would look like. More company secrets, that's for sure.
[0] https://investors.modernatx.com/news-releases/news-release-d...
I strongly believe it is our moral duty to buy-out or invalidate the IP of (at the very least) these viral vector vaccines lest even more people die unnecessarily, while we are having interesting theoretical armchair arguments from the comfort of our increasingly vaccinated western societies.
I know it's theoretical, I'm just saying, perhaps it will not be all good. But we'll deal with that when we get to it. Maybe viral vaccines should be an organized governmental effort from now on. Coordinated by WHO or something.
If US/UK would finally allow vaccine exports like the EU does, _that_ would help India.
It's also maybe a little relevant that the Modi government didn't order nearly enough vaccines early enough.
https://www.reuters.com/business/healthcare-pharmaceuticals/...
I am not sure that the moral panic is even justified.
Makeshift funeral pyres in the middle of a city street don't happen in a country where something hasn't gone terribly wrong
Delhi's official death rate of the last 7 days was 9 per 100k, and University of Michigan are estimating real rates at 2-5 times higher than that for India as a whole.
The same was said in Germany/Saxony (crematoria capacity reached), however they plain omitted the fact that usually these were outsourced to Czech Republic, but borders were closed. Cherry-picking parts of the story but omitting others is so common that I am hesitant to take it as is.
It would be certainly better to have overall mortality, so it would be easier to reason about the veracity of COVID mortality, however I am not convinced by obvious emotional manipulation.
> Delhi's official death rate of the last 7 days was 9 per 100k, and University of Michigan are estimating real rates at 2-5 times higher than that for India as a whole.
9/100k/w is not very high for cities given they are drastically more affected by pandemics in general. 2-5 times is quite a big margin, but I would be interested in how they came to these numbers.
[0]: https://health.kerala.gov.in/pdf/Technical-paper-All-Cause-M...
https://www.google.com/amp/s/www.nytimes.com/2021/04/24/worl...
“It’s a complete massacre of data,” said Bhramar Mukherjee, an epidemiologist at the University of Michigan who has been following India closely. “From all the modeling we’ve done, we believe the true number of deaths is two to five times what is being reported.”
Oh?
" "Manufacturing mRNA vaccines is surprisingly straightforward. Compared to conventional vaccine production, mRNA factories are: * 99 - 99.9% smaller * 95 - 99.7% cheaper * 1,000% faster"
https://news.ycombinator.com/item?id=27061674
https://coronavirus.medium.com/manufacturing-mrna-vaccines-i...
https://twitter.com/doctorow/status/1389978947723546625
https://aiche.onlinelibrary.wiley.com/doi/full/10.1002/amp2....
> These will be special-purpose bespoke machines, and if you ask other drug companies if they have one sitting around, the answer will be “Of course not”. This is not anything close to a traditional drug manufacturing process. And this is the single biggest reason why you cannot simply call up those “dozens” of other companies and ask them to shift their existing production over to making the mRNA vaccines. There are not dozens of companies who make DNA templates on the needed scale. There are definitely not dozens of companies who can make enough RNA. But most importantly, I believe that you can count on one hand the number of facilities who can make the critical lipid nanoparticles.
Also see this article[1] which details the supply chain of mRNA vaccines as well as the bottleneck of lipid nanoparticle assembly. These mRNA vaccines also have strict requirements for storage/distribution, preventing them from wider usage.
[0]: https://blogs.sciencemag.org/pipeline/archives/2021/02/02/my...
[1]: https://blog.jonasneubert.com/2021/01/10/exploring-the-suppl...
I'm going to take a guess, but maybe in ten years time, the answer will be "Of course, yes".
Why wouldn't it be?
Will it be a big deal in the long term then?
There sane way to do this is to buy the patents for a few hundred billions. A small price compared to the benefit these companies have provided the world.
If I was the CEO or the President of those companies I'd close shop and go start a cryptocurrency instead
You are sending the message that if the problem is too important, then you should not work on it because as soon as you find a solution you'd be held at gunpoint to make it availible for free.
There will be a huge slowdown in Selfdriving cars tech as well. If Waymo or Amazon come up with the tech , then you'd see people screaming :
"40,000 deaths per year! Young children, pregnant mothers!!! Release the IP, now!!"
And of course government would follow the mob and force them to do so.
Again, off they go to start a cryptocurrency or in the internet advertising business.
China stealing our vaccine technology has got to be the least convincing threat I've seen. So what if they do? What are they going to do with it? Cure diseases?
Most countries capable of producing vaccines like this are already doing so, as fast as possible, and exporting them to the rest of the world at an incredible rate. Sure, more and faster would be better. Sure, countries are prioritizing their own citizens. But giving away all the IP is not going to change much at all.
By the time the few other countries who are even capable of manufacturing vaccines are able to bring production online, there's likely to already be a glut of extra doses on the market. The US has vaccinated nearly half of adults. Most of those remaining are voluntarily avoiding it. Vaccine shortage isn't a problem in the US at this point. US manufacturers are still increasing output, and soon there will be tens of millions of doses being exported every month, far more than any currently-nonexistent manufacturing facility could hope to produce within the next year.
Two of the worst-off countries that could most-benefit from more vaccine are India and Brazil. India has the means, doesn't really care about IP much in the first place, and already has facilities licensed to produce, but completely failed to plan. They can solve this problem if they get their shit together; the IP isn't a barrier whatsoever. Brazil has an even bigger failure of leadership and failure of public will, and already isn't taking advantage of vaccine that they have, so again, IP isn't the problem.
The simple truth is that anyone who can make these vaccines already is. Look what happened at the Emergent plant in Maryland when they tried to make the J&J vaccine. Even in the US, with good existing facilities and--at least on paper--qualified staff, production was a failure, and many months later, it still isn't producing any vaccine.
- this was not done without some level of agreement (probably not enthusiastic agreement)from the companies affected
- other companies can use the IP, if they can make it work (major challenge with the mRNA vaccines)
- for the mRNA vaccines this will have little to no impact; other companies can use the IP but it will take a year or more before they can start producing vaccines, and by then we’ll be onto v2.0
- the IP holders will enter into licensing agreements before any IP is broken (in exchange for technical help). Companies won’t miss out on much revenue since these werent priority markets anyways
Basically the manufacturers will keep the wealthy western markets to themselves where all the profit is while gaining PR by opening up more access for developing countries
--
Pay the companies whatever they demand to do whatever it takes to get everyone vaccinated asap. Now and into the future.
Graciously award everyone involved Freedom Medals™.
Then later, claw back any and all windfall profits thru radical cashectomies.
Pragmatism is so obvious and easy. And depressingly uncommon.
The US and almost all other countries are in the World Trade Organization (WTO). The WTO has an agreement called TRIPS which covers IP requirements of member states. Part of the requirements of TRIPS is that most member states have to reciprocate patent rights for patents issued by other member states. The WTO can waive this requirement with a vote of the WTO General Council. This is what is being proposed and Biden has declared that the US now supports doing so. This is completely within his powers as President.