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Covid: US backs waiver on vaccine intellectual property

136 points by mattkohl 5y ago

goldforever 5y ago
More importantly, remove the liability waiver from these vaccine manufacturers. Then we'll see the fun.
supernova87a 5y ago
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?
- Kliment 5y ago
  NIH (a US government run institution) holds the main patents on mRNA technology.
  - refurb 5y ago
    No, the NIH helped with the spike protein sequence. There are plenty of other parents needed to make the actual vaccine.
    - beckman466 5y ago
      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?
      - refurb 5y ago
        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.
        meepmorp 5y ago
        You did say > 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.
      - blywi 5y ago
        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. https://www.ipwatchdog.com/2021/04/11/mrna-ip-competitive-landscape-one-year-covid-19-pandemic-part/id=132130/ https://www.ipwatchdog.com/2021/04/11/mrna-ip-competitive-la... https://www.ipwatchdog.com/2021/04/21/mrna-ip-competitive-landscape-translate-bio-arcturus-etherna-startups-lnp-technology-part-ii/id=132287/ https://www.ipwatchdog.com/2021/04/21/mrna-ip-competitive-la... https://www.ipwatchdog.com/2021/04/30/mrna-patent-competitive-landscape-pioneers-litigation-outlook-big-pharmas-next-moves-part-iii/id=132936/ https://www.ipwatchdog.com/2021/04/30/mrna-patent-competitiv...
  - Teracotage 5y ago
    I thought it is the German couple behind mRNA, no? https://www.nytimes.com/2020/11/10/business/biontech-covid-vaccine.html https://www.nytimes.com/2020/11/10/business/biontech-covid-v... https://www.nature.com/articles/d41573-020-00119-8 https://www.nature.com/articles/d41573-020-00119-8
  - DrAwdeOccarim 5y ago
    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...
- titoCA321 5y ago
  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.
  - double-a 5y ago
    Cool. So then these companies should have nothing to fear.
    - tobessebot 5y ago
      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.
      - TheSpiceIsLife 5y ago
        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?
      - beckman466 5y ago
        > This isn't going to help India or anyone in the short term 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?
- PeterisP 5y ago
  > 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.
- celticninja 5y ago
  https://www.mondaq.com/india/patent/865888/patents-and-the-indian-pharmaceutical-industry https://www.mondaq.com/india/patent/865888/patents-and-the-i...
- vkou 5y ago
  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.
  - beckman466 5y ago
    > Patent laws [...] are artificial constructs 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-purge-elon-musk-just-another-hypocritical-tech-billionaire/ https://www.ipwatchdog.com/2019/02/19/dont-fooled-patent-pur...
    - vkou 5y ago
      > 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?
      - beckman466 5y ago
        > 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. Really? What you are basing this off of?
- bumbada 5y ago
  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.
  - beckman466 5y ago
    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. Source: https://www.ipwatchdog.com/2019/02/19/dont-fooled-patent-purge-elon-musk-just-another-hypocritical-tech-billionaire/ https://www.ipwatchdog.com/2019/02/19/dont-fooled-patent-pur...
- AmericanChopper 5y ago
  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.
- jffry 5y ago
  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.
RcouF1uZ4gsC 5y ago
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.
- wolframhempel 5y ago
  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?
- johnchristopher 5y ago
  > 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.
  - da_big_ghey 5y ago
    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.
  - DrAwdeOccarim 5y ago
    I don't agree. I think it just sped things up.
nickpp 5y ago
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. /rant
- TheSpiceIsLife 5y ago
  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? https://www.usatoday.com/story/news/health/2020/08/08/feds-spending-more-than-9-billion-covid-19-vaccine-candidates/5575206002/ 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
  - nickpp 5y ago
    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.
cigaser 5y ago
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.
throwaway4good 5y ago
Something here smells deeply hypocritical. 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?
- fxtentacle 5y ago
  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).
  - andy_ppp 5y ago
    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.
  - elliekelly 5y ago
    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?
- makomk 5y ago
  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.
  - Tarsul 5y ago
baybal2 5y ago
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.
- KirillPanov 5y ago
  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?
  - baybal2 5y ago
    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.
  - makomk 5y ago
    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.
cblconfederate 5y ago
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.
thepasswordis 5y ago
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.
- newsclues 5y ago
  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?
  - thepasswordis 5y ago
    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.
  - mucholove 5y ago
    My understanding is so: 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.
- jfk13 5y ago
  > proudly flaunts patents I'm pretty sure you meant "flouts" here.
teekert 5y ago
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. [0] https://investors.modernatx.com/news-releases/news-release-details/statement-moderna-intellectual-property-matters-during-covid-19/ https://investors.modernatx.com/news-releases/news-release-d...
- akie 5y ago
  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.
  - teekert 5y ago
    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.
BurningFrog 5y ago
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.
ObserverNeutral 5y ago
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.
janekm 5y ago
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.
- kmeisthax 5y ago
  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?
  - janekm 5y ago
    Indeed, how dare they! https://www.ft.com/content/fa1e0d22-71f2-401f-9971-fa27313570ab https://www.ft.com/content/fa1e0d22-71f2-401f-9971-fa2731357... ("Vaccine makers say IP waiver could hand technology to China and Russia")
caymanjim 5y ago
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.
refurb 5y ago
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
specialist 5y ago
Weighing the lives of billions against intellectual property claims and turf. -- 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.
thecleaner 5y ago
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.
credit_guy 5y ago
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?
- tssva 5y ago
  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.
  - credit_guy 5y ago
    Thank you for the explanation.
ta988 5y ago
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.
sjm 5y ago
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.

136 points by mattkohl 5y ago

More importantly, remove the liability waiver from these vaccine manufacturers. Then we'll see the fun.

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?

Kliment 5y ago
NIH (a US government run institution) holds the main patents on mRNA technology.
- refurb 5y ago
  No, the NIH helped with the spike protein sequence. There are plenty of other parents needed to make the actual vaccine.
  - beckman466 5y ago
    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?
    - refurb 5y ago
      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.
      - meepmorp 5y ago
        You did say > 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.
    - blywi 5y ago
      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. https://www.ipwatchdog.com/2021/04/11/mrna-ip-competitive-landscape-one-year-covid-19-pandemic-part/id=132130/ https://www.ipwatchdog.com/2021/04/11/mrna-ip-competitive-la... https://www.ipwatchdog.com/2021/04/21/mrna-ip-competitive-landscape-translate-bio-arcturus-etherna-startups-lnp-technology-part-ii/id=132287/ https://www.ipwatchdog.com/2021/04/21/mrna-ip-competitive-la... https://www.ipwatchdog.com/2021/04/30/mrna-patent-competitive-landscape-pioneers-litigation-outlook-big-pharmas-next-moves-part-iii/id=132936/ https://www.ipwatchdog.com/2021/04/30/mrna-patent-competitiv...
- Teracotage 5y ago
  I thought it is the German couple behind mRNA, no? https://www.nytimes.com/2020/11/10/business/biontech-covid-vaccine.html https://www.nytimes.com/2020/11/10/business/biontech-covid-v... https://www.nature.com/articles/d41573-020-00119-8 https://www.nature.com/articles/d41573-020-00119-8
- DrAwdeOccarim 5y ago
  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...
titoCA321 5y ago
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.
- double-a 5y ago
  Cool. So then these companies should have nothing to fear.
  - tobessebot 5y ago
    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.
    - TheSpiceIsLife 5y ago
      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?
    - beckman466 5y ago
      > This isn't going to help India or anyone in the short term 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?
PeterisP 5y ago
> 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.
celticninja 5y ago
https://www.mondaq.com/india/patent/865888/patents-and-the-indian-pharmaceutical-industry https://www.mondaq.com/india/patent/865888/patents-and-the-i...
vkou 5y ago
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.
- beckman466 5y ago
  > Patent laws [...] are artificial constructs 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-purge-elon-musk-just-another-hypocritical-tech-billionaire/ https://www.ipwatchdog.com/2019/02/19/dont-fooled-patent-pur...
  - vkou 5y ago
    > 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?
    - beckman466 5y ago
      > 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. Really? What you are basing this off of?
bumbada 5y ago
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.
- beckman466 5y ago
  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. Source: https://www.ipwatchdog.com/2019/02/19/dont-fooled-patent-purge-elon-musk-just-another-hypocritical-tech-billionaire/ https://www.ipwatchdog.com/2019/02/19/dont-fooled-patent-pur...
AmericanChopper 5y ago
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.
jffry 5y ago
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.

RcouF1uZ4gsC 5y ago

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.

wolframhempel 5y ago
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?
johnchristopher 5y ago
> 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.
- da_big_ghey 5y ago
  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.
- DrAwdeOccarim 5y ago
  I don't agree. I think it just sped things up.

nickpp 5y ago

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. /rant

TheSpiceIsLife 5y ago
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? https://www.usatoday.com/story/news/health/2020/08/08/feds-spending-more-than-9-billion-covid-19-vaccine-candidates/5575206002/ 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
- nickpp 5y ago
  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.

cigaser 5y ago

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.

throwaway4good 5y ago

Something here smells deeply hypocritical. 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?

fxtentacle 5y ago
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).
- andy_ppp 5y ago
  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.
- elliekelly 5y ago
  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?
makomk 5y ago
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.
- Tarsul 5y ago

baybal2 5y ago

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.

KirillPanov 5y ago
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?
- baybal2 5y ago
  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.
- makomk 5y ago
  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.

cblconfederate 5y ago

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.

thepasswordis 5y ago

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.

newsclues 5y ago
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?
- thepasswordis 5y ago
  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.
- mucholove 5y ago
  My understanding is so: 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.
jfk13 5y ago
> proudly flaunts patents I'm pretty sure you meant "flouts" here.

teekert 5y ago

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. [0] https://investors.modernatx.com/news-releases/news-release-details/statement-moderna-intellectual-property-matters-during-covid-19/ https://investors.modernatx.com/news-releases/news-release-d...

akie 5y ago
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.
- teekert 5y ago
  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.

BurningFrog 5y ago

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.

ObserverNeutral 5y ago

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.

janekm 5y ago

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.

kmeisthax 5y ago
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?
- janekm 5y ago
  Indeed, how dare they! https://www.ft.com/content/fa1e0d22-71f2-401f-9971-fa27313570ab https://www.ft.com/content/fa1e0d22-71f2-401f-9971-fa2731357... ("Vaccine makers say IP waiver could hand technology to China and Russia")

caymanjim 5y ago

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.

refurb 5y ago

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

specialist 5y ago

Weighing the lives of billions against intellectual property claims and turf. -- 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.

thecleaner 5y ago

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.

credit_guy 5y ago

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?

tssva 5y ago
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.
- credit_guy 5y ago
  Thank you for the explanation.

ta988 5y ago

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.

sjm 5y ago

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.