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Waiving IP

The announcement by the Biden administration about waiving IP rights to the coronavirus vaccines obviously calls for some comment. Keep in mind that I have been doing research in the pharma industry for over 30 years now, so my viewpoint is obviously going to be affected by that, for better and for worse.

With that said, what you think about this move will depend on what you hope to accomplish by it. Let’s go to the immediate practical concern: will it open up the near-term supply of vaccines to the world? It will probably come as no surprise, but no, I don’t think it will do that. One big reason is that I don’t think that patent rights are the main reason for supply constraints – they’re not the bottleneck or the “rate-limiting step”, to use the language of chemistry. IP could be, if several other bottlenecks would get out of the way, but for now I don’t think that it is. Update: Alex Tabarrok on this issue here.

Non-IP Constraints on Vaccine Supply

I’ve gone over these other problems before, but here’s a brief summary of those – not in any order, because it’s difficult to rank them and those ranks change. An obvious first problem is hardware: you need specific sorts of cell culture tanks for the adenovirus vaccines, and the right kind of filtration apparatus for both the mRNA and adenovirus ones. You also need specialized mixing equipment for the formation of the mRNA lipid nanoparticles. A good proportion of the world’s supply of such hardware is already producing the vaccines, to the best of my knowledge. Second, you need some key consumable equipment to go along with the hardware. Cell culture bags have been a limiting step for the Novavax subunit vaccine, as have the actual filtration membranes needed for it and others. These are not in short supply because of patents, and waiving vaccine patents will not make them appear. Third, you need some key reagents. Among others, there’s an “end-capping” enzyme that has been a supply constraint, and there are the lipids needed for the mRNA nanoparticles, for those two vaccines. Those lipids are indeed proprietary, but their synthesis is also subject to physical constraints that have nothing to do with patent rights, such as the availability of the ultimate starting materials. Supplies have been increasing via the tried and true method of offering people money to make more, but switching over equipment and getting the synthesis to work within acceptable QC is not as fast a process as you might imagine. Fourth, for all these processes, there is a shortage of actual people to make the tech transfer work. For most reasonably complicated processes, it helps a great deal to have experienced people come out and troubleshoot, because the number of tiny things that can go wrong is not easy to quantify. Moderna, for one, has said that a limiting factor in their tech-transfer efforts is that they simply do not have enough trained people to go around. And keep in mind that these all have to do with producing a stream of liquid vaccine solution – but you need what the industry calls “fill-and-finish” capacity to deal with it after that. Filling and capping sterile vials for injection is a specialized business and the great majority of large-scale capacity is already being used for the existing vaccines. Time and money will fix that, and has been, but waiving vaccine patents won’t.

Short Term Versus Long Term Supply

The mention of scale deserves some comment. We need to vaccinate billions of people around the world – no argument there. But that means that if you’re working under the constraints above, your time and effort are best spent on the largest capacity manufacturing efforts available. I believe that the majority of these are already enlisted in the vaccine production efforts, though, both in the production and fill-and-finish areas. I have seen people talking about how now every country will be able to produce its own vaccines, but that’s not a feasible or useful idea. Most countries do not have industrial cell culture capacity or sterile fill-and-finish lines, and trying to start them from scratch is not a good use of the time, money, and effort. It would be like deciding that Switzerland needs to be self-sufficient in sushi.

Look at a part of pharma world that (while it has its technical aspects, for sure) is much less demanding than vaccines, the production of small-molecule generic drugs. The chemical matter involved is off-patent, and nonpatented routes are available for them. But the great majority of these drugs are still made in a handful of countries, and if you trace the starting material supply chains back, the list of countries and suppliers narrow still more. As with most industries, you find yourself going back to the people with the expertise and equipment to produce things on large scale.

As mentioned several times during the above, these supply problems are all fixable. Indeed, many of them are already greatly improved compared to the situation a few months ago. But from what I can see, none of this fixing would have been aided by waiving the patent rights to the vaccines themselves at some earlier date. The supply of vaccines has been increasing, and would continue to increase without the patent waiver idea. The constraints are physical ones, supply chains and engineering ones, not legal.

We actually have some proof of this already. As others have noted, Moderna announced last October that they would not enforce any of their own patents on the production of the vaccine. But this has not led, as far as I can tell, to any non-Moderna production of it, or even the announcement that anyone is thinking about it. A more cynical person than I am – they exist – might conclude that Moderna knew this full well when they made their announcement, but in either case, this situation largely obtains because of the constraints above.

What Does the Patent Waiver Proposal Entail?

We also need to talk about what the Biden administration has proposed. Despite some headlines, the announcement was not something like “All patents are waived”. The actual text uses this language:

“The administration believes strongly in intellectual property protections, but in service of ending this pandemic supports the waiver of these protections for COVID-19 vaccines. We will actively participate in text-based negotiations with the World Trade Organization (WTO) needed to make that happen. These negotiations will take time given the consensus-based nature of the institution and the complexity of the issues involved.”

That last sentence is actually a bit of a warning and a bit of cover for the amount of time that this will take. No IP has been waived yet, because the WTO and the World Intellectual Property Organization (the international framework for patent protection that most countries belong to) are going to have to weigh in on this. There are several countries involved in the existing patents, and they will all have their say as well. The WTO meets next in June, and at that point we’ll start to see how protracted a process this will be. It could indeed take a while, and what emerges at the end of it is of course not yet clear. Not every government involved is going to be thrilled.

This is why many comments on this decision have called it as much of a public relations move as anything else. I can see the point. It is indeed a big step for a US administration to call for something like this, because the US (with a large proportion of the R&D-driven industry in the world) has traditionally been very hard-line on patent protection. But calling for it is not the same as delivering it (for various definitions of “it” and various values assigned to them!) For now, the US government has agreed to start to think about how to negotiate the issue, with details to follow at an undetermined later point.

The Desirability of IP Waivers, and of Patents in General

I know that many people are ready to argue these points, and I can see why. They’re fun. They’re emotional, and lend themselves to ringing statements of righteous principle, and I feel the temptation as much as anyone. But I’m going to try to hold back, which is one reason I’m writing this post this morning instead of banging something out last night.

First off, I am simply not going to take on the “Big Pharma is evil and they deserve what’s coming to them” point of view. Boy, can you find a lot of that one on social media, and I’m trying not to respond to all of it (although I have slipped a few times). So let me just say that I have not worked the past thirty-something years of my life to poison people, to keep them sick, or to bury cures so no one can find them. I have seen good friends, colleagues, and beloved members of my own family succumb to the very diseases that I have researched treatments for, and if I could have done something for them, I would have. I know it’s fun for passionate activists and grandstanding politicians to pretend that that they’re battling hordes of Vile Inhuman Pharma Fascists, but folks, it’s actually mostly a bunch of people like me. That’s not to say that we don’t have some real bastards in this business, but guess what? So do you, in yours. We stock the buildings with people, and they’re not all gems. I hate the Martin Shkrelis of the world as much as you do.

Now, to patents themselves. It’s not that great a use of our time to have the fight right here, either, but it will come as no surprise that I think that intellectual property protections, while they can be abused, are a net good. I think that incentives are a good thing, and that IP rights provide an incentive to take the risks needed to discover things. But those are broad terms. The degree of such protection and how long it lasts are of course key things to get right, and you can get them wrong, too. For example, I think that current US copyright law is way too restrictive and should be rolled back to something less lengthy. Imagine if drug patents lasted through the lifetimes of the inventors and 70 years past that! Penicillin wouldn’t be generic yet.

Remember, a patent is not a secret. You have to disclose how your invention works and how to make it work in order to be granted one, and others can go ahead and get to work on how to make you obsolete based on that information. Also remember that for many drugs, by the time the patent issues, it often has eaten up most of its lifetime. The clock doesn’t start ticking from approval; it starts from the application priority date. I have found over the years that many people outside of R&D do not realize these two points.

I can imagine different ways of doing it, though, most of which involve some other way of rewarding inventors via prizes and the like. For these to work well, though, I believe that such prizes would need to be on the same order of magnitude as the value of a patent as we issue them now. A tricky aspect of this is that this value is not always immediately obvious – sometimes things turn out to be more valuable, and sometimes less than they appeared. That’s another detail to be worked out in a prize system, but there are several ways to do it. With such systems, you’re still recognizing that there is such a thing as valuable intellectual property – you’re just finding a different way to reward it.

What I don’t see working, though, is the “Get rid of all intellectual property, everything should be free” viewpoint. I’m not even going to debate it, because to be honest, I lost my taste back in college for endless wrangling about infuriating hypotheticals, and that’s all this proposal is. I refuse to take it seriously, and I refuse to take seriously the people who attempt to advance it.

But that means that proposals to abrogate existing IP protections need to be taken seriously, because I believe that you’re messing around with something of great importance. In its crudest form, an IP waiver is a direct taking of such property from its discoverers and owners without compensation, and I don’t like it at all. A system that allows such things to happen whenever people really feel like it will not work as well as one in which property rights are protected.

All That Money

I realize that this talk of IP waivers comes, as fate would have it, while some of the vaccine companies are reporting earnings on the vaccines themselves. Pfizer, for example, has said that they may well have $26 billion of sales of the vaccine that they developed with BioNTech. And while I don’t know what the actual profit will be, it’s going to still be a lot. Allow me to be offensive: good for them. 26 billion is a small fraction of the economic damage that’s been done during the year because of the pandemic, and these vaccines are really the only way out of it. Add to that the incalculable social and psychological damages, and it’s a damned cheap price for all of the vaccines put together. Remember, there was no guarantee that any of these things would work – several large and very competent drug companies (Merck, GSK, Sanofi) failed in their own vaccine efforts.

The vaccines that have worked have been the result of years of work by both academia and industry. Both of these groups have hoped to profit by their efforts. And as I never seem to get tired of pointing out, a lot of that work went into discovering things that didn’t work. RNA constructs that fell apart or didn’t produce much protein. Formulations that didn’t deliver, or were toxic. Viral vectors that weren’t worked-out enough, or couldn’t be produced in sufficient quantity. Genetic payloads that weren’t written in quite the right ways. So when something finally does work, I am all for being able to profit from it, and to cheer on the people who are hoping to profit from the discoveries that are working their way through the academic and industrial labs now.

183 comments on “Waiving IP”

  1. Matthew says:

    As was mentioned, at the next pandemic or health emergency, companies will think twice before putting their own capital at risk. Or even dedicating their Human Resources to the problem, knowing it’s going to hurt the company in the long run.

    1. David E. Young, MD says:

      Excellent point. And not one that has been considered in the Biden’s waiving of patent rights, I’ll wager.

      1. Glenn says:

        Oh, for sure considered. But rejected.

      2. CET says:

        I may be putting too much faith in the intelligence of everyone involved in this decision, but my read is that it is mostly about virtue signaling.

        I would be surprised if the decision was made without both an actual analysis of the situation and closed-door talks in which Moderna, Pfizer, etc, were assured that this was a one-time gesture that no one expects to actually lead to anything rather than a sign that the US was making a 180 turn on patent rights in general.

        But then again, I am often surprised by the extent to which the average person in a position of power and responsibility is no more intelligent or competent than the average walmart greeter, so who knows.

        1. Brian says:

          I expect that you’re quite right that they aren’t intending for this to go anywhere, but virtue signal long enough, and eventually you end up with a legislative body all saying the same thing with an electorate staring them down. And the legislators care more about reelection than long term consequences. I think we should take it seriously when politicians play these games, because it eventually gets away from them.

    2. luysii says:

      Agree. This is incredibly short sighted. Hopefully the next pandemic will a century away when all this will have been forgotten but there is no guarantee of that

      1. Surfactrant says:

        Is this not an over-reaction?

        1. No way this ‘IP rights waiver’ will happen quickly
        and PFE will have already made their well earned cash by the time its implemented (if ever).
        2. as Derek pointed out, its not really the IP that’s limiting production anyway, so even if the IP is free right now, PFE market will hardly suffer.

        I really have a hard time seeing how inhibit the next round of innovation.

      2. Micha Elyi says:

        “The next pandemic” will occur after this current bit of battlespace preparation for a fight to void the whole concept of patents and intellectual property (IP) is over. Mark my words, upon the next pandemic, the same sorts who covet their neighbor’s goods will be back again, in larger numbers, in a well-prepared battlespace. The looters will keep trying until they prevail. It has always been thus.

        Who here cannot name at least three examples of socio-cultural and legal impediments that were swept away in the USA and elsewhere in Western nations for acts that just a few decades ago we were assured, “That will never happen.”

    3. DBrand says:

      Many small innovative start-ups like Biontech, Moderna and Curevac have pioneered mRNA technology for the last 10 to 20 years for cancer therapy, sometimes without making a profit. The earnings from the Covid vaccines will allow these companies to invest more heavily in novel cancer therapies and novel vaccines against infectious disease.

      Waiving their patent rights would devalue these companies and make them easy targets for takeover by the big pharma companies that failed to develop a Covid vaccine.

      1. Anon says:

        “without making a profit. ”
        No company does business without profit. Stop it please.

        1. MMK says:

          “No company does business without a profit”
          This is demonstrably false, especially for startups.

        2. Fidel says:

          I guess capitalism is Big Lie #2…

        3. JasonP says:

          “No company does business without profit. Stop it please.”

          Seriously? What is the “start-up” phase of any new business? They are “in business” but spending more money than they take in.

          Gee, how many years did Amazon go selling books and widgets before it turned a profit? Companies don’t need profits if they can convince investors to keep pumping money in. Seems like you wouldn’t be able to get that pair of sneaks the next day if it weren’t for “profits” from the “cloud” business.

          1. Tom A. says:

            I concur. Another example is Tesla Motors. It’s been a ten year slog of annual losses before they made any kind of reasonable profit. Even then some of that income derives from sale of offsetting emission credits to other car manufacturers.
            Well argued points by Derek and other commenters.

        4. Micha Elyi says:

          Not even President Joe “10% for the Big Guy” Biden works for free.

          [H-word redacted]

    4. WST says:

      “will think twice before putting their own capital at risk” – isn’t it a little bit more complicated then that, and maybe only partially true about current situation?
      18 billion of US public money was spent on Operation Warp Speed
      Sanofi & GSK got 2.1 billion $ and failed, what was the risk they took?
      Apart from direct financing, purchasing guarantees were given.
      And research…lots of it is financed via grants.
      How did all these small innovative companies survived without a product, for 10-20 years ? Grants of public money via state research agencies.
      Even BionTek/Pfizer got hundreds of millions of USD from German government and 2B$ purchase guarantee from US government .
      EU spent round 6B$ in R&D financing and purchase guarantees.
      97% of AZ development was financed by public money and charities (Guardian).

      Even if the IP protection is waved, which doesn’t seem to solve any real issue anyway, I would not worry for the next epidemic, new ways to finance and limit exposure will be found.

      1. Walter Sobchak says:

        The contracts under which the subventions were granted will specify the quantum of rights conveyed to the US government. Whatever those terms were I assume they seemed fair at the time. The companies that failed likely put some of their own resources into those efforts. But, the possibility of failure was no doubt considered and detailed.

      2. Micha Elyi says:

        “…what was the risk they took?”

        Large. As was said on Usenet, WST (5:26 pm), “do your own homework.”

    5. Blaise says:

      I don’t think waiving the patents in this case will alter much the incentives pharma companies face. In the case of a pandemic, billions of dollar of profit can be made by being the 1st to produce a vaccine. The sales are so quick that just a few months of monopoly power is enough to justify R&D costs and risks. Nothing comparable to normal times where it can take decades to pay back the R&D of a novel cancer treatment.

      Do you think Pfizer would have put less efforts developing a vaccine if they had known that sometimes in 2021 patents will be waived? They have already made a huge profit and will continue making a lot of money for a while. And there is a good chance all these pharma companies had already internalized the risk of a patent waiver.

      Anyway, all the people against patent waiving are arguing that it will change nothing because bottlenecks are somewhere else. That’s really possible, but in this case what are they worried about?

    6. Not-an-epidemiologist says:

      In other words, big pharma will save the world only if they can make a profit at the same time? This attitude may well be valid for some companies. But if you wanted to prove, categorically, that big pharma is evil, then you couldn’t have found a better argument.

      (It’s worth noting, incidentally, that this thankfully doesn’t hold, at least not completely — AZ is giving away their vaccine at cost, and as Derek noted, Moderna has stated that they won’t pursue patents on their vaccine.)

      Of course R&D costs money, of course big pharma do an enormous amount of good in the world, and of course we couldn’t live without them. But it’s not nearly as simple as Derek’s post makes out — patent evergreening is a thing, and it’s not cool. And the biggest of Big Pharma (say hello to J&J and Pfizer) are not exactly just scraping by on the poverty line.

      But regardless, pandemics are not normal times and it shouldn’t be business as usual, even for pharma. Will suspending patent IP on covid vaccines make an immediate difference? No. Will it make a difference in 18 months? I’m not as sure as Derek that it won’t (my own country is belatedly planning to establish mRNA vaccine production facilities, and I’m sure it’s not the only one). And I’m very sure that the world will still need covid vaccines in that time-frame. I agree that it’s complicated, but my personal feeling is that an IP waiver has a better chance of helping than not.

      (Incidentally — if an IP waiver does lead to the faster adoption of mRNA tech, then I would imagine BioNTech, Moderna and CureVac will ride their patent trains all the way to the bank for subsequent non-pandemic-related vaccines. Let’s face it, there’s only one direction that vaccine production is headed in the future. And, for those three companies, I’ll very much join the chorus of, “Good for them!” Just, let’s save lives first, ok?)

      1. MMK says:

        “ In other words, big pharma will save the world only if they can make a profit at the same time?”
        Yes. That’s pretty obvious. Why would you expect anything else??

        1. MRK says:

          Jeez…. so, all these companies saying “patients & families come first” were not telling the truth?

          1. Micha Elyi says:

            Yes, they are telling you the truth. The people organized as those companies earn incomes their families rely upon by making the lives of patients better.

            But neither that nor production bottlenecks are the reason for the “Thou shalt not covet thy neighbor’s goods” enshrined in secular law everywhere. You won’t like the alternative of war of all against all after you make all the laws flat.

        2. tim Rowledge says:

          Well, I don’t know – maybe the thought that all their potential future customers, employees, family etc could die might just possibly motivate some people. Not you, obviously.

          1. theasdgamer says:

            Pharma does best from repeat business.

            These vaccines are quite possibly snake oil. As long as people believe that they help, pharma will continue to sell them.

            The pharma studies on vaccines didn’t mention PCR cycle thresholds used and didn’t culture virus. That might have exposed the vaccines to be a scam. For now, we have no real idea whether they are effective or not.

          2. Derek Lowe says:

            Is there some way that you can be persuaded to find another place for your opinions? Honestly, you’re not accomplishing anything around here, and your constant posting is simply too much. I’m trying to ask politely here.

          3. theasdgamer says:

            Derek,

            I also am trying to be polite.

            There are _many_ lurkers and your failure to answer my questions only persuades the lurkers that you can’t answer my questions.

            I don’t expect to persuade panicked sheep, but the unpanicked who are a little skeptical of the narrative might be persuaded.

            I know of quite a few doctors who aren’t buying the narrative.

            Of course, if you answered my questions, you might even persuade _me_ as well as the lurkers. I especially read journal articles, so please link any that you find persuasive.

          4. Derek Lowe says:

            Unfortunately, I’m not persuaded that you’re arguing in good faith, or that you’re truly persuadable. Your relentless posting here is not something I can devote enough of my life of to refuting and arguing every one of your debating points – I have a day job in the Evil Pharma Industry, remember. I wake up in the morning and find another seventeen posts from you, and my heart sinks. I’m just asking you to find another outlet for your overflowing energy, and to stop using the comments section here as a soapbox. Thanks.

          5. theasdgamer says:

            Derek,

            Maybe you could reply to _one_ of my questions and see where we go from there?

            How about this point. Maybe you could start by correcting your post about the RECOVERY trial acknowledging that RECOVERY is a late treatment study of hydroxychloroquine and one of its limitations (which was somehow excluded from the journal article) should be that its conclusions do not apply to early treatment in outpatient settings. By way of comparison, Regeneron was being given early to high risk outpatients in a hospital clinic as part of a trial, which makes sense.

            Is that really too much to ask?

      2. TC says:

        You are making a critique of the underlying capitalist system on an emotional basis, not an outcomes basis. The outcomes were certainly better. I care about the outcomes more personally when it comes to saving people’s lives.

        It worked here, and a lot faster than a control economy would’ve via greed as well as the social impact attracting effort…

        Moderna and BioNTech working hard on this in early January 2020. Central planning would’ve been slower, and probably less effective. Can compare to more centrally controlled economies – market economies got better tech outcomes.

  2. J Curwen says:

    There are 10 nanograms of DNA allowed in the “RNA vaccines”, corresonding to 3.03 x 10^10 300 bp DNA fragments. Their potential for genomic integration in combination with the new LNPs has never been tested.
    Now it turns out that the quality control system for measurement of residual template DNA is done by quantitative PCR with two (2) primers, so only full length inserts are detected, no fragments (after DNAseI digestion!). Therefore the amount of DNA is completely underestimated.
    How can the EMA allow this? Every student knows that absolute DNA quantification is done by acid hydrolysis followed by mass spec.

    1. Anonymous says:

      Are you saying the vaccine will make me Spider-Man? Because that’s what is sounds like you are saying. Sadly, I have yet to realize my wall crawling powers.

      1. Micha Elyi says:

        I expected 5G reception. Two jabs yet nothing. See, capitalism failed us again!

    2. lapsed chemist says:

      What would be an appropriate limit then? … 1ng? How much safer is that? You see where I am heading with this line of thinking – everything has a safe and unsafe limit. You need to draw a line somewhere.

      If you think the current levels are too lax – provide a risk/benefit justification for a lower level.

      1. J Curwen says:

        The 10 nanos were selected for regular vaccines, not for a potent transfection agens. To my understanding the DNA fragments will end up in the LNP droplet due to similar charge as the modRNA , risking genomic integration.

        1. Lapsed chemist says:

          What is a safe level? 0? That is not practical, so we have to accept some risk, or have no vaccines. You appear to have some understanding of PCR, but lack an understanding of the process of setting specifications. Try thinking of this problem from the opposite perspective and you may understand why you are speaking a different language than us..

          1. J Curwen says:

            Thats exactly the point why there has to be some science done before vaccinating the entire young generation. The worst case scenario would probably be germline transformation. The EMA has even guidelines for that risk:
            https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-non-clinical-testing-inadvertent-germline-transmission-gene-transfer-vectors_en.pdf

    3. xrayxtals says:

      I’ve seen this copy/pasted a lot lately, but wanted to point out a couple things.

      Residual DNA is tested for in every Biologic on the market, this isn’t something new to the COVID vaccines.

      Here is a link to the product insert for a residual CHO DNA detection kit (a common source of Biologics production): https://www.thermofisher.com/document-connect/document-connect.html?url=https%3A%2F%2Fassets.thermofisher.com%2FTFS-Assets%2FLSG%2Fmanuals%2Fcms_082358.pdf&title=Q0hPIFJlc2lkdWFsIEROQSBRdWFudGl0YXRpb24gUHJvZHVjdCBCdWxsZXRpbg==

      Refer to Figure 4 to see that fragmentation of the DNA does not affect the ability to accurately quantitate DNA amounts.

      1. J Curwen says:

        This system is interesting for genomic samples.
        However, if you have only two primers for amplification of a 2 kb linearized plasmid (T7-Kozak) which you have beforehand digested with DNAseI, you will not get any signal of fragments beside the uncut full piece. Right?

        1. xrayxtals says:

          I don’t know how the release assay works for determining DNA levels within the mRNA COVID vaccines. But, I would not agree with your statement.

          Amplicons (the piece of DNA being amplified) are typically 50-200 bp in size for qPCR assays. It would be very silly to design your primers for the full length of the linearized vector (because of exactly what you mention). You can absolutely have multiple PCR primer/probe combinations within a single qPCR assay. A well designed residual DNA detection assay would make sure to account for this, based on real-world conditions (e.g. what size fragments are left).

          If the DNA template is digested into fragments, its very likely they are purified/filtered away from the mRNA product prior to generation of the LNPs. So this may be a moot point.

          1. J Curwen says:

            Its exactly as you said ( “It would be very silly to design your primers for the full length of the linearized vector”), this are the primers: “The qPCR master mix is prepared containing fluorescent qPCR quantitation reagent, T7 UP forward primer (5′-CCT GAT TCT GTG GAT AAC CGT ATT ACC GCC A-3′, 0.30 μM), and Kozak reverse primer (5′-CTC TCT GAG TCT GTG GGG ACC AGA AGA ATA C-3’, 0.30 μM) in nuclease-free water.”
            no other internal primers.
            I dont want to link the EMA paper but you can find it if you want.

        2. Kumar Raj says:

          The fact that we are NOT seeing serious immune reactions with these mRNA vaccines (other than the extremely rare cases of anaphylactic reactions), we can safely assume that the DNA present is not problematic. For one, any extraneous DNA in the cytoplasm, that is where the mRNA content of the LNP gets released, would produce immune response through cGAS/STING and other mechanisms and we are probably not seeing that in the general population. Secondly, any DNA in the cytoplasm will get chewed up by various nucleases because DNA is not supposed to be in the cytoplasm. Its home is in the nucleus. Thirdly, the DNA has to translocate from cytoplasm to the nucleus in order for genomic integration has to happen. The point is, this may be a highly unlikely risk.

          1. J Curwen says:

            I agree to “The point is, this may be a highly unlikely risk.”
            How unlikely? Unlikely as the chernobyl super-GAU? Unlikely as the AZ and Sputnik problems?
            Thats exactly the point why there has to be some science done before vaccinating the entire young generation.

          2. Micha Elyi says:

            All right, apart from all the science, what science has Big Pharma done for us?

            I see a parallel…

            “All right, but apart from the sanitation, medicine, education, wine, public order, irrigation, roads, the fresh water system and public health… What have the Romans ever done for us?”–spoken by John Cleese as Reg in Monty Python’s Life of Brian

        3. Not-an-epidemiologist says:

          Why do you think it’s 2kb? The mRNA is transcribed by T7 pol, so the T7 promoter should be just upstream from the Kozak site. And looking the only plasmid map I can find online (a document on some dodgy antivac site, concerningly, but it seems legit) that’s exactly the case — the start of the T7 promoter and the end of the Kozak are 70bp apart. The Kozak primer is 30bp, so let’s assume an amplicon of no more than 100bp — a perfect size to control for any small DNA fragments.

          What am I missing here? 2kb makes no sense.

          1. J Curwen says:

            Thats even worse.
            The quality management for residual DNA remnants of a 7,824 bp plasmid after DNAseI treatment is monitored by the quantification of this snippet? Without any other primers?
            You can never control the digestion in a way that you would get consistent results (see in the same paper the inconsistencies of residual DNA amounts).
            Quite hard knowledge for people who were told they get a “DNA-free” RNA-vaccine without any risk for integration, e.g.:
            https://www.health.gov.au/initiatives-and-programs/covid-19-vaccines/is-it-true/is-it-true-can-covid-19-vaccines-alter-my-dna

          2. Not-an-epidemiologist says:

            Thats even worse.
            The quality management for residual DNA remnants of a 7,824 bp plasmid after DNAseI treatment is monitored by the quantification of this snippet? Without any other primers?

            Of course that’s fine. Do you think DNaseI is selective?? That badboy enzyme takes no prisoners on plasmid DNA, and I can only assume that you’ve never used it or worked in molecular biology. Besides which, this is only the first step in a multi-step purification process designed to remove residual DNA and proteins. And even if all of these QC checks were inadequate (which they’re most certainly not) — even then the risks of any residual free DNA doing you any sort of harm at all are infinitesimally small.

            I don’t know why I’m bothering to feed an obvious troll. But just in case your intentions are good — please, I realise new technology always seems dangerous, but it appears that you don’t know what you’re talking about and you’re well out of your depth (especially on this site). If you don’t believe me and you work in a lab, then just waste a day of your life and $30 of primers to test it out on a construct and see for yourself.

          3. J Curwen says:

            OK, thank you for clarification, you might be right on this.
            Still would not give it to kids.

      2. DrivingBye says:

        I’ve promised myself that after I lose 10 pounds, I’m going to have a fancy steak and some fancy scotch to go with it. There’s going to be about 1,000,000,000 NATO grams of DNA in that steak, and I’m going to eat every one of them.

        1. J Curwen says:

          I know atto, I know NATO, but I never heard about NATO grams.
          I really hope they are not dangerous.

          1. DrivingBye says:

            Chuckle. That’s what I get for using seak-to-text and not reading my post twice before hitting send.

    4. ROGI says:

      love to see you do an acid hydrolysis and recovery on 10 nangrams of substrate, neutralize and shoot into to a quadropole mass spec. Obviously absurd.

      1. bobby says:

        hey, there’s an easy answer to this use 1-10,000 times sample and do some basic maths. it’s absurd to vaccinate our youth with a vaccine against a disease which carries virtually no risk

        1. Tirani Link says:

          The several million people in the United States alone dealing with Long-COVID symptoms would disagree with you about a “disease with virtually no risk.” Additionally, as those kids grow up, if they’re not protected from the disease, they will get it.

          You are using an emotional argument without actually stopping to consider things like facts. As pointed out earlier in this thread, new technology always seems scary.

          Remember how people screamed in the early days of vaccines that was going to infect everyone and kill them? Instead it helped pave the way for inoculation to get rid of smallpox, and almost eradicate polio. You’re repeating the same old song and dance just because it’s new. Replace coronavirus with rabies, smallpox, polio, measles, rubella, you get the idea.

    5. Patrick says:

      This is clearly pseudoscientific scare mongering, designed to have just enough structure to sound bad.

      This absolutely been tested in lab environments, to the extent relevant, and it’s also borderline nonsense. And why the specific mention of the EMA and not literally any other regulatory organizations(s)?

      I know it’s a big ask, but I’d love if we could not copy paste obvious attempts at misinformation and manipulation.

      1. J Curwen says:

        Yes, sure we know everything about the integration behavior of short DNA fragments in combination with the brand new LNP transfection agents.
        You can even get integration of short PCR fragments without transfection agents if you use cells which take up DNA via endocytosis:
        https://biolres.biomedcentral.com/articles/10.1186/s40659-017-0107-x

        1. xrayxtals says:

          From your article:
          “Cancer cells are known for having gene mutations and the evolving ability of endocytosis. Their uptake of DNAs might be different from normal cells; they may take in DNAs directly from the environment. ”

          “The data demonstrated that hepatocellular carcinoma cells possess the ability to take in large DNA fragments directly without a transfection reagent whereas normal liver cells cannot.”

          1. J Curwen says:

            Come on, thats the point!
            The cancer cells show that if you find a way to take up DNA, it will be integrated (the smaller the fragments, the easier), even without transfection agents. A “normal” cell will also integrate any DNA if it is internalized (via the vaccine LNPs). Its clear that cancer cells also have other trouble like polyploidy et al, which might favour integration, but the risk with LNP-DNA exists and has not been analyzed.

          2. qetzal says:

            The paper says nothing about the DNA even entering the nucleus, much less integrating into the genome. In fact, the confocal microscopy with fluorescent labeled DNA clearly shows that *all* the detectable label (in red) is retained in the endocytic vesicles (destined for breakdown in lysozymes, almost certainly). No DNA label is visible in the nuclei (stained blue).

          3. J Curwen says:

            for qetzal (below): Are you kidding me?
            “The 32P-labeled DNA had been integrated into genomic DNAs of Huh7 cells, and all sized DNA fragments in this experiment can enter into the cells with high efficiency even though the efficiency tends to be decreased along an increased length (Fig. 1b).”

  3. Keith says:

    Protecting and respecting IP in the COV-19 vaccine promotes the combating and quenching current pandemic. Most likely, we need new Cov-19 vaccines for the Cov-19 variants. If the waiving IP rights to the coronavirus vaccines is forced to implement, who has the motivation to develop next-generation vaccines. Waiving vaccine IP rights only can delay vaccine development and impede combating pandemics.

  4. How long would it take current producers to supply the entire World? What would be the breakeven production cost?
    When I heard the anthrax/Bayer/Cipro story intro to Maddow’s A block, I thought she would explain how this situation is NOT analogous. Must say I was shocked to hear what followed.
    What I heard last night was IP waivers, raw materials, equipment, tech transfer, validation, training. Without running any numbers, it seems to me that will slow down current vaccine production, not hasten it.
    If additional facilities are needed, I can guarantee that each of the current producers can get an additional facility online quicker than another entity being coached through the process. To me, this sounds more like a JOBS act for whichever countries become the beneficiaries.

    I will freely admit that I’m politically-impaired. I have no clue how to value the Good Will that would come from this action.

    1. Patrick says:

      I think it’s a sop to fools – frankly, and fundamentally. That’s super harsh, but oh well. That’s what it is – I don’t think it’s based in any meaningful analysis that’s worthy of respect.

  5. Druid says:

    There is a lot of virtue-signalling in this demand for waivers, and possibly no-one really wants it, they just want cheap licences, and preferably without any liability for anything that goes wrong (who will be responsible?).
    There are other costs. I suspect a lot of scientists were taken off their projects & clinical trials to help with the fast development, scale-up etc of vaccines. The resulting delays will mean additional loss of earnings from those projects.
    Then, how long will these vaccines be valuable in their current form? Another 12 months perhaps to get return on investment? Who will do that again if patents are taken away?
    Finally, thanks for mentioning other intellectual property rights; even 70 years post mortem is not enough for some greedy rights owners. It is reaching the point where no-one can write a new song without being accused of plagiarism because the copyrights of old songs never expire.

    1. Todd Knarr says:

      All of the waiver proposals I’ve seen haven’t involved a complete waiver of the patents, merely a “mechanical license” scheme where there’s a set (fairly low) royalty rate and anyone who wants to produce the vaccine merely has to pay the set rate and they’re good to produce it. Moderna and Pfizer and the rest would still get paid for all the vaccine produced, they just wouldn’t be able to use their patent monopoly to get “all the market will bear” rates.

      1. Druid says:

        If there are rules to prevent importation from new manufacturers into “home” markets, then everyone would go for it without being forced, I think. Hardly a waiver; apart from the headlines, a sensible approach. Any idea on liabilities?

  6. cynical1 says:

    “I can imagine different ways of doing it, though, most of which involve some other way of rewarding inventors via prizes and the like.” I’m sorry but, respectfully, I don’t think that is a good idea.

    In its current state, inventorship determinations in the pharmaceutical industry are already quite corrupt. Whenever you look at a list of inventors on just about any patent you can pretty much bet your 401K that someone doesn’t belong on it. Usually more than one as well. Add potential “prizes” on top of it and then it’s really going completely off the rails.

    1. Jane says:

      Prizes may be most useful in areas where existing financial incentives don’t work. For example with antibiotics. If you developed an amazing antibiotic, the best antibiotic ever, the infectious disease specialists won’t use it because they don’t want resistance to develop to the new wonder drug. No use = no money, so alternative compensation methods are needed.

      1. cynical1 says:

        That’s actually not true and my last job in the industry was in antibiotic drug discovery. The doctors will use it when the other standard drugs fail for their MDR MRSA infection but they will usually use it as a last resort as opposed to a first line therapy. They are not going to let the patient die. Pfizer made really good money off of Linezolid and it wasn’t first line therapy for anything. No, it’s not chronic therapy like a statin but you can still make good coin off of it. There was a time when the industry would not touch an orphan drug indication. Now, someone taught the bean counters that they can charge out the wazoo for a drug that only treats 10 people. No prize money needed. Used to be that everybody and their sister worked on obesity – arguably the biggest market in the industry. Now, not so much.

        That aside, the “prize” in drug discovery is that you actually get to keep your job for something longer than a few years before they throw your butt to the curb because they want the money from your salary to pay for clinical trials. No one is going to give you a prize today for the possibility that your patent might one day make some money many years in the future. And by the time it does, you’ve already been laid off three times at three separate companies. You are no longer an employee of the company that is going to profit from your invention. And they are not going to track you down and say “Gee, thanks Dude. Here’s some money. See ya later.”

        I am old enough to remember a time when your employer gave you $1 for each one of your patents because there was some school of thought that they had to show that the inventor profited from their invention. At some point, that school of thought changed. You showed up at the patent lawyer’s office, signed the documents and got back to your fume hood. You didn’t even get $1 for your invention.

        1. Druid says:

          Linezolid didn’t do much for Upjohn. Restricted use of new antibiotics is medical practice, so they are always slow burners. It’s always nice to see Pfizer reap the rewards and claim the credit.

        2. Jane says:

          Your experience in antibiotic drug discovery is better than mine. The linezoid years were great, but more recently antibiotic research funding has been in decline as C-suite decides the profitability just isn’t there. I’m no longer doing antibiotics and neither are most of the people I know who used to work in that space. There are a few companies still working on it (often but not always funded by foundations, grants, angel investors etc rather than venture capitalists) but no where near enough.

  7. My comment above doesn’t begin to address the:
    -wisdom of distributing precisely THESE, already developed, vaccines to the entire World
    -impact on development of SARS-CoV-2 vaccine improvements
    -negative impact on future therapeutics’ development.
    I was strictly commenting on getting these vaccines into arms, quickly. CLL

  8. Charles H says:

    This is a *VERY* sticky issue. My real feeling is that drug development should be totally separated from drug vending. The details on how to do that though…calling that tricky is a gross understatement.

    I think that drug development should be done via an network of universities coordinated with an ARPA-like agency, that funding should be totally public, and that there should be a mechanism for long-term funding, not administration-by-administration. How to do that isn’t at all clear. Then the patents should be held by the funding agency and be freely available to individuals, companies, and corporations that are resident in the area paying taxes to support the funding. That gets us up through phase 2 testing.

    Any “practicing entity” should be able to use those patents, etc. (including various production methods, etc.) to produce a drug the run phase 3 testing, after which they could sell the drug if the testing was successful. But that “knowledge transmission” is quite a dicey method, as has been mentioned here earlier.

    I note that there are LOTS of steps in this process that are insufficiently specified to enable it to work. And some of the steps possibly can’t be made sufficiently exact. E.g. even the same company can’t always transfer the knowledge needed for successful operation between production facilities.

    But I really think the current process is also broken. Companies are rewarded for “trivial modifications” (like replacing aspirin with acetaminophen in a formulation) with an extended patent. (And for me acetaminophen doesn’t do an good at all that I can tell. But the formulation with aspirin isn’t available any longer.) Then there’s the cholchicine event, when a generic was taken back into proprietary status. There are other cases.

    1. Dr. Manhattan says:

      “ I think that drug development should be done via an network of universities coordinated with an ARPA-like agency, that funding should be totally public, and that there should be a mechanism for long-term funding, not administration-by-administration. How to do that isn’t at all clear.”

      Having spent 14 years in academia at either end of my career (Rockefeller University, Harvard Medical School) and 26 years in industry (BMS, Pfizer, AstraZeneca) I can tell you that universities are NOT set up to do drug discovery & development. They do not have the necessary resources (therapeutic area biology, med chem, DMPK, animal testing, toxicology, clinical support, CMC, etc.) under one roof to pull off successful programs into Ph. 2. Universities excel at the basic research needed to catalyze new discoveries leading to ideas for therapeutics. But they are not set up structurally to do drug R&D. To do so would fundamentally alter their educational roles.

      1. theasdgamer says:

        Let’s just add veterinarians and animal labs to universities ad nauseam to fix it.

      2. David says:

        And it’s not like the Universities are free of profit motivation either….they also patent their (federally funded) discoveries.

  9. theasdgamer says:

    I can see younger people maybe taking a chance on vaxxes because of work or travel, but why give it to nursing home patients?

    fyi, “As a matter of comparison: There are 20 to 30 deaths reported every year to VAERS related to the flu shot. That’s with 195 million receiving flu shots. Compare that to the COVID shot, which resulted in 2,602 reported deaths through 77 million vaccinations.”

    Apparently, most of the deaths are associated with nursing homes.

    “A physician with a practice in the Kansas City area told LeoHohmann.com that of a recent 500-person sampling of nursing-home patients who received the COVID injection, 22 died within 48 hours. That represents an astonishing 4.4 percent death rate. Most people in the Kansas City area nursing homes are receiving the Pfizer shot, he said.”

    “As a matter of comparison: There are 20 to 30 deaths reported every year to VAERS related to the flu shot. That’s with 195 million receiving flu shots. ”

    https://leohohmann.com/2021/04/30/highly-cited-covid-doctor-comes-to-stunning-conclusion-govt-scrubbing-unprecedented-numbers-of-injection-related-deaths/#more-6304

    1. Nope says:

      I have seen you comment here in the past over ivermectin and hcq. I think you need to realize who your audience here is.
      1. This post is specifically talking about vaccine distribution and whether the waivering of IPs related to vaccine development by drug companies will do anything to speed up vaccination.
      2. Your article that you shared there is by a very little known publisher that is more than likely a predatory type of paper looking for views to increase their revenue from advertisers.
      3. The arguments you present are quoted almost exclusively by fringe doctors who show data that cannot be confirmed or replicated.
      The third point strongly implies that their evidence is not based in full facts. Misinformation is a tricky thing to navigate, especially these days. But bringing these arguments here convinces no one of your theory that vaccines are dangerous or that there are other drugs out there not being used for monetary reasons to fight COVID.

      1. theasdgamer says:

        You say that McCullough is a “fringe” doctor? You _do_ understand that he is managing editor for two major cardiology journals (Cardiorenal Medicine and Reviews in Cardiovascular Medicine) and Vice-Chief of Internal Medicine at Baylor UMC, right?

        If anyone is pseudo-scientific, I don’t think it’s McCullough. (Or Risch. Or Raoult. Or Heneghan.) But I’ll refrain from naming names. Because that would be a logical fallacy and arguments ought to rest on their merits.

        Articles continue to support my positions. Yours, not so much.

        Cool ad hominems, by the way.

        1. Stroodle says:

          Hah to avoid anyone else having to google those 2 “MAJOR” cardio journals, the impact factor of both are less than 1.

          That’s all the fact checking needed for your statements.

          1. theasdgamer says:

            Impact of both journals is at 50% in their subcategories.

            Your fact checking is only exceeded by your shoe size. Which means you might be hired by Politifact.

      2. theasdgamer says:

        Maybe you would believe Newsweek?

        Did 966 people die shortly after receiving Pfizer or Moderna vaccines? Mostly true. But this is old–from March 8th and reporting is slow and deaths are generally undercounted.

        https://www.newsweek.com/covid-vaccine-deaths-cause-pfizer-moderna-fact-check-966-died-1574447

        Is there causality? No, but there should be enough concern to investigate and instead we get people gaslighting about the deaths.

        1. nostradamus says:

          I believe you Adsgamer, it’s obvious. The vaccine efficacy is attributable in part to those susceptible to death from Covid being taken out by the vaccine instead. Norway flagged this right at the start of their campaign when people vaccinated in nursing homes were dropping like flies. UK saw the same surge in deaths, this is recorded in their national statistics. Waive manufacturers indemnity policies and let’s see much that slows down the gravy train that is the vaccine express. The real truth in all of this is that long term there is no chance of vaccines “ending” the pandemic. Moderna’s forecast on vaccine production for 2023 in their SEC filings says as much. Naive people take their shots for nobody’s benefit but the pharma companies, damage is also picked up by tax payers. Time will tell

          1. theasdgamer says:

            Idk about only nursing home residents being vulnerable to the vaxxes. Lots of rows in my VAERS report were under 40.

            Interesting that the CDC guideline for covid breakthrough reports for Ct is 28 or less.

            They couldn’t be massaging the data, could they?

      3. theasdgamer says:

        Derek,

        Have you bothered to do a VAERS search? I grouped by death, vaccine mfgr., age, VAERS ID, vaccine dose, and medications and got over 3k hits.

        1. VAERS says:

          “VAERS accepts reports of adverse events and reactions that occur following vaccination. Healthcare providers, vaccine manufacturers, and the public can submit reports to the system. While very important in monitoring vaccine safety, VAERS reports alone cannot be used to determine if a vaccine caused or contributed to an adverse event or illness. The reports may contain information that is incomplete, inaccurate, coincidental, or unverifiable. In large part, reports to VAERS are voluntary, which means they are subject to biases. This creates specific limitations on how the data can be used scientifically. Data from VAERS reports should always be interpreted with these limitations in mind.”

          1. theasdgamer says:

            Thank you Captain Obvious.

        2. Nope says:

          This is what I meant about knowing your audience.

          https://blogs.sciencemag.org/pipeline/archives/2021/03/10/dealing-with-the-literature

          https://blogs.sciencemag.org/pipeline/archives/2021/02/02/myths-of-vaccine-manufacturing

          https://blogs.sciencemag.org/pipeline/archives/2020/06/04/hydroxychloroquine-for-avoiding-infection

          https://blogs.sciencemag.org/pipeline/archives/2020/05/11/whats-up-with-ivermectin

          https://blogs.sciencemag.org/pipeline/archives/2020/03/29/more-on-cloroquine-azithromycin-and-on-dr-raoult

          There is plenty more that Derek posted about involving your conspiracy stuff that you will just need to comb through and find on your own.

          I realize the links are not clickable so just copy and paste them.

          P.S.
          When you argue science posts using sarcasm, it makes it seem to others that you actually do not know what you are talking about, and weakens your argument.

        3. theasdgamer says:

          Nope,

          I’ve already shown the problems with Boulware and RECOVERY regarding HCQ. Boulware was an underpowered early-to-late HCQ treatment study of low-risk patients. The NEJM paper omitted shipping delays of the drug and has still not been corrected. The paper implies that patients were treated within four days of symptom onset, but actually they were just assigned to an arm within four days.

          “RESULTS Requesting additional data, we found that 52% of subjects received medication 1-2 days after the intended overnight delivery; 19% of them outside the intended four-day intervention lag. After re-analysis, there was a reduced incidence of Covid-19 associated with HCQ compared with placebo (9.6% vs. 16.5%) when received Early (up to 3 days) after exposure (RR 0.58, 95%CI 0.35 – 0.97; p=0.044; NNT 14.5) but not Late (RR 1.22, 95%CI 0.72 – 2.04).

          We found a significant HCQ-associated Covid-19 reduction in subjects 18 to 45 years old with Early (RR 0.54, 95%CI 0.29-0.97; p=0.0448, NNT 11.5) but not Late (RR 1.02, 95%CI 0.55-1.89) prophylaxis, attenuated in older subjects (RR 0.75, 95%CI 0-27-2.05) and by co-morbidities. There were reductions associated with Early prophylaxis in household contacts (RR 0.35, 95%CI 0.13-0.89; p=0.025, NNT 5.7) and Health Care Workers (RR 0.74, 95%CI 0.4-1.38). We did not detect effects of gender, folate, zinc, or ascorbic acid.”

          https://www.medrxiv.org/content/10.1101/2020.11.29.20235218v1

          RECOVERY began treatment a median of 9 days post symptom onset (range 5-13 days). Has Derek corrected his analysis since RECOVERY posted this data?

  10. semiconductorGuy says:

    I am working in the tech industry in the IP field, and I think our industry and mankind would be better off without any patent protection.
    There is a huge barrier to making anything, and by the time you could replicate our products, you will be making an outdated product.

    We have massive cross-licensing agreements with our competition, and use patents more in a MAD way in the sense ‘if the total weight of our patents is about the same as yours, we are not going to litigate’.

    Despite earning money with IP, we would all be better off if we could replace the patent lawyers with engineers to make innovative products.

    IP is a serious impediment to scientific progress.

    For example, we can’t work with academic researchers, because they tend to require exclusive ownership of any IP that we generate together. We are not going to collaborate with someone if it takes away our freedom of action, so in the end, students are deprived of an opportunity to do very rewarding and relevant research.
    Especially universities are extremely aggressive and unprofessional, I do IP agreements with companies all of the time, their lawyers tend to know what is realistic and what not.

    If the industry could get rid of patents (and through cross-licensing we have already done this in a way), all of us would be better off.

    My thinking was always that the pharmaceutical industry is a different case and IP might be required here, as synthesis is fairly generic. The cost of developing a molecule to production is massive, while the barrier to copying the results is fairly low. But of course, I don’t really understand what it takes to make a vaccine.

    I would place the Tech industry on the far right of the Tabarrok curve (patents are harmful), while pharma might be on the left.

    Any thoughts? Do you think you need more or less patent protection in pharma?

    1. AVS-600 says:

      Yeah, I think your instinct is basically correct here: patents are there to help companies recoup up-front costs, so it makes more sense the higher the “buy-in” is for doing research. In pharma, those costs can be billions with a B, once you take into account at-risk spending on all the projects that didn’t make it across the finish line.

      That doesn’t mean there are no downsides to the system, as you’ve pointed out, and there are areas that could legitimately and practically be improved upon to benefit consumers. Fundamentally though, I suspect that If you don’t have patent protection, you don’t have new drugs.

    2. Patrick says:

      Sure! Speaking as someone in the computer industry with a chemistry background… There is *not* a huge barrier to making *most* things pharma develops. While the barrier is non-zero, manufacturing of most small molecule drugs isn’t very hard for companies with nearby experience. If there were no patents (and no alternate method of compensation), profits from the creation of new small molecule drugs would basically disappear.

      This is not true of the mRNA vaccines because they are absolutely cutting edge – there’s a story about how Pfizer only had finished a research scale device for one of the lipid mixing steps, and they decided they didn’t have time to design a bigger one (which was previously their plan for *eventual* large scale production of some mRNA product in the future) – so they just built hundreds and hundreds of the research scale device.

      Anyway, it is quite straightforward, on the whole, to synthesize most drugs at scale, doubly so if you have access to manufacturing details. (I am assuming an “open” information setup rather than massive attempts at secrecy.)

      Chips are fairly hard to design and create and also fairly (very?) hard to manufacture.

      New drugs are insanely hard to design/create (at least as hard as chips and with less certainty on results) and *most* aren’t very hard to make. Not really.

      1. drsnowboard says:

        Who wants to take the drug equivalent of Windows Vista..?

    3. Carl says:

      They’re different. True, open source software has spurred a ton of innovation by lowering barriers to entry. But software is a much different business. For most applications there is no approval process, so products can come to market extremely quickly and for much less cost. A corollary of this is that it’s easier to defend an advantage through agile feature updates and there are network effects as others build on your product. These factors are especially true with SaaS products. It’s harder to defend a drug by improving on it because their range of functionality is limited often to one function, there aren’t opportunities for network effects and because of the longer approval and research process.

    4. van t Oever says:

      Patents may serve multiple different uses.
      We applied for a patent (and was granted) to specifically transfer a vaccine technology to low and middle income countries to prevent big pharma from scooping the market. That way the got a head start on recouping the investments made into new factories and training and build up knowledge.
      The initial vaccine development costs were carried by government, BMGF, rotary.
      So not everything about them is wrong, it is you you apply it.

      Here patents are not the bottleneck, looking at the difficulty we experience in acquiring materials this is one of the main issues. Every material manufacturer is rapidly trying to expand, while every manufacturer tries to squeeze out every little drop. Spillage of vaccine is still occurring and should be looked at as well.

    5. Chris Phoenix says:

      Software patents were rare and hard to get in the U.S. prior to the mid-1980’s when some court decisions made it much easier. The software industry and infrastructure were very innovative prior to that time. (Copyright was relevant, and very useful, all along; it’s not like there was no IP protection. But if you could reimplement an idea, you could use it.)

      As far as I can see, patents have done significant harm to software development, and have not spurred innovation at all.

      Different industries have different needs. But anyone who says “All IP should be patent-worthy to incentivize invention” is overstating the case.

  11. Marcus Theory says:

    This reminds me of the lesser known half of a famous quote:

    “Information wants to be free. Information also wants to be expensive….That tension will not go away” — Stewart Brand

  12. electrochemist says:

    The other option might be for Pfizer, Moderna, et al. to submit and publish monographs in the USP/NF and/or PhEur with release tests and specifications for the vaccines. They could then announce that they will license their IP to the governments of certain countries for free providing those countries require in-country manufactured material to pass the compendial requirements (and that no drug product can be exported from said countries).

  13. Sok Puppette says:

    > it will come as no surprise that I think that intellectual property protections, while they can be abused, are a net good.

    They probably are… in pharma.

    In computers, they are, on net, bad.

    I think that’s because, frankly, mere ideas are cheap. If you have any given idea, others have probably had it before you, and others will probably have it after you.

    However, *in pharma*, if you simply have the idea for something, you’re almost nowhere. The hard part is the work to validate that idea and put it into practice, and you can easily fail at any point. You don’t get a patent until you show that you can actually *do* something, and you can basically never show anything at all without putting in a lot of slogging.

    Patents are a useful risk-and-profit-spreading mechanism for everybody working in pharma. If your idea does not work out, or doesn’t work out in the form you were working on, you may still get *something* new and useful working, and that may give you a patent that you can license to gives you a slice of some real product.

    In computers (not just software, but anything above the lowest hardware layers), if you have an idea for something, you can probably figure out whether it will work, and exactly how to make it work, with an hour’s hard thought. You can have a working prototype in a few days.

    The hard part in computers is combining your new thing with a lot of other random, possibly unrelated stuff in a big system, and building a business around it. But to get the *patent*, you don’t have to *do* the hard part. All you need is the prototype, and sometimes not even that. That gives you a license to tax the people who *do* do the hard work, without really creating much yourself.

    The two are extreme cases, but on the whole, I suspect that much of engineering is more like computers than like pharma. In any case, I think the whole debate becomes a lot more understandable once you understand *why* various people think what they do.

    1. Kaleberg says:

      They’re very different but also very similar.

      Software people often complain that most of their work consists of getting their clever idea to work in a complex framework of APIs, idiosyncratic operating systems and existing components. (I recently read several frightening multi-thousand word articles on the challenge of writing a program to open a file, write a few characters to it and then close it, the challenge being to reliably get the data written to the storage device. In theory this is maybe three lines of code. The articles quickly dropped into the arcana of file system implementations, obscure variations of POSIX processing options and device buffering strategies.)

      Pharma people also complain that most of their work consists of getting their clever idea to work in a complex framework of cellular chemistry, idiosyncratic ADME configurations and evolutionary peculiarities. (If our host hasn’t made aa point of this, a good number of commenters have.)

      I’m sure that people in lots of fields, scientific, technical and otherwise, have a similar problem. A good elevator pitch does not a Hollywood blockbuster make.

      Clever ideas seem to be only a tiny fraction of actually getting things to work. As Mike Tyson put it, “Everybody has a plan until they get punched in the face.”

  14. Ed says:

    The question is, how much profit is too much? We understand that the main purpose of a pharmaceutical company is to make money first, then cure people. This is a special situation that requires special measures. The companies should be able to recover the money invested plus some profit. Again, what would be a reasonable profit in this case?

  15. Nathan says:

    Your language is unnecessarily gentle.

    You should say what this truly is and shout it from the rooftops: an abomination.

  16. John Wayne says:

    If I was leadership in one of the major vaccine providers, I would commit to not taking legal action against anybody who makes the COVID vaccines. Derrek did a great job of summarizing all the reasons why that isn’t going to magically make more doses available, and I agree with him completely.

    To be realistic, people always like a bad guy. So, you have our blessing, go make them. The companies will loose very little and could gain back some trust. If a company comes forward and makes this move before they are forced, it will look great for their brand.

  17. Mammalian scale-up person says:

    Well said! I have been explaining this to non-pharma friends for MONTHS now. They’re definitely sick of hearing it.

    Building a new facility, if you have an existing facility to copy from and you are not changing a single thing, takes about 3 years from breaking ground to being ready for installation & operational qualification in the very best of circumstances with everything going swimmingly.

    We currently have major plastics shortages that are creating long lead times on things like single use tank liners, single use tubing and sample devices, pipette tips, test tubes, etc. Things are not going swimmingly. I don’t see how breaking patents helps the shortage of polypropylene. Everyone is trying to increase their manufacturing capacity as fast as they can, but when everyone puts in orders for tanks and equipment, there’s naturally a backlog.

    If the government needs things they can do to help me get facilities designed and built faster, I got a list. Starts with “modernize utilities” and ends somewhere around “training for tradespeople”. Unfortunately it’s very boring and would probably take longer than four years to see results, so likely will never happen.

  18. Jonathan B says:

    I think Biden’s statement is largely political as you say, merely sharing patents won’t achieve the extra vaccines. But the most powerful country in the world saying that might have a powerful influence in getting some production established elsewhere more quickly.

    The mRNA vaccines are so novel there is no chance whatsoever of any other company being able to replicate them if they had rights, they would need the practical help that comes with a licensing agreement and even then it would be hard. For the adenovirus vaccines I am not too sure, I imagine there must be large scale mammalian cell culture expertise in a number of countries that would make manufacturing at least feasible (thinking of some South American states, South Africa, and – although they have used other methods so far to avoid the worst of Covid – Australia and New Zealand). To be fair, Oxford/AstraZeneca at least have tried to get their vaccine produced widely and it is not their fault that the large volume production they facilitated to substantially supply developing countries has been diverted for domestic use in India.

    Derek’s blog widens to consider IP more generally. I think across most invention-based businesses the current patent arrangement works reasonably well but Pharma is a special case because of the way the requirements for regulatory authorisation (trials etc) can take up much of a patent’s lifetime. Ideally authorisation would give exclusivity for a standard term (like a patent) to re-start the clock and obviate the need to generate disproportionate profits from successful drugs due to the limited period of remaining patent protection. In practice that would probably need a multinational agreement.

  19. 13enster says:

    The only bottlenecks on covid vaccine production are infrastructure, logistics, and know-how. Why else would Moderna or BioNTech make deals with big pharma competitors like Sanofi to assist in the manufacture of their vaccines? If any jackass with the recipe could make a vaccine, then Emergent BioSolutions wouldn’t be on everyone’s shit list.

    This is a sharp stick to the eye of an industry that has gone to unprecedented lengths to find a way out of this public health morass… and it has zero chance of helping in any meaningful way! Cui bono?

  20. debinski says:

    Good for you saying “good for them”! I couldn’t agree more. I’m so sick of the Evil Pharmaceutical company narrative, whether in the media or some bad movie plot.

  21. dearieme says:

    When I hear “waiving IP rights” I know they mean ‘stealing IP rights’. Don’t they?

    I’m sure that if Joe Biden knew about this he’d put a stop to it.

  22. DTX says:

    Making vaccines is difficult, even for the companies that created them in the 1st place. For many years, CDC has listed vaccines in tight supply and usually it’s because the company is having trouble producing their own vaccine (i.e., even though they have full knowledge of how to make it). Even just changing cleaning practices in a manufacturing area or changing the supplier of something as simple as sodium hydroxide can greatly impact yields.

    Merck gave China the technology to make their Hepatitis vaccine in the early 1990s. However, they didn’t just give them the IP, they spent a very long amount of time teaching them how to make the vaccine.

    It’s likely that giving other countries the technology to make the Covid vaccines will have little impact on Covid vaccines, but will allow those countries to out-compete the US and Europe in the future using those technologies to make other vaccines.

    1. mjs says:

      Technology transfer to Baltimore was hard enough. Recall “Vaccine Manufacturing Woes at Emergent” (8 April)

  23. David Catnor says:

    I worked in Pharma R&D for 30 years, and agree with much that you say. I still am morally repulsed by Pharma companies who charge $100,000/year for medications that cost them $1000/year to manufacture – for lifesaving treatments. This is strictly evil, and the fact that the industry allows it to continue says a whole lot.

    1. Anonymous says:

      I also worked in Pharma for a number of years, and at least by the metric of directly making something salable, they didn’t get their money’s worth on me. However, I worked hard and was hopefully a good colleague to those who through inspiration and, frankly, luck did bring home the Big Kahuna, and I reckon those $100,000/year treatments were paying back some of my ultimate lack of productivity. Pharma makes a LOT of money, and the article already allowed that there are some real scumbags in this business. But, there’s safer money to be made, and if there weren’t big rewards in drug discovery and development, all that money would go to yet another messaging app or sucking more carbon out of some poor patch of wilderness. The system takes a bunch of bites to get any apple, and it sucks, and it needs criticism and improvement but those improvements need to be a lot defter than price caps, e.g.

    2. metaphysician says:

      If all you are willing to look at is manufacturing costs, and not research costs? There is no reason to take you seriously, since you are either uninformed or disingenuous.

  24. Bill says:

    Time to re-teach the Killing of the Golden Goose fable.

  25. Walter Sobchak says:

    The president of the United States is not, despite the demented ravings of the talking heads on cable TV or the even more delusional rantings of the twitteratti, is not a king whose word is law. He has only those powers granted to him by the Constitution subject to the limitations therin.

    One of the most important limitations on governmental power is the 5th Amendment to the Constitution which states, in pertinent part:

    nor shall any person … be deprived of life, liberty, or property, without due process of law; nor shall private property be taken for public use without just compensation.

    Intellectual property may be intangible but it is property. If the US government wants to take any part of it it will have to observe due process and compensate the property owners for the deprivation.

    But, that, as they say, is only money and the US Government owns the printing press.

    More importantly, the real limitation on producing the vaccines is the very deep skill and knowledge of the employees of the companies. And the ability of the government to command that is even more constrained by the 13th Amendment “Neither slavery nor involuntary servitude, except as a punishment for crime whereof the party shall have been duly convicted, shall exist within the United States …” [military draft?, jury duty?, I don’t see it]

    In sum, the President has promised far more than he can deliver, and pharmas have less to worry about than the hysterics fret.

    Oh, yes, in case you wondered IAAL. I didn’t just make it up.

    1. Rob McMillin says:

      The Supreme Court in Oil States Energy Services v. Greene’s Energy Group held that patents are a government franchise, not per se property, so I would not bet too heavily on that. (In practice, inter partes patent review has not pulled up too many candidates for revocation, so this hasn’t mattered, but it should.)

      1. Walter Sobchak says:

        Dicta. Not in point here. The question there is procedural. The question here is substantive.

        Art I. Sec. 8 describes patents as: “securing for limited Times to … Inventors the exclusive Right to their … Discoveries”

        It is the only place that the word right is used in the unamended articles of 1787. A valid patent creates a property right subject to the 5th amendment as described above.

  26. Doug H MD says:

    in all likelihood this isnt going anywhere anyhow anytime soon

  27. Omar Stradella says:

    Right on, Derek. All that you said is right. The problem is not IP protection. The problem is that the world was pathetically unprepared to tackle a global pandemic, in spite of the decades of warnings. We had plenty of time to get ready, meaning choosing a suitable platform, at least partially standing up manufacturing lines, and getting starting materials production ready. We didn’t, most likely because we didn’t want to spend so much money preparing for something that might have happened soon or many decades in the future. Waving IP protections now is not going to do any good in time. Let’s hope we learn from this lesson, but I’m afraid we won’t.

    1. theasdgamer says:

      The panic mongering should have started a couple of decades ago. Then the sheep might have been ready.

      1. Wallace Grommet says:

        Stop bleating and change your thumbnail to a ewe.

  28. Albert says:

    Big pharma are saving the world and people ask them to make no money, big techs are making 10 times more money by selling privacies and people are OK with that.

    1. Cassy says:

      Saving the world? How so? Please elaborate.
      0.3% of vaccines administered to developing countries.
      Do you have a crystal ball to see long term efficacy and lack of long term side effects or ADE?
      Albert you are a muppet

  29. Stu West says:

    One thing that’s missing from this analysis is any mention of reports that Pfizer has been attempting to abuse its patent monopoly by demanding that poorer countries use sovereign assets as collateral to indemnify it against legal action, including lawsuits based on acts of “negligence, fraud or malice.” (Quote from the article linked in my name.)

    That’s clearly not acceptable. If, for example, J&J had shipped the 15 million contaminated vaccine doses they produced at their plant in Baltimore, under no circumstances should they be exempt from financial consequences for that. That would be a hell of a moral hazard, and it’s exactly what Pfizer was looking for from Argentina and at least one other country.

    I agree with Derek that Biden is unlikely to get a patent waiver through the WTO. But I also think vaccine patents give the companies that possess them a hell of a whip hand, and this might be a useful warning shot to remind them not to misuse it.

    1. A Nonny Mouse says:

      If the vaccine is approved on a emergency use authorisation, then the company is NOT liable rather the approving government. Certainly, in the UK, the approvals are on a EUA while the EU insisted on full approval as they did not want to accept liability.

      1. bobby says:

        There is no full approval in the EU. It is an emergency use and the clinical trials are still running. The national governments are taking up liability for damages and harms caused, which is completely outrageous.

        EU Parliamentary Question:

        The launch of the COVID-19 vaccination process following the relatively rapid approval of the vaccine (compared to vaccines against other diseases) raises many expectations and, at the same time, concerns among the general public. The question of clear compensation mechanisms for the side effects of the vaccine has not been fully answered. Although it has been announced that pharmaceutical companies will not be exempted from the general safety requirements for medicines, specific answers to questions on the liability of manufacturers are often not provided on the grounds of the confidentiality of contracts. In the absence of a common approach to compensation for vaccine side effects, some Member States have already taken national measures (e.g., a ‘no-fault’ compensation model), but such provisions seem fragmented at EU level.

        1. Is the Commission considering setting up a coordination mechanism (or at least guidelines in the form of recommendations) on who should provide compensation for the side effects of the COVID-19 vaccine and in what manner it should be provided? Are there any plans to regulate the type of side effects that should be compensated? As the no-fault compensation mechanism currently only applies in some Member States, there is a real risk that EU citizens will have differing levels of access to redress, even though it is the same vaccine being used.

        2. Are there any plans to take steps to communicate more transparently about compensation procedures for vaccine side effects? Which vaccine manufacturers have specifically agreed that they will pay compensation for side effects?

        Answer:

        All COVID-19 vaccines that have received a conditional marketing authorisation from the Commission have been assessed with regard to their quality, safety and efficacy.

        The Commission normally authorises a vaccine in the EU following a positive scientific opinion by the European Medicines Agency confirming a positive benefit-risk-ratio for that product.

        Information on possible known side effects is published in the product information, and marketing authorisation holders are obliged to record and inform of any new case report about adverse events to ensure a tight safety monitoring in line with the pharmacovigilance provisions of the EU pharmaceutical legislation.

        In this area, the limited competence of the EU when it comes to health policy has to be taken into account. The definition of health policy, as well as the organisation and delivery of health services and medical care, including their management and the allocation of the resources assigned to them, is a Member State competence under Article 168 of the Treaty on the Functioning of the EU. The Commission is therefore not in a position to intervene and regulate the type of side effects that should be compensated.

        In view of the answer to the first question, communication about compensation procedures for side effects should take place at national level.

      2. Cpt. Obvious says:

        EMA granted only a one year “Conditional Approval” for all 4 covid vaccines (PB, Mo, AZ & J&J) not standard ones. Some of the differences are documented in the Q&A :

        “What is the difference in liability between EU Conditional Marketing Authorisation vs Emergency Use Authorisations?

        Under an EU Conditional Marketing Authorisation (CMA), liability is with the holder of the marketing authorisation. The marketing authorisation holder will be responsible for the product and its safe use.

        The CMA is valid for a one-year period, on a renewable basis and contains the same rights and liability for its holder as per that of a standard marketing authorisation. In addition, the holder of a CMA has specific obligations such as to complete or conduct new studies within a defined time period in order to confirm that the benefit/risk balance remains positive.”

        https://ec.europa.eu/commission/presscorner/detail/en/qanda_20_2390

        1. A Nonny Mouse says:

          Many thanks for putting it more clearly than me; the liability aspect is, though, as I pointed out.

  30. LL says:

    Waiving IP rights is a purely populistic move and totally counterproductive:

    1) Near-midterm shortages are caused by shortages in production capacity, not by economic constraints caused by IP rights.
    Building new production facilities from the ground up takes long time, big investments, and highly skilled personnel. A mid-size GMP production facility for monoclonal antibodies takes some 2 years to build (until it is signed off, test runs are done etc.), investments of 0.5 – 1 Bio USD, and a team of highly trained specialist. Running costs at full capacity including salaries, ingredients, maintenance etc. are somewhere in the neighborhood of 0.5 Bio / year. For a worldwide supply one would need many of these plants, next to chemical plants producing lipids etc. that are currently rate-limiting. No way that is going to happen in a poor country with inexistent pharmaceutical industry.

    2) Money is no constraint at all: From the billions of USD worldwide set aside as ‘stimulus money there would be no problem using some of that for buying vaccine – if the countries would decide to do that.
    If the Western countries there is so much money liberated as stimulus money that there is really no shortage in funding. If the governments would be determined to use a (relatively small) percentage of that for buying vaccines for poor countries that would be an easy and quick fix.

    3) It is key to keep incentives up – as Covid will stay, and we will need multiple new vaccines to come along to address virus variants in the coming years on an aggressive timescale.
    Who in their right mind would invest in the race for new vaccine variants addressing variants, running large-scale clinical trials, and build up supply chains etc. if there is already a precedent of patent right waivers?

    4) There is plenty of evidence for lack of new medicines / investments in the absence of IP rights.
    Taking a look at antibiotics research is sufficient to illustrate that economic incentives are critical for investment in research. New antibiotics are going to be sued as reserve antibiotics (= low volume sales), treatments are short term, and prices are modest – in the general schemes of things. Consequently, it does not make economic sense to develop new antibiotics – even though this is one of the most tractable therapeutics for drug discovery & development (highly predictive preclinical models, hard endpoints in clinical trials, high medical need, perfect synergies with diagnostics e.g. using next generation sequences, etc. etc.).
    The other example is that we have recurrent severe shortages in the supply of generic drugs – many of which are highly critical (antibiotics, anesthetics etc.), leading to really critical situations in clinical practice. The reason is the hard push to squeeze out a few dollars in manufacturing – which for many products leads to a situation where there is only a single production plant in India – and if there is a problem with that single plant, or the manufacturer changes priorities, there is an immediate shortage.

    For all the above reasons waving IP rights is a really bad idea. This is probably also a result of the lack of knowledge in the general public and with politicians how development of new drugs work. Maybe there could be a series of articles in Nature Reviews Drug Discovery, and in Newspapers, explaining the pharmaceutical R&D process and its economy in detail to help disseminating these important facts to a broad audience – at the very least, this will elevate the level of the discourse.

  31. Insilicoconsulting says:

    Disappointed with lop sided thinking regurgitating the same arguments. The patent system was instilled, what, 200 odd years back? What data points do you have to support failure of IP waivers in pandemics? Neve been done right? So all the potential -ve effects cited are probable but never demonstrated. In a global crises the moral imperative truimphs short term thinking. Patents have had many innovation discouraging effects for example in software and also in pharma in greenfielding small molecules etc. Given the usual data/evidence based stance, why not for once try it? With only for global pandemics proviso?

    1. LL says:

      Well, if the idea is ‘to just try it’, doing so in a global emergency with lives at stake is a really bad idea.

      Like in a heart surgery – why not try a new scalpel or anesthetic for the first time? Maybe try in a les critical situation first.

      Putting out inventions without IP protection by the way has been tried many times in many fields of technologies, just keep reading, you will find the examples. Monoclonal antibodies are a good examples, ‘discovered’ at the Basel Institute of Immunology. So, the argument that this should be tried now once and for all is really a reflection of that people have not done their homework – please read up and check for examples.

  32. Pierre Lebeaupin says:

    Multimedia software person here. While I think software patents are an unqualified negative in general, we have a few areas where they can be justified, and audio/video codecs are one, because their development involve human perception, in all of its messy reality. And what has been developed for them is the notion of FRAND licensing: fair, reasonable, and non-discriminatory.

    It works that way: when professionals meet to define a new standard (AAC, H.264, H.265, etc.), they do so in a forum. Back then it was MPEG (motion pictures expert group), under the umbrella of ISO, nowadays it’s more likely to be the ITU (international telecommunications union), under the UN. The experts can propose any technique for inclusion (which will of course be evaluated on merits), including patented ones, but they do have to disclose their own patents on techniques under discussion and pledge making them available under FRAND terms.

    To simplify the whole business for licensees, a dedicated legal entity is set up, like MPEG-LA, which has a license to all the patents for a given standard, sometimes referred to as a patent pool, solely so that entity can sublicense them: the legal entity acts like a one-stop-shop for interested parties, similarly to mechanical licenses, and then dispatches back the collected license fees to the original patent holders.

    (The credibility of these entities is their more important asset, because if a customer later gets sued for usage of a patent not in the pool, they’re going to start asking why they bother going through this designated licensor. However, the process tends to preserve that credibility: that patent would have to be held by a holder that did not contribute to the standardization process, and given the mutual interest in interoperability, that would be interpreted as the holder going rogue including by the holders of the pooled patents. That’s bad for business, to put it lightly).

    Now, obviously pharma products are very different from A/V codecs: H.264, AAC, etc. are little more than the sum of their parts (they’re a akin to bags of tools); furthermore, qualifying the resulting combination for performance, even if that involves viewing in controlled conditions, takes orders of magnitude fewer resources than the clinical trials necessary to get regulator approval.

    But I wonder to which extent getting regulator approval for some products with obvious collective public health benefits (like infectious disease vaccines, and… well I guess vaccines) could be conditioned to making the relevant patents available under FRAND terms. That would amount to the regulatory state using its power to sieze, if not the patent, at least its general availability, but that could be narrow enough and beneficial enough through network effects to get industry acceptation.

    Not that it would do any good in the present situation, not for months at least.

    1. sort_of_knowledgeable says:

      That was interesting, but it seems comparing networks in software to public health is stretching way too far. If all the software people agree to a standard for a sound file more customers will use the sound files standard because they can exchange the files and expect the other users can use it.

      The demand for the vaccine doesn’t increase because another vaccine targets the same virus. Also there are vastly more variations possible. Vaccines that could be shipped dry and stable for months under a wide variety of environmental conditions. Vaccines administered nasally or orally. Vaccines effective against multiple coronaviruses or even a universal virus. Vaccines with side effects and/or most effective for certain portions of the population.

      Whatever the justification for gathering all the patents the public health standards under a FRAND standard they are not similar to the ones for Codecs

      1. Pierre Lebeaupin says:

        Given that the first Covid-19 vaccine to provide an efficacy readout (Pfizer/BioNTech) is also the one with the most severe handling restrictions of the bunch (superfreezers, etc.), you definitely have a point that there needs to be strong incentives for at least some competitors to invent a “better mousetrap” rather than just license the original one. I still think some intermediate between the current situation and the proposed patent waivers could be beneficial, but it’ll clearly take someone smarter than I am to figure it out.

  33. DMT says:

    “Remember, a patent is not a secret. You have to disclose how your invention works and how to make it work in order to be granted one…”

    That’s what I used to think as well, but then it was reported in April that a group of scientists at Stanford had sequenced the Moderna mRNA from a few left over microliters at the bottom of a vial. How did Moderna get a patent without disclosing the sequence information?

    1. 13enster says:

      The earliest patents on a given product are filed before the applicant knows which specific sequence or small molecule will make it through the gauntlet of tests and trials to reach the market. So they generally have genus claims with lots of exemplified compounds or sequences to have some wiggle room in case candidate A crashes or candidate X ends up being the best of the bunch or something.

      Moderna’s product is almost certainly disclosed in their patent filings, but it will not necessarily be obvious which of the sequences therein correspond to the vaccine in the vial until later publications. Also, with biological products, sometimes the first unambiguous substance identification comes from registering the drug’s name.

      1. DMT says:

        Thanks, this was a really helpful reply!
        So the EUA doesn’t count as “registering the drugs’s name”? I was also surprised that none of the EUA docs that I looked at contained the sequence data. (Or the lipid composition data, for that matter.) At what point would these need to be revealed?

        1. 13enster says:

          Sorry, I meant registering an INN (International Nonproprietary Name, better known as a “generic name”) generally includes disclosing the structure/sequences these days. Great way to figure out specifically what the latest and greatest mAb actually is. Vaccines are kind of strange though, because traditional vaccines are not chemically well-defined whereas the lovely mRNAs are as well defined as any other engineered biological product. Usually the INN is approved by the WHO before FDA/EMA approval, but we live in interesting times.

          1. DMT says:

            That’s a good point. It will be interesting to see the changes in the legal framework as mRNA vaccines become more common.

  34. Anon says:

    Derek, you voted for this. Pfizer voted for this.

    It’s hard to have much sympathy for the frog when the scorpion acts according to its nature. https://en.wikipedia.org/wiki/The_Scorpion_and_the_Frog

    1. anon says:

      Pfizer is the frog the way I see it

    2. 13enster says:

      That is nonsense. 1) Voting based on a single issue is generally dumb and lets politicians get away with the unthinkable as long as they toe the line on the symbolic issue du jour and 2) you assume that the frog had a choice between 0 or 1 scorpions. The actual choice was between scorpion A and scorpion B, because “big pharma” is a boogeyman to both parties. The main reason that major legislation has not kneecapped the industry is because bipartisanship is dead.

  35. Danish vikingj says:

    Perhaps the easiest and fastest way to help poor countries in this situation would be to dump some cash on them (by for example forgiving some of their debt) to buy vaccines (preferable at a discount price).

  36. Josh says:

    There is a royalty-free license scheme for a vaccine based on Newcastle Disease Virus, to be produced in Chicken egg culture by influenza vaccine factories. Even this approach adds only a few production sites in the global south and could affect seasonal influenza vaccine production. Novavax has been trying to add production via highly experienced CDMOs and full tech transfer and it’s been hard, so good luck with patent expropriation.

  37. Phil says:

    Who actually paid for the R&D in the case of these vaccines? And scale up manufacturing? Wasn’t the companies who are marketing them. Billions of ‘free’ monies have been donated by WHO global fund raising campaigns, NIH, DOD, EU. Just saying.

  38. Brett says:

    Derek, you’re going to make AOC mad again by your statement of the truth.

  39. J says:

    This article might be of interest as it covers a variety of things?
    “Development of vaccines at the time of COVID-19”
    Published 17 December 2020

    https://academic.oup.com/microlife/article/1/1/uqaa003/6041022

  40. jbosch says:

    “Switzerland needs to be self-sufficient in sushi” I think that’s called tartar 🙂
    Excellent writeup Derek and great comments, as always.

  41. Christophe L Verlinde says:

    We are very lucky that companies like Pfizer, Moderna, Astra-Zeneca, J&J stepped up to the plate – some with governmental help – and QUICKLY provided us with a very useful tool to save millions of lives. Without the vaccines society would linger for a decade or more in a devastating limbo. Spitting in the face of these companies will accomplish nothing, or worse, next time a pandemic hits these companies may simply back out.

    1. Ryan says:

      You seem to know the medium to long term efficacy? Save millions of lives? Based on observed initial short term efficacy or your crystal ball? Exactly how do you know this?

  42. Barry says:

    No one has to waive their IP rights. We’ve had provisions for “compulsory licensing” in our patent law for a hundred years or more.

    1. van ‘t Oever says:

      Correct under article 31(f). The case has been made before: https://www.orfonline.org/research/the-case-for-waiving-intellectual-property-protection-for-covid-19-vaccines/

      This still is only an endorsement and the WTO has to agree with all member states, which will not be easy. However it makes good political capital and can easily be promised.

      The questions remains will it be enough too make additional vaccines or will it cause a further constraint on the already stressed supply chain (for example Novavax’s struggles) with everybody fighting for the same resources and nobody getting a complete set? The analogy of butchering the goose that laid the golden eggs comes in mind.
      Will waiving IP be enough, what if trade secrets are involved as well? Will we enforce the companies these also, how about transfer of the needed cells and viral stocks/plasmids as well together with trainers?

      This may do more harm than good, but at least the political capital has been won.

  43. mallam says:

    So much already said. So much yet to say.
    As stated many times on this blog and elsewhere over the years, Pharma big and small do a terrible job in educating the public about lost investments coming from failed efforts along with the upfront costs to make a new drug, vaccine, etc.

    But more to the point here, who become responsible if / when a bad batch (or two or twelve) made a company / group that is not the originator and patent holder causes severe health problems or death when no problems have resulted from product by the originator? Does the originator have to pay or get sued? Does the Fed gov pick up the libility that it has essentially caused by giving patent waivers?

    Maybe one of the problems with Pharma is the large salaries, bonuses and stock options / grants plus lifetime benefits as healthcare, lifetime requirement payments, golden parachutes given to those in the C suite becomes a visible issue with the seemingly huge profits and payoffs to those on the top. I recently read of the CEO of one particular large drug company whose salary and bonus etc were lower than “comparable competitors” in a commentary to shame the company to pay them more. But the company had a bad year, and has had several poor years in a row with nothing recently to show an improvement coming other than some flashy Powerpoint slides, quarter and quarter after quarter. Does this person really deserve to take home as much? Do they actually deserve what they already are making? Is this really the best use of company cash?

    As said above, Pharma really sucks at self promotion and expaining it’s business to the average Joe and Jane.

    1. J Curwen says:

      Jaenisch! Thank you so much for this!
      So we are bombarded from three sides:
      1) genomic integration via the virus itself
      2) genomic integration via residual DNA/LNP in the mRNA-vaccine
      3) genomic integration via reverse transcription of the modRNA/LNP
      Might be time that some specialist looks into that who is not afraid of another witchhunt.

      >If there ever was a preprint that should be deleted, it is this one! It was irresponsible to even put it up as a preprint, considering the complete lack of relevant evidence. This is now being used by some to spread doubts about the new vaccines,”
      >Marie-Louise Hammarskjöld, a microbiologist at the University of Virginia, posted in a comment on bioRxiv at the time.
      >And what of the original journal submission? “They rejected it,” Jaenisch says.<

      1. theasdgamer says:

        Hammerskjold is just virtue signalling. Lots of politics in science these days. And logical fallacies expressed by scientists, too. Hammerskjold implied, “Because we don’t like the result, we have to reject the scientific argument.”

  44. E Ray says:

    So, the waiving of the IP isn’t what’s holding back more production of vaccine, and the other commenters are right that this is probably calculated virtue signaling by the Biden administration. And it’s true that Pfizer and other Big Pharma giants are going to be just fine, even if some other country does end up trying to make some of their own supply based on waived patents. But I’m more worried about down the line repurcussions of opening this door just a little bit. China and other countries have been pretty persistent in ignoring intellectual property for a while now. Now watch them use this opening to spin their IP disregard as justified for affecting their citizens’ health in some way, even for technologies far removed from pharmaceuticals.

  45. AQR says:

    A patent does not allow someone to practice an invention; it allows the patent holder to prevent others from practicing the invention. Hence, under current laws, a company, university or country could use the information already published in Moderna’s, Pfizer-BioNTech’s, Oxford/AstraZeneca’s, etc. patents to produce the vaccine. It would then be up to the holder of the patent to sue the infringer to enforce the patent. Moderna has already said that they would not enforce their vaccine-related patents during the course of the Covid epidemic. Considering that no one is currently even trying to make Moderna’s vaccine, I think it’s safe to say that Biden’s offer is merely theater and will do nothing to actually increase the supply of vaccines.

    To those who say that the patent holders are holding back information on their inventions, I should note that it is a requirement of a patent that the best method for practicing an invention must be included in the patent application at the time of application. If that is not done, it is grounds for invalidating the patent. That is not to say that there are not trade secrets related to the inventions, but these secrets are not patented and if the infringers of the vaccine patents discover them independently, they are free to use them without fear of legal repercussions.

  46. Stanislav Radl says:

    I am not a patent lawyer, but I believe that according to the TRIPS agreement and Doha Declaration, there is a possibility to forced licencing under some conditions. And covid-19 pandemic could be considered as a reason for such move.

  47. Walter Sobchak says:

    You are quoted:

    “High-tech problem for Joe Biden’s COVID vaccine patent waiver” by David Hogberg, Healthcare Reporter | May 08, 2021
    https://www.washingtonexaminer.com/news/mrna-covid-19-vaccine-tech-obstacle-biden-patent-waiver

  48. jspleiss@me.com says:

    My concern is that Moderna/Pfizer etc are now putting less effort into expanding the supply chain because of uncertainty of demand going forward. Reducing efforts would at least make commercial sense because why would you build a factory if you don’t know whether you need it at all. As mentioned many times, for companies with no experience in vaccines, it will take years to get going and this may result in supply constraints during half the way out of this pandemic. If governments waive IP rights, then they also take on responsibility for continuous supply. I am not sure they will connect those dots.
    This was probably mentioned already in the many comments I couldn’t go through, so apologies for reading it again.

  49. theasdgamer says:

    Breaking…

    “As previously announced, CDC is transitioning to reporting only patients with COVID-19 vaccine breakthrough infection that were hospitalized or died to help maximize the quality of the data collected on cases of greatest clinical and public health importance. That change in reporting will begin on May 14, 2021. In preparation for that transition, the number of reported breakthrough cases will not be updated on May 7, 2021.”

    “_only patients with COVID-19 vaccine breakthrough infection that were hospitalized or died_”

    Let that sink in.

    First the CDC said that PCR run at Ct above 34 would find mostly unculturable positives. Aaaand labs still ran Ct at 37, 40, 42, and 45. And the CDC collected statistics based mostly on unculturable positives to fuel the narrative of an exploding pandemic and didn’t bother to chastise laboratories for their excessive Ct’s and didn’t bother to sample with attempts to culture virus. Obvious panic mongering.

    All of a sudden, the CDC will only collect vaccination breakthrough statistics on PCR Ct run at 28 and below.

    The CDC sees that the stats aren’t good enough to bolster the “vaccines will reduce covid cases”.

    The CDC changes to a new narrative. Vaccines will reduce hospitalization and death.

    The CDC will no longer collect vaccination breakthrough statistics on cases unless they result in hospitalization or death.

    https://www.cdc.gov/vaccines/covid-19/health-departments/breakthrough-cases.html

    How long will people continue to buy the vaccines-are-safe-and-work narrative?

    1. shibadoge says:

      Are you one of those Russian spies…?

    2. stewart says:

      Over the course of the pandemic the UK’s CFR has averaged just short of 3%. Over the last few weeks it’s been in the region of 0.5%. (The UK is still well short of a fully vaccinated population, but has vaccinated the more statistically vulnerable groups.)

    3. theasdgamer says:

      stewart,

      My county has vaccinated half and cases have dropped to nil and we are endemic now. But…

      …county covid deaths began falling December 23, implying that cases began falling at the end of November and vaccinations didn’t begin until December 31 for county health personnel. Care homes began receiving vaxxes in Jan.

      Maybe the vaxx has a time machine adjuvant.

      It helps to try to disprove your own thesis as well as trying to find evidence to support it.

  50. Silbadger says:

    I have come to this article late, so this is probably just me talking to myself, but I wanted to challenge a couple of assumptions and assertions being made in your post. I have family in pharma and I agree with you that most people in the business are good people, who do care about health care and the greater good. You acknowledge that there are some bad apples scattered about. However, what you don’t touch on but I imagine know to be true, those people are not randomly distributed through the company – there are a lot of them at the top. Pretty much any pharma CEO would gladly sentence your grandma to death if it meant the shareholders got more value this year. I work with these companies, this is not an opinion formed from internet message boards. They’re not twirling their mustaches while burying cures to keep people sick, but they sure will kill promising projects if there’s no profit in it, or raise prices as high as they possibly can, or cut corners if they can get away with it. For-profit healthcare can never truly have the patient’s best interest at heart, we all know this, and those at the top didn’t get there by being sentimental.

    The main argument that pharma itself makes against waiving IP is that it will stifle innovation. This would seem to contradict your assertion that pharma is primarily made up of nice people who are motivated by bettering the world. I actually think it’s really unlikely that Pfizer would sit on its hands during the next global pandemic if it lost patent rights in this case. I can give CEOs enough credit to say they would generally not want their own loved ones to suffer if they had the means to prevent it. Given what you say about IP not being the bottleneck (which I am sure is currently true), I don’t understand why the companies have not voluntarily waived it already, avoiding the specter of being forced and what that might imply for the future. IP either isn’t a bottleneck and therefore wouldn’t affect their profits and doesn’t matter and they might as well waive it for the goodwill boost, or there is more potential here than everyone is admitting for the world to ramp up production more rapidly over time without this constraint. And if it’s the latter, it would be incredibly shortsighted of humanity to allow high caseloads to continue brewing new variants in countries with poor vaccine access for even one week longer than necessary.

    1. Derek Lowe says:

      I think the worry is that waiving IP will set a precedent that the drug industry does not want. I don’t think it will increase vaccine production in this case – so it does little or not good – but the idea behind it could go on to do harm in other cases.

      1. Silbadger says:

        That would be why I’m confused about why they don’t just waive their own rights in this case (I think perhaps Moderna already has). Avoid the precedent of authorities doing it for them, get the global goodwill, open the door to possible future expansion of manufacturing (or at least silence critics if you think that’s not feasible), lose nothing that I can see?

    2. Johannes Spleiss says:

      It is the old story using private money for the development of drugs versus public funds. I don’t think that public institutions would be better in that. One could think about adding a global tax on pharma companies that they could deduct from activities in relation to neglected diseases. The money could go into companies that spend more on this than the deductible tax.
      In relation to the vaccines I simply believe that waiving IP rights would trigger bad dynamics. In an environment where demand cannot be planned – because there may be other manufacturers coming in (or not depending on complexities) – private money is less likely to invest. If governments take away the incentive, they take the responsibility to ensure that sufficient manufacturing capacities are available. I doubt they will be able to do that.

  51. James Love says:

    The proposed TRIPS waiver does not waive patents or contracts. It waives WTO rules, including those that restrict exports under a compulsory license (Article 31.f and 31bis), and the obligations regarding undisclosed information, including manufacturing know-how and information given to regulators. Compulsory licenses normally include a royalty. It would be one thing if the waiver would do the sweeping things you suggest, but what is in play are far more modest efforts.

  52. Brussels bureaucrat says:

    In short, it is a very political statement.
    I believe there is two parts to President Biden’s statement. One part is about sending a signal to the rich world that it is now time start vaccinating the poor world – one way or the other. I like this part although the best and fastest thing would be to simply send vaccines from rich to poor countries and do it now. Stop talking and get to work!
    The other part of the statement is a political move. Basically, now that the rich world has vaccinated itself we are about to enter chapter two which is about how to vaccinate the poor world. This represent a classical struggle for so-called “soft power”. Who gets the credit? Here the EU is in a relatively good starting position since it is producing a lot of vaccines and has al ready exported 180 million vaccines. In contrast, the US has hardly exported any vaccines and has banned export of vaccine ingredients. So it makes perfect sense for Biden to make this announcement. Even the statement doesn’t amount to anything it will at least undermine any global political credit that the EU might gain from its continue in exporting vaccines. Smart move, President Biden! 🙂

  53. sgcox says:

    First results about side effects of mixing vaccines.
    https://www.bbc.co.uk/news/health-57075503
    Can it be simply explained by non-overlapping populations prone to develop side effects to adenovirus and mRNA formulations ? Say 15% reacts to Ade only and other 20% to mRNA?
    Mixing it up is sort of double jeopardy and ~35% will get some side effects ?
    Nothing serious so far thankfully.
    Very Interesting of course will be to see the immune protection effects but have to wait till end of June for numbers.

  54. Mark says:

    Completely random thought incited by this (lovely) article: Derek mentioned the despicable Martin Shkreli. The weird thing about him is that he probably isn’t actually evil. He’s just a weird combination of genetics such as bubbles up in the random lottery machine that is the human race. Self-centred, completely dysfunctional, and he did enormous harm before being put behind bars. Meanwhile the Lown institute adopted his name for a prize awarded for the worst profiteering and dysfunction in the health-care system; the Lown institute that grew from the work of Bernard Lown, another extremely unusual combination of genetics that bubbled up from the lottery-machine. This is Bernard Lown who invented the defibrilator, developed cardiac care, and got a Nobel prize for his anti-nuclear-war activities. So the question is this: given that Shkrelis and Lowns will continue to bubble up, how do you organise society so that the Lowns can thrive, and spread their beautiful and human-helping ideas, while the Shkrelis sink without trace?
    It was the same with Elizabeth Holmes and the Theranos affair: the scandal wasn’t so much that Holmes existed and lied, but that society had no resistance to her; a culture of middle-aged blokes with a lot of money and hormones in their pockets couldn’t keep its head when faced with a persuasive person like Holmes, and that is what generated a huge catastrophe.

    1. NMH, the failed scientist and incel says:

      Why do people have no resistance to this? The people who want to resist want to keep their jobs to stay afloat in this make or fall- to-the-ditch-of-crap country (USA). Also, personal charm (and money) probably has a lot to do with disarming otherwise critical thinking people:

      https://www.elle.com/life-love/amp35021224/martin-shkreli-christie-smythe-pharma-bro-journalist/?utm_medium=social-media&utm_source=twitter&utm_campaign=socialflowTWELM&__twitter_impression=true

      1. Wannabe scientist and incel says:

        Dear Mr. Incel,

        Could you expound on why 60% of employees in CDC, NIAID, etc. have refused the vaxxes?

  55. J says:

    Presume this is the article in the Lancet referenced above by another poster.
    “Heterologous prime-boost COVID-19 vaccination: initial reactogenicity data”
    Published 12 May, 2021
    https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)01115-6/fulltext

    Thank you again Derek for this stimulating range of articles and for the informative commentary from various individuals. I only recently found this blog and it has proved welcoming, stimulating and reassuring.

  56. J says:

    You might be interested in this particular article. Deals with the issues related to resources and production as limiting factors for manufacturing large amounts of vaccines.

    “COVID-19 vaccine: Here’s why Russia is struggling to make Sputnik V doses”
    Published 14th May

    https://www.businesstoday.in/sectors/pharma/covid-19-vaccine-here-why-russia-is-struggling-to-make-sputnik-v-doses/story/439057.html

  57. gippgig says:

    May be of interest: Unlocking Vaccines: Open-source Vaccine Summit 2021
    Online event – May 25 10AM-2PM
    radvac.org/eventbrite-event/unlockingvaccines2021/

  58. Nocommonsense says:

    “For example, I think that current US copyright law is way too restrictive and should be rolled back to something less lengthy.”

    I can’t believe you think that way. If anything, prolonging patent life would help both bring down long term drug prices as well as boost innovation.

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