Moderna waiving Intellectual Property rights for the remainder of the pandemic (2020)
investors.modernatx.comMy understanding used to be that this will not change much on an immediate basis since the nano-particle delivery system + its manufacturing chain are quite complicated and not easily scalable. Does anyone know if this is not the case?
For anyone interested: https://blogs.sciencemag.org/pipeline/archives/2021/02/02/my...
Around the time of this post I tried to get a bit more information on this, and ... well, here's the rabbit hole:
- https://www.youtube.com/watch?v=68p3qAm4i7U
Use lithography to create the mold, then cure it, then put it into a pure O2 enivornment, then drop it on a glass plate and you just plasma glued the silicone and the glass.
- https://www.youtube.com/watch?v=EYuyRUjnTgc
- https://www.youtube.com/watch?v=EjyM8sNplm4
- https://www.youtube.com/watch?v=wTmgqFCIbsA
I still have no idea where the bottleneck actually is. Derek Lowe claimed that the manufacturers of the microfluidics devices are. Which is likely, because hacking together something in/for a lab is very different than getting it ready for "FDA GMP [good manufacturing practices] approval" ... but at the same time there are thousands of people dying every day, and I'd like to see the extraordinary evidence to support the extraordinary claim that it's "impossible" to scale up vaccine manufacturing. (Impossible here meaning that it's impossible to get to the same necessary purity and control.)
What is possible given sufficient time, is very different from what is possible in a few months. Even in non-medical situations, getting a high-tech manufacturing process up and running takes years, not months, normally, and working long hours doesn't help as much as you think because the rate of mistakes goes up.
But, having more capacity in a year's time, doesn't necessarily save any lives, since the mRNA vaccines are not the best fit for most of the world anyway, as they require two doses per person and are more demanding in the refrigeration requirements. The adenovirus vaccines, despite the one-in-a-quarter-million side affects, are much more likely to be usable in quantity in most of the world.
So, you could get more capacity up in a year's time, when it won't be needed in the rich world and won't be useful in the rest of the world.
My guess is Moderna just made this announcement to try to dispel the idea that their patent enforcement was somehow getting people killed.
Your post is good overall but I am not so sure about this part:
"as they require two doses per person and are more demanding in the refrigeration requirements."
Moderna doesn't require overly deep refrigeration, that is Pfizer. The difference is a technical one and one that Pfizer believes they can solve. So while it is true of the current Pfizer vaccines, it isn't true of mRNA vaccines generally.
Secondly, the two dose regimen is unnecessary, IMO. Pfizer and Moderna have higher efficacy with one dose than J&J or Astrazeneca have after their one shot. The FDA and others insisting on two doses is because of Pfizer and Moderna's original process called for two doses as they wanted to be sure of the efficacy and that is what they got approval for. Given many doctors are looking at the pandemic from the perspective of a patient rather than that of a population and a disease, they aren't willing to admit that two doses for Pfizer and Moderna is unnecessary and putting far more lives at risk.
The rest of the world can benefit, as those countries that can afford the higher priced vaccine may do so as they are more effective and available now, which helps to get them out of the market of the lower cost vaccines. That decrease in demand for J&J and others can then be filled by countries that don't have the funding or the infrastructure for the current mRNA vaccines, thereby keeping their price low.
Interesting! Looks like you're right about that: https://www.modernatx.com/covid19vaccine-eua/providers/stora...
I have read that J&J also had a two-dose phase 3 going in parallel, but because the one-dose worked well enough they dropped it.
Really, given the shortage of vaccines in the world, and the fact that the U.K. essentially ran a 12-week one-dose experiment on a massive scale, I would think that we have enough data now to make the call. But, everything is more complicated than it seems from afar, so I am sure they have reasons.
Although it does look to me like J&J is a bit less demanding in regards refrigeration; it never requires below freezing storage: https://www.cdc.gov/vaccines/covid-19/info-by-product/jansse...
But still you're right, Moderna does not require anything all that exceptional.
The impossible part is time. You can make a car from ore that you dig yourself - if someone provides you food and shelter you could finish this task in 30 years or so. You could even make the atoms in a super collider given enough time (well energy is probably the limit).
But we need vaccines today. That means we are limited to what can be manufactured today by existing processes and factories. If you need a round iron part accurate to .001 inch (or similar metric) I know plenty of machinists. Need it more accurate and you have eliminated a large part of that supply chain, but I can still get you to .0001 inches, more than that is hard to find anyone who can handle (possibly impossible - temperature becomes a factor).
Yup. Moderna doesn’t have much to worry about. Most of the volume of vaccine will be sold in the next 6-12 months, not enough time for another manufacturer to develop the manufacturing capability, validate it and get FDA approval.
Even if new vaccines are needed for new variants, it won’t be easy for another company to catch up when the cycle are 12 months long and then you’re onto the next version.
Plus, once the pandemic is "over" at least officially, their best case scenario is that other manufacturers did implement their parents.. because they can start collecting license fees, and those manufacturers are likely to have made investments in ways that commit them long-term to using processes covered by Moderna's patent portfolio.
Moderna would probably be happy to license their next vaccine to someone who did invest in a factory. The price would be probably be affordable. I'm not sure it is worth it though, only time will tell if a booster shot is needed.
booster shots for variants are almost guaranteed to be needed.
Everyone says that, and work is ongoing, but so far the current vaccines are holding against variants. Time will tell.
"Their next vaccine" does not need to be a SARS-CoV-2 vaccine.
Yeah, that's what I've read. Basically, even if you could make the necessary mRNA particles properly, the it's useless without the delivery mechanism. Only a few companies even produce the necessary lipid products needed to deliver the vaccine, and they (and their suppliers) are already doing everything they can.
The IP concerns had basically zero effect on the availability of vaccines.
Well it won't have much of an effect unless they price the vaccine exorbitantly. So you can also view this as a binding promise to keep margins reasonable.
Since this was posted 6 month ago, has any company taken advantage of this by now?
Knowing the formula for the vaccine is one thing, being able to manufacture it at large scale is another (that surely require industrial secrets). This article has some more details: https://blogs.sciencemag.org/pipeline/archives/2021/02/02/my...
Developing a manufacturing process for the remainder of the pandemic, after which continuing may make one susceptible to lawsuits is just not a great outlook.
A critical view of this pledge, separately posted on HN:
https://www.jacobinmag.com/2021/04/moderna-patents-covid-19-...
https://news.ycombinator.com/item?id=26941571
TL;DR: Patents these days are effectively worthless at reproducing the invention, they only function as a legal way to stop competitors.
On the up side, the patented technique, including even the "withheld" parts, ought to be worthless by the time it expires, anyway.
We need legislation to eliminate withholding essential parts of what is patented.
> We need legislation to eliminate withholding essential parts of what is patented.
That is the purpose of 35 usc 112 1st paragraph.
October 8, 2020
I know making a vaccine is a little different than making strawberry jam, but why is there so little supply of the Moderna vaccine given this situation?
Before COVID, Moderna was a startup which had never brought a therapy to market. They've managed to stay independent, instead of a marriage to one of the giants like BioNTech has. As such, Moderna's production capacity was almost entirely funded by the US via OWS contracts - so until those orders are fulfilled, almost all Moderna doses have to go to the US, and even after that Pfizer has much larger global production capacity.
Seems like it it very common in the Mountain West region. Especially at the start, it seemed like far more Moderna than Pfizer. Now it seems about equal.
Not OP, just to clarify for US folks: Here in the EU Moderna is only small part of the vaccination effort. The breakdown so far is roughly 70% Pfizer/Biontech, 20% AstraZenca and 10% Moderna. The Moderna deliveries are supposed to increase in Q3, however I am not sure how relevant it will be at that point. The EU also finalized a deal for 1.8 billion Pfizer/Biontech shots for the next couple years. So Moderna will probably also not be super relevant here going forward.
Is there so little supply? I thought there was a glut of vaccines in the US. I just got my second dose of Moderna yesterday (in the US South), and there was nobody at the vaccine center.
I should perhaps noted that I was speaking from an EU perspective. The US seems to be doing great, I wish I could say that we are as well.
I see a lot of Moderna vaccine appointments in MA. Maybe they don't have the scale like Pfizer and most of their supply is staying in MA?
Nope, I got Moderna weeks ago on Staten Island, NYC.
Wonderful step.
An even better one is to immediately release the raw data from the ongoing RCT, as a substantial chorus of scientists has asked, and to which Peter Doshi has given articulate voice in BMJ: https://blogs.bmj.com/bmj/2021/01/04/peter-doshi-pfizer-and-...
This looks like a good gesture from Moderna, but I do not think it will be of much help for most the developing world since the low temperatures needed for the storage of the vaccine are not feasible for the distribution infrastructure of these countries.
Use on delivery should at least be workable in more populated areas.
The shippers work for short term storage ( I expect that's why my county had a delivery of Pfizer early and not another since).
> Beyond Moderna’s vaccine, there are other COVID-19 vaccines in development that may use Moderna-patented technologies. We feel a special obligation under the current circumstances to use our resources to bring this pandemic to an end as quickly as possible. Accordingly, while the pandemic continues, Moderna will not enforce our COVID-19 related patents against those making vaccines intended to combat the pandemic. Further, to eliminate any perceived IP barriers to vaccine development during the pandemic period, upon request we are also willing to license our intellectual property for COVID-19 vaccines to others for the post pandemic period.
This is great! Moderna shows the world that you can be innovative and charitable while still running a for-profit business.
upon request we are also willing to license our intellectual property for COVID-19 vaccines to others
How is that different from what they would be doing normally? Companies generally like to license their IP, it brings in lots of cash for little (extra) effort. Note that they don't claim to be offering reduced license fees in this part of their statement!
Companies like Moderna that are currently using IP are not always willing to license it. Sometimes they prefer to keep it in-house and reserved for their own use.
Especially given not all of the world has a tradition of caring about foreign IP enforcement. Say, post-pandemic and when you'd like to use Moderna's methods for other drugs.
Which, say what you want about IP law, but pharma objectively has the best claim to it -- if we want new drugs and safety, exclusivity periods and sole ownership of IP are the only way to balance the massive initial financial outlay. (Without funding it directly from government)
Sometimes. Most companies have a complex set of what they license and what they don't. In part it is based on fees, in part based on what the other will do it with it.
https://www.nytimes.com/2021/03/21/world/vaccine-patents-us-...
Apparently it’s not as simple as temporarily waiving IP claims. On the one hand they don’t even own some of the rights being waived, and on the other hand they would need to do more than just waiving rights to truly support their stated goal of accelerating immunisation against COVID-19.
This leaves, for me, a weird taste of a PR exercise more than a true commitment to the message they sent out.
What more do you expect from them? The bottleneck - as other comments mentioned - is the supply chain.
I’d expect them to give something closer to the equivalent of a recipe than just a “list of ingredients”, as other comments have highlighted too in this thread. If you ask me how to bake a cake and I just tell you “butter, eggs and cumin” that’s not quite the same as also giving you the timings, measurements, cooking temp, etc.
So, layman question: will it increase moderna's vaccine availability? Or is it about something else entirely?
This is from last year, and the answer is no. The supply constraints are unrelated to IP, and always have been.
Moderna will sue violators of their patents when they lost their primary income source.
https://www.jacobinmag.com/2021/04/moderna-patents-covid-19-...
"Moderna’s Pledge Not to Enforce the Patents on Their COVID-19 Vaccine Is Worthless"
tldr...all the good stuff are trade secrets.
This quickly turns into criticizing Moderna for using their full technical capacity supporting business partners instead of everybody. There isn't infinite capacity to share knowledge and it's unlikely that they are short on potential partners.
That article> This “invulnerable exclusivity” is harmless enough when it protects secret soda formulas and hamburger mystery sauces. It’s less cute when it blocks countries from using their legal right to manufacture and import lifesaving medicines.
This is introduced as if random countries have an established legal (rather than moral) right to manufacture these items covered by patent. I wasn’t able to find (in the article or my brain) the basis for the claim that there’s an established legal right to do so.
Surely random countries have legal rights to do most things they want to, since they make up their own jurisdictions?
Yes, you can have a legal right to manufacture it - which is to say the legal right to try without being sued or breaking a law. That's not the same thing as the legal right to manufacture it successfully, which is what the distinction would be.
The article is blurring the right to attempt to manufacture without legal restriction, and the ability to successfully replicate the formulation. This blurring makes sense from some points of view (especially from Jacobin's POV, and from an argument of immediate justice for the most people), but obviously falls apart from other POVs.
I think what that person you responded to what getting at is a "country" has the legal right to do whatever they want. If a country signed a treaty promising to recognize patents from foreign countries they have the legal right to withdraw from the treaty.
I assume poorer countries are not doing this due to fear of foreign aid being withdrawn, but this isn't really an issue of "rights".
We're bringing up rights because Jacobin framed in the terms of rights. And within the specific context of the article, we don't need to sorry about worrying about repercussions - Moderna has effectively granted a license to allow 'random countries' to make their vaccine without being suited for patent infringement.
Jacobin's point is that the pledge is meaningless because the patent lacks sufficient information to make the vaccine anyways - it's all locked up in trade secrets. Jacobin then frames this in terms of rights.
Jacobin claims that the way patents are usually discussed will imply that patents are about 'positive rights' - that is, if you have a patent or license, then you have the ability to commercialize (or whatever) the thing that is patented. Jacobin then claims that in reality, patents are just a negative right. Having a patent, or a license to a patent is just a freedom from not being sued for commercializing a product - since the real positive right that people want - the ability to successfully produce the object is actually wrapped under trade-secrets. The article is basically arguing that this split is injust, or at least extremely misleading, and is trying to call out the bullshit.
The entire point of the article is that even when patents are expired (or temporarily waived in the case of the Moderna vaccine), the inventions in them still cannot be manufactured by others because the patent does not contain anywhere close to all of the required information.
There is certainly a legal right to manufacture things that are not currently under patent.
While I agree with the author that most companies don't disclose their crown jewels in patents, I disagree with the historical perspective that this is somewhat new. Moreover, the author misses the point, in that while patents really don't disclose most of the secrets, they still pose a significant threat to anyone replicating some of the methods, exactly because they are so broad.
So yes the patents don't disclose how to actually produce the vaccines, but that's actually not the problem (see the published work where people already reverse engineered the vaccines). The problem is that patents still prevent people knowledgable in the field from actually making vaccines, because of the threat of expensive litigation.
I just want to clarify, I'm neither a fan of the current patent system, nor of Moderna (they are clearly doing it because they see business sense in it).
However, the linked article clearly misrepresents the "value" of patents to companies. They want to (and are) using patents to keep out competitors.
The article seems to make the case that if patents actually would disclose how to make something instead of keeping trade secrets things would be fine. I disagree, having trade-secrets is fine, but abolish patents.
That's the right approach though. If you invent and make something it's morally superior to rely on secrecy rather than on people with uniforms and guns to enforce your rights.
That article seems to just assume that Moderna are acting in bad faith there, without a lot of evidence. Certainly if they wanted to be obstructive they still could be, but the article-writer doesn't prove it either way.
I'd be interested to know if that's been tested. For example, have any other companies or countries proposed making the Moderna vaccine at all? And what happened? Co-operation? Grudging support? Full-on obstruction?
That's quite big (and great) news. Many people have been arguing that this should be done so that labs in e.g. India could legally produce the vaccine in particular for countries outside the rich western countries.
This is also much in the interest of the rich western countries, because quicker immunization worldwide reduces the risk of new mutations.
Let's see if the others will follow.
October 8, 2020
Yes I had not heard about it before, I guess we see if there will be any actual effects of this.
India is already producing the AstraZeneca vaccine.
From last year. Unclear when they will declare the pandemic over.