Moderna waiving Intellectual Property rights for the remainder of the pandemic (2020)(investors.modernatx.com) |
Moderna waiving Intellectual Property rights for the remainder of the pandemic (2020)(investors.modernatx.com) |
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.)
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.
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).
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.
The IP concerns had basically zero effect on the availability of vaccines.
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.
We need legislation to eliminate withholding essential parts of what is patented.
That is the purpose of 35 usc 112 1st paragraph.
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-...
The shippers work for short term storage ( I expect that's why my county had a delivery of Pfizer early and not another since).
This is great! Moderna shows the world that you can be innovative and charitable while still running a for-profit business.
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!
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.
"Moderna’s Pledge Not to Enforce the Patents on Their COVID-19 Vaccine Is Worthless"
tldr...all the good stuff are trade secrets.
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.
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.
There is certainly a legal right to manufacture things that are not currently under patent.
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.
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.
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?
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)
"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.
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.
But still you're right, Moderna does not require anything all that exceptional.
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 assume poorer countries are not doing this due to fear of foreign aid being withdrawn, but this isn't really an issue of "rights".
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.