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Mr. Sonia Sotomayor (Kevin Noonan, ex) On Vaccine Production and Why "Waiving IP" Won't Affect Vaccine Production

TwiceHorn

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TwiceHorn

TwiceHorn 31283

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Interesting post by a biotech IP lawyer, therefore biased, on Covid vaccine production and why the cries for "waiving IP" won't help. https://www.patentdocs.org/2021/04/suspending-ip-protection-a-bad-idea-that-wont-achieve-its-desired-goals.html

The most interesting thing is this:

Quote

The evidence evinced by Dr. Lowe is relevant to the question of whether patents create an impediment to COVID vaccine production.  It is apparent that, even if there might be circumstances under which intellectual property negatively affects vaccine availability, suspending patent protection is not an effective answer because the rate-limiting step for COVID vaccine production (at least for the mRNA-based vaccines) involves proprietary machines and methods for making the vaccine that are, more than likely, not covered by patents and never will be.

This ties in to why university and government research can't replace pharma.  Manufacturing these "drugs" and biologicals is hugely difficult in many if not most cases.  Pharmas have expertise that they don't patent:  trade secret machines and processes that only they possess.  All pharmas seem to more or less have similar capabilities if they produce similar types of drugs, but some are better than others.  Apparently, Moderna/BioNTech's processes are better than Pfizer's, which is why Moderna's has been more quickly and reliably available.

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TwiceHorn

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p

41 minutes ago, Neonmoon said:

Big Pharma doesn’t spent shit on R&D. It’s like 20% of their budget. They spend a shit ton on advertising. 

While I agree that their marketing practices are highly suspect, I think this is demonstrably false, at least for big pharma.

Also 20% for R/D is high as fuck.  Ford and GM spend a tiny fraction of that on R/D.

Edited by TwiceHorn
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Willfully Horn

Willfully Horn 7915

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Waiving patents as a general concept seems short sighted, though we’ve lived through a special scenario that makes a compelling case for doing just that. Imminent life and death stuff. I can make exceptions to general beliefs due to my fine compartmentalization skills.* Whoever holds such an exceptional patent should become fabulously wealthy and salve any resentment with the thanks and goodwill of all mankind.
 

*Edit. After all, I am a product of a freedom loving nation that reserves the right to conscript folks into military service, and send their ass off to war. Sent at the direction of men and women with guns, and with a threat to life and Liberty.

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TwiceHorn

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5 minutes ago, Willfully Horn said:

Waiving patents as a general concept seems short sighted, though we’ve lived through a special scenario that makes a compelling case for doing just that. Imminent life and death stuff. I can make exceptions to general beliefs due to my fine compartmentalization skills. Whoever holds such an exceptional patent should become fabulously wealthy and salve any resentment with the thanks and goodwill of all mankind.

As alluded to in the article posted, in the recent past, there has been severe international pressure for third-world countries like India to develop IP regimes and laws and respect the pharmaceutical patents from the first world.  And a similar great resistance from within and without the countries to doing so. One of the reasons cited is how badly they need fundamental medications, most of which aren't patented, anymore.  So there's some sort of bad blood there to begin with.

There is at least unconscious bias in that article because of who is Kevin Noonan.  

But it's one of the more intelligent discussions of the issue.

Currently, there are no actual patents on "Covid 19 Vaccines."   Patents aren't granted that fast.  There may well be patents on enabling mRNA technologies and such that are a few years old that would serve to block any old joe schmoe from making the vaccine.

The problem that the article points out, though, is that it isn't really patents that would stop anyone.  It would be simply the ability to manufacture the vaccine.

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elfenix

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36 minutes ago, TwiceHorn said:

p

While I agree that their marketing practices are highly suspect, I think this is demonstrably false, at least for big pharma.

Also 20% for R/D is high as fuck.  Ford and GM spend a tiny fraction of that on R/D.

ford and gm have to buy materials by the shit ton.  pharma largely doesn't. 

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Anastasis

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There is a balance to be struck. Reward innovation, reward risk taking that results in break throughs. Both the public and the private sector feed off the patent system. The glaring problem I see is that the taxpayer is footing the bill for a large majority of the foundational shit going down, and getting minimum credit on that investment. 

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wildcat09

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It may be correct to say that waiving IP for covid vaccines alone won't be enough to help the third world, but to pretend that's a good reason not to waive IP seems like nonsense to me. Saying it's only step A and that steps B and C would still be required isn't an argument to not do step A. 

 

Edited by wildcat09
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TwiceHorn

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4 minutes ago, wildcat09 said:

It may be correct to say that waiving IP for covid vaccines alone won't be enough to help the third world, but to pretend that's a good reason not to waive IP seems like nonsense to me. Saying it's only step A and that steps B and C would still be required isn't an argument to not to step A. 

 

If it's a "humanitarian" smokescreen to do something to erode patent rights that is ineffective for the stated purpose, then yes it's a problem.

And item B, or C, in your analogy would seem to involve compelling the manufacturers to disclose their trade secret machines and methods, and that's pretty much a non-starter. 

It seems that those who have the capacity to make the vaccines are manufacturing at full capacity.  If there was evidence of sandbagging to manipulate the supply and cost, that might be a different story.

 

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bad_teammate

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On 5/2/2021 at 8:22 PM, Anastasis said:

The glaring problem I see is that the taxpayer is footing the bill for a large majority of the foundational shit going down, and getting minimum credit on that investment. 

This is the case up and down various industries and we really need to, at the very least, start treating the taxpayer like any other investor.

#SocialWealthFunds

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gsoda3

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On 5/2/2021 at 4:26 PM, TwiceHorn said:

Interesting post by a biotech IP lawyer, therefore biased, on Covid vaccine production and why the cries for "waiving IP" won't help. https://www.patentdocs.org/2021/04/suspending-ip-protection-a-bad-idea-that-wont-achieve-its-desired-goals.html

The most interesting thing is this:

This ties in to why university and government research can't replace pharma.  Manufacturing these "drugs" and biologicals is hugely difficult in many if not most cases.  [b]Pharmas have expertise that they don't patent:  trade secret machines and processes that only they possess.  [/b] All pharmas seem to more or less have similar capabilities if they produce similar types of drugs, but some are better than others.  Apparently, Moderna/BioNTech's processes are better than Pfizer's, which is why Moderna's has been more quickly and reliably available.

why don't they patent them?  is it to keep the information secret?

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Anastasis

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On 5/2/2021 at 5:55 PM, TwiceHorn said:

There may well be patents on enabling mRNA technologies and such that are a few years old that would serve to block any old joe schmoe from making the vaccine.

Not sure about PFE, but MRNA definitely licenses technology from a number of different firms, particularly related to the nanoparticle tech, in the production of their vaccine. That is work largely out of UPENN, and absolutely crucial to the viability of the technology. There is of IP and technology limitations that isn't as simple as "just share the recipe" involved. One of the worst outcomes would be if cutting corners on the crucial underlying technology resulted in negative outcomes or a less effective vaccine. The blow back would impact not only the effectiveness in third world implementation, but would reflect on the originating technologies as well. 

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TwiceHorn

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13 minutes ago, gsoda3 said:

why don't they patent them?  is it to keep the information secret?

For one thing, they may not even be patentable.  For a second thing, patents last only 20 years from the filing date.  Trade secret protection is perpetual for as long as secrecy can be maintained, to wit, Coca Cola.

Which is why forcing the companies to release these machines and processes to "unknown" worldwide entities (which doesn't seem to really be "on the table" is problematic).  There is a cat out of the bag problem in that once disclosed, the owners can't unring the bell and the disclosure would have competitive effects far beyond the current Covid crisis and even vaccines more broadly.

As anastasis points out below, too, just letting a bunch of random third-worlders produce genetic vaccines, even using the "recipes" and "machines" seems fraught with danger.  Indians have a decent track record manufacturing "generics," but I believe those are usually the simpler ones, just making molecules.  Don't know about these type things.

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TwiceHorn

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1 minute ago, Anastasis said:

Not sure about PFE, but MRNA definitely licenses technology from a number of different firms, particularly related to the nanoparticle tech, in the production of their vaccine. That is work largely out of UPENN, and absolutely crucial to the viability of the technology. There is of IP and technology limitations that isn't as simple as "just share the recipe" involved. One of the worst outcomes would be if cutting corners on the crucial underlying technology resulted in negative outcomes or a less effective vaccine. The blow back would impact not only the effectiveness in third world implementation, but would reflect on the originating technologies as well. 

Yeah, I suspected as much.  Some may belong to pharmas, some may belong to universities, some may belong to the US government.  I was reading that the earliest enabling technologies/research date back to the 60s.

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Anastasis

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9 minutes ago, TwiceHorn said:

Yeah, I suspected as much.  Some may belong to pharmas, some may belong to universities, some may belong to the US government.  I was reading that the earliest enabling technologies/research date back to the 60s.

Yeah, the tech was developed @ Penn, licensed to cellscript, which then licensed it to MRNA and BNT.  It's the crucial component in the mRNA delivery. But it's not just the IP, the manufacturing processes and technology involved are not easily replicable even if you have the "recipe". And that is just one example of the many moving parts. You understand how these webs of patent protections are built across the entire spectrum of the manufacturing process for these types of novel biotech solutions, far better than I do.  But this just simply isn't as simple as some want to make it out to be.  This stuff is just not easy to scale, and if you try to cut corners (third world manufacturing plants would never do such things, I know), you will be going backwards.  Work through the manufacturers that have these processes built out.  Lean on them to scale their processes, ensure raw material supply chain.  Figure out how to make things cost effective for the third world (adenovirus vector vaccines are much easier to produce so your gonna have to lean on that). 

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Anastasis

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11 minutes ago, bad_teammate said:

A thousand years they had tha tools / We should be takin' 'em
Fuck tha G-ride / I want the machines that are makin' em

or something

Not now socialist. We're busy solving a pandemic by bringing together the best aspects of public and private sector to deliver multiple novel vaccines in record time.  There will be plenty of time to hate on the faults of capitalist influences in healthcare another day.  :)

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bad_teammate

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4 minutes ago, Anastasis said:

Not now socialist. We're busy solving a pandemic by bringing together the best aspect of public and private sector to deliver multiple novel vaccines in record time.  Their will be plenty of time to hate on the faults of capitalist influences in healthcare another day.  :)

you just made the list buddy

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AeroHorn

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Patent licensing is a very small portion of designing and delivering a high volume product. When a company wants do something, they will do it regardless of others having patented it or not. They will claim that their method is different. The patent holder sues, they go back and forth and settle. Look up Apple-Qualcomm, Apple-Samsung and many others. These companies know how to design and build stuff, but may not have been the first to do it, hence the legal wrangling to get that fixed. At the end, the patents are invalidated or the patent holder gets couple of percent of the revenue as royalty. Qualcomm didn't have to implement their CDMA tech in Apple's design centers/factories as part of the deal; Apple knew how to do that and just wanted Qualcomm to not bother them. There is the threat of Qualcomm having courts block Apple products, but the court typically nudges the parties to settle for a fair licensing deal. Of course, the above board approach is to talk to the patent holder, get a license beforehand, and it may include technology transfer contract too where the patent holder teaches the licensee how to implement it in their factories including equipment, processes, etc.

Same thing in big pharma, I suspect. Nothing stops Johnson & Johnson from implementing what Moderna is doing as long as they don't expect Moderna to come teach them. If they can do it and want to, they will and let the lawyers deal with the aftermath. If they can't, then patents are not really the issue.

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TwiceHorn

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50 minutes ago, AeroHorn said:

Patent licensing is a very small portion of designing and delivering a high volume product. When a company wants do something, they will do it regardless of others having patented it or not. They will claim that their method is different. The patent holder sues, they go back and forth and settle. Look up Apple-Qualcomm, Apple-Samsung and many others. These companies know how to design and build stuff, but may not have been the first to do it, hence the legal wrangling to get that fixed. At the end, the patents are invalidated or the patent holder gets couple of percent of the revenue as royalty. Qualcomm didn't have to implement their CDMA tech in Apple's design centers/factories as part of the deal; Apple knew how to do that and just wanted Qualcomm to not bother them. There is the threat of Qualcomm having courts block Apple products, but the court typically nudges the parties to settle for a fair licensing deal. Of course, the above board approach is to talk to the patent holder, get a license beforehand, and it may include technology transfer contract too where the patent holder teaches the licensee how to implement it in their factories including equipment, processes, etc.

Same thing in big pharma, I suspect. Nothing stops Johnson & Johnson from implementing what Moderna is doing as long as they don't expect Moderna to come teach them. If they can do it and want to, they will and let the lawyers deal with the aftermath. If they can't, then patents are not really the issue.

Not entirely true.

Different industries have different patent practices and norms.

Currently, particularly where bigtech is involved, big stupid litigation seems to be the order of the day, kind of in keeping with the software people's notion that everything ought to be free.  And trolls are partly responsible for that.  But it has extended beyond trolls to "legitimate" patent holders.  And standards-essential patents are changing things up some.  Bigtech seems to wield an "innovative arrogance" that I haven't seen in 30 years of practice.

Pharmas don't license/settle their way out of litigation, going mostly for the injunction.

Technologically, sure, they're probably fairly similar in their capabilities, but it seems fairly rare that two pharmas get to similar solutions/drugs independently.  Sometimes, with a blockbuster drug, or a really skinny patent, they'll play the "imitation game," but most of that goes on at the NDA level, before commercial infringement commences, so that is really all about the injunction rather than damages.

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AeroHorn

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Good points. My experience is entirely on the tech side, especially as a small (<1000 people) R&D company in the semiconductor industry. Patents are essentially ignored in the decision making process, with cost and performance as the primary drivers. Even if a big tech company licenses the patent portfolio and had tech transfer contract, they will stop royalty payments within couple of years because from their perspective, the years-long legal process and the eventual settlement is still cheaper to potentially a lot cheaper than continuing the royalty payments.

Due to rapid changes in the tech field, the goal is to settle/license/monetize now because the landscape may change in 3-5 years, whereas the timescale is longer in pharma and hence makes sense to go for injunction rather than settle, as you mentioned.

 

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lmao

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On 5/2/2021 at 2:33 PM, Bookman said:

Why is it that the only opinions I've seen on this issue are from Bill fucking Gates and a bunch of lawyers?

Gates is beyond reproach. The guy who is not a doctor who creates medical edicts can't be questioned for some odd reason.

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