This is often couched as a patent issue, but it is really a technology transfer (knowhow) issue.
Patents are territorial (country-by-country). There are currently no issued patents in any less-developed country that would prevent people from making/using the vaccines there.
2/— Dennis Crouch (@patentlyo) April 29, 2021
via twitter.
I’m lost. Anyone know of a good primer on these subjects?
This has been discussed in detail on multiple threads in that other IP blog.
What does the waiver mean? If India gets an IP waiver, that means that the US (upon Pfizer’s urging) could not force the WTO to enforce the TRIPs provisions against India. If Pfizer had IN patents, then the Indian gov’t would also suspend them as well.
If this was limited to “COVID” patents. That may be o.k. But, the waiver itself is broad “the breadth and vagueness of the proposal, it would be impossible for IP rightholders to understand which products or services would lose IP protection in which country, or for how long.” to quote Hans Sauer of BIO.
In addition, the waiver isn’t limited to patents. Countries are asking for clinical data, manufacturing data, and specifications. Things generally not found in patents. Its confiscatory.
Countries are asking for clinical data, manufacturing data, and specifications.
Where? Where specifically do you see countries asking for these data?
Its confiscatory.
“Asking for” is not confiscation. Where do you see a call to compel the disclosure of trade secrets. Here is the proposed waiver text. Quote for me, please, the provisions that call for compelled disclosure of trade secrets.
Paragraph 10. “Beyond patents…”
link to patentdocs.typepad.com
And paragrpah 8
“The rapid scaling up of manufacturing globally is an obvious crucial solution to address the timely availability and affordability of medical products to all countries in need.”
If we are to give any weight to the words in paragraph 8, it can only be: “teach me how to make it.”
If we are to give any weight to the words in paragraph 8, it can only be: “teach me how to make it.”
Sure, I agree that those paragraphs signify that the petitioners want trade secret info to be shared. Wanting, however, is not the same as getting.
You are citing paragraphs from the preliminary petition (pgs. 1 & 2 of the linked text), not the proposed resolution text (pgs. 3 & 4). The resolution text is the part that (if enacted) would have legal force. The rest is just a lot of throat clearing.
The proposed resolution text says—in relevant part—that “[t]he General Council… [d]ecides… [t]he obligations of Members to implement or apply Section… 7 of Part II of the TRIPS Agreement or to enforce th[is] Section[] under Part III of the TRIPS Agreement, shall be waived in relation to prevention, containment or treatment of COVID-19, for [X] years from the decision of the General Council.” This merely means that if (e.g.) India suspends trade secret protection, the other WTO members cannot bring an action against India. India, however, cannot use this resolution to compel the disclosure of trade secrets that are not kept in India.
If you think that there is a possibility for compelled disclosure of trade secrets in this resolution, you are misreading it. The WTO has no power to compel anything. The most that it can do is to decline to punish member nations for failing to protect IP. The WTO has no jurisdiction to grant injunctions compelling disclosure.
Let’s say an IAVI researchers takes Merck trade secrets from this collaboration (link to iavi.org) to give to India based, Bharat Biotech.
Merck tries to assert theft of trade secrets against Bharat. Germany, on behalf of Merck, cannot enforce WTO actions against India (Bharat) for letting this happen.
Imagine that the scenario you paint were to happen today (in other words, no waiver in effect). The outcome would be exactly the same. Germany has no stronger a case against India in your hypo without the waiver in effect than with the waiver. Your hypo is irrelevant to the waiver’s merits or lack therof.
This exchange is proving to be motte & bailey argument. At the start, Xian, you were asserting that the WTO waiver would be “confiscatory.” Now you are straining to contrive a circumstance in which India might be able to purloin this or that trade secret with impunity. I am not convinced that you have carried any of your theses so far, but one way or the other you seem to be retreating from your initial, bold thesis into a much more tentative (if still not quite defensible) thesis.
Greg,
I can assure you that in my circles, what is being talked about is the Biden administration seriously considering allowing the US to provide clinical data results (of Pfizer, Moderna etc) and manufacturing know-how (i.e., the BLA of Pfizer/Moderna) to these countries (to pass along to a local companies to start making domestic supplies) because the administration recognizes that waiving patent rights won’t result in actual drug product produced in those countries. So the cause for industry concern is exactly as Anon points out in 13.1.2.2.
The next rationale statement becomes, if this “waiver” is granted for COVID? Why should countries not also seek the same for AIDS medication? Cancer drugs? etc.
“Even if a temporary waiver of some IP rights related to COVID-19 could be justified, the
waiver request at issue is excessively broad and far exceeds any reasonable measure to address
the COVID-19 pandemic. The proposed waiver is not limited to patents on vaccines or
treatments for COVID-19—the waiver would also gut protections for copyrights, industrial
designs (e.g., textile patterns or other ornamental designs), and trade secrets.“18
18 – Waiver Request at 3.
(emphasis added) – From link to republicans-judiciary.house.gov statement by twelve Congressional signatories – by way of Ron Katznelson over at IPWatchdog.
Who composes the TRIPS “General Council?” I can’t find nay information on how and how this body is elected?
see link to ustr.gov
Any information would be helpful as this body would be the decider of all waivers and what information is necessary/required under each waiver.
A better link link to wto.org
Well xtian, I think that we see that we are MORE in agreement than we are in disagreement.
xtian,
While Greg is technically correct (and xtian, you also have paragraph 3 of the “intent” portion: (emphasis added) work together to ensure [__] and protection of undisclosed information do not create barriers to the timely access to affordable medical products including vaccines and medicines or to scaling-up of research, development, manufacturing and supply of medical products essential to combat COVID-19”
But Greg (correctly, albeit woodenly) wants something in the body of the draft decision text itself.
Greg does omit from that section:
“Recognizing the need for UNIMPEDED…”
Also – “members shall not challenge ANY measures taken in conformity…”
The “wooden” part of Greg’s analysis comes from his thinking that anything less than an actual and useful end result is going to be something that ”trial” by World public opinion is going to be satisfied with mere patents.
IF the US bows to the aim of the WTO and grants any waiver (the difference between the waiver move under the WTO and any individual country taking a next step is a bit of red herring), the entirety of the body of the CURRENT resolution is what will drive that “court of World public opinion.”
And THAT will not be satisfied with anything less than full scale appropriation of EVERYTHING necessary to make undeveloped countries (of note) to BE capable – and that capability impacts technology beyond just the current COVID vaccines.
The patent act defines infringement as anyone who “makes, uses, offers to sell, or sells any patented invention” within the US. (35 USC 271). So even if you make it in a third world country, you may infringe the US patents by selling or using the vaccine in the US. I believe its the same in other developed nations. The US can use the takings clause of the Constitution, use the technology, and provide a just compensation/reasonable royalty to the patent owner.
Are you looking for discussion of legal issues or scientific? Even if the patents teach the art, this art around making molecules that are going to be injected into bodies is not easy. Pfizer and Moderna are using technology that many companies have attempted and the FDA has never (ever) approved for human use. (Currently we are under an emergency use authorization, which could be revoked after the emergency is over.) Further, some pretty well-established companies and countries have attempted the seemingly easy task of generating an SARS-CoV2 S2 antigen to vaccinate people, and failed. For a scientists/entrepreneur, these companies that succeeded deserve every bit of respect and value that they can achieve from their endeavors.
Referring to this as a ‘know-how’ issue distracts from the point that patents are part of the reason why the developing world is not able to create centres for carrying out high quality R&D and manufacturing. Patents are part of a neo-colonial mechanism that keeps the developing world stuck in the status quo, as well as many other factors. See for example: link to papers.ssrn.com
ROTFLMAO!!!!!!!!
There are many reasons the third world doesn’t engage in R&D or manufacturing of certain things. Patents is not one of them. (When’s the last time a big pharma company filed a patent application in Bangladesh?)
First, I don’t know if there ARE patents that cover any of the Wuhan virus vaccines. Hard to believe that any of the traditional vaccines (containing protein, possibly attached to an adjuvant, as the part that elicits the immune response) would qualify for patent protection, unless they’re using a non-natural amino acid sequence. Maybe something in the formulation? Additionally, as to potential patent for traditional vaccines as well for the mRNA vaccines, unless Pfizer or Moderna filed for Track 1 in the USA, I don’t see where any patents specifically covering their Wuhan virus vaccines their would have issued yet, anywhere.
Second, relating to the discussion below about enablement: the enablement requirement for patents is (far) lower than what the FDA/EMA require for marketing approval. Even if an earlier Pfizer or Moderna patent discloses the technology for how to make an mRNA vaccine (possibly even mentioning coronaviruses without, obviously, mentioning the current coronavirus, the sequence of which wasn’t known until early 2020), that disclosure is presumably sufficient to make *an* mRNA vaccine composition, but that’s a far cry from demonstrating the ability to reproducibly manufacture millions of vials containing vaccine that are identical to each other to within the tolerances required by the FDA. So it’s possible for there to be valid patents that protect the vaccines but do not sufficiently teach how to conduct commercial manufacturing of vaccines.
Assuming that there are some trade secrets involved in the commercial production of the mRNA vaccines, are we now going to make Pfizer and Moderna disclose those secrets, viz. are we going to steal their property? And what happens if the vaccines supposedly produced elsewhere in accordance with Pfizer or Moderna protocols make people sick or kill people in a way that the vaccines produced at sites approved by the FDA don’t: will we now hold Pfizer and Moderna responsible?
Note also that the mRNA vaccines require refrigeration, making their distribution in many parts of the world difficult and at best impractical. So even if a foreign government were to abrogate whatever patent protections may exist, and to steal the companies’ trade secrets, that still wouldn’t necessarily make mRNA vaccines widely available.
The fact that within about a year there were several vaccines approved is unprecedented. The profit motive was no doubt a large part of the calculus, but so what? Without it we’d likely still be waiting for a vaccine. By comparison, we’ve been waiting nearly 40 years for an HIV vaccine. That lack may be due in part to the scientific challenge presented by the rapidity with which the coat protein of that virus mutates. Nevertheless, it’s hard to ignore the fact that once anti-AIDS drug cocktails came along, with their ability to generate long-term profits for their manufacturers, that significantly reduced the incentive to develop a vaccine (at least among the purveyors of the antiretroviral drugs), which might be given once or twice and that’s it. This even though AIDS, when contracted, was in the pre-retroviral drug era nearly always fatal, whereas COVID-19 is not nearly as deadly overall; but it’s much easier to be infected by the airborne Wuhan virus than by the bodily fluid-borne HIV, which makes the latter far easier to avoid, thus again reducing the profit incentive to develop a vaccine.
Having seen up close what happens in traditional drug development when IP protections are insufficient (project doesn’t get picked up and the drug is never developed), I would be hesitant to take IP from companies that have developed Wuhan virus vaccines. My inclinations here align with those of Kevin Noonan in his recent Patentdocs post rather than those of Greg DeLassus here and in PatentDocs: the countries agitating for a lifting of IP rights in the face the present pandemic are not interested in a one-off abrogation of IP rights, they want to return to the pre-GATT/TRIPs status quo. Appeasing them in this manner will reduce incentives not only for future drug development, but reduce incentives to invest resources, period, in technologies where IP protections are a critical part of the investment decision.
First, I don’t know if there ARE patents that cover any of the Wuhan virus vaccines. Hard to believe that any of the traditional vaccines (containing protein, possibly attached to an adjuvant, as the part that elicits the immune response) would qualify for patent protection, unless they’re using a non-natural amino acid sequence. Maybe something in the formulation? Additionally, as to potential patent for traditional vaccines as well for the mRNA vaccines, unless Pfizer or Moderna filed for Track 1 in the USA, I don’t see where any patents specifically covering their Wuhan virus vaccines their would have issued yet, anywhere.
Second, relating to the discussion below about enablement: the enablement requirement for patents is (far) lower than what the FDA/EMA require for marketing approval. Even if an earlier Pfizer or Moderna patent discloses the technology for how to make an mRNA vaccine (possibly even mentioning coronaviruses without, obviously, mentioning the current coronavirus, the sequence of which wasn’t known until early 2020), that disclosure is presumably sufficient to make *an* mRNA vaccine composition, but that’s a far cry from demonstrating the ability to reproducibly manufacture millions of vials containing vaccine that are identical to each other to within the tolerances required by the FDA. So it’s possible for there to be valid patents that protect the vaccines but do not sufficiently teach how to conduct commercial manufacturing of vaccines.
Assuming that there are some trade secrets involved in the commercial production of the mRNA vaccines, are we now going to make Pfizer and Moderna disclose those secrets, viz. are we going to steal their property? And what happens if the vaccines supposedly produced elsewhere in accordance with Pfizer or Moderna protocols make people sick or kill people in a way that the vaccines produced at sites approved by the FDA don’t: will we now hold Pfizer and Moderna responsible?
Note also that the mRNA vaccines require refrigeration, making their distribution in many parts of the world difficult and at best impractical. So even if a foreign government were to abrogate whatever patent protections may exist, and to steal the companies’ trade secrets, that still wouldn’t necessarily make mRNA vaccines widely available.
The fact that within about a year there were several vaccines approved is unprecedented. The profit motive was no doubt a large part of the calculus, but so what? Without it we’d likely still be waiting for a vaccine. By comparison, we’ve been waiting nearly 40 years for an HIV vaccine. That lack may be due in part to the scientific challenge presented by the rapidity with which the coat protein of that virus mutates. Nevertheless, it’s hard to ignore the fact that once anti-AIDS drug cocktails came along, with their ability to generate long-term profits for their manufacturers, that significantly reduced the incentive to develop a vaccine (at least among the purveyors of the antiretroviral drugs), which might be given once or twice and that’s it. This even though AIDS, when contracted, was in the pre-retroviral drug era nearly always fatal, whereas COVID-19 is not nearly as deadly overall; but it’s much easier to be infected by the airborne Wuhan virus than by the blood- or semen-borne HIV, which makes the latter far easier to avoid, thus again reducing the profit incentive to develop a vaccine.
Having seen up close what happens in traditional drug development when IP protections are insufficient (project doesn’t get picked up and the drug is never developed), I would be hesitant to take IP from companies that have developed Wuhan virus vaccines. My inclinations here align with those of Kevin Noonan in his recent Patentdocs post rather than those of Greg DeLassus here and in PatentDocs: the countries agitating for a lifting of IP rights in the face the present pandemic are not interested in a one-off abrogation of IP rights, they want to return to the pre-GATT/TRIPs status quo. Appeasing them in this manner will reduce incentives not only for future drug development, but reduce incentives to invest resources, period, in technologies where IP protections are a critical part of the investment decision.
I believe Covid patents should NOT be enforced for the simple fact that the vaccine was paid for by taxpayers. I saw one statistic that said Moderna was paid over $2.5 billion so in effect, they already got paid and shouldn’t subsequently be allowed to profit on a Covid vaccine based patent that was primarily funded by the people..
Duly noted.
You have a larger issue then with the entire Bayh-Dole act…
Understandable viewpoint, but there are really 2 issues here: whether pharma should be compensated for making/selling the patent-covered product, and whether pharma should be able to prevent others from doing same (patent enforcement).
Vaccines IP should be free is part of the growing disregard for protecting innovation.
I am skeptical of this for two reasons:
(1) What does it mean for the government to “know” something? The government is not a person. Individual government employees know things, but none of them know all of the info that is in government possession. If all you mean is that some government office somewhere has the relevant info in a file drawer somewhere, that does not really mean that the government “knows” it. Is there a person—aware of the info’s existence—who could actually communicate the info to a relevant actor?
(2) I am skeptical that the government actually has all the relevant info in its files. The private sector moves faster than the regulators. We are finding solutions far faster than the government can take note of and record them.
Apparently, multiple parties only required ~2 days to develop a vaccine once the sequence was known, and another ~10 days to spin up manufacturing.
If true, I highly doubt there will be any patents issuing in the U.S. on a COVID vaccine. The sequence itself is a natural phenomena, and everything else appears to be routine skill in the art.
And then, what is the reasonable royalty when there are 4+ more-or-less equivalent products? Game theory would say ~$0.
Yes, there is theoretically an injunction remedy, but doesn’t the 4 part test weigh pretty heavily against it here?
“There are currently no issued patents in any less-developed country that would prevent people from making/using the vaccines there.”
Not sure you can say that for certain, and there may be patents pending in a lot of countries like India etc. that might put a damper on those vaccines being made there, but I’m not 100% sure about any of that, hugely complicated issue.
I agree it’s not a patent issue, but I don’t think it casts an especially favorable light on patents.
After all, if patents really taught people to do things, India and Co. should be able to hire a few people skilled in the to read some patents and get it going.
Explain to the man on the street (in either New York or New Delhi) that the vaccine requires steps A, B, and C, and that the companies only patent step B so they can control the vaccine without actually teaching how to make it, and you will create a new enemy of the patent system.
Agreed. I do not think that a lot of the ultras around these parts realize how dangerous it can be to antagonize public opinion around the patent system.
I don’t know. My guess is that most lay folks’ eyes would just glaze over if the conversation turns to the nitty gritty of patent and IP policy. I think people maybe nod vaguely with approval when a politician brings up the “innovation economy”, but that’s about it. This stuff is pretty much for the diehards (like present company) only, IMO.
Ordinary people do not think about patents much one way or the other. Their default position is one of generic approval (“it is good to recognize and reward inventors,” or some such). If, however, you start antagonizing or annoying ordinary people with patents, their mood sours quickly. None of the coverage around FolNer LLC’s infringement suits against small business owners using Minolta copiers played up how deserving the inventors were of recognition or reward.
If the public image of the patent system comes to be one of trolls and soaring drug prices, the present good-will toward the patent system will evaporate. One should not take the stability of the patent system for granted if it is used in such a way that sours public opinion.
… and then you have those actively souring public opinion…
(think Efficient Infringers and the very ones that made ‘patent Tr011s’ a part of the general lexicon — hint: they did not employ such vigorous propaganda for the benefit of the public)
There is no reason to think what Ben said is the reason.
I am not sure about the reasons why but I am sure that if, say India, hired people skilled in the art and bought the right manufacturing equipment that they could manufacture the vaccines.
Hard to say why these countries don’t do this. They don’t do a lot of things that would be good for their people for lots of reasons. Sometimes it is as simple as the person in power is nothing more than a puppet to foreign interests and being paid well to do what he is told and caring for his people is not on his agenda.
Plus it may just be that the cost benefit analysis of building a pharmaceutical plant to copy western pharmaceuticals is just not worth it to a country outside the first world of countries.
But I think we can be sure what Ben said has little to do with the why.
I am not good at searching this stuff, but timing wise, I don’t think any application would have published yet. To be published, the application would have a priority date before December 2019. It does not add up.
By definition, unpublished IP is not granted IP, and therefore unpublished IP is irrelevant to Prof. Crouch’s point. Even before BioNTech, Moderna, etc. had COVID19 vaccine, however, they had IP on the vaccine platform used to make the COVID19 vaccine. None of this IP was brought into the IN national phase, the ZA national phase, etc.
In other words, the granted IP is not enforceable in the countries who want the waiver. Whether as-yet-ungranted IP has been brought into those countries is irrelevant, because ungranted IP cannot be enforced to stop vaccine manufacture anyway.
Ok, so if I understand correctly, some countries want a waiver to patents that are only indirectly connected to COVID, and possibly connected to the treatment of a bunch of other diseases? If so, no wonder the pharmaceutical industry opposes the waiver,
The patents cover the vaccine when it is used for COVID19, and when it is used for (e.g.) influenza. The proposed waiver—by its own terms—only applies to the patents when they might be used to block manufacture of COVID19 vaccine (“The General Council… Decides as follows:
1. The obligations of Members to implement or… to enforce… the TRIPS Agreement, shall be waived in relation to prevention, containment or treatment of COVID-19, for [X] years from the decision of the General Council,” emphasis added). Even if the waiver were granted, it would have no effect on the enforcement of the same IP against (e.g.) an infringing HPV vaccine.
Moreover, discussion of HPV vaccines, or influenza vaccines, or whatnot is a red herring in the context of this waiver. As it happens, the only vaccine made with either BioNTech’s platform or Moderna’s platform with regulatory approval anywhere in the world is the COVID19 vaccine. There is no other sort of vaccine that could infringe this IP in any country, and there is no likely to be any such vaccine in the [X] years of effect that the waiver is like to have (except in the unlikely scenario that a waiver be granted with X > 5).
OTOH, that language doesn’t seem limited to domestic use. What’s to stop India’s very-large and sophisticated pharma mfg sector from exporting?
Particularly if patents on the vaccine(s) themselves are unlikely. see #5 above.
And also, to answer to Ben at 3.0, it is normal that patents not specific to COVID vaccine may not enable the production of COVID vaccine.
True.
I appreciate your tautology, but I ask that you consider whether patents that are non-specific to the COVID vaccine may still describe technology necessary for the COVID vaccine.
Remembering the rather excellent article that Greg shared a few months ago*, it seems like the truly difficult manufacturing process involved here is the formation of the lipid nanoparticles containing the mRNA. Those processes do appear to be under patent (e.g., US 10,577,403). That they do not include mRNA-1273 doesn’t mean they they do not describe processes necessary for the vaccine. As these processes are rate limiting in the US, then they are clearly a constraint on third world production as well. If US manufacturers cannot just hire some more people, and have them read the patent, to address the rate limiting step in the US, it seems unlikely that India can hire some people, have them read the patent, and have them implement the processes. So how exactly are these patents enabled?
*You don’t remember the article? I don’t believe you. You’re just trying to make me do extra work and distract from the obvious fact that I’m supremely correct. Go find the article on your own so you can admit how right I am.
Just kidding. Here you go:
link to blogs.sciencemag.org
Ben,
The disclosure needs to “enable any person skilled in the art to which it pertains.” 35 USC 112. It is certainly possible that there are some arts where there are just not that many people in the world who qualify as “skilled in the art”.
Also note that it is definitely possible for an ordinary artisan to understand how to perform a method given known inputs x and y and known machine z, even if known inputs x and y or known machine z is unobtainable by many artisans.
While both may be true, I think that the point being aimed at is slightly different — in that an End item (perhaps not the item covered by a patent) that is necessary to actually be effective “in the real world COVID fight” is what is the item that requires “more than” the patent.
I referenced this below as being the “second Ends.”
I actually agree with Greg that by and large the first Ends may well be provided through the means of patented items (even as those patented items are NOT the rate-limiting items, and in and of themselves cannot meet the global desired Ends — the Ends simply being different Ends).
As I see it, another analogy that may apply is that patents are merely pawns in a chess game.
The higher value pieces are not the pawns. That does not mean that pawns may be carelessly played.
I’m not sure you’re right about this. I don’t think a claim to a method of attaching a warp drive to a spaceship gets a pass because the warp drive is an “input”. It seems like the basis for “unobtainable” matters a lot.
Anyways, my point was not that there is a definitive deficiency in those patents. There could be, but there also could be reasons why they’re fine. My point was that it looks bad to someone who is not used to the rules of this game.
An interesting point Ben.
To the extent that there are claims on the specific vaccine (whether pending or published), then there is a problem with the doctrine if a patent waiver would be ineffective because the disclosure is inadequate for a skilled person to “make and use” the claimed invention. And if the input patents (e.g., lipid nanoparticles) are limiting, then similarly a waiver would overcome them unless their disclosure is also inadequate to make and use (and recall that use is not limited for infringement, even if only one use needs to be described). So the key issue as noted is whether skilled persons exist in those jurisdictions. If so, then the problem is legal doctrine if the disclosure are inadequate because they fail to convey sufficient know-how. Stated differently, the public is not getting the benefit of the patent bargain.
The patent bargain requires that the patent teach how to make. It does not require that the patent teach how to make at industrial scale. A patent can be “fully enabling” within the standards that the law requires (complete information about how to synthesize a 50 mL tube of vaccine particle prep) even if it is not much help to someone trying to build a vaccine factory.
I basically agree.
I think that you jumped too fast to think that IP waiver is aimed ONLY at patent waiver.
Further, in an ‘obvious analog to improvement patents, merely having one patent waived does NOT mean that one can practice something (in the positive right sense – as opposed to the negative right sense of what a patent actually provides).
Of course, here (it being in the land of Big Money Pharma), one can readily see that the nuances and complications will surely abound.
One of the aspects hinted at over at Patent Docs (and to which I touch on below), is that some of the ancillary items – and take for argument’s sake that these ancillary items are properly segregated from anything actually protected by patents (which, again, NEED NOT BE the full working item) – we very quickly become ensnared in the ‘pure politics’ of waiving buckets of IP (including Trade Secret type items) that impact FAR MORE than the immediate crises.
I do “get” that you want to focus on a tiny sliver of possibility in that a patent that IS a “be all and end all” may have an issue IF waived, and that waiver does NOT turn out to be enough.
I just think that there is NO such thing as a “be all and end all” item in this very interwoven space.
If I am an American supplier to key or main ingredients to a vaccine that is protected by a US patent, am I liable for exporting those ingredients to another country knowing that they will be combined to make the patented vaccine?
Yes, and nothing about the proposed TRIPS waiver would change that, even if the WTO were to grant the TRIPS waiver.
I don’t think an automatic “yes” is right. If there are other non-infringing uses for that ingredient, then it very likely would not be a problem. If the American supplier sells the ingredient and specifically advertises it as being made specifically for covid vaccine manufacture, that is a different story. Just putting the ingredient out there, without any kind of specific representations regarding its use is very different.
I am not sure what it means to speak of a “key or main ingredient” that has “other non-infringing uses.” Almost by definition, the “key ingredient” or “main ingredient” of a vaccine is the one that is useful only in the vaccine. The ingredients with “other non-infringing uses” would—by definition—be excipients, not “main ingredients.”
In any event, my main point is that nothing about the TRIPS waiver—if granted—would change the liability for a US manufacturer exporting to (e.g.) India.
What is the basis of liability here? While § 271 mentions import, it does not mention export.
§ 271(f)(2)
Granted, the word “export” never occurs, but “supplies or causes to be supplied in or from the United States” covers the same territory.
Yep, I read to fast. Thanks!
I’m not well versed in this at all, so forgive the neophyte question. There must be at least some reason why developing countries want the patent waiver right? I agree it doesn’t seem to make sense in terms of local production because (1) as noted that involves tech xfer, not patents anyway and (2) regardless, they currently have no infrastructure so getting that off the ground would take too long as well. So then what is the reason? The only thing I can think of is they want to accelerate generic production in developed countries and then benefit from that via importation. Does that make sense though? Thanks for indulging me on this one!
There must be at least some reason why developing countries want the patent waiver…
One would think so, but the more I look at the question, the more I think that the countries requesting the waiver are just mistaken in thinking that it will help. The waiver—if granted—would be a big nothingburger.
That is why I think that the US, EP, BR, etc. should stop bothering to oppose the waiver. Just let it happen. Then we will not look like we are obstructing pandemic relief (we are not actually obstructing pandemic relief, even if the waiver never grants, but sometimes appearance is as important as reality, even if only for different reasons). We will not actually be giving up anything worth having, even if the waiver grants.
Thanks. I think I understand. While I don’t want to cast the folks in developing countries as rubes who are going to all this trouble for nothing out of a mistaken belief, I do think it makes sense that, like you and anon suggest, it may just be about the optics, politics, or principle, and/or setting a marker for down the road. That would also explain why PhRMA et al. are pushing back so hard. Your proposed solution for PhRMA definitely has appeal, but anon notes they may have reason to fear the “camel’s nose” (a great expression I didn’t know about).
A lot of the argument against the waiver is phrased as a “camel’s nose” or a “slippery slope,” but this is not really all that convincing to me. If the U.S. government really wants to suspend patent rights (they rightly do not, but if they wanted to), it lies fully within the Congress’ power to do so. Simply declare patent rights suspended, and—hey presto—they are suspended.
If the U.S. government wants to force a disclosure of trade secrets, this is a lot harder. How would the government even know if the (illegal, constitutionally unenforceable) order is being followed? The world in which such an order is made is hard to imagine, but the world in which it is actually carried into effect is even harder to imagine. This is not a worry that should actually enter into our analysis of the proposed waiver.
“The world in which such an order is made is hard to imagine,”
It’s actually hard to imagine a more PollyAnna and disconnected statement.
That would also explain why PhRMA et al. are pushing back so hard.
I think that PhRMA is being every bit as irrational in its opposition as the countries asking for the waiver are in their advocacy. The world in which the waiver is granted will be largely indistinguishable from the world in which it is not granted. Both sides care more about this proposed waiver than there is any rationale reason to care.
As I am beginning to “suss out,” the issue is not (or may not be) so much a specific patent waiver, as much as it is a waiver for all related IP — which would include Trade Secret and actual manufacturing implementation know-how, that once “waived” destroys the value of those Trade Secrets.
As a bottle-neck is not any specific patent waiver, those should be easily granted.
I figuring that doing so though would be a “camel’s nose under the tent,” and the requests would not end there.
To play on my “Ends do not justify the Means” meme, the “Ends” as being ‘suggested,’ and the actual Ends may well be two VERY different things, and the Means of “Patent waiver” really will not bring about EITHER Ends. Once a “political/social” Ends is accepted though, the other (longer term and eminently more valuable) Ends is likely to be demanded, and different Means will be required.
Saying “yes” to one Means (even if it were to be widely understood that that Means cannot provide the Ends – a first Ends) is a world-wide social dilemma of one VERY slippery slope to other Means (for other Ends).
Kevin Noonan hypothesizes (although he does not really know any more than anyone else on this point) that “the call by these governments… should be understood for… an attempt to use the pandemic to achieve a goal of status quo ante (prior to the establishment of the GATT/TRIPS/WTO global trade and patent regime)… .”
This could be true as far as it goes. Even if it is true, however, that does not mean that PHaRMA should oppose the waiver. The New York Times wrote several years ago about a community of Syrian Jews in Brooklyn who refuse to admit converts to their community. They made one exception to this rule, however, when the chief Sephardic rabbi of Israel signed the convert’s papers. The Brooklyn community “reasoned that accepting this case as precedent would actually have a deterrent effect: how many other converts could expect the chief rabbi of Israel to go to bat for them?”
Mutatis mutandis, the same reasoning applies here. Right now, there has never been a TRIPS waiver granted. By taking COVID19 as the cause that triggers the exceptional suspension clause, we set a rigorous precedent as to what sort of conditions justify the invocation of this exceptional clause. PHaRMA would do well to set the bar at this height while the opportunity presents itself, particularly because to do so comes at no real cost.