Big Move: US Supports IP Waiver for COVID Vaccine

by Dennis Crouch

In the USA, COVID vaccines have been widely distributed and are now available at no cost almost on-demand for anyone seeking vaccination.  Vaccines are not widely available in most other countries and global COVID cases are again at an all-time high.

And, people around the world don’t really trust that Pfizer, Moderna, and J&J are going to be serving them anytime soon.  That is where the TRIPS waiver comes into play.

TRIPS:  Countries around the world are asking for a waiver of some aspects of the international intellectual property (IP) agreement known as TRIPS as part of their response to the global COVID pandemic.  This IP Waiver would be a first step toward countries and companies around the world manufacturing, distributing, and importing already developed vaccines, such as those now being distributed in the USA by J&J, Pfizer, and Moderna. Without the IP waiver, a country could suffer trade penalties if they permitted production or importation in violation of rights.  The penalties are setup in a country-versus-country bases and do not allow for any private action by the individual rights holders. Thus,  the TRIPS dispute resolution process does not provide Pfizer standing to sue India for violating IP rights guaranteed under TRIPS; Rather Pfizer could only lobby to the U.S. Government to bring a case, which traditionally might have done.

The U.S. Government is reportedly going to support the waiver proposal, although there are current ongoing negotiations over its actual text and content.  Even without a WTO waiver, the US can also act unilaterally to announce that it would not bring any TRIPS cases associated with violations.  This is a major change of policy under President Biden and his new U.S. Trade Representative Katherine Tai.  In the past, the US has always been on the side of stronger IP rights and more enforcement.

Trade Secrets + Patents: In the short-run, the big difference is more about trade-secrets than patents.  In the longer run, patents may become equally important.

If we take India as an example, right now there are no patents that have been granted in India tied directly to the COVID response.   So, allowing India to waive its promise to enforce patents does not generate any short-term gains. Here, by short-term, I’m really talking about the next two years or so.  Hopefully by that time the pandemic will be gone.

Trade secrets are different, most of the “intellectual property” wrapped up in COVID vaccine manufacture is currently being held as trade secrets.  Obviously the companies manufacturing the product have the information. Many countries also have information that they received in the process of (1) funding the research and (2) determining whether to allow the vaccines to be distributed.  International espionage is also a major element here that will put the information in the hands of various  governmental agencies.

TRIPS require that countries protect trade secrets, and also keep secret the information provided as part of regulatory approval.

Article 39

1. In the course of ensuring effective protection against unfair competition … Members shall protect undisclosed information in accordance with paragraph 2 and data submitted to governments or governmental agencies in accordance with paragraph 3.

2. Natural and legal persons shall have the possibility of preventing information lawfully within their control from being disclosed to, acquired by, or used by others without their consent in a manner contrary to honest commercial practices (10) so long as such information: (a) is secret in the sense that it is not, as a body or in the precise configuration and assembly of its components, generally known among or readily accessible to persons within the circles that normally deal with the kind of information in question; (b) has commercial value because it is secret; and (c) has been subject to reasonable steps under the circumstances, by the person lawfully in control of the information, to keep it secret.

3. Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use. In addition, Members shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use.

[TRIPS Text]

The original proposed WTO waiver would have waived this trade secret protection requirement — a really big deal.

Waiver of the requirement does not force the companies to actually conduct any technology transfer — to provide the information to others who want to manufacture.  BUT, it does open the door to governments sharing the information and also to a major WIKILEAKS style sharing of data and information.  I believe that a whistle-blowing is actually quite likely because so many scientists and business insiders are wanting to do everything they can to spread the vaccine, but don’t believe that it will be permitted by the CEOs and Shareholders.

The other thing that this does is substantially shift the negotiation positions.  This waiver signals to the current vaccine-makers to speed-up global access.

We’ll be looking for President Biden’s action on this as we move forward.  As I mentioned above, negotiations are ongoing and I expect a focus on timelines (when does the waiver end) and scope (exactly what is being waived).

92 thoughts on “Big Move: US Supports IP Waiver for COVID Vaccine

  1. 16

    I don’t know the answer to your question regarding the radio/radar patents.

    But when the US entered WWI, the Departments of War and of the Navy — actually something called the National Advisory Committee for Aeronautics, an early sort of DARPA of that period — pressured (compelled?) the Wright-Martin Company and Curtis Aeroplane to end their patent litigation and cross-license their patented technologies to ensure an adequate supply of airplanes for the war effort. No one wanted to appear to be against the war or otherwise unpatriotic. In any case, the relevant patents were not actually taken from their US owners and any potential antitrust implications from the patent pool were ignored for the national interest. (BMW’s aeronautics patents were seized, and at the end of the war auctioned off [to Boeing?] – after which BMW dedicated their future endeavors into making automobiles instead.)

    I don’t know if anything like that kind of leverage/pressure would really work in the present situation for vaccine supplies; the conditions are very different now.

  2. 15

    I came across a similar situation in my LLM in IP. There are big problems with Biden’s plan involving 5th Amendment Takings Clause and 13th Amendment involuntary servitude. Biden simply can’t give away the intellectual property of pharmaceutical companies without paying compensation at fair market value according to 5th Amendment and the US Supreme Court. Biden’s waiver is an unfunded mandate not authorized by Congress who has the power of the purse. It is up to Congress, not the President, to decide who is going to pay for the IP waiver. Biden also has the problem of involuntary servitude by forcing pharmaceutical companies to actively give over there know how in to make generic vaccines possible in violation of the 13th Amendment prohibition on slavery. Obviously, something needs to be negotiated with the pharmaceutical companies to get their consent rather than trying to force a square peg through a round hole on behalf of foreign countries that have long acted hostilely to the US. Gotten any scam calls on your phone lately from India or seen India’s plan to invade Australia for a “greater India”? If India can send up satellites then certainly India can pay some form of compensation to US pharma for their help.

    1. 15.1

      Go back an re-read the waiver proposal. No US IP rights are being waived—by Biden or anyone else. You are certainly correct that if Biden were proposing to waive US IP rights, then Congressional action would be needed. As it happens, however, no one—including Biden—is proposing to waive any US IP rights, so the talk of V amendment takings and the like is all beside the point.

    2. 15.2

      Curious. When working on your LLM, did you analyze the ‘takings’ issue when the US government seized all german company patents in WWII, and issued trivial license grants to US companies? What about the nationalization (pooling) of the radio and radar patents?

      1. 15.2.1

        Those foreign-owned patents were seized in time of war under the Trading with the Enemy Act of 1917 (50 U.S.C. ch. 53, §§4301 et seq.). The US Supreme Court has ruled that there is no constitutional prohibition against confiscation of enemy property. See, e.g., Stoehr v. Wallace, 255 U.S. 239 (1921); United States v. Chemical Foundation, 272 U.S. 1, 11 (1926); and Silesian-American Corp. v. Clark, 332 U.S. 469 (1947). Moreover, more recently in a drug cartel case, the court ruled that the Takings Clause protections may be invoked for aliens only “when they have come within the territory of the United States and developed substantial connections with this country.” United States v. Verdugo-Urquidez, 494 U.S. 259, 271 (1990).

        No corresponding statute would seem to apply to the present situation to allow a taking of U.S. privately owned patents without compensation. Even the International Emergency Economic Powers Act of 1977 (50 U.S.C. ch. 35, §§1701 et seq.), which deals with economic and trade sanctions against targeted foreigners in time of peace, would not apply. So, any taking for public use would require an act of Congress.

        What the U.S. government could do would be authorize manufacture of patented vaccine on its own behalf, which would be covered by 28 U.S.C. § 1498(a) and (c). The patent holder would be allowed to make a claim for the recovery of his reasonable and entire compensation for such manufacture.

        1. 15.2.1.1

          [M]ore recently in a drug cartel case, the court ruled that the Takings Clause protections may be invoked for aliens only “when they have come within the territory of the United States and developed substantial connections with this country.” United States v. Verdugo-Urquidez, 494 U.S. 259, 271 (1990).

          I did not know that. Thanks for the citation.

          1. 15.2.1.1.1

            Just one caveat: That case was mostly a 4th amendment search case relating to a warrantless search (in Mexico) for evidence against the cartel leader for the notorious murder of DEA agent Salazar. And so, although the discussions about the 5th and 6th amendments as they relate to foreigners would seem to be integral to the court’s basic argument, they might perhaps be viewed as dicta in regard to Takings. The foreign defendant had attempted to argue that because he had been delivered into US custody to stand trial, he was suddenly entitled to a full panoply of rights afforded to US citizens and resident aliens. Chief Justice Renquist and five other justices disagreed.

        2. 15.2.1.2

          Thank you Mark. Excellent response. I’m going to read your cites. To be sure, with an actual declaration of war by congress – everything is out the window. You appear a fount of knowledge. Thanks for appearing. Do you know whether the radio and radar patents (US property) pool also under the war power act or something else.

          1. 15.2.1.2.1

            Yes, I know, it’s a rather, to some, a – how shall we say – a legal point lost to history – but in my understanding – the radio and radar patents were – in a time of war – pandemic? – crisis – were forced (volunteered?) into a patent pool. In other words, patent enforcement was halted while the full industrial national mobilzation was going. Freedom’s Forge link to amazon.com A must read, IMHO, skips on the IP chapter.

  3. 14

    Here is Pfizer’s press release feed. Here is Moderna’s. Not a word about yesterday’s announcement.

    Why is that? Because they know that it is all an empty gesture. If they were really being robbed, they would not sit quiescently. The people who read this as a disaster need to pay attention and learn from those at the center of this story.

    I do not mean to make out that this is “no big deal.” It is a very big deal. When the waiver comes through, it will be the first TRIPS waiver ever granted. That is a big deal. We now know what it takes to get TRIPS to grant a waiver—a global pandemic of truly lethal proportions.

    This does not actually spell the start of a disasterous slide toward abolition of IP, however. Quite the contrary. If the bar for a waiver is this high, such waivers are and will remain rare and exceptional. 2020/2021 is an aberration, not the new normal.

    1. 14.1

      Dozens,

      The portion of your post of “We now know what it takes to get TRIPS to grant a waiver—a global pandemic of truly lethal proportions.” sounds in some of my early posts on the matter — when I was aiming to establish that the legislated presence of the waiver mechanism was very real – and attempted to pull out from people the notion of “if not this, then WHAT?”

      A reflection of this point is: “what else may be ripe for the cross-hairs of “equity.”

    2. 14.2

      Here is the J&J press release feed. Here is AstraZeneca’s. Funny how none of the large vaccine manufacturers have anything to say about the proposed TRIPS waiver.

      Why, you might even conclude that those whose business depends on IP can see the proposed waiver for what it is—a hollow PR gesture—and are not especially perturbed. I am sure, however, that the Cassandra’s prophesying doom must have a better understanding of the situation than those most affected.

      1. 14.2.1

        there are far better and easier to understand reasons why any particular Pharma company would rather NOT step into the limelight of the “PLEASE share NOW” entreaty from the likes of India.

        You might want to pull your head out though to see them.

  4. 13

    Here is Pfizer’s press release feed. Here is Moderna’s. Not a word about yesterday’s announcement.

    Why is that? Because they know that it is all an empty gesture. If they were really being robbed, they would not sit quiescently. The people who read this as a disaster need to pay attention and learn from those at the center of this story.

    I do not mean to make out that this is “no big deal.” It is a very big deal. When the waiver comes through, it will be the first TRIPS waiver ever granted. That is a big deal. We know what it takes to get TRIPS to grant a waiver—a global pandemic of truly lethal proportions.

    It does not actually spell the start of a disasterous slide toward abolition of IP, however. Quite the contrary. If the bar for a waiver is this high, such waivers are and will remain rare and exceptional. 2020/2021 is an aberration, not the new normal.

  5. 11

    Thanks, Dennis. This article is far more informative than anything coming from the mainstream news media, who would have you believe that US patents addressing COVID vaccines are somehow being cancelled by the adminitration. Going solely by what the news media was reporting, I was trying to figure out, without much success, how this alleged action – even if it were legal – would actually solve the current worldwide vaccine shortage. The only thing I could imagine was the US exercising march-in rights in government-sponsored development contracts, claiming partial or full ownership of the patents, or simply contracting with third-party manufacturers to make vaccine in the US for export on behalf of the US government (which would still allow a claim for reasonable royalties in US Claims Court); even then, all of those were a stretch. Thanks again.

  6. 10

    Again, the primary problem here is the news media. Walter Cronkite would have never have reported this nonsense.

  7. 9

    This is an off-topic observation of no real significance, but I am surprised that MM is polluting the two threads above this one with his nonsense sockpuppets (“Derp Thinkin Gene” and “Slurp It Up”), but he has nothing to say on this thread. That surprises me. Shouldn’t we all be neoliberal shills or bloodthirsty profiteers or some such over here?

    1. 8.1

      Given his other writings on patents, I’d think Tabarrok would be even more loathed around these parts than Lemley.

      1. 8.1.1

        I suppose that if Prof. Tabarrok’s work got cited in as many judicial opinions as Prof. Lemley’s, then people around here would dislike T as much as they dislike L. As it happens, however, Prof. Lemley is about 1000x more influential than Prof. Tabarrok. I doubt that more than ~15% of the regulars around here are familiar with Tabarrok’s oeuvre.

          1. 8.1.1.2.1

            Interestingly enough – Prof. Tabarrok goes to pains to make sure that it is NOT a takeaway that he is ‘pro-patent’ and even provides links back to his work that states that patents are TOO strong — very much in the Efficient Infringer mode.

            Just goes to show: not everyone that agrees with you is your friend (and not everyone that disagrees with you is your enemy).

  8. 7

    Interesting article. Will governments approve a “generic” vaccine developed solely/mainly from information obtained from “whistle-blowing … scientists and business insiders,” without cooperation from the brand-name source? Will new testing be required to establish safety/efficacy?

  9. 6

    I somebody has to give up their property rights, why not make it the people who own the factories that would use the patented invention under the waiver? Make them turn the factories over to the patentees to produce the essential vaccines. At least they know what they are doing.

    1. 6.1

      … interesting – a form of Eminent Domain (or, redistribution of resources, taking that from those having a bit, and giving it those that have more).

      What could go wrong with that?

      (btw, not to get too religious, but Matthew 13:12)

  10. 5

    @MaxDrei – So what your saying is the people on this board screening that this is more than a patent waiver were correct? So why didn’t India and Africa just ask for cash or just ask that the technology be given to them?

    Why hide the true purpose of the “waiver?” This approach comes off as disingenuous and doesn’t advance the conversations. It adds skepticism to the negotiations.

  11. 4

    As noted in the post, negotiations are still ongoing and the devil will be in the details. Although Gregg got trolled by several people about his comment, the question I have is why will this even matter in the short run, when, as also noted above, India has not even issued a patient related to this technology. Nothing is stopping any company there from producing any of the vaccines using any published data or information from anywhere in the world. Then again, maybe something is stopping them – technology and know-how. The Pfizer and Moderna vaccines are the first ever using the RNA technology. How many companies have been working in this area, let alone have the expertise to actually reproduce this work? Even if given a road map of trade secrets by their government, how easy would it be to set up a manufacturing plant to work this out? How much money and time would it take to get this kind of manufacturing up and running? Years, if they’re lucky. While this decision makes for a good talking point (for both sides of the political divide), I would be surprised if it has any kind of impact on the pandemic unless (God forbid) it’s still raging in two or three years due to new variants that escape the current vaccines.

    1. 4.1

      >as also noted above, India has not even issued a patient related to this technology.

      I don’t know about India, but the U.S. probably never will… As reported, several labs were able to independently develop their vaccines in ~2 days after the DNA sequence was published. It took another ~10 days to set up small scale mfg.

      In patent terms, the DNA sequence itself is an unpatentable natural phenomena and the evidence seems to show that everything else was obvious.

      1. 4.1.1

        It is unlikely that claim on a hapten having a protein sequence found in the virus (or on an mRNA sequence that codes for the protein sequence) will be granted – that sequence per se is anticipated as soon as the whole sequence is published. But there’s a lot more to a drug, or in this case a vaccine, than just the API or the hapten or mRNA. How that little piece is chemically packaged so that it can get into the body and once in the body, go where it needs to go, may be non-trivial. And getting those chemical packages into packages to be delivered to pharmacies, viz. into vials or blister packs or whatever, likewise can be non-trivial. So I wouldn’t say that there’s NO possibility of ANY patents being granted on technology related to the present crop of vaccines – some of them may have something patentable to them.

        1. 4.1.1.1

          I agree, it may be non-trivial. Factually, it apparently wasn’t here.

          Admittedly, I may be reading too much in to the 2 days of development. Perhaps a spark of genius struck at just the right time.

      2. 4.1.2

        The Pfizer vaccine is patented as US 9,295,717. The Moderna vaccine is still pending as US 16/639,403.

        1. 4.1.2.1

          I did not look at the claims of the patent so I offer no opinion whether it actually covers the Pfizer/BioNtech COVID vaccine. However, the point is whether there is an Indian and African equivalent patent. If not, the statement that there is no IP blocking the domestic (to India and Africa) vaccine production is still accurate.

          1. 4.1.2.1.1

            However, the point is whether there is an Indian and African equivalent patent. If not, the statement that there is no IP blocking the domestic (to India and Africa) vaccine production is still accurate.
            Bingo.

          2. 4.1.2.1.2

            Sorry, just to be clear, neither of those cited IP assets have any IN or ZA phases. I was responding merely to the Old C’s assertion that “I don’t know about India, but the U.S. probably never will… [grant a patent on this technology].” Not only will the U.S. grant a patent on this technology, it already has.

        2. 4.1.2.2

          The Moderna vaccine is still pending as US 16/639,403.

          Sorry, this application is more of a follow-on. The Moderna vaccine is already patented (US 10,022,435).

    2. 4.2

      I think illustrates just how out-of-control the media is.

      The narrative that somehow patents are harming sick people in India is just so good for them to push that facts don’t matter.

      1. 4.2.1

        Indeed, NW. Indeed. The network effect companies, having the PR pumps already primed for the ‘patents stifle innovation’ lie, they can’t help themselves with this head slammer. A TRIPs waiver is nothing but an empty gesture, but it does send the bio-tech stocks plunging. Remember back when Hillary was hatching her Hillary Care plan, she said, if some company discovers the cure for cancer, she would nationalize the IP to the discovery. Sending all the bio-tech stocks into the toilet. To me, it’s part and parcel of this – everything belongs to the government mentality – of privileges vs. rights.

        Different point. I think you IP guys need to adopt a new lexicography concerning “know how” which IMHO, is all the ‘trade secrets’ plus a work force skilled in the minutia of making the product. The demand here is to transfer the now how. Just like having to train your off-shore replacement as your last task at work.

        1. 4.2.1.1

          iwasthere,

          Methinks thou graspeth the situation.

          Relatedly, we may be seeing (at the same time, by different elements of the same faction)

          both

          the dawning realization that a Pharma “divide and conquer (our innovation is different than any other art unit innovation) will not work

          and

          a fervent denial of reality on the World stage of the force (and perhaps more critically, the breadth) of IP waiver.

          Some (like Greg) seem to want to take refuge behind an odd “this is not a forever thing.” This absolutely misses the point unfolding on the world stage, and no one has ever indicated that the actions unfolding WOULD BE any type of forever thing.

          Other then such as Dr. Noonan at PatentDocs (rightfully) pointing out that those items IN the IP waiver net that are not patent items will effectively BE forever lost — due to the irreversibility of transfer of Trade Secrets and know how.

          Greg — and to an alarming degree Wandering through — appear to “rest” their thinking on a (flimsy) “that can’t happen” — even as the Biden administration’s statement tells them the opposite (and in fairness, the devil in the details has not yet been unleashed).

        2. 4.2.1.2

          Remember… when Hillary… said, if some company discovers the cure for cancer, she would nationalize the IP to the discovery.

          No, I do not remember this at all. Are you sure that you are remembering correctly? I cannot find anything like this in a Google search, and I think that I would have noticed if she had said something like this. If you can remember where you read it, I would be obliged for the citation.

    3. 4.3

      India has not even issued a patient related to this technology. Nothing is stopping any company there from producing any of the vaccines using any published data or information from anywhere in the world.
      A HUGE point missed by most. Anyone who knows anything about patents would know that it takes years to get a patent issued. Moreover, I seriously doubt India’s patent office would knowingly issue a patent that would impair its own domestic industry from producing a COVID vaccine.

      There was an interesting article in the NY Times (perhaps a couple days ago??) that explained the process used to make either the Pfizer or Moderna vaccines. It is a fairly complicated process, and I suspect that the devil will be in the details of all the process parameters, which I also suspect are trade secrets.

      Although you say “[n]othing is stopping any company there from producing any of the vaccines,” I think it would better stated that no patents are stopping any company. It is the ‘know how’ (e.g., trade secrets) that is really important, and so long as this agreement does not force a tech transfer that ‘know how’ will be protected.

      A “WIKILEAKS style sharing of data and information” is not made any more or less likely because of this. Corporate espionage has been going on for a very long time.

      What I suspect (hope?) is that the government is going along with this as a grand diplomatic gesture knowing full well that waiving assertion of patent rights is going to change little. However, those that are requesting these waivers should also know the same, which begs the question “why are they asking in the first place?” My suspicion is that they are hijacking the urgency of the COVID crisis as an opening bid to push for weaker intellectual property regimes all across the board and into the future (even for non-COVID related intellectual property).

      I have no personal knowledge of this, but I highly suspect that those at Moderna, Pfizer et al. are putting great efforts into expanding manufacturing capacity. We will never achieve herd immunity, which means variants of COVID will proliferate and spread. This likely means a need for booster shots for the foreseeable future. Moreover, there are other uses for mRNA technology. In both instances, the likes of Moderna and Pfizer will have very strong incentives to continue to increase their manufacturing capacity.

      This pandemic has put the US government in a no-win situation when it comes to this issue. They can stand up for “intellectual property rights” but be vilified in the international community. Alternatively, they can acquiesce (as they have done) and can (hopefully) temporarily set aside certain intellectual property rights (of which there are little to begin with).

      In the end, I suspect that this will have little impact on how quickly vaccines are rolled out in developing countries and will have little enduring impact on the intellectual property rights of the vaccine developers. Everybody parading around like something great has been achieved when in reality very little has changed — this seems to me like the definition of a great “diplomatic” victory.

      1. 4.3.1

        Wandering words—please cut the words down by at least 50%.

        Try to be concise and get to the point.

        1. 4.3.1.1

          Try to be concise and get to the point.
          It would take a slow reader maybe 60-90 seconds to read what I posted. If you think that is too wordy, then that is a ‘you’ problem — not a ‘me’ problem.

          Complicated issues generally cannot be boiled down to two or three sentences. If you have succeeded to do so, it likely means you’ve missed a lot.

            1. 4.3.1.1.1.1

              Yes anon you have the same problem where you can’t seem to figure out where the controversy lies.

              Or Wandering Words you just can’t figure out what the issue is so you meander around yapping about this and that.

              1. 4.3.1.1.1.1.1

                Yes anon you have the same problem where you can’t seem to figure out where the controversy lies.

                Except for the fact that I was the first one to NAIL where the actual controversy is.

                Maybe instead you actually take a little time and recognize that THIS issue has several moving parts, and that the LARGER issue is not the one right in front of your nose (as is OFTEN the case when Big Pharma and Big Politics are involved).

                Or is that “too condescending?”

                1. anon, I will challenge you in the posts that follow to try to express the controversy in a paragraph or less.

                  And don’t include all your ridiculous self-congratulatory sentences.

                2. Your challenge is asinine.

                  Heed the words of Einstein: “Everything should be made as simple as possible, but no simpler.”

        1. 4.3.2.1

          (except for the critical end game – and that is whether or not the NON-patent assets get swept up in any waiver — THAT would be both a huge impact and an immediate (as well as long lasting) one)

          1. 4.3.2.1.1

            (except for the critical end game – and that is whether or not the NON-patent assets get swept up in any waiver — THAT would be both a huge impact and an immediate (as well as long lasting) one)
            Tech transfer is a whole different ball of wax than agreeing not to enforce non-existent IP. I can support the latter, not the former.

            1. 4.3.2.1.1.1

              The “game” here is NOT patents, but “IP” and includes FAR more than merely patents — and directly goes to that area that you cannot support.

              1. 4.3.2.1.1.1.1

                The “game” here is NOT patents, but “IP” and includes FAR more than merely patents — and directly goes to that area that you cannot support.
                The devil is in the details, and while the media may not understand the details, I’m sure whoever is crafting the proposals will.

                1. Certainly – and just as certainly, the waiver request (by India et al) was broader than a patent waiver request.

                2. Certainly – and just as certainly, the waiver request (by India et al) was broader than a patent waiver request.
                  Of course — they are going to ask for everything the initial go around. However, I don’t believe the US et al. are willing to give them everything that they are looking for.

                3. Well, Wt, I am just not as ‘optimistic’ as you are – given the “equity” nature of the Biden (or whoever is pulling the strings) administration.

                  The US seems intent on playing a losing game of World Opinion, and anything short of the type of “NOW” that screams for ALL IP (especially NON patent IP) would be seen as US ‘losing face’ at the international level.

                  As some of Greg’s early comments sounded out (it’s too bad that he buried his head like an ostrich), we could have handled this VERY differently with an EXPRESS “patent only” waiver, with the REST OF THE IP (story – cue Paul Harvey) clearly laid out as NOT being necessary.

                  We dropped the ball on that – and now seem intent on giving unlimited milk for free (with the adage of under those circumstances, who in their right mind would buy the cow?)

      2. 4.3.3

        +1

        [T]he government is going along with this as a grand diplomatic gesture knowing full well that waiving assertion of patent rights is going to change little.

        Bingo. The chicken-littles who think that this represents a grand betrayl of US IP should calm down. This is an empty gesture, nothing more.

        1. 4.3.3.1

          I don’t trust that the current administration is this cunning….You give them more credit than I would.

          1. 4.3.3.1.1

            I don’t trust that the current administration is this cunning….You give them more credit than I would.
            Don’t confuse the politics of the current administration with the people that will actually be putting together the proposal. Once you get beyond the political appointees, there are a bunch of “career” bureaucrats in the government (who actually make things happen) who are far less naïve than you believe them to be. I have little doubt that Pharma has their ear (one way or another).

            1. 4.3.3.1.1.1

              Interestingly, I both agree and disagree with you.

              I agree with the general tenor of ‘less naïve than you believe them to believe.”

              I disagree that the “Pharma has their ear (one way or another)‘ being the definitive driver.

              There is a very real reason why you are seeing the angst amongst Pharma folk and the alarmism that you are seeing – the Pharma folk definitely feel out of control of the situation.

      3. 4.3.4

        Nothing is stopping India or some Indian pharma company from producing any vaccine right now. Just read the patent application, some publication and go right ahead. Of course, lacking in know how, there will be casualties until they figure it out. No one was bringing a TRIPs case on this in the first place, but it does show that the busy bodies at the EU WTO need to shuffle paperwork around. TRIPs waiver. Pfft. Like any patent stopped anybody from doing anything. <— That's the straw man right there. Even in the prior eBay case law, there was public health, as the reason NO COURT would ever issue an injunction. And of course, the other conceit <<– that anybody would obey such an injunction.

        1. 4.3.4.1

          No one was bringing a TRIPs case on this in the first place, but it does show that the busy bodies at the EU WTO need to shuffle paperwork around.

          This is not being driven by the WTO bureaucrats. I expect that they would be just as happy if the whole controversy were to go away.

          This is being driven by the domestic political concerns of India & South Africa. Those nations both have serious outbreaks flaring up, and too few resources to tackle the public health emergency. Their voters are angry, and the leaders need to be seen to be “doing something.”

          The TRIPS waiver is like Sir Humphrey’s famous syllogism: we need to do something; this is something; therefore we must do it. For India & South Africa, merely proposing the waiver is a win-win. If the WTO grants the waiver, then the leaders of those countries can claim to have “fought” the “international bureaucracy” that is “holding them down” and “won.” If the WTO does not grant the waiver, then it is all their fault (and not the fault of Indian or South African elected leaders) that the country lacks adequate vaccines and medicines. Either way, it gives the Indian and South African politicians a talking point to shield them from angry constituents.

          Biden rather cannily realized this for what it is (one politician can spot another). He sees that granting the waiver achieves nothing, really, for weal or woe. The only question, then, is whether the U.S. wants to be PR “bad guy” in this international soap opera, or the “hero.” He chose to make us the hero.

          There will be no real world effect from this one way or the other. The whole thing is just “virtue signalling.”

          1. 4.3.4.1.1

            Both are also (not coincidentally) vying to have massive “generic Pharma” capabilities.

            The non-patent IP prize is most definitely a key part of the equation here.

  12. 3

    What an unbelievable screw-up Biden is.

    Shut down Keystone, put several thousands out of jobs, create more pollution to transport that same oil via truck or train.

    Give away IP developed by US companies, IP that can be used not only for the manufacture of COVID vaccines. And pretend this isn’t going to lead to wholesale abandonment of IP rights in India and other countries. By the time the effects of this ill-considered decision on the re-prioritizing of investments out of pharma and biotech are felt, Biden will be gone from the scene. And even if he was still around, how does one quantify the non-development of new drugs or vaccines that would have been developed if strong IP rights had been in place?

    But Handsy Joe doesn’t say, “Grab ’em by the pu$$y”, so he must be ok.

    1. 3.1

      Biden sucks in every way possible, in fact, it’s like he is going out of his way to suck as bad as possible. But this empty TRIPs gesture will do nothing but tank the bio-tech stocks in the short run – and again spring the debate –> What would you pay for the cure for cancer? Anything. That is, until it’s discovered, then it’s torches and pitch forks for the IP owners. Fairness! It’s like dealing with intellectual 3 year olds.

  13. 1

    Two thoughts:

    1) This is a big deal (first TRIPS waiver ever).
    2) This will not appreciably accelerate the pace of vaccination worldwide to any extent that will be evident in the data.

      1. 1.1.1

        Buying extra vaccine doses and sending them overseas. Sending doses not being used here (already paid for) overseas.

      2. 1.1.2

        The devil is in the details, but it should be plainly evident that Greg is very much in a state of denial as to the US Government moving forward on this (and, as I have noted, the pressures from the larger court of World opinion bearing down on the waiver being more than mere patents in order to have a meaningful effect on the worst global pandemic in over a hundred years).

        Pretty sure that we had no comparable avenues to take for the Spanish Flu.

      3. 1.1.3

        My answer is as obvious as it is unsatisfying: money. Right now, the rate limiting factor is resources (cold chains, staffing, transport, etc). If one really wants to accelerate the pace of vaccination worldwide, what is needed is money, and lots of it.

        I can—in theory—imagine a world in which the wealth countries have unleased such a gusher of funds that money is no longer the rate limiting factor. In such a hypothetical universe, I could imagine that know-how would be the rate limiting factor. If historical levels of foreign aid are anything to go by, however, then the amount of money that the U.S. and our G20 comrades pony up is not going to be anything like so much as to make money no longer the rate limiting factor.

        My prediction is that money will remain the rate limiting factor from now until the point at which everyone worldwide who wants to be vaccinated will have been. IP—of any variety—will never become the rate limiting factor, not because it is impossible for it to be the rate limiting factor, but simply because the entities that have enough money to stop money from being the rate limiting factor will never donate so much money that it ceases to be the rate limiting factor.

        1. 1.1.3.1

          Greg continues to enjoy his visit to Egypt, and spending copious amounts of time on the great river there.

            1. 1.1.3.2.2.1

              Ooh, that’s a good one. Thanks for sharing. I am going to steal that.

        2. 1.1.3.3

          Greg, just to say, what you write fits with my impression, drawn from observation here in Europe.Thanks for setting it out.

      4. 1.1.4

        What would move the needle?
        Those with the most experience manufacturing these vaccines are probably doing everything in their power to increase their manufacturing capacity. Why? Because it is in their own best interest to do so.

        I have little doubt that when manufacturing capacity substantially increases, probably within 6-9 months, that these manufacturers will be giving away doses to underdeveloped countries.

        1. 1.1.4.1

          It is indeed a FAR better path (for them) to give away doses than to have to give away the know-how.

          1. 1.1.4.1.1

            It is indeed a FAR better path (for them) to give away doses than to have to give away the know-how.
            BINGO, which is why I suspect they’ll do so. It is also good marketing. A COVID-19 vaccine is just the initial use of this technology. The more people that are comfortable with the technology, the better for these pharma companies.

            The amount of goodwill they can gain is going to be astronomical. If the pharma companies aren’t playing the long game, then I would be surprised.

            1. 1.1.4.1.1.1

              At the same time – you have others (for example, those actually seeking the waiver FULL IP waivers) that are playing a DIFFERENT long game.

              It is NOT as if the ‘established Big Pharma’ are the ones driving what is going on – quite the contrary, They are the ones reacting here, and being on the defensive.

              1. 1.1.4.1.1.1.1

                It is NOT as if the ‘established Big Pharma’ are the ones driving what is going on – quite the contrary, They are the ones reacting here, and being on the defensive.
                Of course they are reacting. There is no ‘offensive’ to go on.

                As for playing a different long game, I think some of my comments implied the same … albeit not so explicitly stated. However, those that are playing the different long game don’t have the same juice as big pharma to make things happen. The administration is looking for good PR, and that’s what they’ll get even if what they give has no substantive short or long-term impact on COVID-19. Essentially, the administration can have the best of both words — look good to the international community (and to the progressive wing of the party) by supporting this “waiver” and still be in the good graces of pharma by not giving away anything of real value. I assume that the administration is also playing a long game of their own and this presents a win-win situation for them.

                Again, my opinion changes if the administration mandates tech transfer. However, that is not what I’m anticipating.

                1. There is no ‘offensive’ to go on.

                  At the same time, this is a very direct and simple error, as well as one that is massively huge and undergirds a lot of errors in your overall position, leading to a veritable “ostrich head in the sand” approach (and – by the by – practically guarantees that India will obtain what they want.

                2. At the same time, this is a very direct and simple error, as well as one that is massively huge and undergirds a lot of errors in your overall position, leading to a veritable “ostrich head in the sand” approach
                  And this means what?

                3. It means – point blank – that you have an error in your thinking.

                  Certainly, in the unfolding drama, SOME players have been taking the offense. To think that there is “no offense” to be taken by any side is to basically hamstring that side (and the the thinking that attaches to the larger analysis of the situation).

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