Calls for Compulsory Licensing and IP Waivers of COVID-19 Vaccines Ignore Technical Complexities

“While seeking compulsory licensing or IP waivers may seem an attractive solution to address technological disparities across human populations, these mechanisms ignore some of the more technical hurdles to increasing accessibility to vaccination.”

https://depositphotos.com/441471790/stock-photo-coronavirus-vaccine-bottle-corona-virus.htmlThough it is not over, it seems that the end of the Covid-19 pandemic may be in sight. A select group of countries has managed to bring vaccines to the market in record time. Take the United States, for example. At the time of this writing, three U.S. companies have managed to produce vaccines that received approval from the U.S. Food and Drug Administration (FDA). The intellectual property that underlies these products quite literally has life-saving potential.

This achievement no doubt represents a significant feat in human ingenuity, but it also presents a ripe issue in the intellectual property space — namely, compulsory licensing and intellectual property (IP) waivers. Some feel that the cost of sharing this information represents a bold degradation of the intellectual property system. In developing countries, however, the lack of vaccine availability is proving particularly difficult to manage.

While seeking compulsory licensing or IP waivers may seem an attractive solution to address technological disparities across human populations, these mechanisms ignore some of the more technical hurdles to increasing accessibility to vaccination. This post will first briefly explain what compulsory licensing and IP waivers are and then examine three possible causes for why compulsory licenses and IP waiver are not a feasible solution to the current COVID-19 pandemic. 

Compulsory Licensing

One of the agreements that countries must ratify upon joining the World Trade Organization (WTO) is the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). The TRIPS Agreement was negotiated in 1994 to harmonize intellectual property laws across different countries and to establish minimum standards for protecting and enforcing intellectual property rights for all WTO member countries.

There are several provisions under TRIPS that allow governments to provide for limitations to intellectual property rights. In Article 31, for instance, TRIPS allows governments to order domestic manufacturers to make a patented product without permission from the patent holder. This practice is known as compulsory licensing. Article 31 permits countries to engage in compulsory licensing if there is a “case of a national emergency or other circumstances of extreme urgency,” or in cases of “public non-commercial use.” Under these circumstances, the country is first required to negotiate with, or seek approval from, the patent holder of the drug, but if the negotiations fail, is ultimately just permitted to manufacture patented products, such as essential medicines, for its domestic market.

For countries that cannot manufacture drugs themselves, and who would thus not be able to issue compulsory licenses under Article 31, Article 31bis was created to permit a developed country to export a generic drug under a compulsory license to a less developed country.

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IP Waivers

Contrary to compulsory licensing, IP waivers simply ask that countries be exempt from the provisions of TRIPS that require countries to protect and enforce patent rights to COVID-19 treatments and vaccines. In October 2020, India and South Africa petitioned the WTO for a temporary waiver from specific provisions of the TRIPS Agreement that could essentially put entire realms of existing intellectual property law on hold at the international level until widespread vaccination has become globally implemented. Perhaps unsurprisingly, this proposal was met with strong resistance from developed nations while developing and less developed nations were more welcoming towards it. In March 2021, the proposal failed to pass resolution at the WTO.

Covid-19 Vaccines are New

What these proposals fail to take into account is the nature of the Pfizer and Moderna vaccines. The efficacy of both of these proposals turns on a country’s internal technological capabilities to recreate and administer the vaccine. The Pfizer and Moderna vaccines, however, are not typical vaccines. Whereas traditional vaccines functioned by introducing parts of a virus — or a weakened form of a virus — Pfizer’s and Moderna’s vaccines use messenger RNA to cause host cells to produce the protein themselves. These are the first vaccines to utilize this type of technology.

The novelty of these vaccines potentially degrades the utility of a compulsory license or IP waiver. For instance, remdesivir received a great deal of focus early in the pandemic. Bangladesh managed to recreate the drug without Gilead Science’s approval because it is exempt from Article 31 of TRIPS, and Bangladesh was able to produce a sufficient supply for the country by the summer of 2020 because information about the drug was available. Given the fact that Pfizer’s and Moderna’s vaccines represent a new form of vaccine, lacking technical information on how to make this new form of vaccine could lead the countries to create entirely ineffective vaccine replicas.

These issues may be compounded by the fact that many vaccine manufactures rely on trade secret protection more heavily following the Ass’n for Molecular Pathology v. Myriad Genetics, Inc. decision. These trade secrets can withhold critical scientific know-how that might be necessary for replicating a vaccine.

Thus, the new technology behind these messenger RNA vaccines and the lack of accessibility to the related know-how might deter countries from attempting to manufacture them.

Lack of Information

Yet another more fundamental problem exists for replicating these vaccines. Not only do these vaccines represent a new form of vaccine, but information about these particular vaccines is simply unavailable. Even if the Pfizer and Moderna vaccines do not utilize any trade secrets, the discovery of these vaccines is fundamentally different than remdesivir’s timeline, which resulted in Bangladesh’s recreation of the drug. A patent for remdesivir was filed as early as 2015, and thus the information had been publicly available for years.

While the technology underlying mRNA vaccines has been in development for decades, there are likely specific technological hurdles associated with, for instance, the coronavirus, mass production and scale up, and delivery mechanisms that needed to be developed for this specific application of the legacy technology. This additional information will not be found in scientific journals or magazine articles, nor can it be found in any patent application, yet. Patents, moreover, can take up to 18 months from filing to be published. BioNTech made an F-1 filing with the SEC on July 21, 2020, in which it acknowledged its partnership with Pfizer to develop the vaccine. If this filling is at all indicative of when a patent could have been filed, then this would mean the patent may not be available to the public until late-2021–mid-2022.

With Novelty Comes Difficulty

The newness of these vaccines also creates problems due to the complexity in how these types of vaccines function and how to produce them. According to a Wall Street Journal report, manufactures say that vaccine production is difficult both “because some steps are difficult to scale up quickly or because they simply haven’t been done before.” Even Pfizer is having difficulty obtaining the necessary materials for vaccine production.

Here, the complexity of these vaccines demonstrates the potential futility of a compulsory license or IP waivers. Even if other countries could compel manufactures to license the underlying intellectual property and provided them with the information about how to do so, the complexity of manufacturing these types of vaccines could be a particularly high barrier to overcome.

It’s Complicated

Countries face roadblocks for producing a viable vaccine candidate based on Pfizer’s and Moderna’s vaccines. The new technology that utilizes messenger RNA vaccines, coupled with the lack of public information about these vaccines and the vaccines’ complicated nature, present significant hurdles to seeking compulsory licenses or IP waivers.

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The Author

Joanna T. Brougher, Esq., MPH

Joanna T. Brougher, Esq., MPH is the Founder & Principal at BioPharma Law Group, PLLC. She is a patent attorney who focuses on all aspects of services related to patents in the areas of biotechnology, pharmaceuticals and medical devices, including patentability opinions, due diligence, patent drafting, domestic and foreign patent prosecution, development and management of patent portfolios, and general client counseling during all phases of a product’s lifecycle, from concept to commercialization.

For more information or to contact Joanna, please visit her firm profile page.

Joanna T. Brougher, Esq., MPH

Andrew Kingsbury is a Cornell Law School student.

Warning & Disclaimer: The pages, articles and comments on IPWatchdog.com do not constitute legal advice, nor do they create any attorney-client relationship. The articles published express the personal opinion and views of the author as of the time of publication and should not be attributed to the author’s employer, clients or the sponsors of IPWatchdog.com. Read more.

Discuss this

There are currently 26 Comments comments.

  1. Anon March 30, 2021 3:58 pm

    Two quick points:

    1) “… present significant hurdles to seeking compulsory licenses or IP waivers.

    No.

    Such may be hurdles to implementation ONCE compulsory licenses or IP waivers are obtained, but are NOT hurdles to those mechanisms themselves.

    2) And this cuts right through any assertion that anything is being ignored: if this is not the type of thing for which waiver should be sought, then please tell me exactly what type of thing would it need be for waiver to be sought.

  2. Moocow March 31, 2021 6:57 am

    Anon @1: Maybe you could start by explaining to us where IP has held up the development and deployment of Covid vaccines. Please do.

  3. Anon March 31, 2021 9:54 am

    Moocow,

    You insert a non-sequitur, as there is NO NEED to show any such ‘hold up’ to employ the noted compulsory licenses or IP waivers.

    Quite in fact, if we take the notion that you suggest at its face value, then the employment of compulsory licenses or IP waivers will have little to no effect, and then the question (again) can be put to You (the Royal You): why not? – which is of course a corollary to “If not in this situation, then what situation would warrant waiver?

    I am still waiting for an answer – ANY (cognitive) answer – to that question.

  4. Xtian March 31, 2021 1:53 pm

    @Anon – This is quite simple:
    Not in this situation because no IP is an impediment to vaccine creation or production.

    What situation would warrant it? – Where an IP holder cannot create/produce or is unwilling to manufacture the subject invention and there are others in the market that can quickly fill the market need.

    To put it in more relevant terms – If Pfizer/BioNtech had patented technology but were unwilling to produce the vaccine or couldn’t because of resource constraints and there was another manufacturer at the ready (that is, didn’t need any of Pfizer’s trade secrets or know-how from Pfizer on how to manufacture), then I would say a compulsory license would be appropriate.

    My personal trigger for a compulsory license is when the IP holder is unwilling or incapable of producing the patented invention, and there is a third party waiting in the wings who can.

  5. Anon March 31, 2021 3:54 pm

    Xtian,

    Your “quite simple” brings the immediate counter (already provided), of “then, no harm.”

    As to the ‘when warrant,’ answer, you are using the wrong lens. The lens to use is the situation outside of the rights holder.

    This is (simply) less about the mechanics or situation of the rights holder, and more about the external circumstances of a global pandemic.

    As you yourself attest, ‘doing this’ won’t be a “big deal.”

    Through the lens of the global pandemic, even if this is not a “big deal,” there is no reason to try so hard to block it.

    The strenuous of that effort and even the unwillingness in the face of the world-threatening event, creates optics unfavorable to the community of rights holders.

    With this situation, it simply is not about You (the Royal you, not the personal you).

  6. Tim April 1, 2021 5:16 am

    Xtian: well said. But what about the current situation where AZ seems unwilling to produce (enough vaccines, or at least doe snot even come close to the agreed number)? That seems to be warranting the compulsory license trigger

  7. Moocow April 1, 2021 8:20 am

    Anon @3@5: Huh? This is what I understand you’re saying: Let’s waive all IP related to Covid because, uh, why not?

    Please correct me if I misunderstood.

  8. Anon April 1, 2021 11:48 am

    Moocow,

    I cannot force you to understand.

    The dichotomy is quite simple, but the pushback here just does not view the reasoning from the correct perspective.

    That perspective is not from the one holding (any potential meaningful) IP, but rather, it is the perspective of the world-wide, once in a century severity level of a global pandemic.

    My question remains unanswered: if this is not the type of situation that would call for a waiver, what in God’s name would be that type of situation?

    I “get” the (partial, albeit on its face feeble) response of “but what we have in the way of IP is not a pacing item.”

    But such misses the point that the waiver need not be applied to only those things that are pacing items, and — with a waiver in place (used, or not used), THAT hurdle or concern is removed from the concert of actions that may be taken to help the entire world recover from this Century-Severity event.

  9. Moocow April 1, 2021 4:59 pm

    Anon @8: Nope apparently you cannot make me understand. One of us must live in a different reality.

    Let me try and answer your question about what kind of problem would call for a global IP waiver. I think it would be the kind of problem that would be *solved* through a global IP waiver.

    That’s why I keep asking whether you can describe how IP is an obstacle that, absent a waiver, is holding up vaccine access. Now, I don’t know whether to you it is perfectly self-evident that IP is a huge obstacle to fighting Covid, but it isn’t to me.

    And just saying that this problem is so huge that a waiver must be done because it might help, even if we don’t know how – I’m sorry but that just doesn’t convince me. It sounds like the kind of (unhelpful) thing people do in a panic.

    If you want to make a contribution to fair vaccine access, maybe start with export restrictions. The US for example will vaccinate its entire population of low-risk 20-30 year olds before allowing any US-manufactured vaccine to go to a diabetic grandmother in the Gambia. Not very nice.

    If that grandmother can wait until September, things will probably look up. More vaccine production and more vaccine products are coming online fast now. In the fall, wealthy countries will generously begin sharing their vaccine surplus with the developing world (light sarcasm). It’s not going to feel good and it’s not going to feel right, but it will make a real difference at least then. The IP waiver, meanwhile, will do nothing to accelerate things.

  10. Anon April 1, 2021 8:40 pm

    Moocow – your perspective is just not correct. It is the issue that drives the question – and NOT any assertion of whether or not the particular IP rights CAN solve (or can efficiently solve the problem.

    You may be wanting to answer someone else’s question – you are NOT answering my question.

  11. Xtian April 5, 2021 9:30 am

    @anon You view the severity of COVID-19 as justification for waiver of current norms and laws. I fundamentally disagree with this approach. I tend to view expanded governmental reach (like the IP waiver) as something to be cautious about as governments tend to define “emergencies” to suit a political purpose.

    To the point at hand, why would India, a developed country who is a large player in the pharmaceutical industry, need IP waivers? What intellectual property right, in India (or that can’t be waived by the Indian government, i.e., a local country solution), is preventing any one of the numerous capable companies in India from producing a vaccine? To my understanding, there is none. If you dig deeper into the ‘ask’ of the waiver, these countries are requesting access to clinical data, manufacturing know-how, and support from the vaccine producers. This is not just an “IP waiver.”

    To me, the COVID emergency pandemic is being used by these countries as a pretext for a forced IP transfer of RNA technology in general.

  12. Xtian April 5, 2021 9:37 am

    @Tim – I would agree the AZ situation comes close. However, reality gets in the way. Let’s say all of AZ’s technology is transferred to another pharma company to manufacture “AZ’s” vaccine. How long do you think it will take to get that manufacture up and running? How fast will the EMA inspect that plant? It will probably take 2 years. So, during that time, will AZ not produce anything? What if during that time AZ solves the problems?

    What this dilemma brings to light is that for these particular vaccines, it is not IP that is an impediment. Rather, it is having a facility, having the expertise to make the vaccine, and have the quality controls to accurately reproduce the vaccines batch supplies. There is just not that many companies in the world that have this ability.

    If we were to take Anon’s position in this thread, this lack of expertise in the world, would be sufficient justification to force AZ, Pfizer, Moderna to teach other companies the technologies. I am just not there.

  13. Anon April 5, 2021 5:35 pm

    Xtain – “view the severity of COVID-19 as justification for waiver of current norms and laws. I fundamentally disagree with this approach. I tend to view expanded governmental reach (like the IP waiver) as something to be cautious about as governments tend to define “emergencies” to suit a political purpose.

    That’s kind of the point – THIS IS a real emergency.

    Sure, as a general rule, I fully agree with you and any notion of eminent domain, march in, or the like does need to be strictly controlled.

    But what exactly WOULD BE an emergency, if a worldwide pandemic is somehow NOT considered to be one?

  14. Xtian April 6, 2021 8:22 am

    @Anaon – thought experiment – What would NOT be an emergency that is insufficient to use as a justification for an IP waiver? The AIDS epidemic? Hep C? Zika? Heart disease (this is still the number one killer in the U.S.)

  15. Anon April 6, 2021 11:43 am

    Xtian,

    I do not know the answers to your thought experiment.

    But can you answer my question first? And then we may have a frame of reference to move to your counter examples.

  16. Xtian April 7, 2021 9:16 am

    2 Anon – I did answer. See my response at 4. You don’t don’t like my answer.

  17. Anon April 7, 2021 10:22 am

    Xtian, your “answer” at 4 was not an answer to my question as I pointed out at 5, and then mirrored through the same type or response from Moocow at 8 and 10.

    I “did not like your answer” because it was not an answer to MY question. Please use the proper perspective.

  18. Xtian April 12, 2021 10:36 am

    @Anon – “Proper” perspective….. Your true colors are now shown.

  19. Anon April 12, 2021 12:47 pm

    Not at all — in the sense that you would attempt to denigrate.

    My “true colors” are merely aligned with the purpose of having the provision in the first place.

    I am still waiting for people to share the level of calamity that something would need to rise to for the provisions to be considered.

    Also, any view of my “true colors,” would also note my long history here of being extremely pro-innovation.

    You might want to notice when your larger assertion is incongruent with reality — that’s a tip that your position is off.

  20. Moocow April 12, 2021 2:29 pm

    Hey Xtian – I wouldn’t bother. Anon is just trying to bait readers with this “if not now then when” fallacy. It’s a burden-shifting trick: identify a real problem, propose a bogus solution, and then put the onus on others to explain it away. Hence the silly repetition of “you haven’t answered my question.” It’s high school debate team stuff.

  21. Anon April 12, 2021 4:47 pm

    Ahhh, p00r little Moocow is thinking that this is merely a “bait and shift.”

    The problem of course for you, Moocow, is that my question came before YOUR attempted shift – and still has not been answered.

    It is a legitimate question, and the fact of the matter is that there has been NO genuine attempt to answer it.

    You want silly? Look in the mirror.

    In the meantime, the issue that I identified still begs an actual answer.

  22. Xtian April 14, 2021 11:20 am

    @Anon (I’m ignoring the sane, rationale advice of Moocow)

    In the first comment of this thread you asked “please tell me exactly what type of thing would it need be for waiver to be sought.”

    My answer was and again is: Where an IP holder cannot create/produce or is unwilling to manufacture the subject invention and there are others in the market that can quickly fill the market need.

    You dismissed this answer because you think I don’t consider COVID to be an emergency and thus I don’t have the proper perspective (in your view). So you change the question to be about the emergency and ask when is an emergency a sufficient emergency to justify a waiver. I responded by saying I don’t think this is the way we should look at things because of my distrust of public officials to define an “emergency” to fit any need.

    So back to the question at hand – why are global waivers of IP (waivers that also include the required disclosure of clinical trial and manufacturing data) needed in this situation when there are vaccines available; and where individual countries could resolve any IP issue at a country level, i.e., local companies can produce their own vaccine – like in China and Russia? Why isn’t India and the African countries soliciting China or Russia for their vaccines?

  23. Anon April 15, 2021 4:57 pm

    My answer was and again is:

    And as I corrected: you need to use a different perspective.

    The question is NOT based on the perspective of the IP holder, especially in patents, as patents are a negative right.

    I dismissed your answer because you have not provided an answer as to the type of situation – in and of itself.

    I know that you “don’t think this is a proper perspective” but YOUR view on ‘proper perspective’ is not a part of MY question. That is not legitimate for you to dismiss the setting and then seek out a different question to answer. YOUR view leads to an answer of “never – if it the government seeking waiver as an emergency.” That is simply not copesetic with the law of waiver, as it IS the government that enacts that waiver (and not the IP rights holder).

    STILL waiting for a legitimate answer to MY question.

  24. Xtian April 16, 2021 3:15 pm

    @Anon – be specific: from what perspective should I answer from? Maybe re-phrase the question? I am being honest and will engage with you but I truly am having difficulty. I am not being snarkey about this either. I want you to convince me otherwise.

    So if I try to re-word your question, would it be:

    What level of worldwide (or country specific) “emergency” would allow nation X to force a technology transfer, i.e. negate existing international agreements, from companies of nation Y so that the people of Nation X can be saved/cured?

    Is this more like the perspective you want me to view the issue?

  25. Anon April 17, 2021 10:38 am

    Xtian,

    I appreciate the olive branch of, “I am not being snarky” – and want you to know that I am not being snarky either.

    As to “I want you to convince me otherwise” – this is a mindless statement. My position simply does not depend on convincing you.

    It’s abundantly clear that you are looking at the situation strictly from a right’s holder view – and with an incorrect view of that right to boot.

    The right’s holder view is based on HIS interests. The notion of “incorrect to boot” is that patent rights are NEGATIVE rights and there is no such thing as a positive right TO produce something covered by a patent.

    There is no need to “re-word” my question, although your translation will do, if that is what it takes for you to understand the plain words (but I would ask that you also understand the underlying notion of the negative right nature of patents as well).

  26. Xtian April 19, 2021 11:14 am

    I now fully understand your position. I don’t agree with it. But I understand it.

    Yes – patents are a negative right, when the government grants you a patent, this grant only gives you a right to exclude others from doing that which is patented.

    thank you