Patents on vaccines during a pandemic?

As we all know the new coronavirus has spread throughout the world like wildfire. Luckily, many companies jumped to the occasion and designed vaccines, most of them using techniques that have been published already, and scaled them up in record time. However, the virus is multiplying by leaps and bounds, mutating in the process, and this makes the “herd immunity” impossible to achieve. Clearly, we need a way to vaccinate the whole globe FAST, to stop the virus from replicating and mutating even more… But, companies cannot produce billions of doses in a month, they would rather make them in a pace they can manage, and they can spread the profit over a longer period…

            The world needs ~11 billion doses of coronavirus vaccine to immunize 70% (more for variants that are transmitted more easily) of  the 7.8 billion of us. This includes poorer nations – which account for 80% of the world’s population – and so far have access to less than one third of the available vaccines. This is why ~100 countries, led by India and South Africa, have been asking fellow World Trade Organization members to agree to a time-limited lifting of covid-19-related intellectual-property (IP) rights. In an open letter shared by Oxfam, a group of more than 170 former world leaders and Nobel laureates is calling on United States President Joe Biden to do just that [3]. That way, more countries can produce generic vaccines for their own populations and for the lowest-income nations.  

In fact, these vaccines are not entirely new discoveries. Most are based on techniques that were published years earlier, besides the companies have also benefited from billions of dollars in public funding, through both research and development and advance purchase agreements. Once the pandemic is over, IP protections would be restored.

Patents were never designed for use during global emergencies such as wars or pandemics. A patent rewards inventors by protecting their inventions from unfair competition for a limited time. The key word here is ‘competition’. A pandemic is not a competition between companies, but a race between humanity and a virus. Instead of competing, countries and companies need to do all they can, and join forces to bring the pandemic to an end.

This did happen before: During the second world war, the US government asked companies and universities to collaborate to scale up penicillin production, which was needed to protect soldiers from infections. Companies could have argued that this would affect profits, but they understood the necessity of subordinating their interests to the larger goal of saving lives and bringing the war to an end. “For a time the US produced virtually all the penicillin there was. But companies did not sue each other for patent infringement and no one had any desire to hold the world to ransom by charging exorbitant prices” (Dutfield, Univ. of Leeds, UK).

The Biden administration is now considering the merits of an IP waiver, and other countries will likely follow.  The opposition from drug and other companies is fierce, but the act brings an important principle to the fore: There are times when competition helps research and innovation; there are also times when it needs to be set aside, since, what is the use of a patent amidst death and ruins, when nobody can afford your product anyway?  Not only that, but if the virus is not stopped everywhere on earth and a high-virulence mutation shows up somewhere, it can threaten the whole world, vaccinated or not. Don’t forget that it is not always possible to stop a virus with a vaccine; there is no vaccine for the AIDS virus, and several animal coronaviruses either. In that sense, we have been lucky with covid-19, because, just think of the alternative…

As India and most of the rest of the world is sinking under the third wave of the pandemic, how can anybody talk about patents? Still, even PCR tests that are much easier to do after China made the sequence available, are patented…

Regarding the Adenovirus-vector vaccines, there is a very strong Canadian connection: Dr. Frank Graham, later at McMaster University developed the technique of “transfection” ie introduction of DNA into a cell in a way that proteins encoded on it can be produced by the cell. The DNA he used was from Adenovirus. This technique is key for the development of the Adenovirus-vector vaccines and the original 1973 paper has been the most highly cited paper by a Canadian investigator for many years.  The materials to do it are dirt cheap and not patentable. Other well known Canadian investigators worked and published on many aspects of Adenovirus life cycle: Phil Branton, Jo Weber, Jo Mymryk to name a few. Besides, once an adenovirus vector has been designed, growing up large quantities is not difficult; faced with the threat of many deaths, many University research labs can do it. How come then Canada has to beg the big powers for some vaccine?  You can blame free trade agreements…

Canada has had quite a robust Biology/medicine/Biotechnology research ability; Banting and Best were the discoverers of insulin, and the Connaught labs in Toronto have played a very important role in the production of polio vaccines in the 1950’s.  Where did all that potential go? Sacrificed to free trade that started in the 1990’s with PM Mulroney. The philosophy is simple:  If you can buy a vaccine/drug/equipment from someone else, why bother developing it yourself? So, the production ability of Canada was dismantled slowly, later with Chretien, then Harper.  Once the pandemic started, Trump’s edict of “America first” left Canada in the lurch…  

            In February, 2021, the construction of the Novavax production facility in Montreal was announced, but it will be useful for 2022 or later, not now. 

            An interesting novel approach was developed by a company close to Quebec city called Medicago (latin for Alfalfa, the clover-like plant that animals love).  They use a plant bacterium (called Agrobacterium) to introduce the covid spike gene in a tobacco-like plant [2]. This forms virus-like particles with the covid-spike on the outside (Co-VLP’s). To increase effectiveness, adjuvants are added, similar to the ones used in Nicorette gums (GlaxoSmithKlein). Two doses of 3.75 micrograms, 21 days apart are given, and Medicago announced (February 2, 2021) that their phase I/II trial was successful.  Phase III trials were announced in March 16 and are under way around the world.

            The advantage of a vaccine consisting of the spike protein is that it can be stored at 4oC, unlike the mRNA vaccines that require deep freezing. The method used can allow manufacturing large amounts very fast, and the cost is low.  Glycosylation is a big part of antigenicity, but apparently it occurs correctly in the plant. Another advantage is that it does not have any components of the Adenovirus that can cause blood clots, even rare ones, like the AstraZeneca or J&J or the Russian vaccines. Stay tuned!

[1]  Nature 592, 7 (2021). doi: https://doi.org/10.1038/d41586-021-00863-w

[2]  https://globalnews.ca/news/7561871/medicago-covid19-vaccine-tobacco/

https://www.medicago.com/en/media-room/medicago-and-gsk-start-phase-3-trial-of-adjuvanted-covid-19-vaccine-candidate/

https://pubmed.ncbi.nlm.nih.gov/31123605/

[3]  https://www.aljazeera.com/news/2021/4/14/world-leaders-call-on-biden-authorise-covid-vaccine-patent-waiver

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Update:

May 5, 2021:  Good news!  The Biden Administration stated at WTO talks that they support the waiving of patents for coronavirus-2 vaccines!  Canada is following soon.

May 6:  This was followed by the statement of the European Union (EU) commissioner, Ursula von der Leien, that the EU supports the waiver of these patents too! 

Can I say that perhaps the idea originated in Greece?  The past Prime Minister and now leader of the opposition (Alexis Tsipras) proposed in Parliament back in January 2021, that the EU should license the vaccines from the companies, to increase production.  This happened after AstraZeneca was sued by the EU because they did not deliver as many vaccines as promised.  He was scoffedat by the present PM (Mitsotakis) “does the leader of the opposition think that we can nationalize Pfizer just by passing a law?”. As it turns out, not just licensing of patents, but they were waived altogether!   

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