Concerns continue to be raised about the role of patents in the coronavirus pandemic response but, argues IAM life sciences reporter Adam Houldsworth, IP has helped more than hindered efforts to inoculate the world’s population

Pharma and biotech IP owners have faced intense scrutiny from governments, civil society organisations and the media from the beginning of the coronavirus pandemic. Now, as countries around the world struggle to obtain enough doses of newly-approved covid-19 vaccines, the view that IP rights are responsible for shortages continues to be espoused by influential figures.

But despite all the panic over biopharma patents, the real roadblocks affecting vaccine distribution lie elsewhere. As the recent furore over the supply of jabs to EU member states shows, the extraordinary difficulty of manufacturing cutting-edge vaccines and threats to international supply chains are far more pressing problems.

Concerns about the potential for IP rights to obstruct public health responses to the pandemic came to the surface as early as March 2020 when Israel made an unprecedented use of its compulsory licensing laws to import a generic version of AbbVie’s Kaletra to ensure adequate supply for the potential treatment of coronavirus patients. Shortly afterwards, a slew of countries – including high-income ones like Canada, France and Germany – amended their laws to allow for the more efficient circumvention of patent rights should that be deemed necessary.

More significantly, 2020 saw widespread calls for coronavirus-related treatments and technologies to be treated as a “global public good”, with all IP argued to be a potential barrier to the production and supply of medicines, especially vaccines. The WHO Covid-19 Technology Access Pool (C-TAP) and the Open COVID Pledge were launched to promote open-access to patents, data and other valuable IP rights. Proposals were made by several countries and over 400 civil society organisations for the suspension of TRIPS. This was necessary, it was claimed, to ensure adequate supply of inoculations, especially to low and middle-income countries. Pharma innovators have been criticised for clinging on to their exclusivities.

Though leading vaccine innovators have adopted a range of IP and commercial strategies (see here for a detailed guide), none has agreed to treat all of its IP and proprietary information as a public good. Moderna Therapeutics has come closest, declaring that it will not enforce its relevant patents against companies seeking to market covid-19 treatments. AstraZeneca/Oxford University has pledged not to make a profit and has struck large numbers of manufacturing partnerships around the world. Pfizer/BioNTech has, like the others, committed to provide affordable doses to low-income countries, but has robustly defended its right to protect its IP and make a profit.

With several vaccines approved, these companies are now working to produce vast numbers of jabs. But even many high-income countries are having difficulties obtaining sufficient supplies. Talk of a vaccine shortage has hit the headlines in the US, while the European Commission has found itself in a politically controversial dispute with AstraZeneca, which has stated it can now no longer provide EU member states with the 80 million doses in the first quarter of 2021 that had been planned.

The Anglo-Swedish company now anticipates supplying 31 million to the European bloc. Moves by the Commission to restrict vaccine-related exports (including, for a few hours, across the border in Ireland) initially raised concerns in the UK about access to the Pfizer/BioNTech jab, though these worries seem now to have been dispelled.

All this will be interpreted by some as further evidence that IP rights have caused a bottleneck in vaccine production. Indeed, New York City Mayor Bill de Blasio, recently published an NBC News opinion piece arguing that the circumvention of patent laws is necessary to remedy the shortfall and calling on every covid-19 vaccine innovators to “follow Moderna’s lead and stand down on its patents”, before stating: “In a global pandemic, ‘intellectual property’ should not matter. Human lives should.”

De Blasio implies that IP rights are preventing companies from manufacturing and distributing the inoculations – an assumption shared by a DW opinion piece calling on vaccine rights holders to “Share the patents!” in order to overcome European shortages.

But this view overestimates the number of companies capable of producing the cutting-edge vaccines. Unlike small molecule drugs, traditional vaccines and manufactures in other industry sectors, the covid-19 vaccines can only be produced by means of a complex and difficult set of biotechnological processes, depending on an extremely intricate supply chain. This is especially the case for Pfizer/BioNTech and Moderna Therapeutics’ mRNA vaccines, whose labyrinthine manufacturing processes are explained here.

It is this difficulty that largely accounts for AstraZeneca’s troubles supplying its viral vector vaccine to Europe. As CEO Pascal Soriot commented, the processes involved usually take years rather than months to implement; and there is a “variability of yield” across its different supply chains.

This means that the sharing of patent rights would have little or no impact. Large quantities of trade secrets, data and proprietary know-how must also be actively transferred to allow other companies to produce and sell versions of these vaccines.

What’s more, even if companies could be found to do this, it is doubtful that it would be a more efficient way of increasing production than, for example, expanding the web of bilateral partnerships that AstraZeneca has already entered. In fact, Sanofi has recently agreed to produce 100 million doses of the Pfizer/BioNTech inoculation this year, while Novartis - having granted BioNTech access to one of its Swiss manufacturing facilities – is in discussions with other covid-19 vaccine makers.

Finally, let’s not forget that the potential returns offered by IP protection – and the predictability afforded by IP licensing – encouraged the investment of significant sums of money in the manufacture of doses well before any vaccine had been approved. The focus now should be on helping AstraZeneca, Moderna and Pfizer/BioNTech, as well as the makers of other vaccines that may soon be approved, to boost their global manufacturing partnerships and strengthen their cross-border supply chains.

This article first appeared in IAM. For further information please visit  https://www.iam-media.com/corporate/subscribe