Patent law - IVIR

Why a COVID IP Waiver Is not a Good Strategy

2021.

@article{Bostyn2021,
title = {Why a COVID IP Waiver Is not a Good Strategy},
author = {Bostyn, S.},
url = {https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3843327},
year = {2021},
date = {2021-05-17},
abstract = {The COVID-19 pandemic has a profound influence on all aspects of society. The development of successful vaccines in record speed is almost a miracle. But despite the successful development and approval of multiple vaccines, many people still die of this terrible disease, and there is an urgent need to see more vaccines manufactured and distributed across the globe.
The proposed COVID-19 IP waiver has been touted by some to be the perfect solution to a terrible problem. We all agree that there is a terrible problem of insufficient vaccines to inoculate the world population.
An IP waiver is not a good strategy however, to tackle this crisis. There are multiple more effective solution conceivable which do not require a very disruptive IP waiver.
The problem of insufficient supply is much more complicated than a simple IP waiver suggests. This is a complex ecosystem, and there are many moving parts. Moreover, IP rights are only part of the problem relating to more supply of vaccine or therapeutics. In view of the complexities, it will probably take many months to negotiate any kind of IP waiver system that would be acceptable to all WTO member states, if consensus could be reached at all. And the end result is likely to satisfy very few if any countries.
The legality of an IP waiver can be doubted, and it would require retro-active effect, a concept that should be extremely sparingly used.
A multitude of complex issues needs to be sorted out. There are hundreds of patents to navigate. A waiver to the equally patented vaccine platform technology (covering many patents), which may be used to develop any other vaccine, will make those companies who have invested heavily into developing it very nervous indeed, to say the least.
Crucial manufacturing know-how is often not protected by IP rights, but is kept secret, and it will be difficult to force companies to disclose that information, also because one does not know what to ask for.
The present IP waiver proposal also provides for a disclosure of commercially very sensitive information. Companies did not have a chance to adapt their regulatory disclosure strategies to this new reality, which means that information which will be disclosed under the waiver could very well have a major negative impact on future innovation strategies, and may also hamper competitive advantage or leverage.
Market exclusivity is arguably not covered by the IP waiver, which means that separate national statutory intervention will be required to ensure that this market exclusivity is set aside, absent of which the IP waiver cannot have any practical effect.
A quick and determined use of compulsory licensing could be a better way forward, as they have the potential to be a powerful tool. There are inefficiencies in using the instrument however, and invoking them when the need is high will require a relatively long lead time before they sort practical effect. They also require additional statutory intervention to ensure that regulatory exclusivities do not block their practical effect. And they might not necessarily work as well with low and middle-income countries, who would have less leverage in the negotiations.
More efficient solutions can be arrived at by introducing hard clauses into contracts in the context of push and pull mechanisms. Those obligations are much more likely to result in more supply in the shorter to medium term if they are agreed upon long before the vaccine enters the market. It is obviously too late for the contracts that have been concluded in the past, but it should be a template for the future.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}

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The COVID-19 pandemic has a profound influence on all aspects of society. The development of successful vaccines in record speed is almost a miracle. But despite the successful development and approval of multiple vaccines, many people still die of this terrible disease, and there is an urgent need to see more vaccines manufactured and distributed across the globe.
The proposed COVID-19 IP waiver has been touted by some to be the perfect solution to a terrible problem. We all agree that there is a terrible problem of insufficient vaccines to inoculate the world population.
An IP waiver is not a good strategy however, to tackle this crisis. There are multiple more effective solution conceivable which do not require a very disruptive IP waiver.
The problem of insufficient supply is much more complicated than a simple IP waiver suggests. This is a complex ecosystem, and there are many moving parts. Moreover, IP rights are only part of the problem relating to more supply of vaccine or therapeutics. In view of the complexities, it will probably take many months to negotiate any kind of IP waiver system that would be acceptable to all WTO member states, if consensus could be reached at all. And the end result is likely to satisfy very few if any countries.
The legality of an IP waiver can be doubted, and it would require retro-active effect, a concept that should be extremely sparingly used.
A multitude of complex issues needs to be sorted out. There are hundreds of patents to navigate. A waiver to the equally patented vaccine platform technology (covering many patents), which may be used to develop any other vaccine, will make those companies who have invested heavily into developing it very nervous indeed, to say the least.
Crucial manufacturing know-how is often not protected by IP rights, but is kept secret, and it will be difficult to force companies to disclose that information, also because one does not know what to ask for.
The present IP waiver proposal also provides for a disclosure of commercially very sensitive information. Companies did not have a chance to adapt their regulatory disclosure strategies to this new reality, which means that information which will be disclosed under the waiver could very well have a major negative impact on future innovation strategies, and may also hamper competitive advantage or leverage.
Market exclusivity is arguably not covered by the IP waiver, which means that separate national statutory intervention will be required to ensure that this market exclusivity is set aside, absent of which the IP waiver cannot have any practical effect.
A quick and determined use of compulsory licensing could be a better way forward, as they have the potential to be a powerful tool. There are inefficiencies in using the instrument however, and invoking them when the need is high will require a relatively long lead time before they sort practical effect. They also require additional statutory intervention to ensure that regulatory exclusivities do not block their practical effect. And they might not necessarily work as well with low and middle-income countries, who would have less leverage in the negotiations.
More efficient solutions can be arrived at by introducing hard clauses into contracts in the context of push and pull mechanisms. Those obligations are much more likely to result in more supply in the shorter to medium term if they are agreed upon long before the vaccine enters the market. It is obviously too late for the contracts that have been concluded in the past, but it should be a template for the future.

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