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Dr. S.J.R. Bostyn

Former IViR staff

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Publications

Why a COVID IP Waiver Is not a Good Strategy external link

Bostyn, S.

2021

Abstract
Keywords
RIS
Bibtex

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.

access to drugs, covid-19, data exclusivity, frontpage, intellectual property rights, Intellectuele eigendom, market exclusivity, pandemic, Patent law, patents, population health, SARS-CoV-2, trade secrets, TRIPS, vaccines, waiver, WTO

RIS

TY  - JOUR
AU  - Bostyn, S.
PY  - 0517
DA  - 2021-05-17
T1  - Why a COVID IP Waiver Is not a Good Strategy
UR  - https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3843327
AB  - 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.
K1  - access to drugs
K1  - covid-19
K1  - data exclusivity
K1  - frontpage
K1  - intellectual property rights
K1  - Intellectuele eigendom
K1  - market exclusivity
K1  - pandemic
K1  - Patent law
K1  - patents
K1  - population health
K1  - SARS-CoV-2
K1  - trade secrets
K1  - TRIPS
K1  - vaccines
K1  - waiver
K1  - WTO
ER  -

Save .RIS

Bibtex

Article{Bostyn2021,
	title = {Why a COVID IP Waiver Is not a Good Strategy},
	author = {Bostyn, S.},
	year = {0517},
	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 = {access to drugs, covid-19, data exclusivity, frontpage, intellectual property rights, Intellectuele eigendom, market exclusivity, pandemic, Patent law, patents, population health, SARS-CoV-2, trade secrets, TRIPS, vaccines, waiver, WTO},
}

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Effects of Supplementary Protection Mechanisms for Pharmaceutical Products external link

Jongh, T. de, Radauer, A., Bostyn, S. & Poort, J.

2018

Keywords
RIS
Bibtex

bescherming, frontpage, Intellectuele eigendom, medicijnen, pharmaceutische industrie

RIS

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Final report of the Expert Group on the development and implications of patent law in the field of biotechnology and genetic engineering external link

Bostyn, S.

2016

Abstract
Keywords
RIS
Bibtex

Abstract

This is the Final Report of the of the Europen Commission Expert Group on the development and implications of patent law in the field of biotechnology and genetic engineering, which is chaired by Dr. Sven Bostyn. It describes in detail the issues regarding a number of very important topics in the area of biotechnological inventions, i.e., the patentability of plants and processes for making plants, issues relating to human embryonic stem cells and the patentability of human DNA. It finally provides advice for future policy and legislative work.

biotechnology, european commission, frontpage, genetic engineering, Patent law

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Patentability of Plants: At the Crossroads between Monopolizing Nature and Protecting Technological Innovation? external link

Bostyn, S.

The Journal of World Intellectual Property, num: 3-4, pp: 105-149, 2014

Abstract
Keywords
RIS
Bibtex

Abstract

This article provides an in-depth critical analysis of pressing issues regarding the patentability of plants. There is no public interest overarching principle present in the European Patent Convention or any other convention for that matter which would exclude patent protection for plants. The expansionist behavior of some users of the patent system seeking to obtain patent protection for methods and products which are very akin to traditional breeding methods needs to be halted and patent applications in that context deserve very close scrutiny so as to avoid that the border is crossed. Patents for hybrid seeds ought not to be protected by patents, as they in effect protect plant varieties as such. If the patent system is not capable of keeping such innovations outside of the patent territory, the call for excluding all plant-related innovations from patentability will become more influential. Products produced by essentially biological processes should not be patentable. However, in the absence of a statutory basis, the current legal framework does not allow the judiciary to come to such conclusion. The EPC needs to be amended in this respect. Finally, introducing a breeders’ exemption in the patent system could jeopardize the internal and external architecture of the patent system and one should be wary of introducing it.

breeders' exemption, breeding methods, Industrial property, Industriële eigendom, Patent law, plants

RIS

TY  - JOUR
AU  - Bostyn, S.
PY  - 0826
DA  - 2014-08-26
T1  - Patentability of Plants: At the Crossroads between Monopolizing Nature and Protecting Technological Innovation?
JO  - The Journal of World Intellectual Property
NV  - 3-4
SP  - 105-149
UR  - http://www.ivir.nl/publicaties/download/1401.pdf
AB  - This article provides an in-depth critical analysis of pressing issues regarding the patentability of plants. There is no public interest overarching principle present in the European Patent Convention or any other convention for that matter which would exclude patent protection for plants. The expansionist behavior of some users of the patent system seeking to obtain patent protection for methods and products which are very akin to traditional breeding methods needs to be halted and patent applications in that context deserve very close scrutiny so as to avoid that the border is crossed. Patents for hybrid seeds ought not to be protected by patents, as they in effect protect plant varieties as such. If the patent system is not capable of keeping such innovations outside of the patent territory, the call for excluding all plant-related innovations from patentability will become more influential. Products produced by essentially biological processes should not be patentable. However, in the absence of a statutory basis, the current legal framework does not allow the judiciary to come to such conclusion. The EPC needs to be amended in this respect. Finally, introducing a breeders’ exemption in the patent system could jeopardize the internal and external architecture of the patent system and one should be wary of introducing it.
K1  - breeders' exemption
K1  - breeding methods
K1  - Industrial property
K1  - Industriële eigendom
K1  - Patent law
K1  - plants
ER  -

Save .RIS

Bibtex

Article{nokey,
	title = {Patentability of Plants: At the Crossroads between Monopolizing Nature and Protecting Technological Innovation?},
	author = {Bostyn, S.},
	year = {0826},
	date = {2014-08-26},
	journal = {The Journal of World Intellectual Property},
	number = {3-4},
	pages = {105-149},
	abstract = {This article provides an in-depth critical analysis of pressing issues regarding the patentability of plants. There is no public interest overarching principle present in the European Patent Convention or any other convention for that matter which would exclude patent protection for plants. The expansionist behavior of some users of the patent system seeking to obtain patent protection for methods and products which are very akin to traditional breeding methods needs to be halted and patent applications in that context deserve very close scrutiny so as to avoid that the border is crossed. Patents for hybrid seeds ought not to be protected by patents, as they in effect protect plant varieties as such. If the patent system is not capable of keeping such innovations outside of the patent territory, the call for excluding all plant-related innovations from patentability will become more influential. Products produced by essentially biological processes should not be patentable. However, in the absence of a statutory basis, the current legal framework does not allow the judiciary to come to such conclusion. The EPC needs to be amended in this respect. Finally, introducing a breeders’ exemption in the patent system could jeopardize the internal and external architecture of the patent system and one should be wary of introducing it.},
	keywords = {breeders' exemption, breeding methods, Industrial property, Industriële eigendom, Patent law, plants},
}

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Enabling biotechnological inventions in Europe and the United States: a study of the patentability of proteins and DNA sequences with special emphasis on the disclosure requirement external link

Bostyn, S.

2005

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Bibtex

Industriële eigendom, Patent law

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Patenting DNA sequences (polynucletides) and scope of protection in the European Union: an evaluation external link

Bostyn, S.

pp: 162, 2005

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Industriële eigendom, Patent law

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DNA patents in Europe: Controversy remains external link

Bostyn, S.

2005

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RIS
Bibtex

Industriële eigendom, Patent law

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No Contact with the Human Body, Please! Patentability of Diagnostic Method Inventions after G01/04 external link

Bostyn, S.

European Intellectual Property Review, num: 6, pp: 238-244, 2007

Abstract
Keywords
RIS
Bibtex

Abstract

When the referral to the Enlarged Board of Appeal (EBA) was made in respect of diagnostic method inventions, high expectations were present that the decision would bring an end to existing confusion and legal uncertainty with regard to diagnostic method patent applications. As will be seen further in this comment, the EBA had not entirely delivered.

Industriële eigendom, Patent law

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