| Bostyn, S. Why a COVID IP Waiver Is not a Good Strategy In: 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}
}
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. |
| Bostyn, S., Jongh, T. de, Poort, J., Radauer, A. Effects of Supplementary Protection Mechanisms for Pharmaceutical Products 2018, (Rapport met Technopolis Group over beschermingsmechanismen op het gebied van intellectueel eigendom met betrekking tot medicijnen.). @techreport{Jongh2018,
title = {Effects of Supplementary Protection Mechanisms for Pharmaceutical Products},
author = {Jongh, T. de and Radauer, A. and Bostyn, S. and Poort, J.},
url = {https://www.ivir.nl/publicaties/download/effects-of-supplementary-protection-mechanisms-for-pharmaceutical-products.pdf},
year = {2018},
date = {2018-06-19},
note = {Rapport met Technopolis Group over beschermingsmechanismen op het gebied van intellectueel eigendom met betrekking tot medicijnen.},
keywords = {},
pubstate = {published},
tppubtype = {techreport}
}
|
| Bostyn, S. Final report of the Expert Group on the development and implications of patent law in the field of biotechnology and genetic engineering 2016, (European Commission, Directorate General Internal Market, Industry, Entrepreneurship and SMEs (DG GROW).). @misc{Bostyn2016,
title = {Final report of the Expert Group on the development and implications of patent law in the field of biotechnology and genetic engineering},
author = {Bostyn, S.},
url = {http://www.ivir.nl/publicaties/download/Report-of-Biotech-Expert-Group.pdf},
year = {2016},
date = {2016-10-28},
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. },
note = {European Commission, Directorate General Internal Market, Industry, Entrepreneurship and SMEs (DG GROW).},
keywords = {},
pubstate = {published},
tppubtype = {misc}
}
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. |
| Bostyn, S. Patentability of Plants: At the Crossroads between Monopolizing Nature and Protecting Technological Innovation? In: The Journal of World Intellectual Property, nr. 3-4, pp. 105-149, 2014. @article{,
title = {Patentability of Plants: At the Crossroads between Monopolizing Nature and Protecting Technological Innovation?},
author = {Bostyn, S.},
url = {http://www.ivir.nl/publicaties/download/1401.pdf},
year = {2014},
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 = {},
pubstate = {published},
tppubtype = {article}
}
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.
|
| Bostyn, S. No Contact with the Human Body, Please! Patentability of Diagnostic Method Inventions after G01/04 In: European Intellectual Property Review, nr. 6, pp. 238-244, 2007. @article{,
title = {No Contact with the Human Body, Please! Patentability of Diagnostic Method Inventions after G01/04},
author = {S.J.R. Bostyn},
url = {http://www.ivir.nl/publicaties/download/993.pdf},
year = {2007},
date = {2007-08-09},
journal = {European Intellectual Property Review},
number = {6},
pages = {238-244},
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.
},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
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.
|
| Bostyn, S. DNA patents in Europe: Controversy remains 10.05.2005. @misc{,
title = {DNA patents in Europe: Controversy remains},
author = {S.J.R. Bostyn},
url = {http://www.ivir.nl/publicaties/download/994.pdf},
year = {2005},
date = {2005-05-10},
note = {
Lezing gehouden tijdens symposium "The ethics of patenting human genes and stem cells", georganiseerd door University of Copenhagen, Danish Council of Ethics en Biotik, 28 september 2004.
},
keywords = {},
pubstate = {published},
tppubtype = {presentation}
}
|
| Bostyn, S. Patenting DNA sequences (polynucletides) and scope of protection in the European Union: an evaluation 2005. @techreport{,
title = {Patenting DNA sequences (polynucletides) and scope of protection in the European Union: an evaluation},
author = {S.J.R. Bostyn},
url = {http://www.ivir.nl/publicaties/download/patentingdna.pdf},
year = {2005},
date = {2005-01-27},
pages = {162},
note = {
Background study for the European Commission within the framework of the Expert Group on Biotechnological Inventions, European Commission, Directorate-General for Research Food Quality and Safety, 2004.
},
keywords = {},
pubstate = {published},
tppubtype = {techreport}
}
|
| Bostyn, S. 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 2005. @techreport{,
title = {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},
author = {S.J.R. Bostyn},
url = {http://www.ivir.nl/publicaties/download/996.pdf},
year = {2005},
date = {2005-01-27},
note = {
European Patent Office, 2001.
},
keywords = {},
pubstate = {published},
tppubtype = {techreport}
}
|
Dr. Sven Bostyn (LLB, LL.M law; PhD law) is Assistant Professor of Intellectual Property Law, Institute for Information Law (IVIR), University of Amsterdam and also Associate Professor of Biomedical Innovation Law at the Center for Advanced Studies in Biomedical Innovation Law (CeBIL http://jura.ku.dk/cebil/ ), Faculty of Law, University of Copenhagen. He also lectures at the Institute for Information Law (IVIR) of the University of Amsterdam and is Visiting Professor (chargé de cours invité) at the Université de Liège. He is also a regular lecturer on CEIPI courses in Strasbourg.
Sven is one of the most prominent authorities in Europe in the area of patent law in general and in life sciences (including patent law relating to pharmaceuticals, biotech, medical devices, SPC’s, software and artificial intelligence) in particular. He has written extensively on most areas of patent law, and apart from those subjects already mentioned, he has also published in the field of plant patent protection, plant variety rights, software related inventions, European and international harmonization of patent law and the Unitary Patent system.
He was member of a Scientific Advisory Committee at the Dutch Royal Academy of Sciences (Gene Patents Committee) and was from 2013-2016 the Chair of the Expert Committee at the European Commission on the development and implications of patent law in the field of biotechnology and genetic engineering, after having been a member of and Rapporteur at an earlier European Commission Expert Group (between 2003 and 2005). Besides the European Commission, he has also advised both the Belgian and Dutch governments on policy regarding patentability of biotechnological and pharmaceutical inventions. He was recently one of the lead researchers in a study commissioned by the Dutch ministries of Health and Economic Affairs and Climate regarding protection mechanisms for pharmaceuticals (SPC’s, data and market exclusivity, paediatric extensions, orphan drug designations and competition law issues relating to pharmaceuticals).
Sven is the single author of more than 60 scientific publications. amongst which: ‘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, Eposcript Series, nr. 4, EPO, München, 2001, + 340 pp.; A Study prepared for the European Commission, ‘Patenting DNA Sequences (Polynucleotides) and Scope of Protection in the European Union: An Evaluation, European Communities, 2004, + 146 pp.; No contact with the human body, please! Patentability of diagnostic methods inventions after G 1/04, [2007] EIPR, issue 6, 238-244; Do you wish biological or essentially biological vegetables? (Non-)Patentability of essentially biological processes for the production of plants, BioScience Law review, 2006/2007, 146-155; Patenting human embryonic stem cells in peril: the decision of the Enlarged Board of Appeal in G 2/06, BioScience Law Review, vol. 10, 2009, 13-24; How biological is essentially biological? The referrals to the Enlarged Board of Appeal G 2/07 and G 1/08, [2009] EIPR, 549-558; A decade after the birth of the biotech directive: Was it worth the trouble?, in, Biotechnology and Software Patent Law: A Comparative Review on New Developments, Edward Elgar Publishing, 2011, pp. 221-259; Patenting antibodies after HGS v Lilly: More questions raised than answered, CIPA Journal, October 2012, 573-580; Patentability of plants: at the crossroads between monopolising nature and protection technological innovation? The Journal of World Intellectual Property (2013) Vol. 16, no. 3–4, pp. 105–149; Bostyn, Sven and Petit, Nicolas, Patent=Monopoly: A Legal Fiction (December 31, 2013), available at SSRN: http://ssrn.com/abstract=2373471 or http://dx.doi.org/10.2139/ssrn.2373471, 19 pp; Patenting personalised medicine and human rights, in, P. Torremans (ed.), Intellectual Property and Human Rights, Kluwer Law International, 2015, 725-782; Personalised medicine, medical indication patents and patent infringement: emergency treatment required, IPQ, 2016, 151-201; and, Medical treatment methods, medical indication claims and patentability: A quest into the rationale of the exclusion and patentability in the context of the future of personalised medicine, IPQ, 2016, 203-230; Bostyn, S.J.R., Jongh, T. de, Poort, J. Radauer, A., Effects of Supplementary Protection Mechanisms for Pharmaceutical Products, May 2018, Technopolis Group, 169 pp.
Sven is a regular speaker on international conferences, where he speaks on a wide variety of topics, including IP protection in life sciences, pharma patents, SPC’s, regulatory exclusivities in life science, IP issues relating to software and artificial intelligence, patent protection for plants and plant variety rights systems.