The Inventiveness Requirement in Patent Law: An Exploration of Its Foundations and Functioning external link

Pessers, L.
Kluwer Law International, 2016, Series: Information Law Series, ISBN: 9789041167316

Abstract

The Inventiveness Requirement in Patent Law provides a broad and historical perspective on the inventiveness concept in patent law. This groundbreaking work lays a very thorough conceptual basis for further and more in-depth discussions on current standards of inventiveness. Although the pivotal role of the inventiveness requirement in patent law is broadly accepted, it has long remained an ill-defined concept. The question that is often raised in current debates is whether the requirement is capable of functioning as an adequate ‘gate-keeper’. Using a methodology guided by geography and chronology, the author weaves together developments in numerous countries – focusing primarily on the United States, the United Kingdom, Germany, and the Netherlands – into a full-scale analysis of the inventiveness concept.

Kluwer Information Law Series, Octrooirecht

Bibtex

Book{ILS36, title = {The Inventiveness Requirement in Patent Law: An Exploration of Its Foundations and Functioning}, author = {Pessers, L.}, year = {2016}, date = {2016-01-01}, abstract = {The Inventiveness Requirement in Patent Law provides a broad and historical perspective on the inventiveness concept in patent law. This groundbreaking work lays a very thorough conceptual basis for further and more in-depth discussions on current standards of inventiveness. Although the pivotal role of the inventiveness requirement in patent law is broadly accepted, it has long remained an ill-defined concept. The question that is often raised in current debates is whether the requirement is capable of functioning as an adequate ‘gate-keeper’. Using a methodology guided by geography and chronology, the author weaves together developments in numerous countries – focusing primarily on the United States, the United Kingdom, Germany, and the Netherlands – into a full-scale analysis of the inventiveness concept.}, keywords = {Kluwer Information Law Series, Octrooirecht}, }

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

2021

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, Octrooirecht, pandemic, patents, population health, SARS-CoV-2, trade secrets, TRIPS, vaccines, waiver, WTO

Bibtex

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 = {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, Octrooirecht, pandemic, patents, population health, SARS-CoV-2, trade secrets, TRIPS, vaccines, waiver, WTO}, }

Patent Abolition: A Real-Life Historical Case Study external link

van Gompel, S.
American University International Law Review, vol. 34, num: 4, pp: 877-922, 2019

Abstract

Over time, patent abolition has been the subject of fierce academic debate. However, no country in the world has ever abolished patents, except for one. Between 1869 and 1912, the Netherlands officially abandoned patents. This unique case is often mentioned in the literature on patent abolition, but the accounts drawn up so far present an incomplete and somewhat obscure image of the motives behind the decision of the Dutch government to eliminate patents. This paper fills this gap by conducting a full analysis of the various – legal, economic, practical, and political – arguments that have inspired the Dutch to abolish patents. By so doing, it sketches a striking picture of the circumstances that gave rise to the exceptional Dutch case. Translating this to today’s reality, which is so entirely different, it seems unlikely that we will soon witness another case where all the necessary ingredients will so neatly coincide as they did in the Netherlands in the late 1860s. Therefore, another real-life example of a developed country abolishing patents appears far away.

frontpage, Octrooirecht

Bibtex

Article{vanGompel2019f, title = {Patent Abolition: A Real-Life Historical Case Study}, author = {van Gompel, S.}, url = {https://www.ivir.nl/publicaties/download/AUILR_2019.pdf}, year = {0823}, date = {2019-08-23}, journal = {American University International Law Review}, volume = {34}, number = {4}, pages = {877-922}, abstract = {Over time, patent abolition has been the subject of fierce academic debate. However, no country in the world has ever abolished patents, except for one. Between 1869 and 1912, the Netherlands officially abandoned patents. This unique case is often mentioned in the literature on patent abolition, but the accounts drawn up so far present an incomplete and somewhat obscure image of the motives behind the decision of the Dutch government to eliminate patents. This paper fills this gap by conducting a full analysis of the various – legal, economic, practical, and political – arguments that have inspired the Dutch to abolish patents. By so doing, it sketches a striking picture of the circumstances that gave rise to the exceptional Dutch case. Translating this to today’s reality, which is so entirely different, it seems unlikely that we will soon witness another case where all the necessary ingredients will so neatly coincide as they did in the Netherlands in the late 1860s. Therefore, another real-life example of a developed country abolishing patents appears far away.}, keywords = {frontpage, Octrooirecht}, }

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

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

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, Octrooirecht, Patent law, plants

Bibtex

Article{nokey, 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 = {0826}, date = {2014-08-26}, journal = {The Journal of World Intellectual Property}, number = {3-4}, 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, Octrooirecht, Patent law, plants}, }

Finding Vredo: The Dutch Supreme Court Decision on Escitalopram external link

Berichten Industriële Eigendom, num: 2, pp: 41-45, 2014

Abstract

This article is about the pharma patent litigation sparked by Lundbeck's blockbuster drug for 'escitalopram', a drug used for treating depression and generalized anxiety disorder. The key theme is about whether patents can also protect novel substances that can be fully envisaged but cannot yet be made. The decision of the Supreme Court is compared with earlier decisions in Germany and the United Kingdom. The author criticizes the lack of explanation provided by the Supreme Court.

Industriële eigendom, Octrooirecht

Bibtex

Article{nokey, title = {Finding Vredo: The Dutch Supreme Court Decision on Escitalopram}, author = {Tsoutsanis, A.}, url = {http://ssrn.com/abstract=2451438}, year = {0718}, date = {2014-07-18}, journal = {Berichten Industriële Eigendom}, number = {2}, abstract = {This article is about the pharma patent litigation sparked by Lundbeck's blockbuster drug for 'escitalopram', a drug used for treating depression and generalized anxiety disorder. The key theme is about whether patents can also protect novel substances that can be fully envisaged but cannot yet be made. The decision of the Supreme Court is compared with earlier decisions in Germany and the United Kingdom. The author criticizes the lack of explanation provided by the Supreme Court.}, keywords = {Industriële eigendom, Octrooirecht}, }

Comparison of Patent Claim Construction between Netherlands and Germany on Basis of AGA v. Occlutech external link

World Intellectual Property Report, num: 6, pp: 32-34, 2013

Abstract

This article provides a brief overview on how the Dutch and German courts interpret the claims of a patent. It briefly compares each national approach on the basis of the recent AGA v Occlutech litigation in both countries. The dispute between AGA and Occlutech involved socalled ‘‘occluders’’, a collapsible medical device for closing defects in the septum wall of the heart through cardiac catheterisation. Items discussed are: claim construction and judicial balancing under the new "Protocol for the Interpretation of Art. 69 of the European Patent Convention", equivalence, pioneer inventions and file wrapper estoppel.

Industriële eigendom, Octrooirecht

Bibtex

Article{nokey, title = {Comparison of Patent Claim Construction between Netherlands and Germany on Basis of AGA v. Occlutech}, author = {Tsoutsanis, A.}, url = {http://ssrn.com/abstract=2262859}, year = {0627}, date = {2013-06-27}, journal = {World Intellectual Property Report}, number = {6}, abstract = {This article provides a brief overview on how the Dutch and German courts interpret the claims of a patent. It briefly compares each national approach on the basis of the recent AGA v Occlutech litigation in both countries. The dispute between AGA and Occlutech involved socalled ‘‘occluders’’, a collapsible medical device for closing defects in the septum wall of the heart through cardiac catheterisation. Items discussed are: claim construction and judicial balancing under the new "Protocol for the Interpretation of Art. 69 of the European Patent Convention", equivalence, pioneer inventions and file wrapper estoppel.}, keywords = {Industriële eigendom, Octrooirecht}, }

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

2005

Industriële eigendom, Octrooirecht

Bibtex

Report{nokey, 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 = {Bostyn, S.}, url = {http://www.ivir.nl/publicaties/download/996.pdf}, year = {0127}, date = {2005-01-27}, keywords = {Industriële eigendom, Octrooirecht}, }

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

pp: 162, 2005

Industriële eigendom, Octrooirecht

Bibtex

Report{nokey, title = {Patenting DNA sequences (polynucletides) and scope of protection in the European Union: an evaluation}, author = {Bostyn, S.}, url = {http://www.ivir.nl/publicaties/download/patentingdna.pdf}, year = {0127}, date = {2005-01-27}, keywords = {Industriële eigendom, Octrooirecht}, }

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

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

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, Octrooirecht

Bibtex

Article{nokey, title = {No Contact with the Human Body, Please! Patentability of Diagnostic Method Inventions after G01/04}, author = {Bostyn, S.}, url = {http://www.ivir.nl/publicaties/download/993.pdf}, year = {0809}, date = {2007-08-09}, journal = {European Intellectual Property Review}, number = {6}, 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 = {Industriële eigendom, Octrooirecht}, }