Sven Bostyn

Short presentation

Dr. Sven Bostyn (LLB, Lic. Jur., LLM law, PhD law) is 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.

List of relevant publications

2018

• 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, downloadable at https://www.rijksoverheid.nl/ministeries/ministerie-van-volksgezondheid-welzijn-en-sport/documenten/rapporten/2018/05/01/effects-of-supplementary-protection-mechanisms-for-pharmaceutical-products.

2017

• Bostyn, S.J.R., IE Recht & Commentaar, P.G.F.A. Geerts, D.J.G. Visser (red), Kluwer, 2017, artt. 2a, 3, 25, 53a, 53b, 53c Rijksoctrooiwet 1995.

2016

• Bostyn, S.J.R., Personalised medicine, medical indication patents and patent infringement: emergency treatment required, IPQ, 2016, 151-201;
• Bostyn, S.J.R., 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., IE Recht & Commentaar, P.G.F.A. Geerts, D.J.G. Visser (red), Kluwer, 2016, artt. 2a, 3, 25, 53a, 53b, 53c Rijksoctrooiwet 1995;
• Bostyn, S.J.R. et al., Final Report of the Expert Group on the development and implications of patent law in the field of biotechnology and genetic engineering, European Commission, (E02973), 2016. 265 pp. (http://ec.europa.eu/growth/industry/intellectual-property/patents/biotechnological-inventions/index_en.htm)

2015

• Bostyn, S.J.R., Patenting personalised medicine and human rights, in, P. Torremans (ed.), Intellectual Property and Human Rights, Kluwer Law International, 2015, 725-782;

2014

• Bostyn, S.J.R., The unbearable complications of patenting plants, in, TALLACCHINI MARIACHIARA; LEONINI FERNANDO; Ferrari Matteo (eds.), Innovating Food, Innovating the Law. An interdisciplinary approach to the challenges in the agro-food sector, Tricase, Libellula Edizioni, 2014, 296-330;

2013

• Bostyn, S.J.R., Resolving the patentability of plants produced by an essentially biological process conundrum: Squaring the circle? EIPR 2013, 35(7), 383-396;
• Bostyn, S.J.R., 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, S.J.R., 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;
• Bostyn, S.J.R., Amicus curiae brief in G 2/13 case (46 pp);
• Bostyn, S.J.R., IE Recht & Commentaar, Ch. Gielen, D.W.F. Verkade (red), Kluwer, 2013, artt. 2a, 3, 25, 53a, 53b, 53c Rijksoctrooiwet 1995;

2012

• Bostyn, S.J.R., Patenting antibodies after HGS v Lilly: More questions raised than answered, CIPA Journal, October 2012, 573-580;

2011

• Bostyn, S.J.R., 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, p. 221-259;

2009

• Bostyn, S.J.R., 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;
• Bostyn, S.J.R., How biological is essentially biological? The referrals to the Enlarged Board of Appeal G 2/07 and G 1/08, [2009] EIPR, 549-558;
• Bostyn, S.J.R.,IE Recht & Commentaar, Ch. Gielen, D.W.F. Verkade (red), Kluwer, 2009, artt. 2a, 3, 25, 53a, 53b, 53c Rijksoctrooiwet 1995;

2008

• Bostyn, S.J.R., Van planten-DNA, soyameel, uitputtingsleer en beschermingsomvang: een commentaar op Rb. ’s Gravenhage, Monsanto v Cefetra, Argentinië, Vopak en ACTI, BIE, 2008, 342-346;

2007

• Bostyn, S.J.R., No contact with the human body, please! Patentability of diagnostic methods inventions after G 1/04, [2007] EIPR, issue 6, 238-244;
• Bostyn, S.J.R., Book review essay, ‘Llewelyn, M., Adcock, M., European Plant Intellectual Property, Hart Publishing, Oxford – Portland, Oregon, 2006, xxvi + 551 pp., 44 Common Market Law Review 2007, 1558-1560;
• Bostyn, S.J.R., 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;

2005

• Bostyn, S.J.R., Biotech Patents and the Future of Scientific Research, in, Proceedings of the General Assembly Conference ALLEA, 2005, 29-47;
• Bostyn, S.J.R., DNA patents in Europe: Controversy remains, pp. 22-49, in, The Ethics of Patenting Human Genes and Stem Cells, Danish Council of Ethics, Copenhagen, 2005;
• Bostyn, S.J.R., No Cure Without Pay? Referral to the Enlarged Board of Appeal concerning the patentability of diagnostic methods, EIPR, 2005, 412-419;
• Bostyn, S.J.R., Narrow trousers and narrow patents, a health risk? Product protection or purpose-bound protection for biotechnological inventions, Bio-Science Law Review, 2004/2005, 89-95;
• Bostyn, S.J.R., IE Recht & Commentaar, Ch. Gielen, D.W.F. Verkade (red), Kluwer, 2005, artt. 2a, 3, 25, 53a, 53b, 53c Rijksoctrooiwet 1995;

2004

• Bostyn, S.J.R., Patenting DNA Sequences (Polynucleotides) and Scope of Protection in the European Union: An Evaluation, Luxemburg, European Communities 2004, +146 pp.;
• Bostyn, S.J.R., Living in an (Imm)Material World: Bioinformatics and Intellectual Property Protection (Part I), 1 Journal of International Biotechnology Law, 2004, 7-15.
• Bostyn, S.J.R., Living in an (Imm)Material World: Bioinformatics and Intellectual Property Protection (Part II), 1 Journal of International Biotechnology Law, 2004, 54-61;
• Bostyn, S.J.R., ‘The unbearable heaviness of harmonization: SPLT and CP’, p. 105-153, in M. Ricolfi (ed.), I brevetti per invenzione fra diritto europeo e diritto nazionale, Scritti di diritto industriale, Milano: Giuffrè 2004, +160 pp.;

 2003

• KNAW (ed.), De gevolgen van het octrooieren van humane genen voor het wetenschappelijk onderzoek in Nederland. Advies van de Commissie Genoctrooien, KNAW, Amsterdam, 2003, 90 pp;
• Bostyn, S.J.R., International Harmonization of the Patent System (Part III), 28 AIPPI Journal Japan, 2003, 29-37;
• The Prodigal Son: The Relationship Between Patent Law and Health Care, 11 Medical Law Review, 2003, 67-120;
• Bostyn, S.J.R., Written Description after Enzo Biochem: Can The Real Requirement Step Forward Please?,   JPTOS, 2003, 131-152;

2002

• Bostyn, S.J.R., DNA-octrooien; mag het ook een beetje meer zijn?, NJB, 2002, 253-259;
• Bostyn, S.J.R., Tokkyo Seido no Kokusaiteki Chowa, 47 AIPPI Japan Journal, 2002, 20-48;
• Bostyn, S.J.R., International Harmonization of the Patent System (Part I), 27 AIPPI Journal Japan, 2002, 310-323;
• Bostyn, S.J.R., International Harmonization of the Patent System (Part II), 27 AIPPI Journal Japan, 2002, 384-397;
• Bostyn, S.J.R., Book review: Warren-Jones, A.; Patenting rDNA. Human and Animal Biotechnology in the United Kingdom and Europe, Lawtext Publishing, Oxon, 2001, 275 pp., 33 IIC, 2002, 996-1000;
• Bostyn, S.J.R., A European Perspective on the Ideal Scope of Protection and the Disclosure Requirement for Biotechnological Inventions in a Harmonised Patent System; The Quest for the Holy Grail?, 5 Journal of World Intellectual Property, 2002, 1013-1046;
• Bostyn, S.J.R., A Test too Far? A Critical Analysis of the (Non)-Patentability of Diagnostic Methods and Consequences for BRCA1 Gene Type Patents in Europe, 5 Bio-Science Law Review, [2001/2002] 4, 111-121;

2001

• Bostyn, S.J.R., PhD: 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;
• Bostyn et.al (eds.)., Moderne biotechnologie en recht, Serie Recht en Praktijk, 85, 2e druk, Kluwer, Deventer, 2001, + 165 pp;
• Bostyn, S.J.R., Ik denk, dus ik krijg een octrooi. Octrooieerbaarheid van bedrijfsvoeringsmethodes en ideeën in Europa en de Verenigde Staten, BIE, 2001, 77-88;
• Bostyn, S.J.R., Het sprookje is uit. De beslissing van het Europees Hof van Justitie inzake de Nederlandse vordering tegen richtlijn 98/44/EG , BIE, 2001, 392-399;

2000

• Bostyn, S.J.R., Witte rook boven het Europees Octrooibureau. De beslissing van de Grote Kamer van Beroep in de Novartis zaak en de octrooieerbaarheid van planten, BIE, 2000, 201-207;
• Bostyn, S.J.R., One Patent a Day keeps the Doctor Away? Patenting Human Genetic Information and Health Care, 7 European Journal of Health Law, 2000/3, 229-264;

1999

• Bostyn, S.J.R., The Patentability of Genetic Information Carriers, The new E.U. Directive 98/44 on the legal protection of biotechnological inventions, Intellectual Property Quarterly, 1999/1, 1-36;
• Bostyn, S.J.R., Kritiek van de onbegrijpelijke redenering. De Novartis zaak voor het EOB, Intellectuele Eigendom en Reclamerecht (IER), 1999, 65-71;
• Bostyn, S.J.R., The New E.U. Directive 98/44 on the Legal Protection of Biotechnological Inventions; a schematic overview, in, Proceedings of the 4th Euregional Meeting of the Working Group Biotechnology, Aachen, 1999, 26-30;
• Bostyn, S.J.R., Buchbesprechung: VAN OVERWALLE, G., Octrooieerbaarheid van plantenbiotechnologische uitvindingen. Een rechtsvergelijkend onderzoek naar een rechtvaardiging van een uitbreiding van het octrooirecht tot planten, Brussel, Bruylant, 1996, 747 pp., GRUR Int., 1999, 903-905;
• Bostyn, S.J.R., Kloontje, kloontje in de mand, wie is de mooiste van het land? De implementatie van de EU richtlijn 98/44 octrooieerbaarheid biotechnologische uitvindingen in Nederland, Tijdschrift voor Gezondheidsrecht, 1999/8, 500-512;

1998

• Bostyn, S.J.R., Octrooirecht en ge(e)n-et(h)ica. Octrooi op menselijke genen en verwante genetische manipulaties, Tijdschrift voor GezondheidsRecht, 1998/4, 186-201 (awarded with the Goudsmit prize for the best scientific publication in the field);
• Bostyn, S.J.R., Legal protection of biological elements/La protection juridique des éléments  biologiques. Report for the XVth International Congress of Comparative Law 1998, published in, HONDIUS, E. (ed.), Netherlands reports for the XVth International Congress of Comparative Law Bristol 1998, Intersentia, Brussel, 1998, p. 285-316;
• Bostyn, S.J.R., Review Essay: VAN OVERWALLE, G., Octrooirecht, ethiek en biotechnologie, Brussel, Bruylant, 1998, 183 pp., BIE, 1998, 161-164;

1997

• Bostyn, S.J.R., Octrooi op dieren; beestachtig?, Nederlands JuristenBlad, 1997/9, 373-377;
• Bostyn, S.J.R., Octrooieren van klonen en andere biologische merkwaardigheden, De EU ontwerprichtlijn biotechnologische uitvindingen, Bijblad Industriële Eigendom (BIE), 1997, 403-408;

1995

• Bostyn, S.J.R., “Towards a cloned world? Patents in biotechnology.” Paper drafted for a conference at Stockholm University at the Institute for intellectual property law and competition law IFIM (Insitutet för Immaterialrätt och Marknadsrätt) on 07/04/1995, 25 pp;