MIPLC Studies Patents in the Food Sector Eva Willnegger A Retrospective with Special Emphasis on the TRIPs Agreement 1 Nomos https://doi.org/10.5771/9783845210230 , am 29.07.2020, 21:01:34 Open Access - - https://www.nomos-elibrary.de/agb https://doi.org/10.5771/9783845210230 , am 29.07.2020, 21:01:34 Open Access - - https://www.nomos-elibrary.de/agb MIPLC Studies Edited by Prof. Dr. Christoph Ann, Technische Universität München Prof. Robert Brauneis, The George Washington University Law School Prof. Dr. Thomas M.J. Möllers, University of Augsburg Prof. Dr. Dres. h.c. Joseph Straus, Max-Planck-Institute for Intellectual Property, Competition and Tax Law Volume 1 https://doi.org/10.5771/9783845210230 , am 29.07.2020, 21:01:34 Open Access - - https://www.nomos-elibrary.de/agb Eva Willnegger Patents in the Food Sector A Retrospective with Special Emphasis on the TRIPs Agreement Nomos https://doi.org/10.5771/9783845210230 , am 29.07.2020, 21:01:34 Open Access - - https://www.nomos-elibrary.de/agb 1. Auflage 2008 © Nomos Verlagsgesellschaft, Baden-Baden 2008. Printed in Germany. Alle Rechte, auch die des Nachdrucks von Auszügen, der fotomechanischen Wiedergabe und der Übersetzung, vorbehalten. Gedruckt auf alterungsbeständigem Papier. This work is subject to copyright. All rights are reserved, whether the whole or part of the material is concerned, specifically those of translation, reprinting, re-use of illustrations, broadcasting, reproduction by photocopying machine or similar means, and storage in data banks. Under § 54 of the German Copyright Law where copies are made for other than private use a fee is payable to »Verwertungsgesellschaft Wort«, Munich. Die Deutsche Nationalbibliothek verzeichnet diese Publikation in der Deutschen Nationalbibliografie; detaillierte bibliografische Daten sind im Internet über http://www.d-nb.de abrufbar. Die Deutsche Nationalbibliothek lists this publication in the Deutsche Nationalbibliografie; detailed bibliographic data are available in the Internet at http://www.d-nb.de. Zugl.: München, Univ., Diss., 2008 ISBN 978-3-8329-3636-5 https://doi.org/10.5771/9783845210230 , am 29.07.2020, 21:01:34 Open Access - - https://www.nomos-elibrary.de/agb PREFACE My special thanks are directed to Prof. Dr. Dres.h.c. Joseph Straus, director of the Max Planck Institute for Intellectual Property, Competition and Tax Law in Munich, who su- pervised this dissertation. After I studied Crop Sciences, Prof. Straus also gave me the opportunity to familiarize myself with the legal aspects of agriculture, especially patent law. He fostered my studies by means of a generous research scholarship of the Max Planck Society. Prof. Straus made it possible for me to participate in international con- ferences concerning the protection of biotechnological inventions and plant varieties. His expertise in the field of patent law inspired me to a great extent in writing several ar- ticles in this area. I am most obliged to PD Dr. Ulrich Schmoch, director of the Fraunhofer Institute for Systems and Innovation Research in Karlsruhe, for helping me to collect the data on food-related patent applications. Moreover, I would like to thank Dr. Friedrich Baumbach, patent attorney in Berlin, who patiently supervised my first steps in patent law. Furthermore, I would like to thank Prof. Dr. Rudolf Nirk, lawyer at the Federal Court of Justice in Karlsruhe, for his extremely valuable advice and motivation. My final thanks are directed to Prof. Dr. Jürgen F. Strube, Chairman of the Supervisory Board of BASF SE, for his extraordinary support relating to my future career. The most important contribution to this thesis, however, has been provided by my hus- band Ludwig. Without him I definitely would not be in the position in which I am today. Heidelberg, June 18, 2008 Eva Willnegger 5 https://doi.org/10.5771/9783845210230 , am 29.07.2020, 21:01:34 Open Access - - https://www.nomos-elibrary.de/agb https://doi.org/10.5771/9783845210230 , am 29.07.2020, 21:01:34 Open Access - - https://www.nomos-elibrary.de/agb Contents Abbreviations 13 Index of Tables 15 German Index of Tables 16 Introduction 17 Part I. Patentability of food from 1877 to 2005 in Germany compared to Brazil, China, and India 19 A. Patentability of food in Germany 20 I. The exemption in the German Patent Act of 1877 20 1. German Patent Act of 1877 20 2. The scope of the exemption 22 3. Reactions to the exemption 24 II. The Amending Act of 1891 and the Kongorot decision 26 III. The patentability of food in the Amending Act of 1967 28 IV. Consequences of the patentability of food in Germany 30 1. Food-related patent applications in the technological and economic sense 31 2. Rise in food-related German patent applications 36 a. Overview 36 b. Dairy and confectionary 37 c. Feed 38 d. Plants 38 3. Rise in food biotechnology-related German patent applications 41 a. Overview 41 b. Plant biotechnology 42 c. Feed biotechnology 43 d. Biotechnology in other segments of the food sector 43 4. Development of the German food sector and food prices 47 V. Assessment of the exemption in Germany from 1877 to 1967 48 B. Patentability of food under the TRIPs Agreement 51 I. Negotiations with respect to food 53 1. The approach of India 55 2. The approach of Brazil 56 3. The approach of the U.S. 56 4. The approach of the European Communities 57 5. Further negotiations 57 6. Intermediate result 59 7 https://doi.org/10.5771/9783845210230 , am 29.07.2020, 21:01:34 Open Access - - https://www.nomos-elibrary.de/agb 7. Summary 61 II. Contents with respect to food 63 III. Consequences 66 C. Patentability of food in Brazil, China, and India 67 I. Implementation of the TRIPs Agreement in Brazil 67 II. Implementation of the TRIPs Agreement in China 69 III. Implementation of the TRIPs Agreement in India 71 IV. Consequences of the patentability of food-related substances 75 1. Rise of food-related patent applications 75 2. Rise of food biotechnology-related patent applications 77 3. Development of the food sector and food prices in Brazil 79 4. Development of the food sector and food prices in China 81 5. Development of the food sector and food prices in India 83 D. Nestlé and patentability of food 85 E. Assessment 89 Part II. Innovation in today's food sector 91 A. Innovation related to the production of agricultural raw materials 92 I. Innovation related to the production of plant-derived agricultural raw materials 93 II. Innovation related to the production of animal-derived agricultural raw materials 99 B. Innovation related to the production of processed food 101 I. Use of microorganisms in the production of processed food 101 II. Functional food 106 III. Nutraceuticals 109 C. Consumer acceptance of innovation in the food sector 110 Part III. Intellectual property situation of today's food sector 115 A. Protection of inventions related to the production of plant-derived raw materials 115 I. Protection under the plant variety protection system 116 1. Plant variety as protectable subject matter 116 2. Conditions of protection 117 3. Scope of protection 119 8 https://doi.org/10.5771/9783845210230 , am 29.07.2020, 21:01:34 Open Access - - https://www.nomos-elibrary.de/agb a. Essentially derived plant varieties 120 b. Exemptions to plant variety protection 121 4. Assessment 122 II. Protection under the Patent System 123 1. Scope of protection 124 2. Term of protection 124 3. Limitations of protection 127 a. Research exemption and plant breeders' exemption 127 b. Farm-saved seed and coincidental production 129 c. Compulsory license 130 4. Assessment 131 III. Increase in patent applications for non-genetically modified plants 131 1. European patent on herbicide-resistant rice 132 2. Exemption to patentability of essentially biological processes and patentability of artificially induced mutation 134 3. Assessment 134 B. Protection of inventions related to the production of animal-derived raw materials 136 C. Protection of inventions related to the production of processed food 136 I. Patentability of savor nuances 137 II. Food as a macromolecular substance and product-by-process claims 138 1. Patentability of product-by-process claims 139 2. The scope of product-by-process claims 140 a. The scope of product-by-process claims in Europe 141 b. The scope of product-by-process claims in the U.S. 142 aa. The Scripps decision 142 bb. The Atlantic decision 143 III. Food as the product directly obtained by a patented process 147 1. Comparison with the protection by product-by-process claims 147 2. The product directly obtained by a process 148 3. Interpretation of “directly obtained” 148 a. Narrow interpretation: chronological approach 148 b. Broad interpretation: parameter approach 149 4. Interpretation applicable to food-related inventions 150 a. Literal interpretation 150 b. Legislative history of Art. 64(2) EPC 150 c. Systematic interpretation 152 d. Teleological interpretation 152 e. Parameter approach appropriate 153 5. Burden of proof with regard to the product directly obtained by a pro- cess 153 6. Biological inventions 153 7. Case study on food products obtained by a patented process 154 9 https://doi.org/10.5771/9783845210230 , am 29.07.2020, 21:01:34 Open Access - - https://www.nomos-elibrary.de/agb a. The biscuit patent – EP 445 929 155 aa. Background 155 bb. The invention of the biscuit patent 155 cc. Claims and claim interpretation 156 dd. Impacts for products obtained from the biscuit patent technology 157 b. Herbicide-tolerant plants – EP 546 090 158 aa. Background 158 bb. Technology underlying the patent 158 cc. Scope with respect to Art. 64(2) EPC 159 c. Patent on transformation technology – EP 270 615 160 aa. Background 161 bb. The Moloney patent and its scope 162 8. Summary on Art. 64(2) EPC 164 D. Summary 165 Final Summary 166 10 https://doi.org/10.5771/9783845210230 , am 29.07.2020, 21:01:34 Open Access - - https://www.nomos-elibrary.de/agb Zusammenfassung in deutscher Sprache Patente in der Nahrungs- und Genussmittelindustrie – Eine Retrospektive unter besonderer Berücksichtigung des TRIPs Übereinkommens 167 Einleitung 167 Teil I: Die Patentierbarkeit von Nahrungsmitteln im Zeitraum von 1877 bis 2005 in Deutschland im Vergleich zu Brasilien, China und Indien 168 A. Die Patentierbarkeit von Nahrungsmitteln in Deutschland 168 I. Der Patentierungsausschluss und seine Abschaffung 168 II. Die Folgen der Patentierbarkeit von Nahrungsmitteln 170 B. Die Patentierbarkeit von Nahrungsmiteln unter dem TRIPs Übereinkommen 178 I. Rechtlicher Rahmen 180 II. Folgen der Patentierbarkeit von Nahrungsmitteln 181 C. Nestlé und die Patentierbarkeit von Nahrungsmitteln 185 D. Beurteilung 187 Teil II: Innovation im heutigen Nahrungsmittelsektor 188 Teil III: Die Schutzrechtssituation des Nahrungsmittelsektors 189 A. Schutz von pflanzenbezogenen Erfindungen unter dem Sortenschutz 189 B. Schutz von pflanzenbezogenen Erfindungen unter dem Patentrecht 189 C. Schutz von Erfindungen in der Nahrungsmittelverarbeitung 190 Zusammenfassung 192 Literature 193 11 https://doi.org/10.5771/9783845210230 , am 29.07.2020, 21:01:34 Open Access - - https://www.nomos-elibrary.de/agb https://doi.org/10.5771/9783845210230 , am 29.07.2020, 21:01:34 Open Access - - https://www.nomos-elibrary.de/agb Abbreviations ABl Amtsblatt AIPPI Association Internationale pour la Protection de Propriété Intellec- tuelle Art. Article ASSINSEL The International Association of Plant Breeders for the Protection of Plant Varieties BGH Bundesgerichtshof Bl. f. PMZ Blatt für Patent-, Muster- und Zeichenwesen BPatG Bundespatentgereicht CIAA Confederation of the Food and Drink Industries in the EU CPVO Community Plant Variety Protection Office CPVR Regulation (EC) No. 2100/94 on Community Plant Variety Rights of July 17, 1994 Doc. Document ECJ European Court of Justice EG Europäische Gemeinschaften EIPR European Intellectual Property Review EPC European Patent Convention EPO European Patent Office et al. Et alii etc. Et cetera Exemption Exemption to patentability of food-related substances EU European Union FAO Food and Agricultural Organization of the United Nations FDA Food and Drug Administration Food Food-related substances FUFOSE Functional Food Science in Europe GATT General Agreement on Tariffs and Trade GRUR Gewerblicher Rechtsschutz und Urheberrecht GRUR Int. Gewerblicher Rechtsschutz und Urheberrecht, Internationaler Teil IFIC International Food Information Council IIC International Review of Industrial Property and Copyright Law ILSI International Life Sciences Institute IPC International Patent Classification ISAAA International Service for the Acquisition of Agri-Biotech Applications ISF International Seed Federation Mitt. Mitteilungen der deutschen Patentanwälte NACE Nomenclature des Activités dans la Communauté Européenne No. Number Nr. Nummer OJ EC Official Journal of the European Communities PatG Patentgesetz 13 https://doi.org/10.5771/9783845210230 , am 29.07.2020, 21:01:34 Open Access - - https://www.nomos-elibrary.de/agb PCT Patent Cooperation Treaty s. And the subsequent page SaatG Saatgutverkehrsgesetz Sec. Section SIPO State Intellectual Property Office of the People's Republic of China SortG Sortenschutzgesetz SPC Supplementary Protection Certificate ss. And the susbsequent pages Strasbourg Convention on the Unification of Certain Points of Substantive Law Con- vention on Patents for Invention of November 27, 1963 TRIPs Agreement on Trade Related Aspects of Intellectual Property Rights U.S. United States of America U.S.C. United States Code UK United Kingdom UKHL United Kingdom House of Lords UN United Nations UNCTAD United Nations Conference on Trade and Development UPOV International Union for the Protection of New Varieties of Plants USDA United States Department of Agriculture USPTO United States Patent and Trademark Office USTR United States Trade Representative VDI Verein deutscher Ingenieure WHO World Health Organization WIPO World Intellectual Property Organization WTO World Trade Organization 14 https://doi.org/10.5771/9783845210230 , am 29.07.2020, 21:01:34 Open Access - - https://www.nomos-elibrary.de/agb Index of Tables Table 1 Food-related technological subclasses of IPC according to NACE 34 Table 2 Biotechnology-related technological subclasses of IPC according to NACE 36 Table 3 Food-related German patent applications with priority from 1970 to 2001 39 Table 4 Food biotechnology-related German patent applications with a priority from 1970 to 2001 45 Table 5 Food-related Brazilian, Chinese and Indian patent applications with priority from 1990 to 2001 76 Table 6 Food biotechnology-related Brazilian, Chinese, and Indian patent applications with priority from 1990 to 2001 78 Table 7 Nestlé's food-related German, Brazilian, Chinese, and Indian patent applications with priority in 1990-2001 87 Table 8 Nestlé's food biotechnology-related German, Brazilian, Chinese, and Indian patent applications with priority in 1990-2001 88 Table 9 Applications of biotechnology in the production of plant-derived agricultural raw materials 94 Table 10 Fields of biotechnological research related to the production of animal-derived agricultural raw materials 100 Table 11 Uses of enzymes in the production of processed food 103 Table 12 Areas of human physiology that are relevant to functional food 107 15 https://doi.org/10.5771/9783845210230 , am 29.07.2020, 21:01:34 Open Access - - https://www.nomos-elibrary.de/agb German Index of Tables/Tabellenverzeichnis Tabelle 13 Nahrungsmittelbezogene IPC Unterklassen 171 Tabelle 14 Biotechnologische IPC Unterklassen 172 Tabelle 15 Deutsche Nahrungsmittelpatentanmeldungen mit Priorität im Zeitraum von 1970 bis 2001 173 Tabelle 16 Deutsche Nahrungsmittelpatentanmeldungen mit Biotechnolo- giebezug mit Priorität im Zeitraum von 1970 bis 2001 176 Tabelle 17 Brasilianische, chinesische und indische Nahrungsmittelpat- entanmeldungen mit Priorität im Zeitraum von 1970 bis 2001 182 Tabelle 18 Brasilianische, chinesische und indische Nahrungsmittelpat- entanmeldungen mit Biotechnologiebezug mit Priorität im Zeitraum von 1970 bis 2001 184 Tabelle 19 Nestlé's deutsche, brasilianische, chinesische und indische Nahrungsmittelpatentanmeldungen mit Priorität im Zeitraum von 1990 bis 2001 186 Tabelle 20 Nestlé's deutsche, brasilianische, chinesische und indische Nahrungsmittelpatentanmeldungen mit Biotechnologiebezug mit Priorität im Zeitraum von 1990 bis 2001 187 16 https://doi.org/10.5771/9783845210230 , am 29.07.2020, 21:01:34 Open Access - - https://www.nomos-elibrary.de/agb Introduction During the last few centuries a highly industrialized food sector has been evolving. The food sector is now one of the most important industrial sectors. This dissertation reflects on the role of the food sector and its particular role in patent law. Interestingly enough, food, being central to every human being, has been excluded from patentability in many patent laws, e.g. in the very first German Patent Act of 1877. 90 years later, this exemp- tion to patentability has been abolished in Germany. Thus the first chapter is dedicated to the question of why food-related substances, which in the following will be abbreviat- ed with food, were excluded from patentability in Germany and why this exemption was abolished in 1967. It furthermore investigates the consequences of the exemption to patentability of food in Germany, which will in the following be abbreviated with ex- emption. History repeats itself. This is also true for the exemption. As Germany excluded food in its first Patent Act, so did many developing or emerging countries - and are still doing so today. The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) now forces all Members of the World Trade Organization to abolish the exemption. Thus the TRIPs Agreement substantially affected the food sector when it was adopted. Straus 1 has described the impact of the TRIPs Agreement on genomic inventions in a way that generally applies to all food-related inventions and therefore to the food sector as a whole: "Bearing in mind all the specific phases of the food production process it seems clear that under the TRIPs Agreement, WTO Members have to provide patent protection and/or plant variety pro- tection respectively, for all genomic inventions involved in that process at its different stages and their resulting end products including final foods." For this reason, this study looks at the Patent Acts of Germany, Brazil, China, and India in a comparative law approach with respect to the exemption and the effects of its aboli- tion. The second part of this dissertation is dedicated to the description of the food sector of today and particularly its technological developments. Here, first and foremost the influ- ence of biotechnology on the food sector is described. The production of agricultural raw materials has been largely influenced by biotechnology. First, the production of plant-derived agricultural raw materials is shown. Next, the production of animal-de- rived agricultural raw materials is analyzed in this respect. Finally, the influence of bio- technology on the production of processed food is discussed. 1 Straus , Genomics and the Food Industry: Outlook from an Intellectual Property Perspective, in: Vaver&Bently (eds.), Intellectual Property in the New Millennium – Essays in Honour of William R. Cornish, Cambridge 2004, 124, 134. 17 https://doi.org/10.5771/9783845210230 , am 29.07.2020, 21:01:34 Open Access - - https://www.nomos-elibrary.de/agb The third and last part of this dissertation is dedicated to the intellectual property situ- ation of the food sector of today. The protection of food-related inventions under European law is examined. The patentability of inventions related to the production of agricultural raw materials and of processed food is analyzed. It shows that though the exemption has been abolished, protection in this sector is still different from that in oth- er fields of technology. 18 https://doi.org/10.5771/9783845210230 , am 29.07.2020, 21:01:34 Open Access - - https://www.nomos-elibrary.de/agb Part I. Patentability of food from 1877 to 2005 in Germany compared to Brazil, China and India The following review compares retrospectively the patent acts of Germany and of the emerging countries Brazil, China, and India with regard to patentability of food-related inventions, which will in the following be abbreviated with the patentability of food. The food sector is of enormous economic importance, as it is one of the biggest industri- al sectors. Moreover, the food sector has an outstanding position compared to other in- dustrial sectors, as it affects health and nutrition. The food sector covers the basic needs of every human being and has guaranteed the survival of many generations of mankind. This unique position is reflected first and foremost in the patent system, where food has always had an exceptional position. Nevertheless, the food sector has not yet been the focus of patent law and literature. Apart from Straus , 2 who investigated the patentability of genomic inventions in the food sector, there have indeed been few studies on the exemption to patentability of food. Therefore it is the aim of this thesis to identify and analyze the patentability of food in Germany, Brazil, China, and India in a comparative manner in the time period from 1877 to 2005. Many patent systems have one phenomenon in common: the exemption. The very first German patent law, the Patent Act of 1877, excluded food from patentability. This ex- emption was abolished 90 years later. Until 1995, many developing or emerging coun- tries had also excluded food from patentability. The TRIPs Agreement changed this situ- ation sustainably. Art. 27 of the TRIPs Agreement declares inventions in all fields of technology patentable subject matter. By 2005, thanks to the TRIPs Agreement, most countries of the world had provided in- tellectual property protection for food by patents or sui generis rights. This development is exemplified by Germany on the one hand and the developing or emerging countries Brazil, China, and India on the other hand. The exemption in the German Patent Act of 1877 proved to be rather formal in nature. In fact, case law has guaranteed the protection of formally excluded subject matter and by doing so circumvented the legislature's inten- tion. In 1967 food became patentable as such. Germany's food sector has been thriving since then. This prospering period is reflected in an increasing number of food-related patents as will be demonstrated in the following analysis. 2 Straus , Genomics and the Food Industry: Outlook from an Intellectual Property Perspective, in: Vaver&Bently (eds.), Intellectual Property in the New Millennium – Essays in Honour of William R. Cornish, Cambridge 2004, 124. 19 https://doi.org/10.5771/9783845210230 , am 29.07.2020, 21:01:34 Open Access - - https://www.nomos-elibrary.de/agb