This chapter provides a general introduction to the book. The chapter reviews the historical development of the biotechnology industry and the difficulties in applying conventional European patent law rules to genetic inventions. In particular, the chapter presents the concerns regarding the lack of industrial application of patent claims over isolated human DNA sequences and the importance of this requirement in the patenting of inventions concerning human genes.
Nature is the source of all true knowledge. She has her own logic, her own laws, she has no effect without cause nor invention without necessity.
(Leonardo da Vinci)
The term ‘biotechnology’ was first coined by the Hungarian engineer Károly Ereky in 1919 to refer to the process of producing substances from raw materials with the aid of living organisms.1 Today, biotechnology is broadly defined as any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use.2
The vast potential of biotechnology to improve human and animal health, increase agricultural production and protect the environment has been acknowledged in multiple intergovernmental meetings including the 1992 United Nations (UN) Earth Summit.3 In fact, over the last few years, the level of innovation in biotech sciences has often been used as an indicator of a country’s competitiveness and economic performance. Furthermore, governments worldwide usually consider biotechnology to be a key asset for securing a more competitive and sustainable future. In this regard, promoting innovation in biotechnology currently forms an integral part of the European Union’s (EU) strategy towards a knowledge-based economy.
It is commonly known that the origins of biotechnological techniques date back to the ancient times. By 2300 BC Egyptians had already started to use microorganisms in the brewing processes for making products such as beer, wine and cheese.4 However, modern biotechnology, which has had a major impact on the development of today’s biotech industry, is mainly based on the scientific advances that have taken place since the nineteenth century.
The science of zymotechnology, which appeared in the late nineteenth century and included all types of industrial fermentation, rather than just brewing, played a crucial role in bridging the gap between old biotechnology and modern genetic engineering.5 At the same time, Gregor Mendel’s experiments on plant and animal breeding made it possible to define the rules of heredity,6 which represented a tremendous step towards understanding the genetics of organisms. Mendel’s theories in combination with the chromosome theory of inheritance by Thomas Morgan constituted the core of classical genetics. The discipline of molecular biology developed in the subsequent decades.
In the twentieth century, growing bonds between biology and engineering led to the development of biotechnology as a science. The 1953 discovery of the deoxyribonucleic acid (DNA) structure and the development of a recombinant DNA technique in 1973 constitute the two key events that set the groundwork for new and revolutionary advances in biotech sciences. Based on Mendel’s laws, geneticists began to speculate about the chemical structure and functioning of the gene, and the relationship between genes and proteins, at the start of the twentieth century.
The discovery that DNA is the genetic material of organisms started with Griffith’s experiments in 1928, which showed that nonvirulent bacteria strains could be genetically transformed with a substance derived from a heat-killed pathogenic strain.7 Based on further experimental evidence, Crick and Watson proposed the double-helical structure of DNA, in which two complementary polynucleotide chains (made out of the primary nucleobases adenine, thymine, guanine and cytosine) are twisted around each other, held together by hydrogen bonds between pairs of bases, to form a regular double helix.8 In April 1953, the international scientific journal ‘Nature’ published a communication from the two researchers at the Cavendish Laboratory at the University of Cambridge in England, explaining the double helix molecular structure of DNA.9 This publication, which was further supported by a second article,10 proposed the new model of DNA together with some of its genetic implications.
By the autumn of 1953, the ‘central dogma’ was that chromosomal DNA functions were the template for ribonucleic acid (RNA) molecules, which subsequently moved to the cytoplasm of eukaryotic cells, where they determine the arrangement of amino acids within proteins.11 Information therefore flows from DNA to RNA and then to protein. In previous decades, investigators had never seen and rarely studied elements such as DNA and proteins.12 Thus, the scientific foundation established by Crick and Watson allowed a better understanding of previous discoveries, provoking a great transformation of life sciences.
Two decades later, Cohen and Boyer invented a methodology for cutting and splicing DNA segments from different sources, making it possible to transfer genes from one source to the DNA of a different specie. This technology, known as recombinant DNA, set the basis of genetic engineering by allowing the insertion of a fragment of DNA from one cell, for example a human cell, into the genetic sequence of another host cell, for example a bacterium; and then its activation so that the host begins to produce the protein encoded by the inserted DNA sequence. Recombinant DNA has helped investigators to study cancer cells, programmed cell death, antibody production, hormone action and other fundamental biological processes.13 The practical implications of this method include the production of human insulin, which reached the market in 1982 and gradually replaced the insulin extracted from porcine or bovine pancreata,14 human growth hormones and drugs to treat anaemia, cardiovascular disease and cancer, as well as the development of diagnostic tools to detect a variety of diseases.15
Soon after recombinant DNA technology was first developed, the distinction between traditional and modern biotechnology was adopted.16 ‘Traditional biotechnology’ refers to the use of living matter in fermentation, like beer brewing or bread making, and plant and animal hybridization. In contrast, ‘modern biotechnology’ is used to refer to more advanced techniques like manipulation of an organism’s genome, the industrial use of DNA cell fusion and tissue engineering among others.
Since the 1990s, biotech research has been principally focused on the act of identifying which stretches of DNA in an organism correspond to which genes, and recombinant products and processes. Moreover, molecular research started to be increasingly focused on commercial applications, which blurred the boundaries between academic (public) and industrial (private) activities.17 Most recent advances in genetic engineering include protein engineering, nanobiotechnology,18 DNA shuffling and gene therapy.
With the rapid advancement of genetic engineering techniques, patent protection has become a fundamental asset for companies in this industry. Patent rights are government-granted limited monopolies attached to inventions that comply with the requirements of novelty, inventiveness (non-obviousness) and industrial application (utility), and are not excluded from patentability.19 Patents are negative legal rights with potential economic value, which give owners temporary rights to prevent others from using, making or selling a particular invention. Among others, patents can be used for preventing duplication, blocking competitors, securing royalty fees or negotiating licensing contracts.20 For example, a patent right could be infringed if someone sells or otherwise commercializes the invention without the patent holder’s consent, which gives the owner the possibility to enforce his rights in court and obtain compensation for the invention’s benefits that have been unlawfully obtained by the infringer, and other costs incurred.
In order to secure continuous research, companies need to somehow guarantee that investors will be able to capture the value of their creations and recover the invested amounts. In this regard, investors usually see patents on the inventions resulting from the financed research as the best indicator that a company is competitive and that the project is achieving its objectives. Thus, having a valuable patent portfolio is very important today for maintaining a competitive market position, especially for biotechnology firms, which require vast amounts of money to carry out research.
During the 1990s and 2000s the gap between policy and life sciences developments became a primary concern in the EU, which led policy makers to focus on adopting different measures to foster research and innovation in this field. In this regard, patent protection was seen as a crucial element for attracting investors and promoting the successful development of a competitive biotechnology industry in Europe.
The European Patent Convention (EPC) does not contain any express provision excluding genetic inventions from patentability, while Article 27(1) of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement)21 requires that patents are to be available for all fields of technology. However, even though patent laws do not prohibit the patentability of inventions concerning (human) genetic material, the intrinsic characteristics of these types of inventions pose challenges to the application of general patent law rules. For instance, since the launch of the Human Genome Project (HGP) in the 1990s, there has been a significant increase in the number of patent applications concerning human genes and partial sequences, many of which do not easily meet traditional patentability standards. In particular, it has been common to find patent applications for newly discovered, isolated human DNA sequences (and related proteins) for which an industrial application has not yet been identified.
Discussions about the patentability of human genetic inventions were usually focused on questions regarding the novelty, inventiveness or ethical implications of these types of patent applications. However, with the advent of more and more patent claims concerning isolated human genes and gene sequences without a known practical utility in industry, the patent law requirement of industrial application has proved to be a difficult standard to fulfill for these kinds of inventions. In consequence, the criterion of industrial applicability (utility) has become a rather important issue in the debate over the patentability of human genes.
This is especially controversial since the requirement of industrial application is essential to ensure that, where patents are granted for those inventions that make a contribution to the art, they have a real applicability in industry. In the case of gene patents, this requirement serves to guarantee that society is not deprived of using inventions concerning human genetic material, such as diagnostic tests, if the patentee has not been able to indicate what the invention’s practical utility in industry is.
The 1998 Biotech Directive attempted to address this question by introducing a number of provisions that give the requirement of industrial application a determinant role in the patenting of human DNA sequences. The aim was to ensure that patents over genes and gene sequences of human origin contain a real practical value for society that justifies the grant of monopoly rights to such inventions. Moreover, the Biotech Directive did not only raise the industrial applicability standard per se, but further analysis of its text reveals a close link between this requirement and other important provisions in gene patenting, such as the exclusion from patentability of discoveries and the determination of the scope of protection. As a result, the criterion of industrial application itself and in its different dimensions, that is, in connection with other patent law elements, now has a central position in the patenting of genetic material.
This book uses the term ‘biotechnology’ to refer to the techniques that developed after the discovery of the DNA structure in the 1950s. In particular, it refers to the advances in genetic engineering that form part of what is known as modern biotechnology as opposed to traditional biotechnology’s techniques like fermentation.
1.2.2 Genetic Invention, Gene Patent, Genetic Patent, DNA Invention, DNA Patent
The terms ‘genetic invention’, ‘gene patent’, ‘genetic patent’, ‘DNA invention’ or ‘DNA patent’ are employed to refer to inventions, or patents over inventions, in the field of genetic engineering. In most cases, the genetic inventions or genetic patents referred to in this book relate to gene sequences, like DNA or amino acid sequences, of human origin. However, in some instances, reference is made to genetic inventions or patents in general, no matter the origin of the genetic material, or to animal or plant related genetic inventions or patents. In all cases, the origin of the genetic material concerned will be specified.
1 Robert Bud, ‘History of “Biotechnology”’ (1989) 337 Nature 10.
2 UN Convention on Biological Diversity (opened for signature 5 June 1992, entered into force 29 December 1993) 1760 UNTS 79, 143; (1992) 31 ILM 818, art 2.
3 UN Conference on Environment and Development, Rio de Janeiro, 3–14 June 1992 – the Earth Summit Agreements: Agenda 21, the Rio Declaration on Environment and Development, the Statement of Forest Principles, the UN Framework Convention on Climate Change and the UN Convention on Biological Diversity.
4 Robert Bud, The Uses of Life: A History of Biotechnology (Cambridge University Press 1993) 7.
6 Colin Tudge, In Mendel’s Footnotes: An Introduction to the Science and Technologies of the Nineteenth Century to the Twenty-Second (Jonathan Cape 2000) 213. Mendel’s breeding experiments consisting of genetic crosses between strains of peas with different external characteristics led to understanding the rules of heredity (that heredity is controlled by chromosomes, which are the cellular carriers of genes) from parents to offspring in 1865, see James D Watson (ed), Molecular Biology of the Gene (7th edn, Pearson 2014) 6.
8 Ibid 24–25. The term ‘double helix’ became popular with the publication in 1968 of James Watson’s book The Double Helix: A Personal Account of the Discovery of the Structure of DNA (1st Atheneum paperback edn, Atheneum 1980).
9 James D Watson and Francis HC Crick, ‘Molecular Structure of Nucleic Acids: A Structure for Deoxyribose Nucleic Acid’ (1953) 171 Nature 737.
10 James D Watson and Francis HC Crick, ‘Genetical Implications of the Structure of Deoxyribonucleic Acid’ (1953) 171 Nature 964.
11 Watson, Molecular Biology of the Gene (n 6) 33.
12 Eric Vettel, Biotech: The Countercultural Origins of an Industry (University of Pennsylvania Press 2006) 176.
13 Burton E Tropp, Molecular Biology: Genes to Proteins (4th edn, Jones & Bartlett Learning 2012) 24.
14 Insulin was first discovered at the University of Toronto in 1921–1922. Eli Lilly and Company prepared insulin in commercial quantities and a patent was granted for the process of obtaining insulin to the University of Toronto in order to control the quality of insulin sold to diabetics, see Michael Bliss, The Discovery of Insulin (Macmillan Press 1982) 11–12.
15 Tropp (n 13) 24–25. Although initial experiments using recombinant DNA raised suspicion, risks from this technique are now considered to be much lower than originally estimated, and more specifically defined, see Lorance L Greenlee, ‘Biotechnology Patent Law: Perspective of the First Seventeen Years, Prospective on the Next Seventeen Years’ (1991) 68 Denv UL Rev 127.
16 See Albert Sasson, Medical Biotechnology: Achievements, Prospects and Perceptions (UN University Press 2005) 1.
17 Sally Smith Hughes, ‘Making Dollars out of DNA: The First Major Patent in Biotechnology and the Commercialization of Molecular Biology, 1974–1980’ (2001) 92 Isis 541. See also Rohini Acharya, Anthony Arundel and Luigi Orsenigo, ‘The Evolution of European Biotechnology and Its Future Competitiveness’ in Jaqueline Senker (ed), Biotechnology and Competitive Advantage (Edward Elgar 1998) 101.
18 For information about the challenges that nanotechnological inventions may pose to patent law see Herbert Zech, ‘Nanotechnology – New Challenges for Patent Law?’ (2009) 6 SCRIPT-ed 147.
19 Under the European Patent Convention there are some exclusions from patentability, either because the subject matter does not constitute an invention, or because although it can amount to an invention, this one is not patentable, see Convention on the Grant of European Patents (European Patent Convention (EPC)) of 5 October 1973, art 52(2) and (3) and art 53.
20 With regard to the legal nature of patent rights, their analogy with real property is to a certain extent equivocal. Patents are property rights where the term ‘property’ refers to ownership of knowledge or information. Although patents can be traded or transferred through different types of agreements, knowledge substantially differs from physical things in the sense that knowledge is an inexhaustible good that cannot be the subject of physical control and can be transferred without loss to the transferor and infinitely replicated, see William van Caenegem, Technology Law and Innovation (Cambridge University Press 2007) 11–12. In terms of legal validity, the granting of a patent by a country’s government does not guarantee the validity of the rights since it can be invalidated in the event of a dispute over the patent’s compliance with those patent law requirements that constitute revocation grounds.
21 Agreement on Trade-Related Aspects of Intellectual Property Rights of15 April 1994.