Biotechnology is an applied science that involves the deliberate utilization of living organisms, biological processes and biological products to develop products and processes for human use. While there is no internationally agreed definition of “biotechnology” in existing international IP agreements, regional and plurilateral definitions have been adopted. The Organisation for Economic Co-operation and Development (OECD), for example, defines biotechnology as “the application of science and technology to living organisms as well as parts, products and models thereof, to alter living or nonliving materials for the production of knowledge, goods and services”.
Brief history of biotechnology
The first biotechnological applications were developed thousands of years ago. Archeological evidence suggests that humans have been practicing a form of biotechnology for over 6,000 years, beginning with the use of yeasts for brewing and bread making, and the use of microorganisms and enzymes for processing milk into various foods, such as yogurt and cheese. Humans have devised hundreds if not thousands of ways to utilize entire organisms such as bacteria or yeasts, or portions, tissues or extracts of animals, plants or fungi, to provide useful products and processes such as foods, fibers, dyes, compost, silage and medicines. As scientific advances allowed researchers to study normal biological processes at the cellular, molecular and genetic level, they used this knowledge to develop more sophisticated biotechnological tools. Since the 19thcentury, modern biotechnology has increasingly drawn on microbiological and, since the middle of the 20thcentury, also on molecular biological, genetic or genetic engineering findings and methods. This has made possible the development of manufacturing processes for chemical compounds to use as active ingredients for pharmaceuticals or as basic chemicals for the chemical industry, diagnostic methods, biosensors, new plant varieties and more.
The mid-20th century
By the mid-20thcentury, researchers had started using a natural process of gene exchange by means of plasmids (small pieces of deoxyribonucleic acid (DNA), usually circular, that can be transferred from one organism to another and confer new properties) to create novel organisms with desired properties. Subsequently, it was understood that DNA encoded information, that expression of a gene (expression of the encoded information) resulted in a product such as a protein, that ribonucleic acid (RNA) molecules mediated translation and regulation of gene expression, and that DNA molecules could be deliberately manipulated to change the encoded information. This is called the central dogma of molecular biotechnology and the utilization of its various natural subprocesses in technological applications has led to an exponential increase of biotechnological innovations. Concretely, this led to the development of a rapidly expanding toolkit for recombinant DNA technology (also known as “genetic engineering”) whereby coding and regulatory sequences can be assembled by precisely cutting preexisting DNA at defined sequences (often using enzymes derived from bacterial defense systems), and splicing the cut ends (often using enzymes that are normally involved in cellular damage repair) to build a construct that allows expression of a gene in an environment where it does not naturally occur; for example, the expression of a human gene from a construct inserted into a bacterium (often called transgenic expression or heterologous gene expression).
The 1970s
One of the first commercial products of recombinant DNA technology in the 1970s was recombinant insulin made by splicing DNA encoding chains of human insulin into the genetic material of a bacterium and using the cellular machinery of the bacterium to produce insulin chains. Recombinant DNA techniques were soon used successfully to produce other therapeutic proteins including antibody-based therapies for cancers and immune disorders. These techniques were also used to create modified plants and animals with desired traits. Recombinant DNA techniques have thus revolutionized not only therapeutic options through the development of new innovative drugs, such as biopharmaceuticals, and therapeutics, but also diagnostics by providing methods and products for detecting specific genetic signatures or biomarkers associated with specific diseases.
The 1980s and onwards
The groundwork for the development of new products, processes and technologies to address global challenges in healthcare, the environment and food supply was laid by further technical innovations made in the 1980s and continues to develop dynamically. Polymerase chain reaction (PCR) technology enabled great advances in genetic analysis, precision synthesis of DNA and diagnostics. Genome editing techniques allowed researchers to make direct changes to the DNA of a living organism by inserting, deleting or changing sequences at a precise location. It is important to note that genome editing using technologies such as zinc-finger nucleases (ZFNs) or transcription activator-like effector nucleases (TALENs), or the more recently developed (2010s) clustered regularly interspaced short palindromic repeats (CRISPR)-Cas systems, differs from previous recombinant DNA techniques because it makes precise changes to the existing DNA of a living organism to achieve the desired effect, and does not require building and inserting recombinant DNA constructs into a cell. This new technological practice of precise, site-specific editing of genomes of organisms without the use of, often patented, recombinant DNA constructs has also led to new legal practices in the prosecution, acquisition and exercise of IP rights for the resulting inventions, such as new licensing and technology transfer practices.
Alongside the new genome editing techniques, genomic sequencing has been another transformative technology that is reshaping the field of biotechnology. Sequencing parts or all of an organism’s genome is putting vast and ever-increasing amounts of genomic sequence data at the disposal of biotechnological innovation. Just like genome editing, the rise of high-throughput genomic sequencing has led to significant changes in IP practice in many fields of biotechnology and has therefore reshaped technology transfer practices.
Furthermore, these advances in feasible biotechnological applications, such as genome-edited plants rather than genetically modified plants, have created new questions at the interfaces between IP and related regulatory frameworks, which may affect technology transfer for biotechnological inventions. According to current understanding, interventions in the genetic material of organisms are irreversible, and potentially undesirable consequences may only occur phenotypically in the next generation or the generation after that. Thus, a distinction must be made between biotechnological processes that interfere with the genetic material of an organism and those that do not.
While the ever-evolving toolkit for biotechnological innovation continually adds new techniques, it also retains tools such as fermentation and selective breeding that have been used for thousands of years. This is particularly the case in plant breeding, where conventional selective breeding techniques are still used despite the increasing use of new plant breeding techniques. The widespread uptake of biotechnology products and processes has led to attempts to define “categories” of biotechnology based on their field of use and the issues of regulation and perception that are triggered by use in each field.
Main categories
The major categories are:
medical biotechnology (“red biotechnology”) for the development of drugs and therapeutics, vaccines, diagnostics and detection methods; this encompasses a wide range of biotechnological applications from biochips for medical diagnostics and personalized medicine to drug production and gene therapy, often involving the use of genetically modified organisms;
agricultural biotechnology (“green biotechnology”) for the improvement of crops and livestock in agriculture and food production, such as drought-resistant or pest-resistant crops, or biocontrol agents;
industrial biotechnology (“white biotechnology”) for the industrial production of organic chemicals as well as active substances with the help of optimized enzymes, cells or micro-organisms, using living cells or isolated enzymes that have been designed for purposes such as cleaning, degreasing, bioremediation, degradation of biological waste, production of products such as biofuels or biopolymers (bioplastics), or reducing energy needs by acting as biocatalysts.
The expanding use of biotechnology products and processes into new fields to address new problems has generated a rainbow of additional classifications. Descriptions of these classifications vary between life science sectors and thus several classifications and color codes are used. However, one available summary describes them as follows:
This classification scheme is merely a way of trying to organize complex information. There is some overlap between classification systems, as most use the same technical and analytical tools. Similarly, some emerging fields, such as synthetic biology, are difficult to classify because they cannot be clearly assigned to any of the classifications mentioned. Synthetic biology is focused on engineering biomolecular systems with novel capabilities, where the systems may be contained in a cell or organism that produces a novel product or has a novel metabolic pathway, or may be acellular, such as an array of enzymes on a scaffold that form a novel pathway. Products of synthetic biology can be found in most categories of biotechnology. Because every field of biotechnology is based on the same (or similar) underlying biological and technical principles, research in every category will use tools such as PCR, library screening, genome editing, random mutation or phage display as may be needed for a specific project, although certain techniques may be adapted to a specific organism or use. The entire field is supported by platform technologies such as high-throughput screening, large-scale arrays, automation (of assays, sequencing, genetic manipulation) and analytic platforms that utilize existing scientific data such as information from genetic analysis or combinatorial chemistry or that solve problems computationally, such as protein folding, predictive structure–function models or deep genome projects.