Biotechnology Regulations
Expert-defined terms from the Specialist Certification in Intellectual Property Law and Biotechnology course at London School of Business and Administration. Free to read, free to share, paired with a globally recognised certification pathway.
Bacillus thuringiensis (Bt) Cry toxin #
A crystal protein produced by the bacterium Bacillus thuringiensis that is toxic to certain insects, such as moths and butterflies, upon ingestion. The Cry toxin binds to receptors in the midgut of the insect, causing pore formation and eventually leading to the death of the insect. Genetic engineering has enabled the transfer of Bt Cry toxin genes into crops, providing them with resistance to certain insect pests.
Biologicals #
Biological products derived from living organisms or their components, including vaccines, blood and blood components, cells, genes, tissues, and organs. Biologicals are used in various fields such as medicine, agriculture, and industry.
Biotechnology #
The application of biological systems, living organisms, or derivatives thereof, to make or modify products for specific use. This field encompasses various applications, including genetic engineering, cell and tissue culture, fermentation, and bioprocessing.
Biosimilar #
A biologic medical product highly similar to an already approved biologic product (the reference product), in terms of quality, safety, and efficacy, based on comprehensive comparability studies. Biosimilars are typically introduced to the market after the patent for the reference product has expired.
Chimeric Antigen Receptor T #
cells (CAR-T): Genetically modified T-cells that express a chimeric antigen receptor (CAR) on their surface, allowing them to recognize and target specific cancer cells. The CAR consists of an extracellular domain that binds to a tumor-associated antigen, a transmembrane domain, and an intracellular signaling domain that activates the T-cell upon antigen binding.
CRISPR #
Cas9: A genome editing tool that enables precise, targeted modification of DNA sequences. CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) are repetitive DNA sequences present in the genome of bacteria and archaea, while Cas9 (CRISPR-associated protein 9) is an endonuclease that cuts DNA at a specific location guided by a small RNA molecule (gRNA) complementary to the target DNA sequence.
Deoxyribonucleic Acid (DNA) #
A double-stranded nucleic acid molecule that carries genetic information in living organisms. DNA consists of four nucleotide bases (adenine, thymine, guanine, and cytosine) and a sugar-phosphate backbone. The sequence of nucleotides in DNA encodes genetic information that determines the characteristics of an organism.
Expressed Sequence Tags (ESTs) #
Short, single-pass DNA sequences derived from cDNA libraries, which represent the expressed portion of a genome. ESTs serve as molecular markers for gene discovery, genome annotation, and genetic mapping.
Genetically Modified Organisms (GMOs) #
Organisms whose genetic material has been altered using genetic engineering techniques to introduce new traits or modify existing ones. GMOs can be found in various fields such as agriculture, medicine, and industry.
Genomic libraries #
Collections of cloned DNA fragments that represent the entire genome of an organism. Genomic libraries can be used for various purposes, including genome sequencing, gene discovery, and functional genomics studies.
Gene therapy #
The use of genetic material, such as DNA or RNA, to treat or prevent diseases by introducing therapeutic genes into cells to compensate for defective or missing genes. Gene therapy can be accomplished through various methods, including viral and non-viral vectors.
Intellectual Property (IP) #
Creations of the mind, such as inventions, literary and artistic works, symbols, names, images, and designs, that are protected by law through patents, copyrights, trademarks, and trade secrets. IP rights grant the owner exclusive rights to use, sell, and license their creations.
Monoclonal antibodies #
Homogeneous populations of antibodies that are identical in structure and specificity, produced by a single clone of B-cells. Monoclonal antibodies are used in various applications, including diagnostics, research, and therapeutics.
Morpholinos #
Antisense oligonucleotides that consist of a DNA backbone replaced by a morpholine ring, which confers increased stability and resistance to nucleases. Morpholinos are used for gene knockdown in various model organisms, including zebrafish and Xenopus, to study gene function.
Nucleic acid hybridization #
The process of forming a duplex structure between two complementary nucleic acid strands (DNA or RNA) through base pairing. Nucleic acid hybridization is used in various applications, such as Southern blotting, northern blotting, in situ hybridization, and microarray analysis.
Nucleic acid sequencing #
The determination of the nucleotide sequence of a DNA or RNA molecule. Nucleic acid sequencing is a fundamental tool in molecular biology, with applications in genome sequencing, gene discovery, and genetic analysis.
Patent #
An exclusive right granted by a government to an inventor for a limited period, typically 20 years from the filing date, to prevent others from making, using, selling, and importing an invention without permission. Patents are granted for novel, non-obvious, and useful inventions in any field of technology.
Phage display #
A technology that enables the display of peptides or proteins on the surface of bacteriophages, viruses that infect bacteria. Phage display is used for various applications, such as protein engineering, drug discovery, and epitope mapping.
Polymerase Chain Reaction (PCR) #
An in vitro method for amplifying specific DNA sequences using a thermostable DNA polymerase enzyme. PCR involves repeated cycles of DNA denaturation, annealing of primers, and extension of primers by the DNA polymerase, resulting in exponential amplification of the target DNA sequence.
Plasmids #
Small, circular, double-stranded DNA molecules that can replicate independently of the chromosomal DNA in bacteria. Plasmids are commonly used as vectors for genetic engineering, enabling the transfer and expression of foreign genes in host organisms.
Proteomics #
The large-scale analysis of proteins, including their structure, function, and interactions, in a given biological system. Proteomics is a rapidly evolving field, with applications in disease diagnosis, drug discovery, and systems biology.
Reverse transcription #
polymerase chain reaction (RT-PCR): A laboratory technique used to amplify and detect specific RNA sequences. RT-PCR involves reverse transcription of RNA into complementary DNA (cDNA) using reverse transcriptase, followed by PCR amplification of the cDNA using specific primers.
Ribonucleic Acid (RNA) #
A nucleic acid molecule that plays a crucial role in various biological processes, such as protein synthesis, gene regulation, and RNA processing. RNA consists of four nucleotide bases (adenine, uracil, guanine, and cytosine) and a ribose sugar. There are several types of RNA molecules, including messenger RNA (mRNA), ribosomal RNA (rRNA), and transfer RNA (tRNA).
Restriction enzymes #
Endonucleases that cleave double-stranded DNA at specific recognition sites, generating defined DNA fragments. Restriction enzymes are essential tools in molecular biology, used for various applications such as DNA cloning, genome mapping, and DNA fingerprinting.
RNA interference (RNAi) #
A natural cellular process that involves the degradation of specific mRNA molecules, leading to the inhibition of gene expression. RNAi can be induced by introducing small RNA molecules, such as small interfering RNA (siRNA) or microRNA (miRNA), into cells.
Small interfering RNA (siRNA #
Small interfering RNA (siRNA
Adventitious Presence (AP) #
The unintended presence of genetically modified material in a non-genetically modified organism or product. AP can occur during breeding, production, or handling and can have significant regulatory implications.
Bacillus thuringiensis (Bt) #
A soil-dwelling bacterium used in genetically modified crops to express insecticidal proteins that are toxic to specific pests. Bt crops have been widely adopted to control insect damage while reducing pesticide use.
Biosafety #
The practice of ensuring the safe handling, transport, and use of biological materials to minimize potential risks to human health, the environment, and property. Biosafety regulations govern the use of genetically modified organisms (GMOs) and other potentially hazardous biological agents.
Cartagena Protocol on Biosafety (CPB) #
An international treaty, signed in 2000, that aims to ensure the safe handling, transport, and use of living modified organisms (LMOs) resulting from modern biotechnology. The CPB establishes guidelines for risk assessment, notification, and information-sharing among parties.
Co #
existence: The ability to maintain the separate identity of genetically modified and non-genetically modified crops, allowing farmers to choose the production method that best suits their needs. Co-existence strategies aim to prevent cross-contamination between GMOs and non-GMOs and may involve isolation distances, buffer zones, or identity preservation systems.
Confined Field Trials (CFTs) #
Experimental releases of genetically modified organisms (GMOs) in controlled settings to evaluate their performance, environmental impact, and potential risks. CFTs are subject to strict regulations to ensure containment and minimize the risk of unintended release or harm.
Deoxyribonucleic Acid (DNA) #
The genetic material present in the cells of all living organisms. DNA contains the instructions for the development, function, and reproduction of an organism, and can be altered through genetic engineering techniques.
Directive 2001/18/EC #
A European Union directive that regulates the deliberate release of genetically modified organisms (GMOs) into the environment. The directive establishes a framework for risk assessment, public consultation, and post-market monitoring of GMOs, and requires GMOs to be labeled and traceable throughout the supply chain.
Food and Agriculture Organization (FAO) #
A specialized agency of the United Nations that leads international efforts to defeat hunger and improve nutrition and food security. The FAO provides guidance and support for the development and implementation of biotechnology regulations, particularly in developing countries.
Field Release #
The intentional release of a genetically modified organism (GMO) into the environment for experimental or commercial purposes. Field releases are subject to strict regulations and require prior approval from competent authorities to ensure safety and minimize potential risks.
Genetic Engineering (GE) #
The deliberate manipulation of an organism's genetic material using biotechnology techniques, such as recombinant DNA technology, to introduce new traits or modify existing ones. Genetic engineering allows for the creation of genetically modified organisms (GMOs) with desired characteristics.
Genetically Modified (GM) #
An organism whose genetic material has been altered using biotechnology techniques, such as genetic engineering, to introduce new traits or modify existing ones. Genetically modified organisms (GMOs) are used in agriculture, medicine, and research.
Genetically Modified Organism (GMO) #
An organism, including plants, animals, and microorganisms, whose genetic material has been altered using biotechnology techniques to introduce new traits or modify existing ones. GMOs are used in agriculture, medicine, and research to improve crop yields, increase disease resistance, and enhance other desirable characteristics.
Genetic Use Restriction Technologies (GURTs) #
Technologies that limit the use or reproduction of genetically modified organisms (GMOs) by incorporating genetic triggers that restrict their propagation or expression of certain traits. GURTs are controversial and have raised concerns about their potential impact on farmer autonomy, biodiversity, and food security.
Horizontal Gene Transfer (HGT) #
The transfer of genetic material between organisms in a manner that bypasses the traditional vertical transmission from parent to offspring. HGT can occur through various mechanisms, such as transduction, transformation, and conjugation, and can contribute to the spread of antibiotic resistance and other traits.
Intellectual Property (IP) #
Creations of the mind, such as inventions, literary and artistic works, symbols, names, images, and designs, that are protected by law through patents, trademarks, copyrights, and other forms of intellectual property rights. Intellectual property rights provide incentives for innovation and protect the interests of creators and owners.
Labeling #
The requirement to provide information on genetically modified organisms (GMOs) or products containing GMOs on product packaging or in marketing materials. Labeling regulations vary by country and aim to ensure that consumers have the right to know whether a product contains GMOs and can make informed choices.
Living Modified Organism (LMO) #
An organism, including plants, animals, and microorganisms, whose genetic material has been altered using modern biotechnology, such as genetic engineering. LMOs are subject to international regulations under the Cartagena Protocol on Biosafety.
Market Authorization #
The process of obtaining approval from competent authorities to commercially market a genetically modified organism (GMO) or product containing GMOs. Market authorization typically involves a rigorous risk assessment and public consultation process and requires the submission of extensive data on the GMO's safety and efficacy.
Nucleic Acid #
A macromolecule composed of nucleotides that carries genetic information in living organisms. DNA and RNA are the two main types of nucleic acids, with DNA serving as the primary genetic material in cells and RNA playing a role in protein synthesis.
Patent #
An exclusive right granted to an inventor or assignee for a limited period to exclude others from making, using, selling, and importing an invention without permission. Patents provide incentives for innovation and protect the intellectual property rights of inventors in various fields, including biotechnology.
Plant Variety Protection (PVP) #
A form of intellectual property protection that grants breeders exclusive rights to commercially market new plant varieties for a limited period. PVP encourages investment in plant breeding and innovation and helps to ensure that breeders receive fair compensation for their efforts.
Recombinant DNA (rDNA) #
A DNA molecule that is artificially created by combining genetic material from different sources, typically using genetic engineering techniques. Recombinant DNA technology allows for the creation of genetically modified organisms (GMOs) with desired traits.
Risk Assessment #
The process of evaluating the potential adverse effects of a genetically modified organism (GMO) or product containing GMOs on human health, the environment, and biodiversity. Risk assessments are a critical component of biotechnology regulations and inform decision-making regarding the approval and commercialization of GMOs.
Transgenic Organism #
An organism that contains genetic material from a different species that has been introduced using biotechnology techniques, such as genetic engineering. Transgenic organisms are a type of genetically modified organism (GMO) and are used in agriculture, medicine, and research.
United Nations Convention on Biological Diversity (CBD) #
An international treaty that aims to conserve biological diversity, promote the sustainable use of its components, and ensure fair and equitable sharing of benefits arising from the use of genetic resources. The CBD provides a framework for biotechnology regulations and the implementation of the Cartagena Protocol on Biosafety.
Unintended Effects #
The unforeseen or unintended consequences of genetic modification, such as the expression of unintended traits, pleiotropic effects, or off-target effects. Unintended effects can arise during the genetic modification process or as a result of interactions between the genetically modified organism and its environment.
Utility Patent #
A type of patent that covers new and useful processes, machines, manufactures, or compositions of
Bacillus thuringiensis (Bt) Cry toxins #
Bt is a soil-dwelling bacterium that produces crystal proteins (Cry toxins) during sporulation. These toxins are toxic to certain insect pests, such as Lepidoptera (moths and butterflies), Diptera (flies and mosquitoes), and Coleoptera (beetles), making Bt-based biopesticides a valuable tool in integrated pest management.
Biosafety #
Biosafety refers to the prevention of accidents and misuse associated with modern biotechnology, including genetically modified organisms (GMOs) and their products. It encompasses laboratory, field, and transportation safety, as well as risk assessment, mitigation, and communication.
Biotechnology Regulatory Services (BRS) #
BRS is a division of the US Department of Agriculture's (USDA) Animal and Plant Health Inspection Service (APHIS), responsible for regulating genetically engineered organisms to ensure they do not pose a plant pest risk.
Cartagena Protocol on Biosafety #
The Cartagena Protocol is an international agreement on biosafety under the Convention on Biological Diversity (CBD), which aims to protect biological diversity from the potential risks of modern biotechnology. It establishes guidelines for the safe transfer, handling, and use of GMOs.
Chi #
square (χ2) test: A statistical test used to compare observed and expected frequencies in a sample to determine if there is a significant difference, often used in patent analysis to test for independence between two categorical variables.
Co #
existence: Co-existence refers to the ability of different agricultural production systems, including conventional, organic, and genetically modified (GM) crops, to exist and operate simultaneously without negatively affecting each other.
Convention on Biological Diversity (CBD) #
An international treaty aimed at sustaining the diverse forms of life on Earth, promoting the sustainable use of biological resources, and ensuring fair and equitable sharing of benefits arising from their use.
Deoxyribonucleic acid (DNA) #
DNA is a double-stranded molecule that carries genetic information in the form of a code consisting of four nucleotide bases (adenine, thymine, guanine, and cytosine). It is the primary genetic material of all living organisms and many viruses.
Design patents #
Design patents protect the novel, original, and ornamental design of an invention, covering the visual appearance of a product rather than its functional aspects.
Enzyme #
linked immunosorbent assay (ELISA): ELISA is a laboratory technique used to detect the presence of specific proteins, including antibodies and antigens, in a sample. It is often used in biotechnology to detect and quantify gene expression.
European Patent Convention (EPC) #
The EPC is a multilateral treaty establishing the legal framework for the European Patent Office (EPO), which grants European patents that are valid in EPC member states.
European Patent Office (EPO) #
The EPO is an organization responsible for granting European patents, which are valid in EPC member states. The EPO applies the European Patent Convention (EPC) to evaluate patent applications.
Food and Agriculture Organization (FAO) #
The FAO is a specialized agency of the United Nations (UN) responsible for supporting international efforts to ensure food security, promote sustainable agriculture, and eradicate hunger and malnutrition.
Freedom to operate (FTO) #
FTO refers to the ability of a company or organization to conduct business, including research, development, and commercialization of a product, without infringing on existing intellectual property rights.
Gene editing #
Gene editing is the targeted modification of an organism's DNA sequence to alter gene function, typically using techniques such as CRISPR-Cas9, zinc finger nucleases (ZFNs), or transcription activator-like effector nucleases (TALENs).
Genetic engineering #
Genetic engineering is the intentional manipulation of an organism's genetic material to introduce new traits or modify existing ones, typically through the insertion, deletion, or modification of specific genes.
Genetically modified organism (GMO) #
A GMO is an organism whose genetic material has been altered using genetic engineering techniques, resulting in the introduction of new traits or modification of existing ones.
Genomic libraries #
Genomic libraries are collections of DNA fragments cloned into vectors, providing a comprehensive representation of an organism's genome. They are used in genetic research to study gene function, regulation, and evolution.
Glycosylation #
Glycosylation is the process of adding sugar molecules (glycans) to a protein, influencing its stability, activity, and antigenicity. It plays a crucial role in protein function and is a common post-translational modification.
Herbicide #
tolerant crops: Herbicide-tolerant crops are genetically modified to resist specific herbicides, allowing for effective weed control without damaging the crops.
Human Genome Project (HGP) #
The HGP was an international research effort aimed at determining the complete sequence of the human genome, which was completed in 2003.
HtrA protease #
HtrA (high temperature requirement A) proteases are heat-shock-induced enzymes involved in protein quality control, degrading misfolded or damaged proteins in various organisms, including bacteria and mammals.
Hybridization #
Hybridization is the process of combining DNA or RNA molecules from different sources, typically through the formation of base-pairing interactions between complementary nucleotide sequences.
Intellectual property (IP) #
IP refers to creations of the mind, such as inventions, literary and artistic works, symbols, names, images, and designs, which are protected by law through patents, trademarks, copyrights, and trade secrets.
Intellectual property rights (IPRs) #
IPRs are legal rights that protect creations of the mind, allowing inventors, authors, and creators to control and benefit from their inventions, works, and designs.
International Union for the Protection of New Varieties of Plants (UPOV) #
UPOV is an intergovernmental organization responsible for promoting and protecting new plant varieties through the development of plant breeders' rights (PBRs).
In vitro #
In vitro refers to experiments or processes conducted in a controlled laboratory environment, typically using cell cultures or test tubes, as opposed to in vivo (within a living organism).
In vivo #
In vivo refers to experiments or processes conducted within a living organism, as opposed to in vitro (in a controlled laboratory environment).
Ligase enzymes #
Ligases are enzymes that catalyze the formation of covalent bonds between two molecules, typically joining DNA or RNA strands together during replication, repair, or recombination.
Marker #
assisted selection (MAS): MAS is a plant breeding technique that uses molecular markers, such as DNA sequences or genetic fingerprints, to identify and select plants with desired traits, facilitating genetic improvement and reducing breeding time.
Messenger RNA (mRNA) #
mRNA is a single-stranded RNA molecule that carries genetic information encoded in DNA from the nucleus to the cytoplasm, where it is translated into proteins by ribosomes.
Monoclonal antibodies #
Monoclonal antibodies are identical antibodies produced by a single clone of cells, which recognize and bind to a specific antigen, making them valuable tools in diagnostics, research, and therapy.
Morphological markers #
Morphological markers are observable physical traits, such as leaf shape or flower color, used in plant breeding to identify and select plants with desired traits.
Nucleic acid hybridization probes #
Nucleic acid hybridization probes are DNA or RNA molecules used to detect and quantify specific nucleic acid
Bacillus thuringiensis (Bt) is a soil #
dwelling bacterium that produces crystalline proteins (Cry proteins) toxic to certain insects. Bt has been genetically engineered into crops to provide protection against pests, leading to Bt crops.
Biosafety refers to the safe handling, transport, and use of genetically… #
Biosafety refers to the safe handling, transport, and use of genetically modified organisms (GMOs) and their products to prevent adverse effects on human health and the environment.
Biotechnological invention involves the use of biological material (e #
g., genes, cells, organisms) and processes to make, modify, or use products. Biotechnological inventions may be patentable, subject to specific criteria and regulations.
Cartagena Protocol on Biosafety (CPB) is an international agreement that… #
Cartagena Protocol on Biosafety (CPB) is an international agreement that provides guidelines for the safe transfer, handling, and use of GMOs and their products, especially across national borders.
Challenges in biotechnology regulations include ensuring biosafety, asses… #
Challenges in biotechnology regulations include ensuring biosafety, assessing potential risks to human health and the environment, and addressing ethical concerns related to GMOs and their use.
Code of Conduct on Biotechnology is a set of guidelines adopted by the Wo… #
Code of Conduct on Biotechnology is a set of guidelines adopted by the World Health Organization (WHO) to promote responsible use of biotechnology and genetic engineering.
Confidential Business Information (CBI) refers to non #
public information shared with regulatory authorities during the application process for the approval of biotechnological products.
CRISPR #
Cas9 is a powerful gene-editing technology that allows for precise modifications of DNA sequences, enabling the development of novel biotechnological products and applications.
Data exclusivity refers to a period during which regulatory authorities c… #
Data exclusivity refers to a period during which regulatory authorities cannot use or disclose data submitted by a company for the approval of a biotechnological product, providing the company with temporary market exclusivity.
Directed evolution is a laboratory technique that mimics natural evolutio… #
Directed evolution is a laboratory technique that mimics natural evolution to generate novel biological products or improve existing ones, often through iterative mutagenesis and selection processes.
European Patent Office (EPO) is an agency responsible for granting Europe… #
European Patent Office (EPO) is an agency responsible for granting European patents on inventions, including those in the field of biotechnology, provided they meet the patentability criteria.
Ex parte refers to a proceeding in which only one party (applicant or opp… #
Ex parte refers to a proceeding in which only one party (applicant or opponent) is present, as in some patent office appeals and inter partes reviews.
Food and Agriculture Organization (FAO) is a specialized agency of the Un… #
Food and Agriculture Organization (FAO) is a specialized agency of the United Nations (UN) that leads international efforts to defeat hunger and improve nutrition and food security.
Freedom to Operate (FTO) refers to the ability to commercially exploit an… #
Freedom to Operate (FTO) refers to the ability to commercially exploit an invention without infringing on existing intellectual property rights.
Gene patent refers to the exclusive rights granted to an inventor for a g… #
Gene patent refers to the exclusive rights granted to an inventor for a genetically engineered or discovered gene, enabling them to control its use, manufacture, and sale.
Genetic engineering is a set of techniques used to modify the genetic mat… #
Genetic engineering is a set of techniques used to modify the genetic material of an organism, enabling the creation of novel biological products and applications.
Genetic Use Restriction Technologies (GURTs) , also known as terminator te… #
Genetic Use Restriction Technologies (GURTs), also known as terminator technologies, are genetic engineering methods that restrict the use or reproduction of genetically modified plants.
Genetically Modified Microorganisms (GMMs) are microorganisms whose genet… #
Genetically Modified Microorganisms (GMMs) are microorganisms whose genetic material has been altered through genetic engineering techniques to exhibit desired traits or characteristics.
Genetically Modified Organisms (GMOs) are organisms, including plants and… #
Genetically Modified Organisms (GMOs) are organisms, including plants and animals, whose genetic material has been altered through genetic engineering techniques to exhibit desired traits or characteristics.
Genomic databases are collections of genomic data, including DNA sequence… #
Genomic databases are collections of genomic data, including DNA sequences, gene expression profiles, and genetic variations, that can be used for research and development purposes in biotechnology.
Green Biotechnology refers to biotechnological applications focused on im… #
Green Biotechnology refers to biotechnological applications focused on improving agricultural practices, crop yields, and environmental sustainability.
GRUR (Gesellschaft für #
GRUR (Gesellschaft für
urheberrechtlich geschützte Veröffentlichungen der deutschen Rechtsanwälte) is a… #
urheberrechtlich geschützte Veröffentlichungen der deutschen Rechtsanwälte) is a German-language journal on intellectual property law, including patent law and biotechnology regulations.
Horizontal gene transfer is the transfer of genetic material from one org… #
Horizontal gene transfer is the transfer of genetic material from one organism to another, not in a parent-offspring relationship, often through mobile genetic elements like plasmids or viruses.
Human Practices and Ethics (HPE) refers to the ethical implications and s… #
Human Practices and Ethics (HPE) refers to the ethical implications and societal impacts of biotechnological innovations, including gene editing, synthetic biology, and biotechnology regulations.
Industrial Biotechnology refers to the application of biotechnological pr… #
Industrial Biotechnology refers to the application of biotechnological processes and organisms to produce industrial goods, such as biofuels, chemicals, and enzymes.
Intellectual property (IP) refers to creations of the mind, such as inven… #
Intellectual property (IP) refers to creations of the mind, such as inventions, literary and artistic works, symbols, names, images, and designs, that are protected by law through patents, trademarks, copyrights, and trade secrets.
Inter partes review (IPR) is a procedure at the United States Patent and… #
Inter partes review (IPR) is a procedure at the United States Patent and Trademark Office (USPTO) that allows a third party to challenge the validity of an issued patent.
Moral rights are the rights of an author or creator to claim authorship a… #
Moral rights are the rights of an author or creator to claim authorship and prevent the distortion, mutilation, or modification of their work in a manner that would harm their reputation or honor.
Nanobiotechnology is the application of nanotechnology to biotechnology,… #
Nanobiotechnology is the application of nanotechnology to biotechnology, enabling the manipulation and engineering of biological systems at the nanoscale.
Nucleic acid patents refer to patents on nucleic acid sequences, includin… #
Nucleic acid patents refer to patents on nucleic acid sequences, including DNA and RNA, that may be genetically engineered or discovered in nature, and their applications.
Orphan drugs are pharmaceutical products developed for rare diseases, whi… #
Orphan drugs are pharmaceutical products developed for rare diseases, which may receive special regulatory incentives, such as market exclusivity and tax credits, to encourage their development and commercialization.
Patent exhaustion refers to the legal doctrine that a patent holder's rig… #
Patent exhaustion refers to the legal doctrine that a patent holder's rights are "exhausted" after the first sale of a patented product, limiting their ability to control downstream uses or sales.
Patent linkage is a system that connects the marketing approval process f… #
Patent linkage is a system that connects the marketing approval process for pharmaceutical products with the patent status of the active ingredients, preventing the approval of generic versions until patent expiration.
Patent term extensions are additional periods of patent protection grante… #
Patent term extensions are additional periods of patent protection granted to compensate for time lost during regulatory approval processes for pharmaceutical products and medical devices.
Plant Breeders' Rights (PBRs) are intellectual property rights that prote… #
Plant Breeders' Rights (PBRs) are intellectual property rights that protect new plant varieties, providing breeders with exclusive rights to produce and sell the protected variety for a limited period.
Plant variety protection refers to the legal protection of new plant vari… #
Plant variety protection refers to the legal protection of new plant varieties, enabling breeders to control their use, production, and sale for a limited period.
Red Biotechnology refers to biotechnological applications focused on huma… #
Red Biotechnology refers to biotechnological applications focused on human health, such as the development of pharmaceuticals, diagnostics, and gene therapies.
Regulation (EC) No 1924/2006 is a European Union regulation establishing… #
Regulation (EC) No 1924/2006 is a European Union regulation establishing a common framework for the use of health claims on foods, ensuring that such claims are scientifically substantiated and do not mislead consumers.
Regulation (EC) No 258/97 is a European Union regulation on novel foods a… #
Regulation (EC) No 258/97 is a European Union regulation on novel foods and novel food ingredients, establishing a regulatory framework for their approval and market placement.
Regulation (EC) No 1829/2003 is a European Union regulation on geneticall… #
Regulation (EC) No 1829/2003 is a European Union regulation on genetically modified food and feed, establishing a regulatory framework for their approval and market placement.
Regulation (EC) No 1831/2003 is a European Union regulation on geneticall… #
Regulation (EC) No 1831/2003 is a European Union regulation on genetically modified food and feed, establishing a regulatory framework for their approval and market placement.
Regulatory cooperation refers to the collaboration between regulatory aut… #
Regulatory cooperation refers to the collaboration between regulatory authorities and industry stakeholders to ensure the safe and effective development, approval, and commercialization of biotechnological products.
Regulatory Data Protection (RDP) refers to a period of market exclusivity… #
Regulatory Data Protection (RDP) refers to a period of market exclusivity granted to
Bacillus thuringiensis (Bt) is a bacterium used in genetically modifie… #
Bt crops, such as corn and cotton, have been widely adopted to control pests like the European corn borer and cotton bollworm.
Biosafety refers to the safe handling, transport, and use of genetical… #
It involves the implementation of regulations, guidelines, and best practices for risk assessment, containment, and monitoring.
Biotechnological product is a product developed through the application o… #
Biotechnological product is a product developed through the application of biotechnology, which can include: (1) genetically modified organisms (GMOs) and derivatives thereof; (2) non-viable organisms, parts thereof, and products of biotechnology; and (3) biological agents used in biotechnological processes.
Cartagena Protocol on Biosafety is an international agreement under the <… #
It entered into force in 2003 and has been ratified by over 170 countries.
Convention on Biological Diversity (CBD) is an international treaty adopt… #
Its objectives are the conservation of biological diversity, the sustainable use of its components, and the fair and equitable sharing of benefits arising from genetic resources.
Contained use refers to any operation involving genetically modified o… #
Contained use is subject to risk assessment and authorization under national legislation.
Deliberate release is the intentional release of genetically modified… #
Deliberate release is subject to risk assessment, authorization, and monitoring under national and international regulations.
Genetic engineering is a set of techniques used to manipulate an organism… #
This process involves the direct manipulation of genes using molecular biology tools, such as restriction enzymes, DNA ligases, and plasmids, to create genetically modified organisms (GMOs) or transgenic organisms.
Genetically modified organism (GMO) is an organism whose genetic material… #
GMOs can be plants, animals, or microorganisms and are often used in agriculture, industry, and medicine.
Genetic use restriction technologies (GURTs) are techniques aimed at limi… #
There are two types of GURTs: (1) V-GURTs (variety-level GURTs), which restrict the use of a specific plant variety to a single generation; and (2) T-GURTs (trait-level GURTs), which restrict the use of a specific trait to a single generation or make it dependent on the use of a specific input.
Living modified organism (LMO) is an organism, except for human beings, w… #
This term is used interchangeably with genetically modified organism (GMO) in the context of the Cartagena Protocol on Biosafety.
Nucleic acid techniques are laboratory methods used to manipulate, analyz… #
These techniques include: (1) polymerase chain reaction (PCR); (2) gel electrophoresis; (3) sequencing; (4) hybridization; and (5) cloning.
Patent is an exclusive right granted by a national or regional intellectu… #
A patent can be granted for a product or process that is new, involves an inventive step, and is capable of industrial application.
Plant variety protection (PVP) is a form of intellectual property right t… #
PVP aims to encourage plant breeding and the development of new plant varieties by providing breeders with a financial incentive and recognition for their work.
Transboundary movement refers to the movement of living modified organ… #
Transboundary movements are subject to the rules and procedures of the Cartagena Protocol on Biosafety, which aims to ensure safe handling, transport, and use of LMOs to protect human health and the environment.
Transgenic organism is an organism that contains genetic material from an… #
Transgenic organisms are a type of genetically modified organism (GMO) and are used in agriculture, industry, and medicine.
Traditional knowledge refers to knowledge, innovations, and practices of… #
Traditional knowledge is often undocumented and is increasingly recognized as an important source of innovation and biodiversity conservation.
United Nations Convention on the Law of the Sea (UNCLOS) is an internatio… #
Adopted in 1982, UNCLOS establishes principles for the use of ocean resources, marine scientific research, conservation and management of marine environments, and the settlement of disputes.
The above glossary terms provide a comprehensive overview of key concepts in bio… #
Understanding these terms is crucial for specialists working in the field of intellectual property law and biotechnology. By familiarizing themselves with these concepts, specialists can navigate the complex legal landscape of biotechnology regulations and contribute to the development of innovative and sustainable biotechnological solutions while protecting human health, the environment, and intellectual property rights.
Bacillus thuringiensis (Bt) Cry toxins #
A group of insecticidal proteins produced by the bacterium Bacillus thuringiensis that are toxic to certain insects, but not to humans or other mammals. These toxins have been genetically engineered into crops to provide protection against targeted pests.
Biodiversity #
The variety of life in a particular habitat or on Earth as a whole, including the variety of ecosystems, species, and genetic diversity within species. Biotechnology regulations must consider the potential impacts of genetically modified organisms (GMOs) on biodiversity.
Biosafety #
The practices and measures designed to prevent unintended exposure to, or the release of, genetically modified organisms (GMOs) and their products, as well as to protect human health and the environment.
Biotechnological invention #
A new and inventive product or process based on or involving the use of biological material, including genetically modified organisms (GMOs). The protection of biotechnological inventions through patents and other forms of intellectual property rights (IPRs) plays a critical role in fostering innovation in this field.
Cartagena Protocol on Biosafety (CPB) #
An international treaty, adopted in 2000 under the Convention on Biological Diversity (CBD), that aims to ensure the safe handling, transport, and use of genetically modified organisms (GMOs) resulting from modern biotechnology that may have adverse effects on biodiversity.
Challenges in biotechnology regulations #
The complex and multifaceted issues that arise in the regulation of biotechnology, including the need to balance innovation, public safety, and environmental protection; the potential risks and uncertainties associated with genetically modified organisms (GMOs); and the difficulties in assessing long-term impacts.
Clearance #
The process by which regulatory authorities approve the commercial release of a biotechnological product, such as a genetically modified organism (GMO), after evaluating its safety and efficacy.
Code of Conduct on Biotechnology #
A non-binding instrument, adopted by the Organisation for Economic Co-operation and Development (OECD) in 1992, that provides principles and guidelines for responsible life sciences research, including biotechnology, to ensure the safe and ethical development and use of these technologies.
Convention on Biological Diversity (CBD) #
An international treaty, adopted in 1992, that aims to conserve biological diversity, promote the sustainable use of its components, and ensure fair and equitable sharing of benefits arising from the utilization of genetic resources.
Directive 2001/18/EC #
A European Union (EU) directive on the deliberate release of genetically modified organisms (GMOs) into the environment, which lays down the rules and procedures for the authorization, monitoring, and labeling of GMOs.
Food and Agriculture Organization (FAO) #
A specialized agency of the United Nations that leads international efforts to defeat hunger and improve nutrition and food security. The FAO plays a significant role in the regulation and governance of agricultural biotechnology.
Food and Drug Administration (FDA) #
A regulatory agency of the U.S. Department of Health and Human Services responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, food, and cosmetics.
Gene editing #
The targeted modification of an organism's DNA sequence using molecular tools, such as CRISPR-Cas9, to introduce specific changes in the genetic code. Gene editing holds great promise for improving crop yields, treating genetic diseases, and reducing the environmental impact of agriculture.
Genetically modified organism (GMO) #
An organism whose genetic material has been altered using modern biotechnology techniques, such as genetic engineering or gene editing, to introduce specific traits or characteristics that do not occur naturally.
Genetic use restriction technologies (GURTs) #
Technologies that restrict the use of a genetically modified organism (GMO) or its genetic material, often by introducing a genetic trait that renders the organism sterile or unable to reproduce without the addition of a specific chemical or compound.
Genome editing #
A subset of gene editing techniques that involve the targeted modification of an organism's entire genome, using molecular tools like CRISPR-Cas9, to introduce specific changes in the genetic code across multiple genes simultaneously.
Horizon Scanning #
A systematic process of identifying, assessing, and prioritizing potential developments in biotechnology and other emerging technologies to inform regulatory decision-making, risk management, and policy development.
Intellectual property rights (IPRs) #
Legal rights that protect the creations of the mind, such as inventions, literary and artistic works, symbols, names, and images. IPRs, including patents and plant breeders' rights, play a critical role in the development and commercialization of biotechnological innovations.
Labeling of genetically modified organisms (GMOs) #
The requirement to provide information on the presence and characteristics of genetically modified organisms (GMOs) in food, feed, or other products, through labels, markings, or other means, to enable consumers to make informed decisions.
Nagoya Protocol on Access and Benefit #
sharing (ABS): An international treaty, adopted in 2010 under the Convention on Biological Diversity (CBD), that aims to ensure the fair and equitable sharing of benefits arising from the utilization of genetic resources, including those obtained through biotechnology.
Patent #
A legal right that grants an inventor exclusive rights to make, use, and sell an invention for a limited period, typically 20 years from the filing date. Patents play a crucial role in protecting biotechnological inventions.
Plant Breeders' Rights #
Intellectual property rights specifically designed for plant varieties, which grant breeders exclusive rights to produce, reproduce, condition, sell, export, and import the protected variety for a limited period, typically 20-30 years.
Regulation of genetically modified organisms (GMOs) #
The legal framework, policies, and practices governing the research, development, testing, release, and use of genetically modified organisms (GMOs) to ensure the safety, efficacy, and environmental sustainability of these technologies.
Risk analysis #
A systematic process of identifying, assessing, and managing potential risks associated with genetically modified organisms (GMOs) or other emerging technologies, to inform regulatory decision-making, risk management, and policy development.
Safety assessment #
The evaluation of the potential risks and benefits of a biotechnological product, such as a genetically modified organism (GMO), to inform regulatory decision-making, risk management, and policy development.
Substantial equivalence #
A principle used in the risk assessment of genetically modified organisms (GMOs), which states that a GMO is considered to be as safe as its conventional counterpart if it is found to be substantially equivalent in terms of its composition, nutritional value, and potential toxicity.
Terminator technology #
A genetic use restriction technology (GURT) that renders genetically modified organisms (GMOs) sterile or unable to reproduce without the addition of a specific chemical or compound. The use of terminator technology is controversial due to concerns about its potential impacts on biodiversity, food security, and farmers' rights.
Transgenic organism #
An organism that contains genetic material from a different species, introduced through modern biotechnology techniques, such as genetic engineering or gene editing. Transgenic organisms are a subset of genetically modified organisms (GMOs).
Triffid flax #
A variety of flax (Linum usitatissimum) that was genetically modified to be resistant to the herbicide glyphosate. The variety was withdrawn from the market in 2001 due to concerns about cross-contamination with non-genetically modified flax, leading to trade disruptions and market losses for
Adventitious Presence (AP) #
The unintended presence of genetically modified material in a product, crop, or environment. This can occur through cross-contamination during production, transportation, or storage. AP is a significant concern in biotechnology regulations, particularly in the food and agriculture sectors, as it may affect labeling, trade, and environmental safety.
Bacillus thuringiensis (Bt) #
A gram-positive bacterium widely used in biopesticides and genetically modified crops. Bt produces crystalline proteins (Cry proteins) that are toxic to specific insect pests, making it an environmentally friendly alternative to chemical pesticides. Bt crops, such as Bt cotton and Bt corn, have been genetically modified to express the Cry proteins for pest resistance.
Biosafety #
The practice of ensuring the safe handling, transport, and use of biological materials and genetically modified organisms (GMOs) to protect human health, the environment, and biodiversity. Biosafety regulations typically involve risk assessment, containment measures, and monitoring procedures to minimize potential adverse effects associated with GMOs and biotechnological processes.
Cartagena Protocol on Biosafety (CPB) #
An international treaty under the United Nations Convention on Biological Diversity (CBD) that addresses biosafety concerns related to GMOs. The CPB aims to protect biological diversity from potential risks associated with GMOs by establishing a regulatory framework for their transboundary movement, handling, and use. It entered into force in 2003 and has been ratified by over 170 countries.
Coexistence #
The ability of conventional, organic, and genetically modified (GM) crops to grow in close proximity without adversely affecting each other. Coexistence requires the implementation of appropriate isolation distances, pollen control measures, and monitoring systems to prevent cross-contamination and maintain the integrity of each production system.
Confined Field Trial (CFT) #
A type of field experiment conducted to evaluate the performance, safety, and environmental impact of genetically modified organisms (GMOs) under controlled conditions. CFTs are typically subject to strict regulations and monitoring to prevent the unintended release of GMOs into the environment.
Deoxyribonucleic Acid (DNA) #
The genetic material present in the cells of all living organisms, responsible for inheritance and the expression of genetic traits. DNA is a double-stranded molecule composed of four nucleotide bases (adenine, thymine, guanine, and cytosine) arranged in a specific sequence that encodes genetic information.
Directive 2001/18/EC #
A European Union (EU) directive regulating the deliberate release of genetically modified organisms (GMOs) into the environment. The directive establishes a risk assessment and authorization procedure for GMOs, including food and feed, and mandates labeling and traceability requirements for GMOs and products containing GMOs.
Food and Agriculture Organization (FAO) #
A specialized agency of the United Nations responsible for improving nutrition, enhancing agricultural productivity, and ensuring food security worldwide. The FAO collaborates with member countries and international organizations to develop policies, guidelines, and best practices for the safe and sustainable use of biotechnology in agriculture and food production.
Genetic Use Restriction Technologies (GURTs) #
Also known as "terminator technologies," GURTs are genetic engineering techniques that limit the reproduction or use of genetically modified organisms (GMOs) or their products. GURTs can be classified into two categories: "V-GURTs" (variety-level GURTs), which restrict the reproduction of a specific plant variety, and "T-GURTs" (trait-level GURTs), which limit the expression of a specific trait to a particular generation.
Genetically Modified Microorganism (GMM) #
A microorganism, such as bacteria, yeast, or fungi, whose genetic material has been altered using biotechnological techniques to enhance its characteristics or performance. GMMs are used in various applications, including bioremediation, industrial fermentation, and the production of pharmaceuticals, enzymes, and biofuels.
Genetically Modified Organism (GMO) #
An organism, such as a plant, animal, or microorganism, whose genetic material has been modified using biotechnological techniques to introduce new traits or modify existing ones. GMOs are used in various sectors, including agriculture, medicine, and industry, and are subject to strict regulatory oversight to ensure their safety and effectiveness.
Genetic Modification (GM) #
The process of altering the genetic material of an organism using biotechnological techniques, such as recombinant DNA technology or gene editing, to introduce new traits or modify existing ones. GM is used in various applications, including agriculture, medicine, and industry, and is subject to regulatory oversight to ensure its safe and ethical use.
Genetic Use Restriction Technologies (GURTs) #
Also known as "terminator technologies," GURTs are genetic engineering techniques that limit the reproduction or use of genetically modified organisms (GMOs) or their products. GURTs can be classified into two categories: "V-GURTs" (variety-level GURTs), which restrict the reproduction of a specific plant variety, and "T-GURTs" (trait-level GURTs), which limit the expression of a specific trait to a particular generation.
Horizontal Gene Transfer (HGT) #
The transfer of genetic material between organisms through mechanisms other than vertical inheritance (from parent to offspring). HGT can occur through various mechanisms, such as conjugation, transformation, and transduction, and plays a significant role in the evolution and adaptation of organisms. HGT can also pose biosafety concerns, as it may facilitate the spread of antibiotic resistance or harmful traits between organisms.
Intellectual Property (IP) #
The legal rights that protect creations of the mind, such as inventions, literary and artistic works, symbols, names, images, and designs, from unauthorized use or reproduction. IP rights, such as patents, trademarks, copyrights, and trade secrets, provide incentives for innovation and creativity by granting inventors and creators exclusive rights to exploit their inventions or works for a limited period.
Labeling #
The practice of providing information about a product's composition, origin, or characteristics on its packaging or promotional materials. Labeling requirements for genetically modified organisms (GMOs) and products containing GMOs vary by country and jurisdiction, with some requiring mandatory labeling and others allowing voluntary labeling.
Nucleic Acid #
A macromolecule composed of nucleotides, which are the building blocks of genetic material in living organisms. Nucleic acids, such as DNA and RNA, are responsible for storing, transmitting, and expressing genetic information in cells.
Patent #
An exclusive right granted to an inventor or assignee for a limited period to prevent others from making, using, selling, or importing an invention without permission. Patents are a form of intellectual property (IP) right that incentivize innovation and technological development by providing inventors with a temporary monopoly on their inventions.
Plant Variety Protection (PVP) #
A form of intellectual property (IP) right that protects new plant varieties from unauthorized propagation, sale, or importation. PVP is a sui generis system that is separate from patents and aims to promote plant breeding and innovation by granting breeders exclusive rights to their new plant varieties for a limited period.
Recombinant DNA (rDNA) Technology #
A biotechnological technique that involves the manipulation and combination of DNA molecules from different sources to create new genetic constructs. Also known as "genetic engineering," rDNA technology is used in various applications, such as the production of pharmaceuticals, vaccines, enzymes, and genetically modified organisms (GMOs).
Risk Assessment #
The process of evaluating the potential adverse effects of a substance, activity, or technology on human health, the environment, or biodiversity. Risk assessment involves identifying hazards, estimating exposure levels, and evaluating the likelihood and severity of adverse effects. Risk assessment is a key component of biote