Essentially derived varieties in the era of new breeding techniques

The current study sets out to analyse the concept of "essentially derived variety" (EDV) envisaged by the plant variety protection regime when new breeding techniques (NBTs) are employed in the development of new plant varieties. The use of NBTs to develop new plant varieties has grown rapidly over the last years because of their ease of use and their high efficiency. NBT varieties are mono-parental and retain most of the genome of the initial variety, thus most of its essential characteristics. The problem arises when the initial variety used as the source of genetic variation is a variety protected by a plant variety right. In this case, the question is whether the EDV concept should apply to the second variety obtained by NBTs and what can break the EDV chain. It must be noted that the EDV concept has revolutionised the plant variety protection system since it introduced the principle of "limited dependence" as an exception to the general independence principle governing this system. Therefore, as it is an exception, it should be interpreted rigorously.

Biofortification of Cereals and Pulses Using New Breeding Techniques: Current and Future Perspectives

Cereals and pulses are consumed as a staple food in low-income countries for the fulfillment of daily dietary requirements and as a source of micronutrients. However, they are failing to offer balanced nutrition due to deficiencies of some essential compounds, macronutrients, and micronutrients, i.e., cereals are deficient in iron, zinc, some essential amino acids, and quality proteins. Meanwhile, the pulses are rich in anti-nutrient compounds that restrict the bioavailability of micronutrients. As a result, the population is suffering from malnutrition and resultantly different diseases, i.e., anemia, beriberi, pellagra, night blindness, rickets, and scurvy are common in the society. These facts highlight the need for the biofortification of cereals and pulses for the provision of balanced diets to masses and reduction of malnutrition. Biofortification of crops may be achieved through conventional approaches or new breeding techniques (NBTs). Conventional approaches for biofortification cover mineral fertilization through foliar or soil application, microbe-mediated enhanced uptake of nutrients, and conventional crossing of plants to obtain the desired combination of genes for balanced nutrient uptake and bioavailability. Whereas, NBTs rely on gene silencing, gene editing, overexpression, and gene transfer from other species for the acquisition of balanced nutritional profiles in mutant plants. Thus, we have highlighted the significance of conventional and NBTs for the biofortification of cereals and pulses. Current and future perspectives and opportunities are also discussed. Further, the regulatory aspects of newly developed biofortified transgenic and/or non-transgenic crop varieties via NBTs are also presented.

Towards a Fair Scope of Protection for Plant Breeders’ Rights in an Era of New Breeding Techniques: Proposals for a Modernization of the Essentially Derived Variety Concept

Plant breeders’ rights (PBRs) are an important IP right, and as plant breeding has a crucial role to play in sustainability, it is vital that innovations in plant breeding receive the appropriate innovation incentives. The full breeders’ exemption ensures that there is always free access to the plant variety protected by a PBR for developing new varieties. The price to pay for this exemption is that PBR holders cannot prevent third parties from taking advantage of their efforts and investments in developing a new variety. This invites free-riding, at the detriment of the PBR holder. The concept of “essentially derived varieties” (EDV), introduced in 1991, provided a “fix” for this problem. It allows PBR holders to extend, at least to some extent, the scope of protection of their PBR to those varieties which use all or most essential characteristics of the initial protection variety. Decades have passed, but no adequate interpretation of the complex EDV concept has been found. The advent of new breeding techniques (NBTs) has made the discussion about a fair scope of protection of PBRs all the more relevant. This necessitates a modernization of the EDV concept, if the PBR system is to remain relevant and continue to be an innovation-incentivizing mechanism. I argue that a broader scope for the EDV concept is essential and fair. Determining what essential derivation is will remain a difficult task also in the future. This is why I have additionally proposed a collaborative reward model, which will facilitate the functioning of the EDV system and is capable of providing more legal certainty in this area.

The Current Status of GM and GE Crops

In recent months there have been regular announcements of new crops developed via new breeding techniques (NBTs) such as gene editing (GE) and the debate continues whether they should be considered as GM or not in the UK and Europe. It is not surprising that countries who approve cultivation of GM crops are also approving new crops derived from GE technologies, so will gain an advantage from cultivation of these new crop varieties over the UK and Europe. The USA, Brazil and Argentina have a flexible approach for the regulation of crops derived from new breeding techniques such as GE. Canada has recently (March 2021) reassessed their risk assessment policies for genetically engineered (GE) plants and food products and have started approvals.

Micronutrient Biofortification in Rice through New Breeding Techniques (NBTs): Bangladesh Perspective

Background: Micronutrient deficiencies are serious health issues in developing countries of Asia and Africa, where millions of people are suffering from inadequate micronutrient intake. In Bangladesh, micronutrient deficiencies are found severe due to low income, food habits, and rice-based staple food consumption, (rice has an insufficiency of different types of vitamins and minerals). To lessen micronutrient malnutrition, supplementation has been employed but has not yet reached the goal. Agronomic and genetic biofortification has the potential to address micronutrient deficiencies. Biofortification in Rice grain is a convenient and affordable way to supply the desired micronutrients. The development of micronutrient-rich popular rice cultivars through conventional breeding is currently being harnessed for the limitation of natural resources of the related donor rice cultivars containing the required amount of micronutrients. To overcome these hurdles of conventional breeding, genetic engineering and genome editing have emerged as promising tools of micronutrient biofortification in rice. Methods: Identify the needs and explore the potential strategies by the search for relevant literature known to the authors was carried out to complete this review. Results: Highlighted here the sources, functions, and requirements of iron, zinc, vitamin A, vitamin B1, vitamin B9, and betanin in rice and their biofortification through conventional breeding, genetic engineering, and genome editing including their promises and hindrances. Conclusion: New breeding techniques are timely alternatives for developing nutrient-rich rice cultivars to eliminate hidden hunger and poverty in Bangladesh.

Update of Regulatory Options of New Breeding Techniques and Biosafety Approaches among Selected Countries: A Review

A new set of breeding techniques, referred to as New Breeding Techniques developed in the last two decades have potential for enhancing improved productivity in crop and animal breeding globally. These include site directed nucleases based genomic editing procedures-CRISPR and Cas associated proteins, Zinc Finger Nucleases, Meganucleases/Homing Endonucleases and Transcription- Activator Like-Effector Nucleases for genome editing and other technologies including- Oligonucleotide-Directed Mutagenesis, Cisgenesis and intragenesis, RNA-Dependent DNA methylation; Transgrafting, Agroinfiltration, Reverse breeding. There are ongoing global debates on whether the processes of and products emerging from these technologies should be regulated as genetically modified organisms or approved as conventional products. Decisions on whether to regulate as GMOs are based both on understanding of the molecular basis of their development and if the GMO intermediate step was used. For example- cisgenesis, can be developed using Agrobacterium tumefaciens methods of transformation, a process used by GMO but if the selection is properly conducted the intermediate GMO elements will be eliminated and the final product will be identical to the conventionally developed crops. Others like Site Directed Nuclease 3 are regulated as GMOs in countries such as United State of America, Canada, European Union, Argentina, Australia. Progress in genome editing research, testing of genome edited bacterial blight resistant rice, development of Guidelines for regulating new breeding techniques or genome editing in Africa is also covered with special reference to South Africa, Kenya and Nigeria. Science- and evidence-based approach to regulation of new breeding techniques among regulators and policy makers should be strongly supported.