eChapters

Biotechnology is a field of science that applies technology to living organisms, cells, and their molecular components, to develop products and services that improve human life. Biotechnology covers a wide range of applications, from agriculture and food production to medicine and healthcare, environmental management, and industrial biotechnology. Intellectual property rights (IPRs) are legal rights that protect the creations of the human mind, such as inventions, literary and artistic works, symbols, and designs. In the context of biotechnology, IPRs are critical to incentivize research and development, protect the fruits of scientific discoveries, and ensure that the inventors and investors of biotechnological inventions can benefit financially from their investment.

The importance of protecting biotechnological inventions lies in the fact that these inventions can be expensive and time-consuming to develop, and may require significant financial resources bring to market. Without appropriate legal protection, biotechnological inventions may be vulnerable to unauthorized use, duplication, and exploitation by third parties, leading to reduced incentives for research and development and potential loss of economic benefits for inventors and investors.

The plant variety is related to intellectual property that needs to be protected for controlled commercial unitization for a specified period. New plant varieties development requires scientific skill, knowledge, significant investment of land and specialized equipments. These varieties are cultivated by farmers in their adaptive region. In development of new variety 10 to 15 years are required. If developed variety successfully commercialized on farmer’s field, then the market business is much higher than input investment. The major issue in developed variety that can be easily reproduced by someone without permission of original breeder. Thus, the original breeder deprived for their f inancial benefit. It is, therefore, critical to provide an effective system of plant variety protection, which encourages the development of new varieties of plants thereby benefiting the breeder and society at large. The sustainable and long-term breeding effort for development of new varieties needs encouragement and financial reward for investing time and skills. To secure legal protection of the developed variety breeder needs to obtained exclusive right from government.After establishment of WTO in 1995 under TRIP the right to protect plant varieties become mandatory for signatory country. It has also realised that existence of the private seed industry, the protection of plant varieties become necessity.

Introduction

Traditional Knowledge (TK) and Traditional Cultural Expressions (TCEs) are crucial intangible heritage passed down through generations in indigenous communities. TK encompasses indigenous knowledge, practices, and innovations related to cultural traditions, natural resources, and ecosystems, while TCEs are heritage artistic and literary expressions that embody traditional culture and knowledge. TK and TCEs are deeply embedded in the cultural heritage of indigenous communities, and play a vital role in preserving their identities, values, and beliefs. However, they are vulnerable to exploitation and misappropriation, which can lead to cultural loss and undermine the rights of indigenous peoples. Thus, it is crucial to involve indigenous communities in decision-making and protect their rights to safeguard and preserve the integrity of TK and TCEs.

Geographical Indications (GI) are indications or symbols that are affixed to products that possess a specific geographical origin and are known for their unique qualities or reputation. These products can be agricultural, natural, or manufactured goods that are essentially attributed to a particular region, locality, or country where they are produced. According to Article 22.1 of the TRIPS Agreement, GIs identify a good as originating from a specific territory, region, or locality, where a given quality, reputation, or characteristic of the good is essentially attributable to its geographical origin.

GIs are a product of collective tradition and decision-making and continue to evolve. They represent a combination of human effort, culture, land resources, and climatic conditions. GIs are limited to a specific region and are not transferable from one owner or region to another. A product that has a GI tag is associated with a specific geographical area where it is developed, and the GI sign on the product indicates its origin. Products designated with a GI acquire a high reputation and are valuable commercial assets for the geographical region where they originated. However, GIs are also exposed to misappropriation and forgery, and therefore require both national and international protection.

Intellectual Property (IP) refers to intangible assets that are created through human creativity and innovation. These assets can be legally protected and provide exclusive rights to the creators and owners for a certain period of time.

Importance of IP for Innovators and Entrepreneurs

a) Protecting intellectual property (IP) is essential for fostering innovation and creativity, as it encourages inventors, creators, and entrepreneurs to invest their time, energy, and resources into developing new products, services, and technologies without fear of having their ideas stolen or copied.

For Example, if a software company develops a new program that can revolutionize how people interact with technology, it’s essential to protect the IP of the product by patenting and copyright. This protection ensures that no other company can steal the idea or copy the software, providing an incentive for the software company to invest in the product’s development.

Similarly, if a fashion designer creates a unique design for a dress, they can protect their IP by trademarking the design. This protection provides incentivizes the designer to invest their time and resources into developing new designs, knowing that their creations will be legally protected from copycats.

b) Having intellectual property (IP) protection grants a competitive advantage in the marketplace as it enables creators and owners to have exclusive rights to use, sell, and license their creations without the fear of infringement by others.

Copyright is a legal entitlement granted to creators of literary, dramatic, musical, and artistic works, as well as producers of cinematographic films and sound recordings. This legal right encompasses various privileges, including the reproduction, adaptation, translation, and communication to the public of the work. The composition of these rights may vary slightly, depending on the nature of the work. Along with Intellectual Property (IP), Copyright is a legal concept that safeguards the rights of creators and inventors. Copyright confers upon creators the exclusive legal right to reproduce, distribute, and exhibit their work, while IP comprises other legal rights such as patents, trademarks, and trade secrets. Copyright applies to a diverse range of creative works, including literary, dramatic, musical, and artistic works, as well as sound recordings and cinematographic films. Piracy is a worldwide issue that adversely affects various content industries, such as software, television, recording, and movies.

Copyright and IP laws play a crucial role in promoting creativity and innovation by safeguarding the rights of creators and inventors. These laws grant exclusive rights to creators and inventors, allowing them to financially benefit from their work. This encourages investment in research and development, leading to the creation of new ideas, products, and services. Without copyright and IP protection, creators and inventors may be discouraged from investing their time and resources into creating new works, resulting in a decline in innovation and economic growth. These laws also protect consumers by ensuring that they receive original, high-quality products and services instead of counterfeit or low-quality imitations.

To fully harness the potential of human creativity in industrial applications, it’s essential to safeguard and organize it effectively. One of the best ways to achieve this is by obtaining a patent. The term “patent” is derived from the Latin word “patere,” meaning “to lay open” or make available for public inspection. A patent is an exclusive right granted by the government to an inventor/creator for a limited time in exchange for disclosing their invention for public use. With this right, the patent holder can prevent others from making, using, selling, or exploiting the invention for a certain period, thereby providing commercial benefits to the inventor.

Patents are among the oldest forms of intellectual property rights and are territorial in nature, offering protection only within the country where they are granted. However, through conventions and the Patent Cooperation Treaty (PCT), applicants can seek protection in multiple countries. Obtaining a patent grants the inventor a monopoly right to control the product’s production, sale, and marketing. Although the rights granted through a patent are limited to a specific country, extending protection to all contracting countries is possible through a PCT application.

Intellectual property (IP) refers to creations of the human mind, such as inventions, literary and artistic works, symbols, names, images, and designs, which are protected by law. The protection of intellectual property is essential for promoting innovation, creativity, and economic growth. In order to ensure effective protection of intellectual property rights, various governing bodies, organizations, agreements, and treaties have been established at national and international levels. These bodies are responsible for setting and enforcing standards and regulations related to IP, as well as facilitating cooperation and coordination among different countries and stakeholders. Some of the major international organizations and agreements that deal with intellectual property include the World Intellectual Property Organization (WIPO), The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), and the Paris Convention for the Protection of Industrial Property. These organizations and agreements play a crucial role in creating a conducive environment for innovation, investment, and development, while at the same time ensuring fair and equitable access to intellectual property for all.

Intellectual property (IP) refers to the creations of the human mind that can be protected and have commercial value. These creations, or “intellect,” can take various forms, such as inventions, artistic works, and designs. Converting intellectual property into a useful product or process requires resources like time, effort, skill, and financial investment. Intellectual property rights (IPR) are legal rights granted to innovators and creators, giving them exclusive control over the use and monetization of their inventions and creations. IPRs are territorial and allow creators to sell, license, transfer, or otherwise dispose of their rights, similar to physical property.

IPRs are considered crucial for promoting economic growth and development, as they encourage innovation, investment, and entrepreneurship. Without IPRs, inventions and creative works could be easily copied or stolen, resulting in reduced incentives for innovation and decreased economic value. Lack of IPR can also lead to an increase in infringements and economic losses. In recent years, India has been increasing its awareness of IPR and has seen a rise in registrations of indigenous technology, patents, trade secrets, and copyrights among others.

Introduction

• Thus "genetic enhancement" or "pre-breeding" refers to the transfer or introgression of genes or gene combinations from unadapted sources into breeding materials (FAO, 1996).

• Genetic enhancement plays an important role in utilizing unadapted and unutilized germplasm collections and creating vast genetic variability for development of productive cultivars / hybrids.

• Objective of Genetic Enhancement is broadening the genetic base and increases genetic diversity

• Gene pool – Harlan and de Wet (1971).

• Primary gene pool (GP-1): Members of this gene pool are probably in the same "species" (in conventional biological usage) and can intermate freely.

• Secondary gene pool (GP-2): Members of this pool are probably normally classified as different species than the crop species under consideration (the primary gene pool).

• Tertiary gene pool (GP-3): Members of this gene pool are more distantly related to the members of the primary gene pool. The primary and tertiary gene pools can be intermated, but gene transfer between them is impossible without the use of "rather extreme or radical measures such as embryo rescue (or embryo culture, a form of plant organ culture) induced polyploidy (chromosome doubling) bridging crosses (e.g., with members of the secondary gene pool).

Genomics-driven approaches to Genebank management

• Pre-breeding can facilitate the characterization and utilization of PGRs.

• Allele mining involves searching useful alleles of genes from a wide germplasm collection.

• Transformation of germplasm collections into bio-digital resource centres like

• DNA Barcoding,

• DNA fingerprinting.

Pre-breeding

• Pre-breeding is the step before practical breeding.

• Aim - To introduce new desirable traits/genes into an adapted genetic background. This will broaden the genetic base in a breeding material in pace with environmental changes.”

• The main link between the germplasm conservation and its use in plant breeding

• A vital contribution of pre-breeding is increasing the total genetic diversity in crops and finding specific genes and traits.

• Main link between conservation of PGR in gene bank collections and utilisation of these resources in agriculture and horticulture.

• Essential for linking genetic diversity arising from wild relatives and other unimproved materials for utilization.

• These activities are a collaboration between germplasm curator and the plant breeder who need to work germplasm collections and how new traits from these collections can bred into new varieties.

Introduction

The objec tive of genomic research in any species is to sequence the whole genome and to decipher functions of all the different coding and non-coding seq,uences. The technology for large-scale DNA sequencing has enabled the scientists to undertake genome sequencing project in a realistic time scale. Since the time of first ‘large’ genome sequencing in bacteriophage λ in 1983, the projects on different groups have been completed. Eg. Escherichia coli, Saccharomyces cerevisiae, Arabidopsis thaliana, Oryza sativa, Caenorhabditis elegans, Drosophila melanogaster, Mus musculus, Pan troglodytes, Homo sapiens.

There are certain species which have been chosen for genome projects as model organisms. A model organism is a non-human species that is used to understand biological phenomena with a thought of gaining insight into the working of other organisms. They are chosen on the basis of their small genome in size, diploid genetics with a few chromosomes, rapid life cycle, easily transformed, well positioned in plant phylogeny, small stature for plant growth in a small space, large number of seeds produced, convenient for discovery of gene-trait discovery at low cost and speed and well investigated. They include,

• Monocots – Oryza sativa

• Dicots – Arabidopsis thaliana

• Temperate grasses – Brachypodium

Introduction

It refers to all activities designed to identify materials that cannot be used directly in breeding programmes, and further to transfer these traits to an intermediate set of materials that breeders can use further in producing new varieties for farmers. It is a bridge between Genetic Resources and Crop Improvement. That is collaboration between germplasm curator and plant breeder.

Crosses between adapted and exotic materials, where different proportions of introgression are obtained and evaluated, have been denominated as semi exotic materials. That should be readily used in regular breeding programme for cultivar development.

Objectives of pre-breeding 8-10 Years • Improved germplasm and associated genetic knowledge that enhance resistance expression and diversity.

• Reduce genetic uniformity in crops through the use of a wider pool of genetic material to increase yield, resistance to pests and diseases, and other quality traits.

• Identification of desirable traits/genes and their subsequent transfer into a suitable set of parents for further selection.

• Improved parental stocks which can be readily utilized within breeding programs and improved selection methodologies.

• Identify potentially useful genes in a well-organized and documented gene bank Designing strategies that lead to development of an improved germplasm that are ready to use in varietal development.

Mutation: Natural genetic variation has exhausted. Genetic variation can be induced by mutations or changes in the DNA sequences of the plants.

Additional Tools for Plant Improvement

Increase in yield with no additional lands available for cultivation depends on development of high yielding varieties suitable for marginal cultivation.

• Food security

• Nutritional security

Need for additional tools to increase efficiency of breeding methods for genetic enhancement and propagation.

• Genomics

Genomics – Definition

Genomics - Study of an organism's entire genome / full genetic complement of an organism.

PPVFR act is an effective system for protection of plant varieties, the rights of farmers and plant breeders and to encourage the development of new varieties of plants. Stimulate investment for research and development to produce new plant varieties.Facilitate the growth of the seed industry that will ensure the availability of high quality seeds and planting material to the farmers. Registration of a plant variety gives protection only in India. Provides the exclusive right to produce, sell, market, distribute, import, or export the variety.

Milestones in Seed Sector

• 1957- First AICRP

• 1963 -NSC established

• 1966 -Seed act passed

• 1968- Operational

• 1971- Indian Minimum Seed Certification Standards adopted

• 1975- GSSC established

• 1977- AIC NSP launched

• 1980- GSSCA Established

• 2001- PPVFR Act passed

Introduction

Rick (1984) used the term pre-breeding or developmental breeding to describe the same activity. Thus "genetic enhancement" or "pre-breeding" refers to the transfer or introgression of genes or gene combinations from unadapted sources into breeding materials (FAO, 1996)

However, enhancement has been more popularly adopted by PGR scientists. It is an emerging concept emphasizing the use of plant genetic resources

• To meet the market requirement, plant breeders have to develop improved cultivars.

• Crop improvement has led to narrowing down of genetic base resulting in slower progress (genetic gain) in plant breeding and increased risk of genetic vulnerability

Need for Genetic Enhancement

• In improving the level of resistance to biotic and abiotic stress.

• In improving quality characters such as fibre length, strength, fineness, maturity and uniformity.

• In developing early maturing genotypes, which can fit well in multiple cropping systems.

• In developing plant types suitable to machine picking etc.

• Use of germplasm will help in broadening the genetic base of cultivars as well as in creating vast genetic variability.

Introduction

It is carried out by 15 centres that are members of the CGIAR Consortium, in close collaboration with hundreds of partners, including national and regional research institutes, civil society organizations, academia, development organizations, and the private sector.

History

It was formed in response to the widespread concern in the mid-20th century that rapid increase in human populations would soon lead to widespread famine. The Rockefeller Foundation and the Mexican government, in 1943 laid the seeds for the Green Revolution when they established the Office of Special Studies, which led to establishment of the International Rice Research Institute (IRRI) in 1960 and International Maize and Wheat Improvement Centre (CIMMYT) in 1963. However, these foundations alone could not fund all the agricultural research and development efforts needed to feed the world’s population. In 1969, the Pearson Commission on International Development urged the international community to undertake “intensive international effort” to support “research specializing in food supplies and tropical agriculture”. Thus, with the support of World Bank, FAO and UNDP, CGIAR was established on May 19, 1971, to coordinate international agricultural research efforts aimed at reducing poverty and achieving food security in developing countries

Introduction

According to Frankel (1957), plant introduction is the transposition of a genetic entity from an environment to which it is attuned to one in which it is untried. According to Bennett (1965), the introduction of wild plants into cultivation and the successful transfer of cultivars, with their genotypes unaltered, to new environments is called as ‘primary’ plant introduction and the rest as ‘secondary’ introduction. However, both are equally meaningful for effective use of plant germplasm.

Types of Plant Introduction

1. Primary Introduction

2. Secondary Introduction

1. Primary Introduction

When the introduced crop or variety is well suited to the new environment, it is directly grown or cultivated without any alteration in the original genotype. This is known as primary introduction. E.g. IR. 8, IR 20, IR 34, IR 50 rice varieties; oil palm varieties introduced from Malaysia and Mashuri rice from Malaysia.

Introduction

This led to an extended debate and international co-operation in the recognition of plant-related intellectual property rights, resulting in a greater attention being paid to questions of ownership of genetic resources. At the same time concerns for sustainable use of biological diversity were also raised.

One of the major events was the Convention on Biological Diversity (CBD) which came into force in 1993, which was adopted during the Rio Earth Summit of the United Nations. It was the first legally binding institutional mechanism, providing for conservation and sustainable use of all biological diversity and intends to establish the process of the equitable sharing of benefits arising out of the use of biodiversity.

The Convention on Biological Diversity

The CBD was conceived in the 1980s and was negotiated under the leadership of the United Nations Environment Programme (UNEP). It was adapted in June 1992 at Rio de Janeiro, at the Earth Summit, and is effective since December 1993.

Cryopreservation

Cryo is a Greek word (krayos-frost). It literally means preservation in frozen state. Cryopreservation is the non lethal storage of biological material at ultra-low temperatures. At the temperature of liquid nitrogen (-196?C) almost all metabolic activities of cells are ceased and the sample can then be preserved in such state for extended periods. This is to bring plant cells or tissues to a zero metabolism and non-dividing state by reducing the temperature in the presence of cryoprotectant. However only few biological materials can be frozen without affecting the cell viability.

It can be done by using,

• Over solid carbon dioxide (at -79 degree)

• Low temperature deep freezer(-80 degree)

• In vapour phase nitrogen(at -150 degree)

• In liquid nitrogen(at -196 degree)

Among these, liquid nitrogen is most widely used material for cryopreservation because it is chemically inert, relatively low cost, Nontoxic, Non-flammable and Readily available.