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Intellectual Property Issues in Biotechnology

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This book integrates a science and business approach to provide an introduction and an insider view of intellectual property issues within the biotech industry, with case studies and examples from developing economy markets. Broad in scope, this book covers key principles in pharmaceutical, industrial, and agricultural biotechnology within four parts. Part 1 details the principles of intellectual property and biotechnology. Part 2 covers plant biotechnology, including biotic and abiotic stress tolerance, GM foods in sustainable agriculture, microbial biodiversity and bioprospecting for improving crop health and productivity, and production and regulatory requirements of biopesticides and biofertilizers. The third part describes recent advances in industrial biotechnology, such as DNA patenting, and commercial viability of the CRISPR/Cas9 system in genome editing. The final part describes intellectual property issues in drug discovery and development of personalized medicine, and vaccines in biodefence. This book is an ideal resource for all postgraduates and researchers working in any branch of biotechnology that requires an overview of the recent developments of intellectual property frameworks in the biotech sector.

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1: Biotechnology in Agriculture, Medicine and Industry: An Overview



Biotechnology in Agriculture,

Medicine and Industry: An Overview

Harikesh B. Singh,1* Alok Jha2 and Chetan Keswani1


Institute of Agricultural Sciences, Banaras Hindu University, Varanasi, India;

International Livestock Research Institute, New Delhi, India


1.1  Introduction

Biotechnology is a rapidly booming field influencing pharmaceutical, food, agriculture and related industries. Biotechnological based interventions are vital components in virtually any industry employing microorganisms, cells and tissues for the production of biologicals. The global market for biotechnology is estimated to grow at an average compound annual growth rate (CAGR) of 11.6% from 2012 to

2017 and to reach a value of  US$414.5 billion  by the end of 2017. The global market was valued at approximately  US$216.5 billion  in 2011 (PR

Newswire, 2014). India has the third largest biotech industry in the Asia-Pacific region and is amongst the 12 largest biotech destinations in the world.


2: Biotechnology and its Development in Developing Countries: Can Intellectual Property Rights Foster Innovation in the Field?



Biotechnology and its Development in Developing Countries: Can

Intellectual Property Rights Foster

Innovation in the Field?

Dhanay M. Cadillo Chandler*

Faculty of Law, University of Helsinki, Finland

2.1  Introduction

Intellectual property rights (IPR) in principle and according to the Agreement on Trade Related

Aspects on Intellectual Property Rights (TRIPS

Agreement) have extended IP protection to inventions in all fields of technology. However, there are countries still struggling to cope with the implementation and interpretation of TRIPS within their national frameworks. Developments within the biotechnological field have been correlated to inflow of foreign direct investments and national development as well. Understanding each country’s industrial capacity and needs are also key factors when developing both an industry and a regulatory framework.

Among BRICS, China and India are known to have a strong biotechnological industry catering pharmaceuticals to an important share of the world market. The same economies could be considered key players within the agriculture-biotechnological field. Therefore, this chapter intends to analyse how the international framework on IP and biotechnology is fostering developments within the field. To accomplish this goal the chapter will be structured in four parts. The first section will address the concept of biotechnology in general. The second section will present an overview of the relevant international framework to biotechnology and biosafety, and the interplay with


3: Patent Eligibility Issues in Life Science Innovations: Contentious Court Cases



Patent Eligibility Issues in Life

Science Innovations: Contentious

Court Cases

Ananda M. Chakrabarty*

University of Illinois College of Medicine, Chicago, Illinois

3.1  Introduction

While industrial biotechnology primarily involves chemicals, drugs and pharmaceuticals, the recent advancements in biotechnology in the area of genome manipulation, synthetic biology, stem cells and improved plant breeding have created many opportunities but also new legal questions and challenges. Intellectual property (IP) generation, particularly having patentable inventions in industrial biotechnology and other life science areas, is prerequisite for both industrial and economic development. The patent laws in the USA date back from 1790 to 1793 to cover, in the words of

Thomas Jefferson, one of the framers of the US

Constitution, ‘any new and useful art, machine, manufacture, or composition of matter, or any new or useful improvement thereof’. The US Congress in 1952 replaced the word ‘art’ with the word ‘process’. In subsequent decisions by the courts, the predominant theme of the US patent laws has been to emphasize Thomas Jefferson’s philosophy that


4: Checks and Balances in Biotechnology-Related Patents: In Agreement to the Indian Patents (Amendment) Act, 2005



Checks and Balances in

Biotechnology-Related Patents:

In Agreement to the Indian Patents

(Amendment) Act, 2005

Om Prakash1* and Poonam C. Singh2


Maharana Pratap Govt P.G. College, Hardoi, Uttar Pradesh; 2CSIR-National

Botanical Research Institute, Lucknow, Uttar Pradesh, India

4.1  Introduction

A new idea or information may be kept confidential indefinitely; however, it is equally unmanageable to keep the same idea a secret while reaping its benefits.

The intellectual property (IP) protections provide confidentiality, management and provide commercial opportunities to a new idea with a cost for a defined period. India has a vibrant culture, unique lifestyle, lots of traditional knowledge and a dynamic economy, which provides unique knowledge and innovations leading to IP (Birtchnell, 2013). This national asset needs to be protected and commercialized after a qualified evaluation for the benefit of both inventor and people. In India the competent authority is ‘The Indian Patent Office’ (IPO), which carries out the evaluation following the provisions of ‘The Patents (Amendment) Act, 2005’ (IPAA2005).1 Though the fundamentals of patent laws are the same all over the world, procedural differences exist, which make them stringent or liberal. However, patent evaluation is more of a techno-legal evaluation than an exact scientific evaluation.


5: Intellectual Property in the Biotechnology Sector: The Importance of ‘Star Scientists’ in the Entrepreneurship and Universities Environment



Intellectual Property in the Biotechnology Sector:

The Importance of ‘Star Scientists’ in the Entrepreneurship and

Universities Environment

Tomas Gabriel Bas*

Institute of Innovation based on Science, University of Talca, Talca, Chile

5.1  Introduction

Molecular biology, with the integration of the chemical industry, formed what became known as modern biotechnology. Moreover, the development of biopharmaceutical products since 1920 has resulted in the emergence of small and medium-sized firms, in addition to the classic multinational companies that are very intensive in R&D. Historically, biotechnology firms have been largely involved in the pharmaceutical, environment, agrochemical and food industries. These two sectors (biotechnology and pharmaceutical) develop oligopolistic structures formed in an atmosphere of very high competition.

Biotechnology is not an industry but a set of specific activities and technologies such as biomaterials, combinatorial chemistry, DNA markers, genetic engineering, monoclonal antibodies and recombinant DNA. These technologies create new products, new processes for existing products as well as new organisms for environmental cleaning or human consumption. Most major biotechnology firms are spin-offs from research universities or from other firms previously spun-off from academic institutions. In the most developed countries, the institutions provide the firms with adequate infrastructure and resources (Niosi and Bas, 2003). The generation of epistemological knowledge is one of the most components, through the ­ complexity important ­


6: Intellectual Property in Agricultural Biotechnology: From Patent Thickets to Generics



Intellectual Property in Agricultural

Biotechnology: From Patent Thickets to Generics

Monica Alandete-Saez, David J. Jefferson and

Alan B. Bennett*

The Public Intellectual Property Resource for Agriculture, University of California

Davis, Davis, California

6.1  Introduction

Scientific advances in many fields have been treated historically as public goods, and this was particularly true in agriculture. Universities and other public-sector institutions were the leaders in developing improved crop varieties that were transferred to farms through cooperative extension services

(Conway and Toenniessen, 1999). However, in

North America and other world regions, this model has shifted rapidly in the last few decades. Changes have been due largely to the increased utilization of formal intellectual property (IP) protections for agricultural technologies and plant varieties by public sector institutions, as well as the development of a research-intensive private sector that now makes major contributions towards enhancing agricultural productivity (Kowalski et al.,


7: Bioprospecting for Improving Soil Health and Crop Productivity: Indian Patent Landscape



Bioprospecting for Improving Soil

Health and Crop Productivity: Indian

Patent Landscape

Vivek Srivastava, Puneet Singh Chauhan, Sankalp Misra,

Swati Sharma, Aradhana Mishra and Chandra Shekhar


CSIR-National Botanical Research Institute, Lucknow, India

7.1  Introduction

One of the major challenges for the 21st century will be an environmentally sound and sustainable crop production. Global plant production systems must be optimized to produce stable high yields from limited land under changing and variable climates. Demands for food, animal feed, and feedstocks for bioenergy and biorefining applications are increasing with population growth, urbanization and affluence. Current production methods in agriculture, such as improper use of chemical pesticides and fertilizers, create a long list of environmental and health problems

(Gunnell et al., 2007; Leach and Mumford, 2008).

Furthermore, agriculture based on chemicals has made an adverse impact on the beneficial soil microbial communities, significantly lowering the microbial biodiversity (Mäder et al., 2002).


8: Seeds of Change: Genetically Modified Crops, Canada’s Agricultural Growth Act and the Erosion of Farmers’ Privilege



Seeds of Change: Genetically

Modified Crops, Canada’s

Agricultural Growth Act and the

Erosion of Farmers’ Privilege

Elisabeth Abergel*

Department of Sociology and Institut des Sciences de l’Environnement,

­Université du Québec à Montréal, Montréal, Canada

8.1  Introduction

We live in a historical moment where societies face the prospect of having to balance food security needs and environmental sustainability. Large questions concerning the types of agricultural production and the amount of land devoted to agriculture as well as how much of a rural population shall remain productive on farms are all being decided directly or indirectly by governments, corporations and civil society groups in a context of global climate change that includes: land degradation, rapid urbanization, diminishing biodiversity, limited natural resources and water supplies. Issues of global inequality and rising poverty make searching for sustainable and equitable solutions to food production, the rural poor and agricultural development central aspects of the international political agenda. The challenge of what is known as sustainable intensification describes the pressure to intensify food production while using sustainable and socially appropriate means.


9: Recent Innovations in Agricultural Biotechnology: Challenging the Status Quo



Recent Innovations in Agricultural

Biotechnology: Challenging the

Status Quo

Kathleen L. Hefferon*

Department of Food Sciences, Cornell University, Ithaca, New York

9.1  Introduction

Over the past two decades, the patent environment for agricultural biotechnology has been geared toward the enhanced production of crops in order to both increase yield and lower costs. The innovations that arose from this momentum were in response to the need for farmers to produce food more efficiently to sustain a soon to be burgeoning global population, under increasingly difficult environmental conditions resulting from climate change. With climate change are expected increases in both biotic (insects, viruses, fungi and other pests) as well as abiotic (extreme temperatures, drought, flooding) stresses. Unfortunately, patent agricultural innovation has been increasingly politicized, and this new social influence has not served well to stimulate innovation.


10: Chinese Innovation System: The Case of Agricultural Knowledge Sharing



Chinese Innovation System: The

Case of Agricultural Knowledge


Liliana Mitkova1* and Xi Wang2†


Institut de Recherche en Gestion, University of Paris Est Marne-la-Vallée

(UPEM) Champs-sur-Marne France; 2Central University of Finance and

Economics, Beijing, China

10.1  Introduction

The open innovation model has been adopted so as to adapt to the rapid diffusion of knowledge, shortening of the life cycle of products and high international competitiveness. This model proposes to enhance a firm’s innovative ability by acquiring knowledge from external sources, as well as benefit financially by using external paths to market for internally generated technologies (Chesbrough,

2003; Gassmann and Enkel, 2004). Enterprises can benefit from technological and market discontinuities into the open innovation model by sharing knowledge with other institutions and firms. In fact, knowledge sharing is a key component of open innovation (Islam, 2012) and Lichtenthaler


11: Intellectual Property Rights Regime for Agricultural Biotechnology in India



Intellectual Property Rights

Regime for Agricultural

Biotechnology in India

Seweta Srivastava,1* Sujit Kumar Yadav,1

Ravindra Kumar,2 Ashwani Kumar,1 Vinit Pratap

Singh,3 Asha Sinha4 and Rajendra Kumar1


UP Council of Agricultural Research, Lucknow, Uttar Pradesh, India;

ICAR – Indian Agricultural Research Institute, Karnal, Haryana, India;


Lovely Professional University, Phagwara, Punjab, India; 4Institute of

Agricultural Sciences, Varanasi, Uttar Pradesh, India


11.1  Introduction

The biotechnology sector in India, in particular its plant biotechnology branch, is uniquely poised for a major growth transformation. Inventions involving living organisms have formed one of the controversial issues of biotechnology that are often nurtured politically (Archana, 2013). As the country’s agricultural biotechnology boundaries have advanced in the 1990s into r-DNA, transgenics and molecular marker-assisted plant breeding techniques, the Government of India needs to come up to date with a matching policy support and regulatory framework that was created to furnish the path of excellence in R&D, sustainability and biosafety. To a certain extent, improvements on the policy front have been flattered by a vivacious nongovernmental sector that profoundly interceded the sensitivities of modern biotechnology. This chapter emphasizes on the matter of contention and proceeds to further the path of progress achieved by agricultural biotechnology companies in India in the field of commercialization of biotechnological services and products. The particular focal point of this chapter is on intellectual property rights (IPR) related to plant biotechnology.


12: DNA Patenting



DNA Patenting

Michael Blakeney*

Faculty of Law, University of Western Australia, Crawley, Western Australia

12.1  Introduction

Historically, patent law distinguished between patentable inventions and non-patentable discoveries. The evolution of recombinant DNA technology in the 1970s made it possible for scientists to identify useful DNA. Developments in patent law have made it possible to commodify and appropriate commercially useful DNA. The privatization of

DNA has important implications for food security, when private corporations can secure the ownership of DNA which is critical for agricultural innovations at a time of climate change. The patenting of DNA also has equally important implications for modern medicine. This chapter examines the development of patent law beyond the protection of mechanical, electronic and pharmaceutical inventions to embrace the patenting of DNA.

12.2  International Intellectual Property



13: The Development of Patentability of Genetic Patent in Mainland China and Taiwan



The Development of Patentability of Genetic Patent in Mainland

China and Taiwan

Jui-Chu Lin,1 Tzu-Hsun Hung2* and Chien-Te Fan3


College of Intellectual Property Studies, National Taiwan University of

Science & Technology; 2Attorney-at-Law, Taiwan; 3Institute of Law for

Science & Technology, National Tsing Hua University, Taiwan

13.1  Introduction

‘Biotechnology’ literally means technologies related to biology, including agriculture, food and medical sciences. It was defined as ‘Biotechnology means any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use’ (Wang, 2007). At the UN Convention on

Biological Diversity held in Brazil in 1992, Taiwan’s

Ministry of Economic Affairs, in accordance with the international trend and opinions from all quarters, defines it as ‘the sciences and technologies based on life sciences, such as molecular biology, cell biology, immunology, genomics, and proteomics, and technologies such as genetic engineering, protein engineering, cell engineering, and tissue engineering to research and develop, manufacture, or improve product quality in order to improve the quality of human life’ (Taiwan Biotech Industry


14: Bioprospecting Microbial Diversity: Intellectual Property Rights Issues



Bioprospecting Microbial

Diversity: Intellectual Property

Rights Issues

Om Prakash,* Aabheejeet Pansare and

Sunil K. Dhar

Microbial Culture Collection, National Centre for Cell Science, Pune, India

14.1  Introduction

According to the definition of the Organization for

Economic Cooperation and Development (OECD),

‘Biotechnology is defined as the application of science and technology to living organisms as well as parts, products and models thereof, to alter living or non-living materials for the production of knowledge, goods and services’. Biotechnology is continuously healing, fuelling, feeding and enriching human society and civilization. Based on area of specialization and demarcation, biotechnology is divided into five basic groups: red (related to medical and health), green (agricultural biotechnology), white

(industrial biotechnology), blue (biotechnology of freshwater and marine systems) and grey biotechnology or environmental biotechnology. The progress of biotechnology is based on the exploration of biodiversity using the principle of bioprospection. Bioprospecting is the process of the discovery and use of new biomolecules from biological resources for its commercialization and use or in other words exploitation of biological diversity of genetically and biochemically valuable biodiversity for commercial exploitation (Ferrer et al., 2007; Li et al., 2008; Jeon et al., 2009; Joint et al., 2010; Lee et al., 2010; Satpute et al., 2010; Singh, 2010;


15: CRISPR/Cas9 System, A Revolutionary Technology for Genome Editing: Applications and Intellectual Property Disputes



CRISPR/Cas9 System,

A Revolutionary Technology for

Genome Editing: Applications and Intellectual Property Disputes

Kartikay Bisen,1 Chetan Keswani,1* Akanksha Singh,2

Rakesh Pandey,2 Sandhya Mishra,1 Birichi K. Sarma1 and Harikesh B. Singh1


Department of Mycology and Plant Pathology, Institute of Agricultural

Sciences, Banaras Hindu University, Varanasi; 2Department of Microbial

Technology and Nematology, Central Institute of Medicinal and Aromatic

Plants, Lucknow, India

15.1  Introduction

Genetic manipulation through recombinant DNA technology laid the foundation for the manipulation of genetic code and harnessing new knowledge to develop novel medicines and crop verities. Alteration in the targeted genome sequence of living cells and organisms is a powerful tool with potential application in therapeutics and the agriculture sector.

Specific gene insertions and deletion can induce desired changes and incorporation of such useful traits in agricultural crops and livestock development. With recent advancement in genome engineering and editing technologies researchers can now directly edit or alter the function of DNA sequences in any organism of choice. However, the technology inducing precise modification to the genome was limited to certain organisms. A recent development of RNA-guided genome editing technology, CRISPR/


16: Healthcare Innovation, Personalization and the Patent System: Where is the Public Interest?



Healthcare Innovation,

Personalization and the Patent

System: Where is the Public


Graham Dutfield*

School of Law, University of Leeds, Leeds, UK

16.1  Introduction: Current Trends in Healthcare Innovation, and the

Personalization Turn

The relationships between health, innovation and the law are dynamic and arguably changing faster now than ever before. To understand what is going on and why things are happening now, we need to take account of five major drivers of change. These drivers are not all new but their prominence has become more noticeable since the beginning of the modern health biotechnology era in the early

1980s, a time when the pharmaceutical industry was in the midst of a slump with fewer genuinely original drug products entering the market than in the ‘Golden Age’ of the 1960s and 1970s. These are internationalization, complexification, personalization, digitalization and fragmentation.

By internationalization, I mean a number of things. For one, emerging economies such as China and recently developed ones like Singapore and


17: Patentability of Human Embryo Stem Cells: A Comparative Analysis of Case WARF in the United States of America and Europe



Patentability of Human Embryo

Stem Cells: A Comparative

Analysis of Case WARF in the

United States of America and


Jiang Li*

Kenneth Wang School of Law, Soochow University, Su Zhou, China

17.1  Introduction

Human embryonic stem cells are potentially of great therapeutic value in a number of areas including spinal cord injuries, Parkinson’s disease, stroke and transplantation therapy (Thomson, 1998). The patentability of human embryonic stem cells has raised worldwide controversy and dispute in the last two decades, especially in the USA and Europe.

Following the basic principle of ‘anything under the sun that is made by man can be patented’,1 US patents on human embryonic stem cells have been granted. The US Patent and Trademark Office

(USPTO) granted a broad patent on primate embryonic stem cells (ESC) in December 1998 and a second patent on human embryonic stem cells

(HESC) in March 2001 (Loring and Campbell,


18: Innovation and Intellectual Property Issues in the ‘Decade of Vaccines’: A Brazilian Perspective



Innovation and Intellectual

Property Issues in the ‘Decade of

Vaccines’: A Brazilian Perspective

Cristina Possas,1,3* Adelaide Antunes,2,4 Flavia M.L.

Mendes,2 Reinaldo M. Martins1 and Akira Homma1


Bio-Manguinhos, Oswaldo Cruz Foundation, Rio de Janeiro; 2School of Chemistry, Federal University of Rio de Janeiro; 3Evandro Chagas

National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Rio de Janeiro; 4National Institute of Industrial Property, Rio de Janeiro, Brazil

18.1  Introduction

Human and veterinary vaccines are recognized as the most powerful preventive, low-risk and costeffective interventions, with an extensive impact on global health and livestock production. This chapter examines vaccine innovation and intellectual property rights (IPR) issues in biotechnology, from the Brazilian perspective. It discusses how vaccine innovation policies and intellectual property (IP) regimes can affect countries in particular ways, according to their different stages of development.


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