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

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16

Healthcare Innovation,

Personalization and the Patent

System: Where is the Public

Interest?

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

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

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15

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

1

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/

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

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6

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.,

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

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3

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

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

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7

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

Nautiyal*

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).

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